chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site pruritus
Clinical narrative: Itching on 8th day after 1st vaccine; redness on 8th day after 1st vaccine; swollen arm on 8th day after 1st vaccine; Itching on Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine), PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) and VACCINATION SITE PRURITUS (Itching on Injection Site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 120L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on Injection Site). On an unknown date, the patient experienced PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine). On 12-Feb-2021, VACCINATION SITE PRURITUS (Itching on Injection Site) had resolved. At the time of the report, PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was nor provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092047, US-MODERNATX, INC.-MOD-2021-028972 (E2B Linked Report). This case was linked to MOD-2021-091728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional information received On 29-Jun-2021: F/U-2 : To confirm NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092047:Daughter's case US-MODERNATX, INC.-MOD-2021-028972:Son-in-law case -Phone number is same in mother case and this case
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Drowsiness; stuffy nose; fatigue; now a month past his scheduled second dose appointment; tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment), SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No concomitant medications provided.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment). On an unknown date, the patient experienced SOMNOLENCE (Drowsiness), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue). At the time of the report, PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment) had resolved and SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: negative Negative. On 24-Mar-2021, SARS-CoV-2 test: positive Positive. On 09-Apr-2021, SARS-CoV-2 test: negative (Negative) On 8-9 Apr 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported. .Patient received first dose on 26 Feb 2021 with lot (025A21A) in left upper arm(non-dominant). He was a little drowsy, fatigue and stuffy nose after first dose. He was scheduled for second dose on 26 March. On 15 March exposed to COVID, 18 March tested negative for COVID at urgent care, 24 March tested positive for COVID. He quarantined. He tested negative for COVID around 8-9 April. Patient is now a month past his scheduled second dose appointment.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added Patient's phone number.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Drowsiness; stuffy nose; fatigue; now a month past his scheduled second dose appointment; tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment), SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No concomitant medications provided.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment). On an unknown date, the patient experienced SOMNOLENCE (Drowsiness), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue). At the time of the report, PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment) had resolved and SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: negative Negative. On 24-Mar-2021, SARS-CoV-2 test: positive Positive. On 09-Apr-2021, SARS-CoV-2 test: negative (Negative) On 8-9 Apr 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported. .Patient received first dose on 26 Feb 2021 with lot (025A21A) in left upper arm(non-dominant). He was a little drowsy, fatigue and stuffy nose after first dose. He was scheduled for second dose on 26 March. On 15 March exposed to COVID, 18 March tested negative for COVID at urgent care, 24 March tested positive for COVID. He quarantined. He tested negative for COVID around 8-9 April. Patient is now a month past his scheduled second dose appointment.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added Patient's phone number.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Malaise, Pyrexia, Vomiting
Clinical narrative: Deathly sick; Diarrhea; Weak; Throwing up; Running a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever). At the time of the report, MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) outcome was unknown.            No concomitant medications were provided. No treatment details pertained to the events were provided.  The action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-092650 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Oropharyngeal pain
Clinical narrative: injection site lump size of a quarter; slight sore throat; injection site soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) outcome was unknown.            Patient stated that she received her second shot on 23Apr2021 (Lot # 001C21A) and now she experiencing injection site soreness and a lump at the injection site, the size of a quarter. Caller also had a headache and slight sore throat.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Exfoliative rash, Rash pruritic
Clinical narrative: Itchy rash on thigh and arm; rash feels scaly and hardens; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) outcome was unknown. Not Provided          No concomitant medication was reported.Treatment medication included Benadryl lotion.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-066515 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Preoperative care, Vaccination site pain
Clinical narrative: surgery scheduled before date of 2nd dose.; sore arm at vaccine site. right arm; This spontaneous case was reported by a consumer and describes the occurrence of PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.) and VACCINATION SITE PAIN (sore arm at vaccine site. right arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at vaccine site. right arm). On an unknown date, the patient experienced PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.). In April 2021, VACCINATION SITE PAIN (sore arm at vaccine site. right arm) had resolved. At the time of the report, PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient had 2nd dose and no issues.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021 contains non-significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: Heat slightly below area of injection; Rash slightly below area of injection; Redness slightly below area of injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M204) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid nodule since 1992. Concomitant products included LEVOTHYROXINE for Thyroid nodule, CENTRUM SILVER WOMEN 50+, ZINC, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), BIOTIN, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN 81) and PSYLLIUM HUSK [PLANTAGO OVATA HUSK] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection). On 05-Mar-2021, FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was provided by the reporter.      Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant Information updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-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 01-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and FATIGUE (Felt tired) outcome was unknown.            Concomitant products included Blood pressure medications.   Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021, contain significant follow up information including outcome of events not resolved. contact information updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Pyrexia
Clinical narrative: swollen lip,upper lip that is hard and swollen; Aches and pains; fever; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (swollen lip,upper lip that is hard and swollen), PAIN (Aches and pains) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPICOR) for High cholesterol.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (Aches and pains) and PYREXIA (fever). On 28-Apr-2021, the patient experienced LIP SWELLING (swollen lip,upper lip that is hard and swollen). On 27-Apr-2021, PAIN (Aches and pains) and PYREXIA (fever) had resolved. At the time of the report, LIP SWELLING (swollen lip,upper lip that is hard and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache
Clinical narrative: Some discomfort; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Some discomfort) and HEADACHE (Mild headache). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-094832 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lacrimation increased, Oropharyngeal pain, Pruritus
Clinical narrative: Itchiness on neck / mouth / face; Feel weird for 6 days; Sore throat; Watery eye; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye), PRURITUS (Itchiness on neck / mouth / face) and FEELING ABNORMAL (Feel weird for 6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye) and FEELING ABNORMAL (Feel weird for 6 days). On an unknown date, the patient experienced PRURITUS (Itchiness on neck / mouth / face). On 07-Apr-2021, FEELING ABNORMAL (Feel weird for 6 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itchiness on neck / mouth / face) 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.   No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: mild body aches; low grade fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (mild body aches) and PYREXIA (low grade fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (mild body aches) and PYREXIA (low grade fever). On 31-Mar-2021, PAIN (mild body aches) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   First dose was given on 30Mar2021, Lot# 038A21A, IM injection in the right arm (non-dominant) symptoms started same day he had low grade fever, mild body aches lasted for 24 hours.   This case was linked to MOD-2021-094896 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Pyrexia
Clinical narrative: Low grade fever; Chills; Cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red, itchy spot 3-4 inches down from the injection site; Itchy spot 3-4 inches down from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-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 VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) 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.   Treatment medicines were not reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Cancelled second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) in an 88-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 15-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 PRODUCT DOSE OMISSION ISSUE (Cancelled second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Elevated sedimentation Rate; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and LORAZEPAM for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood test: unknown (High) Elevated Sedimentation rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller was calling in behalf of his father, who cannot speak English, who received the first dose of the Moderna COVID-19 vaccine a week ago. His father experienced fever and headache that started two or three days ago, and he still experiencing it at the time of the call. He wanted to know if he should bring his father to a clinic or doctor.Unable to gather adverse event details, contact information, consent, and vaccine details as caller was in a hurry to seek medical treatment for his father. There is no concomitant list   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Worse side effects with the second dose than with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Worse side effects with the second dose than with the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced ADVERSE EVENT (Worse side effects with the second dose than with the first dose). At the time of the report, ADVERSE EVENT (Worse side effects with the second dose than with the first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case reported by a patient (subsequently medically confirmed), describes the occurrence of pyrexia (fever) and chills in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 immunization. No medical history reported. On Feb 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced pyrexia (fever) and chills. Patient treated with Benadryl (diphenhydramine hydrochloride) ongoing since an unknown date; at unknown dosage form; every day. At the time of the report, pyrexia (fever) and chills: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: not applicable. No concomitant medications reported. This case linked to MOD-2021-023270 (patient link). Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swollen arm; Red arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included CALCIUM CITRATE MALATE;MAGNESIUM CITRATE MALATE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Bone disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMIN & MINERAL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Red arm). an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown and ERYTHEMA (Red arm) and PRURITUS (Itching) had resolved.            Treatment information was not provided.    This case was linked to MOD-2021-021955 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: muscle aches and pains; headache; chills; feel as if I am on fire.I just took my temperature and I am running a fever of 100.4; soreness at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the site), MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced INJECTION SITE PAIN (soreness at the site). On an unknown date, the patient experienced MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4). At the time of the report, INJECTION SITE PAIN (soreness at the site), MYALGIA (muscle aches and pains), HEADACHE (headache), CHILLS (chills) and PYREXIA (feel as if I am on fire.I just took my temperature and I am running a fever of 100.4) outcome was unknown.            Concomitant information were not provided by the reporter. Treatment information were not reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03FA21B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            relevant concomitant products usage were not reported by the reporter. Treatment details not included. Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Erythema, Headache, Illness, Intentional product misuse
Clinical narrative: Rash; Body pains; covid injection reaction red itchy and swollen; Itchy; swollen/ swelling in lower back; Hives; Inflammation in hip; Swelling in leg, right thumb; Swelling in both ankles, left wrist; Intentional misuse in product use duration; Nail Psoriasis; Psoriasis; Local swelling; Sickness; Headache; Vaccination site swelling; Vaccination site erythema; General body pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    In March 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 SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash), MYALGIA (Body pains), HEADACHE (Headache), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), ILLNESS (Sickness), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis), PSORIASIS (Psoriasis) and SWELLING (Local swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, PAIN (General body pain), HEADACHE (Headache) and SWELLING (Local swelling) was resolving, RASH (Rash), MYALGIA (Body pains), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis) and PSORIASIS (Psoriasis) outcome was unknown and ILLNESS (Sickness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-140772, MOD-2021-140772 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia, Nail psoriasis, Pain, Peripheral swelling
Clinical narrative: Rash; Body pains; covid injection reaction red itchy and swollen; Itchy; swollen/ swelling in lower back; Hives; Inflammation in hip; Swelling in leg, right thumb; Swelling in both ankles, left wrist; Intentional misuse in product use duration; Nail Psoriasis; Psoriasis; Local swelling; Sickness; Headache; Vaccination site swelling; Vaccination site erythema; General body pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    In March 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 SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash), MYALGIA (Body pains), HEADACHE (Headache), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), ILLNESS (Sickness), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis), PSORIASIS (Psoriasis) and SWELLING (Local swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, PAIN (General body pain), HEADACHE (Headache) and SWELLING (Local swelling) was resolving, RASH (Rash), MYALGIA (Body pains), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis) and PSORIASIS (Psoriasis) outcome was unknown and ILLNESS (Sickness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-140772, MOD-2021-140772 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Rash, Swelling, Urticaria
Clinical narrative: Rash; Body pains; covid injection reaction red itchy and swollen; Itchy; swollen/ swelling in lower back; Hives; Inflammation in hip; Swelling in leg, right thumb; Swelling in both ankles, left wrist; Intentional misuse in product use duration; Nail Psoriasis; Psoriasis; Local swelling; Sickness; Headache; Vaccination site swelling; Vaccination site erythema; General body pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    In March 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 SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash), MYALGIA (Body pains), HEADACHE (Headache), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), ILLNESS (Sickness), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis), PSORIASIS (Psoriasis) and SWELLING (Local swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, PAIN (General body pain), HEADACHE (Headache) and SWELLING (Local swelling) was resolving, RASH (Rash), MYALGIA (Body pains), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis) and PSORIASIS (Psoriasis) outcome was unknown and ILLNESS (Sickness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-140772, MOD-2021-140772 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Rash; Body pains; covid injection reaction red itchy and swollen; Itchy; swollen/ swelling in lower back; Hives; Inflammation in hip; Swelling in leg, right thumb; Swelling in both ankles, left wrist; Intentional misuse in product use duration; Nail Psoriasis; Psoriasis; Local swelling; Sickness; Headache; Vaccination site swelling; Vaccination site erythema; General body pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash) and MYALGIA (Body pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    In March 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 SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), PAIN (General body pain), RASH (Rash), MYALGIA (Body pains), HEADACHE (Headache), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), ILLNESS (Sickness), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis), PSORIASIS (Psoriasis) and SWELLING (Local swelling). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved, PAIN (General body pain), HEADACHE (Headache) and SWELLING (Local swelling) was resolving, RASH (Rash), MYALGIA (Body pains), ERYTHEMA (covid injection reaction red itchy and swollen), PRURITUS (Itchy), SWELLING (swollen/ swelling in lower back), URTICARIA (Hives), ARTHRITIS (Inflammation in hip), PERIPHERAL SWELLING (Swelling in leg, right thumb), JOINT SWELLING (Swelling in both ankles, left wrist), INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), NAIL PSORIASIS (Nail Psoriasis) and PSORIASIS (Psoriasis) outcome was unknown and ILLNESS (Sickness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-140772, MOD-2021-140772 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: back hurts/"hit by a mac truck"; body hurts; Positive COVID test; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurts/"hit by a mac truck"), PAIN (body hurts) and COVID-19 (Positive COVID test) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS for an unknown indication.    Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), SIMVASTATIN and HYDROCODONE for an unknown indication.   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 started VITAMINS NOS (unknown route) at an unspecified dose. On 22-Apr-2021, the patient experienced COVID-19 (Positive COVID test). On an unknown date, the patient experienced BACK PAIN (back hurts/"hit by a mac truck") and PAIN (body hurts). The patient was treated with BAMLANIVIMAB at a dose of UNK dosage form. At the time of the report, BACK PAIN (back hurts/"hit by a mac truck"), PAIN (body hurts) and COVID-19 (Positive COVID test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, SARS-CoV-2 test: positive Positive. On 22-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Other treatment medications include Steroids.