chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: someone pat me on my shoulder and I felt pain; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; arm was red, swollen, raised, and warm; soreness, redness, some swelling at the injection site.; soreness, redness, some swelling at the injection site.; soreness, redness, some swelling at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm) and FEELING HOT (arm was red, swollen, raised, and warm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included PIRFENIDONE (ESBRIET), FENOFIBRATE, COLESTIPOL, LISINOPRIL, METOPROLOL, OMEPRAZOLE, FLUTICASONE, AZELASTINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FISH OIL 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 10-Feb-2021, the patient experienced VACCINATION SITE SWELLING (soreness, redness, some swelling at the injection site.), VACCINATION SITE ERYTHEMA (soreness, redness, some swelling at the injection site.) and VACCINATION SITE PAIN (soreness, redness, some swelling at the injection site.). On 20-Feb-2021, the patient experienced PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm) and FEELING HOT (arm was red, swollen, raised, and warm). At the time of the report, PAIN (someone pat me on my shoulder and I felt pain), ERYTHEMA (arm was red, swollen, raised, and warm), PERIPHERAL SWELLING (arm was red, swollen, raised, and warm), RASH PAPULAR (arm was red, swollen, raised, and warm), FEELING HOT (arm was red, swollen, raised, and warm), VACCINATION SITE SWELLING (soreness, redness, some swelling at the injection site.), VACCINATION SITE ERYTHEMA (soreness, redness, some swelling at the injection site.) and VACCINATION SITE PAIN (soreness, redness, some swelling at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were reported.   This case was linked to MOD-2021-095636 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersomnia, Vaccination site pain
Clinical narrative: diarrhea; can't stop going to sleep; L arm (injection site) is sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Type 2 diabetes mellitus and High cholesterol. Concomitant products included FISH OIL (OMEGA 3 PLUS [FISH OIL]) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore). At the time of the report, DIARRHOEA (diarrhea), HYPERSOMNIA (can't stop going to sleep) and VACCINATION SITE PAIN (L arm (injection site) is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not included.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Rash macular, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red spot close under arm and swollen; Sore arm; arm is red; red spot close under arm and swollen; A spontaneous report was received from a consumer concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm is red, red spot close under arm and swollen.  The patient's medical history was provided blood pressure and cholesterol . Concomitant medications reported were blood pressure meds, cholesterol med, potassium, Metformin for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm is red, red spot close under arm and swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm is red, red spot close under arm and swollen was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: under her arm its very tender; under her arm its very swollen; swollen lymph node under her breast; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (under her arm its very tender), PERIPHERAL SWELLING (under her arm its very swollen) and LYMPHADENOPATHY (swollen lymph node under her breast) in a 56-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 event (no historical condition was reported).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced AXILLARY PAIN (under her arm its very tender), PERIPHERAL SWELLING (under her arm its very swollen) and LYMPHADENOPATHY (swollen lymph node under her breast). At the time of the report, AXILLARY PAIN (under her arm its very tender), PERIPHERAL SWELLING (under her arm its very swollen) and LYMPHADENOPATHY (swollen lymph node under her breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rash
Clinical narrative: hasn't been feeling well 3 weeks after the injection; rash over a large area over my arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't been feeling well 3 weeks after the injection) and RASH (rash over a large area over my arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (hasn't been feeling well 3 weeks after the injection) and RASH (rash over a large area over my arm). At the time of the report, MALAISE (hasn't been feeling well 3 weeks after the injection) and RASH (rash over a large area over my arm) outcome was unknown.            No concomitants or treatment medications were reported. Treatment information was not updated.   This case was linked to MOD21-036991 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Contact information was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for Covid 12Feb2021; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for Covid 12Feb2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039M20A) 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) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced COVID-19 (tested positive for Covid 12Feb2021). At the time of the report, COVID-19 (tested positive for Covid 12Feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     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 details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information. Patient denied consent.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash
Clinical narrative: itching on the injection site; Rash on Injection Site; red injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event (no historical condition was reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site). At the time of the report, INJECTION SITE PRURITUS (itching on the injection site), VACCINATION SITE RASH (Rash on Injection Site) and INJECTION SITE ERYTHEMA (red injection site) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Dizziness, Fall, Mouth swelling, Pharyngeal hypoaesthesia
Clinical narrative: mouth felt swelling; throat feels numb; fell; broke her right shoulder; felt a little bit dizzy; lips started to feel tingly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little bit dizzy), CHEILITIS (lips started to feel tingly), MOUTH SWELLING (mouth felt swelling), PHARYNGEAL HYPOAESTHESIA (throat feels numb) and FALL (fell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (felt a little bit dizzy) and CHEILITIS (lips started to feel tingly). On 22-Jan-2021, the patient experienced FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder). On an unknown date, the patient experienced MOUTH SWELLING (mouth felt swelling) and PHARYNGEAL HYPOAESTHESIA (throat feels numb). In January 2021, DIZZINESS (felt a little bit dizzy) had resolved. At the time of the report, CHEILITIS (lips started to feel tingly) and MOUTH SWELLING (mouth felt swelling) was resolving, PHARYNGEAL HYPOAESTHESIA (throat feels numb) had not resolved and FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Upper limb fracture
Clinical narrative: mouth felt swelling; throat feels numb; fell; broke her right shoulder; felt a little bit dizzy; lips started to feel tingly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little bit dizzy), CHEILITIS (lips started to feel tingly), MOUTH SWELLING (mouth felt swelling), PHARYNGEAL HYPOAESTHESIA (throat feels numb) and FALL (fell) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (felt a little bit dizzy) and CHEILITIS (lips started to feel tingly). On 22-Jan-2021, the patient experienced FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder). On an unknown date, the patient experienced MOUTH SWELLING (mouth felt swelling) and PHARYNGEAL HYPOAESTHESIA (throat feels numb). In January 2021, DIZZINESS (felt a little bit dizzy) had resolved. At the time of the report, CHEILITIS (lips started to feel tingly) and MOUTH SWELLING (mouth felt swelling) was resolving, PHARYNGEAL HYPOAESTHESIA (throat feels numb) had not resolved and FALL (fell) and UPPER LIMB FRACTURE (broke her right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: nausea; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure and Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CHOLESTEROL for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, Urinary tract infection
Clinical narrative: sinus pressure in one ear; running nose; UTI infection; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure in one ear), RHINORRHOEA (running nose) and URINARY TRACT INFECTION (UTI infection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI infection). On 22-Feb-2021, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure in one ear) and RHINORRHOEA (running nose). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure in one ear), RHINORRHOEA (running nose) and URINARY TRACT INFECTION (UTI infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: body ache/pain; fever; fatigue; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-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) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, PAIN (body ache/pain), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 106 (High) 106.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Regulatory Authority - Patient declined for follow-up further
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild arm pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Knee replacement. Concurrent medical conditions included Rheumatoid arthritis, Heart disease, unspecified and No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Mild arm pain). At the time of the report, PAIN IN EXTREMITY (Mild arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: redness; 2-3 inch wide round spot on arm; rash under arm and up to her neck; big spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 an unknown date, the patient experienced ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of benadryl tablets and benadryl cream. At the time of the report, ERYTHEMA (redness), RASH MACULAR (2-3 inch wide round spot on arm), RASH (rash under arm and up to her neck) and RASH (big spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Nausea, Pruritus
Clinical narrative: Wiped out, sleeping on and off; Wiped out, sleeping on and off; Fever of 101 F; chills; Nausea; exhaustion; Internal itch or creepy crawly skin; migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion) and PRURITUS (Internal itch or creepy crawly skin) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition 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 PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), PRURITUS (Internal itch or creepy crawly skin) and MIGRAINE (migraine headache). On 22-Feb-2021, the patient experienced FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off). On 21-Feb-2021, PRURITUS (Internal itch or creepy crawly skin) had resolved. On 23-Feb-2021, PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), MIGRAINE (migraine headache), FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Wiped out, sleeping on and off; Wiped out, sleeping on and off; Fever of 101 F; chills; Nausea; exhaustion; Internal itch or creepy crawly skin; migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion) and PRURITUS (Internal itch or creepy crawly skin) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition 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 PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), PRURITUS (Internal itch or creepy crawly skin) and MIGRAINE (migraine headache). On 22-Feb-2021, the patient experienced FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off). On 21-Feb-2021, PRURITUS (Internal itch or creepy crawly skin) had resolved. On 23-Feb-2021, PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), MIGRAINE (migraine headache), FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness; Itchiness; Swollen Lymph Nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itchiness) and LYMPHADENOPATHY (Swollen Lymph Nodes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included INSULIN, METFORMIN, LISINOPRIL and ATORVASTATIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itchiness) and LYMPHADENOPATHY (Swollen Lymph Nodes). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itchiness) and LYMPHADENOPATHY (Swollen Lymph Nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Felt the same Heart racing; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Felt the same Heart racing) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Felt the same Heart racing). At the time of the report, PALPITATIONS (Felt the same Heart racing) 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.   No concomitant and treatment medications were reported.   This case was linked to MOD21-037045 (E2B Linked Report).; Sender's Comments:  MOD21-037045:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (The patient has severe osteoarthritis.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Feb-2021, 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 IN EXTREMITY (Had a sore arm). On 19-Feb-2021, PAIN IN EXTREMITY (Had a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 -Apr- 2021 contains non significant information ( reporter does not have an email).
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: Increased levels of liver enzymes; This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC ENZYME INCREASED (Increased levels of liver enzymes) 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 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Increased levels of liver enzymes). At the time of the report, HEPATIC ENZYME INCREASED (Increased levels of liver enzymes) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: itching; rash in the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm). At the time of the report, PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm) outcome was unknown.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Myalgia, Rash erythematous
Clinical narrative: Big red round rash; As if coming down with flu; Very tired; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Big red round rash), INFLUENZA LIKE ILLNESS (As if coming down with flu), MYALGIA (Sore muscles) and FATIGUE (Very tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced MYALGIA (Sore muscles). On 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (As if coming down with flu) and FATIGUE (Very tired). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Big red round rash). On 15-Feb-2021, INFLUENZA LIKE ILLNESS (As if coming down with flu) and FATIGUE (Very tired) had resolved. At the time of the report, RASH ERYTHEMATOUS (Big red round rash) and MYALGIA (Sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea; Headaches; Reduced stamina and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Reduced stamina and fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme dizziness to the point of almost fainting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness to the point of almost fainting) and NAUSEA (Nausea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness to the point of almost fainting) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Extreme dizziness to the point of almost fainting) had not resolved and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Diagnosed with positive COVID-19 a few days after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - This case concerns an adult male with a serious unexpected event of COVID-19. Latency a few days after first dose mRNA-1273. Based on 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-034551, US-MODERNATX, INC.-MOD-2021-022629, US-MODERNATX, INC.-MOD-2021-022705, US-MODERNATX, INC.-MOD-2021-022914 (E2B Linked Report).; Sender's Comments: This case concerns an adult male with a serious unexpected event of COVID-19. Latency a few days after first dose mRNA-1273. Based on 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. US-MODERNATX, INC.-MOD-2021-034551: US-MODERNATX, INC.-MOD-2021-022629: US-MODERNATX, INC.-MOD-2021-022705: US-MODERNATX, INC.-MOD-2021-022914:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Some oval shaped redness in upper arm and shoulder near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]), SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Some oval shaped redness in upper arm and shoulder near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: achy; Temperature/ fever; Nausea/Extreme nausea; Shortness of breath; kind of achy with a little headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (Tired) and HEADACHE (kind of achy with a little headache). On 22-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 23-Feb-2021, the patient experienced PAIN (achy), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever), NAUSEA (Nausea/Extreme nausea) and HEADACHE (kind of achy with a little headache) outcome was unknown.            No concomitant products were reported. Treatment information included an inhaler, for shortness of breath. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: achy; Temperature/ fever; Nausea/Extreme nausea; Shortness of breath; kind of achy with a little headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced FATIGUE (Tired) and HEADACHE (kind of achy with a little headache). On 22-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath). On 23-Feb-2021, the patient experienced PAIN (achy), PYREXIA (Temperature/ fever) and NAUSEA (Nausea/Extreme nausea). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (achy), FATIGUE (Tired), PYREXIA (Temperature/ fever), NAUSEA (Nausea/Extreme nausea) and HEADACHE (kind of achy with a little headache) outcome was unknown.            No concomitant products were reported. Treatment information included an inhaler, for shortness of breath. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swelling in feet; body rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash). At the time of the report, PERIPHERAL SWELLING (Swelling in feet) and RASH (body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain in Injection arm; Swelling in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain in Injection arm) and VACCINATION SITE SWELLING (Swelling in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Hot arm of injection site; Hard arm of injection site; Redness of the arm of injection site; Chills; Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took no treatment.; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Hot arm of injection site; Hard arm of injection site; Redness of the arm of injection site; Chills; Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took no treatment.; Sender'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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arms were sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arms were sore at the injection site) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (arms were sore at the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arms were sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Counterfeit product administered
Clinical narrative: Received possible counterfeit vaccine; A spontaneous report was received from a consumer, concerning a 65-year-old, female who received possible counterfeit vaccine.    The patient's medical history was not provided. Concomitant product was not provided.   On 29 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.  The outcome of the event, possible counterfeit vaccine were considered resolved.  Company Comments: The reported event possible counterfeit vaccine administered was not applicable to mRNA-1273.; Reporter's Comments: This report refers to a case of counterfeit product for mRNA-1273, batch number - not provided,  with no associated AEs. Causality is not applicable.