chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: soreness at ankle, hip.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness at ankle, hip.) 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) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRALGIA (soreness at ankle, hip.). At the time of the report, ARTHRALGIA (soreness at ankle, hip.) outcome was unknown.            Patient experienced soreness at ankle and hip after the second dose. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warmth; was a hard lump; , her arm swelled up to almost baseball size; redness; pain at the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site). On 21-Jan-2021, VACCINATION SITE WARMTH (warmth), VACCINATION SITE MASS (was a hard lump), VACCINATION SITE SWELLING (, her arm swelled up to almost baseball size), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (pain at the injection site) 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.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011ML(orC)0A) 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 12-Feb-2021, the patient experienced MYALGIA (body aches) and PYREXIA (fever). At the time of the report, MYALGIA (body aches) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: feeling bloated "like really super bad"; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (feeling bloated "like really super bad") in a 79-year-old female patient 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 an unknown date, the patient experienced ABDOMINAL DISTENSION (feeling bloated "like really super bad"). At the time of the report, ABDOMINAL DISTENSION (feeling bloated "like really super bad") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Flushing, Paraesthesia oral
Clinical narrative: little tingling in my tongue; broke out into a cold sweat; face got really hot and flushed; face got really hot and flushed; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed). On 09-Feb-2021, PARAESTHESIA ORAL (little tingling in my tongue), COLD SWEAT (broke out into a cold sweat), FLUSHING (face got really hot and flushed) and FEELING HOT (face got really hot and flushed) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: have sharp pains in feet; Not feeling good, feels wiped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped). At the time of the report, PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: Involuntary jerking motions in my arms and sometimes my legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs). On 25-Jan-2021, DYSKINESIA (Involuntary jerking motions in my arms and sometimes my legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: shortness of breath; stabbing pain; rash all over body; headache; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: shortness of breath; stabbing pain; rash all over body; headache; muscle pain; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), PAIN (stabbing pain), RASH (rash all over body), HEADACHE (headache), MYALGIA (muscle pain), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness and lightheadedness; arm is little sore; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness and lightheadedness) and PAIN IN EXTREMITY (arm is little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PRAVASTATIN, TROMETHAMINE, HCTZ, FISH OIL, CLOMIPHENE CITRATE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (dizziness and lightheadedness) and PAIN IN EXTREMITY (arm is little sore). On 08-Feb-2021, PAIN IN EXTREMITY (arm is little sore) had resolved. At the time of the report, DIZZINESS (dizziness and lightheadedness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site discolouration, Injection site mass, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), PRURITUS (itchiness on neck) and INJECTION SITE MASS (injection site is a knot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck). In February 2021, the patient experienced PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itch, at an unspecified dose and frequency. On 10-Mar-2021, SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck) had resolved. At the time of the report, INJECTION SITE DISCOLOURATION (injection site is dark pink), PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs include: cream. No concomitant drugs were reported.   This case was linked to MOD-2021-091400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated contact information, patient demographics and the events start date, stop date and outcome of the events ( Swelling eye, Rash on neck, Face rash) from unknown to recovered. Added the second dose details such as vaccine information events and outcome of events and treatment details.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), PRURITUS (itchiness on neck) and INJECTION SITE MASS (injection site is a knot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (injection site is dark pink), SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck). In February 2021, the patient experienced PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itch, at an unspecified dose and frequency. On 10-Mar-2021, SWELLING FACE (facial swelling), EYE SWELLING (Underneath her right eye is swollen), RASH (face rash) and RASH (rash on neck) had resolved. At the time of the report, INJECTION SITE DISCOLOURATION (injection site is dark pink), PRURITUS (itchiness on neck), INJECTION SITE MASS (injection site is a knot) and PRURITUS (itchiness under and on her ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs include: cream. No concomitant drugs were reported.   This case was linked to MOD-2021-091400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated contact information, patient demographics and the events start date, stop date and outcome of the events ( Swelling eye, Rash on neck, Face rash) from unknown to recovered. Added the second dose details such as vaccine information events and outcome of events and treatment details.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Malaise
Clinical narrative: this was why it's Dr. ordered it to take a test for COVID.; feeling unwell; quite a bit of a cough; some mucus on the nose; feeling tired; head ache just a little; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, head ache just a little, and was ordered to take a test for Covid by the doctor.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol for Blood pressure, half tablet once a day, cyanocobalamin for unknown indication, tamsulosin for the prostate gland, has prostate enlargement and Nasal Spray from time to time.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2021 post receiving the vaccine, the patient felt unwell, and tired, had quite a bit of a cough, some mucus on the nose and headache just a little. The patient was ordered to take a test for COVID by their doctor. The patient went to ER, took a test tested positive for Covid 19 on 27 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, headache just a little were considered not resolved at the time of this report and the outcome of the event, was ordered to take a test for Covid by the doctor was resolved at the time of this report.; Reporter's Comments: This case concerns a male of unknown age with a serious unexpected event of COVID-19, and nonserious unexpected cough, secretion discharge, malaise and expected fatigue and headache.  Event onset with unknown latency after first dose mRNA-1273. Events ongoing. 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.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Secretion discharge
Clinical narrative: this was why it's Dr. ordered it to take a test for COVID.; feeling unwell; quite a bit of a cough; some mucus on the nose; feeling tired; head ache just a little; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, head ache just a little, and was ordered to take a test for Covid by the doctor.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Metoprolol for Blood pressure, half tablet once a day, cyanocobalamin for unknown indication, tamsulosin for the prostate gland, has prostate enlargement and Nasal Spray from time to time.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in 2021 post receiving the vaccine, the patient felt unwell, and tired, had quite a bit of a cough, some mucus on the nose and headache just a little. The patient was ordered to take a test for COVID by their doctor. The patient went to ER, took a test tested positive for Covid 19 on 27 Jan 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling unwell, feeling tired, quite a bit of a cough, some mucus on the nose, headache just a little were considered not resolved at the time of this report and the outcome of the event, was ordered to take a test for Covid by the doctor was resolved at the time of this report.; Reporter's Comments: This case concerns a male of unknown age with a serious unexpected event of COVID-19, and nonserious unexpected cough, secretion discharge, malaise and expected fatigue and headache.  Event onset with unknown latency after first dose mRNA-1273. Events ongoing. 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Funny smell when inhaling , smells like salon patch; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Funny smell when inhaling , smells like salon patch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Funny smell when inhaling , smells like salon patch). At the time of the report, PAROSMIA (Funny smell when inhaling , smells like salon patch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lip oedema, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: knot at the injection site; Warm to the touch knot at the injection site; Tenderness at the injection site; right upper lip edema; This spontaneous case was reported by a consumer and describes the occurrence of LIP OEDEMA (right upper lip edema), VACCINATION SITE NODULE (knot at the injection site), VACCINATION SITE WARMTH (Warm to the touch knot at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 74-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LIP OEDEMA (right upper lip edema). On 05-Feb-2021, the patient experienced VACCINATION SITE NODULE (knot at the injection site), VACCINATION SITE WARMTH (Warm to the touch knot at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, LIP OEDEMA (right upper lip edema), VACCINATION SITE NODULE (knot at the injection site), VACCINATION SITE WARMTH (Warm to the touch knot at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness; Pain in the left arm; Headache; Queasy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), VACCINATION SITE PAIN (Pain in the left arm), HEADACHE (Headache) and NAUSEA (Queasy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Soreness), VACCINATION SITE PAIN (Pain in the left arm), HEADACHE (Headache) and NAUSEA (Queasy). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness), VACCINATION SITE PAIN (Pain in the left arm), HEADACHE (Headache) and NAUSEA (Queasy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received by safety 13-Jul-2021 included a significant follow-up: outcome of the events is reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node is swollen and hard; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard). At the time of the report, LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Product dose omission issue, Pruritus, Rash
Clinical narrative: Not received 2nd dose yet; Face got red scaly chapped; Hives on my chest; Skin peeling on face; Itchy; Rash on face; Dead arm the next day; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day) and SKIN EXFOLIATION (Skin peeling on face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day). On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face). On 03-Feb-2021, the patient experienced ERYTHEMA (Face got red scaly chapped) and URTICARIA (Hives on my chest). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet). On 26-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day), SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient was prescribed oral steroids in response to events.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-May-2021 had new events to be updated
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Urticaria, Vaccination site movement impairment
Clinical narrative: Not received 2nd dose yet; Face got red scaly chapped; Hives on my chest; Skin peeling on face; Itchy; Rash on face; Dead arm the next day; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day) and SKIN EXFOLIATION (Skin peeling on face) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day). On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face). On 03-Feb-2021, the patient experienced ERYTHEMA (Face got red scaly chapped) and URTICARIA (Hives on my chest). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet). On 26-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ERYTHEMA (Face got red scaly chapped), URTICARIA (Hives on my chest), VACCINATION SITE MOVEMENT IMPAIRMENT (Dead arm the next day), SKIN EXFOLIATION (Skin peeling on face), PRURITUS (Itchy) and RASH (Rash on face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient was prescribed oral steroids in response to events.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-May-2021 had new events to be updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had her first dose, her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had her first dose, her arm was very sore) in a 69-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.   On 05-Feb-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 an unknown date, the patient experienced PAIN IN EXTREMITY (she had her first dose, her arm was very sore). At the time of the report, PAIN IN EXTREMITY (she had her first dose, her arm was very sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.   Treatment details included She received the second dose on Friday and took Tylenol to prevent pain. She took 2 tablets in, the car before the vaccination, 2 tablets before bedtime, and 2 tablets in the morning.    Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Rash, Vaccination site induration
Clinical narrative: Injection site itchy; Had a burning knot on left arm at injection; Injection site was sore; Injection site puffy and hard; Diarrhea; Chills; Vomiting; Fever; Rash on face on over body (left breast, chest and back); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), CHILLS (Chills) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and RASH (Rash on face on over body (left breast, chest and back)). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE SWELLING (Injection site puffy and hard). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on face on over body (left breast, chest and back)), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE SWELLING (Injection site puffy and hard) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vomiting
Clinical narrative: Injection site itchy; Had a burning knot on left arm at injection; Injection site was sore; Injection site puffy and hard; Diarrhea; Chills; Vomiting; Fever; Rash on face on over body (left breast, chest and back); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), CHILLS (Chills) and VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and RASH (Rash on face on over body (left breast, chest and back)). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE SWELLING (Injection site puffy and hard). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE INDURATION (Had a burning knot on left arm at injection), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on face on over body (left breast, chest and back)), VACCINATION SITE PAIN (Injection site was sore) and VACCINATION SITE SWELLING (Injection site puffy and hard) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tightness at injection site /Feels hard at injection site; redness at injection site; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-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 INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE INDURATION (Tightness at injection site /Feels hard at injection site), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: it still hurts/ pain in the right side of her body and her right leg hurt; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026LZ0A and 026220A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc. Concurrent medical conditions included Pre-diabetic, Cholesterol and Penicillin allergy. Concomitant products included METFORMIN for Pre-diabetic.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (it still hurts/ pain in the right side of her body and her right leg hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Steroid pills since 5Feb up to 10Feb2021.  Concomitant medication includes cholesterol medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: contains information about patient demographics and allergies of patient  was added and event outcome were updated
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Zero Antibodies 2 weeks post second vaccination; A spontaneous report was received from a healthcare, concerning several of his patient who received Moderna's COVID-19 vaccine, they did not develop antibodies 14 days post second Moderna COVID-19 Vaccination  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, prior to the onset of events, their patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. After 14 days, prior to the onset of events, their patient received their second of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.  One of his patients had the second Moderna COVID-19 Vaccine on 26JAN2021, Blood was drawn on 5FEB2021 and sent to Lab. The results came back with zero Antibodies. Other patients had similar results with similar time span No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, Zero Antibodies 2 weeks post second vaccination was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the event (nephrolithiasis) has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Back , chest and neck itches that bleed when are scratched; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Back , chest and neck itches that bleed when are scratched) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRURITUS (Back , chest and neck itches that bleed when are scratched). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Back , chest and neck itches that bleed when are scratched) outcome was unknown.            No concomitant medications provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-107957 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Additional information received on 23-APR-2021. Patient alternate phone number, Email Address and Second dose information added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-107957:second dose case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: diarrhea; muscle spasm; flu like symptoms; chills; stomach upset; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), PARACETAMOL (TYLENOL), CYCLOBENZAPRINE and LOPERAMIDE.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue), MYALGIA (muscle pain), DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: diarrhea; muscle spasm; flu like symptoms; chills; stomach upset; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), PARACETAMOL (TYLENOL), CYCLOBENZAPRINE and LOPERAMIDE.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue), MYALGIA (muscle pain), DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Headache, Illness, Nausea
Clinical narrative: really sick 12 hours after injection; joint pain; nausea; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/90 mmHg (High) 170/90.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash below the injection site; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash below the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:unknown ) for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the event, red rash below the injection site was unknown.