chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Ache; Pregnant; A spontaneous report was received from a consumer concerning his wife, a 35 years old, pregnant, female patient, who received Moderna's Covid-19 Vaccine (mRNA-1273) during pregnancy (vaccine exposure during pregnancy) and experienced chills (chills), fever (fever) and ache (myalgia).  The patient's medical history was not provided. No allergy was reported. The patient had one prior pregnancy. The first pregnancy ended on 22 May 2016 with a live, full term birth. Concomitant product included vitamin once a day via oral route for multiple use (from 12 Jan 2020).  On 26 Jan 2021, approximately 10:00 am the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Her last period on 19 Jan 2021 and estimated conception date was 02 Feb 2021. The patient's estimated due date is on 14 Sep 2021.  On 26 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine and experienced adverse events. Symptoms included pregnancy, chills, fever and ache. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the events, fever, chills and myalgia were resolved on 30 Jan 2021. The outcome, pregnant (vaccine exposure during pregnancy) was considered resolved on 26 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, pyrexia and myalgia, a causal relationship cannot be excluded.  The causality for the event of exposure during pregnancy is not applicable. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Hot to the touch; Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.; just a little ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PAIN (just a little ache) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A-2A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur on 11-Jan-1993, Endometriosis on 10-Jan-2004 and Hypothyroidism on 05-Jan-2012. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) and LYSINE (L LYSINE [LYSINE]) for an unknown indication.  On 14-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (just a little ache).   On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE WARMTH (Hot to the touch).   On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.).   On 31-Jan-2021, VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) had resolved. At the time of the report, VACCINATION SITE PAIN (just a little ache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-020492 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included reporter's contact information. On 19-Apr-2021: Additional information received included: Patient initials and demographic details, Other relevant history, concomitant medications. Additional event and details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020492:Same reporter/ Different patient (Neighbor case)
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Pelvic pain
Clinical narrative: Back pain; Pelvic pain upto neck; Sick to her stomach; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck), ABDOMINAL DISCOMFORT (Sick to her stomach) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30L20A) for COVID-19 vaccination.     Patients medical history was not provided.  Concomitant products included ROSUVASTATIN, LEVOTHYROXINE and AMLODIPINE for an unknown indication.  On 29-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 CHILLS (Chills). On 03-Feb-2021, the patient experienced BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach).   The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 30-Jan-2021, CHILLS (Chills) had resolved.   On 05-Feb-2021, BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site bruising
Clinical narrative: could not move her arm at all as it felt like a huge heavy weight on her; Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm; small black and blue bruise the size of nickel at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel 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 concomitant medication were provided.   This case was linked to MOD-2021-250952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU was received on 07-jul-2021: Dose 2 details updated
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Chest pain, Diarrhoea
Clinical narrative: Losing her voice after receiving the second dose of Moderna COVID-19 vaccine; Chest pains; Diarrhea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported.).   On 25-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 APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain). At the time of the report, APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment for the event included steroids.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Headache, Myalgia
Clinical narrative: got COVID after receiving first vaccination; loss of taste and smell; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-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 COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell). At the time of the report, COVID-19 (got COVID after receiving first vaccination) outcome was unknown and HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported.).   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.   This case was linked to MOD21-036714 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation, Tongue discomfort, Urticaria
Clinical narrative: hives; itchy scalp; burning tongue; itchy/swelling throat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue) and THROAT IRRITATION (itchy/swelling throat). On 05-Feb-2021, the patient experienced URTICARIA (hives). At the time of the report, PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Vision blurred
Clinical narrative: blurry vision; numb hands; soreness; A spontaneous report was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, numb hands, blurry vision.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) soreness. On 20 Feb 2021, the patient experienced the event(s) numb hands, blurry vision.  Treatment details included Paracetamol + concomitant.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), soreness was resolved. The outcome of event(s), numb hands, blurry vision was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Erythema, Hypersensitivity, Hypoaesthesia
Clinical narrative: Sore on her neck; Sore on her  back; Allergy; Rash; Hands went numb; Short of breath; Red; Welts; Sore on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts) and PAIN IN EXTREMITY (Sore on her arm) in a 72-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 No adverse event (no historical condition was reported). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN E NOS, VITAMIN D NOS, IRON, ZINC and PROBIOTICS NOS for an unknown indication.    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 HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts), PAIN IN EXTREMITY (Sore on her arm), HYPERSENSITIVITY (Allergy) and RASH (Rash). On 20-Feb-2021, the patient experienced NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her  back). On 19-Feb-2021, HYPOAESTHESIA (Hands went numb) and DYSPNOEA (Short of breath) had resolved. At the time of the report, ERYTHEMA (Red), URTICARIA (Welts), HYPERSENSITIVITY (Allergy) and RASH (Rash) had resolved and PAIN IN EXTREMITY (Sore on her arm), NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her  back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Rash, Urticaria
Clinical narrative: Sore on her neck; Sore on her  back; Allergy; Rash; Hands went numb; Short of breath; Red; Welts; Sore on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts) and PAIN IN EXTREMITY (Sore on her arm) in a 72-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 No adverse event (no historical condition was reported). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN E NOS, VITAMIN D NOS, IRON, ZINC and PROBIOTICS NOS for an unknown indication.    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 HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts), PAIN IN EXTREMITY (Sore on her arm), HYPERSENSITIVITY (Allergy) and RASH (Rash). On 20-Feb-2021, the patient experienced NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her  back). On 19-Feb-2021, HYPOAESTHESIA (Hands went numb) and DYSPNOEA (Short of breath) had resolved. At the time of the report, ERYTHEMA (Red), URTICARIA (Welts), HYPERSENSITIVITY (Allergy) and RASH (Rash) had resolved and PAIN IN EXTREMITY (Sore on her arm), NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her  back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a 64-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 medical history was reported).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 19-Feb-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood pressure increased, Blue toe syndrome, Hypoaesthesia
Clinical narrative: deep purple toes; elevated BP; her toes felt numb; cold and look like a deep purple color with blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.    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 BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters). At the time of the report, BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Swelling
Clinical narrative: Rash on the face and arm; Rash on the face and arm; swelling in the legs, feet, ankle and knees; Fever 103f; severe chills; A spontaneous report was received from a consumer (patient's mother) which concerns a 39 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever of 103f, severe chills, rash on the face and arm as well swelling in the legs, feet, ankle and knees.  The patient's medical history was not provided. No concomitant product use was reported.  On an unknown date ??-Jan-2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date on ??- Jan-2021, the next day after receiving the vaccine, the patient experienced a fever 103f and severe chills. The patient also experienced a rash on the face and arm as well swelling in the legs, feet, ankle and knees. The patient's chills and fever have lasted for 4 weeks. The patient had to visit 2 internists, an endocrinologist, and a rheumatologist. The patient experienced Kawasaki disease as a child and the reporter felt the symptoms were similar.   The patient was prescribed an antihistamine meloxicam to relieve her side effects.  Action taken with mRNA-1273 was unknown.  The outcome of all the events was unknown.  No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: No appetite; Fever of 101 F; Tired and could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed). On 18-Feb-2021, DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: itch; Its red and swelling; Its red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), VACCINATION SITE SWELLING (Its red and swelling) and VACCINATION SITE ERYTHEMA (Its red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma in 2016. Concurrent medical conditions included Seasonal allergy since 1984. Concomitant products included VITAMIN D [VITAMIN D NOS] and MULTI VITAMINS & MINERALS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRURITUS (itch), VACCINATION SITE SWELLING (Its red and swelling) and VACCINATION SITE ERYTHEMA (Its red). At the time of the report, PRURITUS (itch) had resolved and VACCINATION SITE SWELLING (Its red and swelling) and VACCINATION SITE ERYTHEMA (Its red) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient applied alcohol and witch hazel for the reaction on her left arm. Patient took second dose on 13Feb2021 Intramuscular right arm (013M20A).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Patient demographics, medical history , concomitants and first event outcome were updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Swelling; Left arm was warm to the touch; Redness has spread all over the left arm; Pain on the injection Site; Round red circle on the injection Site; Round red circle on the injection site got bigger; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left arm was warm to the touch), ERYTHEMA (Redness has spread all over the left arm), VACCINATION SITE PAIN (Pain on the injection Site), VACCINATION SITE ERYTHEMA (Round red circle on the injection Site) and VACCINATION SITE ERYTHEMA (Round red circle on the injection site got bigger) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection Site), VACCINATION SITE ERYTHEMA (Round red circle on the injection Site) and VACCINATION SITE ERYTHEMA (Round red circle on the injection site got bigger). On 23-Feb-2021, the patient experienced FEELING HOT (Left arm was warm to the touch) and ERYTHEMA (Redness has spread all over the left arm). On an unknown date, the patient experienced SWELLING (Swelling). On 18-Feb-2021, VACCINATION SITE PAIN (Pain on the injection Site) outcome was unknown. At the time of the report, FEELING HOT (Left arm was warm to the touch), ERYTHEMA (Redness has spread all over the left arm), VACCINATION SITE ERYTHEMA (Round red circle on the injection Site), VACCINATION SITE ERYTHEMA (Round red circle on the injection site got bigger) and SWELLING (Swelling) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: additional info
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discogram abnormal, Spinal pain
Clinical narrative: excruciating pain; 5 bad disks; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks). At the time of the report, SPINAL PAIN (excruciating pain) and DISCOGRAM ABNORMAL (5 bad disks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported. No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site erythema, Pain, Pruritus
Clinical narrative: It's a little hard; Injection site has red spot the size of a head of a thumbtack; arm started itching; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PRURITUS (arm started itching), INDURATION (It's a little hard) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Blood pressure high, High cholesterol, Penicillin allergy, Sulfonamide allergy and Drug allergy (Levaquin allergy.). Concomitant products included BENZOYL PEROXIDE (BP), OMEPRAZOLE and LOSARTAN.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (pain). On 27-Jan-2021, the patient experienced PRURITUS (arm started itching) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack). On an unknown date, the patient experienced INDURATION (It's a little hard). At the time of the report, PAIN (pain), PRURITUS (arm started itching), INDURATION (It's a little hard) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection on their finger; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection on their finger) in a 77-year-old male 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INFECTION (Infection on their finger). At the time of the report, INFECTION (Infection on their finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: not much energy; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (not much energy) and FATIGUE (kind of tired) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (not much energy) and FATIGUE (kind of tired). At the time of the report, ASTHENIA (not much energy) and FATIGUE (kind of tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: second dose information received
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site mass, Pain, Swelling
Clinical narrative: pain; swelling; bump at injection site; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 08-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 (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (pain), SWELLING (swelling), INJECTION SITE MASS (bump at injection site) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache and body ache; Headache and body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache). At the time of the report, HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, COVID-19, Chills, Injection site erythema
Clinical narrative: my arm is red, swollen, and sore; my arm is red, swollen, and sore; my arm is red, swollen, and sore; bed ridden; symptoms like I had COVID all over again; chills; fever up to 104.5; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bed ridden), COVID-19 (symptoms like I had COVID all over again), CHILLS (chills), PYREXIA (fever up to 104.5) and INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced BEDRIDDEN (bed ridden), COVID-19 (symptoms like I had COVID all over again), CHILLS (chills) and PYREXIA (fever up to 104.5). On 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore), INJECTION SITE SWELLING (my arm is red, swollen, and sore) and INJECTION SITE PAIN (my arm is red, swollen, and sore). On 23-Feb-2021, BEDRIDDEN (bed ridden) and PYREXIA (fever up to 104.5) had resolved. At the time of the report, COVID-19 (symptoms like I had COVID all over again), CHILLS (chills), INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore), INJECTION SITE SWELLING (my arm is red, swollen, and sore) and INJECTION SITE PAIN (my arm is red, swollen, and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: upto 104.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: my arm is red, swollen, and sore; my arm is red, swollen, and sore; my arm is red, swollen, and sore; bed ridden; symptoms like I had COVID all over again; chills; fever up to 104.5; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bed ridden), COVID-19 (symptoms like I had COVID all over again), CHILLS (chills), PYREXIA (fever up to 104.5) and INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced BEDRIDDEN (bed ridden), COVID-19 (symptoms like I had COVID all over again), CHILLS (chills) and PYREXIA (fever up to 104.5). On 23-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore), INJECTION SITE SWELLING (my arm is red, swollen, and sore) and INJECTION SITE PAIN (my arm is red, swollen, and sore). On 23-Feb-2021, BEDRIDDEN (bed ridden) and PYREXIA (fever up to 104.5) had resolved. At the time of the report, COVID-19 (symptoms like I had COVID all over again), CHILLS (chills), INJECTION SITE ERYTHEMA (my arm is red, swollen, and sore), INJECTION SITE SWELLING (my arm is red, swollen, and sore) and INJECTION SITE PAIN (my arm is red, swollen, and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: upto 104.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: aching arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (aching arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 23-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 PAIN (aching arm). At the time of the report, VACCINATION SITE PAIN (aching arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Neck pain, Pain in extremity
Clinical narrative: Sinus infection; smelling saline; Chills; Fatigue; arm pain; Neck pain; ear pain; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain) and SINUSITIS (Sinus infection) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 medical history was reported.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced SINUSITIS (Sinus infection) and PAROSMIA (smelling saline). At the time of the report, PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), SINUSITIS (Sinus infection), PAROSMIA (smelling saline), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Parosmia, Sinusitis
Clinical narrative: Sinus infection; smelling saline; Chills; Fatigue; arm pain; Neck pain; ear pain; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain) and SINUSITIS (Sinus infection) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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 medical history was reported.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced SINUSITIS (Sinus infection) and PAROSMIA (smelling saline). At the time of the report, PAIN IN EXTREMITY (arm pain), NECK PAIN (Neck pain), EAR PAIN (ear pain), PAIN IN JAW (Jaw pain), SINUSITIS (Sinus infection), PAROSMIA (smelling saline), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Hard knot around the injection site; Slight headache; red, itchy, hard knot around the injection site; red, itchy, hard knot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, itchy, hard knot around the injection site), VACCINATION SITE PRURITUS (red, itchy, hard knot around the injection site), VACCINATION SITE MASS (Hard knot around the injection site) and HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red, itchy, hard knot around the injection site), VACCINATION SITE PRURITUS (red, itchy, hard knot around the injection site) and HEADACHE (Slight headache).   On an unknown date, the patient experienced VACCINATION SITE MASS (Hard knot around the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE ERYTHEMA (red, itchy, hard knot around the injection site), VACCINATION SITE PRURITUS (red, itchy, hard knot around the injection site), VACCINATION SITE MASS (Hard knot around the injection site) and HEADACHE (Slight headache) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: pain; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PYREXIA (fever) and CHILLS (Chills) in a female patient of an unknown age 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 27-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 PAIN (pain), PYREXIA (fever) and CHILLS (Chills). At the time of the report, PAIN (pain), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Peripheral swelling, Rash papular
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).