chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: legs hurt; sweating; dizziness; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (legs hurt), HYPERHIDROSIS (sweating), DIZZINESS (dizziness), CHILLS (chills) and FATIGUE (fatigue) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age patient given the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient given the Moderna vaccine) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ear) 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 reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in ear). At the time of the report, TINNITUS (ringing in ear) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-071246, MOD21-072080 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071246: MOD21-072080:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Peripheral swelling, Tenderness
Clinical narrative: tender; painful [as though I'm having food poisoning]; pretty hard cramps in my stomach; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got swollen), TENDERNESS (tender), ABDOMINAL PAIN UPPER (pretty hard cramps in my stomach) and PAIN (painful [as though I'm having food poisoning]) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm got swollen). On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (pretty hard cramps in my stomach). On an unknown date, the patient experienced TENDERNESS (tender) and PAIN (painful [as though I'm having food poisoning]). At the time of the report, PERIPHERAL SWELLING (arm got swollen), TENDERNESS (tender), ABDOMINAL PAIN UPPER (pretty hard cramps in my stomach) and PAIN (painful [as though I'm having food poisoning]) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient applied ice on her swollen arm on 07Apr2021 as treatment and no information about any concomitant medications.
Sex: F
Vaccine: COVID19
Symptoms: Product dispensing issue
Clinical narrative: felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her) 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 reported medical history).   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 PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her). At the time of the report, PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her) had resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Arm ache after first dose; Achy all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, PAIN, and HEADACHE in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroid disorder.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY, PAIN, and HEADACHE. On 05-Mar-2021, PAIN IN EXTREMITY had resolved. At the time of the report, PAIN and HEADACHE outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Action taken with mRNA-1273 in response to the events was not applicable. Concomitant product include Three medicines for blood pressure, and Thyroid pills.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: redness going lower down to the arm to elbow; pain in night time; it was sore; very hard; injection site became red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (redness going lower down to the arm to elbow), PAIN (pain in night time), PAIN IN EXTREMITY (it was sore), VACCINATION SITE INDURATION (very hard) and VACCINATION SITE ERYTHEMA (injection site became red) had resolved.            Concomitant Medication includes Blood pressure  and Cholesterol Medication  Treatment Medication includes : Cold Compressive  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Significant followup received on 17-Jun-2021. Event outcome details updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: Severe arm pain/ can't use arm at all; Severe arm pain/ can't use arm at all; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain/ can't use arm at all) and VACCINATION SITE MOVEMENT IMPAIRMENT (Severe arm pain/ can't use arm at all) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain/ can't use arm at all) and VACCINATION SITE MOVEMENT IMPAIRMENT (Severe arm pain/ can't use arm at all). At the time of the report, PAIN IN EXTREMITY (Severe arm pain/ can't use arm at all) and VACCINATION SITE MOVEMENT IMPAIRMENT (Severe arm pain/ can't use arm at all) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided  Treatment included self treatment with pain meds and cold packs
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Skin discolouration
Clinical narrative: Discoloration of the arm; Experiencing achiness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease. Concomitant products included VITAMINS NOS, FISH OIL and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness). At the time of the report, SKIN DISCOLOURATION (Discoloration of the arm), PAIN (Experiencing achiness) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added outcome of events.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on his left arm the length of an egg) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling on his left arm the length of an egg). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Swelling arm, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling on his left arm the length of an egg) had resolved.    Concomitant medication included blood thinner medication and blood pressure medication. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received updated event outcome.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site discolouration
Clinical narrative: Developed a black and blue at injection site; aches; chills; fever of 100 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Developed a black and blue at injection site), PAIN (aches), CHILLS (chills) and PYREXIA (fever of 100 degrees Fahrenheit) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 0414A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Developed a black and blue at injection site), PAIN (aches), CHILLS (chills) and PYREXIA (fever of 100 degrees Fahrenheit). At the time of the report, VACCINATION SITE DISCOLOURATION (Developed a black and blue at injection site), PAIN (aches), CHILLS (chills) and PYREXIA (fever of 100 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 100 (High) fever of 100 degrees Fahrenheit.         No concomitant medications reported by investigator o No treatment medications provided by the reporter.   Action taken with mRNA-1273 Moderna vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUN-2021: Events outcome was updated to recovered/resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Somnolence
Clinical narrative: Made her to got to sleep/Have the best sleep she have ever got in 2 years; chills right after the shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot) in a 71-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, 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 SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot). At the time of the report, SOMNOLENCE (Made her to got to sleep/Have the best sleep she have ever got in 2 years) and CHILLS (chills right after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071496 (E2B Linked Report).; Sender's Comments:  MOD-2021-071496:
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: red and swollen arm at injection site; red and swollen arm at injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site) in a 101-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red and swollen arm at injection site) and VACCINATION SITE SWELLING (red and swollen arm at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hot compress and elevate.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspepsia, Feeling cold, Freezing phenomenon
Clinical narrative: woke up at night and was freezing; shaking; put a jacket on and curled up next to her husband; acid indigestion really bad; been sleeping off a lot; dizzy; sore all over; all joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad) and SOMNOLENCE (been sleeping off a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION, BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (LOTRISONE), CITALOPRAM, EZETIMIBE (ZETIA), FEXOFENADINE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROXYZINE HCL, LATANOPROST, LEVOTHYROXINE, METFORMIN, METHOCARBAMOL, MUPIROCIN, OMEPRAZOLE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TRAZODONE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt). At the time of the report, FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take TUMS as a Treatment medication.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence, Tremor
Clinical narrative: woke up at night and was freezing; shaking; put a jacket on and curled up next to her husband; acid indigestion really bad; been sleeping off a lot; dizzy; sore all over; all joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad) and SOMNOLENCE (been sleeping off a lot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION, BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (LOTRISONE), CITALOPRAM, EZETIMIBE (ZETIA), FEXOFENADINE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROXYZINE HCL, LATANOPROST, LEVOTHYROXINE, METFORMIN, METHOCARBAMOL, MUPIROCIN, OMEPRAZOLE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TRAZODONE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt). At the time of the report, FREEZING PHENOMENON (woke up at night and was freezing), TREMOR (shaking), FEELING COLD (put a jacket on and curled up next to her husband), DYSPEPSIA (acid indigestion really bad), SOMNOLENCE (been sleeping off a lot), DIZZINESS (dizzy), MYALGIA (sore all over) and ARTHRALGIA (all joints hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take TUMS as a Treatment medication.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171321A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Intense burning feeling in the back of her throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Intense burning feeling in the back of her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced THROAT IRRITATION (Intense burning feeling in the back of her throat).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Nasal discomfort, Pain in extremity
Clinical narrative: blocked nose; hurting nose; body aches (in the knee); pain in the arm; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporte.  Concomitant products included LISINOPRIL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued). At the time of the report, NASAL CONGESTION (blocked nose), NASAL DISCOMFORT (hurting nose), PAIN IN EXTREMITY (body aches (in the knee)), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigued) had not 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.   Treatment medication was not provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Light soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Light soreness in the arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 2:00 PM, the patient experienced MYALGIA (Light soreness in the arm). At the time of the report, MYALGIA (Light soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: "feeling out of it"; Fatigue; Numbness in toes on both feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in toes on both feet), FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness in toes on both feet). On 23-Feb-2021, the patient experienced FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue). At the time of the report, HYPOAESTHESIA (Numbness in toes on both feet) had not resolved and FEELING ABNORMAL ("feeling out of it") and FATIGUE (Fatigue) had resolved.            Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071488 (E2B Linked Report).; Sender's Comments:  MOD-2021-071488:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: loss of appetite; face red; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue). On 11-Apr-2021, DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071421 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071421:Original Case : MOD-2021-071421
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: loss of appetite; face red; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue). On 11-Apr-2021, DECREASED APPETITE (loss of appetite), ERYTHEMA (face red), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071421 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071421:Original Case : MOD-2021-071421
Sex: M
Vaccine: COVID19
Symptoms: Alcohol intolerance, Chills, Hyperhidrosis, Myalgia
Clinical narrative: very sensitive to alcohol; Severe chills; Night sweats; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA. At the time of the report, ALCOHOL INTOLERANCE, CHILLS, HYPERHIDROSIS, and MYALGIA outcome was unknown. Not Provided.          This case was linked to MOD-2021-071440.   Reporter did not allow further contact. Sender's Comments: MOD-2021-071440.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067082 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067082:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Eye movement disorder, Head titubation, Headache
Clinical narrative: vibration in top of her head that is randomly after second dose; feel vibration in her eyes; dehydrated; nauseous; throwing up; body chills; headache; bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: vibration in top of her head that is randomly after second dose; feel vibration in her eyes; dehydrated; nauseous; throwing up; body chills; headache; bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Noninfective sialoadenitis, Pain in extremity, Parotid gland enlargement
Clinical narrative: pain in her arm which travelled to her neck and jaw; Parotid gland was clogged; parotid gland was swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm which travelled to her neck and jaw), PAROTID GLAND ENLARGEMENT (Parotid gland was clogged) and NONINFECTIVE SIALOADENITIS (parotid gland was swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history reported.).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm which travelled to her neck and jaw), PAROTID GLAND ENLARGEMENT (Parotid gland was clogged) and NONINFECTIVE SIALOADENITIS (parotid gland was swollen). At the time of the report, PAIN IN EXTREMITY (pain in her arm which travelled to her neck and jaw), PAROTID GLAND ENLARGEMENT (Parotid gland was clogged) and NONINFECTIVE SIALOADENITIS (parotid gland was swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Doctors mentioned that events happened randomly and has nothing to do with the vaccine. Patient was treated with Tylenol.   This case was linked to MOD-2021-071497 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (sensation in her toes) 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 reported). On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 HYPOAESTHESIA (sensation in her toes). At the time of the report, HYPOAESTHESIA (sensation in her toes) had not resolved. Concomitant medication not provided, treatment medication not provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: daughter age 17 received vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine) in a 17-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter age 17 received vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Energy increased, Pain
Clinical narrative: Gave her energy and kept her up; Paining very bad; Pain in her shoulder; Chills all over her back and arms, chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills) in a 71-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 reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills). At the time of the report, ENERGY INCREASED (Gave her energy and kept her up), PAIN (Paining very bad), ARTHRALGIA (Pain in her shoulder) and CHILLS (Chills all over her back and arms, chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided   This case was linked to MOD-2021-071464 (E2B Linked Report).; Sender's Comments:  MOD-2021-071464:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Golf ball size swelling on jaw line below her ear; same pain after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (same pain after the second shot) and SWELLING (Golf ball size swelling on jaw line below her ear) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (same pain after the second shot). On 07-Apr-2021, the patient experienced SWELLING (Golf ball size swelling on jaw line below her ear). At the time of the report, PAIN (same pain after the second shot) and SWELLING (Golf ball size swelling on jaw line below her ear) outcome was unknown.            No concomitant medication reported.  Treatment for the event include paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergic reaction; right arm is puffy and red, like hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CLOPIDOGREL BISULFATE (PLAVIX).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives). At the time of the report, HYPERSENSITIVITY (allergic reaction) and URTICARIA (right arm is puffy and red, like hives) outcome was unknown. Not Provided          Other concomitant medications were reported as silvotrax, high blood pressure medication, trazadone. Treatment medication was reported as paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joints were hurting (9/10 rating); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints were hurting (9/10 rating)) 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.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (joints were hurting (9/10 rating)). At the time of the report, ARTHRALGIA (joints were hurting (9/10 rating)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site reaction
Clinical narrative: "COVID arm"; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness). On 19-Feb-2021, VACCINATION SITE REACTION ("COVID arm") and PRURITUS (itchiness) had resolved. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Patient was scarred to take the second dose and therefore she decided not to take it.   Concomitant products included were blood pressure meds ,cholesterol meds. Treatment included antihistamines and "put ice on it".; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.