chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: hot to the touch; It is really tender; there was a red area on the arm by injection site and then it came back this morning; red area on the arm by injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender), VACCINATION SITE ERYTHEMA (red area on the arm by injection site) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red area on the arm by injection site). On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning). The patient was treated with HYDROCORTISONE on 12-Apr-2021 at an unspecified dose and frequency. On 12-Apr-2021, VACCINATION SITE ERYTHEMA (red area on the arm by injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning) 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.   The concomitant medication included beta blocker, not specified.  On 12-APR-2021, the patient had experienced red area on the arm by injection site. The event had resolved and had returned on 16-APR-2021 and was three times as bad. It went from the size of a golf ball to the size of a grapefruit. The redness is red on the outside with a white spot in the center. It looks like a spider bite. It was really tender and hot to the touch. It looks like cellulitis. She went to the ER due to it coming back worse than the first time. She also mentioned that she is on a beta blocker and wonders if that has something to do with her symptoms. She used hydrocortisone for symptoms.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (body ache). At the time of the report, MYALGIA (body ache) had resolved. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: telephone contact report received on 10-JUN-2021 .Outcome of the event Myalgia updated from unknown to recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Sluggishness
Clinical narrative: Mild fever of 99 degrees farenheit; Migraine; Sluggish; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine), SLUGGISHNESS (Sluggish) and PYREXIA (Mild fever of 99 degrees farenheit) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis since 1990 and Osteoarthritis since 1990. Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) from 1990 to an unknown date for Inflammation, HYDROCODONE from 1990 to an unknown date for Pain.   On 31-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021 at 3:00 PM, the patient experienced MIGRAINE (Migraine) and SLUGGISHNESS (Sluggish). On an unknown date, the patient experienced PYREXIA (Mild fever of 99 degrees farenheit). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. On 06-May-2021, MIGRAINE (Migraine) and SLUGGISHNESS (Sluggish) had resolved. At the time of the report, PYREXIA (Mild fever of 99 degrees farenheit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Added other relevant history. Added time of first and second doses. Added concomitant medications. Added new event migraine. Updated reporter details. Updated patient details. Updated onset date, stop date and outcome of event sluggishness. On 07-Jun-2021: Follow up information received on 07-Jun-2021 contains no significant information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site it's hot; injection site very itchy; injection site a little swollen; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A), and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen). At the time of the report, INJECTION SITE WARMTH (injection site it's hot), INJECTION SITE PRURITUS (injection site very itchy) and INJECTION SITE SWELLING (injection site a little swollen) outcome was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pruritus
Clinical narrative: Numb lips; Random Itching all over her body; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb lips) and PRURITUS (Random Itching all over her body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Various.) and Drug allergy (Benadryl). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 19-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb lips) and PRURITUS (Random Itching all over her body). The patient was treated with FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. On 21-Mar-2021, HYPOAESTHESIA ORAL (Numb lips) and PRURITUS (Random Itching all over her body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: blood sugar dropped/their sugar and it dropped to 63 mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL). At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar dropped/their sugar and it dropped to 63 mg/dL) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood glucose: 63 mg/dl (Low) Blood sugar dropped, 180 mg/dl (Inconclusive) Blood sugar 180mg/dL and 238 mg/dl (Inconclusive) Blood sugar 238 mg/dL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Patient emphasized they were not a diabetic. Patient drank a sugary glass of juice and ate a sandwich.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sluggishness
Clinical narrative: sluggish; mild fever of 99 degrees farenheit; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 039B21A) 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) (unknown route) 1 dosage form. On 29-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 SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (sluggish), PYREXIA (mild fever of 99 degrees farenheit) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-211787 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was taken on 3 April 2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken on 3 April 2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken on 3 April 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken on 3 April 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in fingers of right hands last couple weeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in fingers of right hands last couple weeks) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in fingers of right hands last couple weeks). At the time of the report, HYPOAESTHESIA (numbness in fingers of right hands last couple weeks) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site). On 22-Mar-2021, VACCINATION SITE ERYTHEMA (redness in injection site) had resolved. Not Provided          Concomitant Medication includes: Blood Pressure Medication  No treatment medications were reported.   This case was linked to MOD-2021-211833 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site hot; injection site very itchy; injection site is little swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site very itchy) and VACCINATION SITE SWELLING (injection site is little swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site very itchy) and VACCINATION SITE SWELLING (injection site is little swollen). At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site very itchy) and VACCINATION SITE SWELLING (injection site is little swollen) had not resolved.            This case was linked to MOD-2021-211793 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: redness in injection site (right); headache; muscle pain; fever 100.2 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Blood pressure.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit). At the time of the report, VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit) outcome was unknown. Not Provided          This case was linked to MOD-2021-211820 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Diarrhoea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: had partial lost of taste; Vaccination site swelling; Vaccination site warmth; Vaccination site erythema; Vaccination site Pruritis; Vaccination site rash; diarrhea; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea), CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0263(B?)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  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 VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea) and CHILLS (chills). On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site Pruritis). On 15-Apr-2021, the patient experienced AGEUSIA (had partial lost of taste). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. On 07-Apr-2021, VACCINATION SITE RASH (Vaccination site rash) had resolved. On 10-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site Pruritis) and AGEUSIA (had partial lost of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: had partial lost of taste; Vaccination site swelling; Vaccination site warmth; Vaccination site erythema; Vaccination site Pruritis; Vaccination site rash; diarrhea; chills; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea), CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0263(B?)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  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 VACCINATION SITE RASH (Vaccination site rash), DIARRHOEA (diarrhea) and CHILLS (chills). On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE PRURITUS (Vaccination site Pruritis). On 15-Apr-2021, the patient experienced AGEUSIA (had partial lost of taste). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. On 07-Apr-2021, VACCINATION SITE RASH (Vaccination site rash) had resolved. On 10-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, CHILLS (chills), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site Pruritis) and AGEUSIA (had partial lost of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: left shoulder hurts; Bleeding Injection Site; Bruised Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site), VACCINATION SITE BRUISING (Bruised Injection Site) and ARTHRALGIA (left shoulder hurts) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A)) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) and VACCINATION SITE BRUISING (Bruised Injection Site). On 18-Mar-2021, the patient experienced ARTHRALGIA (left shoulder hurts). On 25-Feb-2021, VACCINATION SITE HAEMORRHAGE (Bleeding Injection Site) had resolved. On 18-Mar-2021, VACCINATION SITE BRUISING (Bruised Injection Site) had resolved. At the time of the report, ARTHRALGIA (left shoulder hurts) had resolved.            no Concomitants product was reported.  no treatment product was reported   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR received on 11-06-2021 updated the outcome of the event. AE was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose was not given within 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema
Clinical narrative: reported on 17Apr2021 -after receiving vaccine her arm is sore; had a red spot at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore) and VACCINATION SITE ERYTHEMA (had a red spot at injection site.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (had a red spot at injection site.). On 17-Apr-2021, the patient experienced MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore). At the time of the report, MYALGIA (reported on 17Apr2021 -after receiving vaccine her arm is sore) and VACCINATION SITE ERYTHEMA (had a red spot at injection site.) had not resolved. Not Provided
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Wrong product administered
Clinical narrative: Received the 2nd dose of the Pfizer vaccine; Pain in the arm of the injection ( right arm); chills that night; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine), MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night). On 16-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine). On 19-Mar-2021, MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night) outcome was unknown. At the time of the report, WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information not provided. THERE IS NO LAB DATA PROVIDED Events :his blood pressure levels Action taken with mRNA-1273 in response to the events was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: swelling in injection arm; heat in injection arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm) in a 58-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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm). At the time of the report, PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Night sweats, Oral herpes, Rhinitis
Clinical narrative: cold sores on the lips; was sick; not feeling any better; terrible night sweats; nose infection; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (was sick), FEELING ABNORMAL (not feeling any better), NIGHT SWEATS (terrible night sweats), RHINITIS (nose infection) and ORAL HERPES (cold sores on the lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (was sick), FEELING ABNORMAL (not feeling any better), NIGHT SWEATS (terrible night sweats) and RHINITIS (nose infection). On 17-Apr-2021, the patient experienced ORAL HERPES (cold sores on the lips). At the time of the report, ILLNESS (was sick), FEELING ABNORMAL (not feeling any better), NIGHT SWEATS (terrible night sweats), RHINITIS (nose infection) and ORAL HERPES (cold sores on the lips) outcome was unknown. Not Provided          no concomitant and treatment medications were provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral pain, Rash
Clinical narrative: mouth sores; bad rash on her face and neck where she had her radiations; lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (mouth sores), RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0096B21A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy. Concurrent medical conditions included Cancer in remission.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling). On 26-Mar-2021, the patient experienced ORAL PAIN (mouth sores). At the time of the report, ORAL PAIN (mouth sores), RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking unspecified concomitant medications. No treatment medications were given.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received and contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Fear, Feeling abnormal, Illness, Nasopharyngitis, Pyrexia
Clinical narrative: Cold; Feel awful; Scared; Sick; Feverish; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feel awful), FEAR (Scared), ILLNESS (Sick) and PYREXIA (Feverish) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feel awful), FEAR (Scared), ILLNESS (Sick) and PYREXIA (Feverish). At the time of the report, NASOPHARYNGITIS (Cold), FEELING ABNORMAL (Feel awful), FEAR (Scared), ILLNESS (Sick) and PYREXIA (Feverish) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Co-suspect product Pfizer vaccine details were updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Vaccination site is swollen; Vaccination site red; Nausea; Headache; swollen all the way down to her elbow; red all the way down to her elbow; pruritis; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache) and PERIPHERAL SWELLING (swollen all the way down to her elbow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis). At the time of the report, VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis) outcome was unknown. Not Provided          Concomitant medications were not provided Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Vaccination site is swollen; Vaccination site red; Nausea; Headache; swollen all the way down to her elbow; red all the way down to her elbow; pruritis; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache) and PERIPHERAL SWELLING (swollen all the way down to her elbow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis). At the time of the report, VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Vaccination site red), NAUSEA (Nausea), HEADACHE (Headache), PERIPHERAL SWELLING (swollen all the way down to her elbow), ERYTHEMA (red all the way down to her elbow) and PRURITUS (pruritis) outcome was unknown. Not Provided          Concomitant medications were not provided Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia, Myalgia
Clinical narrative: numbness in right arm initially and then in her left arm.; High Blood Pressure; Achy; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy). At the time of the report, HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy) outcome was unknown. Not Provided          Patient visited her doctor and doctor asked her to get tested for some blood work.  The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fall, Influenza like illness, Mobility decreased
Clinical narrative: body aches; diarrhea; felt so dizzy she fell and couldn't get up; felt so dizzy she fell and couldn't get up; it felt like she came down with the flu; felt so dizzy she fell and couldn't get up; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and FALL (felt so dizzy she fell and couldn't get up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (it felt like she came down with the flu) and FALL (felt so dizzy she fell and couldn't get up). On an unknown date, the patient experienced MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up), FALL (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches; diarrhea; felt so dizzy she fell and couldn't get up; felt so dizzy she fell and couldn't get up; it felt like she came down with the flu; felt so dizzy she fell and couldn't get up; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and FALL (felt so dizzy she fell and couldn't get up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (it felt like she came down with the flu) and FALL (felt so dizzy she fell and couldn't get up). On an unknown date, the patient experienced MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (it felt like she came down with the flu), MYALGIA (body aches), DIARRHOEA (diarrhea), DIZZINESS (felt so dizzy she fell and couldn't get up), FALL (felt so dizzy she fell and couldn't get up) and MOBILITY DECREASED (felt so dizzy she fell and couldn't get up) outcome was unknown. Not Provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on her arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her arm) in a 58-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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (Hives on her arm). At the time of the report, URTICARIA (Hives on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking unspecified concomitant medications No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Testicular pain
Clinical narrative: Right testicular started hurting/ feels like they were being pinched internally on the right testicles; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR PAIN (Right testicular started hurting/ feels like they were being pinched internally on the right testicles), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041821A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 06-Jun-2021, the patient experienced TESTICULAR PAIN (Right testicular started hurting/ feels like they were being pinched internally on the right testicles). At the time of the report, TESTICULAR PAIN (Right testicular started hurting/ feels like they were being pinched internally on the right testicles), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-212218 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Sinusitis, Taste disorder
Clinical narrative: everything smelt rotten and had a rotten, burnt chemical smell; everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection). At the time of the report, PAROSMIA (everything smelt rotten and had a rotten, burnt chemical smell), TASTE DISORDER (everything smelt rotten and had a rotten, burnt chemical taste to anything he put in his mouth) and SINUSITIS (sinus infection) outcome was unknown. Not Provided          Patient is using Antibiotic to treatment of symptoms. No concomitant medications were reported.