chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction at the sites of where she injected her with filler and botox; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction at the sites of where she injected her with filler and botox) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-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 VACCINATION COMPLICATION (Adverse reaction at the sites of where she injected her with filler and botox). At the time of the report, VACCINATION COMPLICATION (Adverse reaction at the sites of where she injected her with filler and botox) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Fatigue, Pain in extremity
Clinical narrative: Arm pain; Slight chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Allergy to Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and SACCHAROMYCES BOULARDII (FLORASTOR [SACCHAROMYCES BOULARDII]) for Irritable bowel syndrome, RALOXIFENE for Osteopenia and Osteoporosis.   On 16-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue). On 14-Feb-2021, PAIN IN EXTREMITY (Arm pain), CHILLS (Slight chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) High.         Treatment information not reported.   This case was linked to MOD-2021-027332 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Skin irritation
Clinical narrative: Irritation on upper thigh which then turned into shingles; Irritation on upper thigh which then turned into shingles; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Irritation on upper thigh which then turned into shingles) and HERPES ZOSTER (Irritation on upper thigh which then turned into shingles) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE, ROSUVASTATIN, FENOFIBRATE, IBANDRONATE SODIUM (BONIVA), PANTOPRAZOLE and ATENOLOL for an unknown indication.   On 08-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 17-Jun-2021, the patient experienced SKIN IRRITATION (Irritation on upper thigh which then turned into shingles) and HERPES ZOSTER (Irritation on upper thigh which then turned into shingles). The patient was treated with GABAPENTIN at a dose of UNK, prn. At the time of the report, SKIN IRRITATION (Irritation on upper thigh which then turned into shingles) and HERPES ZOSTER (Irritation on upper thigh which then turned into shingles) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to Moderna dose one; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to Moderna dose one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to Moderna dose one). At the time of the report, HYPERSENSITIVITY (Allergic reaction to Moderna dose one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm was sore). At the time of the report, PAIN IN EXTREMITY (Right arm was sore) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.    This case was linked to MOD-2021-037061 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain on and off; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain on and off) 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 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced MYALGIA (Muscle pain on and off). At the time of the report, MYALGIA (Muscle pain on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Headache, Heart rate
Clinical narrative: Chest pain; Weakness; High heart rate/beating; Light muscle ache; Severe headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0503C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Jul-2021, CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Blood pressure measurement: 118/100 (High) Very high blood pressure. On 07-Jul-2021, Heart rate: 120 (High) High heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: Chest pain; Weakness; High heart rate/beating; Light muscle ache; Severe headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0503C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 08-Jul-2021, CHEST PAIN (Chest pain), ASTHENIA (Weakness), HEART RATE INCREASED (High heart rate/beating), MYALGIA (Light muscle ache) and HEADACHE (Severe headache/Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Blood pressure measurement: 118/100 (High) Very high blood pressure. On 07-Jul-2021, Heart rate: 120 (High) High heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been fifteen weeks (since the first dose) and the patient would like to get the second dose now.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; swelling; Itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (swelling) and PRURITUS (Itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa), Drug allergy (Codiene) and Penicillin allergy. Concomitant products included AZELASTINE for Allergy, DENOSUMAB (PROLIA) from 05-Jul-2020 to an unknown date and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3) for Osteoporosis, MIRABEGRON (MYRBETRIQ) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 20-Jul-2019 to an unknown date for an unknown indication.   On 12-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (Redness), SWELLING (swelling) and PRURITUS (Itching). On 16-Mar-2021, ERYTHEMA (Redness), SWELLING (swelling) and PRURITUS (Itching) had resolved.            No treatment medication were reported.   This case was linked to MOD-2021-026610 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Illness, Neurological symptom, Paranoia, Suspiciousness
Clinical narrative: thinks someone in house, someone listening to her conversation, someone bugged the car; Cannot report to work; rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios; Drastic neurological changes; Extreme paranoid; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid), SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car), ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios) and ILLNESS (Cannot report to work) 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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid) and ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios). On 10-Mar-2021, the patient experienced SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car) and ILLNESS (Cannot report to work). At the time of the report, NEUROLOGICAL SYMPTOM (Drastic neurological changes), PARANOIA (Extreme paranoid), SUSPICIOUSNESS (thinks someone in house, someone listening to her conversation, someone bugged the car), ABNORMAL BEHAVIOUR (rearrange things, keep talking about puzzle pieces, putting them together again, does not make sense in different situations and scenarios) and ILLNESS (Cannot report to work) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to receive 2nd dose of the vaccine after 45 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days). In April 2021, PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Patient called in to seek assistance regarding second dose. Patient lost the vaccination card. Patient has no contact information of the one who gave it. Patient first dose was somewhere in April (no specific date given), 2nd dose was scheduled to be on May (no specific date given).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received on 12-07-21 with non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)) 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.   Concomitant medication use was not reported.   Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). At the time of the report, SNEEZING (Sneezing) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: lump under my right arm about the size of a jelly bean; first dose > 35 days ago; lymph nodes swelled; hurts all the time; injection hurt like a flu shot; Lymph nodes hurt; headaches; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time) and VACCINATION SITE PAIN (injection hurt like a flu shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: INFLUENZA VIRUS VACCINE.    On 01-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 AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches). At the time of the report, AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches) 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 medications were not reported.  The treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: lump under my right arm about the size of a jelly bean; first dose > 35 days ago; lymph nodes swelled; hurts all the time; injection hurt like a flu shot; Lymph nodes hurt; headaches; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time) and VACCINATION SITE PAIN (injection hurt like a flu shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: INFLUENZA VIRUS VACCINE.    On 01-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 AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches). At the time of the report, AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches) 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 medications were not reported.  The treatment information was not provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product dose omission issue
Clinical narrative: Patient has not yet received the second dose in the Moderna vaccine series (> 42 days); Patient administered expired Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)) in an 18-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)). On 24-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired Moderna vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose in the Moderna vaccine series (> 42 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were unknown.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: right tear trough is sore to touch; hard and swollen enough that my eyelashes intertwine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EYE PAIN (right tear trough is sore to touch) and EYE SWELLING (hard and swollen enough that my eyelashes intertwine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: RESTYLANE (Patient received Restylane injection to her tear trough area.) in July 2020 and RESTYLANE since 2021.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced EYE PAIN (right tear trough is sore to touch) and EYE SWELLING (hard and swollen enough that my eyelashes intertwine). At the time of the report, EYE PAIN (right tear trough is sore to touch) and EYE SWELLING (hard and swollen enough that my eyelashes intertwine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details are not provided by the Reporter. In JULY2021 Patient had Restylane injection to her tear trough area and had both Moderna vaccines in Jan2021 and Feb2021. Since Mar2021,Patient had  the right tear trough sore to touch, hard and swollen enough that eyelashes intertwined. Patient had the fillers performed. She received Restylane injection to her tear trough area July 2020.Action taken with mRNA is not applicable.   This case was linked to MOD-2021-252455 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Burning tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Burning tongue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced TONGUE DISCOMFORT (Burning tongue). At the time of the report, TONGUE DISCOMFORT (Burning tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient experienced burning tongue which started 4-5 hours after receiving the vaccine. No relevant concomitant medications were provided. No treatment information was provided. No lab data was provided by the reporter
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dysphemia, Hypoaesthesia, Muscle twitching, Tremor
Clinical narrative: head numbness; stutter; twitch; shaking; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 041c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-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 HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking). At the time of the report, HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: low (Low) blood pressure drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Rash, Skin discolouration, Vaccination site erythema, Vaccination site pain
Clinical narrative: "Had a temperature of 100.5 over the injection site and a 97.9 temperature"; Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.; "Has COVID arm"; From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink; Red rash formed by the injection site; Right arm was hard and like a baseball; Tenderness at right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Right arm was hard and like a baseball), VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink), VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature") and RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at right arm injection site). On 04-Jul-2021, the patient experienced INDURATION (Right arm was hard and like a baseball). On 05-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash formed by the injection site). On 06-Jul-2021, the patient experienced VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink) and RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.). On an unknown date, the patient experienced VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature"). At the time of the report, INDURATION (Right arm was hard and like a baseball), VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink), VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature"), RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.), VACCINATION SITE PAIN (Tenderness at right arm injection site) and VACCINATION SITE ERYTHEMA (Red rash formed by the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included IVIG on this past Tuesday 6 Jul 2021 and Wednesday 7Jul 2021. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: "Had a temperature of 100.5 over the injection site and a 97.9 temperature"; Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.; "Has COVID arm"; From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink; Red rash formed by the injection site; Right arm was hard and like a baseball; Tenderness at right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Right arm was hard and like a baseball), VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink), VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature") and RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at right arm injection site). On 04-Jul-2021, the patient experienced INDURATION (Right arm was hard and like a baseball). On 05-Jul-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash formed by the injection site). On 06-Jul-2021, the patient experienced VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink) and RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.). On an unknown date, the patient experienced VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature"). At the time of the report, INDURATION (Right arm was hard and like a baseball), VACCINATION SITE REACTION ("Has COVID arm"), SKIN DISCOLOURATION (From 6Jul2021 to 9Jul2021 her arm is a shade of dark pink), VACCINATION SITE WARMTH ("Had a temperature of 100.5 over the injection site and a 97.9 temperature"), RASH (Rash traveled down the arm to the elbow/rash is now down past elbow about 4 inches from wrist.), VACCINATION SITE PAIN (Tenderness at right arm injection site) and VACCINATION SITE ERYTHEMA (Red rash formed by the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included IVIG on this past Tuesday 6 Jul 2021 and Wednesday 7Jul 2021. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had an adverse reaction from Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine) 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 Cognitive impairment (Mild cognitive decline that is affecting his esophagus).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient received first dose of Moderna COVID vaccine in Feb-2021 or Mar-2021  Concomitant products included blood pressure medication.  No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Facility accidentally gave her an expired vaccine  it was out of the fridge for 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  The patient was reported to be a breast-feeding mother of a four-month old.    This case was linked to MOD-2021-252960 (Parent-Child Link).   See case MOD-2021-252960 for details regarding the child case.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (I've had ongoing side effects for 11 weeks immediately following the second Moderna vaccine) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Vaccination complication
Clinical narrative: Normal side effects; Feeling of throat being full/ cant clear/ cant cough it clear; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear). At the time of the report, VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needle sensation on her back and on her chest under her both arm pits; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needle sensation on her back and on her chest under her both arm pits) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA (Pins and needle sensation on her back and on her chest under her both arm pits). At the time of the report, PARAESTHESIA (Pins and needle sensation on her back and on her chest under her both arm pits) outcome was unknown.            Concomitant products included Birth control medications.  No treatment information was provided.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Amenorrhoea, Anosmia, Cough, Nasopharyngitis
Clinical narrative: Cold; Loss of smell; Loss of taste; Cough; Missed her menstrual cycle the last two month; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), COUGH (Cough) and AMENORRHOEA (Missed her menstrual cycle the last two month) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and W2C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-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 NASOPHARYNGITIS (Cold), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), COUGH (Cough), AMENORRHOEA (Missed her menstrual cycle the last two month) and PYREXIA (Fever). The patient was treated with AZITHROMYCIN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), AMENORRHOEA (Missed her menstrual cycle the last two month) and PYREXIA (Fever) outcome was unknown and ANOSMIA (Loss of smell), AGEUSIA (Loss of taste) and COUGH (Cough) had not resolved.            Concomitant medications were not provided by the reporter. Other treatment  medication included Bromphen-pse( cough medicine).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cold; Loss of smell; Loss of taste; Cough; Missed her menstrual cycle the last two month; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), COUGH (Cough) and AMENORRHOEA (Missed her menstrual cycle the last two month) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and W2C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-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 NASOPHARYNGITIS (Cold), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), COUGH (Cough), AMENORRHOEA (Missed her menstrual cycle the last two month) and PYREXIA (Fever). The patient was treated with AZITHROMYCIN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), AMENORRHOEA (Missed her menstrual cycle the last two month) and PYREXIA (Fever) outcome was unknown and ANOSMIA (Loss of smell), AGEUSIA (Loss of taste) and COUGH (Cough) had not resolved.            Concomitant medications were not provided by the reporter. Other treatment  medication included Bromphen-pse( cough medicine).