chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: sickness; Covered in hive like a lobster, face, throat; face, throat, tongue swelling; face, throat, tongue swelling; face, throat, tongue swelling; vomiting and diarrhea.....; vomiting; 104 temp; felt like she had the flu; body aches; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling) and PHARYNGEAL SWELLING (face, throat, tongue swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-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) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE). On an unknown date, the patient experienced ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea.....), VOMITING (vomiting) and PYREXIA (104 temp). On 20-Mar-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), MYALGIA (body aches) and HEADACHE (HEADACHE) had resolved. At the time of the report, ILLNESS (sickness), URTICARIA (Covered in hive like a lobster, face, throat), SWELLING FACE (face, throat, tongue swelling), PHARYNGEAL SWELLING (face, throat, tongue swelling), SWOLLEN TONGUE (face, throat, tongue swelling), DIARRHOEA (vomiting and diarrhea...), VOMITING (vomiting) and PYREXIA (104 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 temp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-091854, MOD-2021-092133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 28-May-2021 included additional events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Nausea; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Muscle aches) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.    This case was linked to MOD-2021-091809.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; FEVER; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (FEVER) and CHILLS (Chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-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 HYPERHIDROSIS (Sweating), PYREXIA (FEVER) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), PYREXIA (FEVER) and CHILLS (Chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.    This case was linked to MOD-2021-091846 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: ice edge going through her skull; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (ice edge going through her skull) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (ice edge going through her skull). At the time of the report, HEADACHE (ice edge going through her skull) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia
Clinical narrative: he does not feel well; muscle pain/ muscle soreness; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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 23-Apr-2021, the patient experienced MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, MALAISE (he does not feel well), MYALGIA (muscle pain/ muscle soreness) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No relevant concomitant medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (lump at the injection site) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE MASS (lump at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (lump at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-091836 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Sweats; Fever; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) 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 18-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) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills). On 19-Apr-2021, HYPERHIDROSIS (Sweats), PYREXIA (Fever), VOMITING (Vomiting) and CHILLS (Chills) had resolved.            No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.  Reporter stated daughter missed 2 days of work due to the side effects from the second dose of vaccine.   This case was linked to MOD21-082785 (E2B Linked Report). This case was linked to MOD-2021-091829 (Patient Link).; Sender's Comments:  MOD21-082785:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Diagnosed with COVID 4 days after receiving first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine). At the time of the report, COVID-19 (Diagnosed with COVID 4 days after receiving first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drugs were not reported.  It was reported that, 4 days after the vaccination, patient was diagnosed with COVID. Received monoclonal antibodies as treatment for COVID-19.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal discomfort, Neck pain, Tinnitus, Vaccination site pain
Clinical narrative: Ringing in the ears; Neck soreness; Soreness of injection site; Fatigue; Creak in the neck; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021. The most recent information was received on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Creak in the neck), TINNITUS (Ringing in the ears), NECK PAIN (Neck soreness), VACCINATION SITE PAIN (Soreness of injection site) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient has never been diagnosed with/ tested positive for COVID-19.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SIMVASTATIN from 25-Mar-2018 to an unknown date for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Creak in the neck), NECK PAIN (Neck soreness), VACCINATION SITE PAIN (Soreness of injection site) and FATIGUE (Fatigue). On 10-Apr-2021, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Creak in the neck), TINNITUS (Ringing in the ears), NECK PAIN (Neck soreness) and VACCINATION SITE PAIN (Soreness of injection site) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported tinnitus predominately on his  left side ear/head on or around 10-Apr-2021 in the a.m. It was constant to this day. It did fluctuate from being extremely loud to moderately loud, but noticeable 24 hrs a day.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received on 28 APR 2021 updated suspect drug batch number. On 29-Jun-2021: Follow up received on 29-JUN-2021 - New event of Neck soreness added. Event outcome , Patient race , Concomitant medication updated. Event onset of tinnitus was updated. Clinical course updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: buzzing sensation in his ears within 2 days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing sensation in his ears within 2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Jan-2021, the patient experienced TINNITUS (buzzing sensation in his ears within 2 days). At the time of the report, TINNITUS (buzzing sensation in his ears within 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-091903 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091903:Second dose case
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Dental pain on and off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Dental pain on and off) 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 Pain (Dental Pain on and off for months).    On 25-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 TOOTHACHE (Dental pain on and off). The patient was treated with IBUPROFEN for Toothache, at a dose of ibuprofen 200mg 4 times daily for dental pain. At the time of the report, TOOTHACHE (Dental pain on and off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by an other caregiver and describes the occurrence of HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: Diarrhoea; headache; Pain in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhoea), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Product included Anxiety medication   This case was linked to US-MODERNATX, INC.-MOD-2021-091890 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091890:Second dose
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Limb discomfort, Muscle twitching, Muscular weakness, Myalgia
Clinical narrative: strange reaction to the Moderna COVID-19; Inflammation in different areas of her body; gluteal muscle twitching; gluteal muscle soreness; Entire left arm tight; Entire left arm sore; Entire left arm achy; Right leg tingling; Sore feet; Fatigue in her legs; Twitching in her legs; Weakness in her legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness) and LIMB DISCOMFORT (Entire left arm tight) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, ASCORBIC ACID (VITAMIN C ACID) and VITAMIN D NOS.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Feb-2021, the patient experienced VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs). At the time of the report, VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs) outcome was unknown.            Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: strange reaction to the Moderna COVID-19; Inflammation in different areas of her body; gluteal muscle twitching; gluteal muscle soreness; Entire left arm tight; Entire left arm sore; Entire left arm achy; Right leg tingling; Sore feet; Fatigue in her legs; Twitching in her legs; Weakness in her legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness) and LIMB DISCOMFORT (Entire left arm tight) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, ASCORBIC ACID (VITAMIN C ACID) and VITAMIN D NOS.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Feb-2021, the patient experienced VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs). At the time of the report, VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs) outcome was unknown.            Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: Covid-19; sneezing; sore throat; loss of taste; loss of smell; post nasal drip; Cough; lack of drug effect; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste) and ANOSMIA (loss of smell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough), DRUG INEFFECTIVE (lack of drug effect) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 24-Apr-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough) and FATIGUE (fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Up on internal review on 09-AUG-2021, An event lack of drug effect has been added. Treatment medication coded.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Sneezing, Upper-airway cough syndrome
Clinical narrative: Covid-19; sneezing; sore throat; loss of taste; loss of smell; post nasal drip; Cough; lack of drug effect; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste) and ANOSMIA (loss of smell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough), DRUG INEFFECTIVE (lack of drug effect) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 24-Apr-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Covid-19), SNEEZING (sneezing), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (loss of taste), ANOSMIA (loss of smell), UPPER-AIRWAY COUGH SYNDROME (post nasal drip), COUGH (Cough) and FATIGUE (fatigue) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Up on internal review on 09-AUG-2021, An event lack of drug effect has been added. Treatment medication coded.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable. All other events are in consistence with COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Diarrhoea, Headache, Musculoskeletal stiffness
Clinical narrative: eyes feel different; neck stiffness; craving salt; always thirsty; ringing in ears; taste disturbances; diarrhea; Arm sore; hot arm at the injection site; armpit (of the same arm as the injection) hurts; chills; slight fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty) and TINNITUS (ringing in ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache) had not resolved.            Concomitant medication included Anxiety medication for unspecified indication. Treatment medication included Tylenol to alleviate symptoms. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091871 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091871:First dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain in extremity, Pyrexia, Salt craving, Taste disorder
Clinical narrative: eyes feel different; neck stiffness; craving salt; always thirsty; ringing in ears; taste disturbances; diarrhea; Arm sore; hot arm at the injection site; armpit (of the same arm as the injection) hurts; chills; slight fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty) and TINNITUS (ringing in ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache) had not resolved.            Concomitant medication included Anxiety medication for unspecified indication. Treatment medication included Tylenol to alleviate symptoms. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091871 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091871:First dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Tinnitus, Vaccination site warmth
Clinical narrative: eyes feel different; neck stiffness; craving salt; always thirsty; ringing in ears; taste disturbances; diarrhea; Arm sore; hot arm at the injection site; armpit (of the same arm as the injection) hurts; chills; slight fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty) and TINNITUS (ringing in ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache) had not resolved.            Concomitant medication included Anxiety medication for unspecified indication. Treatment medication included Tylenol to alleviate symptoms. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091871 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091871:First dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Disorientation, Dysarthria, Dyspnoea
Clinical narrative: experiencing numbness; tingling; difficulty breathing; chest pain on left side; weak; disoriented; difficulty talking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side) and ASTHENIA (weak) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c2114or9A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Viral infection (Fluid found in his lungs).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side), ASTHENIA (weak), DISORIENTATION (disoriented) and DYSARTHRIA (difficulty talking). At the time of the report, HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side), ASTHENIA (weak), DISORIENTATION (disoriented) and DYSARTHRIA (difficulty talking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided. No treatment drugs were reported
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: experiencing numbness; tingling; difficulty breathing; chest pain on left side; weak; disoriented; difficulty talking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side) and ASTHENIA (weak) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c2114or9A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Viral infection (Fluid found in his lungs).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side), ASTHENIA (weak), DISORIENTATION (disoriented) and DYSARTHRIA (difficulty talking). At the time of the report, HYPOAESTHESIA (experiencing numbness), PARAESTHESIA (tingling), DYSPNOEA (difficulty breathing), CHEST PAIN (chest pain on left side), ASTHENIA (weak), DISORIENTATION (disoriented) and DYSARTHRIA (difficulty talking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided. No treatment drugs were reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chemotherapy
Clinical narrative: Chemotherapy; This spontaneous case was reported by a consumer and describes the occurrence of CHEMOTHERAPY (Chemotherapy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On 29-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 CHEMOTHERAPY (Chemotherapy). On 15-Apr-2021, CHEMOTHERAPY (Chemotherapy) outcome was unknown. Not Provided      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 patient will start radiation soon.   This case was linked to MOD-2021-091916 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, No adverse event
Clinical narrative: No adverse reaction; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (History of allergies).   On 25-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 25-Apr-2021, the patient experienced NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness). At the time of the report, NO ADVERSE EVENT (No adverse reaction) and FATIGUE (Tiredness) outcome was unknown.            Concomitant product use was unknown by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: felt very sick; face was red; lethargic; felt like she got hit by a train; very tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train) and FATIGUE (very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-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 MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever). At the time of the report, MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided .  No treatment medications are provided
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt very sick; face was red; lethargic; felt like she got hit by a train; very tired; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train) and FATIGUE (very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-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 MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever). At the time of the report, MALAISE (felt very sick), ERYTHEMA (face was red), LETHARGY (lethargic), FEELING ABNORMAL (felt like she got hit by a train), FATIGUE (very tired) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided .  No treatment medications are provided
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Ear pain, Headache, Hot flush
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening) and chills in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 21, 2021,  patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unspecified dose. On Apr 21, 2021, patient had muscle tightness (muscles started tightening), chills and vomiting (puked 3 or 4 times). On Apr 22, 2021, patient experienced back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt) and aching headache. At the time of the report, back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening), chills, vomiting (puked 3 or 4 times) and aching headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening) and chills in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 21, 2021,  patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; unspecified dose. On Apr 21, 2021, patient had muscle tightness (muscles started tightening), chills and vomiting (puked 3 or 4 times). On Apr 22, 2021, patient experienced back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt) and aching headache. At the time of the report, back pain (back started hurting/felt like compressions), hot flush (hot flashes), ear pain (back of her ears hurt), muscle tightness (muscles started tightening), chills, vomiting (puked 3 or 4 times) and aching headache outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After 2nd dose, buzzing sensation got worse and he still has buzzing sensation; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Feb-2021, the patient experienced TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation). At the time of the report, TINNITUS (After 2nd dose, buzzing sensation got worse and he still has buzzing sensation) had not resolved. Not Provided          No concomitant medication and treatment information were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091861 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091861:First dose case