chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Muscle spasms, Musculoskeletal discomfort, Oropharyngeal discomfort, Photopsia
Clinical narrative: Speech impaired; Dominance difficulty in understanding speech,; Tired; Eyes hurting; I feel like I want to go to sleep; Eyes flashing; Breathing problems; Cramps in legs and buttocks; Hair problems; Throat is bothering me; My neck and joints is bothering me; My armpits are bothering me; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) 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 was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] and SIMETICONE (GAS RELIEF) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) and DISCOMFORT (My armpits are bothering me). On 07-Jun-2021, the patient experienced EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing) and FATIGUE (Tired). On an unknown date, the patient experienced SPEECH DISORDER (Speech impaired) and MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,). At the time of the report, DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me), DISCOMFORT (My armpits are bothering me), EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing), SPEECH DISORDER (Speech impaired), MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,) and FATIGUE (Tired) was resolving.        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.   The patient states she was taking some medications for her mind, for breathing. The patient gave medications that are prescribed to her, which were not specified.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021:  updated
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder
Clinical narrative: Speech impaired; Dominance difficulty in understanding speech,; Tired; Eyes hurting; I feel like I want to go to sleep; Eyes flashing; Breathing problems; Cramps in legs and buttocks; Hair problems; Throat is bothering me; My neck and joints is bothering me; My armpits are bothering me; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) 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 was provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] and SIMETICONE (GAS RELIEF) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me) and DISCOMFORT (My armpits are bothering me). On 07-Jun-2021, the patient experienced EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing) and FATIGUE (Tired). On an unknown date, the patient experienced SPEECH DISORDER (Speech impaired) and MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,). At the time of the report, DYSPNOEA (Breathing problems), MUSCLE SPASMS (Cramps in legs and buttocks), HAIR DISORDER (Hair problems), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), MUSCULOSKELETAL DISCOMFORT (My neck and joints is bothering me), DISCOMFORT (My armpits are bothering me), EYE PAIN (Eyes hurting), SOMNOLENCE (I feel like I want to go to sleep), PHOTOPSIA (Eyes flashing), SPEECH DISORDER (Speech impaired), MOTOR DYSFUNCTION (Dominance difficulty in understanding speech,) and FATIGUE (Tired) was resolving.        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.   The patient states she was taking some medications for her mind, for breathing. The patient gave medications that are prescribed to her, which were not specified.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021:  updated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ANASTROZOLE for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm). At the time of the report, VACCINATION SITE RASH (side effect occur locally at the injection site/rush about 2 and 1/2 by 3 inches at injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Dizziness; Weird feeling, feeling "off", Feeling hypnotized; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FEELING ABNORMAL (Weird feeling, feeling "off", Feeling hypnotized) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (Dizziness) and FEELING ABNORMAL (Weird feeling, feeling "off", Feeling hypnotized). At the time of the report, DIZZINESS (Dizziness) and FEELING ABNORMAL (Weird feeling, feeling "off", Feeling hypnotized) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Sinusitis
Clinical narrative: Second shot was due on 03JUN2021 but she missed it due to her sinus infection; Sinus Infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection) and PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SINUSITIS (Sinus Infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection). At the time of the report, SINUSITIS (Sinus Infection) had not resolved and PRODUCT DOSE OMISSION ISSUE (Second shot was due on 03JUN2021 but she missed it due to her sinus infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medications includes antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles) 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 HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  The patient enquired whether Is it safe to receive the second dose during a course of antivirals for shingles No treatment information provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: my hole body was aching; having like nauseas; headache; had a lot of fatigue; started shaking; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas) and HEADACHE (headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (started shaking) and PYREXIA (fever). On 12-May-2021, the patient experienced MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-May-2021, TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Vitamin supplements for an unknown indication. Patient reported that he felt like when he had COVID.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: my hole body was aching; having like nauseas; headache; had a lot of fatigue; started shaking; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas) and HEADACHE (headache) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (started shaking) and PYREXIA (fever). On 12-May-2021, the patient experienced MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-May-2021, TREMOR (started shaking), PYREXIA (fever), MYALGIA (my hole body was aching), NAUSEA (having like nauseas), HEADACHE (headache) and FATIGUE (had a lot of fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Vitamin supplements for an unknown indication. Patient reported that he felt like when he had COVID.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I had problems with my lymph nodes swelling; I am having a lot of problems with my left lymph nodes under my breast., They are really sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I had problems with my lymph nodes swelling) and LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast., They are really sore and painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and GERD. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, OMEPRAZOLE for GERD.    On 05-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 LYMPHADENOPATHY (I had problems with my lymph nodes swelling) and LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast., They are really sore and painful). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (I had problems with my lymph nodes swelling) and LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast., They are really sore and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-211470   (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Attempting to receive the second dose of the vaccine 21 days after the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Attempting to receive the second dose of the vaccine 21 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR added. No new information added.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Really pink; Hard; Scratchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040521A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-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 VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy). At the time of the report, VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported. No treatment medication were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: I had problems with my lymph nodes swelling; I have not been well since I had it.; I am having a lot of problems with my left lymph nodes under my breast.,They are really sore and painful/gradually getting worse.; I am exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I had problems with my lymph nodes swelling), MALAISE (I have not been well since I had it.), LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast.,They are really sore and painful/gradually getting worse.) and FATIGUE (I am exhausted all the time) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and GERD. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Depression, OMEPRAZOLE for GERD.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 LYMPHADENOPATHY (I had problems with my lymph nodes swelling), MALAISE (I have not been well since I had it.), LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast.,They are really sore and painful/gradually getting worse.) and FATIGUE (I am exhausted all the time). The patient was treated with PARACETAMOL (TYLENOL) at a dose of occasionally. At the time of the report, LYMPHADENOPATHY (I had problems with my lymph nodes swelling), MALAISE (I have not been well since I had it.), LYMPH NODE PAIN (I am having a lot of problems with my left lymph nodes under my breast.,They are really sore and painful/gradually getting worse.) and FATIGUE (I am exhausted all the time) outcome was unknown.            The patient had both the vaccines and had problems with their lymph nodes swelling. The patient stated it went down after a while, but the patient was having a lot of problems with their left lymph nodes under their breast. They were really sore and painful. The patient reported that they never had this problem before and had bad reactions to both doses. The patient also reported that most recently about 2 weeks before when this started and it went away after the initial couple of weeks, but it started back two weeks ago and was gradually getting worse.   Reportedly, the patient has not been well since vaccine and felt exhausted all the time.  The patient took concomitant medications Lexapro for depression x 8 years and Omeprazole 40 mg for stomach issues (GERD) x 6 years   This case was linked to MOD-2021-211466 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Invalid doses delivered to 4 patients; 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 EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid doses delivered to 4 patients) 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 reported by the reporter. No treatment medications were reported by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Feeling abnormal, Lymphadenopathy, Skin tightness, Swelling face
Clinical narrative: Side of face particularly in right ear lobe's lymph glad was swollen; The skin felt tight; It was like very freaky; Side of face particularly in right ear lobe's lymph glad was swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen). The patient was treated with CLINDAMYCIN at a dose of 150 mg. At the time of the report, SWELLING FACE (Side of face particularly in right ear lobe's lymph glad was swollen), SKIN TIGHTNESS (The skin felt tight), FEELING ABNORMAL (It was like very freaky) and LYMPHADENOPATHY (Side of face particularly in right ear lobe's lymph glad was swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was  received and the event outcome was updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of rash (in arms and upper legs), vaccination site pruritus (very itchy wanted to tear her skin off) and vaccination site rash  (around site of injection) in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 023C21A and 016C21A) for COVID-19 immunization. Concomitant products included Tylenol (paracetamol) for an unknown indication. On Apr 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (in arms and upper legs), vaccination site pruritus (very itchy wanted to tear her skin off) and vaccination site rash (around site of injection). At the time of the report, rash (in arms and upper legs) and vaccination site rash (around site of injection) resolved; and vaccination site pruritus (very itchy wanted to tear her skin off) outcome: unknown. No treatment details reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder hurts when using arm/ it is slightly sore, very little when he touches it; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it). At the time of the report, ARTHRALGIA (Shoulder hurts when using arm/ it is slightly sore, very little when he touches it) had not resolved.            Concomitant medications were not provided by the reporter. No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Light headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache) and FATIGUE (Tiredness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Gout and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, ALOPURINOL for Gout.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced HEADACHE (Light headache) and FATIGUE (Tiredness). On 16-May-2021, HEADACHE (Light headache) had resolved. On 29-May-2021, FATIGUE (Tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy). At the time of the report, RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy) outcome was unknown.            No relevant concomitant medications were reported.  No treatment details were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Rash, Somnolence, Vaccination site pain
Clinical narrative: Patient is suffering from headaches very seldom; I woke up and noticed on both legs, red points like a rash, just in the front/both arms internal parts, from elbow to wrist, same rash that I have on my legs/a rash on my back, neck and cheeks/belly, palms, and hands and head; I was sleepy; Very little dizziness/I woke up really dizzy for 3 days and then I felt better; Pain in my arm where received the vaccine/a little pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very little dizziness/I woke up really dizzy for 3 days and then I felt better), SOMNOLENCE (I was sleepy), RASH (I woke up and noticed on both legs, red points like a rash, just in the front/both arms internal parts, from elbow to wrist, same rash that I have on my legs/a rash on my back, neck and cheeks/belly, palms, and hands and head), VACCINATION SITE PAIN (Pain in my arm where received the vaccine/a little pain in my arm) and HEADACHE (Patient is suffering from headaches very seldom) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in my arm where received the vaccine/a little pain in my arm). On 19-May-2021, the patient experienced DIZZINESS (Very little dizziness/I woke up really dizzy for 3 days and then I felt better). On 20-May-2021, the patient experienced SOMNOLENCE (I was sleepy). On 05-Jun-2021, the patient experienced RASH (I woke up and noticed on both legs, red points like a rash, just in the front/both arms internal parts, from elbow to wrist, same rash that I have on my legs/a rash on my back, neck and cheeks/belly, palms, and hands and head). On an unknown date, the patient experienced HEADACHE (Patient is suffering from headaches very seldom). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date at a dose of UNK dosage form, qd. At the time of the report, DIZZINESS (Very little dizziness/I woke up really dizzy for 3 days and then I felt better), RASH (I woke up and noticed on both legs, red points like a rash, just in the front/both arms internal parts, from elbow to wrist, same rash that I have on my legs/a rash on my back, neck and cheeks/belly, palms, and hands and head) and VACCINATION SITE PAIN (Pain in my arm where received the vaccine/a little pain in my arm) had not resolved and SOMNOLENCE (I was sleepy) and HEADACHE (Patient is suffering from headaches very seldom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant products included ZINC, VITAMIN C , VITAMIN D and FISH OIL for an unknown indication.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose of Moderna vaccine, passed 42 days after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine, passed 42 days after the 1st 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine, passed 42 days after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine, passed 42 days after the 1st dose) had resolved.            Concomitant product use was not provided. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection; Fatigue; Chills; Brain fog; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection), FATIGUE (Fatigue) and CHILLS (Chills) in a 38-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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), FATIGUE (Fatigue) and CHILLS (Chills) had resolved and PAIN IN EXTREMITY (Soreness in arm of injection /Today she stated she has occasional on and off soreness in arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Above mentioned events were experienced after patient received second dose of vaccine on unspecified date. No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-017694 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (head cold) 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 NASOPHARYNGITIS (head cold). At the time of the report, NASOPHARYNGITIS (head cold) outcome was unknown.        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.   No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose (46 days since first one); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)). On 07-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) had resolved.            No concomitant medication was reported by the reporter. No treatment medications were reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose over 42 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TORSEMIDE for Blood pressure, ROSUVASTATIN for Cholesterol, FLUCONAZOLE for Fungal dermatitis NOS, PANTOPRAZOLE for GERD, FAMOTIDINE for Gastroesophageal reflux disease, LAMOTRIGINE for Psychological disorder NOS, SUCRALFATE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort
Clinical narrative: symptoms in her legs; brain fog; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches). At the time of the report, LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were provided by the reporter.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic to moderna vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic to moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No information regarding corrective treatment was reported by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after 2nd shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing after 2nd shot). At the time of the report, COUGH (Coughing after 2nd shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient given expired vaccine) had resolved.        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 product use was not provided by the reporter.   ? No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received on 10 -Jun-2021 had no new information.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swollen; Red; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch) 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 05-Jun-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 05-Jun-2021, the patient experienced SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch). At the time of the report, SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch) outcome was unknown.            No concomitant medication reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Hand numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand numbness) 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 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 HYPOAESTHESIA (Hand numbness). At the time of the report, HYPOAESTHESIA (Hand numbness) outcome was unknown.            No concomitant information was reported. Treatment information was not reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: it will be more than 42 days after first vaccine dose; as painful as it was; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (as painful as it was) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     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 23-Apr-2021, the patient experienced PAIN (as painful as it was). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose). At the time of the report, PAIN (as painful as it was) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it will be more than 42 days after first vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter. for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment