chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Red color; Very itchy; Rash in arm; Bump on arm; Heart was beating very fast like Tachycardia; Felt so bad; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color) and PRURITUS (Very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced TACHYCARDIA (Heart was beating very fast like Tachycardia) and FEELING ABNORMAL (Felt so bad). On 14-Jun-2021, the patient experienced PERIPHERAL SWELLING (Bump on arm). On an unknown date, the patient experienced ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm). At the time of the report, TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Blood pressure measurement: 173/103 (High) BP was 173/103..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  On 13-Jun-2021, at 5AM the patient got up to go to bathroom and her heart was beating very fast like Tachycardia and called 911. Her BP was 173/103 and she felt so bad but was not transported to hospital. The following day she had rash in arm with big bump, the red color lasted a week and it was very itchy.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Wheezing
Clinical narrative: Why can't I smell; Why cant i taste; can't get rid of this cough; can't get rid of this wheezing; 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 ANOSMIA (Why can't I smell), AGEUSIA (Why cant i taste), COUGH (can't get rid of this cough) and WHEEZING (can't get rid of this wheezing) 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 ANOSMIA (Why can't I smell), AGEUSIA (Why cant i taste), COUGH (can't get rid of this cough) and WHEEZING (can't get rid of this wheezing). At the time of the report, ANOSMIA (Why can't I smell), AGEUSIA (Why cant i taste), COUGH (can't get rid of this cough) and WHEEZING (can't get rid of this wheezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Bald spot appeared towards the back of her head after the first vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Bald spot appeared towards the back of her head after the first 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 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 ALOPECIA (Bald spot appeared towards the back of her head after the first vaccine). At the time of the report, ALOPECIA (Bald spot appeared towards the back of her head after the first vaccine) 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 medications were reported.    This case was linked to MOD-2021-238746 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle twitching
Clinical narrative: twitching arm spasms in the same are; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache). At the time of the report, MUSCLE TWITCHING (twitching arm spasms in the same are) and HEADACHE (severe headache) outcome was unknown.            Concomitant medication information were not provided. Patient had severe headache off and on every day. No treatment information were given. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Aphonia, Chills, Dysphonia, Fatigue, Headache
Clinical narrative: fatigued; headaches; Voice still strained; Losing voice; Chills; Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice still strained), APHONIA (Losing voice), FATIGUE (fatigued), HEADACHE (headaches) and CHILLS (Chills) in a patient of an unknown age and gender 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-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever). On 20-Jun-2021, the patient experienced DYSPHONIA (Voice still strained) and APHONIA (Losing voice). On an unknown date, the patient experienced FATIGUE (fatigued) and HEADACHE (headaches). On 20-Jun-2021, CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever) had resolved. At the time of the report, DYSPHONIA (Voice still strained), FATIGUE (fatigued) and HEADACHE (headaches) had not resolved and APHONIA (Losing voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fatigued; headaches; Voice still strained; Losing voice; Chills; Body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice still strained), APHONIA (Losing voice), FATIGUE (fatigued), HEADACHE (headaches) and CHILLS (Chills) in a patient of an unknown age and gender 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-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever). On 20-Jun-2021, the patient experienced DYSPHONIA (Voice still strained) and APHONIA (Losing voice). On an unknown date, the patient experienced FATIGUE (fatigued) and HEADACHE (headaches). On 20-Jun-2021, CHILLS (Chills), MYALGIA (Body ache) and PYREXIA (Fever) had resolved. At the time of the report, DYSPHONIA (Voice still strained), FATIGUE (fatigued) and HEADACHE (headaches) had not resolved and APHONIA (Losing voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects to first 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 VACCINATION COMPLICATION (Side effects to first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects to first dose). At the time of the report, VACCINATION COMPLICATION (Side effects to first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Vaccination site erythema
Clinical narrative: A hot spot; It has progressed to an from my shoulder down to elbow with swelling; I noticed redness in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (A hot spot), PERIPHERAL SWELLING (It has progressed to an from my shoulder down to elbow with swelling) and VACCINATION SITE ERYTHEMA (I noticed redness in the shot area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced FEELING HOT (A hot spot), PERIPHERAL SWELLING (It has progressed to an from my shoulder down to elbow with swelling) and VACCINATION SITE ERYTHEMA (I noticed redness in the shot area). At the time of the report, FEELING HOT (A hot spot), PERIPHERAL SWELLING (It has progressed to an from my shoulder down to elbow with swelling) and VACCINATION SITE ERYTHEMA (I noticed redness in the shot area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: No specific follow-up information recorded.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old male had just received his first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 20210625) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a facility administered this expired vaccine to up to 70 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a facility administered this expired vaccine to up to 70 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 EXPIRED PRODUCT ADMINISTERED (a facility administered this expired vaccine to up to 70 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a facility administered this expired vaccine to up to 70 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information or concomitant medications were provided.  Nurse stated that a facility administered this expired vaccine to up to 70 patients.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Followup received on 28-June-2021 and reporter details has been updated
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Still have itching where I got my shot; Still have redness where I got my shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my shot). At the time of the report, VACCINATION SITE PRURITUS (Still have itching where I got my shot) and VACCINATION SITE ERYTHEMA (Still have redness where I got my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in my upper arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in my upper arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in my upper arm). At the time of the report, MYALGIA (pain in my upper arm) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity
Clinical narrative: like the blood isn't flowing properly or something; left leg has been hurting all day; Feeling kind of sore/ muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (like the blood isn't flowing properly or something), PAIN IN EXTREMITY (left leg has been hurting all day) and MYALGIA (Feeling kind of sore/ muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (like the blood isn't flowing properly or something), PAIN IN EXTREMITY (left leg has been hurting all day) and MYALGIA (Feeling kind of sore/ muscle pain). At the time of the report, MALAISE (like the blood isn't flowing properly or something), PAIN IN EXTREMITY (left leg has been hurting all day) and MYALGIA (Feeling kind of sore/ muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Post herpetic neuralgia
Clinical narrative: About 10 weeks post vax my PHN got bad; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad) 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 Post herpetic neuralgia and Stenosis.    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 POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad). At the time of the report, POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided/unknown.  Treatment medication were not reported/unknown.  Company Comment: Very limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Additional information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant Follow-up  received on 06-aug-2021. patient details are updated; Sender's Comments: Very limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Myalgia
Clinical narrative: Burning in his feet ascending up his legs; severe pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in his feet ascending up his legs) and MYALGIA (severe pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-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 26-Jun-2021, the patient experienced BURNING SENSATION (Burning in his feet ascending up his legs) and MYALGIA (severe pain). At the time of the report, BURNING SENSATION (Burning in his feet ascending up his legs) and MYALGIA (severe pain) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node on armpit). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy, Product dose omission issue
Clinical narrative: Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days; later she got conceived; This spontaneous pregnancy case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Dec-2021. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Wife delayed the second dose because of early pregnancy/decided not to take 2nd covid vaccine after 28days) and PREGNANCY (later she got conceived) 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.   Patient took her 1st COVID moderna vaccine on may 16th 2021 and later she got conceived and decided not to take 2nd covid vaccine after 28days.. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: significant live follow up on 28-06-2021 was  added.Email added was added.The date of first dose was changed which Is given as 16-05-2021.Events are added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruises in arm of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruises in arm of vaccination) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruises in arm of vaccination). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CONTUSION (bruises in arm of vaccination) 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 medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Second Dose Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Second Dose Side Effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Second Dose Side Effects). At the time of the report, VACCINATION COMPLICATION (Second Dose Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    Reporter did not allow further contact
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021 at 8:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine). On 25-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An unauthorized age group patient received 1st dose of moderna vaccine instead of Pfizer vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Spot is red; Spot is itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy) 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 ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy). At the time of the report, ERYTHEMA (Spot is red) and PRURITUS (Spot is itchy) outcome was unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Discomfort, General physical health deterioration, Gingival pain, Hypoacusis
Clinical narrative: Her body is deteriorating; hard at hearing; She doesn't know what is happening; Tongue doesn't look right.; I have all of the symptoms after the vaccine; She has been experiencing pain; Her gums are sore; Her tongue is turning red; Her throat is sore now; inappropriate dose scheduling; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Her throat is sore now), PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red) and GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate dose scheduling). On 26-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Her throat is sore now). On 05-Jul-2021, the patient experienced PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore) and TONGUE ERYTHEMA (Her tongue is turning red). On 26-Jul-2021, the patient experienced PARAESTHESIA ORAL (Tongue doesn't look right.) and DISCOMFORT (I have all of the symptoms after the vaccine). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating), HYPOACUSIS (hard at hearing) and CONFUSIONAL STATE (She doesn't know what is happening). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate dose scheduling) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Her throat is sore now), PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating), HYPOACUSIS (hard at hearing), CONFUSIONAL STATE (She doesn't know what is happening), PARAESTHESIA ORAL (Tongue doesn't look right.) and DISCOMFORT (I have all of the symptoms after the vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.  On an unknown date, it was reported that the patient was administered the COVID-19 molecular test. The results were negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up recieved- Event updated , dose details updated
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Pain, Paraesthesia oral, Tongue erythema
Clinical narrative: Her body is deteriorating; hard at hearing; She doesn't know what is happening; Tongue doesn't look right.; I have all of the symptoms after the vaccine; She has been experiencing pain; Her gums are sore; Her tongue is turning red; Her throat is sore now; inappropriate dose scheduling; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Her throat is sore now), PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red) and GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate dose scheduling). On 26-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Her throat is sore now). On 05-Jul-2021, the patient experienced PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore) and TONGUE ERYTHEMA (Her tongue is turning red). On 26-Jul-2021, the patient experienced PARAESTHESIA ORAL (Tongue doesn't look right.) and DISCOMFORT (I have all of the symptoms after the vaccine). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating), HYPOACUSIS (hard at hearing) and CONFUSIONAL STATE (She doesn't know what is happening). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate dose scheduling) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Her throat is sore now), PAIN (She has been experiencing pain), GINGIVAL PAIN (Her gums are sore), TONGUE ERYTHEMA (Her tongue is turning red), GENERAL PHYSICAL HEALTH DETERIORATION (Her body is deteriorating), HYPOACUSIS (hard at hearing), CONFUSIONAL STATE (She doesn't know what is happening), PARAESTHESIA ORAL (Tongue doesn't look right.) and DISCOMFORT (I have all of the symptoms after the vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.    Treatment information was not provided.  On an unknown date, it was reported that the patient was administered the COVID-19 molecular test. The results were negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up recieved- Event updated , dose details updated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Tenderness, Ultrasound scan
Clinical narrative: swollen lymph nodes under her right arm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under her right arm) and TENDERNESS (tender to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: (normal) Clear. On an unknown date, Ultrasound scan: (normal) Clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications for Blood Pressure and Hormonal replacement.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms; chills; sore arm - "it was bad"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Antidepressant therapy, VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad"). At the time of the report, INFLUENZA LIKE ILLNESS (flulike symptoms), CHILLS (chills) and MYALGIA (sore arm - "it was bad") had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported that she was still experiencing the same side effects about 138 days later after her first and second dose. She saw her physician but they didn't know what to do for her. Treatment was reported as none taken.   This case was linked to MOD-2021-238895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event outcomes were updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination complication
Clinical narrative: Other adverse events after receiving the moderna cov-19; Had some joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain) in a 60-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain). At the time of the report, VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: antibiotic taken at time of ssecond shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (antibiotic taken at time of ssecond shot) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (antibiotic taken at time of ssecond shot). At the time of the report, ADVERSE EVENT (antibiotic taken at time of ssecond shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Vaccination site pain
Clinical narrative: Sore arm and that the shot on the right side was worse; flu-like symptoms; Chills ever since the shot/not like goosebumps chills like internal chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse), CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARIPRAZINE HYDROCHLORIDE (VRAYLAR) for Depression, VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-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 CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, VACCINATION SITE PAIN (Sore arm and that the shot on the right side was worse), CHILLS (Chills ever since the shot/not like goosebumps chills like internal chills) and INFLUENZA LIKE ILLNESS (flu-like symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-238880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains event information-no new information - Patient reported that she was still experiencing the same side effects 138 days later after her 2nd dose. On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains no new information - Patient saw her Doctor. On 21-Jul-2021: Follow-up information received on 21 Jul 2021,contains physician details added. On 27-Jul-2021: Follow Up Information received on 27 Jul 2021, chills not recovered, met doctor twice
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site erythema, Vaccination site pain
Clinical narrative: I had the shot a couple of days ago and did go down like a brick that night and the next day; the injection site is still really red on my arm; very sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I had the shot a couple of days ago and did go down like a brick that night and the next day), VACCINATION SITE ERYTHEMA (the injection site is still really red on my arm) and VACCINATION SITE PAIN (very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I had the shot a couple of days ago and did go down like a brick that night and the next day), VACCINATION SITE ERYTHEMA (the injection site is still really red on my arm) and VACCINATION SITE PAIN (very sore). At the time of the report, FEELING ABNORMAL (I had the shot a couple of days ago and did go down like a brick that night and the next day) was resolving and VACCINATION SITE ERYTHEMA (the injection site is still really red on my arm) and VACCINATION SITE PAIN (very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced dry pain on my knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experienced dry pain on my knees) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and APIXABAN (ELIQUIS) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (experienced dry pain on my knees). At the time of the report, ARTHRALGIA (experienced dry pain on my knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.   This case was linked to MOD-2021-238940.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: she started with swelling in hands; SWELLING FACE; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL and PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE). The patient was treated with CHLORPHENAMINE MALEATE (CHLOR-TRIMETON) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (she started with swelling in hands) and SWELLING FACE (SWELLING FACE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-238930 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Is feeling nausea a normal side effect; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Is feeling nausea a normal side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Is feeling nausea a normal side effect). At the time of the report, NAUSEA (Is feeling nausea a normal side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, COVID-19
Clinical narrative: I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.; One of my symptoms was canker sores in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth) 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 COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth). At the time of the report, COVID-19 (I contracted COVID-19 about 10 days after receiving my first Moderna vaccine.) and APHTHOUS ULCER (One of my symptoms was canker sores in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Next day after receiving 2nd dose, she started with noise in her head,still bothering her; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Next day after receiving 2nd dose, she started with noise in her head,still bothering her) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL and PROPRANOLOL HYDROCHLORIDE (INDERAL) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Next day after receiving 2nd dose, she started with noise in her head,still bothering her).        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.   This case was linked to MOD-2021-238917 (Patient Link).