chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (I was totally deaf in one ear) 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 04-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing). On 07-Apr-2021, the patient experienced DEAFNESS UNILATERAL (I was totally deaf in one ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (I was totally deaf in one ear), HYPOACUSIS (had mild hearing loss in the other) and HYPOACUSIS (problems with my hearing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication was reported. SD narrative:  I received my second Moderna shot on April 4th.  By April 6th I was having problems with my hearing.  By April 7th I was totally deaf in one ear and had mild hearing loss in the other.  Went to a ENT and" No Treatment was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Events seriousness per IME list
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a vaccine that was punctured over the weekend then given to her on Monday.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was punctured over the weekend then given to her on Monday.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and no treatment medications were reported.  Reporter asking about storage and handling.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old). On 19-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received the first dose of the Moderna COVID-19 vaccine in February; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received the first dose of the Moderna COVID-19 vaccine in February) had resolved.            No Concomitant medication were reported.  No treatment medication were reported.  The patient now wants to get the second dose. The patient explained they lost their vaccine card and would like to know how to get a replacement?
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Missed the second dose more than 3 months a go; Sick with her other medical conditions after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick with her other medical conditions after first dose) and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Sick with her other medical conditions after first dose). On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go). At the time of the report, ILLNESS (Sick with her other medical conditions after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed the second dose more than 3 months a go) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia, Insomnia, Mobility decreased, Vaccination site pain
Clinical narrative: hard to pick up my son with both hands; range of motion is completely messed up; not sleeping well,cannot find a position to sleep in; exhausted of having shoulder pain; extreme pain in our shoulders on the side where we got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and CYCLOBENZAPRINE for Adverse event, at a dose of Unknown. At the time of the report, HYPOKINESIA (hard to pick up my son with both hands), MOBILITY DECREASED (range of motion is completely messed up), INSOMNIA (not sleeping well,cannot find a position to sleep in), ARTHRALGIA (exhausted of having shoulder pain) and VACCINATION SITE PAIN (extreme pain in our shoulders on the side where we got the vaccine) outcome was unknown.            No concomitant medications were reported.  It has mentioned that the patient healthcare professional thought that the shoulder pain may be due to an injury during the administration of the vaccine, got recommended physical therapy, using pain killers and taking sleeping pills for the symptoms.   This case was linked to MOD-2021-288027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Patient demographic details were added.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: contracted COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (contracted COVID-19). At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  It was reported that patient contracted COVID-19 in the middle on 24 Jul 2 021 or 25 Jul 2021.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Had a metal implant in his right leg and his foot  turned in; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in). At the time of the report, LIMB DISCOMFORT (Had a metal implant in his right leg and his foot  turned in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The reporter stated that her husband had undergone a surgery in his right leg but was not sure whether it was performed before or after the vaccination. The reporter was also not sure whether he was administered with both doses of vaccine or not.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Myalgia
Clinical narrative: first shot made me fell like the flu with no temperture; No energy; lot od muscle ackes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes) in an 86-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes). At the time of the report, INFLUENZA LIKE ILLNESS (first shot made me fell like the flu with no temperture), ASTHENIA (No energy) and MYALGIA (lot od muscle ackes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Product information was provided. No Treatment Medication was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: she had headache every morning; and is very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had headache every morning) and FATIGUE (and is very tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A or 014M20A) for COVID-19 vaccination.     No Medical History information was reported.  The patient's past medical history included Chickenpox. Concomitant products included DICLOFENAC for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (she had headache every morning) and FATIGUE (and is very tired). At the time of the report, HEADACHE (she had headache every morning) and FATIGUE (and is very tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter   This case was linked to MOD-2021-288281 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Malaise, Nasal congestion
Clinical narrative: coughing up mucus; stuffy nose; lost sense of taste; lost sense of smell; headache; throwing up; The next day was feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced MALAISE (The next day was feeling really sick). On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Vomiting
Clinical narrative: coughing up mucus; stuffy nose; lost sense of taste; lost sense of smell; headache; throwing up; The next day was feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced MALAISE (The next day was feeling really sick). On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurting from first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Arm hurting from first dose) 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 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (Arm hurting from first dose). At the time of the report, VACCINATION SITE PAIN (Arm hurting from first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. Pharmacist called regarding a patient who received both doses of Moderna Vaccine but his arm was still hurting from his first dose when getting the second one on the same arm. Pharmacist wanted to know if patient can take painkillers.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash, Vaccination site discolouration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccination site hot to touch; developed a rash; Vaccination site very swollen; her arm is still sore; red and blue arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No medical history for the patient was reported.  Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE SWELLING (Vaccination site very swollen) and MYALGIA (her arm is still sore). In July 2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch) and RASH (developed a rash). The patient was treated with PARACETAMOL (TYLENOL) on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency and LORATADINE on 08-Aug-2021 for Vaccination site erythema, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (red and blue arm), VACCINATION SITE WARMTH (Vaccination site hot to touch), RASH (developed a rash) and VACCINATION SITE SWELLING (Vaccination site very swollen) was resolving and MYALGIA (her arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Oxygen saturation, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: low grade fever; experienced pounding tachycardia; Shortness of breath; inappropriate age at the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (experienced pounding tachycardia), DYSPNOEA (Shortness of breath), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) and PYREXIA (low grade fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0077727399/012M20A and 0077727399/031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa(rash)), Allergy (many Airborne allergy), Food allergy (some food) and Autism spectrum disorder since 23-Nov-2003. Concomitant products included MELATONIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination). On 13-Mar-2021, the patient experienced TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced PYREXIA (low grade fever). On 13-Mar-2021, TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) had resolved and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Oxygen saturation: 92 percent (Inconclusive) 92 percent oxygen saturation per pulse oximeter. On an unknown date, Body temperature: inconclusive (Inconclusive) low grade fever.         No treatment medications were reported.   This case was linked to MOD-2021-035571 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: low grade fever; experienced pounding tachycardia; Shortness of breath; inappropriate age at the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (experienced pounding tachycardia), DYSPNOEA (Shortness of breath), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) and PYREXIA (low grade fever) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0077727399/012M20A and 0077727399/031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa(rash)), Allergy (many Airborne allergy), Food allergy (some food) and Autism spectrum disorder since 23-Nov-2003. Concomitant products included MELATONIN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination). On 13-Mar-2021, the patient experienced TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced PYREXIA (low grade fever). On 13-Mar-2021, TACHYCARDIA (experienced pounding tachycardia) and DYSPNOEA (Shortness of breath) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at the vaccination) had resolved and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Oxygen saturation: 92 percent (Inconclusive) 92 percent oxygen saturation per pulse oximeter. On an unknown date, Body temperature: inconclusive (Inconclusive) low grade fever.         No treatment medications were reported.   This case was linked to MOD-2021-035571 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received Pfizer vaccine for first two doses and Moderna vaccine for third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Patient received both doses of the Pfizer vaccine. The patient took a Booster dose of the Moderna Covid-19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Lymphadenopathy
Clinical narrative: heartburn; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) 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 DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling). At the time of the report, DYSPEPSIA (heartburn) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Since then she has has aches in her thigh area.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Since then she has has aches in her thigh area.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D211A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Since then she has has aches in her thigh area.). On 02-Aug-2021, PAIN IN EXTREMITY (Since then she has has aches in her thigh area.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is scheduled for shoulder surgery on 31-Aug and 2nd dose is due 23-Aug-2021.  No concomitant medication was reported.  The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Ocular hyperaemia
Clinical narrative: Received 3rd dose; Bloodshot eyes; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 EXTRA DOSE ADMINISTERED (Received 3rd dose) and OCULAR HYPERAEMIA (Bloodshot eyes). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3rd dose) had resolved and OCULAR HYPERAEMIA (Bloodshot eyes) outcome was unknown.            No concomitant medications information were reported. Patient had 3rd dose of Moderna COVID-19 vaccine and experienced bloodshot eyes at the time of report. No treatment medications were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Headache, Nausea, Pain in extremity, Tenderness
Clinical narrative: there was a sewer smell and she couldn't smell it; tender; when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her; nausea; had a headache every day for almost a whole week since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concurrent medical conditions included Diabetes, Blood pressure high and Neuropathy. Concomitant products included METFORMIN, GLIMEPIRIDE, LISINOPRIL, GABAPENTIN (NEURONTIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (there was a sewer smell and she couldn't smell it). August 2021, the patient experienced TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 220 mg. At the time of the report, ANOSMIA (there was a sewer smell and she couldn't smell it), TENDERNESS (tender), PAIN IN EXTREMITY (when she is laying down on her side, it hurts/her left arm is still sore and still aggravates her), NAUSEA (nausea) and HEADACHE (had a headache every day for almost a whole week since vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia oral, Product dose omission issue
Clinical narrative: Red face; Tingly tongue and lips; I did not receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-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 ERYTHEMA (Red face), PARAESTHESIA ORAL (Tingly tongue and lips) and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose). At the time of the report, ERYTHEMA (Red face) and PARAESTHESIA ORAL (Tingly tongue and lips) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I did not receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment drugs were not reported by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), IBUPROFEN, ATENOLOL, ALBUTEROL [SALBUTAMOL] and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided by the reporter.   This case was linked to MOD-2021-289346 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest injury, Erythema, Limb discomfort, Limb injury, Mobility decreased
Clinical narrative: Something hit his shoulder,It's a pretty hard hit; there is a little red on the top of his shoulder; there is a little swelling on the top of his shoulder; Turned red around the skin area where he got the vaccine; something hit his chest; His right hand feels very heavy; He could hardly lift it up to his head level; This spontaneous case was reported by a consumer and describes the occurrence of CHEST INJURY (something hit his chest) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced LIMB DISCOMFORT (His right hand feels very heavy) and MOBILITY DECREASED (He could hardly lift it up to his head level). On an unknown date, the patient experienced CHEST INJURY (something hit his chest) (seriousness criterion medically significant), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine). At the time of the report, CHEST INJURY (something hit his chest), LIMB DISCOMFORT (His right hand feels very heavy), MOBILITY DECREASED (He could hardly lift it up to his head level), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema
Clinical narrative: Something hit his shoulder,It's a pretty hard hit; there is a little red on the top of his shoulder; there is a little swelling on the top of his shoulder; Turned red around the skin area where he got the vaccine; something hit his chest; His right hand feels very heavy; He could hardly lift it up to his head level; This spontaneous case was reported by a consumer and describes the occurrence of CHEST INJURY (something hit his chest) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced LIMB DISCOMFORT (His right hand feels very heavy) and MOBILITY DECREASED (He could hardly lift it up to his head level). On an unknown date, the patient experienced CHEST INJURY (something hit his chest) (seriousness criterion medically significant), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine). At the time of the report, CHEST INJURY (something hit his chest), LIMB DISCOMFORT (His right hand feels very heavy), MOBILITY DECREASED (He could hardly lift it up to his head level), LIMB INJURY (Something hit his shoulder,It's a pretty hard hit), ERYTHEMA (there is a little red on the top of his shoulder), SWELLING (there is a little swelling on the top of his shoulder) and VACCINATION SITE ERYTHEMA (Turned red around the skin area where he got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Stomach Ache; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002S21A) for COVID-19 vaccination.     Concomitant products included DOCUSATE SODIUM (COLACE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]), PHENYTOIN (DILANTIN [PHENYTOIN]), CHLORPROMAZINE, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), MIRABEGRON (MYRBETRIQ), OMEPRAZOLE, SIMVASTATIN, PARACETAMOL (TYLENOL), MAGNESIUM HYDROXIDE (MILK OF MAGNESIA) and ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MAALOX ALUM MILK) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 14-Aug-2021, the patient experienced DIARRHOEA (Diarrhea). On 17-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 14-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose was given 6 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago) 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 PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose was given 6 months ago) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication reported.  No treatment medication provided.  The patient had already waited more than 1 month for the second dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Illness, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Injected arm feels like having a knot. It is warm, hot to the touch; like when you are getting sick; scratchy feeling in throat, throat felt weird; dry cough a little bit; sore throat; throat felt weird; Injected arm feels like having a knot; thumb sore in the joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit) and OROPHARYNGEAL PAIN (sore throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit), OROPHARYNGEAL PAIN (sore throat), OROPHARYNGEAL DISCOMFORT (throat felt weird), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint). On 10-Aug-2021, THROAT IRRITATION (scratchy feeling in throat, throat felt weird), OROPHARYNGEAL PAIN (sore throat) and OROPHARYNGEAL DISCOMFORT (throat felt weird) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), COUGH (dry cough a little bit), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Cholesterol medication. No treatment medications were provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site induration, Vaccination site warmth
Clinical narrative: Injected arm feels like having a knot. It is warm, hot to the touch; like when you are getting sick; scratchy feeling in throat, throat felt weird; dry cough a little bit; sore throat; throat felt weird; Injected arm feels like having a knot; thumb sore in the joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit) and OROPHARYNGEAL PAIN (sore throat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), THROAT IRRITATION (scratchy feeling in throat, throat felt weird), COUGH (dry cough a little bit), OROPHARYNGEAL PAIN (sore throat), OROPHARYNGEAL DISCOMFORT (throat felt weird), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint). On 10-Aug-2021, THROAT IRRITATION (scratchy feeling in throat, throat felt weird), OROPHARYNGEAL PAIN (sore throat) and OROPHARYNGEAL DISCOMFORT (throat felt weird) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injected arm feels like having a knot. It is warm, hot to the touch), ILLNESS (like when you are getting sick), COUGH (dry cough a little bit), VACCINATION SITE INDURATION (Injected arm feels like having a knot) and ARTHRALGIA (thumb sore in the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Cholesterol medication. No treatment medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: mixed normal saline with Moderna COVID19 vial; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial). On 17-Aug-2021, PRODUCT PREPARATION ISSUE (mixed normal saline with Moderna COVID19 vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported. No treatment was reported.  It was reported that when administering the Moderna COVID-19 vaccine, the medical assistant mixed normal saline with the Moderna vaccine vial. She mixed 2 mLs of normal saline into the vial of the vaccine and administered 0.5 mL to each patient. The patient was not experiencing any symptoms and was monitored for 15 minutes. This was the second dose for the patient.