chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: normal chills 2nd dose; headache (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)). In April 2021, CHILLS (normal chills 2nd dose) and HEADACHE (headache (2nd dose)) had resolved.            Reporter informed that Lot number was illegible on vaccination card.  No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395622, MOD-2021-395645 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 14 Doses administered beyond expiration date(Date the vial was initially stored in the refrigerator: 25Oct2021); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 Doses administered beyond expiration date(Date the vial was initially stored in the refrigerator: 25Oct2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.No Medical History information was reported. On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 Doses administered beyond expiration date(Date the vial was initially stored in the refrigerator: 25Oct2021)). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (14 Doses administered beyond expiration date(Date the vial was initially stored in the refrigerator: 25Oct2021)) 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 concomitant medications reported.No treatment information was provided.Reporter informed that 13 booster doses and one first dose (total of 14 doses) were administered with an expired vaccine. On 25-Oct-2021, the vial was initially stored in the refrigerator. No temperature excursion was reported.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid). At the time of the report, SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid) outcome was unknown.      Patient was not taking any concomitant medications.  No treatment was provided for the side effect.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no relevant medical history reported, who experienced non serious, unexpected event of Suspected COVID 19. The event occurred on an unknown date after the second dose dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose administered to a 16 year old patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to a 16 year old patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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 24-Nov-2021: Follow up received- Patient information and dose start date added
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: about 10 to 12 patients received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (about 10 to 12 patients received expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (about 10 to 12 patients received expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (about 10 to 12 patients received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired vaccine was administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Illness, Impaired work ability, Influenza like illness
Clinical narrative: Felt sick; like she is having the flu; could not do anything; was in bed the whole day; Headache; Achy; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever) had resolved.            No concomitant medication reported.   This case was linked to MOD-2021-395584, MOD-2021-395713 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Felt sick; like she is having the flu; could not do anything; was in bed the whole day; Headache; Achy; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, ILLNESS (Felt sick), INFLUENZA LIKE ILLNESS (like she is having the flu), IMPAIRED WORK ABILITY (could not do anything), HYPOKINESIA (was in bed the whole day), HEADACHE (Headache), MYALGIA (Achy) and PYREXIA (Had fever) had resolved.            No concomitant medication reported.   This case was linked to MOD-2021-395584, MOD-2021-395713 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: (mild) fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ((mild) fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced FATIGUE ((mild) fatigue). At the time of the report, FATIGUE ((mild) fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported. No treatment information was provided.  The lot number of the first dose was either 0011321A or 001B21A (hard to read). The subject received the second dose and booster dose as well.   This case was linked to MOD-2021-395738, MOD-2021-395749 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: her arm completely swelled up; the swelling has gone down but the circle with the fine bump is still there; headache that won't go away; sensitive to the touch; formed another small swollen fine circle in that area; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her arm completely swelled up), VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there), HEADACHE (headache that won't go away), VACCINATION SITE PAIN (sensitive to the touch) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (her arm completely swelled up), VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there), HEADACHE (headache that won't go away), VACCINATION SITE PAIN (sensitive to the touch) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area). In November 2021, PERIPHERAL SWELLING (her arm completely swelled up) and VACCINATION SITE SWELLING (formed another small swollen fine circle in that area) had resolved. At the time of the report, VACCINATION SITE INDURATION (the swelling has gone down but the circle with the fine bump is still there) and HEADACHE (headache that won't go away) had not resolved and VACCINATION SITE PAIN (sensitive to the touch) outcome was unknown.            No concomitant drugs were reported. No treatment drugs were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hot flush, Insomnia, Pain, Thirst
Clinical narrative: whole body is cold to the bone; she has so much pain/so painful she cannot stand it; felt so thirsty; so much body heat; she could not sleep since she was in so much pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat), INSOMNIA (she could not sleep since she was in so much pain) and FEELING COLD (whole body is cold to the bone) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat) and INSOMNIA (she could not sleep since she was in so much pain). On 23-Nov-2021, the patient experienced FEELING COLD (whole body is cold to the bone). At the time of the report, PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat), INSOMNIA (she could not sleep since she was in so much pain) and FEELING COLD (whole body is cold to the bone) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: (mild) fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ((mild) fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 0011321A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE ((mild) fatigue). At the time of the report, FATIGUE ((mild) fatigue) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395714, MOD-2021-395749 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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 RASH (rash). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: pain at injection site; headache; achy/under arm sore; really tired/Fatigue; Significantly worsened; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), HEADACHE (headache), MYALGIA (achy/under arm sore), FATIGUE (really tired/Fatigue) and CONDITION AGGRAVATED (Significantly worsened) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909 and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at injection site), HEADACHE (headache), MYALGIA (achy/under arm sore), FATIGUE (really tired/Fatigue) and CONDITION AGGRAVATED (Significantly worsened). At the time of the report, VACCINATION SITE PAIN (pain at injection site), HEADACHE (headache), MYALGIA (achy/under arm sore), FATIGUE (really tired/Fatigue) and CONDITION AGGRAVATED (Significantly worsened) outcome was unknown.            Concomitant medications were not reported. Treatment details not reported. 2 lot no. was reported for first dose of moderna   This case was linked to MOD-2021-395714, MOD-2021-395738 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Illness, Pyrexia
Clinical narrative: Sick; Fever of 103 F; Received 1mL for 1st and 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sick), PYREXIA (Fever of 103 F) and ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A, 011M21A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose). On an unknown date, the patient experienced ILLNESS (Sick) and PYREXIA (Fever of 103 F). On 13-Mar-2021, ACCIDENTAL OVERDOSE (Received 1mL for 1st and 2nd dose) had resolved. At the time of the report, ILLNESS (Sick) and PYREXIA (Fever of 103 F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other Treatment medication were reported.  After taking the Booster dose she has cold and she took Tylenol.   This case was linked to MOD-2021-395678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Nov-2021: Follow-up received on 27-Nov-2021: contains Non-Significant information.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain, Vaccination site bruising, Vaccination site pain
Clinical narrative: A bruise started coming up on his injection site arm; He could no longer lift his arm above shoulder length, or above his head; Excruciating pain if he tried to lift it or lift something above his head; A bruise started coming up on his injection site arm, & giving him a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm), LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head), PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hard of hearing.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm) and LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head). 05-Nov-2021, the patient experienced PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Nov-2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL, TRAMADOL HYDROCHLORIDE (ULTRACET) on 22-Nov-2021 for Pain, at a dose of 37.5-325mg mg take every 6 hrs twice daily for 7 days. At the time of the report, VACCINATION SITE BRUISING (A bruise started coming up on his injection site arm), LIMB DISCOMFORT (He could no longer lift his arm above shoulder length, or above his head), PAIN (Excruciating pain if he tried to lift it or lift something above his head) and VACCINATION SITE PAIN (A bruise started coming up on his injection site arm, & giving him a lot of pain) outcome was unknown.            No Concomitant medication was reported.  The patient had no pain if he let his arm just hang down. Patient called the pharmacist on 18 Nov 2021 and he told to take Tylenol and call the doctor if it didn't get better. On 22 Nov 2021 the patient went to emergency clinic (Urgent Care). The doctor gave him a mild pain pill Ultracet 37.5-325mg mg take every 6 hrs twice daily for 7 days. He only took 1 today at around 9:30am. They thought he might have a blood clot and went to Urgent Care and Doctor said he doesn't  have blood clot.  The patient had no reaction from the first 2 doses of vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Pain at injection site; Received second dose 2 weeks after the first dose (off-label); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)) and VACCINATION SITE PAIN (Pain at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)). On 22-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). In November 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Headache, Myalgia
Clinical narrative: Llittle bit of cough; Arm still hurts a little bit; I feel like I have sinus infection kind of; Fuzzy headed; Body ache; Swollen a little bit at the site, when touches it hurts; Swollen a little bit at the site, when touches it hurts; Bad chills (2nd dose); Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-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 COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts), CHILLS (Bad chills (2nd dose)) and HEADACHE (Real bad headache). At the time of the report, COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts) and CHILLS (Bad chills (2nd dose)) outcome was unknown and HEADACHE (Real bad headache) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-395585, MOD-2021-395755 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sinusitis, Vaccination site pain, Vaccination site swelling
Clinical narrative: Llittle bit of cough; Arm still hurts a little bit; I feel like I have sinus infection kind of; Fuzzy headed; Body ache; Swollen a little bit at the site, when touches it hurts; Swollen a little bit at the site, when touches it hurts; Bad chills (2nd dose); Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-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 COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts), CHILLS (Bad chills (2nd dose)) and HEADACHE (Real bad headache). At the time of the report, COUGH (Llittle bit of cough), PAIN IN EXTREMITY (Arm still hurts a little bit), SINUSITIS (I feel like I have sinus infection kind of), FEELING ABNORMAL (Fuzzy headed), MYALGIA (Body ache), VACCINATION SITE SWELLING (Swollen a little bit at the site, when touches it hurts), VACCINATION SITE PAIN (Swollen a little bit at the site, when touches it hurts) and CHILLS (Bad chills (2nd dose)) outcome was unknown and HEADACHE (Real bad headache) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-395585, MOD-2021-395755 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: There area was raised, like a pimple. It's still there.; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore). At the time of the report, VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-395776, MOD-2021-395777 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: A dark spot, It looks like a foreign object in there, It's adhered to the bottle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (A dark spot, It looks like a foreign object in there, It's adhered to the bottle) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) 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, the patient experienced PRODUCT QUALITY ISSUE (A dark spot, It looks like a foreign object in there, It's adhered to the bottle). At the time of the report, PRODUCT QUALITY ISSUE (A dark spot, It looks like a foreign object in there, It's adhered to the bottle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. It was reported that the vaccine expiration date as 01-JAN-1900.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick after 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 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 ILLNESS (felt sick after first dose). At the time of the report, ILLNESS (felt sick after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-395893 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: fatigue after receiving the second Moderna Covid-19 vaccine; Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021). On an unknown date, the patient experienced FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine). On 20-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 1Apr2021 and Patient received her second vaccine on 20APR2021) had resolved. At the time of the report, FATIGUE (fatigue after receiving the second Moderna Covid-19 vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Ankles, feet, hands and wrists are swollen; Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears; Reaction to the vaccine; Ankles, feet, hands and wrists are swollen; Rash hot; Rash bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A, 036A21A and 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears). On an unknown date, the patient experienced PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red), PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears) had not resolved.            The patient after getting the booster dose on the next day began getting a bad rash all over their body, which was hot and bright red. The patient reported it started in legs and arms but now it was spreading to back and ears. The ankles, feet, hands, and wrists were swollen. The symptoms were still going on.  Treatment medication reported also included Steroid shot on 22-Nov-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Ankles, feet, hands and wrists are swollen; Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears; Reaction to the vaccine; Ankles, feet, hands and wrists are swollen; Rash hot; Rash bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A, 036A21A and 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears). On an unknown date, the patient experienced PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reaction to the vaccine), JOINT SWELLING (Ankles, feet, hands and wrists are swollen), SKIN WARM (Rash hot), RASH ERYTHEMATOUS (Rash bright red), PERIPHERAL SWELLING (Ankles, feet, hands and wrists are swollen) and RASH (Getting a bad rash all over my body/rash in arms and legs/rash is spreading to back and ears) had not resolved.            The patient after getting the booster dose on the next day began getting a bad rash all over their body, which was hot and bright red. The patient reported it started in legs and arms but now it was spreading to back and ears. The ankles, feet, hands, and wrists were swollen. The symptoms were still going on.  Treatment medication reported also included Steroid shot on 22-Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 104.5; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever of 104.5) 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, the patient experienced PYREXIA (fever of 104.5). At the time of the report, PYREXIA (fever of 104.5) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Illness, Nausea
Clinical narrative: no appetite; looked and felt sick; nauseous; tired/fatigue; chills; felt groggy/slept; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous) and FATIGUE (tired/fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 039A21A and 065S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (felt groggy/slept). On 07-May-2021, the patient experienced NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite) and ILLNESS (looked and felt sick). At the time of the report, SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills) outcome was unknown.            The patient received the first vaccine in her left arm shoulder deltoid muscle. The patient had no adverse reactions to her first Moderna COVID-19 vaccine.   Concomitant medication of the patient was not reported.  The patient received the second vaccine in her left arm shoulder deltoid muscle.    No treatment information was provided by the reporter.  The patient received the booster dose in her left arm shoulder deltoid. The patient had no adverse reactions after her booster Moderna COVID-19 vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: no appetite; looked and felt sick; nauseous; tired/fatigue; chills; felt groggy/slept; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous) and FATIGUE (tired/fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 039A21A and 065S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (felt groggy/slept). On 07-May-2021, the patient experienced NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite) and ILLNESS (looked and felt sick). At the time of the report, SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills) outcome was unknown.            The patient received the first vaccine in her left arm shoulder deltoid muscle. The patient had no adverse reactions to her first Moderna COVID-19 vaccine.   Concomitant medication of the patient was not reported.  The patient received the second vaccine in her left arm shoulder deltoid muscle.    No treatment information was provided by the reporter.  The patient received the booster dose in her left arm shoulder deltoid. The patient had no adverse reactions after her booster Moderna COVID-19 vaccine.