chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Cardiac failure congestive
Clinical narrative: congestive heart failure/fluid build up/could hardly breath; Anemic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) (seriousness criterion medically significant) and ANAEMIA (Anemic). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) and ANAEMIA (Anemic) outcome was unknown.            No concomitant medication was reported.  Patient had first shot in 05-Feb-2021 and second shot 05-Mar-2021. One month later patient was diagnosed with congestive heart failure. Patient went to hospital could not find anything wrong. Later found that she had fluid buildup that required two trips to the doctor to drain the fluid. She was given Lasix injections since it got so bad, she could hardly breath no other symptoms. She was also found to be anemic and given blood then sent to GI doctor. She thinks in second week in month of April, she was vaccinated in the right arm.  Company Comment: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vials which undergone temperature excursion might have been administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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 PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients). At the time of the report, PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: bit foggy headed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (bit foggy headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D NOS for an unknown indication.    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 FEELING ABNORMAL (bit foggy headed). At the time of the report, FEELING ABNORMAL (bit foggy headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided for 1 st Dose   This case was linked to MOD-2021-343986, MOD-2021-343987, MOD-2021-343986 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he had COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fracture, Liver disorder and Dialysis (he was on a dialysis machine for his kidneys). Concurrent medical conditions included Congestive heart failure.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (he had COVID) (seriousness criterion death). The reported cause of death was he had Covid. It is unknown if an autopsy was performed.            Concomitant medications was not provided by the reporter Treatment information was not provided He ended up contracting COVID which pushed all these pre-existing conditions to the max and led to his death.  Company Comment: This case refers to a 61-year-old male patient with a medical history of liver disorder, congestive heart failure and on dialysis who experienced the unexpected event of COVID-19 at an unknown date after exposure to both doses of the  Moderna COVID-19 Vaccine (dates of exposure for both doses not provided). Rechallenge was assessed as not applicable due to limited information. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 61-year-old male patient with a medical history of liver disorder, congestive heart failure and on dialysis who experienced the unexpected event of COVID-19 at an unknown date after exposure to both doses of the  Moderna COVID-19 Vaccine (dates of exposure for both doses not provided). Rechallenge was assessed as not applicable due to limited information. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: he had COVID
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site reaction
Clinical narrative: Had a hard time lifting her arm/felt like a horse kicked her in the arm; Felt like had muscle failure in vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. Treatment information were not provided.   This case was linked to MOD-2021-343782 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Severe headache; fisrt dose 11 Aug 2021 and second dose on 30 Sep 2021; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (fisrt dose 11 Aug 2021 and second dose on 30 Sep 2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE from 10-Jun-2021 to an unknown date for Thyroid disorder NOS, VALACYCLOVIR [VALACICLOVIR] from 08-Jun-2021 to an unknown date for an unknown indication.   On 11-Aug-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021 at 1:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 11 Aug 2021 and second dose on 30 Sep 2021). On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 30-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 11 Aug 2021 and second dose on 30 Sep 2021) had resolved. On 02-Oct-2021, HEADACHE (headache) had resolved. Not Provided          other concomitant medications includes oral Desogstr Ethestrad Eth estra  birth control pill using from 31-july-2021. Valacyclovir is being used for HPV prevention. Oral Nature Made D3 50 mcg for general health from 01-jan-2021.  no treatment medications were reported.   This case was linked to MOD-2021-293903 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (real bad headache) 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 HEADACHE (real bad headache). At the time of the report, HEADACHE (real bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported No treatment medication was reported
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Myalgia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much). At the time of the report, ILLNESS (Got so sick), INFLUENZA (It was comparable to the worst flu she's ever had), MYALGIA (Horrible body pain/was as sick as she's ever been) and VOMITING (threw up so much) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information IV was provided. Concomitant medication was not provided.   This case was linked to MOD-2021-343774 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Induration
Clinical narrative: arm is painful; her body feels warm inside and outside; her arm is hard; aching all over; could not keep warm/ but was still cold; woke up with chills; had a fever of 100°F; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and CHILLS (woke up with chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FC1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction (she had a chemical reaction 3 years ago). Concurrent medical conditions included Alopecia, Vitiligo and Sweating (for one year she has sweats: constantly wet and dripping. Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats). Concomitant products included TRAZODONE for Sleep disorder.    On 05-Oct-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a fever of 100°F). On 06-Oct-2021 at 3:00 AM, the patient experienced FEELING COLD (could not keep warm/ but was still cold). 06-Oct-2021 at 3:00 AM, the patient experienced CHILLS (woke up with chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and MYALGIA (aching all over). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and PARAFLU [CLOFEDANOL HYDROCHLORIDE;DIPHENYLPYRALINE HYDROCHLORIDE;GUAIFENESIN;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard), CHILLS (woke up with chills), MYALGIA (aching all over) and PYREXIA (had a fever of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is currently using other Concomitant medications that she does not want to disclose further. Treatment information also included she put on socks and a cover but was still cold, a hot tea that she is about to have.   This case was linked to MOD-2021-343838, MOD-2021-343839 .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm is painful; her body feels warm inside and outside; her arm is hard; aching all over; could not keep warm/ but was still cold; woke up with chills; had a fever of 100°F; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and CHILLS (woke up with chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004FC1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergic reaction (she had a chemical reaction 3 years ago). Concurrent medical conditions included Alopecia, Vitiligo and Sweating (for one year she has sweats: constantly wet and dripping. Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats). Concomitant products included TRAZODONE for Sleep disorder.    On 05-Oct-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a fever of 100°F). On 06-Oct-2021 at 3:00 AM, the patient experienced FEELING COLD (could not keep warm/ but was still cold). 06-Oct-2021 at 3:00 AM, the patient experienced CHILLS (woke up with chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard) and MYALGIA (aching all over). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and PARAFLU [CLOFEDANOL HYDROCHLORIDE;DIPHENYLPYRALINE HYDROCHLORIDE;GUAIFENESIN;PARACETAMOL;PHENYLEPHRINE HYDROCHLORIDE] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (could not keep warm/ but was still cold), PAIN IN EXTREMITY (arm is painful), FEELING HOT (her body feels warm inside and outside), INDURATION (her arm is hard), CHILLS (woke up with chills), MYALGIA (aching all over) and PYREXIA (had a fever of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is currently using other Concomitant medications that she does not want to disclose further. Treatment information also included she put on socks and a cover but was still cold, a hot tea that she is about to have.   This case was linked to MOD-2021-343838, MOD-2021-343839 .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reactions to the first dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (reactions to the first dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions to the first dose). At the time of the report, VACCINATION COMPLICATION (reactions to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication given as  yes, does not want to disclose further.  Treatment given as :Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats.   This case was linked to MOD-2021-343810 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reactions to the second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (reactions to the second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0088712A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Alopecia and Vitiligo. Concomitant products included TRAZODONE for Sleep disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions to the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and FLUFENAMIC ACID (PARAFLU [FLUFENAMIC ACID]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (reactions to the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications: yes, does not want to disclose further. Patient has chemical reaction 3 years ago,also for one year she has sweats: constantly wet and dripping. Her PCP took her off from trazadone (for sleep) 2weeks ago, but she still gets the sweats.   This case was linked to MOD-2021-343810 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients administered dose from vial greater then 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021 at 12:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 patients administered dose from vial greater then 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided. Date the vial was initially stored in the refrigerator: 30Aug2021 at 8:45 pm   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product after taste, Vaccination site pain
Clinical narrative: tasted it; she had a sore right arm; headaches; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (tasted it), VACCINATION SITE PAIN (she had a sore right arm) and HEADACHE (headaches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-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 DYSGEUSIA (tasted it), VACCINATION SITE PAIN (she had a sore right arm) and HEADACHE (headaches). On 16-Aug-2021, HEADACHE (headaches) had resolved. At the time of the report, DYSGEUSIA (tasted it) and VACCINATION SITE PAIN (she had a sore right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported. Patient reported that she is not the kind of person who gets headaches.   This case was linked to MOD-2021-343895 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Oedematous kidney, Pain, Renal pain
Clinical narrative: In a lot of pain; Kidney area on right side started hurting really bad; Infection in right kidney; Had a swollen right kidney; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney area on right side started hurting really bad), KIDNEY INFECTION (Infection in right kidney), OEDEMATOUS KIDNEY (Had a swollen right kidney) and PAIN (In a lot of pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced RENAL PAIN (Kidney area on right side started hurting really bad), KIDNEY INFECTION (Infection in right kidney) and OEDEMATOUS KIDNEY (Had a swollen right kidney). On 06-Oct-2021, the patient experienced PAIN (In a lot of pain). At the time of the report, RENAL PAIN (Kidney area on right side started hurting really bad), KIDNEY INFECTION (Infection in right kidney) and OEDEMATOUS KIDNEY (Had a swollen right kidney) outcome was unknown and PAIN (In a lot of pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not provided. The patient does not took any medications. The patient had no underlying health issues.  On 04-Oct-2021, the patient received first dose but after nine hours, the patient had swollen right kidney and an infection in right kidney. The patient had no health issues until vaccination. The kidney area on the right side also started hurting really bad.  On 05-Oct-2021, the patient went to urgent care and was currently off work. The patient did not plan to take second vaccine. The patient received a shot of an antibiotic Cefdinir in the urgent care.   On 06-Oct-2021, the patient was in lot in pain.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had a sore arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (I had a sore arm). At the time of the report, PAIN IN EXTREMITY (I had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-343894 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received on 08- Oct -2021 contains No New Information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not have second dose of Moderna until 9 months later after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Macrobid), Allergy to animals (dust animals), Pollen allergy, Blood pressure high, Thyroid disorder NOS and Anxiety. Concomitant products included PAROXETINE from 01-Apr-2015 to an unknown date for Anxiety, HYDROCHLOROTHIAZIDE from 01-Jan-2000 to an unknown date, LISINOPRIL from 01-Jan-2000 to an unknown date and METOPROLOL from 01-Jan-2000 to an unknown date for Blood pressure high, LEVOTHYROXINE from 01-Jan-1995 to an unknown date for Thyroid disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose). On 16-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not have second dose of Moderna until 9 months later after the first dose) had resolved. Not Provided          No treatment medication was reported.   This case was linked to MOD-2021-287478 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product after taste
Clinical narrative: Tasted it; Headaches/ Headaches were so bad they brought tears to her eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-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 DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Tasted it) and HEADACHE (Headaches/ Headaches were so bad they brought tears to her eyes) outcome was unknown.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-343847 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: cannot raise my arm up my shoulder; my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot raise my arm up my shoulder) and VACCINATION SITE PAIN (my arm was really hurting, in my muscle, where the shot occurred/If I want to do anything in my right hand it really hurt) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  Concomitant medications were reported.  It was reported patient sometimes move it okay, most of the times he could not.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Both doses were expired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Both doses were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Both doses were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received the 2 doses with less than 25 days apart, and both of them were expired.  No concomitant medications were reported.  No treatment information was reported   This case was linked to MOD-2021-342394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Potentially received doses that have undergone temperature excursions; Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.; 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 (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) 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 EXPIRED PRODUCT ADMINISTERED (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Potentially received doses that have undergone temperature excursions) and PRODUCT STORAGE ERROR (Vials were stored in an ultra low freezer at -70 ºC for probably 2 weeks.) 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 were reported.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient administered dose on 2Oct2021 from vial that was beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 30-Aug-2021 at 8:45 pm, the vial was initially stored in the refrigerator and had 30 day use by date expiration of 29-Sep-2021.  As per reporter vial punctured on 2-Oct-2021 approximately around 3:35pm and Reporter declined that patient experienced any side effects that he was aware of.  No relevant concomitant medication was reported. Treatment information were not provided.      Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: 2 days of feeling bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (2 days of feeling bad) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and Vitamin D for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (2 days of feeling bad). At the time of the report, FEELING ABNORMAL (2 days of feeling bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by the reporter.   This case was linked to MOD-2021-343987, MOD-2021-343765 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: vomiting; nausea; super tired; dizzy; right arm itchy; terrible headache; fever; super high energy after the vaccination; foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird; arm hot to touch /feeling boiling hot; sleepy; right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen) and DIZZINESS (dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 29-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), PRURITUS (right arm itchy), HEADACHE (terrible headache), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination). On 30-Sep-2021, the patient experienced DIZZINESS (dizzy) and FATIGUE (super tired). On 02-Oct-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), DIZZINESS (dizzy), PRURITUS (right arm itchy), HEADACHE (terrible headache), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (super tired), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination) outcome was unknown.            This case was linked to MOD-2021-343986, MOD-2021-343765 .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Pyrexia, Somnolence
Clinical narrative: vomiting; nausea; super tired; dizzy; right arm itchy; terrible headache; fever; super high energy after the vaccination; foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird; arm hot to touch /feeling boiling hot; sleepy; right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen) and DIZZINESS (dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 29-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), PRURITUS (right arm itchy), HEADACHE (terrible headache), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination). On 30-Sep-2021, the patient experienced DIZZINESS (dizzy) and FATIGUE (super tired). On 02-Oct-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), DIZZINESS (dizzy), PRURITUS (right arm itchy), HEADACHE (terrible headache), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (super tired), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination) outcome was unknown.            This case was linked to MOD-2021-343986, MOD-2021-343765 .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Vomiting
Clinical narrative: vomiting; nausea; super tired; dizzy; right arm itchy; terrible headache; fever; super high energy after the vaccination; foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird; arm hot to touch /feeling boiling hot; sleepy; right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen) and DIZZINESS (dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 29-Sep-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), PRURITUS (right arm itchy), HEADACHE (terrible headache), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination). On 30-Sep-2021, the patient experienced DIZZINESS (dizzy) and FATIGUE (super tired). On 02-Oct-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (foggy headed/ I feel really bad./ been a week and it don't feel right./feeling weird), FEELING HOT (arm hot to touch /feeling boiling hot), SOMNOLENCE (sleepy), PERIPHERAL SWELLING (right arm swollen), DIZZINESS (dizzy), PRURITUS (right arm itchy), HEADACHE (terrible headache), VOMITING (vomiting), NAUSEA (nausea), FATIGUE (super tired), PYREXIA (fever) and THERAPEUTIC RESPONSE UNEXPECTED (super high energy after the vaccination) outcome was unknown.            This case was linked to MOD-2021-343986, MOD-2021-343765 .