chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Lost the appetite.; Fatigue, exhaustion; Fever; Felt pretty sick for two days; Spasm and cramping in both legs; Pain was like more than 10, screaming because of the pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt pretty sick for two days), MUSCLE SPASMS (Spasm and cramping in both legs), PAIN (Pain was like more than 10, screaming because of the pain), DECREASED APPETITE (Lost the appetite.) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS], AMLODIPINE BESILATE (NORVASC) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (Felt pretty sick for two days), PAIN (Pain was like more than 10, screaming because of the pain) and PYREXIA (Fever). 04-Feb-2021, the patient experienced MUSCLE SPASMS (Spasm and cramping in both legs). On 05-Feb-2021, the patient experienced DECREASED APPETITE (Lost the appetite.) and FATIGUE (Fatigue, exhaustion). At the time of the report, ILLNESS (Felt pretty sick for two days), MUSCLE SPASMS (Spasm and cramping in both legs), PAIN (Pain was like more than 10, screaming because of the pain), DECREASED APPETITE (Lost the appetite.), PYREXIA (Fever) and FATIGUE (Fatigue, exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 99°f (High) 99°F.         Concomitant medication included blood pressure pill. Treatment information included lots of heat and blanket to make the patient more comfortable.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Non significant follow up appended and AE contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 40-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 02-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 02-Apr-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  No medical problems or concomitant medications provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Red rash at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash at injection site) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 01-Apr-2021, the patient experienced VACCINATION SITE RASH (Red rash at injection site). At the time of the report, VACCINATION SITE RASH (Red rash at injection site) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm still sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Right arm still sore at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Right arm still sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Right arm still sore at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue, Product storage error
Clinical narrative: Temperature dropped in the freezer where vaccines were stored; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was reported.     On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored). On 02-Apr-2021, PRODUCT QUALITY ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Temperature dropped in the freezer where vaccines were stored) had resolved. Not Provided      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.   On an unknown date, there was temperature drop to -13.79C in the freezer for 47 min while 12C in the refrigerator for 59 min which contained vials. Doses were given to 63 patients. No Concomitant  information was  provided. No Treatment information was  provided.    This case was linked to MOD-2021-066578 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medicines were reported. No treatment information were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Malaise, Product dose omission issue, Rhinorrhoea
Clinical narrative: Has not received 2nd dose yet; felt sick; felt bad; runny nose; Felt like she was coming down with something; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose), DEPRESSED MOOD (Felt like she was coming down with something) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose) and DEPRESSED MOOD (Felt like she was coming down with something). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet). At the time of the report, MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose) and DEPRESSED MOOD (Felt like she was coming down with something) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose delayed to kidney transplant; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose delayed to kidney transplant) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose delayed to kidney transplant). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose delayed to kidney transplant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps). At the time of the report, MUSCLE SPASMS (Cramps) outcome was unknown.            Treatment included ibuprofen.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: had swollen eyelids; fever 99F; cough; some pain in the kidneys; agitaded breath; fogginess; tiredness; difficulty sleeping; chills; congestion in his nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), INSOMNIA (difficulty sleeping), COUGH (cough) and DYSPNOEA (agitaded breath) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Medullary sponge kidney.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NASAL CONGESTION (congestion in his nose). On 27-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess) and FATIGUE (tiredness). On 01-Apr-2021, the patient experienced DYSPNOEA (agitaded breath). On 02-Apr-2021, the patient experienced RENAL PAIN (some pain in the kidneys). On an unknown date, the patient experienced COUGH (cough), SWELLING OF EYELID (had swollen eyelids) and PYREXIA (fever 99F). The patient was treated with IBUPROFEN for Fever, at a dose of 2 half pills. On 29-Mar-2021, INSOMNIA (difficulty sleeping) had resolved. At the time of the report, NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), COUGH (cough), DYSPNOEA (agitaded breath), RENAL PAIN (some pain in the kidneys), SWELLING OF EYELID (had swollen eyelids), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (fever 99F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 99 (High) 99 F. On 29-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications were not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.    This case was linked to MOD21-068246 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 contained non-significant information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Nasal congestion, Pyrexia, Renal pain
Clinical narrative: had swollen eyelids; fever 99F; cough; some pain in the kidneys; agitaded breath; fogginess; tiredness; difficulty sleeping; chills; congestion in his nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), INSOMNIA (difficulty sleeping), COUGH (cough) and DYSPNOEA (agitaded breath) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Medullary sponge kidney.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NASAL CONGESTION (congestion in his nose). On 27-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess) and FATIGUE (tiredness). On 01-Apr-2021, the patient experienced DYSPNOEA (agitaded breath). On 02-Apr-2021, the patient experienced RENAL PAIN (some pain in the kidneys). On an unknown date, the patient experienced COUGH (cough), SWELLING OF EYELID (had swollen eyelids) and PYREXIA (fever 99F). The patient was treated with IBUPROFEN for Fever, at a dose of 2 half pills. On 29-Mar-2021, INSOMNIA (difficulty sleeping) had resolved. At the time of the report, NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), COUGH (cough), DYSPNOEA (agitaded breath), RENAL PAIN (some pain in the kidneys), SWELLING OF EYELID (had swollen eyelids), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (fever 99F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 99 (High) 99 F. On 29-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications were not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.    This case was linked to MOD21-068246 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 contained non-significant information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling of eyelid
Clinical narrative: had swollen eyelids; fever 99F; cough; some pain in the kidneys; agitaded breath; fogginess; tiredness; difficulty sleeping; chills; congestion in his nose; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), INSOMNIA (difficulty sleeping), COUGH (cough) and DYSPNOEA (agitaded breath) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Medullary sponge kidney.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NASAL CONGESTION (congestion in his nose). On 27-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping) and CHILLS (chills). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (fogginess) and FATIGUE (tiredness). On 01-Apr-2021, the patient experienced DYSPNOEA (agitaded breath). On 02-Apr-2021, the patient experienced RENAL PAIN (some pain in the kidneys). On an unknown date, the patient experienced COUGH (cough), SWELLING OF EYELID (had swollen eyelids) and PYREXIA (fever 99F). The patient was treated with IBUPROFEN for Fever, at a dose of 2 half pills. On 29-Mar-2021, INSOMNIA (difficulty sleeping) had resolved. At the time of the report, NASAL CONGESTION (congestion in his nose), FEELING ABNORMAL (fogginess), COUGH (cough), DYSPNOEA (agitaded breath), RENAL PAIN (some pain in the kidneys), SWELLING OF EYELID (had swollen eyelids), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (fever 99F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 99 (High) 99 F. On 29-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications were not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.    This case was linked to MOD21-068246 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 contained non-significant information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by a health care professional and describes the occurrence of the first episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and the second episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced the first episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and the second episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, last episode of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Warm Transferred from Moderna Customer Care Case No.00135704. HCP reported on 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.  No concomitant medications were provided.   This case was linked to MOD-2021-066578 (Patient Link).; Sender's Comments: This report refers to a case of Product storage error and Expired product adminsitered for mRNA-1273, lot # 003B21A  with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) 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) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (knee pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) had resolved.            Treatment details include Tylenol and Advil to alleviate the pain but despite feeling somewhat better her knee pain had not really subsided to the usual degree of pain about a week.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: VAER
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Minimal blood spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Minimal blood spotting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), ROSUVASTATIN for Cholesterol, GABAPENTIN for Neuropathy, NAPROXEN for Pain.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Minimal blood spotting). On 04-Mar-2021, VAGINAL HAEMORRHAGE (Minimal blood spotting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache, Myalgia, Skin discolouration
Clinical narrative: little pain in bones; developed a spot on his left hand (on his pinky finger) like a bluish purple color resembles a; a little bit of muscle pain; very little headache; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (developed a spot on his left hand (on his pinky finger) like a bluish purple color resembles a), BONE PAIN (little pain in bones), MYALGIA (a little bit of muscle pain) and HEADACHE (very little headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 030A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN EC), ZINC, VITAMIN D3 and ASCORBIC ACID, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE, MANGANESE SULFATE (GLUCOSAMINE CHONDROITIN COMPLEX [ASCORBIC ACID;CHONDROITIN SULFATE SODIUM;GLUCOSAMINE SULFATE;MANGANESE SULFATE]) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (a little bit of muscle pain) and HEADACHE (very little headache). On 01-Apr-2021, the patient experienced SKIN DISCOLOURATION (developed a spot on his left hand (on his pinky finger) like a bluish purple color resembles a). On 02-Apr-2021, the patient experienced BONE PAIN (little pain in bones). On 02-Apr-2021, SKIN DISCOLOURATION (developed a spot on his left hand (on his pinky finger) like a bluish purple color resembles a), BONE PAIN (little pain in bones) and HEADACHE (very little headache) had resolved and MYALGIA (a little bit of muscle pain) outcome was unknown.            treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. Treatment included heating pad for his muscle pain   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Hight, weight, concomitant medications, 1st dose of vaccine, new event and outcome of the events was updated, date of the 2nd vaccine taken was changed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: arm hurts a lot today compared to yesterday; Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 31-Oct-2021. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 01-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109463 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109463:Husband's case
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Part of the dose is lost; Needle was not screwed tightly; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly). On 02-Apr-2021, UNDERDOSE (Part of the dose is lost) and DEVICE CONNECTION ISSUE (Needle was not screwed tightly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided Treatment information was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Lymph nodes swollen; Injection area is swollen, itchy; Injection area is swollen, itchy; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy). At the time of the report, LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy) outcome was unknown.            No concomitant medicines were reported.  No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: immediately felt lightheaded/awaken to dizziness, but explained that it's more lightheadedness than dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (immediately felt lightheaded/awaken to dizziness, but explained that it's more lightheadedness than dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 010AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (immediately felt lightheaded/awaken to dizziness, but explained that it's more lightheadedness than dizziness). At the time of the report, DIZZINESS (immediately felt lightheaded/awaken to dizziness, but explained that it's more lightheadedness than dizziness) outcome was unknown.            Concomitant medications were reported to be antihistamines (not specified) which she takes a few hours after waking up. No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15-JUN-2021. Event-Dizziness outcome was updated to recovered/resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.  No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) 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.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where temperature dropped to -13.79 C for 47 minutes and 12 C for 59 minutes respectively.  No concomitant products were reported.  No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: minimal blood spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (minimal blood spotting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), ROSUVASTATIN for Cholesterol, GABAPENTIN for Neuropathy, NAPROXEN for Pain.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (minimal blood spotting). At the time of the report, VAGINAL HAEMORRHAGE (minimal blood spotting) outcome was unknown. Not Provided          No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Loose stools; Injected arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools) and VACCINATION SITE PAIN (Injected arm became sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injected arm became sore). On 27-Mar-2021, the patient experienced DIARRHOEA (Loose stools). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Loose stools) outcome was unknown and VACCINATION SITE PAIN (Injected arm became sore) had resolved.            The patient's concomitant medications included heart medications and blood thinner medications (unspecified).     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Followup added on 19-JUL-2021,AE Details and outcome updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Chills, Dizziness
Clinical narrative: feeling like was about to pass out; difficulty breathing and shortness of breath; Weakness; arm pain and foot pain; Malaise; Right side pain/Pain on my right side of my body; Arthritis pain; dizziness; Heart palpitations; chills; Joint Pain; Exhaustion/tired/No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain) and MALAISE (Malaise) in a 73-year-old female patient 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache). At the time of the report, PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. Patient was reported to still have headache, asthenia, shortness of breath, fatigue and pain. She was reported to have sought doctor's consultation.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up was received on 16-JUN-2021. Physician office visit was checked. Patient's events status information was added in inarrative supplement.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Malaise, Pain
Clinical narrative: feeling like was about to pass out; difficulty breathing and shortness of breath; Weakness; arm pain and foot pain; Malaise; Right side pain/Pain on my right side of my body; Arthritis pain; dizziness; Heart palpitations; chills; Joint Pain; Exhaustion/tired/No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain) and MALAISE (Malaise) in a 73-year-old female patient 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache). At the time of the report, PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. Patient was reported to still have headache, asthenia, shortness of breath, fatigue and pain. She was reported to have sought doctor's consultation.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up was received on 16-JUN-2021. Physician office visit was checked. Patient's events status information was added in inarrative supplement.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Presyncope
Clinical narrative: feeling like was about to pass out; difficulty breathing and shortness of breath; Weakness; arm pain and foot pain; Malaise; Right side pain/Pain on my right side of my body; Arthritis pain; dizziness; Heart palpitations; chills; Joint Pain; Exhaustion/tired/No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain) and MALAISE (Malaise) in a 73-year-old female patient 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache). At the time of the report, PRESYNCOPE (feeling like was about to pass out), DYSPNOEA (difficulty breathing and shortness of breath), ASTHENIA (Weakness), PAIN IN EXTREMITY (arm pain and foot pain), MALAISE (Malaise), PAIN (Right side pain/Pain on my right side of my body), ARTHRITIS (Arthritis pain), DIZZINESS (dizziness), PALPITATIONS (Heart palpitations), CHILLS (chills), ARTHRALGIA (Joint Pain), FATIGUE (Exhaustion/tired/No energy) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. Patient was reported to still have headache, asthenia, shortness of breath, fatigue and pain. She was reported to have sought doctor's consultation.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up was received on 16-JUN-2021. Physician office visit was checked. Patient's events status information was added in inarrative supplement.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (ACHES) and PYREXIA (Fever) 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 an unknown date, the patient experienced PAIN (ACHES) and PYREXIA (Fever). At the time of the report, PAIN (ACHES) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: arm itching; arm has a red spot of the size of a quarter  like a lump; arm is tender; arm has a red spot of the size of a quarter  like a lump; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Nickel sensitivity (usually gets rashes for her nickel allergy).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump). The patient was treated with CORTISONE for Pruritus, Erythema and Tenderness, at an unspecified dose and frequency. At the time of the report, PRURITUS (arm itching), ERYTHEMA (arm has a red spot of the size of a quarter  like a lump), TENDERNESS (arm is tender) and PERIPHERAL SWELLING (arm has a red spot of the size of a quarter  like a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Nausea
Clinical narrative: lower back pain; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products usage were not reported by the reporter. treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter email was updated.