chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Body aches; Chills; Headache; Possibly a fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Possibly a fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN and GLIMEPIRIDE for Diabetes.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Possibly a fever). At the time of the report, MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Possibly a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was reported as none.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Tendonitis
Clinical narrative: Tendinitis or bursitis; Tendinitis or bursitis; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis). The patient was treated with IBUPROFEN for Tendinitis and Bursitis, at an unspecified dose and frequency and CORTICOSTEROID NOS for Tendinitis and Bursitis, at an unspecified dose and frequency. At the time of the report, TENDONITIS (Tendinitis or bursitis) and BURSITIS (Tendinitis or bursitis) 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.   The treatment medication included Ibuprofen and Cortical steroid.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Jan-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Uterine spasm
Clinical narrative: spotting; uterine cramp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HEAVY MENSTRUAL BLEEDING (spotting) and UTERINE SPASM (uterine cramp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.; Sender's Comments: Based on current available information and the temporal relationship between product use and the start date of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (low grade fever) in a male 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness). At the time of the report, MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (low grade fever) in a male 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness). At the time of the report, MOBILITY DECREASED (limited my mobility), VACCINATION SITE PAIN (injection site and surrounding muscle soreness), FATIGUE (fatigue), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (injection site and surrounding muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Heat near Injection Site; Blotchy right below the injection site; Redness right below the injection site; Pain near Injection Site; Swelling near Injection Site; A spontaneous report was received from a Consumer concerning a 55 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site pain, Injection site rash, Injection site erythema, Injection site swelling and Injection site warmth.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Upper Arm for prophylaxis of COVID-19 infection.  On 09 Jan 2021, The patient experienced Redness, Pain, Blotchy and Swollen Skin that projects Heat.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event(s) Injection site pain, Injection site rash, Injection site erythema, Injection site swelling and Injection site warmth were unknown; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination complication
Clinical narrative: Patient wasn't feel good; Felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish). On 12-Jan-2021, VACCINATION COMPLICATION (Patient wasn't feel good) and SLUGGISHNESS (Felt sluggish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 Positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 Positive) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (COVID-19 Positive). At the time of the report, COVID-19 (COVID-19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test (positive-negative): positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 test positive and COVID-19 symptoms after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Minumum exposure to a person covid positive before the day he got the vaccine; A spontaneous report was received from a 30-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had minimum exposure to a person covid positive before the day he got the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 12 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot: 011L20A) intramuscularly in left arm for prophylaxis of COVID-19. On the same day of administration, the patient was informed that he was directly exposed to a person COVID positive. He stated that the contact with this person (a few days prior to the vaccination) was minimum and short. He wanted to know "is this will affect somehow". No symptoms reported. No treatment information provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, minimum exposure to a person covid positive before the day he got the vaccine, was unknown.; Sender's Comments: Based on the fact that the event occurred prior to administration of mRNA-1273 the event is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Urinary tract infection
Clinical narrative: serious UTI; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (serious UTI) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced URINARY TRACT INFECTION (serious UTI). At the time of the report, URINARY TRACT INFECTION (serious UTI) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     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.   Caller said he received his 1st shot of Moderna COVID vaccine on 6th Jan 2021 and on 17th Jan 2021 he had to go to hospital , tested for COVID got negative and diagnosed with serious UTI and the doctor gave him iv antibiotics and prescribed some oral antibiotics, he is still feeling pretty sick, but his got tested yesterday (20Jan2021) and informed by his Doctor that his UTI is resolving. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: runny nose; tickle in my throat; occasional cough; COVID-19 positive; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (runny nose), THROAT IRRITATION (tickle in my throat), COUGH (occasional cough) and SARS-COV-2 TEST POSITIVE (covid-19 positive) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 positive). On an unknown date, the patient experienced RHINORRHOEA (runny nose), THROAT IRRITATION (tickle in my throat) and COUGH (occasional cough). At the time of the report, RHINORRHOEA (runny nose), THROAT IRRITATION (tickle in my throat), COUGH (occasional cough) and SARS-COV-2 TEST POSITIVE (covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     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 medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Itching; did not sleep; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and INSOMNIA (did not sleep) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included METOPROLOL, GLIPIZIDE, CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, SIMVASTATIN and RIVAROXABAN (XARELTO) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRURITUS (Itching) and INSOMNIA (did not sleep). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and INSOMNIA (did not sleep) 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 medications reported included giordian and one other that he is unsure.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      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.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this Unknown age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: experiencing symptoms of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: palpitation; a rash all over her body including arms to the sole of her feet; short of breath; injection site itching; injection site swelling; injection site redness; A spontaneous report (United States) was received from a nurse concerning a female patient of 44 year old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Injection site redness/vaccination site erythema, injection site swelling/vaccination site swelling, injection site itching/vaccination site pruritus, short of breath/dyspnoea, palpitation and rash all over body.  The patient's medical history was not provided. No relevant Concomitant medications were reported.  On 29 Dec 2020, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 vaccine via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, patient experienced a rash all over the body including arms to the sole of feet, patient was short of breath and had palpitation. On 05 Jan 2021, seven days after vaccination, patient experienced Injection site redness, injection site swelling and injection site itching. Treatment information for the event included cream and Benadryl.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event Injection site redness, injection site swelling, injection site itching, short of breath, palpitation and rash all over body was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: palpitation; a rash all over her body including arms to the sole of her feet; short of breath; injection site itching; injection site swelling; injection site redness; A spontaneous report (United States) was received from a nurse concerning a female patient of 44 year old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Injection site redness/vaccination site erythema, injection site swelling/vaccination site swelling, injection site itching/vaccination site pruritus, short of breath/dyspnoea, palpitation and rash all over body.  The patient's medical history was not provided. No relevant Concomitant medications were reported.  On 29 Dec 2020, prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 vaccine via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, patient experienced a rash all over the body including arms to the sole of feet, patient was short of breath and had palpitation. On 05 Jan 2021, seven days after vaccination, patient experienced Injection site redness, injection site swelling and injection site itching. Treatment information for the event included cream and Benadryl.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event Injection site redness, injection site swelling, injection site itching, short of breath, palpitation and rash all over body was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Gynaecological examination normal, Intermenstrual bleeding, Menstruation delayed, Oligomenorrhoea, Pregnancy test negative
Clinical narrative: Since march right after my second dose my period has been extremely late. Ranging from 30-40 days for my cycles cycles. Up until the covid 19 vaccine I was so regular that I would get my period on the 28th day of my cycle at 7 am. On top of the length of my cycle, I now have breakthrough bleeding since April halfway through my cycle lasting for 2-3 days of the same fluid and frequency of changing tampons and pads as a regular period.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea
Clinical narrative: Headache, shortness of breath, nausea. Started several hours after vaccine. No treatment used so far
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Pain through injection site arm all the way into middle finger. End of finger started swelling and turning purple. Remained this way until the next day.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: Patient reports itchiness to opposite forearm (right).  Redness to right forearm 2x1 in. size.  Pt. states no pain in area.  Redness subsided.  SOB.   No signs of discomfort or anaphylaxis.  Pt. left facility in stable condition.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Flushing, Headache, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: explained to patient that possible immune response but pediatrician wanted us to report to be safe
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Severe, Additional Details: explained to patient that possible immune response but pediatrician wanted us to report to be safe
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: Patient returned 4 days after recieving injections and was encouraged to see physician.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Nausea
Clinical narrative: Warm at injection side (left arm); Cough; Chills; Nausea; Sore muscles; Headache; Med Info Agent: Got call from customer care and case number is  MOD2021-005990. Caller stated that he received a voicemail from moderna agent that they need the caller's email address to update and the caller provided the email address. provided updated email address.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Warm at injection side (left arm); Cough; Chills; Nausea; Sore muscles; Headache; Med Info Agent: Got call from customer care and case number is  MOD2021-005990. Caller stated that he received a voicemail from moderna agent that they need the caller's email address to update and the caller provided the email address. provided updated email address.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Systemic: hyperglycemia-Severe, Additional Details: patient's father came in 8/9/21, said his son's blood glucose level went up to 400 about 6 hours after getting 1 vaccine pfizer
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: Patient scheduled appointment online to receive Moderna vaccine at our location. Patient received vaccine on 8/8. patient was counseled to return to pharmacy in 28 days for 2nd dose and that patient must receive moderna for 2nd dose because vaccines are not interchangeable. Patient agreed. Patient called the pharmacy 8/9 and said his daughter reminded him he had already received 1 dose of the pfizer vaccine 3-4 months prior. counseled to contact Md. Patient denies any side effects
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Movement disorder, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: Skin looked shriveled; skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny; upper chest (right below the neck) became red and slightly itchy; upper chest (right below the neck) became red; could barely lift her arm; swollen arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and MOVEMENT DISORDER (could barely lift her arm). On 09-Jan-2021, the patient experienced PRURITUS (upper chest (right below the neck) became red and slightly itchy) and ERYTHEMA (upper chest (right below the neck) became red). On 12-Jan-2021, the patient experienced SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny). At the time of the report, PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled), RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) and MOVEMENT DISORDER (could barely lift her arm) outcome was unknown. 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.   Treatment information include calamin lotion.  . No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Skin wrinkling
Clinical narrative: Skin looked shriveled; skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny; upper chest (right below the neck) became red and slightly itchy; upper chest (right below the neck) became red; could barely lift her arm; swollen arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and MOVEMENT DISORDER (could barely lift her arm). On 09-Jan-2021, the patient experienced PRURITUS (upper chest (right below the neck) became red and slightly itchy) and ERYTHEMA (upper chest (right below the neck) became red). On 12-Jan-2021, the patient experienced SKIN WRINKLING (Skin looked shriveled) and RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny). At the time of the report, PERIPHERAL SWELLING (swollen arm), PRURITUS (upper chest (right below the neck) became red and slightly itchy), ERYTHEMA (upper chest (right below the neck) became red), SKIN WRINKLING (Skin looked shriveled), RASH MACULAR (skin looked shriveled, blotchy,got all red and looks like I got a sunburn,skin looked shriveled, blotchy, and shiny) and MOVEMENT DISORDER (could barely lift her arm) outcome was unknown. 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.   Treatment information include calamin lotion.  . No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: Right arm was black and blue about the size of a quarter; Right arm pain; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter) and VACCINATION SITE PAIN (Right arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2020, the patient experienced VACCINATION SITE PAIN (Right arm pain). On 12-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter). At the time of the report, VACCINATION SITE DISCOLOURATION (Right arm was black and blue about the size of a quarter) outcome was unknown and VACCINATION SITE PAIN (Right arm pain) 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.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: aBased on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Pain in the arm of the injection; Tenderness in the arm of the injection; fever; chills; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication, LEVOTHYROXINE for product used for unkown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 14-Jan-2021, VACCINATION SITE PAIN (Pain in the arm of the injection), VACCINATION SITE PAIN (Tenderness in the arm of the injection), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Pyrexia
Clinical narrative: Coughing; difficulty breathing worsened; difficulty breathing; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), CONDITION AGGRAVATED (difficulty breathing worsened), COUGH (Coughing) and PYREXIA (Fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing) and PYREXIA (Fever). On 11-Jan-2021, the patient experienced CONDITION AGGRAVATED (difficulty breathing worsened). On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, DYSPNOEA (difficulty breathing), CONDITION AGGRAVATED (difficulty breathing worsened) and COUGH (Coughing) had not resolved and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Jan-2021, coughing and difficulty breathing worsened. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Tongue went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tongue went numb) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: POLIO in December 2020. Concurrent medical conditions included Breast cancer.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Tongue went numb). At the time of the report, HYPOAESTHESIA ORAL (Tongue went numb) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a pill for breast cancer.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site inflammation, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site is warm; injection site is so itchy like a mosquito bite; injection site was raised - almost oval shape; injection site was dark/pink a little bit; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape), VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit), VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Penicillin allergy, Penicillin allergy (Amoxicillin ), Allergy to antibiotic (Keflex), Allergy to vaccine (Itchiness after getting the flu vaccine 30 years ago.) and Glaucoma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) 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 06-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape) and VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE INFLAMMATION (injection site was raised - almost oval shape) and VACCINATION SITE DISCOLOURATION (injection site was dark/pink a little bit) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site is warm) and VACCINATION SITE PRURITUS (injection site is so itchy like a mosquito bite) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vaccination site erythema, Vaccination site pain
Clinical narrative: Dizziness; Weakness; sore in the injection site; redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), VACCINATION SITE PAIN (sore in the injection site) and VACCINATION SITE ERYTHEMA (redness in the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620-4) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), VACCINATION SITE PAIN (sore in the injection site) and VACCINATION SITE ERYTHEMA (redness in the injection site). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), VACCINATION SITE PAIN (sore in the injection site) and VACCINATION SITE ERYTHEMA (redness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Sinus headache
Clinical narrative: Fever started getting as high as 100.9 degrees; Sinus-like headache; Aches and pains; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus-like headache), MYALGIA (Aches and pains), CHILLS (Chills) and PYREXIA (Fever started getting as high as 100.9 degrees) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced SINUS HEADACHE (Sinus-like headache), MYALGIA (Aches and pains) and CHILLS (Chills). On 10-Jan-2021, the patient experienced PYREXIA (Fever started getting as high as 100.9 degrees). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (Sinus-like headache) had not resolved and MYALGIA (Aches and pains), CHILLS (Chills) and PYREXIA (Fever started getting as high as 100.9 degrees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.