chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavy period/had never seen a period heavy like that before/it's coming like a storm for three days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     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 08-Jan-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy period/had never seen a period heavy like that before/it's coming like a storm for three days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported like a storm for three days.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-Significant FU; 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: Pain
Clinical narrative: pain on 1st day; Worse on second day; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, and pain worsen on the second day. The patient's medical history was not provided . No relevant concomitant medications was reported. On an unknown date , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On the same day, the patient experienced pain in the injection site , and the pain worsen on the second day. Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events, pain at injection site and pain worsen on the next day was unknown
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Date of Conception was reported as 08-NOV-2020 . Concomitant medications was not reported . Treatment history was not  reported .  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscle tightness, Pain in extremity, Pruritus
Clinical narrative: On the underside of arm, if she raises her arm, is very tight; Itchy; It was pink; Typical sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight), PAIN IN EXTREMITY (Typical sore arm), PRURITUS (Itchy) and ERYTHEMA (It was pink) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Typical sore arm). On 10-Jan-2021, the patient experienced MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight), PRURITUS (Itchy) and ERYTHEMA (It was pink). On 04-Jan-2021, PAIN IN EXTREMITY (Typical sore arm) had resolved. On 13-Jan-2021, ERYTHEMA (It was pink) had resolved. At the time of the report, MUSCLE TIGHTNESS (On the underside of arm, if she raises her arm, is very tight) and PRURITUS (Itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Very dizzy; Very Weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very dizzy) and ASTHENIA (Very Weak) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): unknown.     MEDICAL HISTORY (Patient): Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL for Blood pressure management, METFORMIN for Diabetes, DICYCLOMINE [DICYCLOVERINE] and ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Very dizzy) and ASTHENIA (Very Weak). On 15-Jan-2021, DIZZINESS (Very dizzy) and ASTHENIA (Very Weak) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient had several drinks after vaccination.  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.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received  on 12MAY2021 and did not contain any significant information; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Dehydrated; achiness; Very tired after getting the first shot; injection site had been kind of achy and sore for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of DEHYDRATION (Dehydrated), MYALGIA (achiness), VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days) and FATIGUE (Very tired after getting the first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and MINERALS for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days). On 13-Jan-2021, the patient experienced MYALGIA (achiness) and FATIGUE (Very tired after getting the first shot). On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEHYDRATION (Dehydrated). On 14-Jan-2021, VACCINATION SITE PAIN (injection site had been kind of achy and sore for 2 days) had resolved. On 15-Jan-2021, FATIGUE (Very tired after getting the first shot) had resolved. At the time of the report, DEHYDRATION (Dehydrated) and MYALGIA (achiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided. Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-Apr-2021 included second dose vaccine details, AE dehydration updated.; 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 26 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (26 weeks pregnant) in a 28-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 2005.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Jul-2020 and the estimated date of delivery was 03-May-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (26 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (26 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Internal review on 25JUN2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of 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 information was reported.    On an unknown date, the patient received 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 EXPOSURE DURING PREGNANCY (Pregnancy). The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female (age unknown). Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: mild itching; some redness; sore; A spontaneous report was received from a consumer concerning, a 65-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced sore, redness, and very mild itching at the injection site.  The patient's medical history was not provided. Concomitant product use was unknown by the reporter.  On 17 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced some redness right after receiving the vaccine and had a mild itching. On 18 Jan 2021, the injection site was sore.   On 26 Jan 2021, the patient experienced the redness and very mild itching around the injection site.  The patient didn't take any treatment for the events.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the event, sore at the injection site was considered resolved at the time of this report. The outcome of the events, the redness and very mild itching around the injection site was unknown at the time of this report.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 12-May-2020 and the estimated date of delivery was 16-Feb-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2020, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. Previous pregnancy end date was 09 OCT 2018 with outcome live birth.   This case was linked to MOD-2021-015597 (Patient Link).; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness.  The patient's medical history was not provided.  Concomitant medications like IVABRADINE HYDROCHLORIDE once daily, OMEPRAZOLE once daily, FLUDROCORTISONE ACETATE once daily and DESVENLAFAXINE SUCCINATE once daily were reported.    On 12th Jan 2021, prior to the onset of the event, the patient received their first dose of mRNA-1273 (batch/ lot # 0113l20A.) for prophylaxis of COVID-19 infection.  Within over 24 hours after at 11:30 pm on Wednesday 13Jan2021 the patient experienced the event Dizziness.  Laboratory details was not provided.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered as 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Chills; Soreness at the site of injection; Case reference number MOD-2021-008777 is a spontaneous case report sent by a Non-Health Professional on 17-JAN-2021 00:00:00 , which refers to a Male aged 64 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  2 days later,  the patient developed Diarrhea. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed Chills,Soreness at the site of injection. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Diarrhoea . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Non-Health Professional did not declare any relatedness between Diarrhea and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .    Brief 3 line summary of above for  listing: Report Source- Non-Health Professional,  Age- 64 Years,  Sex- Male,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Diarrhea - Unknown,Soreness at the site of injection - Unknown,Chills - Unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red circle around injection site/Red sweelling started on day 6-7; Itching/woke up in the night, it was itching like crazy; Swollen/Red swelling started on day 6-7; Hot; Small bluish bruise; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Small bluish bruise), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7) and PRURITUS (Itching/woke up in the night, it was itching like crazy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Cellulitis, at a dose of 500 milligram four times per day; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Redness, at a dose of 1 dosage form once a day. On 24-Jan-2021, VACCINATION SITE BRUISING (Small bluish bruise) and PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7) 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 medications were provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email updated On 02-Jul-2021: Event information updated for vaccination site swelling and pain in extremity from not recovered to recovered; 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: This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (16 weeks pregnant) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (16 weeks pregnant). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (16 weeks pregnant) had resolved. 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. Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Upon internal review on 27 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness at the injection site; Redness injection site; swelling injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site) and VACCINATION SITE SWELLING (swelling injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site) and VACCINATION SITE SWELLING (swelling injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness injection site) and VACCINATION SITE SWELLING (swelling injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: large welt puffy; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (large welt puffy) and TENDERNESS (tenderness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (large welt puffy) and TENDERNESS (tenderness). At the time of the report, SWELLING (large welt puffy) and TENDERNESS (tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information received
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Pregnancy test
Clinical narrative: Pregnancy; headache; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and HEADACHE (headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391C202A) 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. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 08-Jan-2021, the patient experienced HEADACHE (headache). On 12-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 12-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Pregnancy test: positive (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.   No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This is a case of product exposure during pregnancy with Headache in this 31-year-old female patient. Based on the current available information and temporal association between the use of the product and the start date of the Headache, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Follow up received on 02-Feb-2021 and event headache was included.; Sender's Comments: This is a case of product exposure during pregnancy with Headache in this 31-year-old female patient. Based on the current available information and temporal association between the use of the product and the start date of the Headache, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash, Vaccination site pain, Vaccination site pruritus
Clinical narrative: vaccination site began itching; vaccination site began  soreness and hurting; rash; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), RASH (rash), VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Arrhythmia (Heart Rhytm) and Clot blood (Blood clots). Concomitant products included FLECAINIDE for Arrhythmia, OLMESARTAN for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, APIXABAN (ELIQUIS) for Clot blood, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN +PHARMA) and METOPROLOL.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Jan-2021, the patient experienced PAIN (pain). On 09-Jan-2021, the patient experienced RASH (rash). On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting). On 05-Jan-2021, PAIN (pain) had resolved. On 17-Jan-2021, RASH (rash) had resolved. On 19-Jan-2021, VACCINATION SITE PRURITUS (vaccination site began itching) and VACCINATION SITE PAIN (vaccination site began  soreness and hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given was normal ointment Other medical condition also included prostate; 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: U
Vaccine: COVID19
Symptoms: Contusion, Vaccination site cellulitis
Clinical narrative: Cellulitis; bruise red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red). At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis) and CONTUSION (bruise red) 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 provided.  No treatment information provided
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Maternal exposure during pregnancy, Myalgia, Pregnancy test
Clinical narrative: arm pain at the injection site; fatigue; Joint ache; Muscle ache; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) in a 41-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Allergy to wool and Allergic skin reaction. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ESCITALOPRAM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm pain at the injection site; fatigue; Joint ache; Muscle ache; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician assistant and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) in a 41-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Allergy to wool and Allergic skin reaction. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ESCITALOPRAM for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain at the injection site), FATIGUE (fatigue), ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Pregnancy test: positive (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.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (Nausea) 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 11-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 DIARRHOEA (diarrhea) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-237221, MOD-2021-237221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-jun-2021, confirms initial is of 1st dose and it describes patient received the 2nd dose; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Allergy, SIMVASTATIN for Cholesterol, CENTRUM.    On 13-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 treatment information was provided. Caller received Moderna vaccine last Jan 13th and experienced the following symptoms: Jan 13th Arm soreness Jan 17th on and off Fatigue 17JAN2021 TDS; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Itch on back; itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist) and PRURITUS (Itch on back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist). On an unknown date, the patient experienced PRURITUS (Itch on back). At the time of the report, RASH PRURITIC (itchy rash starting between shoulder blades then got worse, now on whole back up to shoulder down to the waist) and PRURITUS (Itch on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had self-medicated with hydrocortisone ointment 2.5 % and a clear anti-itch lotion from a local pharmacy which is unopened and expired. the lotions contained pramoxine HCl 1 % and zinc acetate 0.1 % which was applied at 4 to 5 AM on 17 Jan 2021.; 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. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) 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 relevant concomitant medications were reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068997, US-MODERNATX, INC.-MOD-2021-069012 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-069012: US-MODERNATX, INC.-MOD-2021-068997:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Diarrhea; Stomachache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomachache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided 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: F
Vaccine: COVID19
Symptoms: Asthenia, Blood count, Blood pressure measurement, Dizziness, Scan brain
Clinical narrative: Severe dizziness; severe weakness; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dizziness, and severe weakness.   The patient's medical history included stroke. Concomitant product use was unknown by the reporter.  On 23 Jan 2021 at 10:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Jan 2021 at around 4:00 pm, she started experiencing severe dizziness and weakness. She went to the kitchen and didn't have energy to go back to the couch. That's when her husband took her to ER. They made her a brain scan, blood count and blood pressure (all normal).  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events dizziness and weakness was unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient experienced non serious adverse event of severe dizziness and severe weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Headache, Vertigo
Clinical narrative: Vertigo/ room is spinning; Dizziness; Slight head pressure; little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness), HEAD DISCOMFORT (Slight head pressure) and HEADACHE (little bit of a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness), HEAD DISCOMFORT (Slight head pressure) and HEADACHE (little bit of a headache). At the time of the report, VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness) and HEAD DISCOMFORT (Slight head pressure) had resolved and HEADACHE (little bit of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient reported that the events resolved after 5-6 days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Event head pressure updated. Outcome of events reported earlier updated to resolved. On 07-May-2021: Reporter's contact information updated .; 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.