chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and soreness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PAIN (pain and soreness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 17-Jan-2021, VACCINATION SITE PAIN (pain and soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-014130 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site warm; Injection site itching; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site reaction
Clinical narrative: a reaction; rash on the arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a reaction) and INJECTION SITE RASH (rash on the arm (injection site)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE RASH (rash on the arm (injection site)). On an unknown date, the patient experienced VACCINATION SITE REACTION (a reaction). At the time of the report, VACCINATION SITE REACTION (a reaction) outcome was unknown and INJECTION SITE RASH (rash on the arm (injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Lethargy, Nausea
Clinical narrative: weakness; diarrhea; was not coherent/ mindlessness; nausea; reflexes were abnormal; lethargic; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea) and REFLEXES ABNORMAL (reflexes were abnormal) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Narcolepsy and COVID-19.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea), REFLEXES ABNORMAL (reflexes were abnormal) and LETHARGY (lethargic). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea), REFLEXES ABNORMAL (reflexes were abnormal) and LETHARGY (lethargic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Reflexes abnormal, SARS-CoV-2 test
Clinical narrative: weakness; diarrhea; was not coherent/ mindlessness; nausea; reflexes were abnormal; lethargic; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea) and REFLEXES ABNORMAL (reflexes were abnormal) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Narcolepsy and COVID-19.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea), REFLEXES ABNORMAL (reflexes were abnormal) and LETHARGY (lethargic). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), CONFUSIONAL STATE (was not coherent/ mindlessness), NAUSEA (nausea), REFLEXES ABNORMAL (reflexes were abnormal) and LETHARGY (lethargic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: I'll be dead probably by the next business day; Bad nausea; rally bad fever; Can't keep anything in stomach; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'll be dead probably by the next business day), NAUSEA (Bad nausea), PYREXIA (rally bad fever) and VOMITING (Can't keep anything in stomach) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'll be dead probably by the next business day), NAUSEA (Bad nausea), PYREXIA (rally bad fever) and VOMITING (Can't keep anything in stomach). At the time of the report, VACCINATION COMPLICATION (I'll be dead probably by the next business day), NAUSEA (Bad nausea), PYREXIA (rally bad fever) and VOMITING (Can't keep anything in stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: dizziness; weakness; headache; low grade fever; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (low grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (positive).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (low grade fever). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 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 concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (Breast feeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID (VITAMIN C CITRUS), IRON and AMBROXOL HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOXOL) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced BREAST FEEDING (Breast feeding). At the time of the report, BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19
Clinical narrative: Patient tested positive for covid after Covid vaccine; Patient have no taste; Patient have no smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid after Covid vaccine), AGEUSIA (Patient have no taste) and ANOSMIA (Patient have no smell) in a 77-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 13-Jan-2021, the patient experienced AGEUSIA (Patient have no taste) and ANOSMIA (Patient have no smell). On 14-Jan-2021, the patient experienced COVID-19 (Patient tested positive for covid after Covid vaccine). At the time of the report, COVID-19 (Patient tested positive for covid after Covid vaccine), AGEUSIA (Patient have no taste) and ANOSMIA (Patient have no smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Stomach Pain; Gassiness; Diarrhea; A spontaneous report was received from a consumer who is a 68-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach pain, gassiness and diarrhea.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29-Jan-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 29-JAN-2021, the patient experienced stomach pain, gassiness and diarrhea.  Treatment for the events included Miralax.    Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events, stomach pain, gassiness and diarrhea, was considered as not resolved/not recovered.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection (L) when lifting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection (L) when lifting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ANORO (COPD). Concurrent medical conditions included Hypertension and COPD.    On 14-Jan-2021 at 5:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection (L) when lifting). On 15-Jan-2021, INJECTION SITE PAIN (Pain at injection (L) when lifting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain
Clinical narrative: Feeling cold; Feeling tired; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over). On 29-Jan-2021, FEELING COLD (Feeling cold), FATIGUE (Feeling tired) and PAIN (Achy all over) had resolved.        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 information and temporal association between the use of the product and the start date of these events, a causal relationship is possibly related.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-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 reported, which was an 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 information and temporal association between the use of the product and the start date of these events, a causal relationship is possibly related.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: possible reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (possible reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (possible reaction). At the time of the report, VACCINATION COMPLICATION (possible reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: really bad diarrhea on Sunday and Monday morning; A spontaneous report was received from a consumer who is a 66 Years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient medical history was not provided. No concomitant medications are reported.  On 30-JAN-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273.   On 31-JAN-2021, the patient experienced the event really bad diarrhea until 01-FEB-2021.  No treatment medication has been 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 really bad diarrhea is 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 event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination site rash; Vaccination site Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site Itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site Itchy). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: my arm was sore a little bit; Reports headaches every day; Case reference number MOD-2021-013708 is a spontaneous case report sent by a Non-Health Professional on 27-JAN-2021, which refers to a Male patient aged 78 Years .  Patient received the dose for Moderna covid-19 vaccine on 21JAN2021.Later  the patient developed headache every other day. After certain days his cardiologist identified isosorbide as the cause for headaches which he stated to be resolved and developed little bit  sore in his and nothing else."  No treatment medication information was provided.   The patient was recovered without any treatment medication for headache .The action taken  for Moderna COVID-19 Vaccine for sore arm  and its outcome was unknown.   The Non-Health Professional cited in the report considered the event headache as not related to Moderna COVID-19 Vaccine. The Non-Health Professional did not declare any relatedness between headache and Moderna COVID-19 Vaccine In their opinion.   .
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy injection site; red injection site; Swollen injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE SWELLING (Swollen injection site) and INJECTION SITE ERYTHEMA (red injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swollen injection site). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy injection site) and INJECTION SITE ERYTHEMA (red injection site). At the time of the report, INJECTION SITE PRURITUS (Itchy injection site) and INJECTION SITE ERYTHEMA (red injection site) outcome was unknown and INJECTION SITE SWELLING (Swollen injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is itchy; Injection site is painful; Injection site is red; Injection site is red; Injection site is swollen; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (Injection site is itchy), the first episode of INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and the second episode of INJECTION SITE ERYTHEMA (Injection site is red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced the first episode of INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site is swollen) and the second episode of INJECTION SITE ERYTHEMA (Injection site is red). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE PAIN (Injection site is painful). At the time of the report, INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and the last episode of INJECTION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: itch; a rash surrounding the site of the needle; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: tdap. Past adverse reactions to the above products included Vaccination site rash with tdap.    On 18-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle). At the time of the report, PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle) 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.  Treatment medications included alcohol..
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Injection site pain
Clinical narrative: dry mouth, so she got up in the middle of the night; little sore in the injection site; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-2A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes.    On 30-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 DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ALKA SELTZER PLUS [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (dry mouth, so she got up in the middle of the night) and INJECTION SITE PAIN (little sore in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-013713 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Fatigue, Pyrexia
Clinical narrative: Chills; Dry mouth; Slight fever; Soreness; next day evening she "felt tired"; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (Dry mouth) and PYREXIA (slight fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.  The patient's past medical history included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Diabetes.  On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DRY MOUTH (Dry mouth). On 29-Jan-2021, the patient experienced PYREXIA (slight fever). The patient was treated with IBUPROFEN for Fever and Chills, at an unspecified dose and frequency and ALKA SELTZER PLUS COLD & COUGH FORMULA for Cold and Flu, at an unspecified dose and frequency. On 31-Jan-2021, PYREXIA (slight fever) had resolved. At the time of the report, DRY MOUTH (Dry mouth) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-013712 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: She states about 18 hours later she felt a fever blister; This spontaneous case was reported by a patient and describes the occurrence of ORAL HERPES (She states about 18 hours later she felt a fever blister) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ORAL HERPES (She states about 18 hours later she felt a fever blister). At the time of the report, ORAL HERPES (She states about 18 hours later she felt a fever blister) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: vial of vaccine administered with a greenish hue; A spontaneous report was received from a pharmacist concerning a 76-year old, female patient who received a vaccine from vials with a greenish hue at the top and bottom.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The vial was used on 13 Feb 2021, then, the next day, the pharmacist noticed that the vail has greenish hue at the top and bottom. He was not sure if it is just the glass of the vial because the product looked normal it's off white suspension and clear and the glass looked thicker. No adverse event was reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, product quality issue, was considered resolved on 13 Feb 2021.  Reporter's Comments: This report refers to a Product quality issue for mRNA-1273, lot # 004M20A with no associated AEs.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Vaccination site pain
Clinical narrative: rash; Headache, dizziness, nausea; Headache, dizziness, nausea; Headache, dizziness, nausea; diarrhea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea) and NAUSEA (Headache, dizziness, nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea). At the time of the report, VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash; Headache, dizziness, nausea; Headache, dizziness, nausea; Headache, dizziness, nausea; diarrhea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea) and NAUSEA (Headache, dizziness, nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea). At the time of the report, VACCINATION SITE RASH (rash), DIZZINESS (Headache, dizziness, nausea), VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache, dizziness, nausea), NAUSEA (Headache, dizziness, nausea) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site) in a 57-year-old female patient 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) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PAIN (pain at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Fatigue, Head injury, Loss of consciousness
Clinical narrative: passed out; hit her head...head still hurts; slept the entire day; joints were achy; did not sleep well...woke up multiiple times; feet were cramped so she could not stand up very well; abdomen was painful to the touch; extremely thirsty; shaking so bad; very nauseous; low grade fever; A spontaneous report was received from a consumer concerning a 63 year old, female patient who experienced sore and tight red arm that was very hot, nausea, pain in abdomen, extreme thirst, woke up multiple times during the night, severe tremor, fever, achy joints, foot cramps, loss of consciousness, head injury, fatigue and headache.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number 029L20Ar) on 14-JAN-2021.  On 11-FEB-2021 prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:016M20A) intramuscularly for prophylaxis of COVID-19 infection.    After the second dose, she had a low-grade fever 6-7 hours post vaccination. She did not sleep well. She woke up at 10:30PM and was very nauseous, abdomen was painful to the touch, and extremely thirsty. She woke up multiple times in the night. Patient was shaking so bad she couldn't put a thermometer in her mouth as her teeth would not unclench. She had a temperature of 101F. Her joints were achy, and her feet were cramped so she could not stand up very well. At 6AM, she went to get another drink of water, she stood up then passed out. She hit her head on the floor. She was bleeding a little but there was no bump. She consulted her MD friend who recommended an Advil and to ice her head so she did. After the fall, her ankle, feet, hands, and joints were very achy. Her temperature was in the 100s and she slept the entire day. Her head still hurts. Treatment for the event included Advil.     The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event(s) was/were unknown/not reported.; Reporter'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. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Sleep deficit, Thirst
Clinical narrative: passed out; hit her head...head still hurts; slept the entire day; joints were achy; did not sleep well...woke up multiiple times; feet were cramped so she could not stand up very well; abdomen was painful to the touch; extremely thirsty; shaking so bad; very nauseous; low grade fever; A spontaneous report was received from a consumer concerning a 63 year old, female patient who experienced sore and tight red arm that was very hot, nausea, pain in abdomen, extreme thirst, woke up multiple times during the night, severe tremor, fever, achy joints, foot cramps, loss of consciousness, head injury, fatigue and headache.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number 029L20Ar) on 14-JAN-2021.  On 11-FEB-2021 prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:016M20A) intramuscularly for prophylaxis of COVID-19 infection.    After the second dose, she had a low-grade fever 6-7 hours post vaccination. She did not sleep well. She woke up at 10:30PM and was very nauseous, abdomen was painful to the touch, and extremely thirsty. She woke up multiple times in the night. Patient was shaking so bad she couldn't put a thermometer in her mouth as her teeth would not unclench. She had a temperature of 101F. Her joints were achy, and her feet were cramped so she could not stand up very well. At 6AM, she went to get another drink of water, she stood up then passed out. She hit her head on the floor. She was bleeding a little but there was no bump. She consulted her MD friend who recommended an Advil and to ice her head so she did. After the fall, her ankle, feet, hands, and joints were very achy. Her temperature was in the 100s and she slept the entire day. Her head still hurts. Treatment for the event included Advil.     The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event(s) was/were unknown/not reported.; Reporter'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. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: passed out; hit her head...head still hurts; slept the entire day; joints were achy; did not sleep well...woke up multiiple times; feet were cramped so she could not stand up very well; abdomen was painful to the touch; extremely thirsty; shaking so bad; very nauseous; low grade fever; A spontaneous report was received from a consumer concerning a 63 year old, female patient who experienced sore and tight red arm that was very hot, nausea, pain in abdomen, extreme thirst, woke up multiple times during the night, severe tremor, fever, achy joints, foot cramps, loss of consciousness, head injury, fatigue and headache.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number 029L20Ar) on 14-JAN-2021.  On 11-FEB-2021 prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:016M20A) intramuscularly for prophylaxis of COVID-19 infection.    After the second dose, she had a low-grade fever 6-7 hours post vaccination. She did not sleep well. She woke up at 10:30PM and was very nauseous, abdomen was painful to the touch, and extremely thirsty. She woke up multiple times in the night. Patient was shaking so bad she couldn't put a thermometer in her mouth as her teeth would not unclench. She had a temperature of 101F. Her joints were achy, and her feet were cramped so she could not stand up very well. At 6AM, she went to get another drink of water, she stood up then passed out. She hit her head on the floor. She was bleeding a little but there was no bump. She consulted her MD friend who recommended an Advil and to ice her head so she did. After the fall, her ankle, feet, hands, and joints were very achy. Her temperature was in the 100s and she slept the entire day. Her head still hurts. Treatment for the event included Advil.     The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event(s) was/were unknown/not reported.; Reporter'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. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: lot of mucus; Congested/chest staffed; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (lot of mucus), ARTHRALGIA (sore shoulder) and RESPIRATORY TRACT CONGESTION (Congested/chest staffed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). On 24-Jan-2021, the patient experienced RHINORRHOEA (lot of mucus) and RESPIRATORY TRACT CONGESTION (Congested/chest staffed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (lot of mucus) and RESPIRATORY TRACT CONGESTION (Congested/chest staffed) had not resolved and ARTHRALGIA (sore shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red; arm soreness; Itching; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042698) for COVID-19 vaccination.  No medical history was reported by the reporter. Concomitant products included CALCIUM, MAGNESIUM (CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]), VITAMIN D [VITAMIN D NOS], Vitamin C, VITAMIN B COMPLEX and FOLIC ACID for an unknown indication.   On 15-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 VACCINATION SITE PAIN (arm soreness). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (red). On 16-Jan-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (red) 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Skin reaction, Skin texture abnormal
Clinical narrative: Small white patch on right site 2-3 mm, pretty small; Little red bumps in left hand/ little red all over the left hand; Hand look odd, the texture is not normal; Little soreness; 8mm white patch in her shoulder, higher the injection site (left arm); This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of PAIN (Little soreness), SKIN REACTION (8mm white patch in her shoulder, higher the injection site (left arm)), ERYTHEMA (Little red bumps in left hand/ little red all over the left hand), SKIN TEXTURE ABNORMAL (Hand look odd, the texture is not normal) and SKIN REACTION (Small white patch on right site 2-3 mm, pretty small) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 PAIN (Little soreness). On 10-Jan-2021, the patient experienced ERYTHEMA (Little red bumps in left hand/ little red all over the left hand) and SKIN TEXTURE ABNORMAL (Hand look odd, the texture is not normal). In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN REACTION (8mm white patch in her shoulder, higher the injection site (left arm)). On an unknown date, the patient experienced SKIN REACTION (Small white patch on right site 2-3 mm, pretty small). On 07-Jan-2021, PAIN (Little soreness) had resolved. At the time of the report, SKIN REACTION (8mm white patch in her shoulder, higher the injection site (left arm)), ERYTHEMA (Little red bumps in left hand/ little red all over the left hand), SKIN TEXTURE ABNORMAL (Hand look odd, the texture is not normal) and SKIN REACTION (Small white patch on right site 2-3 mm, pretty small) 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: Swelling on the joints; Sore arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and JOINT SWELLING (Swelling on the joints) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced JOINT SWELLING (Swelling on the joints). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, JOINT SWELLING (Swelling on the joints) 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.