chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: weakness; nausea; vomitting; red blotchy skin,blotches under the skin on both arms and legs that look like bruises; tired; shivering; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired) and CHILLS (shivering) in a 27-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 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired) and CHILLS (shivering). On 12-Feb-2021, the patient experienced ASTHENIA (weakness). At the time of the report, NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired), CHILLS (shivering) and ASTHENIA (weakness) outcome was unknown.            No relevant concomitant medications were reported  Treatment details included medication for nausea.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: horrible headache; fever of 101 Degrees Farenheight; horrible chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills) 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 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills). At the time of the report, HEADACHE (horrible headache), PYREXIA (fever of 101 Degrees Farenheight) and CHILLS (horrible chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 101 F.     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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; nausea.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome and GERD.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea.). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: soreness in the shoulder to the back of the neck; red circle around injection site; itchy circle around injection site; knot feeling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red circle around injection site), INJECTION SITE PRURITUS (itchy circle around injection site), INJECTION SITE MASS (knot feeling at injection site) and ARTHRALGIA (soreness in the shoulder to the back of the neck) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m2oa) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red circle around injection site), INJECTION SITE PRURITUS (itchy circle around injection site) and INJECTION SITE MASS (knot feeling at injection site). On an unknown date, the patient experienced ARTHRALGIA (soreness in the shoulder to the back of the neck). At the time of the report, INJECTION SITE ERYTHEMA (red circle around injection site), INJECTION SITE PRURITUS (itchy circle around injection site), INJECTION SITE MASS (knot feeling at injection site) and ARTHRALGIA (soreness in the shoulder to the back of the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Cold compress and Tylenol(paracetamol).
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Head discomfort, Impaired work ability, Vaccination complication
Clinical narrative: very severe side effects/very bad issues; Pressure in her head; not able to work; very bad issues; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (very severe side effects/very bad issues), HEAD DISCOMFORT (Pressure in her head), IMPAIRED WORK ABILITY (not able to work) and ADVERSE REACTION (very bad issues) 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 VACCINATION COMPLICATION (very severe side effects/very bad issues), HEAD DISCOMFORT (Pressure in her head), IMPAIRED WORK ABILITY (not able to work) and ADVERSE REACTION (very bad issues). At the time of the report, VACCINATION COMPLICATION (very severe side effects/very bad issues), HEAD DISCOMFORT (Pressure in her head), IMPAIRED WORK ABILITY (not able to work) and ADVERSE REACTION (very bad issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-056916 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received and two events ( head discomfort and impaired work ability) were added.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling around neck on day dose was given) and PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced SWELLING (Swelling around neck on day dose was given). On 17-Feb-2021, the patient experienced PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today). At the time of the report, SWELLING (Swelling around neck on day dose was given) and PHARYNGEAL SWELLING (Able to palpate swelling around right side of the throat today) had not resolved. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth abscess
Clinical narrative: tooth abscess; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   treatment information of amoxicillin was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, TAMSULOSIN, OMEPRAZOLE and LISINOPRIL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pains; Muscle pains; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SILDENAFIL CITRATE (VIAGRA CONNECT) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains). At the time of the report, ARTHRALGIA (Joint pains) and MYALGIA (Muscle pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Not terribly itchy; Rash on her arm 5 inches in length and 2 inches wide; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy). On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, RASH (Rash on her arm 5 inches in length and 2 inches wide) and PRURITUS (Not terribly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on left armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on left armpit) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node on left armpit). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on left armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.  ).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Treatment for the event included antiviral medication.      Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: arm pain in both arms; Rapid heart beat; A spontaneous report was received from a consumer concerning a 84 years female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of rapid heart beat and arm pain.  The patient's medical history included arthritis. No relevant concomitant medications were reported.  On 23JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 23JAN2021, the patient  experienced rapid heart beat for hours and resolved on the same day. On 30JAN2021, she had arm pain when she lifts her arm over her head in both arms but greater in the left where she had the injection.  She does have a history of arthritis but has not had this pain prior to the vaccine.  There was no treatment information provided.  Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event of rapid heart beat was resolved on 23JAN2021.  The outcome of the event of arm pain was 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 events, a causal relationship cannot be excluded. However, the patient's age and history of arthritis may confound causality assessment.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Nauseous; A little headache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and HEADACHE (A little headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient takes regular blood pressure pills.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nauseous) and HEADACHE (A little headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nauseous) was resolving, DIARRHOEA (Diarrhea) outcome was unknown and HEADACHE (A little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional initial document received
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Oropharyngeal pain, Throat tightness, Tongue disorder
Clinical narrative: Sore throat; throat is constricted; thick tongue; Nasal burning; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (thick tongue), NASAL DISCOMFORT (Nasal burning), OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Drug allergy (Allergic to a bunch of antibiotics. ) and Food allergy (Shellfish).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced TONGUE DISORDER (thick tongue) and NASAL DISCOMFORT (Nasal burning). On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted). At the time of the report, TONGUE DISORDER (thick tongue), NASAL DISCOMFORT (Nasal burning), OROPHARYNGEAL PAIN (Sore throat) and THROAT TIGHTNESS (throat is constricted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea, not completely runny, but not real firm, more like soft and mushy, not normal; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea, not completely runny, but not real firm, more like soft and mushy, not normal) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced DIARRHOEA (diarrhea, not completely runny, but not real firm, more like soft and mushy, not normal). The patient was treated with AMMONIUM CHLORIDE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea, not completely runny, but not real firm, more like soft and mushy, not normal) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication dicyclomime 10mg was prescribed but not taken.  Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: White scaly patches on skin; Broke out in rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (White scaly patches on skin) and RASH (Broke out in rash all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042I20A) for COVID-19 vaccination.     Concomitant products included SEMAGLUTIDE (OZEMPIC) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 23-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 RASH (Broke out in rash all over the body). On 28-Jan-2021, the patient experienced ECZEMA (White scaly patches on skin). On 27-Jan-2021, RASH (Broke out in rash all over the body) had resolved. At the time of the report, ECZEMA (White scaly patches on skin) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using Antihistamine for rash was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) 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 INFECTION (infection). At the time of the report, INFECTION (infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported. The patient wanted to know if penicillin would have any contraindications on second vaccination.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intentional product use issue, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: early onset of menstrual cycle; very heavy very painful periods; very heavy very painful periods; only received one dose of Moderna COVID-19 Vaccine; spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting), MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.    On 23-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 INTERMENSTRUAL BLEEDING (spotting). On an unknown date, the patient experienced MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine). On 03-Feb-2021, INTERMENSTRUAL BLEEDING (spotting) had resolved. At the time of the report, MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods) and DYSMENORRHOEA (very heavy very painful periods) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pregnancy test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information provided by the reporter.  The patient reported, she has not had the second dose and was unsure if she should get a second dose or if she needs to start over or try a different type of COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated patient details (initials), events and reporter demographics.; 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test
Clinical narrative: early onset of menstrual cycle; very heavy very painful periods; very heavy very painful periods; only received one dose of Moderna COVID-19 Vaccine; spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting), MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.    On 23-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 INTERMENSTRUAL BLEEDING (spotting). On an unknown date, the patient experienced MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods), DYSMENORRHOEA (very heavy very painful periods) and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine). On 03-Feb-2021, INTERMENSTRUAL BLEEDING (spotting) had resolved. At the time of the report, MENSTRUAL DISORDER (early onset of menstrual cycle), HEAVY MENSTRUAL BLEEDING (very heavy very painful periods) and DYSMENORRHOEA (very heavy very painful periods) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (only received one dose of Moderna COVID-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pregnancy test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information provided by the reporter.  The patient reported, she has not had the second dose and was unsure if she should get a second dose or if she needs to start over or try a different type of COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated patient details (initials), events and reporter demographics.; 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eczema, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Hives; Blotches around the neck; Round circles under both armpits; Body aches; Headaches; Chills; Fever; Pain in the arm; Sweating profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 06-Jan-2019 to an unknown date and LISINOPRIL from 06-Jan-2019 to an unknown date for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 17-Mar-2021, URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) had resolved.            Steroid cream was provided to treat the rash from  17-FEB-2021 to 17-MAR-2021.   This case was linked to MOD-2021-248017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Non-significant FU: updated contact details. On 06-Jul-2021: Significant FU: patient characteristics, concomitant medications, reaction start/end date, causality, and treatment for the event.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Urticaria, Vaccination site pain
Clinical narrative: Hives; Blotches around the neck; Round circles under both armpits; Body aches; Headaches; Chills; Fever; Pain in the arm; Sweating profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 06-Jan-2019 to an unknown date and LISINOPRIL from 06-Jan-2019 to an unknown date for an unknown indication.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in the arm), HYPERHIDROSIS (Sweating profusely), MYALGIA (Body aches), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever) had resolved. On 17-Mar-2021, URTICARIA (Hives), RASH MACULAR (Blotches around the neck) and ECZEMA (Round circles under both armpits) had resolved.            Steroid cream was provided to treat the rash from  17-FEB-2021 to 17-MAR-2021.   This case was linked to MOD-2021-248017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Non-significant FU: updated contact details. On 06-Jul-2021: Significant FU: patient characteristics, concomitant medications, reaction start/end date, causality, and treatment for the event.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: warm at injection site; hard at injection site; red mark at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE INDURATION (hard at injection site) and VACCINATION SITE ERYTHEMA (red mark at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine, blood thinners and statins. Treatment included antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received on 04-MAY-2021 and contains patient initials.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: unable to lay down on either side; unable to breathe easily; upset stomach; chest pain - in the middle of her of her chest; coldness from her neck to her stomach; diarrhea; sore throat; body aches; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and DYSPNOEA (unable to breathe easily) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat). On 15-Feb-2021, the patient experienced CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and ABDOMINAL DISCOMFORT (upset stomach). On 17-Feb-2021, the patient experienced DYSPNOEA (unable to breathe easily). On an unknown date, the patient experienced INSOMNIA (unable to lay down on either side). On 14-Feb-2021, DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach), DYSPNOEA (unable to breathe easily), ABDOMINAL DISCOMFORT (upset stomach), INSOMNIA (unable to lay down on either side), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant-Events resolved
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Insomnia, Myalgia, Oropharyngeal pain
Clinical narrative: unable to lay down on either side; unable to breathe easily; upset stomach; chest pain - in the middle of her of her chest; coldness from her neck to her stomach; diarrhea; sore throat; body aches; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and DYSPNOEA (unable to breathe easily) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat). On 15-Feb-2021, the patient experienced CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and ABDOMINAL DISCOMFORT (upset stomach). On 17-Feb-2021, the patient experienced DYSPNOEA (unable to breathe easily). On an unknown date, the patient experienced INSOMNIA (unable to lay down on either side). On 14-Feb-2021, DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach), DYSPNOEA (unable to breathe easily), ABDOMINAL DISCOMFORT (upset stomach), INSOMNIA (unable to lay down on either side), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant-Events resolved
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: unable to lay down on either side; unable to breathe easily; upset stomach; chest pain - in the middle of her of her chest; coldness from her neck to her stomach; diarrhea; sore throat; body aches; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and DYSPNOEA (unable to breathe easily) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat). On 15-Feb-2021, the patient experienced CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach) and ABDOMINAL DISCOMFORT (upset stomach). On 17-Feb-2021, the patient experienced DYSPNOEA (unable to breathe easily). On an unknown date, the patient experienced INSOMNIA (unable to lay down on either side). On 14-Feb-2021, DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, CHEST PAIN (chest pain - in the middle of her of her chest), FEELING COLD (coldness from her neck to her stomach), DYSPNOEA (unable to breathe easily), ABDOMINAL DISCOMFORT (upset stomach), INSOMNIA (unable to lay down on either side), MYALGIA (body aches), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant-Events resolved
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm to touch; Redness the size of a sliver dollar on arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to touch) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness the size of a sliver dollar on arm of the 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 reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (feels a lot better and all of her body ache's have seemed to disappear since getting the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The patient's past medical history included Inflammation (Severe inflammation) and Arm discomfort (Difficulty moving right arm). Concurrent medical conditions included Arthritis and Sjogren's syndrome. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (feels a lot better and all of her body ache's have seemed to disappear since getting the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (feels a lot better and all of her body ache's have seemed to disappear since getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment medications  were not provided by the reporter. Patient reported that all of her body aches have seemed to disappear. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 and it contains Updated patient demographics. On 13-Jul-2021: Follow-up information received on 13 Jul 2021 contains no new 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 event, a causal relationship cannot be excluded. The patient's severe inflammation, arthritis, difficulty moving right arm, Sjogren's syndrome, have been better.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Somnolence
Clinical narrative: foggy; drowsy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (foggy), SOMNOLENCE (drowsy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.