chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Muscle pain; Headache; Fever; Chills; Joint pain; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been using Antihistaminic ( every morning) , Annihilator and vitamins as a concomitant medication.  As treatment the AEs patient took Advil.  Action taken with mRNA-123 is not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fatigue; Muscle pain; Headache; Fever; Chills; Joint pain; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been using Antihistaminic ( every morning) , Annihilator and vitamins as a concomitant medication.  As treatment the AEs patient took Advil.  Action taken with mRNA-123 is not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot
Clinical narrative: Too cold - can't get warm; Too hot; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events too cold - can't get warm/ feeling cold, too hot/ feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events too cold - can't get warm, too hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, too cold - can't get warm, too hot was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: I am so dizzy i cannot sit up. Everything in my kitchen is turning; I feel weak too; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I am so dizzy i cannot sit up. Everything in my kitchen is turning) and ASTHENIA (I feel weak too) in a female patient of an unknown age 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.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I am so dizzy i cannot sit up. Everything in my kitchen is turning) and ASTHENIA (I feel weak too). At the time of the report, DIZZINESS (I am so dizzy i cannot sit up. Everything in my kitchen is turning) and ASTHENIA (I feel weak too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain, Rash
Clinical narrative: blackly rash up from waste to arm of injection; sore throat; ear pain/discomfort; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear pain/discomfort) and RASH (blackly rash up from waste to arm of injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FINASTERIDE, TAMSULOSIN, MIRTAZAPINE and MEMANTINE HYDROCHLORIDE (NAMENDA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (ear pain/discomfort). On 13-Feb-2021, the patient experienced RASH (blackly rash up from waste to arm of injection). At the time of the report, OROPHARYNGEAL PAIN (sore throat), EAR PAIN (ear pain/discomfort) and RASH (blackly rash up from waste to arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment medications provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site infection, Pruritus, Rash
Clinical narrative: diagnosed with bacterial infection at site of injection; spreading rash; rash area felt hot; raised red blob; itchy; very fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy), INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection) and RASH (spreading rash) in a 77-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.     The patient's past medical history included No adverse event.    On 03-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 FATIGUE (very fatigue). On 15-Feb-2021, the patient experienced FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy) and RASH (spreading rash). On an unknown date, the patient experienced INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy), RASH (spreading rash) and FATIGUE (very fatigue) had not resolved and INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: diagnosed with bacterial infection at site of injection; spreading rash; rash area felt hot; raised red blob; itchy; very fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy), INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection) and RASH (spreading rash) in a 77-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.     The patient's past medical history included No adverse event.    On 03-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 FATIGUE (very fatigue). On 15-Feb-2021, the patient experienced FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy) and RASH (spreading rash). On an unknown date, the patient experienced INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, FEELING HOT (rash area felt hot), RASH PAPULAR (raised red blob), PRURITUS (itchy), RASH (spreading rash) and FATIGUE (very fatigue) had not resolved and INJECTION SITE INFECTION (diagnosed with bacterial infection at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: a little bit muscle soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (a little bit muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Zemplar                                                        Paricalcitol, ROMOSOZUMAB and Minivelle                                                      Estradiol for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (a little bit muscle soreness). On 12-Feb-2021, MYALGIA (a little bit muscle soreness) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: fever; headache; chills; muscle pain; little bit of swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm (Injection Site); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm (Injection Site)) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm (Injection Site)). At the time of the report, PAIN IN EXTREMITY (Sore Arm (Injection Site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm has just been sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm has just been sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00076190) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm has just been sore). At the time of the report, PAIN IN EXTREMITY (arm has just been sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain
Clinical narrative: soreness has toned down a bit; his upper arm was tender and sore and it radiated down his left arm; especially uncomfortable since he sleeps on that shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (his upper arm was tender and sore and it radiated down his left arm), INSOMNIA (especially uncomfortable since he sleeps on that shoulder) and ARTHRALGIA (soreness has toned down a bit) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (his upper arm was tender and sore and it radiated down his left arm) and INSOMNIA (especially uncomfortable since he sleeps on that shoulder). On 18-Feb-2021, the patient experienced ARTHRALGIA (soreness has toned down a bit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain and Arthralgia, at an unspecified dose and frequency. At the time of the report, PAIN (his upper arm was tender and sore and it radiated down his left arm), INSOMNIA (especially uncomfortable since he sleeps on that shoulder) and ARTHRALGIA (soreness has toned down a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Contact detail updated
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient tested positive before the second dose; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose) 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 No adverse event.    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 SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive before the second dose) 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 concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: knot at injection site; warm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot at injection site) and VACCINATION SITE WARMTH (warm at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 VACCINATION SITE MASS (knot at injection site) and VACCINATION SITE WARMTH (warm at injection site). At the time of the report, VACCINATION SITE MASS (knot at injection site) and VACCINATION SITE WARMTH (warm at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FENTANYL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-051600 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Positive for COVID-19 after first shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19 after first shot of the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, blood pressure medicine and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive for COVID-19 after first shot of the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive for COVID-19 after first shot of the vaccine) 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Nicotine abuse from 2010 to 2018. Concurrent medical conditions included Hyperthyroidism since 2014. Concomitant products included LEVOTHYROXINE 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.         No Treatment information provided Previous pregnancy included 14 Apr 2008 and 13 Jul 2009 with live birth.; Reporter's Comments: levothyroxine 100 mcg .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: Congestion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Congestion) and HEADACHE (Headache) had resolved.            Patient stated she usually takes an antihistamine (not specified) but did not take the dose prior to receiving the vaccine on 18-Feb-2021.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received on 14-jul-2021. Reporter's contact information and event outcome updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site induration, Vaccination site rash
Clinical narrative: rash at injection site; ard bump at injection site; pain in their left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in their left shoulder), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-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 ARTHRALGIA (pain in their left shoulder). On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site). At the time of the report, ARTHRALGIA (pain in their left shoulder), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE INDURATION (ard bump at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness
Clinical narrative: Severe diarrhea; Stomach pain; Light headed off and on; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach pain) and DIZZINESS (Light headed off and on) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (Light headed off and on). On 17-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIARRHOEA (Severe diarrhea), ABDOMINAL PAIN UPPER (Stomach pain) and DIZZINESS (Light headed off and on) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash around the injection site; Itchy around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) and VACCINATION SITE PRURITUS (Itchy around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Pain in arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and PRURITUS (Itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red mark at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red mark at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red mark at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Feb-2021, the patient experienced NAUSEA (Nausea). On 15-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) had not resolved and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Fatigue
Clinical narrative: Joint pain started in their right shoulder and moved into their left shoulder; Fatigued / tired; Feeling wobbly on their feet; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Feeling wobbly on their feet), ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.). Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced BALANCE DISORDER (Feeling wobbly on their feet). On an unknown date, the patient experienced ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired). On 08-Feb-2021, BALANCE DISORDER (Feeling wobbly on their feet) had resolved. At the time of the report, ARTHRALGIA (Joint pain started in their right shoulder and moved into their left shoulder) and FATIGUE (Fatigued / tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: itching; redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (soreness) and VACCINATION SITE ERYTHEMA (redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE PAIN (soreness). On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). On 13-Feb-2021, VACCINATION SITE PAIN (soreness) had resolved, VACCINATION SITE ERYTHEMA (redness) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itching; red mark; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and ERYTHEMA (red mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and ERYTHEMA (red mark). At the time of the report, PRURITUS (itching) and ERYTHEMA (red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on right arm; itchy on right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on right arm) and PRURITUS (itchy on right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced URTICARIA (hives on right arm) and PRURITUS (itchy on right arm). At the time of the report, URTICARIA (hives on right arm) and PRURITUS (itchy on right arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: hives or little bumps; injection site red; arm felt itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site). The patient was treated with CALAMINE for Hives, at an unspecified dose and frequency. At the time of the report, INJECTION SITE URTICARIA (hives or little bumps), INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (arm felt itchy at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: Achy; he feels like he is getting the Covid-19 again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and MALAISE (he feels like he is getting the Covid-19 again) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Achy) and MALAISE (he feels like he is getting the Covid-19 again). At the time of the report, PAIN (Achy) and MALAISE (he feels like he is getting the Covid-19 again) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Headache
Clinical narrative: chills; No Appetite (haven't been able to eat very much); headache; terrible diarrhea; pain in the arm; nauseous; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of   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 Blood pressure.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medications provided by the reporter.   This case was linked to MOD21-030914 (E2B Linked Report).; Sender's Comments:  MOD21-030914:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: chills; No Appetite (haven't been able to eat very much); headache; terrible diarrhea; pain in the arm; nauseous; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of   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 Blood pressure.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medications provided by the reporter.   This case was linked to MOD21-030914 (E2B Linked Report).; Sender's Comments:  MOD21-030914:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Slight itching; A spontaneous report  was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight itching/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced Slight itching/pruritus.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of  slight itching/pruritus was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: describes the itching sensation as coming and going in "flares" every few hours; arm is a bit red at the site of injection; itching at injection site; reports itching can be intense at times, but is not continuous; soreness at injection site 6 hours post vaccine administration; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (describes the itching sensation as coming and going in "flares" every few hours) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (describes the itching sensation as coming and going in "flares" every few hours). At the time of the report, PRURITUS (describes the itching sensation as coming and going in "flares" every few hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fever (103°F); Extremely tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever (103°F)), FATIGUE (Extremely tired) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: injection site itching; Injection site rash; spread down his arm to his elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GLIPIZIDE, METFORMIN, SIMVASTATIN and LISINOPRIL for an unknown indication.    On 09-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 INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow). At the time of the report, INJECTION SITE PRURITUS (injection site itching), INJECTION SITE RASH (Injection site rash) and RASH (spread down his arm to his elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Benadryl as a Treatment medication
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Computerised tomogram, Diarrhoea, Headache
Clinical narrative: I got chills; Fever was around 102F; diarrhea again; I got headache again; I could not lift up my arm; having long lasting side effects that are not going away; The lymph nodes in right arm swelled up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea again), VACCINATION SITE MOVEMENT IMPAIRMENT (I could not lift up my arm), VACCINATION COMPLICATION (having long lasting side effects that are not going away), HEADACHE (I got headache again) and CHILLS (I got chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and TRAZODONE for an unknown indication.    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 DIARRHOEA (diarrhea again) and HEADACHE (I got headache again). On 15-Feb-2021, the patient experienced CHILLS (I got chills) and PYREXIA (Fever was around 102F). In February 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I could not lift up my arm), VACCINATION COMPLICATION (having long lasting side effects that are not going away) and LYMPHADENOPATHY (The lymph nodes in right arm swelled up). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse event, at a dose of 1000 mg four times per day and LOPERAMIDE HYDROCHLORIDE (IMODIUM) in February 2021 for Adverse event, at a dose of UNK dosage form. On 17-Feb-2021, CHILLS (I got chills) and PYREXIA (Fever was around 102F) had resolved. At the time of the report, DIARRHOEA (diarrhea again), VACCINATION SITE MOVEMENT IMPAIRMENT (I could not lift up my arm), VACCINATION COMPLICATION (having long lasting side effects that are not going away), HEADACHE (I got headache again) and LYMPHADENOPATHY (The lymph nodes in right arm swelled up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 102 f (High) High. On an unknown date, Computerised tomogram: normal (normal) Normal.         It was reported that the lymph nodes in right arm was about the base ball size.