chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Tremor
Clinical narrative: shakes; chills; muscle aches; no energy whatsoever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever). On 08-Feb-2021, TREMOR (shakes), CHILLS (chills), MYALGIA (muscle aches) and ASTHENIA (no energy whatsoever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Pruritus, Rash
Clinical narrative: itchy; little raised bump on her arm at the injection site, 15 days after the first dose; yellowish color, like a healing black and blue bruise; around the bump there is a 2-inch light pink rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN SODIUM (COUMADIN) 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 25-Feb-2021, the patient experienced PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash). At the time of the report, PRURITUS (itchy), MASS (little raised bump on her arm at the injection site, 15 days after the first dose), CONTUSION (yellowish color, like a healing black and blue bruise) and RASH (around the bump there is a 2-inch light pink rash) 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Chills on and off; left arm hurt; Fatigue; headache; muscle pain; fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-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 CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills on and off; left arm hurt; Fatigue; headache; muscle pain; fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-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 CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills on and off), PAIN IN EXTREMITY (left arm hurt), FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever of 100F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; A bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (A bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and HEADACHE (A bad headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (A bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-026536 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: my arm hurt very bad; Fever of 103.5 F; every piece of my body hurt; joints and muscle hurt; sick as a dog; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt very bad), PYREXIA (Fever of 103.5 F), MYALGIA (every piece of my body hurt), ARTHRALGIA (joints and muscle hurt) and ILLNESS (sick as a dog) in a 66-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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (my arm hurt very bad), PYREXIA (Fever of 103.5 F), MYALGIA (every piece of my body hurt), ARTHRALGIA (joints and muscle hurt) and ILLNESS (sick as a dog). On 25-Feb-2021, PYREXIA (Fever of 103.5 F) had resolved. At the time of the report, PAIN IN EXTREMITY (my arm hurt very bad), MYALGIA (every piece of my body hurt), ARTHRALGIA (joints and muscle hurt) and ILLNESS (sick as a dog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for covid-19) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 COVID-19 (positive for covid-19). At the time of the report, COVID-19 (positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Vaccination complication
Clinical narrative: normal side effects; sore arm; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0276) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) and RIZATRIPTAN BENZOATE (MAXALT) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Muscular weakness
Clinical narrative: weakness in right leg/left leg got weak but not as bad as right one; tremendous pain behind right eye; Headache; A spontaneous report was received from a 65 year old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, eye pain and weakness in lower extremities.  The patient's medical history included diabetes. Concomitant medications included glipizide.  On 30 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in upper left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, the patient experienced weakness in her right leg.  She could barely drag the leg along and it got progressively worse. That night, she woke up with tremendous pain behind her right eye that recurred twice but did not effect her vision.    On 03 Feb 2021, the patient's left leg started to get weak, but not as bad as the right one.  She said she walked with a case.  On an unknown date in February 2021, she had a headache.    Treatment for the events included ibuprofen.  Action taken with mRNA-1273 was unknown (patient was scheduled to receive second shot of vaccine in March 2021 but stated "I need some more time to make that decision").  The outcome of the events, headache, eye pain and weakness in lower extremities, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, headache, eye pain and weakness in lower extremities, a causal relationship cannot be excluded.
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 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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Bowel movement irregularity, Diarrhoea, Fatigue, Pain
Clinical narrative: diarrhea; bowel movement; cramping; fatigue; his left arm swollen; pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his left arm swollen), PAIN (pain), DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement) and ABDOMINAL PAIN (cramping) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL TARTRATE (LOPRESSOR), AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LOSARTAN POTASSIUM, ATORVASTATIN, DIAZEPAM (VALIUM), TAMSULOSIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain). On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. On 23-Feb-2021, PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain) had resolved. At the time of the report, DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 25Feb2021, he had diarrhea, bowel movement, cramping, he went 4 times to the bathroom in 4 hours and it is semisolid.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up information received on 28-APR-2021, added, patient requested no further follow-up On 11-May-2021: Follow-up information received on 11-MAY-2021, added Email ID. Patient stated that he is doing much better past 3 weeks. Outcome of all the events updated to recovered or resolved.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: diarrhea; bowel movement; cramping; fatigue; his left arm swollen; pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his left arm swollen), PAIN (pain), DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement) and ABDOMINAL PAIN (cramping) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL TARTRATE (LOPRESSOR), AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LOSARTAN POTASSIUM, ATORVASTATIN, DIAZEPAM (VALIUM), TAMSULOSIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain). On 25-Feb-2021, the patient experienced DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at a dose of UNK dosage form. On 23-Feb-2021, PERIPHERAL SWELLING (his left arm swollen) and PAIN (pain) had resolved. At the time of the report, DIARRHOEA (diarrhea), BOWEL MOVEMENT IRREGULARITY (bowel movement), ABDOMINAL PAIN (cramping) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that on 25Feb2021, he had diarrhea, bowel movement, cramping, he went 4 times to the bathroom in 4 hours and it is semisolid.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up information received on 28-APR-2021, added, patient requested no further follow-up On 11-May-2021: Follow-up information received on 11-MAY-2021, added Email ID. Patient stated that he is doing much better past 3 weeks. Outcome of all the events updated to recovered or resolved.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012A21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 19-Jan-2021 and the estimated date of delivery was 26-Oct-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The estimated date of conception was reported as 06-Jan-2021. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Lymphadenopathy, Nausea
Clinical narrative: Diarrhea; Nausea; Fatigue; Swollen Neck Glands; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen Neck Glands) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Dysphonia
Clinical narrative: tested positive for COVID; voice was almost gone; voice was bad; A spontaneous report  was received from a healthcare professional concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid, voice was bad, voice was almost gone.  The patient's medical history was not provided. Concomitant medications reported were exemestane 25 mg have not taken it since Friday for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20A) via unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event tested positive for covid. On 4 Feb 2021, the patient experienced the events voice was bad, voice was almost gone.  Treatment details included Tylenol, ibuprofen, they were given azithromycin and an inhaler because when they got busy they, run out of breath.  Action taken with mRNA-1273 in response to the events was not reported.  On 4 Feb 2021 the outcome of event voice was bad was resolved.  On5 Feb 2021 the outcome of event  voice was almost gone was resolved. The outcome of event tested positive for covid was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: headache; nausea; fever; body aches; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 25-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (arm soreness), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Pyrexia
Clinical narrative: stomach ache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PAIN (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), PROBIOTICS NOS and IRON for Pregnancy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 20-May-2020 and the estimated date of delivery was 02-Mar-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2020, Pregnancy test: positive (Positive) Positive. In 2021, Ultrasound scan: normal (normal) Normal. In November 2021, Blood glucose: normal (normal) Normal.         Treatment history was not reported .
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: itching at injection site; soreness; sweling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling).   At the time of the report, INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (soreness) and VACCINATION SITE SWELLING (sweling) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095685 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095685:Wife's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Injection site pain, Lymph node pain, Lymphadenopathy, Pain in jaw
Clinical narrative: aw pain like TMJ pain; painful swollen lymph nodes that were really hard near her left neck; painful swollen lymph nodes that were really hard near her left ear; sore arm; injection site reaction up to her finger tips; dry mouth; Very thirsty; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth), THIRST (Very thirsty) and LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty). On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) and LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear). On an unknown date, the patient experienced PAIN IN JAW (aw pain like TMJ pain). On 10-Feb-2021, INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty) had resolved. At the time of the report, LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck), LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear) and PAIN IN JAW (aw pain like TMJ pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vaccination site reaction
Clinical narrative: aw pain like TMJ pain; painful swollen lymph nodes that were really hard near her left neck; painful swollen lymph nodes that were really hard near her left ear; sore arm; injection site reaction up to her finger tips; dry mouth; Very thirsty; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth), THIRST (Very thirsty) and LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty). On 17-Feb-2021, the patient experienced LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck) and LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear). On an unknown date, the patient experienced PAIN IN JAW (aw pain like TMJ pain). On 10-Feb-2021, INJECTION SITE PAIN (sore arm), VACCINATION SITE REACTION (injection site reaction up to her finger tips), DRY MOUTH (dry mouth) and THIRST (Very thirsty) had resolved. At the time of the report, LYMPHADENOPATHY (painful swollen lymph nodes that were really hard near her left neck), LYMPH NODE PAIN (painful swollen lymph nodes that were really hard near her left ear) and PAIN IN JAW (aw pain like TMJ pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Skin reaction, Swelling
Clinical narrative: itching a lot; kinda hard around it; The area still feels different compared to the surrounding skin; red; a little bit raised; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) 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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hard knot with swelling and itching for about 3 days; Hard knot with swelling and itching; Itchiness around injection site; Itchiness around injection site; Pain; Swelling around the injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard knot with swelling and itching), the second episode of VACCINATION SITE PRURITUS (Itchiness around injection site), the first episode of VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days) and VACCINATION SITE PAIN (Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Codiene) and Penicillin allergy. Concomitant products included AZELASTINE for Allergy, DENOSUMAB (PROLIA) from 07-May-2020 to an unknown date and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE WITH VITAMIN D3) for Osteoporosis, MIRABEGRON (MYRBETRIQ) from 07-Feb-2019 to an unknown date and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) 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 12-Feb-2021, the patient experienced the first episode of VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard knot with swelling and itching), the second episode of VACCINATION SITE PRURITUS (Itchiness around injection site) and VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days). On 16-Feb-2021, VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around injection site) had resolved. On 25-Feb-2021, VACCINATION SITE INDURATION (Hard knot with swelling and itching), the last episode of VACCINATION SITE PRURITUS (Itchiness around injection site) and VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: redness; swelling in the left arm; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dry mouth and Sjogren's.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness). At the time of the report, ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: "bright red belly button"; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("bright red belly button") in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA ("bright red belly button"). At the time of the report, ERYTHEMA ("bright red belly button") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: cough; runny nose; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), FATIGUE (fatigue) and HEADACHE (headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 COUGH (cough), RHINORRHOEA (runny nose), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (cough), RHINORRHOEA (runny nose), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included anti-hypertensives.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Sinus congestion
Clinical narrative: Felt a little sinus congestion; Low grade fever of 99.3; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache). At the time of the report, SINUS CONGESTION (Felt a little sinus congestion), PYREXIA (Low grade fever of 99.3) and HEADACHE (Very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99.3 (Inconclusive) Low grade fever 99.3.         No concomitant and treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site swelling
Clinical narrative: Fever; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE SWELLING (Injection site swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PYREXIA (Fever). an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: not provided (Inconclusive) not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Drainage, Myalgia, Nausea
Clinical narrative: Throat tingling; Throat swelling; Drainage; Fever; Joint aches; Chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever) and ARTHRALGIA (Joint aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (5 months ago the patient had COVID-19). Concomitant products included GLIPIZIDE, IRBESARTAN, ALPRAZOLAM, LINAGLIPTIN (TRADJENTA) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Feb-2021, PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Pharyngeal swelling, Pyrexia
Clinical narrative: Throat tingling; Throat swelling; Drainage; Fever; Joint aches; Chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever) and ARTHRALGIA (Joint aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (5 months ago the patient had COVID-19). Concomitant products included GLIPIZIDE, IRBESARTAN, ALPRAZOLAM, LINAGLIPTIN (TRADJENTA) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Feb-2021, PHARYNGEAL PARAESTHESIA (Throat tingling), PHARYNGEAL SWELLING (Throat swelling), DRAINAGE (Drainage), PYREXIA (Fever), ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash, Rash macular, Skin discolouration
Clinical narrative: Discolouration; 3 circular macular rashes; a left arm rash; redness; pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (CIPROFLOXACIN).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain). At the time of the report, SKIN DISCOLOURATION (Discolouration), RASH MACULAR (3 circular macular rashes), RASH (a left arm rash), ERYTHEMA (redness) and PAIN (pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Phantom limb syndrome
Clinical narrative: phantom pain; This spontaneous case was reported by a consumer and describes the occurrence of PHANTOM LIMB SYNDROME (phantom pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     The patient's past medical history included Amputation.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PHANTOM LIMB SYNDROME (phantom pain). At the time of the report, PHANTOM LIMB SYNDROME (phantom pain) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-JUL-2021 contains no significant information. Case corrected from initial version, relevant medical history ongoing updated, dose no. updated, 1st dosage regimen added, Action taken, de-challenge and re-challenge updated, narrative regenerated. On 23-Jul-2021: Patient initials updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Covid arm; Hot injection site; Red injection site; Swollen injection site; Bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump at the injection site), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) 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 historical condition reported).    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 VACCINATION SITE MASS (Bump at the injection site). On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, VACCINATION SITE MASS (Bump at the injection site), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-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.       Patient compares her pain with that of her other flu shots. Concomitant medication was not provided by the reporter.  The treatment information was unknown.   This case was linked to MODERNATX, INC.-MOD-2021-026635 (E2B Linked Report). This case was linked to MOD-2021-026132 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-026635:Family member case