chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site) in a 78-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 (No reported medical history).    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 VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site). On 26-Feb-2021, VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE WARMTH (Warm to Touch - Near Injection Site) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced NAUSEA (nausea). On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, NAUSEA (nausea) had resolved. On 25-Feb-2021, DIARRHOEA (diarrhea) had resolved.            The patient's medical history was not provided. Relevant concomitant products usage were not reported by the reporter.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Sore arm; hotness at the injection site; Swelling at injection site; Tenderness at injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (hotness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Tenderness at injection) in a 73-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 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 PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (hotness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Tenderness at injection). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (hotness at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Tenderness at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Dizziness; Tiredness; headaches; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma.    On 25-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 DIZZINESS (Dizziness), FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 650 milligram. At the time of the report, DIZZINESS (Dizziness), FATIGUE (Tiredness), HEADACHE (headaches) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Extreme chills; Extreme nausea; Body aches; Fever of 101.6; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6) in a 55-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 (Tested positive) on 04-Jan-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6). At the time of the report, CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.6 (High) 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Aching all over the body; chills; headache, no fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever). At the time of the report, MYALGIA (Aching all over the body), CHILLS (chills) and HEADACHE (headache, no fever) had not resolved.            Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection shoulder extremely sore and aching; swelling in injection shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), IRBESARTAN (AVAPRO), DOXAZOSIN, POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), SALBUTAMOL (VENTOLIN [SALBUTAMOL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), CALCIUM, MAGNESIUM, ASCORBIC ACID (VITAMIN C ACID), METFORMIN HCL, DIAZEPAM (VALIUM), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder). At the time of the report, VACCINATION SITE PAIN (Injection shoulder extremely sore and aching) and VACCINATION SITE SWELLING (swelling in injection shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Energy increased, Feeling of relaxation, Irritability, Pain in extremity
Clinical narrative: Slightly Firm Injection Site; Positive Reaction; Felt more energetic; Feels healthier post second vaccination; Overall Health Improved; Sore Arm a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm a little), IRRITABILITY (Slightly Firm Injection Site), ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic) and FEELING OF RELAXATION (Feels healthier post second vaccination) in a 66-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 Fibromyalgia and Disorders of carbohydrate transport and metabolism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm a little). On 25-Feb-2021, the patient experienced IRRITABILITY (Slightly Firm Injection Site), ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic), FEELING OF RELAXATION (Feels healthier post second vaccination) and FEELING OF RELAXATION (Overall Health Improved). On 25-Jan-2021, PAIN IN EXTREMITY (Sore Arm a little) had resolved. On 26-Feb-2021, IRRITABILITY (Slightly Firm Injection Site) had resolved. At the time of the report, ADVERSE REACTION (Positive Reaction), ENERGY INCREASED (Felt more energetic), FEELING OF RELAXATION (Feels healthier post second vaccination) and FEELING OF RELAXATION (Overall Health Improved) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-027902 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Wheezing
Clinical narrative: Coughing; Wheezing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN), ROSUVASTATIN CALCIUM (CRESTOR), VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), CARVEDILOL, TURMERIC [CURCUMA LONGA RHIZOME], APPLE CIDER VINEGAR, COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) and MULTIVITAMIN N [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE MONONITRATE].    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache). At the time of the report, COUGH (Coughing), WHEEZING (Wheezing) and HEADACHE (Headache) outcome was unknown.            Treatment information were not provided. Action taken with mRNA-1273 was not spplicable
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness in the legs) in a male 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 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 MUSCULAR WEAKNESS (muscle weakness in the legs). At the time of the report, MUSCULAR WEAKNESS (muscle weakness in the legs) outcome was unknown. Not Provided
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia, trouble sleeping for 7 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Insomnia, trouble sleeping for 7 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia, trouble sleeping for 7 days). At the time of the report, INSOMNIA (Insomnia, trouble sleeping for 7 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Sick all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick all night) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (Sick all night). At the time of the report, MALAISE (Sick all night) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Pain at the injection site; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   No treatment medications provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: extreme weakness; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ASTHENIA (extreme weakness) and HEADACHE (headache). At the time of the report, ASTHENIA (extreme weakness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temperature of 102F; A spontaneous report was received from a consumer concerning a female patient of unknown age,who received Modena's COVID-19 vaccine (mRNA-1273) and experienced fever. The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown)  for prophylaxis of COVID-19 infection.  On an unspecified date,the patient developed fever,temperature of 102 F. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown . The outcome of the event pyrexia was unknown at the time of the report
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Really bad headache). On 11-Feb-2021, HEADACHE (Really bad headache) had resolved.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore right arm; A spontaneous report was received from a consumer concerning a 70-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore right arm.  The patient's medical history was not provided. Concomitant medications as provided by the reporter are phenobarbital and lovastatin.  On an unknown date, patient received the first of the two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25 Feb 2021, approximately 1 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  Patient received the vaccine on 25 Feb 2021. On 26 Feb 2021, patient called in to report a sore right arm and ask if can take an advil to treat it. Treatment for the events was not mentioned. Action taken with mRNA-1273 in response to the events is not applicable as patient has taken both doses of the vaccine.   The outcome of the event, sore right arm, was considered unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: vaccination site pruritus; nasal congestion; sneezing; vaccination site swelling; A spontaneous report was received from a consumer concerning a 89- year old-female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced injection site swelling and itching,nasal congestion and sneezing.  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 their planned dose of mRNA-1273 (lot/batch 011M20A) intramuscularly  for prophylaxis of COVID-19 infection.   On 16-Feb-2021,she had an egg shaped swelling on the injection site which started to itch on day 4 post vaccination. this was associated with nasal congestion and sneezing. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the events,injection site swelling,injection site itching,nasal congestion and sneezing was considered as unknown at the time of the report
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, SARS-CoV-2 test, Sluggishness
Clinical narrative: Sluggish; Tired; Sneezing; Nasal congestion; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion). At the time of the report, COVID-19 (Tested positive for Covid), SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: Positive.     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.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Sluggish; Tired; Sneezing; Nasal congestion; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion). At the time of the report, COVID-19 (Tested positive for Covid), SLUGGISHNESS (Sluggish), FATIGUE (Tired), SNEEZING (Sneezing) and NASAL CONGESTION (Nasal congestion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: Positive.     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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to the touch IS; Redness IS; Swollen IS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS). At the time of the report, INJECTION SITE WARMTH (Warm to the touch IS), INJECTION SITE ERYTHEMA (Redness IS) and INJECTION SITE SWELLING (Swollen IS) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR added. Reporter said it's been a while those reactions happened. She doesn't want to do any follow up as she is fine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Sinus headache, Vaccination site pain
Clinical narrative: flu like symptoms; sinus headache; injection site arm aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included GABAPENTIN, BACLOFEN, PANTOPRAZOLE, ESCITALOPRAM, RIVAROXABAN, VITAMIN D3, ASCORBIC ACID (VIT C) and CALCIUM for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (injection site arm aches) and NAUSEA (nausea) outcome was unknown.            Patient received the Moderna Covid-19 vaccine in her right arm shoulder deltoid muscle
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I had cold sores; A spontaneous report was received from a consumer concerning a 75 year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced oral herpes.  The patient's medical history was provided as sore lips and had breast cancer on her left side. The Concomitant medication reported was Livalo.  On 11 Feb 2021 , approximately 12 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.   On 23 Feb 2021 tuesday, patient developed cold sores and she took Denavir which was prescribed to her earlier. The patient's second dose is due on 11 Mar 2011.She enquired if she can take the second dose.  The treatment taken for the events was reported as Denavir.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events were considered as resolving.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Rash erythematous, Swelling face
Clinical narrative: Felt warm; Pink rash near the injection site; Swelling on face and cheek; Face was flushed; A spontaneous report was received from a consumer concerning an 80-year-old, female patient, who received Moderna's covid-19 vaccine and experienced swelling on the face and cheek(swelling face), flushing of face(flushing), felt warm (feeling hot) and pink rash near the injection site(rash erythematous).    The patient's medical history was not provided. Patient was allergic to Penicillin and Augmentin. Concomitant medications included paroxetine 30mg, hydrochlorothiazide 12.5mg, rosuvastatin, lisinopril, Tylenol, vitamin D, alprazolam and aspirin 81mg.   On 25 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number:013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 25 Feb 2021, after the vaccination,patient started experiencing swelling on her face and cheek.Her face was flushed.On 26 Feb 2021, she felt warm and pink rash appeared near the injection site.She has not received any treatment for her symptoms and the symptoms were ongoing.  Action taken with mRNA-1273 in response to the event was not applicable.  Outcome of the events, swelling on the face and cheek, flushing of face, felt warm and pink rash near the injection site, were considered as not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 102.7 F; Shivering; Tired; Muscle Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) in a 33-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 26-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) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm) and MYALGIA (Muscle Aches). On 27-Feb-2021, the patient experienced PYREXIA (Fever 102.7 F), CHILLS (Shivering) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102 (High) Fever.         No concomitant medications were reported.  Treatment included Luke warm shower and luke warm water on her forehead
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever 102.7 F; Shivering; Tired; Muscle Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) in a 33-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 26-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) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm) and MYALGIA (Muscle Aches). On 27-Feb-2021, the patient experienced PYREXIA (Fever 102.7 F), CHILLS (Shivering) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Sore Arm), PYREXIA (Fever 102.7 F), MYALGIA (Muscle Aches), CHILLS (Shivering) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 102 (High) Fever.         No concomitant medications were reported.  Treatment included Luke warm shower and luke warm water on her forehead
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: Sore arm; Rash on the face, neck and chest; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache) in a 49-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 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, Pain in arm and Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Rash on the face, neck and chest) and HEADACHE (Headache) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: Generally doesn't feel good; Achy/ hurts all over; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included PAROXETINE, AJMALINE (CARDIA), LOSARTAN and EZETIMIBE 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 MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache) 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 medications include eye drops, two inhalers.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Taste disorder
Clinical narrative: Certain food has tasted different; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Certain food has tasted different) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TASTE DISORDER (Certain food has tasted different) and PAIN IN EXTREMITY (Sore arm). At the time of the report, TASTE DISORDER (Certain food has tasted different) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given 16 minutes after 6 hour window; A spontaneous report was received from a health care provider concerning a patient of unknown age and gender who received Modern's COVID-19 vaccine (mRNA-1273) and experienced a used punctured vial 16 minutes after the allowed 6 hour window to administer a dose/expired product used.  The patient's medical history was not provided. No relevant concomitant medication was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that a punctured vial was used 16 minutes after the allowed 6-hour window to administer the dose.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event dose given 16 minutes after 6 hour window/ expired product used was recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 014M20A)  with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Cough; Headache; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), HEADACHE (Headache), MYALGIA (sore arm) and PYREXIA (Fever) in a 56-year-old male 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.    On 17-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 COUGH (Cough), HEADACHE (Headache), MYALGIA (sore arm) and PYREXIA (Fever). At the time of the report, COUGH (Cough), HEADACHE (Headache), MYALGIA (sore arm) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Dysphonia, Peripheral swelling, Rash, Rash pruritic
Clinical narrative: scratchy voice; hives that were red itchy; dry arm; arm was swollen; spot at the injection site; hives; redness that covered the whole forearm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE DISCOLOURATION (spot at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history not provided.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), PRAMIPEXOLE and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm). At the time of the report, DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site discolouration
Clinical narrative: scratchy voice; hives that were red itchy; dry arm; arm was swollen; spot at the injection site; hives; redness that covered the whole forearm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE DISCOLOURATION (spot at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history not provided.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), PRAMIPEXOLE and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm). At the time of the report, DYSPHONIA (scratchy voice), RASH PRURITIC (hives that were red itchy), DRY SKIN (dry arm), PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE DISCOLOURATION (spot at the injection site), URTICARIA (hives) and RASH (redness that covered the whole forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: sore arm/body aches; chills; fever; headache; swollen lymph nodes on her neck on the left side; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced MYALGIA (sore arm). On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side). At the time of the report, MYALGIA (sore arm/body aches), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes on her neck on the left side) and MYALGIA (sore arm) outcome was unknown.            Treatment included Ibuprofen
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: I am pregnant and got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine) in a 31-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ectopic pregnancy, Induced abortion (Induced abortion) and Alcohol use (Sporadically). Concurrent medical conditions included Sugar blood increased (Problems with the sugar(it's been monitored during pregnancy)). Concomitant products included OMEPRAZOLE from 22-Feb-2021 to an unknown date for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-May-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine). The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) ongoing since an unknown date at an unspecified dose and frequency. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (I am pregnant and got the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Pregnancy test: positive (Positive) Positive. On 22-Feb-2021, Ultrasound scan: normal (normal) normal Everything fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were unknown. Patient had cousin with Down syndrome. In Feb 2021, genetic test was performed results were normal, everything was fine. Patient had previous pregnancy which was ectopic pregnancy.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: COVID arm (6.5 x 4 inches rash on the arm); Lot of pain in the arm / arm was still sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Lot of pain in the arm / arm was still sore) and RASH (COVID arm (6.5 x 4 inches rash on the arm)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Broken wrist (The patient has just nine fingers on the hand).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in the arm / arm was still sore). On 15-Feb-2021, the patient experienced RASH (COVID arm (6.5 x 4 inches rash on the arm)). On 15-Feb-2021, PAIN IN EXTREMITY (Lot of pain in the arm / arm was still sore) had resolved. At the time of the report, RASH (COVID arm (6.5 x 4 inches rash on the arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received on 19-JUN-2021 contains updated outcome of event "Rash" into Recovered/Resolved.