chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medication include Arthritis Medication, Blood Pressure medication and Prostrate Medication.  Patient reported his symptoms with CDC and he was told to call Moderna and find out if this is something related to the vaccination.  Treatment include probiotics but symptom persists.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID-19 after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID-19 after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant product was reported.  no treatment product was reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ear pain, Headache, Myalgia, Pruritus, Somnolence
Clinical narrative: itching and hives which made her sleepy; ear pain; body aches; headache; itching; hives; "Covid Arm" (left Arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives) and EAR PAIN (ear pain) in a 25-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.     Concurrent medical conditions included Diabetes, Thyroid disorder and ADHD. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN), Adderal and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for ADHD, INSULIN for Diabetes, LEVOTHYROXINE for Thyroid disorder.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE REACTION ("Covid Arm" (left Arm)). On 12-May-2021, the patient experienced PRURITUS (itching), URTICARIA (hives) and HEADACHE (headache). On 13-May-2021, the patient experienced EAR PAIN (ear pain) and MYALGIA (body aches). On an unknown date, the patient experienced SOMNOLENCE (itching and hives which made her sleepy). At the time of the report, VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives), EAR PAIN (ear pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Benadryl for itching and hives.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: itching and hives which made her sleepy; ear pain; body aches; headache; itching; hives; "Covid Arm" (left Arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives) and EAR PAIN (ear pain) in a 25-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.     Concurrent medical conditions included Diabetes, Thyroid disorder and ADHD. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN), Adderal and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for ADHD, INSULIN for Diabetes, LEVOTHYROXINE for Thyroid disorder.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE REACTION ("Covid Arm" (left Arm)). On 12-May-2021, the patient experienced PRURITUS (itching), URTICARIA (hives) and HEADACHE (headache). On 13-May-2021, the patient experienced EAR PAIN (ear pain) and MYALGIA (body aches). On an unknown date, the patient experienced SOMNOLENCE (itching and hives which made her sleepy). At the time of the report, VACCINATION SITE REACTION ("Covid Arm" (left Arm)), SOMNOLENCE (itching and hives which made her sleepy), PRURITUS (itching), URTICARIA (hives), EAR PAIN (ear pain), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Benadryl for itching and hives.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (red big circle on arm of injection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red big circle on arm of injection). At the time of the report, ERYTHEMA (red big circle on arm of injection) outcome was unknown. Not Provided. No concomitant medications were reported. No treatment was reported for this event. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13-May-2021 updated patient's DOB.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (explosive diarrhea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Back pain, ACICLOVIR (ZOVIRAX [ACICLOVIR]), SIMVASTATIN, METFORMIN, DOXEPIN and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (explosive diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Adverse event, at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency; FIBRE, DIETARY (BENEFIBRE) for Adverse event, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (explosive diarrhea) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Shortness of breath; Congestion; Coughing up sputum/Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congestion), COUGH (Coughing up sputum/Cough) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congestion), COUGH (Coughing up sputum/Cough) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congestion), COUGH (Coughing up sputum/Cough) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient would like donate plasma or whatever information needed to further research for Covid 19.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 an unknown date, the patient experienced DIARRHOEA (severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Diarrhea, at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency; DEXTRIN (BENEFIBER [DEXTRIN]) for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diarrhea) had not resolved.            Concomitant product use was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (left arm hurting), back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030M20A) for COVID-19 immunization. No medical history provided. On May 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 5, 2021, patient experienced back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache. On an unknown date, patient experienced pain in extremity (left arm hurting). The patient treated with Tylenol (paracetamol); ongoing since an unknown date at an unspecified dose and frequency. On May 8, 2021, pain in extremity (left arm hurting), back pain (back ache), nausea (nauseous), myalgia (muscle ache) and headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or concomitant medication. Reporter did not allow further contact.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: I felt really bad; I felt body pain; Arm pain that lasted about three days; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort), FEELING ABNORMAL (I felt really bad) and PAIN (I felt body pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort) and PAIN (I felt body pain). On 18-Apr-2021, the patient experienced FEELING ABNORMAL (I felt really bad). On 20-Apr-2021, PAIN IN EXTREMITY (Arm pain that lasted about three days), DISCOMFORT (Discomfort), FEELING ABNORMAL (I felt really bad) and PAIN (I felt body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.The patient did not take any medication to alleviate the symptoms
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling, Vaccination site reaction
Clinical narrative: I had a bad reaction in my right arm.; On Saturday night , I noticed a swelling under my arm; On Friday I was on bed whole day / On Saturday I was on bed whole day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had a bad reaction in my right arm.), ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day) and PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day). On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm). On an unknown date, the patient experienced VACCINATION SITE REACTION (I had a bad reaction in my right arm.). The patient was treated with METHYLPREDNISOLONE ongoing since an unknown date for Swelling arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (I had a bad reaction in my right arm.) and ILLNESS (On Friday I was on bed whole day / On Saturday I was on bed whole day) outcome was unknown and PERIPHERAL SWELLING (On Saturday night , I noticed a swelling under my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. treatment medicine include Methylprednisolone  Action taken with mRNA-1273 in response to the event was unknown
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Somnolence
Clinical narrative: sleepy; just don't feel good; arm hurts more than suggested.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FEELING ABNORMAL (just don't feel good) and PAIN IN EXTREMITY (arm hurts more than suggested.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included AMOXYCILLIN [AMOXICILLIN] for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (sleepy), FEELING ABNORMAL (just don't feel good) and PAIN IN EXTREMITY (arm hurts more than suggested.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SOMNOLENCE (sleepy), FEELING ABNORMAL (just don't feel good) and PAIN IN EXTREMITY (arm hurts more than suggested.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old got her first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got her first dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got her first dose of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got her first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site pain
Clinical narrative: Slight reaction; Pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm). At the time of the report, ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-127871, US-MODERNATX, INC.-MOD-2021-127431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127871:Baby case US-MODERNATX, INC.-MOD-2021-127431:Husband case
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of palpitations (experiencing heart palpitations/anxiety) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A and 020B21A) for COVID-19 immunization. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Apr 30, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced palpitations (experiencing heart palpitations/anxiety). At the time of the report, palpitations (experiencing heart palpitations/anxiety) outcome: unknown. No concomitant and treatment medications reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Hypersensitivity
Clinical narrative: Severe allergic reaction; Allergy to Polysorbate 80 which is a component of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction) and ALLERGY TO VACCINE (Allergy to Polysorbate 80 which is a component of Moderna vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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 HYPERSENSITIVITY (Severe allergic reaction) and ALLERGY TO VACCINE (Allergy to Polysorbate 80 which is a component of Moderna vaccine). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction) and ALLERGY TO VACCINE (Allergy to Polysorbate 80 which is a component of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No relevant medical history was reported.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   No treatment medication was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Tinnitus
Clinical narrative: Extreme ringing in both ears; Lost his balance; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history 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 TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance). At the time of the report, TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash). At the time of the report, VACCINATION SITE MASS (developed a large lump on arm), SOMNOLENCE (Felt sleepy), SLUGGISHNESS (sluggish), VACCINATION SITE PRURITUS (Arm was itchy) and VACCINATION SITE RASH (Arm has a rash) outcome was unknown. Treatment information not provided. Concomitant medications were not provided.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: Got very sick; Thought she was going to die; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die) in a 101-year-old female patient 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 ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die). At the time of the report, ILLNESS (Got very sick) and FEELING ABNORMAL (Thought she was going to die) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Non-Significant follow up was received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Thinking abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking), CONTUSION (Bruising of the arm 24 hours later), HEADACHE (Ongoing moderate to severe headache dosen't go away) and FATIGUE (Shortly after there was fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21 and 047A21A) for COVID-19 vaccination. Medical history was not provided.  Concomitant products included NIFEDIPINE, GLIMEPIRIDE (AMARYL), VALSARTAN and CEFIXIME (ZIAC [CEFIXIME]) for an unknown indication.On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking) and FATIGUE (Shortly after there was fatigue). On 16-Apr-2021, the patient experienced CONTUSION (Bruising of the arm 24 hours later). On 22-Apr-2021, the patient experienced HEADACHE (Ongoing moderate to severe headache dosen't go away). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Headache, at a dose of UNK dosage form. At the time of the report, THINKING ABNORMAL (Have a hard time getting thoughts together/when having a headache and its not treated it scrambles thinking), CONTUSION (Bruising of the arm 24 hours later), HEADACHE (Ongoing moderate to severe headache dosen't go away) and FATIGUE (Shortly after there was fatigue) 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. On an unknown date, the patient reported visiting the doctor. Patient also reports with ibuprofen, the headaches came down to 0 or very mild.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: He had to miss his scheduled 2nd shot which was in Mid March; Covid infection contracted after 1st shot; This spontaneous case was reported by a patient and describes the occurrence of OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March) and COVID-19 (Covid infection contracted after 1st shot) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 10-Mar-2021, the patient experienced COVID-19 (Covid infection contracted after 1st shot). On an unknown date, the patient experienced OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March). At the time of the report, OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March) had resolved and COVID-19 (Covid infection contracted after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided   This case was linked to MOD-2021-127936 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Headache, Somnolence, Vaccination site reaction
Clinical narrative: Covid arm; Slept for about 24 hours; It wasn't terrible but didn't feel good; Noticed the arm was red; Horrible head ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), SOMNOLENCE (Slept for about 24 hours), FEELING ABNORMAL (It wasn't terrible but didn't feel good), ERYTHEMA (Noticed the arm was red) and HEADACHE (Horrible head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), SOMNOLENCE (Slept for about 24 hours), FEELING ABNORMAL (It wasn't terrible but didn't feel good), ERYTHEMA (Noticed the arm was red) and HEADACHE (Horrible head ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), SOMNOLENCE (Slept for about 24 hours), FEELING ABNORMAL (It wasn't terrible but didn't feel good), ERYTHEMA (Noticed the arm was red) and HEADACHE (Horrible head ache) outcome was unknown.            No relevant concomitant medications were reported.    This case was linked to MOD-2021-127588 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Migraine, Oropharyngeal pain
Clinical narrative: Nose bleeds; Headaches / migraines; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nose bleeds), MIGRAINE (Headaches / migraines) and OROPHARYNGEAL PAIN (Sore throat) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02CB21A) for COVID-19 vaccination.     Concurrent medical conditions included Clot blood. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.    On 30-Apr-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 EPISTAXIS (Nose bleeds), MIGRAINE (Headaches / migraines) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, EPISTAXIS (Nose bleeds), MIGRAINE (Headaches / migraines) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first dose was Pfizer, second dose was Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer, second dose was Moderna) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer, second dose was Moderna). On 13-May-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer, second dose was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non-significant follow up was received and  Updated email.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Shortness of Breath; Swelling in leg; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg). At the time of the report, DYSPNOEA (Shortness of Breath) and PERIPHERAL SWELLING (Swelling in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021, no new significant information
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Feeling hot, Nausea, Presyncope
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ) and PYREXIA (Started to feel like he had a fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028c21a and 037a218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers) outcome was unknown. No relevant concomitant medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ) and PYREXIA (Started to feel like he had a fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028c21a and 037a218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like he was going to pass out after the 2nd dose), FEELING HOT (Felt hot), FEEDING DISORDER (Couldn't eat ), NAUSEA (Nausea ), PYREXIA (Started to feel like he had a fever) and CHILLS (Chills, shivers) outcome was unknown. No relevant concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Joint range of motion decreased, Migraine
Clinical narrative: Delayed motor skills; Extreme pain in vision aura's; Complex migraine; Vomiting; Slight headache / extreme pain in headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Tired) and HEADACHE (Slight headache / extreme pain in headache). On 09-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine) and VOMITING (Vomiting). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired), VOMITING (Vomiting) and HEADACHE (Slight headache / extreme pain in headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Delayed motor skills; Extreme pain in vision aura's; Complex migraine; Vomiting; Slight headache / extreme pain in headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Tired) and HEADACHE (Slight headache / extreme pain in headache). On 09-Apr-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine) and VOMITING (Vomiting). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (Delayed motor skills), EYE PAIN (Extreme pain in vision aura's), MIGRAINE (Complex migraine), FATIGUE (Tired), VOMITING (Vomiting) and HEADACHE (Slight headache / extreme pain in headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days; Covid infection contracted after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection contracted after 1st shot) and OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 10-Mar-2021, the patient experienced COVID-19 (Covid infection contracted after 1st shot). On an unknown date, the patient experienced OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days). At the time of the report, COVID-19 (Covid infection contracted after 1st shot) outcome was unknown and OFF LABEL USE (He had to miss his scheduled 2nd shot which was in Mid March. Doctor told him that he has to wait for 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Reportedly the Doctor told the patient that he needs to wait for 90 days and then scheduled his 2nd appointment on 22-Jun-2021. Consent obtained for safety follow up.   This case was linked to MOD-2021-127903 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: fast heart beat of 100 beats per minute; fever of 101.6 degrees Fahrenheitfever fluctuating between 99 and 101 F; chills/could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat of 100 beats per minute), PYREXIA (fever of 101.6 degrees Fahrenheitfever fluctuating between 99 and 101 F) and CHILLS (chills/could not get warm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPROXEN SODIUM (COMPLEMENT) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced HEART RATE INCREASED (fast heart beat of 100 beats per minute), PYREXIA (fever of 101.6 degrees Fahrenheitfever fluctuating between 99 and 101 F) and CHILLS (chills/could not get warm). At the time of the report, HEART RATE INCREASED (fast heart beat of 100 beats per minute) outcome was unknown and PYREXIA (fever of 101.6 degrees Fahrenheitfever fluctuating between 99 and 101 F) and CHILLS (chills/could not get warm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Body temperature: 101.6 (High) fever of 101.6 degrees Fahrenheit. On 13-May-2021, Heart rate: High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes Multivitamins for Vegans along with above mentioned medication. No treatment drugs were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17y/o patient received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine). On 13-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17y/o patient received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Swelling, Vaccination site erythema
Clinical narrative: numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.; hands were tingling; redness in the area where the shot was at; soreness; a little swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness), SWELLING (a little swelling), HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.), PARAESTHESIA (hands were tingling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (soreness), SWELLING (a little swelling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at). On 20-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.) and PARAESTHESIA (hands were tingling). At the time of the report, PAIN (soreness), SWELLING (a little swelling), HYPOAESTHESIA (numbness in feet and legs, which moved up to her mid-section, all the way to under her breast and hands.), PARAESTHESIA (hands were tingling) and VACCINATION SITE ERYTHEMA (redness in the area where the shot was at) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       no known allergies were reported. the concomitant history was not provided by the reporter.   This case was linked to MOD-2021-127972 (Patient Link).