chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ligament sprain, Vaccination site bruising
Clinical narrative: left hip tightness; bruise size of a quarter at injection site; (left hip) pain; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], SELENIUM, CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) and ASCORBIC ACID, QUERCETIN (QUERCITIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain). At the time of the report, LIGAMENT SPRAIN (left hip tightness), VACCINATION SITE BRUISING (bruise size of a quarter at injection site) and ARTHRALGIA ((left hip) pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: had an arm sore, lasted 3 to 5 days; Head ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache). At the time of the report, PAIN IN EXTREMITY (had an arm sore, lasted 3 to 5 days) and HEADACHE (Head ache) outcome was recovered/resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes Tylenol   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash, Rash macular
Clinical narrative: 3 blotches with red dots.; Like a punch on the upper part of the arm, it was very sore; Headache; Strange rash on mid upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore), RASH (Strange rash on mid upper arm) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included NATALIZUMAB for Multiple sclerosis, CLONAZEPAM, PAROXETINE (DAVOL [PAROXETINE]), TRAZODONE, PRAVASTATIN, ARIPIPRAZOLE, VITAMIN D3 and CALCIUM CARBONATE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Strange rash on mid upper arm). On an unknown date, the patient experienced RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore), RASH (Strange rash on mid upper arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: NNI
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: weak; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and DIZZINESS (dizzy) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ASTHENIA (weak) and DIZZINESS (dizzy). At the time of the report, ASTHENIA (weak) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Vaccination site pain
Clinical narrative: diarrhea; very tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE PAIN (sore arm) and FATIGUE (very tired) in an 82-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 (sore arm). On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and FATIGUE (very tired). On 27-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, DIARRHOEA (diarrhea) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling cold, Injection site pain
Clinical narrative: SNEEZING; RUNNY NOSE; MILD COUGH; COLD; ARM PAIN; BRIEF CHILLS; MILD FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD) and INJECTION SITE PAIN (ARM PAIN) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD), INJECTION SITE PAIN (ARM PAIN), CHILLS (BRIEF CHILLS) and FATIGUE (MILD FATIGUE). At the time of the report, SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD), INJECTION SITE PAIN (ARM PAIN), CHILLS (BRIEF CHILLS) and FATIGUE (MILD FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO concomitant or treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: SNEEZING; RUNNY NOSE; MILD COUGH; COLD; ARM PAIN; BRIEF CHILLS; MILD FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD) and INJECTION SITE PAIN (ARM PAIN) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD), INJECTION SITE PAIN (ARM PAIN), CHILLS (BRIEF CHILLS) and FATIGUE (MILD FATIGUE). At the time of the report, SNEEZING (SNEEZING), RHINORRHOEA (RUNNY NOSE), COUGH (MILD COUGH), FEELING COLD (COLD), INJECTION SITE PAIN (ARM PAIN), CHILLS (BRIEF CHILLS) and FATIGUE (MILD FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO concomitant or treatment medications were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who is 17 years old, received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old, received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old, received the vaccine). On 04-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient who is 17 years old, received the vaccine) 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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: NNI
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Nausea, Peripheral swelling
Clinical narrative: arm swell up a little bit; arm turned red from the shoulder to the elbow; fever; bad headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swell up a little bit), ERYTHEMA (arm turned red from the shoulder to the elbow), PYREXIA (fever), HEADACHE (bad headache) and NAUSEA (Nausea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-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 PERIPHERAL SWELLING (arm swell up a little bit), ERYTHEMA (arm turned red from the shoulder to the elbow), PYREXIA (fever), HEADACHE (bad headache), NAUSEA (Nausea) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, PYREXIA (fever), HEADACHE (bad headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swell up a little bit) and ERYTHEMA (arm turned red from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment for swelling included ice pack.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: arm swell up a little bit; arm turned red from the shoulder to the elbow; fever; bad headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swell up a little bit), ERYTHEMA (arm turned red from the shoulder to the elbow), PYREXIA (fever), HEADACHE (bad headache) and NAUSEA (Nausea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-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 PERIPHERAL SWELLING (arm swell up a little bit), ERYTHEMA (arm turned red from the shoulder to the elbow), PYREXIA (fever), HEADACHE (bad headache), NAUSEA (Nausea) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Feb-2021, PYREXIA (fever), HEADACHE (bad headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swell up a little bit) and ERYTHEMA (arm turned red from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment for swelling included ice pack.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Vulvovaginal discomfort
Clinical narrative: sensation of internal itching; prickling sensation over the skin; focused and prevalent to the pubic area; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (sensation of internal itching), PARAESTHESIA (prickling sensation over the skin) and VULVOVAGINAL DISCOMFORT (focused and prevalent to the pubic area) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included DULOXETINE 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. On 26-Feb-2021, the patient experienced PRURITUS (sensation of internal itching), PARAESTHESIA (prickling sensation over the skin) and VULVOVAGINAL DISCOMFORT (focused and prevalent to the pubic area). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PRURITUS (sensation of internal itching), PARAESTHESIA (prickling sensation over the skin) and VULVOVAGINAL DISCOMFORT (focused and prevalent to the pubic area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Vaccination site pruritus
Clinical narrative: The injection area on her arm was itchy; Her throat  and neck were itchy on the outside not inside; Flushed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The injection area on her arm was itchy), PRURITUS (Her throat  and neck were itchy on the outside not inside) and FLUSHING (Flushed) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (Anaphylactic reaction to nuts). Concurrent medical conditions included Food allergy (Nuts).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (The injection area on her arm was itchy), PRURITUS (Her throat  and neck were itchy on the outside not inside) and FLUSHING (Flushed). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and ALARIA ESCULENTA at a dose of 180 mg. At the time of the report, VACCINATION SITE PRURITUS (The injection area on her arm was itchy), PRURITUS (Her throat  and neck were itchy on the outside not inside) and FLUSHING (Flushed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. Treatment information included benadryl
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Influenza like illness, Pain
Clinical narrative: Numbness in leg; Numbness of limbs; Flu like symptoms; Chills; Ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in leg), HYPOAESTHESIA (Numbness of limbs), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache). On 28-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in leg) and HYPOAESTHESIA (Numbness of limbs). At the time of the report, HYPOAESTHESIA (Numbness in leg), HYPOAESTHESIA (Numbness of limbs), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache) outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Vaccination site mass
Clinical narrative: Swollen on the Injection Site; Itching on the Injection Site; Lump came back on the Injection Site; Soreness on the Injection Site; Redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness on the Injection Site), INJECTION SITE ERYTHEMA (Redness on the Injection Site), INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness on the Injection Site) and INJECTION SITE ERYTHEMA (Redness on the Injection Site). On 03-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site). On 26-Feb-2021, INJECTION SITE PAIN (Soreness on the Injection Site) and INJECTION SITE ERYTHEMA (Redness on the Injection Site) had resolved. At the time of the report, INJECTION SITE SWELLING (Swollen on the Injection Site), INJECTION SITE PRURITUS (Itching on the Injection Site) and VACCINATION SITE MASS (Lump came back on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Vaccination site swelling
Clinical narrative: 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 VACCINATION SITE SWELLING (swelling of the injection site). On 03-Mar-2021, the patient experienced CHEST PAIN (mild chest pain) and DYSPNOEA (shortness of breath). At the time of the report, VACCINATION SITE SWELLING (swelling of the injection site), CHEST PAIN (mild chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: rash at injection site that is 2 to 3 inches in diameter; pain at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). On 25-Feb-2021, the patient experienced INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter). On 21-Feb-2021, INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: After thawing the vial she forgot to let it sit at room temp for 15 min; A spontaneous report was received from a pharmacist concerning an unidentifiable patient who was administered  mRNA-1273  for prophylaxis of COVID-19 infection. The pharmacist.forgot to let vaccine sit at room temp for 15 min before administration (PT: Wrong technique in product usage process).    The patient's medical history was not provided.  No concomitant product use was provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. After administering the vaccine, the pharmacist stated that they forgot to let the vaccine sit at room temperature for 15 min before administration.   Action taken with mRNA-1273 in response to the events was not provided.  The event forgot to let vaccine sit at room temp for 15 min before administration was considered resolved.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # unknown.  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given on day 42; A spontaneous report was received from an unknown  years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second dose given on day 42 (inappropriate schedule of product administration).  The patients medical history was not provided. The relevant concomitant medications were also not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number:unknown   ) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA (Lot number: unknown   ) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the  patient experienced that second dose was given on day 42. It was a medication error.  No laboratory data was provided. No treatment information was provided..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate irregular, Rash, Vaccination site erythema
Clinical narrative: Elevating and fluctuating heartbeat; Got an infection that went down her arm; Dizziness; Weakness; Went down to half of the right arm, purple circles after having the rash; Rash; Itch; Pink under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness) and RASH (Went down to half of the right arm, purple circles after having the rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL, LOVASTATIN, LEVOTHYROXINE, GABAPENTIN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PARACETAMOL (TYLENOL), B12, FISH OIL, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), PROBIOTIC 10 and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 16-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 HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Went down to half of the right arm, purple circles after having the rash), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (Pink under the skin). At the time of the report, HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Went down to half of the right arm, purple circles after having the rash), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (Pink under the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included were CEPHALEXIN for the infection and BENADRYL SPRAY for rash and itch
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Elevating and fluctuating heartbeat; Got an infection that went down her arm; Dizziness; Weakness; Went down to half of the right arm, purple circles after having the rash; Rash; Itch; Pink under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness) and RASH (Went down to half of the right arm, purple circles after having the rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALLOPURINOL, LOVASTATIN, LEVOTHYROXINE, GABAPENTIN, OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PARACETAMOL (TYLENOL), B12, FISH OIL, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), PROBIOTIC 10 and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 16-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 HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Went down to half of the right arm, purple circles after having the rash), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (Pink under the skin). At the time of the report, HEART RATE IRREGULAR (Elevating and fluctuating heartbeat), VACCINATION SITE INFECTION (Got an infection that went down her arm), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Went down to half of the right arm, purple circles after having the rash), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itch) and VACCINATION SITE ERYTHEMA (Pink under the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included were CEPHALEXIN for the infection and BENADRYL SPRAY for rash and itch
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Arm was a little itchy after the shot; Redness in the same are as the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site). At the time of the report, PRURITUS (Arm was a little itchy after the shot) and INJECTION SITE ERYTHEMA (Redness in the same are as the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-Significant follow-up
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dry mouth, Dysgeusia, Pyrexia
Clinical narrative: Eats half of what he use to eat/doesn't enjoy eating; Mouth gets very dry at night; Fever; Metallic taste/funny taste constantly in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste/funny taste constantly in my mouth), DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) for Taste abnormality.  On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste/funny taste constantly in my mouth) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating) and DRY MOUTH (Mouth gets very dry at night).   At the time of the report, DYSGEUSIA (Metallic taste/funny taste constantly in my mouth), DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating) and DRY MOUTH (Mouth gets very dry at night) had not resolved and PYREXIA (Fever) outcome was unknown.      Treatment information was not provided. Patient places hard candy or cough drops in his mouth throughout the day.   This case was linked to MOD-2021-032579 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated event outcome; Sender's Comments:  MOD-2021-032579:Same reporter/Different patient (husband case)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye swelling, Heart rate increased, Injection site pain, Pruritus
Clinical narrative: weakness; Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and; A fast heartbeat; swelling under the right eye; Pain at the injection site and headache; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug (allergic to piroxicam.) on 02-Mar-2021, Allergic skin reaction (allergic to propylene glycol) on 02-Mar-2021 and Allergic reaction to drug (allergic to polysorbate.) on 02-Mar-2021.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Non-Significant information Appended - NNI received
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) outcome was unknown.            Concomitant medications was not provided. Treatment information was not provided.   This case was linked to MOD-2021-032346 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: Tingling feeling of lower extremities; Muscle spasm; Missed the 2nd dose of Moderna vaccine; Sweating; Burning chest and arms; Dizziness; Rash for 7 days; Body aches; Headaches; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling feeling of lower extremities), MUSCLE SPASMS (Muscle spasm), PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine), HYPERHIDROSIS (Sweating) and BURNING SENSATION (Burning chest and arms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A (or) 011L2019?) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), BURNING SENSATION (Burning chest and arms), DIZZINESS (Dizziness), RASH (Rash for 7 days), MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (Nausea). On an unknown date, the patient experienced PARAESTHESIA (Tingling feeling of lower extremities), MUSCLE SPASMS (Muscle spasm) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine). The patient was treated with DEXAMETHASONE for Adverse event, at a dose of UNK dosage form and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (Tingling feeling of lower extremities) and MUSCLE SPASMS (Muscle spasm) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine), HYPERHIDROSIS (Sweating), BURNING SENSATION (Burning chest and arms), DIZZINESS (Dizziness), RASH (Rash for 7 days), MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was advised by allergist not to take second dose. The patient did some blood work by the recommendation of allergist and report came normal.So the allergist referred the patient to contact the Neurologist for the symptoms persisting.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Anatomical location of vaccination, treatment details and contact details were updated. On 05-May-2021: Events and lab data updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Product dose omission issue, Rash
Clinical narrative: Tingling feeling of lower extremities; Muscle spasm; Missed the 2nd dose of Moderna vaccine; Sweating; Burning chest and arms; Dizziness; Rash for 7 days; Body aches; Headaches; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling feeling of lower extremities), MUSCLE SPASMS (Muscle spasm), PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine), HYPERHIDROSIS (Sweating) and BURNING SENSATION (Burning chest and arms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A (or) 011L2019?) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), BURNING SENSATION (Burning chest and arms), DIZZINESS (Dizziness), RASH (Rash for 7 days), MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (Nausea). On an unknown date, the patient experienced PARAESTHESIA (Tingling feeling of lower extremities), MUSCLE SPASMS (Muscle spasm) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine). The patient was treated with DEXAMETHASONE for Adverse event, at a dose of UNK dosage form and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (Tingling feeling of lower extremities) and MUSCLE SPASMS (Muscle spasm) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine), HYPERHIDROSIS (Sweating), BURNING SENSATION (Burning chest and arms), DIZZINESS (Dizziness), RASH (Rash for 7 days), MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient was advised by allergist not to take second dose. The patient did some blood work by the recommendation of allergist and report came normal.So the allergist referred the patient to contact the Neurologist for the symptoms persisting.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Anatomical location of vaccination, treatment details and contact details were updated. On 05-May-2021: Events and lab data updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: difficult to walk; left leg pain; pain going from her right shoulder and going down to her back; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back). At the time of the report, GAIT DISTURBANCE (difficult to walk), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (pain going from her right shoulder and going down to her back) outcome was unknown.            Patient's concomitant medications included unspecified medicines for high blood pressure.  Patient did not use any treatment medicines for the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up report included no new information
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Vaccine dripping down the arm; Product administration error; A spontaneous report was received from a pharmacist for a patient (unknown age and gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine dripping down the arm/ under dose and product administration error.   The patient's medical history was not provided. No concomitant product use was reported.  On 25-FEB-2021, the patient received their unknown dose of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. While receiving vaccine patient noticed the vaccine dripped down the arm. The reporter wanted to know if the patient should get re-vaccinated or not.  Action taken with mRNA-1273 was unknown.  The outcome of the events, vaccine dripping down the arm and product administration error were considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of product administration error and underdose  for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Injection site pain
Clinical narrative: Ear infection; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and INJECTION SITE PAIN (Soreness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection site). On 03-Mar-2021, the patient experienced EAR INFECTION (Ear infection). At the time of the report, EAR INFECTION (Ear infection) and INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Joint swelling, Skin discolouration
Clinical narrative: Bursitis of elbow; Whole elbow to wrist turned black and blue/Elbow turned purple and red; Elbow is starting to swell like there is fluid with a size of an egg; Elbow hurting; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis of elbow), SKIN DISCOLOURATION (Whole elbow to wrist turned black and blue/Elbow turned purple and red), JOINT SWELLING (Elbow is starting to swell like there is fluid with a size of an egg) and ARTHRALGIA (Elbow hurting) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SKIN DISCOLOURATION (Whole elbow to wrist turned black and blue/Elbow turned purple and red), JOINT SWELLING (Elbow is starting to swell like there is fluid with a size of an egg) and ARTHRALGIA (Elbow hurting). On 08-Mar-2021, the patient experienced BURSITIS (Bursitis of elbow). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) in March 2021 for Adverse reaction, at a dose of 1 UNK and NAPROXEN SODIUM (ALEVE) in March 2021 for Adverse reaction, at an unspecified dose and frequency. On 08-Mar-2021, SKIN DISCOLOURATION (Whole elbow to wrist turned black and blue/Elbow turned purple and red) had resolved. At the time of the report, BURSITIS (Bursitis of elbow) had not resolved, JOINT SWELLING (Elbow is starting to swell like there is fluid with a size of an egg) was resolving and ARTHRALGIA (Elbow hurting) outcome was unknown.            Patient does not take any medications on daily basis as concomitant medications.  Patient's swelling came down within 24 hours of administering diphenhydramine. However, on 07-MAR-2021, the swelling from the same elbow with the size of the egg came back. The blue and black discoloration stayed on until 08-MAR-2021. Patient's physician diagnosed it as bursitis of elbow. At the time of report, on 02-MAR-2021, the swelling was greatly improved, and was slowly going away.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up information was received on 02 May 2021, patient initials an DOB updated, new events with out come of the events updated, treatment information updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: reactions, it wasn't good; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reactions, it wasn't good) in a 60-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) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ADVERSE EVENT (reactions, it wasn't good).   At the time of the report, ADVERSE EVENT (reactions, it wasn't good) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.