chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal, SARS-CoV-2 antibody test negative
Clinical narrative: Negative antibodies after 2 doses; Antibodies less 0.02% after two shots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) and SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ASPIRIN [ACETYLSALICYLIC ACID], ACETYLSALICYLIC ACID (ECOTRIN), DUTASTERIDE (AVODART), MAGNESIUM, MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]), NYSTATIN (MICOSTATIN), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL SUCCINATE (TOPROL), HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) and RIVAROXABAN (XARELTO) 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 17-Mar-2021, the patient experienced ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots). On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses). At the time of the report, ANTIBODY TEST ABNORMAL (Antibodies less 0.02% after two shots) and SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative antibodies after 2 doses) outcome was unknown.            No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Achy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (in remission 2 to 2 1/2 years).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Achy) and CHILLS (Chills). At the time of the report, PAIN (Achy) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Annoying headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Annoying headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Annoying headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 17-Mar-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Annoying headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic, Skin disorder
Clinical narrative: Itchy; Rash; Chitlains; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), RASH PRURITIC (Rash) and SKIN DISORDER (Chitlains) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Unspecified, has unusual reactions).    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 PRURITUS (Itchy), RASH PRURITIC (Rash) and SKIN DISORDER (Chitlains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash pruritic, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy) and RASH PRURITIC (Rash) had not resolved and SKIN DISORDER (Chitlains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient reported an additional treatment was a topical steroid cream on an unknown start date. She also received a lowdose steroid injection as treatment for her adverse events from her dermatologist on an unknown start date.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine after temperature excursion; A Spontaneous report was received from a consumer, concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) after temperature excursion/product storage error.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 18 Mar 2021, prior to the onset of the events, the patient received planned doses of mRNA-1273 for prophylaxis of COVID-19 infection which underwent temperature excursion/ product storage error.  Laboratory details was not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event received vaccine after temperature excursion was considered as resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknown  with no associated AEs.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: Freezing to death; Weakness; Diarrhea; Chills; Headache - head is killing me; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache - head is killing me) in a 58-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache - head is killing me), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache - head is killing me), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Freezing to death; Weakness; Diarrhea; Chills; Headache - head is killing me; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills) and HEADACHE (Headache - head is killing me) in a 58-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache - head is killing me), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Freezing to death), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache - head is killing me), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: monoclonal antibodies and the Moderna vaccine with a 46 days of difference; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference). At the time of the report, OFF LABEL USE (monoclonal antibodies and the Moderna vaccine with a 46 days of difference) 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 treatment related information has been reported. No concomitant medications were reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site induration, Vaccination site swelling
Clinical narrative: Feels nauseous; Site is swollen; Site is hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Site is hard), NAUSEA (Feels nauseous) and VACCINATION SITE SWELLING (Site is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, EZETIMIBE and LOSARTAN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Site is hard) and VACCINATION SITE SWELLING (Site is swollen). On 17-Mar-2021, the patient experienced NAUSEA (Feels nauseous). At the time of the report, VACCINATION SITE INDURATION (Site is hard), NAUSEA (Feels nauseous) and VACCINATION SITE SWELLING (Site is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner and blood pressure medicine.  No treatment information was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Tremor
Clinical narrative: Shaking so bad; Head ache over the eye and the cheek; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking so bad), HEADACHE (Head ache over the eye and the cheek) and NAUSEA (Nauseated) was resolving.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-049647 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Unevaluable event
Clinical narrative: unspecified symptoms; Dizziness when lying on her back; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when lying on her back) and UNEVALUABLE EVENT (unspecified symptoms) in a 70-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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (Dizziness when lying on her back). On an unknown date, the patient experienced UNEVALUABLE EVENT (unspecified symptoms). At the time of the report, DIZZINESS (Dizziness when lying on her back) and UNEVALUABLE EVENT (unspecified symptoms) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.   No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021; Sore arm; 16 year old patient received moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine) and OFF LABEL USE (received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced OFF LABEL USE (received moderna vaccine on his left arm on 2Mar2021 and on 5Mar2021). On 02-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient received moderna vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      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 related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Heart rate increased, Vaccination site rash
Clinical narrative: Rapid heart beat; Stomach issues; Develop a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site). At the time of the report, HEART RATE INCREASED (Rapid heart beat), ABDOMINAL DISCOMFORT (Stomach issues) and VACCINATION SITE RASH (Develop a rash at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Limb discomfort, Migraine
Clinical narrative: Arm pain; Migraine headache; Weak stomach; lack of energy; sleepiness; Foggy eyes; dizziness; Difficulty moving arm; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy) and SOMNOLENCE (sleepiness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Low platelets, Hemoglobin low and WBC abnormal (low). Concomitant products included PARACETAMOL (TYLENOL) and MELOXICAM for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy), SOMNOLENCE (sleepiness), VISION BLURRED (Foggy eyes), DIZZINESS (dizziness), LIMB DISCOMFORT (Difficulty moving arm) and DIZZINESS (lightheadedness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy), SOMNOLENCE (sleepiness), VISION BLURRED (Foggy eyes), DIZZINESS (dizziness), LIMB DISCOMFORT (Difficulty moving arm) and DIZZINESS (lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history included historical treatment with chemotherapy for an unknown indication.   Additional concomitant medications included chemotherapy and an unspecified allergy tablet for drug use for unknown indication.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Vision blurred
Clinical narrative: Arm pain; Migraine headache; Weak stomach; lack of energy; sleepiness; Foggy eyes; dizziness; Difficulty moving arm; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy) and SOMNOLENCE (sleepiness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Low platelets, Hemoglobin low and WBC abnormal (low). Concomitant products included PARACETAMOL (TYLENOL) and MELOXICAM for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy), SOMNOLENCE (sleepiness), VISION BLURRED (Foggy eyes), DIZZINESS (dizziness), LIMB DISCOMFORT (Difficulty moving arm) and DIZZINESS (lightheadedness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headache), ABDOMINAL DISCOMFORT (Weak stomach), ASTHENIA (lack of energy), SOMNOLENCE (sleepiness), VISION BLURRED (Foggy eyes), DIZZINESS (dizziness), LIMB DISCOMFORT (Difficulty moving arm) and DIZZINESS (lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history included historical treatment with chemotherapy for an unknown indication.   Additional concomitant medications included chemotherapy and an unspecified allergy tablet for drug use for unknown indication.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: didn't feel the needle go in/no pin prick; This spontaneous case was reported by a nurse and describes the occurrence of MEDICATION ERROR (didn't feel the needle go in/no pin prick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No adverse event history reported.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MEDICATION ERROR (didn't feel the needle go in/no pin prick). On 18-Mar-2021, MEDICATION ERROR (didn't feel the needle go in/no pin prick) 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.   Treatment information not provided.; Sender's Comments: Very limited information has been provided for the event at this time.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site reaction
Clinical narrative: moderna arm; little red mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark) in a 74-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 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark). At the time of the report, VACCINATION SITE REACTION (moderna arm) and ERYTHEMA (little red mark) outcome was unknown.            Concomitants were not provided. No treatment information
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: In her Left Clavicle a knout (like a bump); Minor injection site pain (L arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor injection site pain (L arm)) and LYMPHADENOPATHY (In her Left Clavicle a knout (like a bump)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Minor injection site pain (L arm)). On 17-Mar-2021, the patient experienced LYMPHADENOPATHY (In her Left Clavicle a knout (like a bump)). At the time of the report, VACCINATION SITE PAIN (Minor injection site pain (L arm)) and LYMPHADENOPATHY (In her Left Clavicle a knout (like a bump)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified asthma inhaler (occasionally). The patient did not receive any treatment medications.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Received vaccine after temperature excursion; Received vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Received vaccine after temperature excursion) had resolved.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Received vaccine following temperature excursion; Received vaccine following temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine following temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received vaccine following temperature excursion) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine following temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received vaccine following temperature excursion). On 18-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine following temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Received vaccine following temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Oral pain, Peripheral swelling
Clinical narrative: mouth is sore; swollen toes; swollen arm; weak; taste the medicine in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth), ORAL PAIN (mouth is sore) and PERIPHERAL SWELLING (swollen toes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, ATORVASTATIN, PANTOPRAZOLE and VITAMINS NOS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth) and PERIPHERAL SWELLING (swollen toes). On 18-Mar-2021, the patient experienced ORAL PAIN (mouth is sore). The patient was treated with ALCOHOL for Swelling, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), ASTHENIA (weak), DYSGEUSIA (taste the medicine in her mouth), ORAL PAIN (mouth is sore) and PERIPHERAL SWELLING (swollen toes) 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.   Applied alcohol on arm for swelling.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vomiting; Chills; Fever; Injection site was red; Injection site was swollen; Injection site was hurts to touch; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 18-Mar-2021, VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up included non-significant data: Reporter e-mail id added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Chills; Fever; Injection site was red; Injection site was swollen; Injection site was hurts to touch; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 18-Mar-2021, VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE PAIN (Injection site was hurts to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up included non-significant data: Reporter e-mail id added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Pain, Swelling face
Clinical narrative: Jaw is all swelled; Infection; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), SWELLING FACE (Jaw is all swelled) and INFECTION (Infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Sore). On 18-Mar-2021, the patient experienced SWELLING FACE (Jaw is all swelled) and INFECTION (Infection). At the time of the report, PAIN (Sore), SWELLING FACE (Jaw is all swelled) and INFECTION (Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included antibiotic which dentist wanted to prescribe the patient.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product administration interrupted, Product availability issue, Pyrexia
Clinical narrative: Spiking fever of 101.9; Headaches; Product administration interrupted; Product unavailable due to pandemic; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Spiking fever of 101.9), HEADACHE (Headaches), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic). On an unknown date, the patient experienced PYREXIA (Spiking fever of 101.9) and HEADACHE (Headaches). On 23-Jan-2021, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic) had resolved. At the time of the report, PYREXIA (Spiking fever of 101.9) and HEADACHE (Headaches) outcome was unknown. Not Provided          Patient was treated with antibiotics, steroids and had extensive bloodwork done.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness at the injection site; swelling at the injection site; redness at the injection site; joint pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain) and HEADACHE (headache) in a  patient of an unknown age and gender 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: itchiness at the injection site; swelling at the injection site; redness at the injection site; joint pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain) and HEADACHE (headache) in a  patient of an unknown age and gender 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Little itching; Little red circle the size of nickel  at the injection site; Fatigue; vaccination site swelling; vaccination site tenderness; warm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site), FATIGUE (Fatigue), PRURITUS (Little itching), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (vaccination site tenderness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN (NOVOLIN 30R [INSULIN]), GLIMEPIRIDE (AMARYL), WARFARIN SODIUM, CLOPIDOGREL BISULFATE (PLAVIX), CETIRIZINE, BIOTIN and SIMETICONE (GAS X) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site). On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site). On an unknown date, the patient experienced PRURITUS (Little itching). On 13-Mar-2021, FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site) had resolved. On 13-Apr-2021, VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site) had resolved. At the time of the report, PRURITUS (Little itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked .   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional1-The followup was received on 09 apr 2021. Patient's mail id updated. Some other events were also added. Concomitant medicines also added. Information about the second dose and its AE were added. On 12-May-2021: Additional2; Sender's Comments:  FIRST DOSE
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Little itching; Little red circle the size of nickel  at the injection site; Fatigue; vaccination site swelling; vaccination site tenderness; warm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site), FATIGUE (Fatigue), PRURITUS (Little itching), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (vaccination site tenderness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN (NOVOLIN 30R [INSULIN]), GLIMEPIRIDE (AMARYL), WARFARIN SODIUM, CLOPIDOGREL BISULFATE (PLAVIX), CETIRIZINE, BIOTIN and SIMETICONE (GAS X) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site). On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site). On an unknown date, the patient experienced PRURITUS (Little itching). On 13-Mar-2021, FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site) had resolved. On 13-Apr-2021, VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site) had resolved. At the time of the report, PRURITUS (Little itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked .   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional1-The followup was received on 09 apr 2021. Patient's mail id updated. Some other events were also added. Concomitant medicines also added. Information about the second dose and its AE were added. On 12-May-2021: Additional2; Sender's Comments:  FIRST DOSE
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: dizziness; arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VACCINATION SITE PAIN (arm still hurts) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hernia. Concomitant products included TRAMADOL from 14-Mar-2021 to an unknown date for Hernia.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (dizziness) and VACCINATION SITE PAIN (arm still hurts). At the time of the report, DIZZINESS (dizziness) and VACCINATION SITE PAIN (arm still hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take medication to treat his symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling lightheaded and kind of dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling lightheaded and kind of dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feeling lightheaded and kind of dizzy). At the time of the report, DIZZINESS (Feeling lightheaded and kind of dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness; Headache; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 08-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            Relevant text: The patient post receiving the second dose of vaccine had a headache, developed fever, nausea, vomiting and dizziness. The patient reported that all these events subsided except for Dizziness.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medications for the events included paracetamol (Tylenol) and ibuprofen (Advil).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information was added
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: sore and red arm / bigger patch of redness on arm; sore and red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm). At the time of the report, VACCINATION SITE ERYTHEMA (sore and red arm / bigger patch of redness on arm) and VACCINATION SITE PAIN (sore and red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported after 12 days there was a bigger patch of redness on arm. Concomitant medications were not provided. Treatment information was not reported.