chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: He started to get itchy, He has an itch that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (He started to get itchy, He has an itch that comes and goes) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (He started to get itchy, He has an itch that comes and goes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (He started to get itchy, He has an itch that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient also used an unspecified topical lotion for the treatment of itching.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site itchiness; injection site is sore; injection site redness; feeling Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site redness) and FATIGUE (feeling Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Immune disorder (NOS). Concurrent medical conditions included Chemical sensitivity. Concomitant products included PANTOPRAZOLE, SIMVASTATIN, LORAZEPAM, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) and FAMOTIDINE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site redness) and FATIGUE (feeling Tired). At the time of the report, VACCINATION SITE PRURITUS (injection site itchiness) had not resolved and VACCINATION SITE PAIN (injection site is sore), VACCINATION SITE ERYTHEMA (injection site redness) and FATIGUE (feeling Tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient isn't sure is she received the vaccine in the muscle, as the injection site in on the front aspect of her arm .   This case was linked to MOD-2021-143522 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: 2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertensive.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 24-MAR-2021, contains non-significant information (reporter's Address).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; Patient has not taken second dose till day 40 after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not taken second dose till day 40 after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Follow up received on 23-MAR-2021. Patient's age and batch number has been  updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Pain in extremity, Reflux gastritis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak), pain in extremity (arm was very sore) and chills (shivering for a number of minutes, pretty hard) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002A21A) for COVID-19 immunization. No medical history provided. Concomitant products included atenolol and baby aspirin (acetylsalicylic acid) for an unknown indication. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak) and chills (shivering for a number of minutes, pretty hard). On an unknown date, the patient experienced pain in extremity (arm was very sore). On Feb 25, 2021, abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak) and chills (shivering for a number of minutes, pretty hard) resolved. At the time of the report, pain in extremity (arm was very sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment information not provided. This case linked to MOD-2021-266531 (patient link). Most recent follow-up information incorporated above includes: On May 7, 2021: Follow-up information received contains no new information. On Jul 26, 2021: Received- Added new event: Pain in arm.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: could not taste food very well; nausea; low fever; sore arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Loss of smell (Symptom of COVID-19.) in December 2020.    On 16-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 PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills). On 17-Mar-2021, the patient experienced AGEUSIA (could not taste food very well), NAUSEA (nausea) and PYREXIA (low fever). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low fever) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: could not taste food very well; nausea; low fever; sore arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Loss of smell (Symptom of COVID-19.) in December 2020.    On 16-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 PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills). On 17-Mar-2021, the patient experienced AGEUSIA (could not taste food very well), NAUSEA (nausea) and PYREXIA (low fever). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, AGEUSIA (could not taste food very well), PAIN IN EXTREMITY (sore arm), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low fever) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 24-Feb-2021, the patient experienced URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INSOMNIA (Insomnia). At the time of the report, INSOMNIA (Insomnia) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in his arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in his arm at injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O11M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in his arm at injection site). At the time of the report, VACCINATION SITE PAIN (pain in his arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-061126 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Red Spot; Hot; swollen; itchy; Raised tattoo edges.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Spot), INJECTION SITE WARMTH (Hot), INJECTION SITE SWELLING (swollen), INJECTION SITE PRURITUS (itchy) and SWELLING (Raised tattoo edges.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Spot), INJECTION SITE WARMTH (Hot), INJECTION SITE SWELLING (swollen), INJECTION SITE PRURITUS (itchy) and SWELLING (Raised tattoo edges.). At the time of the report, INJECTION SITE ERYTHEMA (Red Spot), INJECTION SITE WARMTH (Hot), INJECTION SITE SWELLING (swollen), INJECTION SITE PRURITUS (itchy) and SWELLING (Raised tattoo edges.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Nasopharyngitis, Nausea
Clinical narrative: little bit of discomfort in her arm; cold; slight headache; tired; little nausea for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (little bit of discomfort in her arm), NASOPHARYNGITIS (cold), HEADACHE (slight headache), FATIGUE (tired) and NAUSEA (little nausea for 20 minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included SULFASALAZINE, VITAMIN D3 and MAGNESIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (little bit of discomfort in her arm), NASOPHARYNGITIS (cold), HEADACHE (slight headache), FATIGUE (tired) and NAUSEA (little nausea for 20 minutes). On 26-Jan-2021, NAUSEA (little nausea for 20 minutes) had resolved. On 28-Jan-2021, LIMB DISCOMFORT (little bit of discomfort in her arm) had resolved. At the time of the report, NASOPHARYNGITIS (cold), HEADACHE (slight headache) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-049610 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: legs felt so weak; he was not able to get up; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULAR WEAKNESS (legs felt so weak) and DYSSTASIA (he was not able to get up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (legs felt so weak) and DYSSTASIA (he was not able to get up). At the time of the report, MUSCULAR WEAKNESS (legs felt so weak) and DYSSTASIA (he was not able to get up) 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 provided by the reporter.   Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash around the injection site in circle spreading up and down in the arm; Injection site is hard; Rash around the injection site in circle; Injection site is swelling; Itchy spot in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE PRURITUS (Itchy spot in the injection site), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048X21AH) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Latex allergy, Diabetic and Hearing impaired.    On 10-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 PRURITUS (Itchy spot in the injection site). On 17-Mar-2021, the patient experienced RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling). At the time of the report, RASH (Rash around the injection site in circle spreading up and down in the arm), VACCINATION SITE PRURITUS (Itchy spot in the injection site), VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE RASH (Rash around the injection site in circle) and VACCINATION SITE SWELLING (Injection site is swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified low pressure and depression medications. Treatment medication included unspecified cream.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Vertigo; large red and warm spot on left arm; large red and warm spot on left arm; sore arm; felt run down; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (felt run down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-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 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever). On 03-Mar-2021, the patient experienced VERTIGO (Vertigo). On 19-Feb-2021, FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever) had resolved. On 23-Feb-2021, VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved.            No concomitant medications were provided.  Treatment for the events included Meclizine and Amoxicillin/Clavulanic Acid 500/125mg (twice a day for 7 days).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vertigo
Clinical narrative: Vertigo; large red and warm spot on left arm; large red and warm spot on left arm; sore arm; felt run down; Headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (felt run down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-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 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever). On 03-Mar-2021, the patient experienced VERTIGO (Vertigo). On 19-Feb-2021, FEELING ABNORMAL (felt run down), HEADACHE (Headache) and PYREXIA (fever) had resolved. On 23-Feb-2021, VACCINATION SITE WARMTH (large red and warm spot on left arm), RASH MACULAR (large red and warm spot on left arm) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VERTIGO (Vertigo) had not resolved.            No concomitant medications were provided.  Treatment for the events included Meclizine and Amoxicillin/Clavulanic Acid 500/125mg (twice a day for 7 days).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: very big pain down my arm, from elbow to hand; also in shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, VITAMINS NOS for Nutritional supplementation.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (very big pain down my arm, from elbow to hand) and PAIN (also in shoulder blade) outcome was unknown.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Injection site mass, Myalgia
Clinical narrative: Received HPV vaccine 3 days before the 2nd shot of the moderna; muscle pain; joint pain; headache; shoulder pain; cold; had a little lump; With the 1st dose got arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (With the 1st dose got arm pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna), NASOPHARYNGITIS (cold), INJECTION SITE MASS (had a little lump) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HPV VACCINE (Received HPV vaccine 3 days before the 2nd shot of the moderna).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and INJECTION SITE MASS (had a little lump). On 15-Mar-2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder pain). On 16-Mar-2021, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced PAIN (With the 1st dose got arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (With the 1st dose got arm pain), NASOPHARYNGITIS (cold), INJECTION SITE MASS (had a little lump), HEADACHE (headache) and ARTHRALGIA (shoulder pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Received HPV vaccine 3 days before the 2nd shot of the moderna; muscle pain; joint pain; headache; shoulder pain; cold; had a little lump; With the 1st dose got arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (With the 1st dose got arm pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna), NASOPHARYNGITIS (cold), INJECTION SITE MASS (had a little lump) and HEADACHE (headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: HPV VACCINE (Received HPV vaccine 3 days before the 2nd shot of the moderna).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and INJECTION SITE MASS (had a little lump). On 15-Mar-2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (shoulder pain). On 16-Mar-2021, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced PAIN (With the 1st dose got arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (With the 1st dose got arm pain), NASOPHARYNGITIS (cold), INJECTION SITE MASS (had a little lump), HEADACHE (headache) and ARTHRALGIA (shoulder pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received HPV vaccine 3 days before the 2nd shot of the moderna), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Myalgia, Pain
Clinical narrative: Painful to touch; Itch; Arm pain with a red apple sized area on her arm; Body pain; Fever; Arm pain with a red apple sized area on her arm; Chills; Exhaustion; Arm pain with a red apple sized area on her arm; "Too sick to get up"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Too sick to get up"), PAIN (Painful to touch), PRURITUS (Itch), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm) and MYALGIA (Body pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced ILLNESS ("Too sick to get up"), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), MYALGIA (Body pain), PYREXIA (Fever), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm), CHILLS (Chills), FATIGUE (Exhaustion) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm). On an unknown date, the patient experienced PAIN (Painful to touch) and PRURITUS (Itch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Mar-2021, ILLNESS ("Too sick to get up"), MYALGIA (Body pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion) had resolved. On 19-Mar-2021, PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm) had resolved. At the time of the report, PAIN (Painful to touch) and PRURITUS (Itch) outcome was unknown.            Treatment for the event included Anti-itch cream.   This case was linked to MOD-2021-049619 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Painful to touch; Itch; Arm pain with a red apple sized area on her arm; Body pain; Fever; Arm pain with a red apple sized area on her arm; Chills; Exhaustion; Arm pain with a red apple sized area on her arm; "Too sick to get up"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Too sick to get up"), PAIN (Painful to touch), PRURITUS (Itch), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm) and MYALGIA (Body pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced ILLNESS ("Too sick to get up"), PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), MYALGIA (Body pain), PYREXIA (Fever), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm), CHILLS (Chills), FATIGUE (Exhaustion) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm). On an unknown date, the patient experienced PAIN (Painful to touch) and PRURITUS (Itch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-Mar-2021, ILLNESS ("Too sick to get up"), MYALGIA (Body pain), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Exhaustion) had resolved. On 19-Mar-2021, PERIPHERAL SWELLING (Arm pain with a red apple sized area on her arm), VACCINATION SITE PAIN (Arm pain with a red apple sized area on her arm) and VACCINATION SITE ERYTHEMA (Arm pain with a red apple sized area on her arm) had resolved. At the time of the report, PAIN (Painful to touch) and PRURITUS (Itch) outcome was unknown.            Treatment for the event included Anti-itch cream.   This case was linked to MOD-2021-049619 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash, Rash pruritic
Clinical narrative: Itchy rash; Rash with bumps; Headache; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), RASH (Rash with bumps), HEADACHE (Headache) and FATIGUE (Exhausted) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash), RASH (Rash with bumps), HEADACHE (Headache) and FATIGUE (Exhausted). At the time of the report, RASH PRURITIC (Itchy rash), RASH (Rash with bumps), HEADACHE (Headache) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (received vaccine after temperature excursion) in a 48-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (received vaccine after temperature excursion). On 18-Mar-2021, PRODUCT STORAGE ERROR (received vaccine after temperature excursion) 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 information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 37-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 01-Oct-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ?No treatment information was provided. ? The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Slight soreness; Very slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) and FATIGUE (Very slight fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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-Feb-2021, the patient experienced PAIN (Slight soreness) and FATIGUE (Very slight fatigue). At the time of the report, PAIN (Slight soreness) and FATIGUE (Very slight fatigue) 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.   This case was linked to MOD-2021-049611, MOD-2021-049611 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Lump at the injection site; size of an egg; arm was very sore; a red dot 3 inches below the top of her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Lump at the injection site), VACCINATION SITE PAIN (arm was very sore), VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder) and VACCINATION SITE SWELLING (size of an egg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN HCTZ) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder). On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 18-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Lump at the injection site) and VACCINATION SITE SWELLING (size of an egg). At the time of the report, VACCINATION SITE INDURATION (Lump at the injection site), VACCINATION SITE PAIN (arm was very sore), VACCINATION SITE ERYTHEMA (a red dot 3 inches below the top of her shoulder) and VACCINATION SITE SWELLING (size of an egg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  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.; 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: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Small amount of tingling on face; Pain at injection site (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Small amount of tingling on face) and VACCINATION SITE PAIN (Pain at injection site (left) arm) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Viral infection. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and FAMCICLOVIR (FAMVIR [FAMCICLOVIR]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (left) arm). On 18-Mar-2021, the patient experienced PARAESTHESIA (Small amount of tingling on face). At the time of the report, PARAESTHESIA (Small amount of tingling on face) and VACCINATION SITE PAIN (Pain at injection site (left) arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetyl salicylic acid.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Myalgia, Pain in extremity, Vaccination site swelling
Clinical narrative: Body Aches; Little chills; Swollen Injection Site; Teeth were Chattering, she had Chills, and Uncontrollable Shivering; Sore Left Arm; Could not Lift her Left Arm beyond shoulder level; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level), MYALGIA (Body Aches), CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) and CHILLS (Little chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had only minimal symptoms (Only Fatigue).) on 01-Jan-2021.    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 PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level), CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) and VACCINATION SITE SWELLING (Swollen Injection Site). On 18-Mar-2021, the patient experienced MYALGIA (Body Aches) and CHILLS (Little chills). On 17-Mar-2021, CHILLS (Teeth were Chattering, she had Chills, and Uncontrollable Shivering) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Left Arm), LIMB DISCOMFORT (Could not Lift her Left Arm beyond shoulder level) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown and MYALGIA (Body Aches) and CHILLS (Little chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Fingers become numb; Fingers become cold; Don't feel anything on his fingers can´t even put on the shirt button; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button). At the time of the report, HYPOAESTHESIA (Fingers become numb), PERIPHERAL COLDNESS (Fingers become cold) and HYPOAESTHESIA (Don't feel anything on his fingers can´t even put on the shirt button) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medicine and diabetes medicine.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: Rash which became itchy after using benadryl and moved to armpit; rash is more red; really hurt after bumping into the door; extremely sore arm, lift arm more than half way was more painful; uncomfortable for a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful), DISCOMFORT (uncomfortable for a week), PAIN (really hurt after bumping into the door), RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included SULFASALAZINE, VITAMIN D3 and MAGNESIUM for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful) and DISCOMFORT (uncomfortable for a week). On 27-Feb-2021, the patient experienced PAIN (really hurt after bumping into the door). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 27-Feb-2021, PAIN (really hurt after bumping into the door) had resolved. At the time of the report, PAIN IN EXTREMITY (extremely sore arm, lift arm more than half way was more painful) and DISCOMFORT (uncomfortable for a week) outcome was unknown and RASH PRURITIC (Rash which became itchy after using benadryl and moved to armpit) and RASH ERYTHEMATOUS (rash is more red) had not resolved.            This case was linked.