chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo, Vision blurred
Clinical narrative: pain in the arm; bone pain; difficulty to see or keep view on something; difficulty hearing; fever; chills; body aches; joint pain; headache; sweating; fast heart beat; vertigo; blood pressure was a little low; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low), HYPERHIDROSIS (sweating), PALPITATIONS (fast heart beat) and PAIN IN EXTREMITY (pain in the arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low) and PALPITATIONS (fast heart beat). On 23-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (pain in the arm), BONE PAIN (bone pain), VISION BLURRED (difficulty to see or keep view on something), HYPOACUSIS (difficulty hearing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg every 5 hours. On 22-Mar-2021, VERTIGO (vertigo), HYPOTENSION (blood pressure was a little low) and PALPITATIONS (fast heart beat) had resolved. On 24-Mar-2021, HYPERHIDROSIS (sweating), BONE PAIN (bone pain), VISION BLURRED (difficulty to see or keep view on something), HYPOACUSIS (difficulty hearing), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in the arm) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100f (High) 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Rash, Vaccination site rash
Clinical narrative: It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week.; It was rashy, red, hard, itchy for about a week; Rash under the site; Little swollen; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021. The most recent information was received on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week) and VACCINATION SITE RASH (Rash under the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen). On an unknown date, the patient experienced ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.) and RASH (It was rashy, red, hard, itchy for about a week). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and CORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week), VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen) had resolved.            No concomitant medication was reported  Treatment Included application of Ice   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-Up received. Added Events, Updated event outcome and  treatment details
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week; It was rashy, red, hard, itchy for about a week.; It was rashy, red, hard, itchy for about a week; Rash under the site; Little swollen; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021. The most recent information was received on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week) and VACCINATION SITE RASH (Rash under the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen). On an unknown date, the patient experienced ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.) and RASH (It was rashy, red, hard, itchy for about a week). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and CORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ERYTHEMA (It was rashy, red, hard, itchy for about a week), INDURATION (It was rashy, red, hard, itchy for about a week), PRURITUS (It was rashy, red, hard, itchy for about a week.), RASH (It was rashy, red, hard, itchy for about a week), VACCINATION SITE RASH (Rash under the site) and VACCINATION SITE SWELLING (Little swollen) had resolved.            No concomitant medication was reported  Treatment Included application of Ice   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-Up received. Added Events, Updated event outcome and  treatment details
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: her whole neck "broke out in hives"; It is also red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (her whole neck "broke out in hives") and ERYTHEMA (It is also red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Memory disturbance (short term memory isn't good). Concurrent medical conditions included Drug allergy, Hypertension, Stroke (2 Stroke,), Drug allergy and Drug allergy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced URTICARIA (her whole neck "broke out in hives") and ERYTHEMA (It is also red). At the time of the report, URTICARIA (her whole neck "broke out in hives") and ERYTHEMA (It is also red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush
Clinical narrative: Bad headache; Hot flashes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), HEADACHE (Bad headache) and CHILLS (Chills) in a 67-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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2012, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced HOT FLUSH (Hot flashes). On 15-Mar-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flashes) and CHILLS (Chills) had not resolved and HEADACHE (Bad headache) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment medication include paracetamol and patient took Tylenol for bad headache. Concomitant product use was unknown by the reporter. There was no blood in the urine it was a large amount of beet consumption was updated in follow up. It was also reported that 2nd shot went well no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information received on 10-May 2021 through email. Patient updated about the events, action taken updated and states that patient has been administered with second shot with no side effects.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinusitis, Sneezing
Clinical narrative: Persistent sneezing (seven or eight in a row, each two hours; Sinus infection; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and FISH OIL for an unknown indication.    On 24-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 SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion). The patient was treated with PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED COLD & SINUS                                              runny nose) for Runny nose, at an unspecified dose and frequency. At the time of the report, SNEEZING (Persistent sneezing (seven or eight in a row, each two hours), SINUSITIS (Sinus infection) and NASAL CONGESTION (Congestion) 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.   Other concomitant medication included Assured sinus congestion.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dental care, Pain, Pain in extremity
Clinical narrative: Have her dental work done; Sore arm; Achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and DENTAL CARE (Have her dental work done) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Achy). On an unknown date, the patient experienced DENTAL CARE (Have her dental work done). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 21-Mar-2021, PAIN IN EXTREMITY (Sore arm) and PAIN (Achy) had resolved. At the time of the report, DENTAL CARE (Have her dental work done) outcome was unknown.        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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immune system disorder, Vertigo
Clinical narrative: hair loss; Vertigo; immune defenses on overdrive; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss), VERTIGO (Vertigo) and IMMUNE SYSTEM DISORDER (immune defenses on overdrive) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included ESTROGEN NOS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and FISH OIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ALOPECIA (hair loss), VERTIGO (Vertigo) and IMMUNE SYSTEM DISORDER (immune defenses on overdrive). At the time of the report, ALOPECIA (hair loss), VERTIGO (Vertigo) and IMMUNE SYSTEM DISORDER (immune defenses on overdrive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Concomitant Medications included multivitamin.   No Treatment History was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 72-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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications was not provided.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; body pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and PAIN (body pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 PYREXIA (fever), HEADACHE (headache) and PAIN (body pain). At the time of the report, PYREXIA (fever), HEADACHE (headache) and PAIN (body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant  concomitant medications reported No relevant treatment reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: felt like she had a minor case of the flu; runny nose; aches; pains; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (felt like she had a minor case of the flu), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Kidney failure.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA (felt like she had a minor case of the flu), RHINORRHOEA (runny nose), PAIN (aches), PAIN (pains) and HEADACHE (headache). On 23-Mar-2021, RHINORRHOEA (runny nose) outcome was unknown. At the time of the report, INFLUENZA (felt like she had a minor case of the flu), PAIN (aches), PAIN (pains) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Pain, Pruritus
Clinical narrative: Feels a little uneasiness; Little bit more sore than the typical flu shot; Joint pain that is similar to arthritical pain; Itching; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot), PRURITUS (Itching) and ARTHRALGIA (Joint pain that is similar to arthritical pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Patient felt  little uneasiness and it was a little bit more sore than the typical flu shot). Concomitant products included CORTISONE, CLOBETASOL and BACITRACIN.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot) and ARTHRALGIA (Joint pain that is similar to arthritical pain). At the time of the report, DISCOMFORT (Feels a little uneasiness), PAIN (Little bit more sore than the typical flu shot) and ARTHRALGIA (Joint pain that is similar to arthritical pain) had not resolved and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains reporter Information and event(itching) added
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm that went away and now has come back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm that went away and now has come back) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm that went away and now has come back). At the time of the report, PAIN IN EXTREMITY (Pain in her arm that went away and now has come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wants to know if it fine to take pain relievers like Advil and Alieve.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Took First dose of vaccine more than 42 days ago and is yet to get a second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CABERGOLINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose). On 24-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Took First dose of vaccine more than 42 days ago and is yet to get a second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Received 0.5 ml of Moderna vaccine extra; Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLOZAPINE, LITHIUM, HALOPERIDOL and DIPHENHYDRAMINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine). On 19-Mar-2021, EXTRA DOSE ADMINISTERED (Received 0.5 ml of Moderna vaccine extra) and INTERCHANGE OF VACCINE PRODUCTS (Received 1st , 2nd dose of Pfizer vaccine and then took moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abscess limb, Erythema, Hypersensitivity, Neurological symptom, Product dose omission issue
Clinical narrative: This case was initially received via Regulatory Authority (Reference number: US-irms-MOD21-127586) on 24-Mar-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and VACCINATION SITE REACTION (COVID arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  On an unknown date patient saw dermatologist and had a biopsy done, at the time of the report results were unknown.  Patient also reported having pictured available.  Treatment information also included seven days of an antibiotic, 2 topical creams, and an antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received on 6-AUG-2021 and included new events added and medication information changed. On 06-Aug-2021: TCR was received on 7-AUG-2021 and new event added.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: This case was initially received via Regulatory Authority (Reference number: US-irms-MOD21-127586) on 24-Mar-2021. The most recent information was received on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN, ABSCESS LIMB, ABSCESS LIMB, ERYTHEMA, HYPERSENSITIVITY, NEUROLOGICAL SYMPTOM, and VACCINATION SITE REACTION (COVID arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  On an unknown date patient saw dermatologist and had a biopsy done, at the time of the report results were unknown.  Patient also reported having pictured available.  Treatment information also included seven days of an antibiotic, 2 topical creams, and an antihistamine.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information received on 6-AUG-2021 and included new events added and medication information changed. On 06-Aug-2021: TCR was received on 7-AUG-2021 and new event added.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Today it is about 4 inches and has bumps; swollen; itches; red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), PRURITUS (itches), ERYTHEMA (red) and RASH (Today it is about 4 inches and has bumps) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SWELLING (swollen), PRURITUS (itches) and ERYTHEMA (red). On 24-Mar-2021, the patient experienced RASH (Today it is about 4 inches and has bumps). At the time of the report, SWELLING (swollen), PRURITUS (itches), ERYTHEMA (red) and RASH (Today it is about 4 inches and has bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: could not walk; COVID-19 like symptoms; every single bone hurts; sore arm; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and PREDNISONE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: could not walk; COVID-19 like symptoms; every single bone hurts; sore arm; could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and PREDNISONE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (could not walk), COVID-19 (COVID-19 like symptoms), BONE PAIN (every single bone hurts), PAIN IN EXTREMITY (sore arm) and FATIGUE (could not get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Rash, Throat irritation, Urticaria
Clinical narrative: Rash on eyelids; Rash on neck; Rash; Itchy throat; refused from second vaccine dose; Rash returned and spread on left arm; Rash on back; Rash on hips; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), THROAT IRRITATION (Itchy throat), INTENTIONAL DOSE OMISSION (refused from second vaccine dose), RASH (Rash returned and spread on left arm) and RASH (Rash on eyelids) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-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 URTICARIA (Hives). On 11-Mar-2021, the patient experienced RASH (Rash returned and spread on left arm), RASH (Rash on back) and RASH (Rash on hips). On 14-Mar-2021, the patient experienced THROAT IRRITATION (Itchy throat), INTENTIONAL DOSE OMISSION (refused from second vaccine dose), RASH (Rash on eyelids), RASH (Rash on neck) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 25 mg; HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 09-Mar-2021, URTICARIA (Hives) had resolved. On 12-Mar-2021, RASH (Rash returned and spread on left arm), RASH (Rash on back) and RASH (Rash on hips) had resolved. On 14-Mar-2021, THROAT IRRITATION (Itchy throat) had resolved. On 20-Mar-2021, RASH (Rash on eyelids), RASH (Rash on neck) and RASH (Rash) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (refused from second vaccine dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) 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 was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient calling to be added to the pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in June 2020.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-May-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry). On 23-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient calling to be added to the pregnancy registry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: Internal review on 28JUN2021 resulted in updates to pregnancy details.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Product dose omission issue
Clinical narrative: Second dose not received; every day is a "nightmare"; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received), FEELING ABNORMAL (every day is a "nightmare") and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received) and FEELING ABNORMAL (every day is a "nightmare"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received), FEELING ABNORMAL (every day is a "nightmare") and HEADACHE (Headache) 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 included Excedrin    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event details updated and Second dose not given
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Throat tightness
Clinical narrative: throat closed; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, THROAT TIGHTNESS (throat closed), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), PRAZOSIN, VITAMIN D NOS and LORAZEPAM for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Allergy medicine. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Rash
Clinical narrative: Headache; Rash on arm; swollen arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), RASH (Rash on arm) and PERIPHERAL SWELLING (swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm). On an unknown date, the patient experienced HEADACHE (Headache) and RASH (Rash on arm). At the time of the report, HEADACHE (Headache) and RASH (Rash on arm) outcome was unknown and PERIPHERAL SWELLING (swollen arm) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERIPHERAL SWELLING (swollen arm) to be related. No further causality assessments were provided for HEADACHE (Headache) and RASH (Rash on arm).    Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-056395 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added VAER; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056395:patient 2- first dose
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-056135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11 May 2021 in which contact information was updated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid + between doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid + between doses) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 04-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 COVID-19 (covid + between doses). At the time of the report, COVID-19 (covid + between doses) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 08-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: hives from head to toe; fall straight asleep; weakness in arms and legs; fatigue; chills; shortness of breath/difficulty breathing; loss of appetite; headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing) and DECREASED APPETITE (loss of appetite) in a 50-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 13-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 MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Somnolence, Urticaria
Clinical narrative: hives from head to toe; fall straight asleep; weakness in arms and legs; fatigue; chills; shortness of breath/difficulty breathing; loss of appetite; headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing) and DECREASED APPETITE (loss of appetite) in a 50-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 13-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 MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.