chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: Hard to turn neck from one side to other; Muscle ache; Knee Muscle Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain). At the time of the report, NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-037537 (E2B Linked Report).; Sender's Comments:  MOD-2021-037537:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: he did not give the entire vial, and there was still something left in the syringe.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.). At the time of the report, ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Vision blurred
Clinical narrative: burning on her arm; Blurred Vision; headaches; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bipolar disorder. Concomitant products included LITHIUM for COVID-19 vaccination, QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches). At the time of the report, BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: little itchy injection site; swelling injection site; "reddish near 8cm size " on injection site; rash began small and increased for approximately 12 days, then subsided; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive plaster sensitivity (Area of adhesive bandage becomes red, swollen, itchy) since 02-Feb-2021 and Hypersensitivity reaction (NOS). Concomitant products included FISH OIL, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) for an unknown indication.    On 12-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided). On 11-Apr-2021, VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  Concomitant medicines include Fish oil, AREDS-2, Calcium-D  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-may-2021. Added reporters middle name, phone number. Updated reporter's mail id, patient initials, height, weight, race. Added other relevant history. Added event  vaccination site rash. Updated outcome of events and stop date of events, event assessment. Updated action taken in product tab and event product details tab.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: 24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY; FELT ITCHY; RASH LIKE WELT AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adverse event (No medical information provided).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (FELT ITCHY) and VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE). On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY). At the time of the report, VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications were reported no treatment drugs were reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Inappropriate schedule of product administration, Malaise
Clinical narrative: delay in second vaccine dose; feeling cold; "not feeling good"; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING COLD (feeling cold), MALAISE ("not feeling good") and HEADACHE (headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose). At the time of the report, FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called to ask questions about travelling to state and timing of second dose Patient is scheduled for second dose on 31Mar2021 but wants to travel to state on 29Mar2021.  Patient asked Customer Care if it was ok to delay second dose until her return.  Patient confirmed with Customer Care agent that her HCP at the vaccine facility already okayed her to delay her second dose. Patient hung up during transfer. Patient was called back and there was no answer; patient does not have voicemail set up. Consent was not obtained.     This case was linked to MOD21-075365 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up- patient answered wanted to inquire at day 43 could she still get second dose added. Patient consented to be contacted if needed- updated; Sender's Comments:  MOD21-075365:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: body discomforts; some soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     no medical history was provided by reporter.     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 DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm). At the time of the report, DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     concomitant medication included high blood pressure medication,cholesterol medication no treatment information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: itchy on her arm; red on her arm; rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle atrophy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm). At the time of the report, PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Viral infection
Clinical narrative: Viral Infection; left arm still has soreness; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included ACYCLOVIR [ACICLOVIR] from 17-Feb-2021 to 17-Feb-2021 for Viral infection.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness). At the time of the report, VIRAL INFECTION (Viral Infection) outcome was unknown and VACCINATION SITE PAIN (left arm still has soreness) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported he took acyclovir 800 mg three times a day five days after first dose of vaccine and one day after the second dose of vaccine for one day. No other concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-053267 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053267:Crosslinked with dose 2
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: On 20Mar2021, she had pain in left knees, left leg and left calf.; On 20Mar2021, she had pain in left knees, left leg and left calf.; On 20Mar2021, she had pain in left knees, left leg and left calf.; Patient started getting aches in her legs, and arms next day after receiving 2nd dose; Patient started getting aches in her legs, and arms next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the second episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the first episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.), the second episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.) in a 74-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Mar-2021, the patient experienced the first episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose) and the second episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose). On 20-Mar-2021, the patient experienced the first episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.), the second episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, last episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the last episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.) outcome was unknown.            Concomitant medications included DIABETIC medication (NOS) and CHEMOTHERAPY (NOS).   Action taken with mRNA-1273 in response to the events was not Applicable.  Patient consents to contact.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: email address added
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Ear discomfort, Inflammation, Neck pain
Clinical narrative: bad pain in her left wrist like arthritis; ringing in both ears; dull pain in her neck on the right side; inflammation (in her ear); pains in her breasts; Right ear felt like it was clogged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)) and BREAST PAIN (pains in her breasts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In February 2021, ARTHRALGIA (bad pain in her left wrist like arthritis) and TINNITUS (ringing in both ears) had resolved. At the time of the report, NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. She was prescribed steroids in which she decided not to take but took Advil instead hoping that would help.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: bad pain in her left wrist like arthritis; ringing in both ears; dull pain in her neck on the right side; inflammation (in her ear); pains in her breasts; Right ear felt like it was clogged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)) and BREAST PAIN (pains in her breasts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In February 2021, ARTHRALGIA (bad pain in her left wrist like arthritis) and TINNITUS (ringing in both ears) had resolved. At the time of the report, NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. She was prescribed steroids in which she decided not to take but took Advil instead hoping that would help.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size; Itchiness; injection site was tender initially; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), INJECTION SITE PAIN (injection site was tender initially) and VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 12-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site was tender initially). On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size). On 14-Mar-2021, INJECTION SITE PAIN (injection site was tender initially) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included cold compress to relieve the itchiness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe pain; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) 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) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-053275 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021 included reporter information
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Viral infection
Clinical narrative: Left arm still has soreness; Took acyclovir between two doses for viral infection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection). At the time of the report, PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection) had not resolved. Not Provided          Treatment information not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Chest pressure; Her stomach was squeezing; Shortness of breath; Racing heartbeats; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Racing heartbeats), CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Racing heartbeats). On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing). The patient was treated with LOSARTAN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing) outcome was unknown and HEART RATE INCREASED (Racing heartbeats) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure measurement: 111/59 (Inconclusive) 111/59. On 19-Mar-2021, Blood pressure measurement: 106/56 (Inconclusive) 106/56. On 20-Mar-2021, Blood pressure measurement: 83/48 (Inconclusive) 83/48. On 21-Mar-2021, Blood pressure measurement: 102/55 (Inconclusive) 102/55.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter details updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a rash all over her neck down to her abdomen; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Broke out in a rash all over her neck down to her abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B211A) 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) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (Broke out in a rash all over her neck down to her abdomen). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Broke out in a rash all over her neck down to her abdomen) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After receiving 1st dose of vaccine patient had a broke out in a rash all over her neck down to her abdomen. Patient took Tylenol and it went away.  Concomitant medications were not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: redness in the palm; Itching in the Palm; Rash on the palm of the hand; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in the palm), PRURITUS (Itching in the Palm) and RASH (Rash on the palm of the hand) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced ERYTHEMA (redness in the palm), PRURITUS (Itching in the Palm) and RASH (Rash on the palm of the hand). At the time of the report, ERYTHEMA (redness in the palm), PRURITUS (Itching in the Palm) and RASH (Rash on the palm of the hand) had not resolved. Unknown          No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Fatigue, Headache
Clinical narrative: cough; fever 99.8-100.2 fluctuation; headache; a little nausea; fatigue; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-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 COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea), FATIGUE (fatigue) and ARTHRALGIA (achy joints). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea), FATIGUE (fatigue) and ARTHRALGIA (achy joints) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 99.8-100.2 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: cough; fever 99.8-100.2 fluctuation; headache; a little nausea; fatigue; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-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 COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea), FATIGUE (fatigue) and ARTHRALGIA (achy joints). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, COUGH (cough), PYREXIA (fever 99.8-100.2 fluctuation), HEADACHE (headache), NAUSEA (a little nausea), FATIGUE (fatigue) and ARTHRALGIA (achy joints) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 99.8-100.2 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives or welts on upper back; Itchy; Hive or welts on legs and butt; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hive or welts on legs and butt), URTICARIA (Hives or welts on upper back) and PRURITUS (Itchy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Acid reflux (esophageal). Concomitant products included BUSPIRONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced URTICARIA (Hive or welts on legs and butt). On 21-Mar-2021, the patient experienced URTICARIA (Hives or welts on upper back) and PRURITUS (Itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria, at an unspecified dose and frequency. On 20-Mar-2021, URTICARIA (Hive or welts on legs and butt) had resolved. On 21-Mar-2021, URTICARIA (Hives or welts on upper back) had resolved. At the time of the report, PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication and acid reflux medication.  Treatment information provided  included applied a cold ice pack.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: itchiness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and MYALGIA (body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (itchiness) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchiness) and MYALGIA (body aches) 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chest discomfort, Dysphagia, Fatigue, Pruritus
Clinical narrative: arm itched; fatigue; could not swallow; Chest tightened; adverse event; general body itching; arm swelled; arm turned red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching) and VACCINATION SITE SWELLING (arm swelled) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itched). At the time of the report, DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and VACCINATION SITE PRURITUS (arm itched) had not resolved and FATIGUE (fatigue) 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 reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up included non significant information as reporter contact details updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm itched; fatigue; could not swallow; Chest tightened; adverse event; general body itching; arm swelled; arm turned red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching) and VACCINATION SITE SWELLING (arm swelled) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itched). At the time of the report, DYSPHAGIA (could not swallow), CHEST DISCOMFORT (Chest tightened), ADVERSE EVENT (adverse event), PRURITUS (general body itching), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE ERYTHEMA (arm turned red) and VACCINATION SITE PRURITUS (arm itched) had not resolved and FATIGUE (fatigue) 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 reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up included non significant information as reporter contact details updated
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain
Clinical narrative: diarrhea; pain; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. On 20-Mar-2021, PAIN (pain), HEADACHE (headaches) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (diarrhea) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information added.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout real bad in both feet; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout real bad in both feet) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified, Atrial fibrillation, Heart block NOS, Shortness of breath and Heart enlarged. Concomitant products included APIXABAN (ELIQUIS), ISOSORBIDE, METOPROLOL, SPIRONOLACTONE (SPIRONOL), FUROSEMIDE, POTASSIUM and BENAZEPRIL for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout real bad in both feet). At the time of the report, GOUT (Gout real bad in both feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications : Conoylos 0.6mg twice first day and then once a day.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A terrible case of tinnitus (ringing in the ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (A terrible case of tinnitus (ringing in the ear)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (A terrible case of tinnitus (ringing in the ear)). At the time of the report, TINNITUS (A terrible case of tinnitus (ringing in the ear)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The action taken with mRNA-1273 with the events was considered as not applicable
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Peripheral swelling, Pyrexia, Vaccination site erythema
Clinical narrative: arm swelled up and got hot; emotional and cries a lot; faint red spot the size of a baseball underneath where she was injected; fever of 99.7 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) 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) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit). At the time of the report, PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Myalgia, Tremor
Clinical narrative: Shaky; Dizzy; Brain-Fogged; Lightheaded; Vomited; Tired; Body Pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded) and MYALGIA (Body Pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Body Pain). On 14-Mar-2021, the patient experienced TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), VOMITING (Vomited) and FATIGUE (Tired). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), MYALGIA (Body Pain), VOMITING (Vomited) and FATIGUE (Tired) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shaky; Dizzy; Brain-Fogged; Lightheaded; Vomited; Tired; Body Pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded) and MYALGIA (Body Pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Body Pain). On 14-Mar-2021, the patient experienced TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), VOMITING (Vomited) and FATIGUE (Tired). The patient was treated with DIAZEPAM (VALIUM) at an unspecified dose and frequency. At the time of the report, TREMOR (Shaky), DIZZINESS (Dizzy), FEELING ABNORMAL (Brain-Fogged), DIZZINESS (Lightheaded), MYALGIA (Body Pain), VOMITING (Vomited) and FATIGUE (Tired) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.