chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Slight fever; Pain in arm; Swelling of lymph node under the chin on the opposite side of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection). At the time of the report, PYREXIA (Slight fever) had resolved and PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swelling of lymph node under the chin on the opposite side of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. Treatment medication included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Vaccination site joint inflammation
Clinical narrative: Inflammation in arm; pain in arm; Difficulty moving arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT INFLAMMATION (Inflammation in arm), PAIN IN EXTREMITY (pain in arm) and HYPOKINESIA (Difficulty moving arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE JOINT INFLAMMATION (Inflammation in arm), PAIN IN EXTREMITY (pain in arm) and HYPOKINESIA (Difficulty moving arm). At the time of the report, VACCINATION SITE JOINT INFLAMMATION (Inflammation in arm), PAIN IN EXTREMITY (pain in arm) and HYPOKINESIA (Difficulty moving arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medication includes methyl prednisone dose.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: TCR form was attached and it contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Really large tender spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Really large tender spot on arm) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Really large tender spot on arm). At the time of the report, INJECTION SITE PAIN (Really large tender spot on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Oropharyngeal discomfort, Rash
Clinical narrative: lymph node in the left neck and was swollen and tender; lymph node in the left neck and was swollen and tender; Peculiar throat sensation; rash on the left ear which spread to face, neck, and chest; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (rash on the left ear which spread to face, neck, and chest), LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation) 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 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced RASH (rash on the left ear which spread to face, neck, and chest). On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation). At the time of the report, RASH (rash on the left ear which spread to face, neck, and chest), LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation) 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.   Treatment Medications included Benadryl, Steroid, Pepcid, IV fluid,Cephalexin, Prednisone, Benadryl, and Epi- Pen. No concomitant medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Itchiness; Swollen (Injection Site); A spontaneous report was received from a consumer concerning a 54 year old female patient who received Moderna COVID-19 vaccine (mRNA-1273) who experienced itchy, injection site swelling.  The patient's medical history and concomitant medication were not reported.  On 06Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011JZ0A) intramuscular route for prophylaxis of COVID-19 infection.  On 19jan2021, The patient experienced itchy, injection site swelling. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event itchy, injection site swelling is unknown.  The consumer assessed the events itchy, injection site swelling were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm was a little sore; Red spot below the injection site; spot slightly raised; spot warm to the touch; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), VACCINATION SITE WARMTH (spot warm to the touch), VACCINATION SITE SWELLING (spot slightly raised) and VACCINATION SITE ERYTHEMA (Red spot below the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.  No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot below the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (spot warm to the touch) and VACCINATION SITE SWELLING (spot slightly raised). On 10-Jan-2021, PAIN IN EXTREMITY (Arm was a little sore) had resolved. At the time of the report, VACCINATION SITE WARMTH (spot warm to the touch), VACCINATION SITE SWELLING (spot slightly raised) and VACCINATION SITE ERYTHEMA (Red spot below the injection site) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: broke out in shingles, diagnosed with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (broke out in shingles, diagnosed with shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced HERPES ZOSTER (broke out in shingles, diagnosed with shingles). At the time of the report, HERPES ZOSTER (broke out in shingles, diagnosed with shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included chemo therapy infusions and lot of other medications. No treatment medications were provided by reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash, Vaccination site pain
Clinical narrative: rash; soreness on arm; vaccination site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on arm), INJECTION SITE PRURITUS (vaccination site itchiness) and RASH (rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K00A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (soreness on arm) and INJECTION SITE PRURITUS (vaccination site itchiness). On 18-Jan-2021, the patient experienced RASH (rash). On 31-Dec-2020, VACCINATION SITE PAIN (soreness on arm) and INJECTION SITE PRURITUS (vaccination site itchiness) had resolved. At the time of the report, RASH (rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include Hydrocortisone cream (still using it) and lee pills. No relevant concomitant medications were reported.    Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Larger than it was; 2-inch red spot around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2-inch red spot around the injection site) and VACCINATION SITE ERYTHEMA (Larger than it was) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOCLOPRAMIDE, PRAVASTATIN, CITALOPRAM and VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (2-inch red spot around the injection site). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Larger than it was). At the time of the report, VACCINATION SITE ERYTHEMA (2-inch red spot around the injection site) had not resolved and VACCINATION SITE ERYTHEMA (Larger than it was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: left knee started becoming swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left knee started becoming swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Right knee replacement.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced JOINT SWELLING (left knee started becoming swollen). At the time of the report, JOINT SWELLING (left knee started becoming swollen) outcome was unknown. Few hours after injection, patient's left knee started swelling. Difficult in walking as the joint is swollen. Used ice packs on her knee and took ADVIL and she also elevated her leg by sitting in a recliner. After 3 days, It subsided and can walk now but with a cane.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients reports using ice packs on her knee and she took ADVIL
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Arm was itchy; deltoid area being warm; Welts in the back of the arm where she got her injection; allergic reaction; Arm got red; A spontaneous report was received from HCP  concerning an unknown years-old female patient who received the COVID-19 vaccine (mRNA-1273).  The patient's medical history is not reported. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number:Unknown) via an unknown route for prophylaxis of COVID-19 infection.   On date 13 Jan 2021, the patient experienced the events itchy, red, warmth, rash and allergic reaction at the injection site.    No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events adverse reaction, arm was itchy,  arm got red,  band around her bicep, deltoid area being red, deltoid area being warm, felt like she had welts on the back of her arm and allergic reaction was resolved on 16 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Tinnitus, Vomiting
Clinical narrative: Blinking/shuttering noise in her brain; Vomiting; Nausea; Chills; Fever; A spontaneous report was received from a consumer concerning a 77-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vomiting, nausea, chills, fever and blinking/shuttering noise in brain.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 15 Jan 2020, approximately 12 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 702195013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 16 Jan 2020, about 12 hours following vaccine administration, the patient experienced vomiting, nausea, chills and fever that lasted for 48 hours. She also began hearing a blinking/shuttering noise in her brain. Treatment for the event included paracetamol, ibuprofen, and emetrol.  Action taken with mRNA-1273 in response to the events was not reported.  The events vomiting, nausea, chills and fever, were resolved on 18 Jan 2021. The outcome of the event blinking/shuttering noise in brain was unknown.; Reporter's Comments: This case concerns 77-year old, female patient who experienced non-serious expected events of vomiting, nausea, chills, fever and non-serious unexpected event of blinking/shuttering noise in brain. The events occurred about 12 hours after the first dose of mRNA-1273 vaccine.  Treatment for the events included paracetamol, ibuprofen, and emetrol. Vomiting, nausea, chills, fever resolved, however outcome of blinking/shuttering noise in brain was reported as unknown.  All events were assessed as related to mRNA-1273 vaccine due to temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Itchy hives on the injection site; Itchy hives on the injection site; Arm hurt for a day; A spontaneous report was received from a consumer who was also a 77-years-old female patient who received Moderna's COVID-19 vaccine and experienced  Pain in arm ,and Itchy hives on the injection site.  Patient's medical history was not provided, and concomitant medicines taken by the patient include Pregabalin, Duloxetine and Spironolactone.  On 12 Jan 2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced  Pain in arm ,and Itchy hives on the injection site.   Action taken with mRNA-1273 was not reported.  The outcome of the events, Pain in arm ,and Itchy hives on the injection site is not available.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Rash papular, Vaccination site erythema
Clinical narrative: Raised red rash; Red rash at injection site; It was itching near site; Some hives were forming; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming), RASH PAPULAR (Raised red rash) and VACCINATION SITE ERYTHEMA (Red rash at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming) and VACCINATION SITE ERYTHEMA (Red rash at injection site). On an unknown date, the patient experienced RASH PAPULAR (Raised red rash). At the time of the report, INJECTION SITE PRURITUS (It was itching near site), INJECTION SITE URTICARIA (Some hives were forming), RASH PAPULAR (Raised red rash) and VACCINATION SITE ERYTHEMA (Red rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red blotch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red blotch on the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotch on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red blotch on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment.   Reportedly, the patient denied any allergies and PMH.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Email address is updated On 04-Jun-2021: Event outcome updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Fever; felt really bad; Pain in the injection site; A spontaneous report was received from a Consumer concerning a 71 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- pyrexia, vaccination site pain and malaise.   The patient's medical history was not provided. Patient was taking cholesterol pills as concomitant medication.    On 19/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  Patient reported she received the first dose of the Moderna covid-19 vaccine on 19Jan2021 at 12:15 am and mentioned she felt really bad on 20 Jan 2021, she has fever 101 °F on 19 Jan 2021 and pain in the injection site (left arm) on 19 Jan 2021.  Laboratory data include- She was having fever, 101°F.  Patient did not take any medications for treatment for the events.  Action taken with mRNA-1273 in response to the events was not reported.   On the reported date, the outcome of the events, fever, pain at the injection site and malaise were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Oropharyngeal pain, Vaccination site pain
Clinical narrative: chest tightness; sore throat pain 4 out of 5; right arm sore where injected; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat pain 4 out of 5), VACCINATION SITE PAIN (right arm sore where injected) and CHEST DISCOMFORT (chest tightness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (right arm sore where injected). On 21-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat pain 4 out of 5). On 22-Jan-2021, the patient experienced CHEST DISCOMFORT (chest tightness). At the time of the report, OROPHARYNGEAL PAIN (sore throat pain 4 out of 5), VACCINATION SITE PAIN (right arm sore where injected) and CHEST DISCOMFORT (chest tightness) outcome was unknown. Not Provided   No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: redness on injection site; Itchiness on injection site; A?spontaneous?report was received to a 79-year old male patient, who received?Moderna's?COVID-19 vaccine?(mRNA-1273). he started having redness and itchiness on injection site.  Patient received Moderna COVID19 vaccine on 13-Jan-2021 and on 21-Jan-2021 and he got the vaccine on his left arm as intramuscular injection. Agreed to follow up calls. Patient is calling to check on side effects. On 21-Jan-2021 he started having redness and itchiness on injection site.  The patient's medical history, was not provided by the reporter.  Treatment for the events were not included.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event also was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever; Cough; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), COUGH (Cough), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Pyrexia, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches) outcome was unknown and PYREXIA (Fever) and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment includes Ibuprofen
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inflammation, Nausea, Paraesthesia
Clinical narrative: severe vertigo; dizziness; inflammation causing vertigo and dizziness; nausea; tingling in right foot; tingling in the left side of face; pain on left side of head; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo) and DIZZINESS (dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease and BPPV (Experienced nausea and vertigo). Concomitant products included CARVEDILOL, PRAVASTATIN, ESTRADIOL (VAGIFEM), L-ARGININE HCL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021 at 1:30 PM, the patient experienced TINNITUS (tinnitus). On 18-Jan-2021, the patient experienced PARAESTHESIA (tingling in the left side of face) and HEADACHE (pain on left side of head). On 19-Jan-2021, the patient experienced PARAESTHESIA (tingling in right foot). On an unknown date, the patient experienced VERTIGO (severe vertigo), DIZZINESS (dizziness), INFLAMMATION (inflammation causing vertigo and dizziness) and NAUSEA (nausea). The patient was treated with PROMETHAZINE for Vertigo and Dizziness, at a dose of 1 dosage form at bedtime; PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, PHENYLPROPANOLAMINE HYDROCHLORIDE (DIMETAPP (PPA)) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (pain on left side of head) had resolved and INFLAMMATION (inflammation causing vertigo and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional information added. On 09-Jun-2021: Outcome of events updated, additional events added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: severe vertigo; dizziness; inflammation causing vertigo and dizziness; nausea; tingling in right foot; tingling in the left side of face; pain on left side of head; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo) and DIZZINESS (dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease and BPPV (Experienced nausea and vertigo). Concomitant products included CARVEDILOL, PRAVASTATIN, ESTRADIOL (VAGIFEM), L-ARGININE HCL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021 at 1:30 PM, the patient experienced TINNITUS (tinnitus). On 18-Jan-2021, the patient experienced PARAESTHESIA (tingling in the left side of face) and HEADACHE (pain on left side of head). On 19-Jan-2021, the patient experienced PARAESTHESIA (tingling in right foot). On an unknown date, the patient experienced VERTIGO (severe vertigo), DIZZINESS (dizziness), INFLAMMATION (inflammation causing vertigo and dizziness) and NAUSEA (nausea). The patient was treated with PROMETHAZINE for Vertigo and Dizziness, at a dose of 1 dosage form at bedtime; PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, PHENYLPROPANOLAMINE HYDROCHLORIDE (DIMETAPP (PPA)) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus), PARAESTHESIA (tingling in the left side of face), PARAESTHESIA (tingling in right foot), VERTIGO (severe vertigo), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (pain on left side of head) had resolved and INFLAMMATION (inflammation causing vertigo and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional information added. On 09-Jun-2021: Outcome of events updated, additional events added.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19 one and a half weeks later; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Diagnosed with COVID-19 one and a half weeks later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced COVID-19 (Diagnosed with COVID-19 one and a half weeks later). At the time of the report, COVID-19 (Diagnosed with COVID-19 one and a half weeks later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Huge hot reaction at injection site; Itchy reaction at the injection site; Burning reaction at the injection site; Injection site hurt; A little red patch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site), VACCINATION SITE PAIN (Injection site hurt), VACCINATION SITE ERYTHEMA (A little red patch around the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid nodule (large). Concomitant products included PROPRANOLOL, FISH OIL and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (A little red patch around the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Ice therapy) for Vaccination site warmth; Physical therapy (Ice therapy) for Vaccination site pruritus; Physical therapy (Ice therapy) for Vaccination site pain; Physical therapy (Ice therapy) for Vaccination site erythema and Physical therapy (Ice therapy) for Vaccination site pain. On 09-Jan-2021, VACCINATION SITE PAIN (Injection site hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (Huge hot reaction at injection site), VACCINATION SITE PRURITUS (Itchy reaction at the injection site) and VACCINATION SITE PAIN (Burning reaction at the injection site) had not resolved and VACCINATION SITE ERYTHEMA (A little red patch around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take  Tylenol and use ice.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Follow-up received on 20-JAN-2021 contains information regarding patient demographic details, medical history, concomitant medications and the events. On 13-Apr-2021: Follow up received on 13-Apr-2021 does contains any new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: one inch and a half knot under the injection reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (one inch and a half knot under the injection reaction) in a 75-year-old female patient who received mRNA-1273 (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE MASS (one inch and a half knot under the injection reaction).        The action taken with mRNA-1273 (Intramuscular) was unknown.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pyrexia
Clinical narrative: headache; Fever; Fatigue; cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), HEADACHE (headache), FATIGUE (Fatigue) and PYREXIA (Fever) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced COUGH (cough). On 18-Jan-2021, the patient experienced FATIGUE (Fatigue). On 20-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (Fever). At the time of the report, COUGH (cough), HEADACHE (headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: substantial headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (substantial headache) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (substantial headache). On 17-Jan-2021, HEADACHE (substantial headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I had a fever 101 degrees Fahrenheit when i woke up.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.). At the time of the report, PYREXIA (I had a fever 101 degrees Fahrenheit when i woke up.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature (Unknown-101): 101 degrees (High) 101 degrees.     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.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE (PULMICORT) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABNORMAL DREAMS (vivid dreams). At the time of the report, ABNORMAL DREAMS (vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild pain on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild pain on the injection site). At the time of the report, VACCINATION SITE PAIN (mild pain on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Skin felt a little leathery; It was warm; it was red; Swollen; Itchy; A small egg-sized lump on her arm/hard lump in the center; Arm hurt to touch and move it; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE ERYTHEMA (it was red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE PAIN (Arm hurt to touch and move it). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 16-Jan-2021, the patient experienced DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (Swollen). On 10-Jan-2021, VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE PAIN (Arm hurt to touch and move it) had resolved. At the time of the report, DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (Swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Reporter contact details, Patient demographics, suspect product information,  new events and outcome of events updated. On 04-Jun-2021: Outcome of events updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Skin felt a little leathery; It was warm; it was red; Swollen; Itchy; A small egg-sized lump on her arm/hard lump in the center; Arm hurt to touch and move it; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE ERYTHEMA (it was red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE PAIN (Arm hurt to touch and move it). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). On 16-Jan-2021, the patient experienced DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (Swollen). On 10-Jan-2021, VACCINATION SITE INDURATION (A small egg-sized lump on her arm/hard lump in the center) and VACCINATION SITE PAIN (Arm hurt to touch and move it) had resolved. At the time of the report, DRY SKIN (Skin felt a little leathery), VACCINATION SITE WARMTH (It was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (Swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Reporter contact details, Patient demographics, suspect product information,  new events and outcome of events updated. On 04-Jun-2021: Outcome of events updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (headache). 19-Jan-2021, the patient experienced NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Body temperature, Chills, Constipation
Clinical narrative: Felt increasingly weak; chills; headache; cough; runny nose; body ached so bad; had no taste for anything; CONGETSTED; RUNNY NOSE; constipated; Fever progressed; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated) and PYREXIA (Fever progressed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), CHILLS (chills) and HEADACHE (headache). On 16-Jan-2021, the patient experienced ASTHENIA (Felt increasingly weak). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 16-Jan-2021, COUGH (cough), NASAL CONGESTION (CONGETSTED), CONSTIPATION (constipated), PYREXIA (Fever progressed), ASTHENIA (Felt increasingly weak) and CHILLS (chills) had resolved. On 17-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 99f (normal) 99F. On 16-Jan-2021, Body temperature (Unknown-high): 104°f (High) 104°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.