chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hard red nodule on arm; itchy arm; arm swelling/ bee sting appearance arm; red spot at site of injection; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm), VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection) in a 67-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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection). On 09-Mar-2021, the patient experienced VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE NODULE (hard red nodule on arm), VACCINATION SITE PRURITUS (itchy arm), VACCINATION SITE SWELLING (arm swelling/ bee sting appearance arm) and VACCINATION SITE ERYTHEMA (red spot at site of injection) outcome was unknown.            Concomitant medications include Claritin, Ice pack for an unknown indication. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow-up information include:Reported details updated(email).2nd dose details provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Pain in arm; headache; Tiredness; Numbness facial; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness facial), PALPITATIONS (Heart racing), PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure) and Depression. Concomitant products included PROPRANOLOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ). On 09-Mar-2021, HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood pressure measurement: 155/100 (High) BP raised to 155/100.         No concomitant medications were reported.  No laboratory details were  provided.  No treatment 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 24-May-2021: Follow-up document contains  No New Information
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pain in arm; headache; Tiredness; Numbness facial; Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness facial), PALPITATIONS (Heart racing), PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood Pressure) and Depression. Concomitant products included PROPRANOLOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing). On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ). On 09-Mar-2021, HYPOAESTHESIA (Numbness facial) and PALPITATIONS (Heart racing) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm ), HEADACHE (headache) and FATIGUE (Tiredness ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Blood pressure measurement: 155/100 (High) BP raised to 155/100.         No concomitant medications were reported.  No laboratory details were  provided.  No treatment 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 24-May-2021: Follow-up document contains  No New Information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Paraesthesia, Vaccination site pain
Clinical narrative: It felt burning; It felt tingling; Still hurting; It is still sore/somewhat painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (It felt burning), PARAESTHESIA (It felt tingling), DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BURNING SENSATION (It felt burning), PARAESTHESIA (It felt tingling), DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful). On 13-Feb-2021, BURNING SENSATION (It felt burning) and PARAESTHESIA (It felt tingling) had resolved. At the time of the report, DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence
Clinical narrative: Bloated; Gassy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy). At the time of the report, ABDOMINAL DISTENSION (Bloated) and FLATULENCE (Gassy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and RHINORRHOEA (Running nose) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Running nose). At the time of the report, SNEEZING (Sneezing) and RHINORRHOEA (Running nose) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Oropharyngeal pain, Pruritus
Clinical narrative: sore throat, nausea and diarrhea for 24hs; sore throat, nausea and diarrhea for 24hs; sore throat, nausea and diarrhea for 24hs; Within 15min of the injection patient developed itchiness on her right hand; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs), PRURITUS (Within 15min of the injection patient developed itchiness on her right hand) and NAUSEA (sore throat, nausea and diarrhea for 24hs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01da21a) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS (The patient used Ondansetron to treat symptoms for her stomach problems.). Concomitant products included INSULIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]), SIMVASTATIN, GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 05-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) at an unspecified dose. On 05-Mar-2021, the patient experienced PRURITUS (Within 15min of the injection patient developed itchiness on her right hand). On 06-Mar-2021, the patient experienced DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs) and NAUSEA (sore throat, nausea and diarrhea for 24hs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. On 05-Mar-2021, PRURITUS (Within 15min of the injection patient developed itchiness on her right hand) had resolved. On 07-Mar-2021, DIARRHOEA (sore throat, nausea and diarrhea for 24hs), OROPHARYNGEAL PAIN (sore throat, nausea and diarrhea for 24hs) and NAUSEA (sore throat, nausea and diarrhea for 24hs) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Papule, Rash, Skin burning sensation
Clinical narrative: Tiny Red bumps that were itching and burning; Tiny red bumps that were itching and burning; Rash on forearms and crease of elbow as well as chest; Bump on back right side of neck; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. At the time of the report, PAPULE (Tiny Red bumps that were itching and burning), SKIN BURNING SENSATION (Tiny red bumps that were itching and burning), RASH (Rash on forearms and crease of elbow as well as chest) and RASH (Bump on back right side of neck) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Nasopharyngitis, Pain in extremity, Urticaria
Clinical narrative: lips got really swollen; Cold symptoms; hives were really bad and covered my whole body/chest/neck/whole torso/right arm/left leg; soreness in arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm for 24 hours), LIP SWELLING (lips got really swollen), NASOPHARYNGITIS (Cold symptoms) and URTICARIA (hives were really bad and covered my whole body/chest/neck/whole torso/right arm/left leg) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Lupus).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm for 24 hours). On 05-Mar-2021, the patient experienced LIP SWELLING (lips got really swollen), NASOPHARYNGITIS (Cold symptoms) and URTICARIA (hives were really bad and covered my whole body/chest/neck/whole torso/right arm/left leg). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Hives, at an unspecified dose and frequency. On 05-Mar-2021, PAIN IN EXTREMITY (soreness in arm for 24 hours) had resolved. At the time of the report, LIP SWELLING (lips got really swollen), NASOPHARYNGITIS (Cold symptoms) and URTICARIA (hives were really bad and covered my whole body/chest/neck/whole torso/right arm/left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Oropharyngeal pain
Clinical narrative: sore throat; dizziness; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (high blood pressure) and OROPHARYNGEAL PAIN (sore throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizziness) and HYPERTENSION (high blood pressure). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (high blood pressure) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vaccination site rash, Vomiting
Clinical narrative: she developed a localized large rash around the injection site; vomited; nausea; tired; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VACCINATION SITE RASH (she developed a localized large rash around the injection site), VOMITING (vomited), NAUSEA (nausea) and FATIGUE (tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (she is a cancer survivor and has had some of the lymph nodes on that side removed during lumpectomy surgery) since an unknown date and Lumpectomy.   On 07-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) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy), VOMITING (vomited), NAUSEA (nausea) and FATIGUE (tired). On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (she developed a localized large rash around the injection site). On 09-Mar-2021, DIZZINESS (dizzy), VOMITING (vomited) and NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE RASH (she developed a localized large rash around the injection site) and FATIGUE (tired) outcome was unknown.            No concomitant medicines were reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Diarrhea; Body aches; Fever of 100.2 F; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Body aches), PYREXIA (Fever of 100.2 F) and FATIGUE (Tiredness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Body aches), PYREXIA (Fever of 100.2 F) and FATIGUE (Tiredness). On 09-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, MYALGIA (Body aches), PYREXIA (Fever of 100.2 F) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-039342 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up received no new significant information available.; Sender's Comments:  MOD-2021-039342:cross linked, daughter case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Asthenia, Decreased appetite, Pyrexia, Thirst decreased
Clinical narrative: She has not been able to get out of bed; She hasn't eaten anything; she doesn't want water or anything; she talks nonsense to me; high fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything), ABNORMAL BEHAVIOUR (she talks nonsense to me) and PYREXIA (high fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 08-Mar-2021, the patient experienced PYREXIA (high fever). On 09-Mar-2021, the patient experienced ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything) and ABNORMAL BEHAVIOUR (she talks nonsense to me). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything), ABNORMAL BEHAVIOUR (she talks nonsense to me) and PYREXIA (high fever) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Sweating; Nausea; Sore throat; Stomach ache; Pain; Chills; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired). On 08-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Nausea). On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). At the time of the report, PAIN (Pain), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include Cold and Flu medication for symptoms. Concomitant medication include Cold and flu for an unknown indication.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sweating; Nausea; Sore throat; Stomach ache; Pain; Chills; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired). On 08-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache) and NAUSEA (Nausea). On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). At the time of the report, PAIN (Pain), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN UPPER (Stomach ache), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include Cold and Flu medication for symptoms. Concomitant medication include Cold and flu for an unknown indication.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Oropharyngeal pain, Pain, Toothache
Clinical narrative: Sore Throat; All her Teeth Ache; Pain in the Ears; Cheeks hurt; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dental cavity.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache). On 07-Mar-2021, OROPHARYNGEAL PAIN (Sore Throat) had resolved. At the time of the report, TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: NNI received
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Vaccination site pain, Vaccination site pruritus
Clinical narrative: No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Tired). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site), VACCINATION SITE REACTION (Reaction on the Injection Site Left Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Hurt Injection Site) and VACCINATION SITE RASH (Rash Injection Site Left Arm (Oval shape 3'X4")). On 02-Mar-2021, the patient experienced PAIN (Real Achy all over the body). On 09-Mar-2021, the patient experienced MYALGIA (Muscle Aches). On 01-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN (Real Achy all over the body), VACCINATION SITE WARMTH (Warm to the Touch Injection Site), VACCINATION SITE REACTION (Reaction on the Injection Site Left Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Hurt Injection Site), VACCINATION SITE RASH (Rash Injection Site Left Arm (Oval shape 3'X4")) and MYALGIA (Muscle Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Tired). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site), VACCINATION SITE REACTION (Reaction on the Injection Site Left Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Hurt Injection Site) and VACCINATION SITE RASH (Rash Injection Site Left Arm (Oval shape 3'X4")). On 02-Mar-2021, the patient experienced PAIN (Real Achy all over the body). On 09-Mar-2021, the patient experienced MYALGIA (Muscle Aches). On 01-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, PAIN (Real Achy all over the body), VACCINATION SITE WARMTH (Warm to the Touch Injection Site), VACCINATION SITE REACTION (Reaction on the Injection Site Left Arm), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Hurt Injection Site), VACCINATION SITE RASH (Rash Injection Site Left Arm (Oval shape 3'X4")) and MYALGIA (Muscle Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Electrocardiogram, Paraesthesia
Clinical narrative: Blood pressure went to 250; Almost past out after receiving vaccine; Tingling sensation in hand and arm; Light headed; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood pressure went to 250, light headedness, tingling sensation in hand and arm, almost passed out after receiving vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced the event(s) light headed, tingling sensation in hand and arm, almost past out after receiving vaccine. Her blood pressure was reported as high 250/XXX mmHg. The patient forgot the diastolic number. No treatment information was provided.  On 09 Mar 2021, the patient visited her primary physician office where they checked her EKG. The results were normal. The blood pressure was at 142/86 mmHg. The patient's doctor stated that she should not take the second dose based on her medical records.  Action taken with mRNA-1273 in response to the events was drug withdrawn.   The outcome of events, light headed, tingling sensation in hand and arm, almost past out after receiving vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Blood pressure went to 250; Almost past out after receiving vaccine; Tingling sensation in hand and arm; Light headed; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood pressure went to 250, light headedness, tingling sensation in hand and arm, almost passed out after receiving vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced the event(s) light headed, tingling sensation in hand and arm, almost past out after receiving vaccine. Her blood pressure was reported as high 250/XXX mmHg. The patient forgot the diastolic number. No treatment information was provided.  On 09 Mar 2021, the patient visited her primary physician office where they checked her EKG. The results were normal. The blood pressure was at 142/86 mmHg. The patient's doctor stated that she should not take the second dose based on her medical records.  Action taken with mRNA-1273 in response to the events was drug withdrawn.   The outcome of events, light headed, tingling sensation in hand and arm, almost past out after receiving vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: dizziness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and MYALGIA (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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness after first injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (arm soreness after first injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness after first injection). On 12-Feb-2021, VACCINATION SITE PAIN (arm soreness after first injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided.  No treatment 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 24-May-2021: The Non significant follow up received on 24-MAY-2021. The patient states that she already reported the adverse events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itches a lot; rash appeared on her chest. It then moved to her back and arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches a lot) and RASH (rash appeared on her chest. It then moved to her back and arms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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 04-Mar-2021, the patient experienced PRURITUS (itches a lot) and RASH (rash appeared on her chest. It then moved to her back and arms). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itchy rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (itches a lot) and RASH (rash appeared on her chest. It then moved to her back and arms) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 101.5 F; Achy all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy all over the body) and PYREXIA (Fever 101.5 F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 227A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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 08-Mar-2021, the patient experienced MYALGIA (Achy all over the body). On 09-Mar-2021, the patient experienced PYREXIA (Fever 101.5 F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Achy all over the body) and PYREXIA (Fever 101.5 F) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Malaise
Clinical narrative: cough; chills; headache; felt like fever; didn't feel good; extremely tired; tasted alcohol in chicken/chicken tasted like 10 lemons; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons), COUGH (cough), MALAISE (didn't feel good), FATIGUE (extremely tired) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included CARVEDILOL, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER), OMEPRAZOLE, CALCIUM, MAGNESIUM, IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    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 TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons). On 06-Mar-2021, the patient experienced MALAISE (didn't feel good) and FATIGUE (extremely tired). On 08-Mar-2021, the patient experienced COUGH (cough), CHILLS (chills), HEADACHE (headache) and PYREXIA (felt like fever). At the time of the report, TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons), COUGH (cough), MALAISE (didn't feel good), FATIGUE (extremely tired), CHILLS (chills), HEADACHE (headache) and PYREXIA (felt like fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: cough; chills; headache; felt like fever; didn't feel good; extremely tired; tasted alcohol in chicken/chicken tasted like 10 lemons; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons), COUGH (cough), MALAISE (didn't feel good), FATIGUE (extremely tired) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included CARVEDILOL, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER), OMEPRAZOLE, CALCIUM, MAGNESIUM, IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.    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 TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons). On 06-Mar-2021, the patient experienced MALAISE (didn't feel good) and FATIGUE (extremely tired). On 08-Mar-2021, the patient experienced COUGH (cough), CHILLS (chills), HEADACHE (headache) and PYREXIA (felt like fever). At the time of the report, TASTE DISORDER (tasted alcohol in chicken/chicken tasted like 10 lemons), COUGH (cough), MALAISE (didn't feel good), FATIGUE (extremely tired), CHILLS (chills), HEADACHE (headache) and PYREXIA (felt like fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Dysphonia, Fatigue
Clinical narrative: coughing - dry cough; weakness; flushed a little bit; Not hungry have not had dinner no breakfast, No appetite; voice is deeper; Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite) and DYSPHONIA (voice is deeper) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with acetaminophen (Tylenol).
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache
Clinical narrative: coughing - dry cough; weakness; flushed a little bit; Not hungry have not had dinner no breakfast, No appetite; voice is deeper; Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite) and DYSPHONIA (voice is deeper) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (coughing - dry cough), ASTHENIA (weakness), FLUSHING (flushed a little bit), DECREASED APPETITE (Not hungry have not had dinner no breakfast, No appetite), DYSPHONIA (voice is deeper), HEADACHE (Headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with acetaminophen (Tylenol).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort
Clinical narrative: didn't feel real good; could not move his fingers around like his right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel real good) and LIMB DISCOMFORT (could not move his fingers around like his right arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, CALCITRIOL, CEFDINIR, CHOLECALCIFEROL, CINACALCET, DIALYVITE, FUROSEMIDE, LOSARTAN, SERTRALINE and SUCROFERRIC OXYHYDROXIDE for an unknown indication, GLYBURIDE.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel real good) and LIMB DISCOMFORT (could not move his fingers around like his right arm). At the time of the report, FEELING ABNORMAL (didn't feel real good) and LIMB DISCOMFORT (could not move his fingers around like his right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swollen top lip; Swollen cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen cheek) and LIP SWELLING (Swollen top lip) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    Concurrent medical conditions included Shellfish allergy (and monosodium glutamate), Nickel sensitivity and Allergy to vaccine.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced SWELLING FACE (Swollen cheek). On 02-Mar-2021, the patient experienced LIP SWELLING (Swollen top lip). On 07-Mar-2021, SWELLING FACE (Swollen cheek) and LIP SWELLING (Swollen top lip) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact