chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decubitus ulcer, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: laying in bed all day; tired; a little bit odd; walking up a stairs she felt breathless; she also has a funny feeling under the armpit; kind of weird; slight chills; a feeling of malaise; a feeling of unwellness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (kind of weird), CHILLS (slight chills), MALAISE (a feeling of unwellness), DECUBITUS ULCER (laying in bed all day) and FATIGUE (tired) in a 64-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 was provided by the reporter.  Concomitant products included TERIPARATIDE (FORTEO) and DIAZEPAM (VALIUM) 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 10-Feb-2021, the patient experienced FEELING ABNORMAL (kind of weird), CHILLS (slight chills) and MALAISE (a feeling of unwellness). On 16-Feb-2021, the patient experienced DECUBITUS ULCER (laying in bed all day), FATIGUE (tired), FEELING ABNORMAL (a little bit odd), DYSPNOEA (walking up a stairs she felt breathless) and FEELING ABNORMAL (she also has a funny feeling under the armpit). On 10-Feb-2021, FEELING ABNORMAL (kind of weird), CHILLS (slight chills) and MALAISE (a feeling of unwellness) had resolved. At the time of the report, DECUBITUS ULCER (laying in bed all day), FATIGUE (tired), FEELING ABNORMAL (a little bit odd), DYSPNOEA (walking up a stairs she felt breathless) and FEELING ABNORMAL (she also has a funny feeling under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications .Forteo , Valium Treatment details were not provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: laying in bed all day; tired; a little bit odd; walking up a stairs she felt breathless; she also has a funny feeling under the armpit; kind of weird; slight chills; a feeling of malaise; a feeling of unwellness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (kind of weird), CHILLS (slight chills), MALAISE (a feeling of unwellness), DECUBITUS ULCER (laying in bed all day) and FATIGUE (tired) in a 64-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 was provided by the reporter.  Concomitant products included TERIPARATIDE (FORTEO) and DIAZEPAM (VALIUM) 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 10-Feb-2021, the patient experienced FEELING ABNORMAL (kind of weird), CHILLS (slight chills) and MALAISE (a feeling of unwellness). On 16-Feb-2021, the patient experienced DECUBITUS ULCER (laying in bed all day), FATIGUE (tired), FEELING ABNORMAL (a little bit odd), DYSPNOEA (walking up a stairs she felt breathless) and FEELING ABNORMAL (she also has a funny feeling under the armpit). On 10-Feb-2021, FEELING ABNORMAL (kind of weird), CHILLS (slight chills) and MALAISE (a feeling of unwellness) had resolved. At the time of the report, DECUBITUS ULCER (laying in bed all day), FATIGUE (tired), FEELING ABNORMAL (a little bit odd), DYSPNOEA (walking up a stairs she felt breathless) and FEELING ABNORMAL (she also has a funny feeling under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications .Forteo , Valium Treatment details were not provided
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Confusional state, Dizziness, Myalgia, Nausea
Clinical narrative: Nausea; pretty severe dizziness; confusion; fever; muscle aches; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (muscle aches). On 24-Feb-2021, the patient experienced NAUSEA (Nausea), DIZZINESS (pretty severe dizziness) and PYREXIA (fever). On an unknown date, the patient experienced CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and SCOPOLAMINE [HYOSCINE] for Adverse event, at a dose of UNK dosage form. At the time of the report, NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative (Negative) negative.     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.   This case was linked to MOD-2021-030149, MOD-2021-030149 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; pretty severe dizziness; confusion; fever; muscle aches; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MYALGIA (muscle aches). On 24-Feb-2021, the patient experienced NAUSEA (Nausea), DIZZINESS (pretty severe dizziness) and PYREXIA (fever). On an unknown date, the patient experienced CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and SCOPOLAMINE [HYOSCINE] for Adverse event, at a dose of UNK dosage form. At the time of the report, NAUSEA (Nausea), MYALGIA (muscle aches), DIZZINESS (pretty severe dizziness), CONFUSIONAL STATE (confusion) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: negative (Negative) negative.     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.   This case was linked to MOD-2021-030149, MOD-2021-030149 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin irritation
Clinical narrative: itchy; rash; red spot; irritated if touched; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), RASH (rash), ERYTHEMA (red spot) and SKIN IRRITATION (irritated if touched) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), RASH (rash), ERYTHEMA (red spot) and SKIN IRRITATION (irritated if touched). At the time of the report, PRURITUS (itchy), RASH (rash), ERYTHEMA (red spot) and SKIN IRRITATION (irritated if touched) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Swelling
Clinical narrative: my knee swelled up; knee started bothering; swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (my knee swelled up), ARTHRALGIA (knee started bothering) and SWELLING (swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 JOINT SWELLING (my knee swelled up), ARTHRALGIA (knee started bothering) and SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, JOINT SWELLING (my knee swelled up), ARTHRALGIA (knee started bothering) and SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Vertigo
Clinical narrative: Muscles cramped; dizzy; vertigo; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscles cramped, spasmed, biting, dizzy, vertigo, couldn't stand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) muscles cramped . On 5 Feb 2021, the patient experienced the event(s) spasmed . On 5 Feb 2021, the patient experienced the event(s) biting . On 5 Feb 2021, the patient experienced the event(s) dizzy . On 5 Feb 2021, the patient experienced the event(s) vertigo . On 5 Feb 2021, the patient experienced the event(s) couldn't stand.  Treatment details included Took Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), muscles cramped was unknown.The outcome of event(s), spasmed was unknown.The outcome of event(s), biting was unknown.The outcome of event(s), dizzy was unknown.The outcome of event(s), vertigo was unknown.The outcome of event(s), couldn't stand was unknown..
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site; A spontaneous report  was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at injection site(Injection site rash).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Patient experienced rash on her arm after receiving the COVID- 19 vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash at injection site was unknown..
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: pain; soreness; pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness), PAIN IN EXTREMITY (pain) and PAIN (pain) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 immunization.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (soreness) and PAIN IN EXTREMITY (pain). On 01-Mar-2021, the patient experienced PAIN (pain). At the time of the report, ARTHRALGIA (soreness), PAIN IN EXTREMITY (pain) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint stiffness, Vaccination site erythema, Vaccination site joint swelling, Vaccination site pruritus
Clinical narrative: next day it was a larger area; arm was red; arm was slightly itchy; arm was stiff; headache; A spontaneous report was received from a Consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was stiff(Joint stiffness), headache, arm was slightly itchy(Vaccination site pruritus), red(Vaccination site erythema), mild itch, next day it was a larger area(Vaccination site joint swelling).  The patient's medical history was not provided. Concomitant medications reported were Calcium for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) arm was stiff, headache . On 12 Feb 2021, the patient experienced the event(s) arm was slightly itchy, red, mild itch . On 13 Feb 2021, the patient experienced the event(s) next day it was a larger area.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was stiff, headache, arm was slightly itchy ,red, mild itch, next day it was a larger area was unknown..
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Swelling
Clinical narrative: Lower Back Pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of   in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for COVID-19 vaccination.     Concomitant products included ASCORBIC ACID (VIT C) for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Unknown          No concomitant medications reported. Other treatment includes stretching and massage.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Influenza like illness, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site warmth (left arm site of injection hot), influenza-like illness (feels like flu symptoms), dizziness (dizzy), pyrexia (fever) and headache in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine), for COVID-19 immunization. Concomitant products included multivitamin & mineral for an unknown indication. On Jan 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine, batch# 010M20A), intramuscular; 1 dosage form. On Feb 16, 2021, patient experienced injection site warmth (left arm site of injection hot), pyrexia (fever) and headache. On Feb 17, 2021, patient experienced influenza-like illness (feels like the flu symptoms) and dizziness (dizzy). At the time of the report, injection site warmth (left arm site of injection hot), influenza-like illness (feels like the flu symptoms), dizziness (dizzy), pyrexia (fever) and headache outcome: unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (soreness at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (soreness at the injection site). At the time of the report, ARTHRALGIA (soreness at 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.   No concomitants or treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: "Feeling Sick"; Positive COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Feeling Sick") and COVID-19 (Positive COVID-19 Test) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On an unknown date, the patient experienced ILLNESS ("Feeling Sick"). At the time of the report, ILLNESS ("Feeling Sick") and COVID-19 (Positive COVID-19 Test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site induration, Injection site rash, Pain
Clinical narrative: Body aches; Chills; Arm was sore; Injection site was hard; Really bad rash at the injection site; Rash spread down his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site), RASH (Rash spread down his arm) and CHILLS (Chills) in a male 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site) and RASH (Rash spread down his arm). On an unknown date, the patient experienced PAIN (Body aches), CHILLS (Chills) and ARTHRALGIA (Arm was sore). At the time of the report, PAIN (Body aches), INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site), RASH (Rash spread down his arm), CHILLS (Chills) and ARTHRALGIA (Arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Body aches; Chills; Arm was sore; Injection site was hard; Really bad rash at the injection site; Rash spread down his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site), RASH (Rash spread down his arm) and CHILLS (Chills) in a male 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site) and RASH (Rash spread down his arm). On an unknown date, the patient experienced PAIN (Body aches), CHILLS (Chills) and ARTHRALGIA (Arm was sore). At the time of the report, PAIN (Body aches), INJECTION SITE INDURATION (Injection site was hard), INJECTION SITE RASH (Really bad rash at the injection site), RASH (Rash spread down his arm), CHILLS (Chills) and ARTHRALGIA (Arm was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Light headed; Bodyache; Sweats; throwing up; Headache /extreme headache at night; Fever 101F; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous) and VOMITING (throwing up) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LAMOTRIGINE (LAMICTAL) and Breo inhaler for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills) 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Light headed; Bodyache; Sweats; throwing up; Headache /extreme headache at night; Fever 101F; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous) and VOMITING (throwing up) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), LAMOTRIGINE (LAMICTAL) and Breo inhaler for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), PAIN (Bodyache), HYPERHIDROSIS (Sweats), NAUSEA (Nauseous), VOMITING (throwing up), HEADACHE (Headache /extreme headache at night), PYREXIA (Fever 101F) and CHILLS (chills) 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.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Pyrexia
Clinical narrative: had a fever of 100.6; he lost his appetite and wouldn't drink; he didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.  On 12-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 PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well). At the time of the report, PYREXIA (had a fever of 100.6), DECREASED APPETITE (he lost his appetite and wouldn't drink) and MALAISE (he didn't feel well) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  Treatment details included Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Aches; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and HEADACHE (HEADACHE) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.  On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Aches) and HEADACHE (HEADACHE). At the time of the report, PAIN (Aches) and HEADACHE (HEADACHE) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Joint pain; sweating without fever/ Sweats; headache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills), FATIGUE (fatigue) and ARTHRALGIA (Joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy and Seasonal allergy (grass, trees). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 01-Jan-2020 to an unknown date for Allergy, DIHYDRALAZINE SULFATE, HYDROCHLOROTHIAZIDE, RESERPINE, TRIAMTERENE (NO 0), VITAMIN B COMPLEX from 01-Jan-2020 to an unknown date, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) from 01-Jan-2020 to an unknown date and ZINC from 01-Jan-2020 to an unknown date for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills), FATIGUE (fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, COVID-19: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details included Ibuprofen.   This case was linked to MOD-2021-096361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter information, Patient demographics, allergic conditions, concomitant medicines and an event were updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Joint pain; sweating without fever/ Sweats; headache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills), FATIGUE (fatigue) and ARTHRALGIA (Joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy and Seasonal allergy (grass, trees). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 01-Jan-2020 to an unknown date for Allergy, DIHYDRALAZINE SULFATE, HYDROCHLOROTHIAZIDE, RESERPINE, TRIAMTERENE (NO 0), VITAMIN B COMPLEX from 01-Jan-2020 to an unknown date, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) from 01-Jan-2020 to an unknown date and ZINC from 01-Jan-2020 to an unknown date for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating without fever/ Sweats), HEADACHE (headache), CHILLS (Chills), FATIGUE (fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, COVID-19: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details included Ibuprofen.   This case was linked to MOD-2021-096361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Reporter information, Patient demographics, allergic conditions, concomitant medicines and an event were updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Night mares; Runny nose; Brain felt hot; Fatigue that comes and goes; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes), NAUSEA (Nausea) and 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 reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Night mares; Runny nose; Brain felt hot; Fatigue that comes and goes; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ABNORMAL DREAMS (Night mares), RHINORRHOEA (Runny nose), FEELING ABNORMAL (Brain felt hot), FATIGUE (Fatigue that comes and goes), NAUSEA (Nausea) and 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 reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DIARRHOEA (diarrhea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (headache). On 12-Feb-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and DIARRHOEA (diarrhea) 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: Fatigue, Pain, Rash pruritic
Clinical narrative: Hot itchy rash about the size of her hand on arm; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; ARNICA EXTRACT at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Hot itchy rash about the size of her hand on arm), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No relevant concomitant medications were reported.  Treatment details included Benadryl cream, Benadryl tablet, Ice, Arnica topical gel and Tylenol.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 89-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: left arm like a red bump/left arm red bump increasing; left arm itching; left arm hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left arm like a red bump/left arm red bump increasing), VACCINATION SITE PRURITUS (left arm itching) and VACCINATION SITE WARMTH (left arm hot to touch) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Allergy (Patient was once hospitalized due to anaphylactic reactions. she says she is allergic to something, which she doesn't know). Concomitant products included ATORVASTATIN and LOSARTAN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm like a red bump/left arm red bump increasing), VACCINATION SITE PRURITUS (left arm itching) and VACCINATION SITE WARMTH (left arm hot to touch). At the time of the report, VACCINATION SITE ERYTHEMA (left arm like a red bump/left arm red bump increasing), VACCINATION SITE PRURITUS (left arm itching) and VACCINATION SITE WARMTH (left arm hot to touch) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included lotion to try to stop the itching, took Tylenol every now and then.   Reporter did not allow further contact
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; she was not ale to breathe; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing; she was not ale to breathe) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing; she was not ale to breathe). The patient was treated with Physical therapy (Given oxygen) for Dyspnoea. At the time of the report, DYSPNOEA (difficulty breathing; she was not ale to breathe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication include Benadryl. (diphenhydramine HCL)
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Hypoaesthesia, Swelling
Clinical narrative: felt swollen on the inside but not the out; had a headache. These headaches have continued for over a month, she still gets them randomly; right side of her face was numb; had pain by her right eye; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache. These headaches have continued for over a month, she still gets them randomly), HYPOAESTHESIA (right side of her face was numb), EYE PAIN (had pain by her right eye) and SWELLING (felt swollen on the inside but not the out) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE), SPIRONOLACTONE and HYDRALAZINE for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (had a headache. These headaches have continued for over a month, she still gets them randomly), HYPOAESTHESIA (right side of her face was numb) and EYE PAIN (had pain by her right eye). On an unknown date, the patient experienced SWELLING (felt swollen on the inside but not the out). At the time of the report, HEADACHE (had a headache. These headaches have continued for over a month, she still gets them randomly), HYPOAESTHESIA (right side of her face was numb), EYE PAIN (had pain by her right eye) and SWELLING (felt swollen on the inside but not the out) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ADVERSE EVENT (adverse side effects). At the time of the report, ADVERSE EVENT (adverse side effects) outcome was unknown. Not Provided    No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heavy heartburn, Acidic stomach; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heavy heartburn, Acidic stomach) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heavy heartburn, Acidic stomach). At the time of the report, DYSPEPSIA (Heavy heartburn, Acidic stomach) outcome was unknown.            Concomitant medication information not provided.  Treatment information was not given.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09 Jul 2021. contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Hypotension, Paraesthesia, Pruritus
Clinical narrative: low BP; numbness; tingling; skin sensation; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low BP), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), PRURITUS (skin sensation) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to codeine, losartan.).  On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (low BP), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), PRURITUS (skin sensation) and DYSPNOEA (shortness of breath). At the time of the report, HYPOTENSION (low BP), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), PRURITUS (skin sensation) and DYSPNOEA (shortness of breath) 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: swelling at injection site; injection site warmth; low grade fever; tenderness in the arm where the vaccination was; redness increased at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness increased at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness increased at injection site). On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was). At the time of the report, INJECTION SITE ERYTHEMA (redness increased at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE WARMTH (injection site warmth), PYREXIA (low grade fever) and INJECTION SITE PAIN (tenderness in the arm where the vaccination was) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information included putting ice pack.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numbness in the upper lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness in the upper lip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in the upper lip). At the time of the report, HYPOAESTHESIA ORAL (numbness in the upper lip) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   No relevant concomitant medications were reported.  Treatment details not provided.