chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration
Clinical narrative: Body so weak he can't get up; Going to the bathroom every hour to urinate; Equilibrium is off; Knot at the injection site; Fever 101.0; Hurt likes hell; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site) and PYREXIA (Fever 101.0) in a 70-year-old male 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 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site), PYREXIA (Fever 101.0) and MYALGIA (Hurt likes hell). At the time of the report, ASTHENIA (Body so weak he can't get up), POLLAKIURIA (Going to the bathroom every hour to urinate), BALANCE DISORDER (Equilibrium is off), VACCINATION SITE INDURATION (Knot at the injection site), PYREXIA (Fever 101.0) and MYALGIA (Hurt likes hell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Fever 101.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rhinorrhoea
Clinical narrative: I have runny nose after taking moderna vaccine; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (I have runny nose after taking moderna vaccine) and FATIGUE (felt tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination, TORSEMIDE, MIRTAZAPINE, Tenatoprazole sobder, oxygen                                                         taken, TORSEMIDE, MIRTAZAPINE, Tenatoprazole sobder, LISINOPRIL, SPIRONOLACTONE, clopidogerel, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), vitamn D, isopsorbide mono ni ER, ATORVASTATIN, PARACETAMOL (TYLENOL), laxative                                                       every other day and Nitro                                                          for heart as needed for an unknown indication, LISINOPRIL.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced RHINORRHOEA (I have runny nose after taking moderna vaccine) and FATIGUE (felt tired). At the time of the report, RHINORRHOEA (I have runny nose after taking moderna vaccine) and FATIGUE (felt tired) outcome was unknown. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: raised bump at injection site; itchy; sore arm for 2 to 3 days; area red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-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 VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site). At the time of the report, VACCINATION SITE MASS (raised bump at injection site), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (sore arm for 2 to 3 days) and VACCINATION SITE ERYTHEMA (area red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient developed horrible COVID like symptoms for 8 days after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Patient developed horrible COVID like symptoms for 8 days after receiving the first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had the COVID-19 virus in end of January 2021) in January 2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SUSPECTED COVID-19 (Patient developed horrible COVID like symptoms for 8 days after receiving the first dose). At the time of the report, SUSPECTED COVID-19 (Patient developed horrible COVID like symptoms for 8 days after receiving the first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. Had the COVID-19 virus in end of January 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient 22 hours after receiving their first dose of Moderna vaccine developed horrible COVID like symptoms for 8 days. The patient reported that they had the COVID-19 virus in end of January 2021, and they experienced similar side effects after vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red injection site (The Size of a Small Apple); Itchy Injection Site; Hot to the touch Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of Red injection site (The Size of a Small Apple), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE WARMTH (Hot to the touch Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced Red injection site (The Size of a Small Apple), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE WARMTH (Hot to the touch Injection Site). At the time of the report, Red injection site (The Size of a Small Apple), VACCINATION SITE PRURITUS (Itchy Injection Site) and VACCINATION SITE WARMTH (Hot to the touch Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product usage were not provided. Treatment details were also not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder, Pruritus, Urticaria, White blood cell count
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER DISORDER (Discrepancy near her liver), URTICARIA (Hives) and PRURITUS (Hives were itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (Hives) and PRURITUS (Hives were itchy). On an unknown date, the patient experienced LIVER DISORDER (Discrepancy near her liver). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency; CLAVULANATE POTASSIUM for Adverse event, at an unspecified dose and frequency; VITAMINS NOS for Adverse event, at an unspecified dose and frequency and PROBIOTICS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, LIVER DISORDER (Discrepancy near her liver), URTICARIA (Hives) and PRURITUS (Hives were itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) high. No concomitant medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness in the left arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (soreness in the left arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     no medical history provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (soreness in the left arm). At the time of the report, MYALGIA (soreness in the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for the events.    This case was linked to MOD-2021-086047 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in jaw
Clinical narrative: Numbness in the R sided of the head; Sensitive Jaw; Headache on the right side of the head; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the R sided of the head), PAIN IN JAW (Sensitive Jaw) and HEADACHE (Headache on the right side of the head) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in the R sided of the head), PAIN IN JAW (Sensitive Jaw) and HEADACHE (Headache on the right side of the head). At the time of the report, HYPOAESTHESIA (Numbness in the R sided of the head), PAIN IN JAW (Sensitive Jaw) and HEADACHE (Headache on the right side of the head) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086002 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086002:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Decreased appetite, Diarrhoea
Clinical narrative: diarrhea; fever; aches / severe pain; no appetite; weakness; headaches; sharp shoulder pain; balance was off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off). At the time of the report, DIARRHEA (diarrhea), PYREXIA (fever), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off) outcome was unknown and PAIN (aches / severe pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter  Treatment medication included Tylenol
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: diarrhea; fever; aches / severe pain; no appetite; weakness; headaches; sharp shoulder pain; balance was off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHEA (diarrhea), PYREXIA (fever), PAIN (aches / severe pain), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off). At the time of the report, DIARRHEA (diarrhea), PYREXIA (fever), DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (headaches), ARTHRALGIA (sharp shoulder pain) and BALANCE DISORDER (balance was off) outcome was unknown and PAIN (aches / severe pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter  Treatment medication included Tylenol
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain, Pain in extremity, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy) and FATIGUE (Fatigued) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy), FATIGUE (Fatigued) and VACCINATION SITE PAIN (Sore arm at the injection site). On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red). On an unknown date, the patient experienced LIMB DISCOMFORT (Injection site arm hurts to move). At the time of the report, VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red) had not resolved and PAIN (Achy) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient had the first dose of the Moderna Covid-19 vaccine and had a sore arm at the injection site. On 14-Apr-2021, the patient was achy, and their arm was sore, warm and the patient was fatigued.  On 22-Apr-2021, the patient had their arm still swollen, painful, red, and warm to the touch. The patient also reported that their arm hurts too much to be able to comfortably move it.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy) and FATIGUE (Fatigued) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), PAIN IN EXTREMITY (My arm was sore), PAIN (Achy), FATIGUE (Fatigued) and VACCINATION SITE PAIN (Sore arm at the injection site). On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red). On an unknown date, the patient experienced LIMB DISCOMFORT (Injection site arm hurts to move). At the time of the report, VACCINATION SITE WARMTH (Injection arm warm/ my arm is still warm to the touch), LIMB DISCOMFORT (Injection site arm hurts to move), PAIN IN EXTREMITY (My arm was sore), VACCINATION SITE PAIN (Sore arm at the injection site), VACCINATION SITE SWELLING (Injection site swollen/  My arm is still swollen) and VACCINATION SITE ERYTHEMA (Injection site red/  my arm is still red) had not resolved and PAIN (Achy) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient had the first dose of the Moderna Covid-19 vaccine and had a sore arm at the injection site. On 14-Apr-2021, the patient was achy, and their arm was sore, warm and the patient was fatigued.  On 22-Apr-2021, the patient had their arm still swollen, painful, red, and warm to the touch. The patient also reported that their arm hurts too much to be able to comfortably move it.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Liver function test, Pain in extremity
Clinical narrative: after the 1st dose he has a sore arm; after the 1st dose he has a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 036A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), NIACIN, Citadel and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache). On 07-Feb-2021, PAIN IN EXTREMITY (after the 1st dose he has a sore arm) and HEADACHE (after the 1st dose he has a headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: ALT 79, AST 49..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by the reporter.
Age: 66.0
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 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Headache, at a dose of 300 mg; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DOXYCYCLINE HYCLATE on 20-Apr-2021 at a dose of 100 mg. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information includes Used a cold bag of frozen Vegetable in injection site.   This case was linked to MOD21-071824, MOD21-071883, MOD21-080612 (E2B Linked Report). This case was linked to MOD-2021-086105 (Patient Link).; Sender's Comments:  MOD21-071824: MOD21-071883: MOD21-080612:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness in legs; tingling in legs; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs) 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 HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs). At the time of the report, HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs) outcome was unknown. Not Provided      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.   No concomitant medications were provided.  No treatment medications were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling jittery, Feeling of body temperature change, Headache, Influenza
Clinical narrative: Red rash on torso; Jittery; Cold then hot; Sore; Worst flu she's ever had; Nausea worse than nausea from chemo; Headache so bad thought head was going to explode; Felt like she had been hit by a mac truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore) in a 68-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 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by a mac truck). On 20-Apr-2021, the patient experienced INFLUENZA (Worst flu she's ever had), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode). On 21-Apr-2021, the patient experienced FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore). On 22-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on torso). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot), PAIN (Sore), RASH ERYTHEMATOUS (Red rash on torso), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash erythematous
Clinical narrative: Red rash on torso; Jittery; Cold then hot; Sore; Worst flu she's ever had; Nausea worse than nausea from chemo; Headache so bad thought head was going to explode; Felt like she had been hit by a mac truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore) in a 68-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 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by a mac truck). On 20-Apr-2021, the patient experienced INFLUENZA (Worst flu she's ever had), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode). On 21-Apr-2021, the patient experienced FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot) and PAIN (Sore). On 22-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on torso). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by a mac truck), INFLUENZA (Worst flu she's ever had), FEELING JITTERY (Jittery), FEELING OF BODY TEMPERATURE CHANGE (Cold then hot), PAIN (Sore), RASH ERYTHEMATOUS (Red rash on torso), NAUSEA (Nausea worse than nausea from chemo) and HEADACHE (Headache so bad thought head was going to explode) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chest pain, Chills, Lymphadenitis
Clinical narrative: neck swollen glands; chills (high layers on); 2 hours after with a temperature of 102F (from the normal 97); chest pain; very weak; arm hurt at night time; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak), LYMPHADENITIS (neck swollen glands) and CHILLS (chills (high layers on)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (arm hurt at night time). On 22-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak) and CHILLS (chills (high layers on)). On an unknown date, the patient experienced LYMPHADENITIS (neck swollen glands). At the time of the report, BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak), LYMPHADENITIS (neck swollen glands), CHILLS (chills (high layers on)) and MYALGIA (arm hurt at night time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided   This case was linked to MOD-2021-086022 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: neck swollen glands; chills (high layers on); 2 hours after with a temperature of 102F (from the normal 97); chest pain; very weak; arm hurt at night time; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak), LYMPHADENITIS (neck swollen glands) and CHILLS (chills (high layers on)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (arm hurt at night time). On 22-Apr-2021, the patient experienced BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak) and CHILLS (chills (high layers on)). On an unknown date, the patient experienced LYMPHADENITIS (neck swollen glands). At the time of the report, BODY TEMPERATURE INCREASED (2 hours after with a temperature of 102F (from the normal 97)), CHEST PAIN (chest pain), ASTHENIA (very weak), LYMPHADENITIS (neck swollen glands), CHILLS (chills (high layers on)) and MYALGIA (arm hurt at night time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided   This case was linked to MOD-2021-086022 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; temperature of 100.9; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills) and PYREXIA (temperature of 100.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Endometrial carcinoma (Included Keytruda Infusions). Concomitant products included LENVATINIB MESILATE (LENVIMA) for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (temperature of 100.9). At the time of the report, CHILLS (chills) and PYREXIA (temperature of 100.9) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated patient had history of Keytruda infusions. No treatment reported for this events.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval of 17 days between shots; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of 17 days between shots) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.   This case was linked to MOD-2021-074957 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: body hurts; Itchy; fever; chills; swollen right arm; injection site reactions as Red mark; Burning and Painful area on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills) and INJECTION SITE SWELLING (swollen right arm) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 99-101.9 (High) 99-101.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: body hurts; Itchy; fever; chills; swollen right arm; injection site reactions as Red mark; Burning and Painful area on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills) and INJECTION SITE SWELLING (swollen right arm) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. At the time of the report, PAIN (body hurts), PRURITUS (Itchy), PYREXIA (fever), CHILLS (chills), INJECTION SITE SWELLING (swollen right arm), INJECTION SITE ERYTHEMA (injection site reactions as Red mark) and INJECTION SITE PAIN (Burning and Painful area on the right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 99-101.9 (High) 99-101.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Memory impairment
Clinical narrative: Dizziness; poor memory; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and MEMORY IMPAIRMENT (poor memory) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]) for Hypertension.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Dizziness) and MEMORY IMPAIRMENT (poor memory). At the time of the report, DIZZINESS (Dizziness) had not resolved and MEMORY IMPAIRMENT (poor memory) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. He is scheduled to get the second shot on 05 May 2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Swelling
Clinical narrative: itching at site of injection; 3 and a half by 3 inch red swelling area " at site of injection; (area)swelling; extreme itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at site of injection), INJECTION SITE ERYTHEMA (3 and a half by 3 inch red swelling area " at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INJECTION SITE PRURITUS (itching at site of injection), INJECTION SITE ERYTHEMA (3 and a half by 3 inch red swelling area " at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching). At the time of the report, INJECTION SITE PRURITUS (itching at site of injection), SWELLING ((area)swelling) and PRURITUS (extreme itching) 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: localized itching around vaccination site; inability to lift arm "more than half way up"; swollen arm; red arm; itchy arm; circular rash on arm "the size of a 50 cent piece"; sore  painful tender arm; knot formation post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm) and RASH (circular rash on arm "the size of a 50 cent piece") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), TIZANIDINE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm) and VACCINATION SITE INDURATION (knot formation post vaccination). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (localized itching around vaccination site). At the time of the report, LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm), VACCINATION SITE INDURATION (knot formation post vaccination) and VACCINATION SITE PRURITUS (localized itching around vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site induration, Vaccination site pruritus
Clinical narrative: localized itching around vaccination site; inability to lift arm "more than half way up"; swollen arm; red arm; itchy arm; circular rash on arm "the size of a 50 cent piece"; sore  painful tender arm; knot formation post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm) and RASH (circular rash on arm "the size of a 50 cent piece") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), TIZANIDINE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm) and VACCINATION SITE INDURATION (knot formation post vaccination). On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (localized itching around vaccination site). At the time of the report, LIMB DISCOMFORT (inability to lift arm "more than half way up"), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (red arm), PRURITUS (itchy arm), RASH (circular rash on arm "the size of a 50 cent piece"), MYALGIA (sore  painful tender arm), VACCINATION SITE INDURATION (knot formation post vaccination) and VACCINATION SITE PRURITUS (localized itching around vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Whole body is aching; Arm is swollen; Can't lift arm; Restless; Didn't sleep after 2nd dose; Terrible headache; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless) and SLEEP DEFICIT (Didn't sleep after 2nd dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Sleep deficit
Clinical narrative: Whole body is aching; Arm is swollen; Can't lift arm; Restless; Didn't sleep after 2nd dose; Terrible headache; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless) and SLEEP DEFICIT (Didn't sleep after 2nd dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Whole body is aching), PERIPHERAL SWELLING (Arm is swollen), LIMB DISCOMFORT (Can't lift arm), RESTLESSNESS (Restless), SLEEP DEFICIT (Didn't sleep after 2nd dose), HEADACHE (Terrible headache) and PYREXIA (Feverish) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.