chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiffness; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) and MYALGIA (Achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) and MYALGIA (Achiness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and MYALGIA (Achiness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included warm and cold compress.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Body ache; Headache; Llow grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and PYREXIA (Llow grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication and concomitant medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore Arm; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ATENOLOL, LISINOPRIL, MONTELUKAST SODIUM (SINGULAIR), SIMVASTATIN (ZOCOR), ESTRADIOL and CLOBETASOL for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and CHILLS (Extreme chills) outcome was unknown.            Concomitant medications included water pills.  Treatment details included Tylenol. atenolol, lisinopril, water pill, singulair, Zocor, estres cream, Clobetasol.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Followup received on 10-May-2021. Outcome of event updated.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Anxiety, COVID-19, Cough, Discomfort
Clinical narrative: PANIC DISORDER; Felt lead like body; ANXIETY; FELT BAD; Tired and fatigued; throwing up all day; had a low-grade fever,; Contracted the COVID-19 virus; cough, cold; cold; migraine; Body felt like lead; Massive headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PANIC DISORDER (PANIC DISORDER) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Exposure to COVID-19 (twice).    On 07-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 LIMB DISCOMFORT (Body felt like lead) and HEADACHE (Massive headache). On 16-Jan-2021, the patient experienced COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PYREXIA (had a low-grade fever,). On 17-Jan-2021, the patient experienced VOMITING (throwing up all day). On 18-Jan-2021, the patient experienced FATIGUE (Tired and fatigued). On an unknown date, the patient experienced PANIC DISORDER (PANIC DISORDER), DISCOMFORT (Felt lead like body), ANXIETY (ANXIETY) and FEELING ABNORMAL (FELT BAD). At the time of the report, COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine), DISCOMFORT (Felt lead like body), FEELING ABNORMAL (FELT BAD), LIMB DISCOMFORT (Body felt like lead), PYREXIA (had a low-grade fever,), HEADACHE (Massive headache) and VOMITING (throwing up all day) outcome was unknown and PANIC DISORDER (PANIC DISORDER), ANXIETY (ANXIETY) and FATIGUE (Tired and fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Antibody test: 250 (Inconclusive) Antibodies (results on 07-FEB-2021).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to have her second dose of the vaccine on 04-Feb-2021. She was tested positive for COVID and the nurse advised her to wait for 3 months. She was concerned whether she could take vaccine or not as she has developed antibodies for COVID.  No concomitant product use was reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Limb discomfort, Migraine
Clinical narrative: PANIC DISORDER; Felt lead like body; ANXIETY; FELT BAD; Tired and fatigued; throwing up all day; had a low-grade fever,; Contracted the COVID-19 virus; cough, cold; cold; migraine; Body felt like lead; Massive headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PANIC DISORDER (PANIC DISORDER) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Exposure to COVID-19 (twice).    On 07-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 LIMB DISCOMFORT (Body felt like lead) and HEADACHE (Massive headache). On 16-Jan-2021, the patient experienced COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PYREXIA (had a low-grade fever,). On 17-Jan-2021, the patient experienced VOMITING (throwing up all day). On 18-Jan-2021, the patient experienced FATIGUE (Tired and fatigued). On an unknown date, the patient experienced PANIC DISORDER (PANIC DISORDER), DISCOMFORT (Felt lead like body), ANXIETY (ANXIETY) and FEELING ABNORMAL (FELT BAD). At the time of the report, COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine), DISCOMFORT (Felt lead like body), FEELING ABNORMAL (FELT BAD), LIMB DISCOMFORT (Body felt like lead), PYREXIA (had a low-grade fever,), HEADACHE (Massive headache) and VOMITING (throwing up all day) outcome was unknown and PANIC DISORDER (PANIC DISORDER), ANXIETY (ANXIETY) and FATIGUE (Tired and fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Antibody test: 250 (Inconclusive) Antibodies (results on 07-FEB-2021).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to have her second dose of the vaccine on 04-Feb-2021. She was tested positive for COVID and the nurse advised her to wait for 3 months. She was concerned whether she could take vaccine or not as she has developed antibodies for COVID.  No concomitant product use was reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Panic disorder, Pyrexia, Vomiting
Clinical narrative: PANIC DISORDER; Felt lead like body; ANXIETY; FELT BAD; Tired and fatigued; throwing up all day; had a low-grade fever,; Contracted the COVID-19 virus; cough, cold; cold; migraine; Body felt like lead; Massive headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PANIC DISORDER (PANIC DISORDER) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Exposure to COVID-19 (twice).    On 07-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 LIMB DISCOMFORT (Body felt like lead) and HEADACHE (Massive headache). On 16-Jan-2021, the patient experienced COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine) and PYREXIA (had a low-grade fever,). On 17-Jan-2021, the patient experienced VOMITING (throwing up all day). On 18-Jan-2021, the patient experienced FATIGUE (Tired and fatigued). On an unknown date, the patient experienced PANIC DISORDER (PANIC DISORDER), DISCOMFORT (Felt lead like body), ANXIETY (ANXIETY) and FEELING ABNORMAL (FELT BAD). At the time of the report, COVID-19 (Contracted the COVID-19 virus), COUGH (cough, cold), NASOPHARYNGITIS (cold), MIGRAINE (migraine), DISCOMFORT (Felt lead like body), FEELING ABNORMAL (FELT BAD), LIMB DISCOMFORT (Body felt like lead), PYREXIA (had a low-grade fever,), HEADACHE (Massive headache) and VOMITING (throwing up all day) outcome was unknown and PANIC DISORDER (PANIC DISORDER), ANXIETY (ANXIETY) and FATIGUE (Tired and fatigued) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Antibody test: 250 (Inconclusive) Antibodies (results on 07-FEB-2021).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was scheduled to have her second dose of the vaccine on 04-Feb-2021. She was tested positive for COVID and the nurse advised her to wait for 3 months. She was concerned whether she could take vaccine or not as she has developed antibodies for COVID.  No concomitant product use was reported  No treatment information was provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). On 10-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose of the vaccine 6 weeks apart from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine). On 24-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose of the vaccine 6 weeks apart from the first vaccine) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Pain in leg; Fever; Nights sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nights sweats), PAIN IN EXTREMITY (Pain in leg) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 01L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESOMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 18-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) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced NIGHT SWEATS (Nights sweats) and PYREXIA (Fever). In March 2021, the patient experienced PAIN IN EXTREMITY (Pain in leg). At the time of the report, NIGHT SWEATS (Nights sweats), PAIN IN EXTREMITY (Pain in leg) and PYREXIA (Fever) outcome was unknown.            The action taken with mRNA-1273( Moderna COVID-19 vaccine) was not applicable. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-06-2021 and contains no significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema
Clinical narrative: 5 inch red circle at injection site; Exhaustion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (5 inch red circle at injection site), HEADACHE (Headache) and FATIGUE (Exhaustion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Headache). On 09-Mar-2021, the patient experienced FATIGUE (Exhaustion). On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (5 inch red circle at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (5 inch red circle at injection site), HEADACHE (Headache) and FATIGUE (Exhaustion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up contains No new information
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Headache, Injection site pain, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10A02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches). On 02-Mar-2021, the patient experienced DIZZINESS (Light headedness/dizziness) and HEADACHE (Strange headaches). On 08-Mar-2021, the patient experienced EPISTAXIS (Bloody nose) and RHINORRHOEA (Nose dripping). At the time of the report, DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore), MYALGIA (Body aches) and HEADACHE (Strange headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Anti-anxiety and Anti-depressant medications. The patient used ice packs to treat the sore arm and body aches, and peppermint oil for the headaches and dizziness.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 10A02A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE PAIN (injection arm became sore) and MYALGIA (Body aches). On 02-Mar-2021, the patient experienced DIZZINESS (Light headedness/dizziness) and HEADACHE (Strange headaches). On 08-Mar-2021, the patient experienced EPISTAXIS (Bloody nose) and RHINORRHOEA (Nose dripping). At the time of the report, DIZZINESS (Light headedness/dizziness), EPISTAXIS (Bloody nose), RHINORRHOEA (Nose dripping), INJECTION SITE PAIN (injection arm became sore), MYALGIA (Body aches) and HEADACHE (Strange headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Anti-anxiety and Anti-depressant medications. The patient used ice packs to treat the sore arm and body aches, and peppermint oil for the headaches and dizziness.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AJMALINE (CARDIA), LOSARTAN, ATORVASTATIN, ALENDRONATE SODIUM (ALENDRONATE), CINNAMON [CINNAMOMUM VERUM], VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM 600 WITH VITAMIN D3) and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided          The patient reported that her sore arm was on the left non dominant deltoid where she received the second shot. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching at injection site upper left arm; Rash on from Mid left upper arm to shoulder; Sore left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left upper arm), VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METOPROLOL, ROSUVASTATIN, INSULIN ASPART (NOVOLOG), INSULIN DEGLUDEC (TRESIBA), PARACETAMOL (TYLENOL), METHOCARBAMOL (ROBAXIN), METFORMIN and OMEPRAZOLE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left upper arm). On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder). At the time of the report, PAIN IN EXTREMITY (Sore left upper arm), VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for symptoms: Itching cream application to the area
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Feeling hot, Headache
Clinical narrative: Malaise; Body ache; Left jaw pain; Chills; Low grade fever; Headaches that were on and off for an entire week; Palms of her hands became red right away; Sweating; Feeling hot, like hot flashes from menopause; Generalized itching that night, with no visible rash; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause), PRURITUS (Generalized itching that night, with no visible rash) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash). On 13-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headaches that were on and off for an entire week). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency; OMEPRAZOLE at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) at an unspecified dose and frequency. On 12-Feb-2021, HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash) had resolved. On 13-Feb-2021, MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ERYTHEMA (Palms of her hands became red right away) and HEADACHE (Headaches that were on and off for an entire week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: low (Low) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain, Pain in jaw, Pruritus
Clinical narrative: Malaise; Body ache; Left jaw pain; Chills; Low grade fever; Headaches that were on and off for an entire week; Palms of her hands became red right away; Sweating; Feeling hot, like hot flashes from menopause; Generalized itching that night, with no visible rash; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause), PRURITUS (Generalized itching that night, with no visible rash) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash). On 13-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headaches that were on and off for an entire week). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency; OMEPRAZOLE at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) at an unspecified dose and frequency. On 12-Feb-2021, HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash) had resolved. On 13-Feb-2021, MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ERYTHEMA (Palms of her hands became red right away) and HEADACHE (Headaches that were on and off for an entire week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: low (Low) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Malaise; Body ache; Left jaw pain; Chills; Low grade fever; Headaches that were on and off for an entire week; Palms of her hands became red right away; Sweating; Feeling hot, like hot flashes from menopause; Generalized itching that night, with no visible rash; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause), PRURITUS (Generalized itching that night, with no visible rash) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Palms of her hands became red right away), HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash). On 13-Feb-2021, the patient experienced MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headaches that were on and off for an entire week). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency; OMEPRAZOLE at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) at an unspecified dose and frequency. On 12-Feb-2021, HYPERHIDROSIS (Sweating), FEELING HOT (Feeling hot, like hot flashes from menopause) and PRURITUS (Generalized itching that night, with no visible rash) had resolved. On 13-Feb-2021, MALAISE (Malaise), PAIN (Body ache), PAIN IN JAW (Left jaw pain), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ERYTHEMA (Palms of her hands became red right away) and HEADACHE (Headaches that were on and off for an entire week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: low (Low) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations for 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations for 4 hours) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced PALPITATIONS (Palpitations for 4 hours). On 16-Jan-2021, PALPITATIONS (Palpitations for 4 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-040876 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnambulism
Clinical narrative: On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs; Patient had a sleep walking episode on the night of receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose). At the time of the report, PARAESTHESIA (On evening of receiving 1st dose, patient started experiencing extreme tingling in left arm/ tingling in both legs) and SOMNAMBULISM (Patient had a sleep walking episode on the night of receiving 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient reported that she had tingling in left arm and both legs. It was very extreme as if someone was stabbing. She had sleep walking episode on Monday night. It was very unusual since this was the first time this had happened to her. Treatment information included warm bath.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Musculoskeletal pain, Nausea
Clinical narrative: Pain in most of the leg and part of the glute; Pain in most of the leg and part of the glute; Numbness in the left thigh/couldn't feel left thigh; Felt like nerve type of pain; Upset stomach; Minor headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh), NEURALGIA (Felt like nerve type of pain) and ABDOMINAL DISCOMFORT (Upset stomach) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) and NEURALGIA (Felt like nerve type of pain). The patient was treated with PARACETAMOL (TYLENOL) on 26-Feb-2021 for Headache, at an unspecified dose and frequency. On 26-Feb-2021, ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea) had resolved. On 11-Mar-2021, HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in most of the leg and part of the glute) was resolving and MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute) and NEURALGIA (Felt like nerve type of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient reported that he went to get evaluated with chiropractor. They couldn't figure out what was wrong.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Pain in most of the leg and part of the glute; Pain in most of the leg and part of the glute; Numbness in the left thigh/couldn't feel left thigh; Felt like nerve type of pain; Upset stomach; Minor headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh), NEURALGIA (Felt like nerve type of pain) and ABDOMINAL DISCOMFORT (Upset stomach) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in most of the leg and part of the glute), MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute), HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) and NEURALGIA (Felt like nerve type of pain). The patient was treated with PARACETAMOL (TYLENOL) on 26-Feb-2021 for Headache, at an unspecified dose and frequency. On 26-Feb-2021, ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Minor headache) and NAUSEA (Nausea) had resolved. On 11-Mar-2021, HYPOAESTHESIA (Numbness in the left thigh/couldn't feel left thigh) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in most of the leg and part of the glute) was resolving and MUSCULOSKELETAL PAIN (Pain in most of the leg and part of the glute) and NEURALGIA (Felt like nerve type of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient reported that he went to get evaluated with chiropractor. They couldn't figure out what was wrong.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: chest pains; tightness in the chest and upper back; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) and CHEST DISCOMFORT (tightness in the chest and upper back) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LITHIUM, FLUOXETINE, LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE and NORTRIPTYLINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CHEST PAIN (chest pains) and CHEST DISCOMFORT (tightness in the chest and upper back). At the time of the report, CHEST PAIN (chest pains) and CHEST DISCOMFORT (tightness in the chest and upper back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction NOS. Concomitant products included PARACETAMOL (TYLENOL) for Toothache, APIXABAN (ELIQUIS) and CARVEDILOL (COREG) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: Feeling Sick; Nausea; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concomitant products included DILTIAZEM, ACETYLSALICYLIC ACID (BABY ASPIRIN), FUROSEMIDE, METOPROLOL, CLOPIDOGREL, POTASSIUM, VITAMIN D3 and OMEPRAZOLE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling). On 11-Mar-2021, MALAISE (Feeling Sick), NAUSEA (Nausea) and FATIGUE (Tired feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment taken.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lipohypertrophy, Rash macular, Vaccination site erythema
Clinical narrative: Pink blotch spreading on her arm; Lump around injection site; Red blotch around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Pink blotch spreading on her arm), LIPOHYPERTROPHY (Lump around injection site) and VACCINATION SITE ERYTHEMA (Red blotch around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 080A21A) 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) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced LIPOHYPERTROPHY (Lump around injection site) and VACCINATION SITE ERYTHEMA (Red blotch around injection site). On 11-Mar-2021, the patient experienced RASH MACULAR (Pink blotch spreading on her arm). On 11-Mar-2021, LIPOHYPERTROPHY (Lump around injection site) had resolved. At the time of the report, RASH MACULAR (Pink blotch spreading on her arm) and VACCINATION SITE ERYTHEMA (Red blotch around injection site) outcome was unknown.            Treatment included Tylenol on 10-Mar-2021. concomitant medications not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant after 1st dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant after 1st dose). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant after 1st dose) had resolved. 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 relevant concomitant medications were reported. No treatment information was provided. Patient would like to be on the pregnancy registry.   This case was linked to MOD-2021-040962 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Reaction has spread out; Reaction at the injection site that is hard; Reaction at the injection site that is itchy/Scratching at the injection site; Reaction at the injection site that is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Symptomatic treatment, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency and URTICA DIOICA ROOT (STINGING NETTLE ROOT) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: dead arm; stomach upset; sore in her left arm; nauseous; headache; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (dead arm), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (sore in her left arm), NAUSEA (nauseous) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (dead arm), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (sore in her left arm), NAUSEA (nauseous) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA (dead arm), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (sore in her left arm), NAUSEA (nauseous) and HEADACHE (headache) 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 relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-Jun-2021, included no new information.