chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Upset stomach; Very weak; Headache; Fever; Chills; Nausea; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in an 83-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.     Concurrent medical conditions included COPD and Blood pressure high.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued) had resolved.        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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Upset stomach; Very weak; Headache; Fever; Chills; Nausea; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in an 83-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.     Concurrent medical conditions included COPD and Blood pressure high.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), ASTHENIA (Very weak), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness, Pyrexia, Weight decreased
Clinical narrative: flue like symptoms; he got very severe diarrhea for 6 to 7 days; lost 12 pounds of weight.; fever; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Laparoscopy (laparoscopy for bowel obstruction.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flue like symptoms), DIARRHOEA (he got very severe diarrhea for 6 to 7 days), WEIGHT DECREASED (lost 12 pounds of weight.) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Odynophagia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: sniffles; post-nasal drip; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles), NASAL DISCOMFORT (post-nasal drip), NAUSEA (nausea) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (sniffles), NASAL DISCOMFORT (post-nasal drip), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of unk dosage form. At the time of the report, RHINORRHOEA (sniffles), NASAL DISCOMFORT (post-nasal drip), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up was received on 05 may 2021 included no new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: not in pain unless he pinch it or push; arm on the injection site is a little bit sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (not in pain unless he pinch it or push) and INJECTION SITE PAIN (arm on the injection site is a little bit sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (not in pain unless he pinch it or push) and INJECTION SITE PAIN (arm on the injection site is a little bit sore). At the time of the report, PAIN (not in pain unless he pinch it or push) and INJECTION SITE PAIN (arm on the injection site is a little bit sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Back pain, Diarrhoea, Headache, Nausea
Clinical narrative: Severe backpain; bad reaction; Diarrhea; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe backpain), ADVERSE REACTION (bad reaction), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) 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 (no medical history reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Severe backpain), ADVERSE REACTION (bad reaction), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, BACK PAIN (Severe backpain), ADVERSE REACTION (bad reaction), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness and itchiness at injection site; Soreness at injection site; Redness and itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site). At the time of the report, PRURITUS (Redness and itchiness at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness and itchiness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. After about 2-3 days, the patient experienced soreness, itchiness and redness that was 2-3 inches in diameter and was getting bigger.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives all over her body; overwhelmingly itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over her body) and PRURITUS (overwhelmingly itchy) 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.   Patient use prescription cream as treatment as well.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dysphonia, Fatigue, Nausea
Clinical narrative: heat rash, tiny ones, on her stomach; 5 big hives on her chest; still feeling dizzy; extremely tired; left arm is still swelling around the injection site; upset stomach; voice is all scratchy; itchy on the same arm of the injection site, also inside of her elbow; big hives on the same arm of the injection site, also inside her elbow; arm is itchy; nauseous, but nothing severe; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach) and URTICARIA (5 big hives on her chest) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced NAUSEA (nauseous, but nothing severe). On 08-Feb-2021, the patient experienced PRURITUS (arm is itchy). On 09-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow). On an unknown date, the patient experienced RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach) and DYSPHONIA (voice is all scratchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach), DYSPHONIA (voice is all scratchy) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: heat rash, tiny ones, on her stomach; 5 big hives on her chest; still feeling dizzy; extremely tired; left arm is still swelling around the injection site; upset stomach; voice is all scratchy; itchy on the same arm of the injection site, also inside of her elbow; big hives on the same arm of the injection site, also inside her elbow; arm is itchy; nauseous, but nothing severe; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach) and URTICARIA (5 big hives on her chest) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced NAUSEA (nauseous, but nothing severe). On 08-Feb-2021, the patient experienced PRURITUS (arm is itchy). On 09-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow). On an unknown date, the patient experienced RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach) and DYSPHONIA (voice is all scratchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous, but nothing severe), PRURITUS (arm is itchy), VACCINATION SITE URTICARIA (big hives on the same arm of the injection site, also inside her elbow), RASH (heat rash, tiny ones, on her stomach), URTICARIA (5 big hives on her chest), DIZZINESS (still feeling dizzy), FATIGUE (extremely tired), VACCINATION SITE SWELLING (left arm is still swelling around the injection site), ABDOMINAL DISCOMFORT (upset stomach), DYSPHONIA (voice is all scratchy) and PRURITUS (itchy on the same arm of the injection site, also inside of her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: aches in the lumbar area and legs; aches in the lumbar area and legs; she felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aches in the lumbar area and legs), PAIN IN EXTREMITY (aches in the lumbar area and legs) and FATIGUE (she felt extremely tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced BACK PAIN (aches in the lumbar area and legs), PAIN IN EXTREMITY (aches in the lumbar area and legs) and FATIGUE (she felt extremely tired). On 11-Feb-2021, BACK PAIN (aches in the lumbar area and legs) and PAIN IN EXTREMITY (aches in the lumbar area and legs) had resolved. At the time of the report, FATIGUE (she felt extremely tired) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Headache, Hyperhidrosis, Limb discomfort
Clinical narrative: Couldn't lift arm about the shoulder; Arm felt warm; Thought she would pass out; Dizzy; Couldn't eat anything; Sweating like she was going to pass out; Barfing; Arm hurt a little bit; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy) and DECREASED APPETITE (Couldn't eat anything) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy), DECREASED APPETITE (Couldn't eat anything), HYPERHIDROSIS (Sweating like she was going to pass out), VOMITING (Barfing), VACCINATION SITE PAIN (Arm hurt a little bit) and HEADACHE (Headache). At the time of the report, LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy), DECREASED APPETITE (Couldn't eat anything), HYPERHIDROSIS (Sweating like she was going to pass out), VOMITING (Barfing), VACCINATION SITE PAIN (Arm hurt a little bit) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vaccination site pain, Vaccination site warmth, Vomiting
Clinical narrative: Couldn't lift arm about the shoulder; Arm felt warm; Thought she would pass out; Dizzy; Couldn't eat anything; Sweating like she was going to pass out; Barfing; Arm hurt a little bit; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy) and DECREASED APPETITE (Couldn't eat anything) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy), DECREASED APPETITE (Couldn't eat anything), HYPERHIDROSIS (Sweating like she was going to pass out), VOMITING (Barfing), VACCINATION SITE PAIN (Arm hurt a little bit) and HEADACHE (Headache). At the time of the report, LIMB DISCOMFORT (Couldn't lift arm about the shoulder), VACCINATION SITE WARMTH (Arm felt warm), PRESYNCOPE (Thought she would pass out), DIZZINESS (Dizzy), DECREASED APPETITE (Couldn't eat anything), HYPERHIDROSIS (Sweating like she was going to pass out), VOMITING (Barfing), VACCINATION SITE PAIN (Arm hurt a little bit) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock, Headache, Lip swelling, Lymphadenopathy
Clinical narrative: electric shocks from the waist up and also down both his arm; Lips were swollen a little bit; lymph node was swollen on left side neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK (electric shocks from the waist up and also down both his arm), LIP SWELLING (Lips were swollen a little bit), LYMPHADENOPATHY (lymph node was swollen on left side neck) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. In January 2021, the patient experienced ELECTRIC SHOCK (electric shocks from the waist up and also down both his arm), LIP SWELLING (Lips were swollen a little bit), LYMPHADENOPATHY (lymph node was swollen on left side neck) and HEADACHE (headache). At the time of the report, ELECTRIC SHOCK (electric shocks from the waist up and also down both his arm) and LIP SWELLING (Lips were swollen a little bit) had resolved and LYMPHADENOPATHY (lymph node was swollen on left side neck) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up received on 24-04-2021:Additional information in TCR- Outcome for lymph node was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: arm soreness; arm swollen; red rash down half his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm). At the time of the report, PAIN IN EXTREMITY (arm soreness), PERIPHERAL SWELLING (arm swollen) and RASH (red rash down half his arm) outcome was unknown. Not Provided          concomitant medication include blood thinner, antihypertensive and anticholesterol . no treatment medication reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100.5-101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5-101.5) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever 100.5-101.5). At the time of the report, PYREXIA (Fever 100.5-101.5) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: high (High) 100.5-101.5.       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.; 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Back discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Back discomfort) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and PROGESTERONE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Back discomfort). The patient was treated with PARACETAMOL (TYLENOL) for Back discomfort, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Back discomfort) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she took half of Tylenol for a few days for her discomfort back,
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Prostatic specific antigen: 299.99 (High) Prostate Specific Antigen (PSA) was very high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 08-Feb-2021, the patient received their second dose of the Moderna vaccine. Few days later the patient reported that their prostate specific antigen (PSA) was done and it was very high. On 15-Feb-2021, the patient reported that PSA result from 12-Feb-2021 was 229.99 and the normal range was less than 4 as per the physician. No Concomitant product use was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Follow-up was received on 16-Feb-2021. Added and updated the PSA value in lab data.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Pain in Legs; Pain in Arms; Soreness; Headache; Fatigue; Lightheadedness; Pain in Neck; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms) and MYALGIA (Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CANDESARTAN, METOPROLOL, FAMOTIDINE (PEPCID AC), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in Legs). At the time of the report, DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in Legs; Pain in Arms; Soreness; Headache; Fatigue; Lightheadedness; Pain in Neck; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms) and MYALGIA (Soreness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CANDESARTAN, METOPROLOL, FAMOTIDINE (PEPCID AC), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in Legs). At the time of the report, DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dizziness, Dry mouth, Dyspnoea, Muscular weakness
Clinical narrative: bad reaction; injection arm felt weak/legs were wobbly; dizzy; dry mouth; trouble breathing; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026Z20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included METFORMIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication include vitamins, medication for blood pressure and cholesterol She mentioned that she's not planning to take the second dose of the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: bad reaction; injection arm felt weak/legs were wobbly; dizzy; dry mouth; trouble breathing; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth) and DYSPNOEA (trouble breathing) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026Z20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included METFORMIN for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, ADVERSE REACTION (bad reaction), MUSCULAR WEAKNESS (injection arm felt weak/legs were wobbly), DIZZINESS (dizzy), DRY MOUTH (dry mouth), DYSPNOEA (trouble breathing) and NAUSEA (felt nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication include vitamins, medication for blood pressure and cholesterol She mentioned that she's not planning to take the second dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the same arm of the injection) 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 (No medical history reported. ).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the same arm of the injection). At the time of the report, VACCINATION SITE PAIN (Pain in the same arm of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Symptom recurrence
Clinical narrative: Feels better for a few days then it comes back; Really tired; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Feels better for a few days then it comes back), FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 11-Feb-2021, the patient experienced SYMPTOM RECURRENCE (Feels better for a few days then it comes back). At the time of the report, SYMPTOM RECURRENCE (Feels better for a few days then it comes back), FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were rescue inhaler for asthma.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Malaise, Pain in extremity
Clinical narrative: red arm; Dizziness; No energy all day; arm hard as a rock; itchy arm; Could barely get out of bed; Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day) and VACCINATION SITE INDURATION (arm hard as a rock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Could barely get out of bed). On 13-Feb-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock) and VACCINATION SITE PRURITUS (itchy arm). On 15-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Feb-2021 at a dose of UNK, q4h. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock), VACCINATION SITE PRURITUS (itchy arm), FATIGUE (Could barely get out of bed) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 98.7 (High) Body temperature increased. On 13-Feb-2021, Body temperature: 98.3 (Inconclusive) 98.3. On 14-Feb-2021, Body temperature: 97.3 (Inconclusive) 97.3.         No concomitant medication were provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received included no new significant information - contact information added
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: red arm; Dizziness; No energy all day; arm hard as a rock; itchy arm; Could barely get out of bed; Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day) and VACCINATION SITE INDURATION (arm hard as a rock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Could barely get out of bed). On 13-Feb-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock) and VACCINATION SITE PRURITUS (itchy arm). On 15-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Feb-2021 at a dose of UNK, q4h. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock), VACCINATION SITE PRURITUS (itchy arm), FATIGUE (Could barely get out of bed) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 98.7 (High) Body temperature increased. On 13-Feb-2021, Body temperature: 98.3 (Inconclusive) 98.3. On 14-Feb-2021, Body temperature: 97.3 (Inconclusive) 97.3.         No concomitant medication were provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received included no new significant information - contact information added
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: vomiting; had a headache (ongoing); arm hurt; He also had fever; chills; A spontaneous report was received from a consumer concerning a 59 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, vomiting, had a headache(headache), arm hurt(pain in extremity). fever(pyrexia) and chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On , 14 Feb 2021, approximately 1 day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: ) (route unknown) for prophylaxis of COVID-19 infection.  On 14 Feb 2021, patient experienced vomiting, had a headache, arm hurt, fever and chills  .No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, had headache is not recovered/resolved andnn  the outcome of the events,  vomiting, arm hurt, fever and chills is unknown
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Swelling, Vaccination site pain
Clinical narrative: Redness raised tender; Swelling; headache intermittent; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness raised tender), SWELLING (Swelling), HEADACHE (headache intermittent) and VACCINATION SITE PAIN (Pain at injection site) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ERYTHEMA (Redness raised tender), SWELLING (Swelling), HEADACHE (headache intermittent) and VACCINATION SITE PAIN (Pain at injection site). On 27-Jan-2021, ERYTHEMA (Redness raised tender), SWELLING (Swelling) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, HEADACHE (headache intermittent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided