chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain in extremity, Peripheral swelling
Clinical narrative: Terrible pain under the arm at the fatty of the brest; Chills; Swollen; A little bit hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (A little bit hurt), AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1138) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen) and PAIN IN EXTREMITY (A little bit hurt). On 15-Jan-2021, the patient experienced AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills). At the time of the report, PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (A little bit hurt), AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Swollen tongue, Tongue discomfort, Tongue erythema
Clinical narrative: tongue started to swell, it got red, it was burning; tongue started to swell, it got red, it was burning; tongue started to swell, it got red, it was burning; Canker sores; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores). At the time of the report, SWOLLEN TONGUE (tongue started to swell, it got red, it was burning), TONGUE ERYTHEMA (tongue started to swell, it got red, it was burning), TONGUE DISCOMFORT (tongue started to swell, it got red, it was burning) and APHTHOUS ULCER (Canker sores) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient said she had these mixed nuts containing peanuts, walnuts and almonds from Christmas and ate some on Jan14. The patient thought this was weird as she never had a nut allergy and she didn't see this as one of the side effects from the Moderna COVID-19 vaccine. No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021:  On 18-Jun-2021: Reporter contact information updated; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site induration, Vaccination site urticaria
Clinical narrative: hard lump on the injection site; hive on injection site; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard lump on the injection site), VACCINATION SITE URTICARIA (hive on injection site) and INJECTION SITE PAIN (soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard lump on the injection site) and VACCINATION SITE URTICARIA (hive on injection site). At the time of the report, VACCINATION SITE INDURATION (hard lump on the injection site) and VACCINATION SITE URTICARIA (hive on injection site) had not resolved and INJECTION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site warm; injection site hard; injection site itchy; injection site swollen; big red welt; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (injection site warm), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (big red welt) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING), METFORMIN, LISINOPRIL, GLIPIZIDE, SPIRONOLACTONE, DOXYCYCLINE and vitamin c.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warm), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (big red welt). At the time of the report, INJECTION SITE WARMTH (injection site warm), VACCINATION SITE INDURATION (injection site hard) and VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown and VACCINATION SITE SWELLING (injection site swollen) and VACCINATION SITE ERYTHEMA (big red welt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: arm hurts; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), PAIN (body ache) and HEADACHE (headache) 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 13-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 PAIN IN EXTREMITY (arm hurts), PAIN (body ache) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm hurts), PAIN (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: broke out with a large reaction at the injection site; hot; itchy; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) 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 No adverse event (No medical history provided).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (broke out with a large reaction at the injection site), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Very itchy; Fiery red; Pink most of the week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink most of the week), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink most of the week). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink most of the week) outcome was unknown and VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Fiery red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  pain) and PYREXIA (Fever) in a 69-year-old female patient 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 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 PAIN IN EXTREMITY (Arm  pain). On 16-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm  pain) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        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 medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Internal review on 19 Jul 2021 resulted in updating the event verbatim and outcome and pregnancy information (birth type and fetal outcome).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chest pain, Chills, Disturbance in attention
Clinical narrative: some trouble concentrating; pain in my chest; both  arm are sore; slight congestion; anxiety; tired; slight pain at the injection site; temperature and it was up to 100.7; headache; light chills,; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion) and ANXIETY (anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.7 (High) Fahrenheit and 99.1 (High) Fahrenheit at 4:15pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nasal congestion, Pain in extremity
Clinical narrative: some trouble concentrating; pain in my chest; both  arm are sore; slight congestion; anxiety; tired; slight pain at the injection site; temperature and it was up to 100.7; headache; light chills,; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion) and ANXIETY (anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.7 (High) Fahrenheit and 99.1 (High) Fahrenheit at 4:15pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: some trouble concentrating; pain in my chest; both  arm are sore; slight congestion; anxiety; tired; slight pain at the injection site; temperature and it was up to 100.7; headache; light chills,; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion) and ANXIETY (anxiety) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (some trouble concentrating), CHEST PAIN (pain in my chest), PAIN IN EXTREMITY (both  arm are sore), NASAL CONGESTION (slight congestion), ANXIETY (anxiety), FATIGUE (tired), INJECTION SITE PAIN (slight pain at the injection site), PYREXIA (temperature and it was up to 100.7), HEADACHE (headache) and CHILLS (light chills,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.7 (High) Fahrenheit and 99.1 (High) Fahrenheit at 4:15pm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Pharyngeal swelling
Clinical narrative: Swollen throat; Hard to swallow; little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), DYSPHAGIA (Hard to swallow) and FATIGUE (little bit of fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).    On 11-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 PHARYNGEAL SWELLING (Swollen throat), DYSPHAGIA (Hard to swallow) and FATIGUE (little bit of fatigue). At the time of the report, PHARYNGEAL SWELLING (Swollen throat) and DYSPHAGIA (Hard to swallow) outcome was unknown and FATIGUE (little bit of fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 13-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 INJECTION SITE PAIN (soreness at the injection site).   At the time of the report, INJECTION SITE PAIN (soreness at the injection site) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; 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
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: cellulitis where I got my injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE CELLULITIS (cellulitis where I got my 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. Concurrent medical conditions included Cellulitis.    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 VACCINATION SITE CELLULITIS (cellulitis where I got my injection). At the time of the report, VACCINATION SITE CELLULITIS (cellulitis where I got my injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Vaccination site pain
Clinical narrative: Tender axillary lymph node in the right arm; Tiredness; Pain in her right arm where she received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Tender axillary lymph node in the right arm), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine) in a 21-year-old female patient 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine). On 10-Jan-2021, the patient experienced LYMPH NODE PAIN (Tender axillary lymph node in the right arm). On 08-Jan-2021, FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain in her right arm where she received the vaccine) had resolved. At the time of the report, LYMPH NODE PAIN (Tender axillary lymph node in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Lump; Redness; Swelling; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121120) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-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 INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Pain) and VACCINATION SITE RASH (Rash) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain). On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE PAIN (Pain) and VACCINATION SITE RASH (Rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: flashes of light when he closes his eyes/ left eye; This spontaneous case was reported by an other health care professional and describes the occurrence of PHOTOPSIA (flashes of light when he closes his eyes/ left eye) in a male 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 reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PHOTOPSIA (flashes of light when he closes his eyes/ left eye). At the time of the report, PHOTOPSIA (flashes of light when he closes his eyes/ left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Bruise at the injection site about an area of 1.5 to 3 cm; The site was firm; Injection site a little tender; Injection site a little sore; Warm at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy (Had allergies when he was a boy. Fifty years from now.). Concurrent medical conditions included Renal disorder (Mild) and Hypertension. Concomitant products included HISTAMINE, LISINOPRIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 13-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore). On 13-Jan-2021, VACCINATION SITE WARMTH (Warm at the injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site about an area of 1.5 to 3 cm), VACCINATION SITE INDURATION (The site was firm), VACCINATION SITE PAIN (Injection site a little tender) and VACCINATION SITE PAIN (Injection site a little sore) was resolving.        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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness; Itching; Swelling; Tenderness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching), SWELLING (Swelling) and TENDERNESS (Tenderness of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that her reaction spread but not through the whole body and she was very uncomfortable with the allergic reaction. And by the time she got her second shot, it had  almost gone away  Other treatment included warm and cold compress.   This case was linked to MOD-2021-207872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 3-Jun-2021, spreading of adverse events reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: swelling in my arm, area of swelling is a golf ball size; pain (not throbbing pain; it's constant pain); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)) 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 No adverse event (no medical history was reported).    On 08-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 PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)). At the time of the report, PERIPHERAL SWELLING (swelling in my arm, area of swelling is a golf ball size) and PAIN (pain (not throbbing pain; it's constant pain)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt a little bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bad) 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 historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt a little bad). At the time of the report, FEELING ABNORMAL (felt a little bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pruritus, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: could not move her left arm; left side of neck was becoming numb; pain burning; Itching from waist to face; pain; injection site started hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face) and PAIN (pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to codeine) and Cough. Concomitant products included MONTELUKAST, OMEPRAZOLE and IBUPROFEN.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face), PAIN (pain) and VACCINATION SITE PAIN (injection site started hurting really bad). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her left arm), HYPOAESTHESIA (left side of neck was becoming numb), PAIN (pain burning), PRURITUS (Itching from waist to face), PAIN (pain) and VACCINATION SITE PAIN (injection site started hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: location reaction on day 9-10; Itching at the site; Swelling at the site; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PRURITUS (Itching at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE REACTION (location reaction on day 9-10) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-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 INJECTION SITE PRURITUS (Itching at the site) and INJECTION SITE SWELLING (Swelling at the site). On an unknown date, the patient experienced INJECTION SITE REACTION (location reaction on day 9-10). At the time of the report, INJECTION SITE PRURITUS (Itching at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE REACTION (location reaction on day 9-10) 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 treatment was received no concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Hard at injection site; Really Really Itchy; It came back Swollen; It was itchy; It hurt for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was itchy), VACCINATION SITE PAIN (It hurt for a couple of days), VACCINATION SITE SWELLING (It came back Swollen), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE PRURITUS (Really Really Itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event found.).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE PAIN (It hurt for a couple of days). On 16-Jan-2021, the patient experienced VACCINATION SITE SWELLING (It came back Swollen) and VACCINATION SITE PRURITUS (Really Really Itchy). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hard at injection site). At the time of the report, VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE PAIN (It hurt for a couple of days) had resolved, VACCINATION SITE SWELLING (It came back Swollen) and VACCINATION SITE INDURATION (Hard at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Really Really Itchy) had not resolved. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (vomiting) 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 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 NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Tenderness, Urticaria, Vaccination site urticaria
Clinical narrative: Itching on the left side of her neck; Swelling; Hives spread to her shoulder, tricep and chest; Tenderness; About two to three inches below the injection site developed some hives; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives spread to her shoulder, tricep and chest), TENDERNESS (Tenderness), PRURITUS (Itching on the left side of her neck), SWELLING (Swelling) and VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives). On 14-Jan-2021, the patient experienced URTICARIA (Hives spread to her shoulder, tricep and chest) and TENDERNESS (Tenderness). On an unknown date, the patient experienced PRURITUS (Itching on the left side of her neck) and SWELLING (Swelling). At the time of the report, URTICARIA (Hives spread to her shoulder, tricep and chest), TENDERNESS (Tenderness) and VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives) was resolving and PRURITUS (Itching on the left side of her neck) and SWELLING (Swelling) 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site erythema
Clinical narrative: Chills; Fatigue; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 56-year-old female patient 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 provided). Concomitant products included LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ESTRADIOL.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 15-Jan-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Paracetamol.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site warmth; injection site became hard; very itchy; "at the injection site just a little redness, a little swelling and the muscle sore"; very swollen; Muscle soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore") and VACCINATION SITE SWELLING (very swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026I20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore"), VACCINATION SITE SWELLING (very swollen) and MYALGIA (Muscle soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard) and VACCINATION SITE PRURITUS (very itchy). The patient was treated with CORTISONE (topical) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA ("at the injection site just a little redness, a little swelling and the muscle sore"), VACCINATION SITE SWELLING (very swollen) and MYALGIA (Muscle soreness) had not resolved.        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 medication included for high blood pressure medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.