chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity, Skin reaction
Clinical narrative: Arm sore; Delayed injection site reaction; Injection site itchy; Injection site red; This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (Delayed injection site reaction), PAIN IN EXTREMITY (Arm sore), INJECTION SITE PRURITUS (Injection site itchy) and INJECTION SITE ERYTHEMA (Injection site red) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20-A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site itchy) and INJECTION SITE ERYTHEMA (Injection site red). On 07-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction). On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). At the time of the report, SKIN REACTION (Delayed injection site reaction), PAIN IN EXTREMITY (Arm sore), INJECTION SITE PRURITUS (Injection site itchy) and INJECTION SITE ERYTHEMA (Injection site red) 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.   At 04:00 PM on 28 Dec 2020, patient received COVID vaccine and arm was sore for 1 to 2 days. 9 Hours later in evening patient had injection site itch and red (around 7-8 cm diameter). No swelling noted. Area was not warm to touch. Patient was instructed to monitor temperature, check for any axillary lymph node swelling. Patient can use cool pack to area and take Tylenol/Ibuprofen as directed as needed. Also, to check temperature prior to taking Tylenol.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Delayed injection site reaction; Arm swollen,red, hot and itchy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy). At the time of the report, SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: Delayed injection site reaction; Arm swollen,red, hot and itchy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy). At the time of the report, SKIN REACTION (Delayed injection site reaction) and PERIPHERAL SWELLING (Arm swollen,red, hot and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Flushing, Throat tightness
Clinical narrative: felt flush; throat tightness; eyes were swollen; Spontaneous case report sent by other Health Professional on 19-JAN-2021, which refers to a Female aged 42 Years. Patient experienced the adverse events including felt flush (LLT: flushed),throat tightness and swollen eyes. Patient received Moderna COVID-19 Vaccine for COVID-19 vaccination on 11-01-2021 at 3pm, intramuscularly (batch number not provided). Patient experienced the events on 13/01/2021 and the treatment for the event was provided. After vaccination patient experienced the events but was resolved quickly. After 30 minutes patient experienced the same events so Benadryl 25mgPO was provided and was observed for 30 minutes. Later eyes were swollen, again Benadryl 25mg PO was provided and paramedics were informed. The action taken and the outcome was not reported.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to preexisting disease); there is no possible mechanism to implicate the drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Dyspepsia, Fatigue
Clinical narrative: Nausea; Lightheaded; Woozy; Dizzy; Hot feeling in abdomnen and Skin; skin was burning on my thighs; Itchy on abdomen and back; It was going in waves; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy) and BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.    On 14-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 NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves). At the time of the report, NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves) 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.   Concomitant product use was not provided by the reporter.  On 14-JAN-2021 the patient has taken diphenhydramine HCl(Benadryl) and famotidine(pepcid ) as a treatment in response to the event with mRNA-1273.; 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, COVID19
Symptoms: Feeling hot, Hunger, Immediate post-injection reaction, Nausea, Nervousness
Clinical narrative: Nausea; Lightheaded; Woozy; Dizzy; Hot feeling in abdomnen and Skin; skin was burning on my thighs; Itchy on abdomen and back; It was going in waves; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy) and BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.    On 14-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 NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves). At the time of the report, NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves) 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.   Concomitant product use was not provided by the reporter.  On 14-JAN-2021 the patient has taken diphenhydramine HCl(Benadryl) and famotidine(pepcid ) as a treatment in response to the event with mRNA-1273.; 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, COVID19
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: Nausea; Lightheaded; Woozy; Dizzy; Hot feeling in abdomnen and Skin; skin was burning on my thighs; Itchy on abdomen and back; It was going in waves; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy) and BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.    On 14-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 NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves). At the time of the report, NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves) 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.   Concomitant product use was not provided by the reporter.  On 14-JAN-2021 the patient has taken diphenhydramine HCl(Benadryl) and famotidine(pepcid ) as a treatment in response to the event with mRNA-1273.; 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, COVID19
Symptoms: Body temperature increased, Dizziness, Ill-defined disorder, Nausea, Pruritus
Clinical narrative: Nausea; Lightheaded; Woozy; Dizzy; Hot feeling in abdomnen and Skin; skin was burning on my thighs; Itchy on abdomen and back; It was going in waves; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy) and BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.    On 14-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 NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves). At the time of the report, NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves) 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.   Concomitant product use was not provided by the reporter.  On 14-JAN-2021 the patient has taken diphenhydramine HCl(Benadryl) and famotidine(pepcid ) as a treatment in response to the event with mRNA-1273.; 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, COVID19
Symptoms: Skin burning sensation
Clinical narrative: Nausea; Lightheaded; Woozy; Dizzy; Hot feeling in abdomnen and Skin; skin was burning on my thighs; Itchy on abdomen and back; It was going in waves; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy) and BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.    On 14-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 NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves). At the time of the report, NAUSEA (Nausea), DIZZINESS (Lightheaded), DIZZINESS (Woozy), DIZZINESS (Dizzy), BODY TEMPERATURE INCREASED (Hot feeling in abdomnen and Skin), SKIN BURNING SENSATION (skin was burning on my thighs), PRURITUS (Itchy on abdomen and back) and ILL-DEFINED DISORDER (It was going in waves) 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.   Concomitant product use was not provided by the reporter.  On 14-JAN-2021 the patient has taken diphenhydramine HCl(Benadryl) and famotidine(pepcid ) as a treatment in response to the event with mRNA-1273.; 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, COVID19
Symptoms: Induration, Lymph node pain, Oedema peripheral
Clinical narrative: Lymph node enlargement in left Axilla (Armpit); Pain Injection Site; Swelling Injection Site; A spontaneous report was received  from a other health care professional  concerning a 39-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 5 days later, on 01JAN2021 started with Lymph node enlargement in left Axilla (Armpit), pain, and swelling in the injection site. symptoms lasted about 4 days , the lymph node is better (not as enlarged) but still going on.  As provided by the reporter the patient does not have medical history.  On 27 DEC 2020 at 9 am, the patient received their first of first planned doses of mRNA-1273 (Lot number: 026L20A) deltoid muscle of the left Arm for prophylaxis of COVID-19 infection.   On  27 DEC 2020,  After  receiving mRNA-1273, the patient Experienced On 14Jan2021 experienced 5 days later, on 01JAN2021 started with Lymph node enlargement in left Axilla (Armpit), pain, and swelling in the injection site. symptoms lasted about 4 days , the lymph node is better (not as enlarged) but still going on.  Action taken with mRNA-1273 in response to the events was not 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Lymph node enlargement in left Axilla (Armpit); Pain Injection Site; Swelling Injection Site; A spontaneous report was received  from a other health care professional  concerning a 39-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 5 days later, on 01JAN2021 started with Lymph node enlargement in left Axilla (Armpit), pain, and swelling in the injection site. symptoms lasted about 4 days , the lymph node is better (not as enlarged) but still going on.  As provided by the reporter the patient does not have medical history.  On 27 DEC 2020 at 9 am, the patient received their first of first planned doses of mRNA-1273 (Lot number: 026L20A) deltoid muscle of the left Arm for prophylaxis of COVID-19 infection.   On  27 DEC 2020,  After  receiving mRNA-1273, the patient Experienced On 14Jan2021 experienced 5 days later, on 01JAN2021 started with Lymph node enlargement in left Axilla (Armpit), pain, and swelling in the injection site. symptoms lasted about 4 days , the lymph node is better (not as enlarged) but still going on.  Action taken with mRNA-1273 in response to the events was not 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 event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: same rash developing on her forearms; itchy; red raised bumps; 2 inch circle red rash on her left lateral thigh; A spontaneous report was received from a consumer concerning a 46 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  Rash, Pruritus, Rash aggravated and Rash over arms. The patient's medical history was not  as provided by the reporter.  No concomitant medications was reported.   On 04-JAN-2021 the patient received their first of two planned doses of mRNA-1273 ( lot number : 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06-JAN-2021 Patient experienced  a 2 inch circle, red rash on her left lateral thigh it was itchy and irritated and had red raised bumps and patient's  whole body was itchy.  On 19-Jan-2021, patient experienced  the same rash developing on both forearms. The patient went to the hospital. On 20-Jan-2021 patient experienced rash on both forearms and her left thigh. No Laboratory details was provided. No treatment information  provided include  cortisone cream and Benadryl on 06-Jan-2021 and patient  had a steroid shot, oral steroid pack, and pharmacy grade cream.  Action taken with mRNA-1273 in response to the events was not reported. At  the  time of this report outcome of the events , Rash, Pruritus, Rash aggravated and Rash over arms was not resolved.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: same rash developing on her forearms; itchy; red raised bumps; 2 inch circle red rash on her left lateral thigh; A spontaneous report was received from a consumer concerning a 46 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  Rash, Pruritus, Rash aggravated and Rash over arms. The patient's medical history was not  as provided by the reporter.  No concomitant medications was reported.   On 04-JAN-2021 the patient received their first of two planned doses of mRNA-1273 ( lot number : 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06-JAN-2021 Patient experienced  a 2 inch circle, red rash on her left lateral thigh it was itchy and irritated and had red raised bumps and patient's  whole body was itchy.  On 19-Jan-2021, patient experienced  the same rash developing on both forearms. The patient went to the hospital. On 20-Jan-2021 patient experienced rash on both forearms and her left thigh. No Laboratory details was provided. No treatment information  provided include  cortisone cream and Benadryl on 06-Jan-2021 and patient  had a steroid shot, oral steroid pack, and pharmacy grade cream.  Action taken with mRNA-1273 in response to the events was not reported. At  the  time of this report outcome of the events , Rash, Pruritus, Rash aggravated and Rash over arms was not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eschar, Injection site pain, Limb discomfort, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: 3 papules on chest; Scabe on shoulder; Itchy Rash on Right Shoulder and Chest; Extreme itching on Right shoulder and chest; Experienced soreness, achiness and periodic sharp pain in Right Foot; Soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest) and SCAB (Scabe on shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN (Soreness). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot). On 18-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (Extreme itching on Right shoulder and chest). On 18-Jan-2021 at 8:00 PM, the patient experienced RASH PRURITIC (Itchy Rash on Right Shoulder and Chest). 18-Jan-2021 at 8:00 PM, the patient experienced SCAB (Scabe on shoulder) and PAPULE (3 papules on chest). At the time of the report, PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest), SCAB (Scabe on shoulder) and PAPULE (3 papules on chest) 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.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash papular, Rash pruritic
Clinical narrative: 3 papules on chest; Scabe on shoulder; Itchy Rash on Right Shoulder and Chest; Extreme itching on Right shoulder and chest; Experienced soreness, achiness and periodic sharp pain in Right Foot; Soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest) and SCAB (Scabe on shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN (Soreness). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot). On 18-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (Extreme itching on Right shoulder and chest). On 18-Jan-2021 at 8:00 PM, the patient experienced RASH PRURITIC (Itchy Rash on Right Shoulder and Chest). 18-Jan-2021 at 8:00 PM, the patient experienced SCAB (Scabe on shoulder) and PAPULE (3 papules on chest). At the time of the report, PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest), SCAB (Scabe on shoulder) and PAPULE (3 papules on chest) 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.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Papule, Pruritus, Rash pruritic
Clinical narrative: 3 papules on chest; Scabe on shoulder; Itchy Rash on Right Shoulder and Chest; Extreme itching on Right shoulder and chest; Experienced soreness, achiness and periodic sharp pain in Right Foot; Soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest) and SCAB (Scabe on shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN (Soreness). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot). On 18-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (Extreme itching on Right shoulder and chest). On 18-Jan-2021 at 8:00 PM, the patient experienced RASH PRURITIC (Itchy Rash on Right Shoulder and Chest). 18-Jan-2021 at 8:00 PM, the patient experienced SCAB (Scabe on shoulder) and PAPULE (3 papules on chest). At the time of the report, PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest), SCAB (Scabe on shoulder) and PAPULE (3 papules on chest) 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.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scab
Clinical narrative: 3 papules on chest; Scabe on shoulder; Itchy Rash on Right Shoulder and Chest; Extreme itching on Right shoulder and chest; Experienced soreness, achiness and periodic sharp pain in Right Foot; Soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest) and SCAB (Scabe on shoulder) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN (Soreness). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot). On 18-Jan-2021 at 2:00 PM, the patient experienced PRURITUS (Extreme itching on Right shoulder and chest). On 18-Jan-2021 at 8:00 PM, the patient experienced RASH PRURITIC (Itchy Rash on Right Shoulder and Chest). 18-Jan-2021 at 8:00 PM, the patient experienced SCAB (Scabe on shoulder) and PAPULE (3 papules on chest). At the time of the report, PAIN (Soreness), PAIN IN EXTREMITY (Experienced soreness, achiness and periodic sharp pain in Right Foot), PRURITUS (Extreme itching on Right shoulder and chest), RASH PRURITIC (Itchy Rash on Right Shoulder and Chest), SCAB (Scabe on shoulder) and PAPULE (3 papules on chest) 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.   No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; itching at injection site; swelling at the injection site; axillary pain; swollen lymph nodes; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 42year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273).  The patient  experienced axillary pain and swollen lymph nodes,redness, itching, and swelling at the injection site.  .  The patient's medical history was not provided. Concomitant  medication include multivitamins,calcium, vitamin D.  The patient received suspect product  mRNA-1273 on 14-Jan-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:026L20A)intramuscularly on the right hand for prophylaxis of COVID-19 infection on 21JAN2021, she developed axillary pain and swollen lymph nodes. 9 days post vaccination, on 23-JAN-2021, she started developing redness, itching, and swelling at the injection site. It is now day 3 since the delayed onset reactions started and it's getting better Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: redness at injection site; itching at injection site; swelling at the injection site; axillary pain; swollen lymph nodes; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 42year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273).  The patient  experienced axillary pain and swollen lymph nodes,redness, itching, and swelling at the injection site.  .  The patient's medical history was not provided. Concomitant  medication include multivitamins,calcium, vitamin D.  The patient received suspect product  mRNA-1273 on 14-Jan-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:026L20A)intramuscularly on the right hand for prophylaxis of COVID-19 infection on 21JAN2021, she developed axillary pain and swollen lymph nodes. 9 days post vaccination, on 23-JAN-2021, she started developing redness, itching, and swelling at the injection site. It is now day 3 since the delayed onset reactions started and it's getting better Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness at injection site; itching at injection site; swelling at the injection site; axillary pain; swollen lymph nodes; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 42year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273).  The patient  experienced axillary pain and swollen lymph nodes,redness, itching, and swelling at the injection site.  .  The patient's medical history was not provided. Concomitant  medication include multivitamins,calcium, vitamin D.  The patient received suspect product  mRNA-1273 on 14-Jan-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:026L20A)intramuscularly on the right hand for prophylaxis of COVID-19 infection on 21JAN2021, she developed axillary pain and swollen lymph nodes. 9 days post vaccination, on 23-JAN-2021, she started developing redness, itching, and swelling at the injection site. It is now day 3 since the delayed onset reactions started and it's getting better Action taken with the second dose of mRNA-1273  in response to the event was not reported
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Ear pruritus, Headache, Hypersensitivity
Clinical narrative: Ear itching; difficulty breathing; rush around her neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear itching), DYSPNOEA (difficulty breathing), RASH (rush around her neck) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Difficulty breathing on 27-Jan-2021 and Itching on 27-Jan-2021. Concurrent medical conditions included Headache since 27-Jan-2021. Concomitant products included THYROID THERAPY for Thyroid therapy.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced EAR DISCOMFORT (Ear itching), RASH (rush around her neck) and HEADACHE (Headache). 27-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 27-Jan-2021 for Difficulty breathing, at an unspecified dose and frequency; EPINEPHRINE 27-Jan-2021 at an unspecified dose and frequency and PREDNISONE ongoing from 27-Jan-2021 at an unspecified dose and frequency.   At the time of the report, EAR DISCOMFORT (Ear itching) and HEADACHE (Headache) had not resolved and DYSPNOEA (difficulty breathing) and RASH (rush around her neck) 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.   Patient has been prescribed with allergy medications.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Ear itching; difficulty breathing; rush around her neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear itching), DYSPNOEA (difficulty breathing), RASH (rush around her neck) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Difficulty breathing on 27-Jan-2021 and Itching on 27-Jan-2021. Concurrent medical conditions included Headache since 27-Jan-2021. Concomitant products included THYROID THERAPY for Thyroid therapy.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced EAR DISCOMFORT (Ear itching), RASH (rush around her neck) and HEADACHE (Headache). 27-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 27-Jan-2021 for Difficulty breathing, at an unspecified dose and frequency; EPINEPHRINE 27-Jan-2021 at an unspecified dose and frequency and PREDNISONE ongoing from 27-Jan-2021 at an unspecified dose and frequency.   At the time of the report, EAR DISCOMFORT (Ear itching) and HEADACHE (Headache) had not resolved and DYSPNOEA (difficulty breathing) and RASH (rush around her neck) 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.   Patient has been prescribed with allergy medications.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Ear discomfort, Headache, Rash
Clinical narrative: Ear itching; difficulty breathing; rush around her neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear itching), DYSPNOEA (difficulty breathing), RASH (rush around her neck) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Difficulty breathing on 27-Jan-2021 and Itching on 27-Jan-2021. Concurrent medical conditions included Headache since 27-Jan-2021. Concomitant products included THYROID THERAPY for Thyroid therapy.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced EAR DISCOMFORT (Ear itching), RASH (rush around her neck) and HEADACHE (Headache). 27-Jan-2021, the patient experienced DYSPNOEA (difficulty breathing). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 27-Jan-2021 for Difficulty breathing, at an unspecified dose and frequency; EPINEPHRINE 27-Jan-2021 at an unspecified dose and frequency and PREDNISONE ongoing from 27-Jan-2021 at an unspecified dose and frequency.   At the time of the report, EAR DISCOMFORT (Ear itching) and HEADACHE (Headache) had not resolved and DYSPNOEA (difficulty breathing) and RASH (rush around her neck) 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.   Patient has been prescribed with allergy medications.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, Chest X-ray normal, Dizziness, Electrocardiogram abnormal
Clinical narrative: I became feverish in morning day after 2nd vaccination,ran a temp of 101. By 3:30 in afternoon I had become unable to stand or to get out of chair. When this persisted I was taken to ER. Because I could not maintain balance or stand unassisted I was admitted for overnight observation and I believe hydration. I improved and was discharged the following afternoon. In ER and in hospital I was told I had a reaction to vaccine. The neurologist treating my Parkinson?s said it was a likely response by my body to the perceived ?insult? of the vaccine. I recovered and have had no further ill effects. I am grateful I was vaccinated and would do it again. I would also receive a booster if available and warranted.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Heart rate increased, Laboratory test normal, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I became feverish in morning day after 2nd vaccination,ran a temp of 101. By 3:30 in afternoon I had become unable to stand or to get out of chair. When this persisted I was taken to ER. Because I could not maintain balance or stand unassisted I was admitted for overnight observation and I believe hydration. I improved and was discharged the following afternoon. In ER and in hospital I was told I had a reaction to vaccine. The neurologist treating my Parkinson?s said it was a likely response by my body to the perceived ?insult? of the vaccine. I recovered and have had no further ill effects. I am grateful I was vaccinated and would do it again. I would also receive a booster if available and warranted.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Body temperature increased, Dysstasia, Mobility decreased, Pyrexia
Clinical narrative: I became feverish in morning day after 2nd vaccination,ran a temp of 101. By 3:30 in afternoon I had become unable to stand or to get out of chair. When this persisted I was taken to ER. Because I could not maintain balance or stand unassisted I was admitted for overnight observation and I believe hydration. I improved and was discharged the following afternoon. In ER and in hospital I was told I had a reaction to vaccine. The neurologist treating my Parkinson?s said it was a likely response by my body to the perceived ?insult? of the vaccine. I recovered and have had no further ill effects. I am grateful I was vaccinated and would do it again. I would also receive a booster if available and warranted.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Arthralgia, Biopsy bone marrow, C-reactive protein increased, Full blood count
Clinical narrative: Serve pain. Inflammation marks, weight loss
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Thrombocytopenia, Weight decreased
Clinical narrative: Serve pain. Inflammation marks, weight loss
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood test, Full blood count, Inflammatory marker test, Pain
Clinical narrative: Serve pain. Inflammation marks, weight loss
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Serve pain. Inflammation marks, weight loss
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Tingling; Rash; The rash was also at my knees extending about 10 inches up; Sinus infection; A spontaneous report was received on 21-JAN-2021 from a consumer, concerning  male patient of 75 years old, who received Moderna's COVID-19 vaccine and experienced : Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07-JAN-2021, the patient received her first dose of the Modena vaccine mRNA-1273((Lot #   Unknown) via unknown route for COVID-19 infection prophylaxis.    18-JAN-2021 he went to the ER for his rash, but no lab data was provided by the     reporter  and he was prescribed with steroids and Benadryl.  As a treatment medication he has taken diphenhydramine HCl (Benadryl), Amoxylin, Calamine lotion and steroids as a treatment in response to the event with mRNA-1273.  The outcome of the events Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up. was considered to be Not Recovered/Not Resolved at the time of this report.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Paraesthesia, Rash, Sinusitis
Clinical narrative: Tingling; Rash; The rash was also at my knees extending about 10 inches up; Sinus infection; A spontaneous report was received on 21-JAN-2021 from a consumer, concerning  male patient of 75 years old, who received Moderna's COVID-19 vaccine and experienced : Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07-JAN-2021, the patient received her first dose of the Modena vaccine mRNA-1273((Lot #   Unknown) via unknown route for COVID-19 infection prophylaxis.    18-JAN-2021 he went to the ER for his rash, but no lab data was provided by the     reporter  and he was prescribed with steroids and Benadryl.  As a treatment medication he has taken diphenhydramine HCl (Benadryl), Amoxylin, Calamine lotion and steroids as a treatment in response to the event with mRNA-1273.  The outcome of the events Sinus infection when he got the vaccine, hands started tingling, rash appeared between his fingers, extending up to his shoulders on each arm, rash was also at his knees extending about 10 inches up. was considered to be Not Recovered/Not Resolved at the time of this report.