chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Head discomfort, Headache
Clinical narrative: headache; like a pressure in the frontal lobe of my forehead; mild fever at 99.8°F; chills; was tired/feel tired the rest of the following day; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead), HEADACHE (headache), PYREXIA (mild fever at 99.8°F), CHILLS (chills) and FATIGUE (was tired/feel tired the rest of the following day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest pain.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches). On 21-Sep-2021, the patient experienced HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches) had resolved. At the time of the report, HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 99.8 (High) 99.8 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  The patient was previously diagnosed of potential heart pain.   This case was linked to MOD-2021-334971 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: headache; like a pressure in the frontal lobe of my forehead; mild fever at 99.8°F; chills; was tired/feel tired the rest of the following day; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead), HEADACHE (headache), PYREXIA (mild fever at 99.8°F), CHILLS (chills) and FATIGUE (was tired/feel tired the rest of the following day) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest pain.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches). On 21-Sep-2021, the patient experienced HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Sep-2021, PYREXIA (mild fever at 99.8°F), CHILLS (chills), FATIGUE (was tired/feel tired the rest of the following day) and MYALGIA (body aches) had resolved. At the time of the report, HEAD DISCOMFORT (like a pressure in the frontal lobe of my forehead) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 99.8 (High) 99.8 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  The patient was previously diagnosed of potential heart pain.   This case was linked to MOD-2021-334971 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Influenza, Nausea
Clinical narrative: not immunocompromised and went to get a booster because of her age and condition; very ill; felt like she was coming down with the flu; weak; tired/fatigued; had nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition). In September 2021, the patient experienced ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea). On 02-Sep-2021, PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition) had resolved. At the time of the report, ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: not immunocompromised and went to get a booster because of her age and condition; very ill; felt like she was coming down with the flu; weak; tired/fatigued; had nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition). In September 2021, the patient experienced ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea). On 02-Sep-2021, PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition) had resolved. At the time of the report, ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Migraine, Pyrexia
Clinical narrative: Couldn't eat for four days because he wasn't hungry; It was like I was sick; Headache, like a migraine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry), ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry), ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in September 2021 for Adverse event, at an unspecified dose and frequency. On 02-Sep-2021, ILLNESS (It was like I was sick), MIGRAINE (Headache, like a migraine) and PYREXIA (Fever) had resolved. On 03-Sep-2021, DECREASED APPETITE (Couldn't eat for four days because he wasn't hungry) had resolved.            Concomitant medications included Diabetes medication and High blood pressure medications. Patient was hard to understand and was very confused. Injection was given on upper left arm - non dominant.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: after second dose of moderna Covid-19 vaccine person got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick). At the time of the report, ILLNESS (after second dose of moderna Covid-19 vaccine person got very sick) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Chest pain.    On 22-Aug-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 pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) 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.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-334946 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Impaired driving ability, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her; She cannot lift her hand/she cannot lift her arm; sometime it goes numb/she cannot use it; she has to drive with her left arm due to the pain; second shot outside recommended time interval; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it), IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot outside recommended time interval) had resolved. At the time of the report, PAIN IN EXTREMITY (pain she got after both shots/arm pain where she thought she slept on her arm bad/it is just painful/feel the pain when they injected her), HYPOKINESIA (She cannot lift her hand/she cannot lift her arm), HYPOAESTHESIA (sometime it goes numb/she cannot use it) and IMPAIRED DRIVING ABILITY (she has to drive with her left arm due to the pain) had not resolved.            Concomitant medications were not provided Patient made an appointment with the doctor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Gait disturbance, Magnetic resonance imaging
Clinical narrative: blood clots in her lungs; getting out of breath; couldn't walk very far; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far). On 01-Apr-2021, the patient experienced PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Apr-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots in her lungs), DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown unknown. On an unknown date, Computerised tomogram: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown unknown.         No concomitant medications were reported. She was admitted to the hospital on 01/Apr/2021 and had many tests which included bloodwork and a magnetic resonance imaging scan (MRI) or computed tomography (CAT) scan. They found blood clots in her lungs.  Company Comment: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: blood clots in her lungs; getting out of breath; couldn't walk very far; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far). On 01-Apr-2021, the patient experienced PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Apr-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots in her lungs), DYSPNOEA (getting out of breath) and GAIT DISTURBANCE (couldn't walk very far) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown unknown. On an unknown date, Computerised tomogram: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown unknown.         No concomitant medications were reported. She was admitted to the hospital on 01/Apr/2021 and had many tests which included bloodwork and a magnetic resonance imaging scan (MRI) or computed tomography (CAT) scan. They found blood clots in her lungs.  Company Comment: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 ear-old female patient with no reported medical history, who experienced the unexpected serious event of Pulmonary embolism. The event occurred 12 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypersensitivity, Intentional dose omission, Tachycardia
Clinical narrative: tachycardia; started feeling pressure in her ears that went down to her throat; Decided not to get the second dose; symptoms of an allergic reaction/anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0NCZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin).    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis). The patient was treated with Benadryl for Adverse event, at an unspecified dose and frequency. On 29-May-2021, TACHYCARDIA (tachycardia), EAR DISCOMFORT (started feeling pressure in her ears that went down to her throat), INTENTIONAL DOSE OMISSION (Decided not to get the second dose) and HYPERSENSITIVITY (symptoms of an allergic reaction/anaphylaxis) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient does not have an history of COVID-19 and myopericarditis .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Pain in extremity, Paraesthesia
Clinical narrative: sore arm; rash on the arm; little twitching around lip; burning cramping pain that run down from my right thigh to my ankle; burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AC1A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (Patient has multiple sclerosis). Concomitant products included INTERFERON BETA-1A (AVONEX) for Multiple sclerosis, DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm). In March 2021, the patient experienced MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle) and PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode). At the time of the report, MUSCLE TWITCHING (little twitching around lip), PAIN (burning cramping pain that run down from my right thigh to my ankle), PARAESTHESIA (burning cramping pain that run down from my thigh to my ankle, like a tingling sensation,/every day have at least one episode), PAIN IN EXTREMITY (sore arm) and RASH (rash on the arm) outcome was unknown.            No treatment information was reported by the reporter. Concomitant product includes blood pressure medication. Dexilant concomitant was used  for Reflux. Reporter stated that Patient has multiple sclerosis and takes Avonex, which suppresses her immune system. Patient said she takes a shot once a week, and for both doses of the vaccine she took the Avonex shot half way (meaning, took the shot, waited three days, got Moderna Vaccine, three more days, and then again the Avonex shot).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: lymph nodes under her left arm became painful; lymph nodes under her left arm became  swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen). In September 2021, LYMPH NODE PAIN (lymph nodes under her left arm became painful) and LYMPHADENOPATHY (lymph nodes under her left arm became  swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided.  Treatment details were not provided.   This case was linked to MOD-2021-335078 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient came down with delta variant after getting both does of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (patient came down with delta variant after getting both does of the vaccine) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (patient came down with delta variant after getting both does of the vaccine). At the time of the report, COVID-19 (patient came down with delta variant after getting both does of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a severe headache, shortness of breath, and lost smell and taste manifested under final diagnosis of COVID-19. However, she was not like "oh! she needs to go to the ER".  No concomitant drugs were reported.  No treatment drugs were reported.  Reporter work at a nursing home where covid-19 cases are surging. Reporter wonder if there is a date set for the approval, also if there is a antibody level range to assure a person is protected still, and whether they should get the available booster from Pfizer or wait for Moderna's.  Reporter mentioned a patient came down with delta variant after getting both does of the vaccine.  Reporter would like to escalate the question about which range of antibody levels that indicates if a person is still protected, because they feel it would make people feel more confident about getting the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains Significant information-New events added-Severe headache, shortness of breath,lost smell,lost taste.; Sender's Comments: This case concerns a female patient of unknown age with no details on previous relevant medical history, who experienced the unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the second dose of Spikevax, temporal relationship unknown. The rechallenge is not assessable.  The benefit-risk relationship of Spikevax vaccine is not affected by this report. Very limited information has been provided at this time. Vaccination failure was not captured since exact schedule of vaccination and temporal relationship with COVID-19 are unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaginal discharge
Clinical narrative: Vaginal discharge; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge) and DIARRHEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced DIARRHEA (Diarrhea). On 04-Sep-2021, the patient experienced VAGINAL DISCHARGE (Vaginal discharge). The patient was treated with BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) on 02-Sep-2021 for Diarrhea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) 02-Sep-2021 for Diarrhea, at a dose of one tab. On 02-Sep-2021, DIARRHEA (Diarrhea) had resolved. In September 2021, VAGINAL DISCHARGE (Vaginal discharge) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  Due to vaginal discharge, the patient went to the doctor, who gave her a shot and the discharge went away. She was allergic to the shot and had to take Benadryl.   This case was linked to MOD-2021-335094 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Thyroid disorder and Hypertension. Concomitant products included METFORMIN for Diabetes, OLMESARTAN MEDOXOMIL for Hypertension, LEVOTHYROXINE for Thyroid disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache). On 08-Feb-2021, HEADACHE (Shortly after she got the injection, she had a headache that passed through quickly and was gone/Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-335151 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Area around the injection site very red; Area around the injection site very, very itchy; Lymph nodes under left arm swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 015E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Area around the injection site very red), VACCINATION SITE PRURITUS (Area around the injection site very, very itchy) and LYMPHADENOPATHY (Lymph nodes under left arm swollen) outcome was unknown.            No Concomitant medication reported. No treatment medication reported   This case was linked to MOD-2021-335046 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: Numbness in hand; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand) and FATIGUE (fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Chlorathzine for Hypertension.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced FATIGUE (fatigue). On 14-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness in hand). At the time of the report, HYPOAESTHESIA (Numbness in hand) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Skin haemorrhage, Somnolence
Clinical narrative: Bleed under skin easily; Taking more naps than usual; Hair stared falling out; Been tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A, 0U4A21A and 033L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PREDNISONE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual), ALOPECIA (Hair stared falling out) and FATIGUE (Been tired). At the time of the report, SKIN HAEMORRHAGE (Bleed under skin easily), SOMNOLENCE (Taking more naps than usual) and FATIGUE (Been tired) outcome was unknown and ALOPECIA (Hair stared falling out) was resolving.            No treatment medications were reported.  The patient has underlying conditions and got third Moderna boost. The patient tends to bleed under skin easily. The patient reported that a cat bumped leg and blood went all the down front of leg and was black.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Palpitations
Clinical narrative: heart palpitations; dying because of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine). At the time of the report, PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM AD) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications was reported.   This case was linked to MOD-2021-335070 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Influenza like illness, Nausea, Photophobia
Clinical narrative: she noted huge hives (3-4 inches) which started at the injection site (left arm); fever; chills; was feeling "fluish"; nauseous; dizzy; vision smoky; light her my eye; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye), INFLUENZA LIKE ILLNESS (was feeling "fluish") and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye) and NAUSEA (nauseous). On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills). On 16-Aug-2021, the patient experienced VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Vaccination site urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site urticaria, at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown, VISION BLURRED (vision smoky) and PHOTOPHOBIA (light her my eye) had resolved. On 13-Aug-2021, INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills) had resolved. On 18-Aug-2021, VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site urticaria, Vision blurred
Clinical narrative: she noted huge hives (3-4 inches) which started at the injection site (left arm); fever; chills; was feeling "fluish"; nauseous; dizzy; vision smoky; light her my eye; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye), INFLUENZA LIKE ILLNESS (was feeling "fluish") and NAUSEA (nauseous) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced DIZZINESS (dizzy), VISION BLURRED (vision smoky), PHOTOPHOBIA (light her my eye) and NAUSEA (nauseous). On 11-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills). On 16-Aug-2021, the patient experienced VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Vaccination site urticaria, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site urticaria, at an unspecified dose and frequency. On 10-Aug-2021, DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown, VISION BLURRED (vision smoky) and PHOTOPHOBIA (light her my eye) had resolved. On 13-Aug-2021, INFLUENZA LIKE ILLNESS (was feeling "fluish"), PYREXIA (fever) and CHILLS (chills) had resolved. On 18-Aug-2021, VACCINATION SITE URTICARIA (she noted huge hives (3-4 inches) which started at the injection site (left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Minor sore arm). At the time of the report, PAIN IN EXTREMITY (Minor sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was also taken for irritable bowel syndrome.  No treatment medication was provided.   This case was linked to MOD-2021-335133.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Could not get out of bed for 24 hours; Had flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had flu-like symptoms) and FATIGUE (Could not get out of bed for 24 hours) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu-like symptoms). On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Could not get out of bed for 24 hours). On 23-Feb-2021, FATIGUE (Could not get out of bed for 24 hours) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Had flu-like symptoms) outcome was unknown.      Treatment information was not provided.   This case was linked to MOD-2021-335120, MOD-2021-335141 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza, Lymphadenopathy, Night sweats
Clinical narrative: night sweats; felt like he had the flu; swollen lymph nodes; chills; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), PAIN IN EXTREMITY (sore arm), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Sep-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills). At the time of the report, NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes), CHILLS (chills) and PYREXIA (fever) was resolving and PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 102 (High) Patient had fever that got up to 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that from the 5th day the side effects started to get better.  No concomitant medications were reported.  No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: night sweats; felt like he had the flu; swollen lymph nodes; chills; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), PAIN IN EXTREMITY (sore arm), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Sep-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills). At the time of the report, NIGHT SWEATS (night sweats), INFLUENZA (felt like he had the flu), LYMPHADENOPATHY (swollen lymph nodes), CHILLS (chills) and PYREXIA (fever) was resolving and PAIN IN EXTREMITY (sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 102 (High) Patient had fever that got up to 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that from the 5th day the side effects started to get better.  No concomitant medications were reported.  No treatment information was provided.