chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: stomach cramps; diarrhea; chills; fatigue; vomiting; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN) for Blood pressure management, TESTOSTERONE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced NAUSEA (nauseous). On 13-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and VOMITING (vomiting). On 14-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 13-Jun-2021, VOMITING (vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: stomach cramps; diarrhea; chills; fatigue; vomiting; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN) for Blood pressure management, TESTOSTERONE for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced NAUSEA (nauseous). On 13-Jun-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and VOMITING (vomiting). On 14-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 13-Jun-2021, VOMITING (vomiting) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-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 (sore arm). On 13-May-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications  were reported.   This case was linked to MOD-2021-222173 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information was received contains No new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Malaise
Clinical narrative: lost of taste; lost of smell; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well). At the time of the report, AGEUSIA (lost of taste), ANOSMIA (lost of smell) and MALAISE (not feeling well) 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.   Treatment information not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Back pain worse on moving; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Back pain worse on moving) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain since May 2021.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PAIN (Back pain worse on moving). The patient was treated with PREDNISONE for Back pain, at a dose of 1 dosage form; CYCLOBENZAPRINE for Back pain, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) ongoing since an unknown date for Back pain, at a dose of 1 dosage form and LIDOCAINE ongoing since an unknown date for Back pain, at a dose of 1 dosage form. At the time of the report, PAIN (Back pain worse on moving) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.   It was reported that patient has another appointment on 15-Jun-2021 with his doctor and is scheduled for an x-ray.
Sex: U
Vaccine: COVID19
Symptoms: Nerve compression
Clinical narrative: 3 people that have same issue of pinched nerve in their back after receiving 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose). At the time of the report, NERVE COMPRESSION (3 people that have same issue of pinched nerve in their back after receiving 2nd dose) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cardiac disorder, Decreased appetite, Fatigue, Headache
Clinical narrative: heart problem; did not have any appetite; fatigue; overall body aches; little fever about 24 hours 100.4F; headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches) and PYREXIA (little fever about 24 hours 100.4F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), IBUPROFEN and MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL] 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 an unknown date, the patient experienced CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 °F (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not have an email and prefers to be contact via fax.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up document received contains NNI.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: heart problem; did not have any appetite; fatigue; overall body aches; little fever about 24 hours 100.4F; headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches) and PYREXIA (little fever about 24 hours 100.4F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), IBUPROFEN and MULTIVITAMINS WITH IRON [ASCORBIC ACID;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PHOSPHORUS;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL] 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 an unknown date, the patient experienced CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CARDIAC DISORDER (heart problem), DECREASED APPETITE (did not have any appetite), FATIGUE (fatigue), MYALGIA (overall body aches), PYREXIA (little fever about 24 hours 100.4F) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 °F (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not have an email and prefers to be contact via fax.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up document received contains NNI.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: The back pain was constant. If he is sitting, it's bearable, but moving makes it worse; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse). At the time of the report, BACK PAIN (The back pain was constant. If he is sitting, it's bearable, but moving makes it worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: some side effects 15 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose). The patient was treated with IBUPROFEN at a dose of 400 milligram twice a day and PARACETAMOLUM at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (some side effects 15 hours after 2nd dose) outcome was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Was not able to sleep at all last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Was not able to sleep at all last night) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced INSOMNIA (Was not able to sleep at all last night). At the time of the report, INSOMNIA (Was not able to sleep at all last night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Out come of the event updated.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: difficult; joint pain in knees; joint pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (difficult), ARTHRALGIA (joint pain in knees) and ARTHRALGIA (joint pain in hips) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (difficult), ARTHRALGIA (joint pain in knees) and ARTHRALGIA (joint pain in hips). At the time of the report, CONDITION AGGRAVATED (difficult), ARTHRALGIA (joint pain in knees) and ARTHRALGIA (joint pain in hips) had not resolved.            No concomitant medications were reported.  No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick in bed), dizziness, lethargy (lethargic), headache and nausea in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jun 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 12, 2021, patient experienced  lethargy (lethargic) and fatigue (tired). On Jun 14, 2021, patient had a headache, nausea and chills. On Jun 15, 2021, patient experienced illness (sick in bed). On an unknown date, patient experienced dizziness. On Jun 13, 2021, lethargy (lethargic) and fatigue (tired) resolved. At the time of the report, illness (sick in bed): not resolved; and dizziness, headache, nausea and chills outcome: unknown. No concomitant medication or treatment information reported. Most recent follow-up information incorporated: On Jun 15, 2021: Follow-up received on Jun 15, 2021 contained significant information: Product details including dose details and route of administration were updated. The new events added included lethargy, chills and illness.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick in bed), dizziness, lethargy (lethargic), headache and nausea in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jun 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 12, 2021, patient experienced  lethargy (lethargic) and fatigue (tired). On Jun 14, 2021, patient had a headache, nausea and chills. On Jun 15, 2021, patient experienced illness (sick in bed). On an unknown date, patient experienced dizziness. On Jun 13, 2021, lethargy (lethargic) and fatigue (tired) resolved. At the time of the report, illness (sick in bed): not resolved; and dizziness, headache, nausea and chills outcome: unknown. No concomitant medication or treatment information reported. Most recent follow-up information incorporated: On Jun 15, 2021: Follow-up received on Jun 15, 2021 contained significant information: Product details including dose details and route of administration were updated. The new events added included lethargy, chills and illness.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: clinic is not sure how much got into the patient arm; the needle was not aligned properly on the syringe; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe). At the time of the report, UNDERDOSE (clinic is not sure how much got into the patient arm) and DEVICE CONNECTION ISSUE (the needle was not aligned properly on the syringe) 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 concomitant medications were reported. Treatment information was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient administered expired Moderna COVID-19 vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 14, 2021, patient administered expired product (patient administered expired Moderna COVID-19 vaccine). On Jun 14, 2021, administered expired product (patient administered expired Moderna COVID-19 vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to  MOD21-111094 and MOD-2021-222613 (patient link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus, Skin mass
Clinical narrative: After the second dose, the patient experienced a sore arm until 09June2021; Line of bumps along arm; Red Bumps; Itchy Bumps; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red Bumps), PRURITUS (Itchy Bumps), SKIN MASS (Line of bumps along arm) and MYALGIA (After the second dose, the patient experienced a sore arm until 09June2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced ERYTHEMA (Red Bumps) and PRURITUS (Itchy Bumps). On 15-Jun-2021, the patient experienced SKIN MASS (Line of bumps along arm). On an unknown date, the patient experienced MYALGIA (After the second dose, the patient experienced a sore arm until 09June2021). At the time of the report, ERYTHEMA (Red Bumps), PRURITUS (Itchy Bumps), SKIN MASS (Line of bumps along arm) and MYALGIA (After the second dose, the patient experienced a sore arm until 09June2021) outcome was unknown.            No concomitant medications were  provided No treatment medications were provided   This case was linked to MOD-2021-222102 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non new information received
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: heart inflammation/chest felt sore and bruised; injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore). At the time of the report, CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Pyrexia
Clinical narrative: contracted Covid-19 after getting both shots ofModerna vaccine; cough; lack of drug effect; fever; headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect) in an elderly patient of an unknown gender 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 COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches), COUGH (cough) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.            No concomitant medications reported. The patient was over 80 years old that have been vaccinated with both shots and contracted Covid-19, presenting fever, headaches and cough. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: howlong am I supposed to be sick after the 2nd COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (howlong am I supposed to be sick after the 2nd COVID shot) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 (howlong am I supposed to be sick after the 2nd COVID shot). At the time of the report, ILLNESS (howlong am I supposed to be sick after the 2nd COVID shot) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea
Clinical narrative: GI bloating; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender 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, the patient experienced ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Patient had events 4 days after the first vaccination. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the site of injection) 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 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain on the site of injection). At the time of the report, VACCINATION SITE PAIN (Pain on the site of injection) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Feeling abnormal, Headache
Clinical narrative: Generally didn't feel this way; Nosebleeds; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Generally didn't feel this way), EPISTAXIS (Nosebleeds), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced HEADACHE (Headaches) and FATIGUE (Fatigue). On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Generally didn't feel this way) and EPISTAXIS (Nosebleeds). At the time of the report, FEELING ABNORMAL (Generally didn't feel this way), EPISTAXIS (Nosebleeds), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness after the 1st dose) in a patient of an unknown age and gender 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, the patient experienced FATIGUE (Tiredness after the 1st dose). At the time of the report, FATIGUE (Tiredness after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose) in a patient of an unknown age and gender 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received 1st dose of Moderna COVID 19 vaccine and did not receive 2nd dose) had resolved.            Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Headache
Clinical narrative: Headache; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia, Diabetes and Thyroid disorder. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 24-Feb-2021, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) patient did not have any antibodies to the vaccine.     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 got her 1st dose of the Moderna vaccine on 22Feb2021 and her 2nd dose on 27Mar2021, both in her left, non-dominant arm in the deltoid region. For both vaccinations, experienced tiredness and headache, both started the day of their vaccines and lasted for 2 days. No medications were taken for these symptoms. Patient called as she got an antibody test done and it showed that did not have any antibodies to the vaccine and wanted to inquire about this.  Treatment information was not provided   This case was linked to MOD-2021-222249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 28-JUL-2021 and does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my arm hurts super bad; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my arm hurts super bad) in a patient of an unknown age and gender 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 MYALGIA (my arm hurts super bad). At the time of the report, MYALGIA (my arm hurts super bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (cold) and rhinorrhea (one side of nose is running) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016CZI1) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasopharyngitis (cold) and rhinorrhea (one side of nose is running). At the time of the report, nasopharyngitis (cold) and rhinorrhea (one side of nose is running) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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, the patient experienced URTICARIA (hives). The patient was treated with HYDROCORTISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that two weeks after the vaccination patient had the event and was due for her second shot next day. Treatment also included OTC Anti histamines for the events.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: My daugther has painful sore throat on the 4th day after 2nd vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination). At the time of the report, OROPHARYNGEAL PAIN (My daugther has painful sore throat on the 4th day after 2nd vaccination) outcome was unknown.            No treatment medication was reported. No concomitant medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included INSULIN GLARGINE (LANTUS) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). On 29-Mar-2021, FATIGUE (Tiredness) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: mildly itchy feeling in the arm; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (mildly itchy feeling in the arm) and PAIN (Pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PRURITUS (mildly itchy feeling in the arm) and PAIN (Pain). At the time of the report, PRURITUS (mildly itchy feeling in the arm) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamins. Treatment medication not reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: When I got the 1st shot, my arm was hurting.; The back of my head is hurting ever since; It hurts right where my neck meets the back of my head on both sides.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.), HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.). On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.). At the time of the report, PAIN IN EXTREMITY (When I got the 1st shot, my arm was hurting.), HEADACHE (The back of my head is hurting ever since) and NECK PAIN (It hurts right where my neck meets the back of my head on both sides.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No relevant concomitant medications were reported. Consent given for Safety follow up/contact. Reporter stated  ,"If I don't answer, tell them to just leave a message".   This case was linked to MOD-2021-223105 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Diarrhoea, Erythema, Feeling hot
Clinical narrative: Fast heartbreak/ fast heart rate; Diarrhea; Burning in a chest/ got constant burning in the chest; Face and arms and chest turning red; Skin feeling hot; Got a little of a fever 98. 7; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red) and FEELING HOT (Skin feeling hot) in a patient of an unknown age and gender 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red), FEELING HOT (Skin feeling hot) and PYREXIA (Got a little of a fever 98. 7). At the time of the report, HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red), FEELING HOT (Skin feeling hot) and PYREXIA (Got a little of a fever 98. 7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 (Inconclusive) little fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received included additional events.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fast heartbreak/ fast heart rate; Diarrhea; Burning in a chest/ got constant burning in the chest; Face and arms and chest turning red; Skin feeling hot; Got a little of a fever 98. 7; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red) and FEELING HOT (Skin feeling hot) in a patient of an unknown age and gender 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red), FEELING HOT (Skin feeling hot) and PYREXIA (Got a little of a fever 98. 7). At the time of the report, HEART RATE INCREASED (Fast heartbreak/ fast heart rate), DIARRHOEA (Diarrhea), CHEST PAIN (Burning in a chest/ got constant burning in the chest), ERYTHEMA (Face and arms and chest turning red), FEELING HOT (Skin feeling hot) and PYREXIA (Got a little of a fever 98. 7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 (Inconclusive) little fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received included additional events.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash on arm, nausea (nauseous) and fatigue (extremely tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011D21A) for COVID-19 immunization. No medical history reported. On Jun 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 8, 2021, patient experienced rash on arm, nausea (nauseous) and fatigue (extremely tired). Patient treated with ibuprofen at an unspecified dose and frequency (to alleviate the symptoms experienced). At the time of the report, rash on arm, nausea (nauseous) and fatigue (extremely tired) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a patient of an unknown age and gender 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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.