chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Off label use, Sensation of foreign body, Tachycardia
Clinical narrative: Light in the chest; Lump in the throat; Tachycardia; Dizziness; Her doctor recommended her to delay the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia), DIZZINESS (Dizziness) and OFF LABEL USE (Her doctor recommended her to delay the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient had cancer 10 year ago.). Concomitant products included METOPROLOL SUCCINATE for Blood pressure, MELATONIN for Sleep disorder, THYROID (ARMOUR THYROID) for Thyroid disorder.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced OFF LABEL USE (Her doctor recommended her to delay the vaccine). On 18-Sep-2021, the patient experienced CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness). On 15-Sep-2021, OFF LABEL USE (Her doctor recommended her to delay the vaccine) had resolved. At the time of the report, CHEST DISCOMFORT (Light in the chest), SENSATION OF FOREIGN BODY (Lump in the throat), TACHYCARDIA (Tachycardia) and DIZZINESS (Dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On the night of  the 17sep2021 Patient took wells sleep tea for Sleeping aid. No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-323073 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: got a 104 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got a 104 fever) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (got a 104 fever). At the time of the report, PYREXIA (got a 104 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) Fever.         No relevant concomitant medications were reported. Treatment information was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling hot, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 050E21A) for COVID-19 immunization. No medical history reported. On Sep 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 16, 2021, patient experienced  dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain). At the time of the report, dizziness (feel dizzy), feeling hot (feel warm), headache and arthralgia (joint pain) outcome: unknown. 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 provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: period delayed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (period delayed for 4 days) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa).    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, the patient experienced MENSTRUATION DELAYED (period delayed for 4 days). At the time of the report, MENSTRUATION DELAYED (period delayed for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants medication were provided.  No treatment medication were provided.  Second dose is scheduled on 8-Oct-2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood pressure measurement, Electrocardiogram, Headache, Hypertension
Clinical narrative: left eye started jumping; blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90; severe headache with a pain scale of 7/10/  intermittent headache; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Uterine fibroids (Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.) and Drug allergy. Concomitant products included LISINOPRIL (LISINOPRIL ACTAVIS [LISINOPRIL]), LINACLOTIDE (LINZESS), SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM, ZINC and VITAMIN D3 for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache). On 17-Sep-2021, the patient experienced BLEPHAROSPASM (left eye started jumping) and HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form (2 Tylenol ) and NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form (1 Aleve). At the time of the report, BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Pain assessment: 7/10 (Inconclusive) 7/10. On 17-Sep-2021, Blood pressure measurement: 170/100 (High) Patient unsure of the exact measurement. On 18-Sep-2021, Blood pressure measurement: 165/95 (High) high and 144/80 (abnormal) blood pressure was slightly lower than before at 144/80. On 18-Sep-2021, Electrocardiogram: normal (normal) heart was fine. On an unknown date, Blood pressure measurement: 186/90 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was allergic to powder and latex gloves Patient was put on blood pressure medication. Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: left eye started jumping; blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90; severe headache with a pain scale of 7/10/  intermittent headache; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Uterine fibroids (Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.) and Drug allergy. Concomitant products included LISINOPRIL (LISINOPRIL ACTAVIS [LISINOPRIL]), LINACLOTIDE (LINZESS), SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM, ZINC and VITAMIN D3 for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache). On 17-Sep-2021, the patient experienced BLEPHAROSPASM (left eye started jumping) and HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form (2 Tylenol ) and NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form (1 Aleve). At the time of the report, BLEPHAROSPASM (left eye started jumping), HYPERTENSION (blood pressure of 170/100 something/ Upon waking up, blood pressure was still high today at 165/95/ blood pressure was at 186/90) and HEADACHE (severe headache with a pain scale of 7/10/  intermittent headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Pain assessment: 7/10 (Inconclusive) 7/10. On 17-Sep-2021, Blood pressure measurement: 170/100 (High) Patient unsure of the exact measurement. On 18-Sep-2021, Blood pressure measurement: 165/95 (High) high and 144/80 (abnormal) blood pressure was slightly lower than before at 144/80. On 18-Sep-2021, Electrocardiogram: normal (normal) heart was fine. On an unknown date, Blood pressure measurement: 186/90 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was allergic to powder and latex gloves Patient was put on blood pressure medication. Gigantic uterine fibroids with a size of a 14th week pregnancy was also noted.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: dizziness; Could not lift head off pillow; very sore arm/arm pain; Headache; Vomited; fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache) and VOMITING (Vomited) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Bronchiectasis, Allergy to antibiotic (allergy to vancomycin) and Allergy to plants (allergy to Echinacea).    On 11-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100 (High) 100.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. The patient slept for 2 days, rested and self hydrated for treatment.   This case was linked to MOD-2021-323632, MOD-2021-310473 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: dizziness; Could not lift head off pillow; very sore arm/arm pain; Headache; Vomited; fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache) and VOMITING (Vomited) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Bronchiectasis, Allergy to antibiotic (allergy to vancomycin) and Allergy to plants (allergy to Echinacea).    On 11-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Jan-2021, DIZZINESS (dizziness), MOBILITY DECREASED (Could not lift head off pillow), PAIN IN EXTREMITY (very sore arm/arm pain), HEADACHE (Headache), VOMITING (Vomited), PYREXIA (fever) and FATIGUE (Tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100 (High) 100.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. The patient slept for 2 days, rested and self hydrated for treatment.   This case was linked to MOD-2021-323632, MOD-2021-310473 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm(For the first 2 doses); This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (Gabapentin makes patient nauseated and have vertigo), Asthma (underlying asthma which is usually in control) and Autoimmune disorder NOS. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-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 PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)). At the time of the report, PAIN IN EXTREMITY (had a sore arm(For the first 2 doses)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  For the first 2 doses, patient had no trouble at all, only had a sore arm that went away after a fewdays.
Sex: U
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: Multiple heart attack patients (4 to 5); 2 people died; 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 DEATH (2 people died) and MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) 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 DEATH (2 people died) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) (seriousness criteria hospitalization and medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDIAL INFARCTION (Multiple heart attack patients (4 to 5)) outcome was unknown.            Concomitant medications were not reported. Multiple people had heart attacks after vaccine. Two people died after getting the COVID-19 vaccine. Treatment information was not provided.  Company Comment: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected events of myocardial infarction and death. Cause of death was unknown. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-323668, MOD21-144997 (Patient Link).; Sender's Comments: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected events of myocardial infarction and death. Cause of death was unknown. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Hypoacusis
Clinical narrative: Hollow Talk; Loss of hearing after the second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included BUDESONIDE for Colitis, WARFARIN SODIUM (COUMADIN) for Seizures, VITAMINS NOS, PROBIOTICS NOS, CLONAZEPAM and MONTELUKAST for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-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 DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination). At the time of the report, DYSPHONIA (Hollow Talk) and HYPOACUSIS (Loss of hearing after the second Moderna vaccination) outcome was unknown.            Concomitant medication includes Lobotrixine, Totermine, Antrictalis. Treatment information was not provided. Doctor tell her that there was nothing wrong whit her ears.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: stomach pain; upset stomach; 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 ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) 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, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: "I took my vaccine and I had chills."; 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 CHILLS ("I took my vaccine and I had chills.") 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 CHILLS ("I took my vaccine and I had chills."). At the time of the report, CHILLS ("I took my vaccine and I had chills.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles 3 months after vaccination; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles 3 months after vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024L20A and 025021) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (Patient was on Chemotherapy for approximately 5 months.). Concurrent medical conditions included Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced HERPES ZOSTER (Shingles 3 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles 3 months after vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     The patient had no known allergies.  The patient's past medical history included Vasectomy. Concomitant products included FISH OIL (FISH OIL OMEGA 3), ROSUVASTATIN, NIACIN, ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of 800 mg. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PAIN (pain at injection site) and CHILLS (Chills) outcome was unknown.            As treatment the patient also used cold compress.   This case was linked to MOD-2021-323843.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Off label use, Pain in extremity, Pruritus, Synovial cyst
Clinical narrative: didn't feel well for two days; hot and itchy; still sore; bakers cyst; hot and itchy; very large bullseye rash at the injection site; not considered immunocompromised/Received 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst) and VACCINATION SITE WARMTH (hot and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F2119, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Concomitant products included LABETALOL for Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced OFF LABEL USE (not considered immunocompromised/Received 3rd dose). On an unknown date, the patient experienced MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst), VACCINATION SITE WARMTH (hot and itchy) and VACCINATION SITE RASH (very large bullseye rash at the injection site). At the time of the report, MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), VACCINATION SITE WARMTH (hot and itchy) and OFF LABEL USE (not considered immunocompromised/Received 3rd dose) outcome was unknown, PAIN IN EXTREMITY (still sore) had not resolved and SYNOVIAL CYST (bakers cyst) and VACCINATION SITE RASH (very large bullseye rash at the injection site) was resolving.            No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Significant Follow up contains added events: Malaise, pruritus, pain in extremity, synovial cyst, vaccination site warmth, vaccination site rash
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: didn't feel well for two days; hot and itchy; still sore; bakers cyst; hot and itchy; very large bullseye rash at the injection site; not considered immunocompromised/Received 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst) and VACCINATION SITE WARMTH (hot and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F2119, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Concomitant products included LABETALOL for Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced OFF LABEL USE (not considered immunocompromised/Received 3rd dose). On an unknown date, the patient experienced MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), PAIN IN EXTREMITY (still sore), SYNOVIAL CYST (bakers cyst), VACCINATION SITE WARMTH (hot and itchy) and VACCINATION SITE RASH (very large bullseye rash at the injection site). At the time of the report, MALAISE (didn't feel well for two days), PRURITUS (hot and itchy), VACCINATION SITE WARMTH (hot and itchy) and OFF LABEL USE (not considered immunocompromised/Received 3rd dose) outcome was unknown, PAIN IN EXTREMITY (still sore) had not resolved and SYNOVIAL CYST (bakers cyst) and VACCINATION SITE RASH (very large bullseye rash at the injection site) was resolving.            No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Significant Follow up contains added events: Malaise, pruritus, pain in extremity, synovial cyst, vaccination site warmth, vaccination site rash
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: some doses that might have been administered up to 50 days after being in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (some doses that might have been administered up to 50 days after being in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 EXPIRED PRODUCT ADMINISTERED (some doses that might have been administered up to 50 days after being in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (some doses that might have been administered up to 50 days after being in the refrigerator) 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 concomitant drug details were reported.  No treatment details were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: bad migraine; dizziness; Vaccination site red; painful to touch; swollen site - nickel; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Cinnamon, Aspirin, Penicillin, Morphine).    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel). At the time of the report, MIGRAINE (bad migraine), DIZZINESS (dizziness), VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (painful to touch) and VACCINATION SITE SWELLING (swollen site - nickel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Arm pain; Headache; Lymph node on right side of collar bone swell up; Lymph node on right side of collar bone painful; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node on right side of collar bone swell up), LYMPH NODE PAIN (Lymph node on right side of collar bone painful), VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced LYMPHADENOPATHY (Lymph node on right side of collar bone swell up) and LYMPH NODE PAIN (Lymph node on right side of collar bone painful). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form; IBUPROFEN at a dose of UNK dosage form and HYDROCODONE at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Lymph node on right side of collar bone swell up), LYMPH NODE PAIN (Lymph node on right side of collar bone painful), VACCINATION SITE PAIN (Arm pain) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: premature exhaustion/ fatigue; 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 FATIGUE (premature exhaustion/ fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (premature exhaustion/ fatigue). At the time of the report, FATIGUE (premature exhaustion/ fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.  No treatment medications were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Malaise, Nasal congestion, Nasal discomfort, Respiratory disorder
Clinical narrative: My nose is very stuff; Upper respiratory problems; Tinnitus/Tinnitus is very aggravating; General malaise worst after the 2nd dose; Mendnebular nose; Runny nose; I am very scared; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose) and NASAL DISCOMFORT (Mendnebular nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Blood pressure management and Diabetes. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, INSULIN DEGLUDEC (TRESIBA) for Diabetes, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared) had resolved.            Concomitant medication were reported. Treatment medication were reported. The patient had upper respiratory problems. The patient was immunocompromised and was very scared. The patient nose was very stuff, Tinnitus was very aggravated. Went away finally and came back immediately after 3rd dose.   This case was linked to MOD-2021-324159 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tinnitus
Clinical narrative: My nose is very stuff; Upper respiratory problems; Tinnitus/Tinnitus is very aggravating; General malaise worst after the 2nd dose; Mendnebular nose; Runny nose; I am very scared; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose) and NASAL DISCOMFORT (Mendnebular nose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised, Blood pressure management and Diabetes. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure management, INSULIN DEGLUDEC (TRESIBA) for Diabetes, ADALIMUMAB (HUMIRA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LORAZEPAM (ATIVAN) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (My nose is very stuff), RESPIRATORY DISORDER (Upper respiratory problems), TINNITUS (Tinnitus/Tinnitus is very aggravating), MALAISE (General malaise worst after the 2nd dose), NASAL DISCOMFORT (Mendnebular nose), RHINORRHOEA (Runny nose) and FEAR (I am very scared) had resolved.            Concomitant medication were reported. Treatment medication were reported. The patient had upper respiratory problems. The patient was immunocompromised and was very scared. The patient nose was very stuff, Tinnitus was very aggravated. Went away finally and came back immediately after 3rd dose.   This case was linked to MOD-2021-324159 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast cancer, Headache, Nausea, Pain in extremity
Clinical narrative: Breast cancer; Really bad reaction; My arm hurt; All my joints hurt; Nauseous; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from March 2020 to April 2020. Concurrent medical conditions included Blood pressure abnormal, Cholesterolosis NOS and Diabetes. Concomitant products included METOPROLOL for Blood pressure management, ROSUVASTATIN and GEMFIBROZIL for Cholesterolosis NOS, METFORMIN for Diabetes mellitus, DULOXETINE HYDROCHLORIDE (CYMBALTA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), PAIN IN EXTREMITY (My arm hurt), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache). In May 2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Surgery for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer), VACCINATION COMPLICATION (Really bad reaction), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache) outcome was unknown and PAIN IN EXTREMITY (My arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that the symptoms were similar to COVID-19 which she had in Mar to Apr-2020 and found out that she still had antibodies from it. She also stated that she was as not aware of breast cancer at that time.  Company Comment: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Breast cancer; Really bad reaction; My arm hurt; All my joints hurt; Nauseous; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Breast cancer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from March 2020 to April 2020. Concurrent medical conditions included Blood pressure abnormal, Cholesterolosis NOS and Diabetes. Concomitant products included METOPROLOL for Blood pressure management, ROSUVASTATIN and GEMFIBROZIL for Cholesterolosis NOS, METFORMIN for Diabetes mellitus, DULOXETINE HYDROCHLORIDE (CYMBALTA) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), PAIN IN EXTREMITY (My arm hurt), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache). In May 2021, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Surgery for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer), VACCINATION COMPLICATION (Really bad reaction), ARTHRALGIA (All my joints hurt), NAUSEA (Nauseous) and HEADACHE (Bad headache) outcome was unknown and PAIN IN EXTREMITY (My arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that the symptoms were similar to COVID-19 which she had in Mar to Apr-2020 and found out that she still had antibodies from it. She also stated that she was as not aware of breast cancer at that time.  Company Comment: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, female patient with relevant medical history of diabetes, who experienced the unexpected event of breast cancer. The event occurred approximately 2 months after the first dose of COVID-19 vaccine mRNA was administered. The rechallenge was not applicable since the patient has not received the second dose yet. The benefit-risk relationship of COVID-19 vaccine mRNA is not affected by this report.