chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: loss my sense of smell; loss my sense of  taste; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included Cellulitis from 19-Aug-2021 to 24-Aug-2021 and Hysterectomy in July 2008. Concurrent medical conditions included Pseudomyxoma peritonei (surgery) since 28-May-2008, Lichen sclerosus (Honey) since 22-Nov-2012, Laryngopharyngeal reflux since 10-May-2014, UTI (Antibiotics) since 05-Nov-1964, Asthma (Allergy shots) since 12-Feb-1975, OA knee, Allergy to antibiotic (Flagyl allergy), Peanut allergy (Peanuts allergies), Bee sting hypersensitivity (Bee stings allergy), Drug allergy (Oral steroids allergy), Allergy to topical drugs (topical steroids allergy), Allergy to antibiotic (clindamycin allergy), Drug allergy (macrodantin allergy), Drug allergy (decongestants allergy), Allergic reaction to analgesics (dilaudid allergy), Drug allergy (Antihistamines allergy minus), Allergy to nuts (Allergy to all nuts), Allergy to antibiotic (Allergy to cipro), Allergy to antibiotic (Augmentin allergy) and Drug allergy (Sulfa allergy). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (XANAX) for Muscle spasm, SIMETICONE (GAS X) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-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 ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste). At the time of the report, ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatments was provided by the reporter.   This case was linked to MOD-2021-321274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: First and second dose information,Historical conditions, current conditions, Allergic status Concomitant medications were added.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Influenza, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Blood sugar better controlled; Sore left injection site arm; Got the flu shortly after; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D1A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) and INSULIN ASPART (NOVOLOG) for Type 2 diabetes mellitus, METFORMIN for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled) and VACCINATION SITE PAIN (Sore left injection site arm). In August 2021, the patient experienced INFLUENZA (Got the flu shortly after). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Blood glucose: 160 (abnormal) blood sugar went down to 160. On an unknown date, Blood glucose: 250 to 300 (High) 250 to 300.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. The reporter states that the patient received first dose of Moderna Covid-19 vaccine and patient noticed that blood sugar was dropped, and patient blood sugar was running between 250 to 300 after the first dose of vaccine patient blood sugar went down to 160 and reporter states that the Patient was struggled to manage type 2 diabetes and taking insulin shots, after first dose patient diabetes seemed easier to control and patient got flu shortly after couldn't really exercise much. patient taking Metformin and other medications .   This case was linked to MOD-2021-321336 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received.Concomitant medications were added, new event influenza  was added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: sore right injection site arm; headache; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) in a 70-year-old female patient 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided. No treatment information were provided. As per source document the age at the time of event given is 10.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: first dose arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (first dose arm pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E or F 21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfur medication). Concomitant products included AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, VITAMIN 15 for an unknown indication.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (first dose arm pain). On 22-Aug-2021, MYALGIA (first dose arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used by the patient included multivitamins and cardiac medication. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-322348 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Kidney infection, Renal impairment
Clinical narrative: Kidney infection; kidney function effect; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-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 KIDNEY INFECTION (Kidney infection) (seriousness criterion medically significant) and RENAL IMPAIRMENT (kidney function effect) (seriousness criterion medically significant). At the time of the report, KIDNEY INFECTION (Kidney infection) and RENAL IMPAIRMENT (kidney function effect) outcome was unknown.            The concomitant medications were not provided. The Treatment information includes antibiotics.  Company Comment : This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 54-year-old, male with unknown medical history, who experienced the unexpected events of kidney infection and renal impairment. The event occurred after the second dose of mRNA-1273 Moderna vaccine (Spikevax) with no precise onset date. The rechallenge was unknown/since no information regarding the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Gait disturbance, Headache
Clinical narrative: Sick for 2 days; Hard to walk up and down the stairs; Sweating; Shaking/a little shaky; freezing; Sore left arm/body aches; Extreme fatigue/exhaustion/feels exhausted; Headache; Fever (temperature not measured); Chills for 24hrs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky) and FEELING COLD (freezing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 037B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease and Hashimoto's disease. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), ZOLPIDEM TARTRATE (AMBIEN), MAGNESIUM MALATE, OMEGA-3 FATTY ACIDS, VITAMIN D [VITAMIN D NOS], VITAMIN K [VITAMIN K NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], GLUTATHIONE, PHOSPHATIDYL CHOLINE (LIPOSOMAL GLUTATHIONE), BORON and ZINC PICOLINATE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache), PYREXIA (Fever (temperature not measured)) and CHILLS (Chills for 24hrs). 16-Sep-2021, the patient experienced FEELING COLD (freezing). In September 2021, ILLNESS (Sick for 2 days) had resolved. On 17-Sep-2021, CHILLS (Chills for 24hrs) had resolved. At the time of the report, GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), FEELING COLD (freezing), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache) and PYREXIA (Fever (temperature not measured)) outcome was unknown and TREMOR (Shaking/a little shaky) had not resolved.            No treatment medication was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Myalgia, Pyrexia, Tremor
Clinical narrative: Sick for 2 days; Hard to walk up and down the stairs; Sweating; Shaking/a little shaky; freezing; Sore left arm/body aches; Extreme fatigue/exhaustion/feels exhausted; Headache; Fever (temperature not measured); Chills for 24hrs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky) and FEELING COLD (freezing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 037B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease and Hashimoto's disease. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), ZOLPIDEM TARTRATE (AMBIEN), MAGNESIUM MALATE, OMEGA-3 FATTY ACIDS, VITAMIN D [VITAMIN D NOS], VITAMIN K [VITAMIN K NOS], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], GLUTATHIONE, PHOSPHATIDYL CHOLINE (LIPOSOMAL GLUTATHIONE), BORON and ZINC PICOLINATE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced ILLNESS (Sick for 2 days), GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), TREMOR (Shaking/a little shaky), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache), PYREXIA (Fever (temperature not measured)) and CHILLS (Chills for 24hrs). 16-Sep-2021, the patient experienced FEELING COLD (freezing). In September 2021, ILLNESS (Sick for 2 days) had resolved. On 17-Sep-2021, CHILLS (Chills for 24hrs) had resolved. At the time of the report, GAIT DISTURBANCE (Hard to walk up and down the stairs), HYPERHIDROSIS (Sweating), FEELING COLD (freezing), MYALGIA (Sore left arm/body aches), FATIGUE (Extreme fatigue/exhaustion/feels exhausted ), HEADACHE (Headache) and PYREXIA (Fever (temperature not measured)) outcome was unknown and TREMOR (Shaking/a little shaky) had not resolved.            No treatment medication was provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersensitivity, Malaise, Pyrexia
Clinical narrative: little under the weather; A little tired; fever; chills; allergy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) in a 22-year-old female patient 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 MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 2 negative rapid tests and negative (Negative) negative PCR test.         No concomitant medications were reported.    This case was linked to MOD-2021-322232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received, New events and the treatment medication added.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: little under the weather; A little tired; fever; chills; allergy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) in a 22-year-old female patient 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 MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (little under the weather), FATIGUE (A little tired), PYREXIA (fever), CHILLS (chills) and HYPERSENSITIVITY (allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 2 negative rapid tests and negative (Negative) negative PCR test.         No concomitant medications were reported.    This case was linked to MOD-2021-322232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received, New events and the treatment medication added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Some discomfort in his arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Some discomfort in his arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced LIMB DISCOMFORT (Some discomfort in his arm). At the time of the report, LIMB DISCOMFORT (Some discomfort in his arm) outcome was unknown.            Concomitant medication were not provided by the reporter.  Treatment medication were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram, Myalgia, Pain
Clinical narrative: pain is very light with the tablet but it starts moving through the body; muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder; muscle pain/muscle pain is moving right now/pain starts moving through the body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain is very light with the tablet but it starts moving through the body), ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder) and MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body). On an unknown date, the patient experienced PAIN (pain is very light with the tablet but it starts moving through the body) and ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder). At the time of the report, PAIN (pain is very light with the tablet but it starts moving through the body), ARTHRALGIA (muscle pain is moving, it's on the shoulder and moves to the back of the shoulder,pain in left hand shoulder) and MYALGIA (muscle pain/muscle pain is moving right now/pain starts moving through the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (normal) came back negative, so it was told it was just a muscle pain..         Concomitant medication included Blood pressure medicine and Colestor tablet for sugar on the dinner. Treatment medication included Nephrotic 250 tablets and was advised to put cold on it and that used a hot water pouch and put the hot water on the arm and it helps but then it starts feeling pain again.  The patient went two times to emergency where received medication for the pain and on it's second visit had an ECG done and bloodwork which both came back negative, so it was told it was just a muscle pain. The patient said the pain is very light with the tablet but it starts moving through the body. The patient then went to it's regular doctor who prescribed the same medicine, Nephrotic 250 mg tablets. Patient never had a muscle pain like this. In 10 to 15 years ago stopped the blood pressure medicine because it was under new medicine then got the pain, didn't want long pain from the medicine.   This case was linked to MOD-2021-322257 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema nodosum, Fatigue, Feeling abnormal
Clinical narrative: I have generally felt bad; Erythema Nodosum; tired and sluggish; left side of my face went numb; low energy for a couple of days; sore left injection site arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA NODOSUM (Erythema Nodosum) and HYPOAESTHESIA (left side of my face went numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA (left side of my face went numb) (seriousness criterion medically significant), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm) and CHILLS (chills). On 01-Jun-2021, the patient experienced ERYTHEMA NODOSUM (Erythema Nodosum) (seriousness criterion medically significant), FEELING ABNORMAL (I have generally felt bad) and FATIGUE (tired and sluggish). At the time of the report, ERYTHEMA NODOSUM (Erythema Nodosum), HYPOAESTHESIA (left side of my face went numb), FEELING ABNORMAL (I have generally felt bad), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm), CHILLS (chills) and FATIGUE (tired and sluggish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medication has been reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company comment - This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.   This case was linked to MOD-2021-322417 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia
Clinical narrative: I have generally felt bad; Erythema Nodosum; tired and sluggish; left side of my face went numb; low energy for a couple of days; sore left injection site arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA NODOSUM (Erythema Nodosum) and HYPOAESTHESIA (left side of my face went numb) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HYPOAESTHESIA (left side of my face went numb) (seriousness criterion medically significant), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm) and CHILLS (chills). On 01-Jun-2021, the patient experienced ERYTHEMA NODOSUM (Erythema Nodosum) (seriousness criterion medically significant), FEELING ABNORMAL (I have generally felt bad) and FATIGUE (tired and sluggish). At the time of the report, ERYTHEMA NODOSUM (Erythema Nodosum), HYPOAESTHESIA (left side of my face went numb), FEELING ABNORMAL (I have generally felt bad), ASTHENIA (low energy for a couple of days), MYALGIA (sore left injection site arm), CHILLS (chills) and FATIGUE (tired and sluggish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment medication has been reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Company comment - This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.   This case was linked to MOD-2021-322417 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female patient with no relevant medical history, who experienced the unexpected events of hypoaesthesia and Erythema nodosum. The event hypoaesthesia occurred on the same day after first dose of Spikevax. The event erythema nodosum occurred 4 months and 3 days after second dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report. Further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: made her arm a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (made her arm a little sore) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced VACCINATION SITE PAIN (made her arm a little sore). At the time of the report, VACCINATION SITE PAIN (made her arm a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Lymph node pain
Clinical narrative: strange tenderness on left side of breast; painful within her breast or lymph nodes; painful within her breast or lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E12A, 018B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes). At the time of the report, BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Hyperhidrosis, Insomnia
Clinical narrative: Head spinning; Blacked out; Fever of 102.7F; Chills; Sweating the whole night; Unable to sleep (just rest her eyes); Muscle cramps  and/or muscle convulsions; Felling freezing; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)) and MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing) and CHILLS (Chills). On 18-Sep-2021, the patient experienced VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out) and PYREXIA (Fever of 102.7F). At the time of the report, VERTIGO (Head spinning) had not resolved and LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing), PYREXIA (Fever of 102.7F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 102.7 (High) 102.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 32 year old female, with no details on medical history provided, who experienced the unexpected event of LOSS OF CONSCIOUSNESS. The event occurred approximately one day after receiving a dose of Spikevax, which dose number is unknown. Rechallenge is unknown as there is no information about other doses of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of loss of consciousness was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle spasms, Pyrexia, Vertigo
Clinical narrative: Head spinning; Blacked out; Fever of 102.7F; Chills; Sweating the whole night; Unable to sleep (just rest her eyes); Muscle cramps  and/or muscle convulsions; Felling freezing; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)) and MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing) and CHILLS (Chills). On 18-Sep-2021, the patient experienced VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out) and PYREXIA (Fever of 102.7F). At the time of the report, VERTIGO (Head spinning) had not resolved and LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing), PYREXIA (Fever of 102.7F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 102.7 (High) 102.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 32 year old female, with no details on medical history provided, who experienced the unexpected event of LOSS OF CONSCIOUSNESS. The event occurred approximately one day after receiving a dose of Spikevax, which dose number is unknown. Rechallenge is unknown as there is no information about other doses of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of loss of consciousness was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: sore arm; did not get second shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Coronary artery disease.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (did not get second shot). At the time of the report, MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter.  Company comment: This case concerns a 60-year-old, female patient with relevant medical history of coronary artery disease, who experienced the expected event of Myalgia and unexpected event of Product dose omission. The event of Myalgia occurred on an unknown date and the patient did not receive the second dose of the Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event of Myalgia happened after the first dose. The events were considered related to the product per the reporter's assessment. The event of Myalgia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old, female patient with relevant medical history of coronary artery disease, who experienced the expected event of Myalgia and unexpected event of Product dose omission. The event of Myalgia occurred on an unknown date and the patient did not receive the second dose of the Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event of Myalgia happened after the first dose. The events were considered related to the product per the reporter's assessment. The event of Myalgia is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: still not coming; period should have come at the beginning of September; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September) 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 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-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 MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September). At the time of the report, MENSTRUATION IRREGULAR (still not coming) and MENSTRUATION DELAYED (period should have come at the beginning of September) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Moderna vaccine to a 6 years old instead of Flu vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concomitant products included GUANFACINE HYDROCHLORIDE (TENEX) for an unknown indication.    On 18-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine). On 18-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered Moderna vaccine to a 6 years old instead of Flu vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist was doing immunizations today, She accidentally grabbed a Moderna Covid 19 Vaccine instead of a Flu vaccine and administered it to a pediatric (6years old) patient.   No treatment medications were given.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia
Clinical narrative: left arm became numb; feeling extreme cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Myositis.    On 14-Apr-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 HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold). At the time of the report, HYPOAESTHESIA (left arm became numb) and FEELING COLD (feeling extreme cold) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had ILB (abbreviation unknown) as prior health conditions.  The patient was not on any concomitant medications.   This case was linked to MOD-2021-322849, MOD-2021-322850 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Have a high fever 24hrs after the vaccine. 101.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) 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 PYREXIA (Have a high fever 24hrs after the vaccine. 101.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PYREXIA (Have a high fever 24hrs after the vaccine. 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) high fever 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adolescent received Moderna COVID-19 vaccine/child was too young; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adolescent received Moderna COVID-19 vaccine/child was too young) to be possibly related.    No concomitant medications were provided. No treatment medications were reported. It was reported that   Moderna  instructed that if the child was between the ages of 12-17 that the second dose of Moderna covid vaccine should be given following 28 days from the first dose and hence the second dose was given.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant follow-up appended: Patient demographics, dose 1 and 2 details, event details added.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Nausea, Swollen tongue, Urticaria
Clinical narrative: tongue is swelling a bit that she cannot see the uvula when she opens her mouth; hives around her neck; body temperature is now 100 degrees Fahrenheit; A bit nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth), URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth), URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (tongue is swelling a bit that she cannot see the uvula when she opens her mouth) had not resolved and URTICARIA (hives around her neck), BODY TEMPERATURE INCREASED (body temperature is now 100 degrees Fahrenheit) and NAUSEA (A bit nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 degrees fahrenheit (High) 100 degrees Fahrenheit.         No concomitant medications were provided.