chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I havnt had my second shot yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I havnt had my second shot yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received moderna vaccine in january and never went back for second dosing; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received moderna vaccine in january and never went back for second dosing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood sodium, Decreased appetite, Dyspnoea, Heart rate
Clinical narrative: Low appetite; Diagnosed with central sleep apnea; high blood pressure and high heart rate; Mucus blocking windpipe; Trouble breathing at nighttime; > 35 Days past first dose; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe) and DYSPNOEA (Trouble breathing at nighttime) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and AZELASTINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood sodium: low (Low) Low sodium. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.Treatment medication  was reported as Sterile Saline 3%.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Increased viscosity of upper respiratory secretion, Product dose omission issue, Sleep apnoea syndrome
Clinical narrative: Low appetite; Diagnosed with central sleep apnea; high blood pressure and high heart rate; Mucus blocking windpipe; Trouble breathing at nighttime; > 35 Days past first dose; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe) and DYSPNOEA (Trouble breathing at nighttime) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and AZELASTINE for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Low appetite), SLEEP APNOEA SYNDROME (Diagnosed with central sleep apnea), HYPERTENSION (high blood pressure and high heart rate), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (Mucus blocking windpipe), DYSPNOEA (Trouble breathing at nighttime) and PRODUCT DOSE OMISSION ISSUE (> 35 Days past first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Blood sodium: low (Low) Low sodium. On an unknown date, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.Treatment medication  was reported as Sterile Saline 3%.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Patient took the first dose of the Moderna COVID-19 vaccine and was unsure about date, he was confused it being mid of March 2021 but in his calendar he has 17-Feb-2021 and the date was not recorded in the vaccination card, only that his second dose was supposed to be on ??-Apr-2021 and he has not got his second dose as patient was outside of the 42 days window.   This case was linked to CASE  MOD21-122483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 contains non-significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Ear pain, Fatigue, Heart rate, Ultrasound scan
Clinical narrative: feeling tired; Ear ache; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear ache) and FATIGUE (feeling tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038621A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced EAR PAIN (Ear ache). On an unknown date, the patient experienced FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear ache) and FATIGUE (feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (abnormal) high 102 degree. On an unknown date, Heart rate: high (High) Heart rate > 100 beats per min. On an unknown date, Ultrasound scan: normal (normal) normal.         patient had external temperature of 102 but orally it was normal. This case was linked to MOD-2021-073554, MOD-2021-073554 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle discomfort, Musculoskeletal discomfort, Myalgia, Pain
Clinical narrative: snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving; can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position; something about the muscle; it hurt and it hurt; right arm sore/  it's still sore; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, PRAVASTATIN and GABAPENTIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore). At the time of the report, LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 contains non- significant informations.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: recieved first dose in APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021) 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.    In April 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 PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (recieved first dose in APR-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Can the Moderna vaccine cause stomach issues?; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?). At the time of the report, ABDOMINAL DISCOMFORT (Can the Moderna vaccine cause stomach issues?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       . No concomitant medications reported. No treatment reported
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had their 1st dose of the Moderna Covid-19 vaccine on 09Mar2021) 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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Vomiting
Clinical narrative: Got first shot yesterday today  feel sick; Arm also hurts really bad; Headache; Can't keep anything down; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Got first shot yesterday today  feel sick), PAIN IN EXTREMITY (Arm also hurts really bad), HEADACHE (Headache) and VOMITING (Can't keep anything down) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Got first shot yesterday today  feel sick), PAIN IN EXTREMITY (Arm also hurts really bad), HEADACHE (Headache) and VOMITING (Can't keep anything down). At the time of the report, MALAISE (Got first shot yesterday today  feel sick), PAIN IN EXTREMITY (Arm also hurts really bad), HEADACHE (Headache) and VOMITING (Can't keep anything down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Oral mucosal eruption, Rash, Skin disorder
Clinical narrative: mouth that was dry; mouth that was rashy; problems with my skin; breakouts (mostly on my face) and one area around my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (mouth that was dry), ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (mouth that was dry), ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth). At the time of the report, DRY MOUTH (mouth that was dry) outcome was unknown and ORAL MUCOSAL ERUPTION (mouth that was rashy), SKIN DISORDER (problems with my skin) and RASH (breakouts (mostly on my face) and one area around my mouth) had not resolved.            No relevant concomitant medications were reported.  Patient reported that the second dose of vaccine was received in late Apr-2021, since then there was skin problems. The reaction was not severe but the rash did not resolve despite seeing a doctor and taking unspecified medicine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) 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 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 21-Jul-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue
Clinical narrative: Swelling in her legs, "It wasn't severe, it was noticeable to me but it wasn't severe"; More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her legs, "It wasn't severe, it was noticeable to me but it wasn't severe") and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her legs, "It wasn't severe, it was noticeable to me but it wasn't severe"). On 09-Mar-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling in her legs, "It wasn't severe, it was noticeable to me but it wasn't severe") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient did not receive any treatment for the swelling. The patient had an ultrasound done at her veins and they were normal. The patient experienced some swelling in her legs that lasted for about 1 month and a half.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site macule, Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: 2 red dots for both shots in the upper arm; Sore arm; Injection site hurts; Has 2 red dots for both shots in upper arm; can feel them at touch; fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MACULE (2 red dots for both shots in the upper arm), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 23-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced INJECTION SITE MACULE (2 red dots for both shots in the upper arm), PAIN IN EXTREMITY (Sore arm), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, INJECTION SITE MACULE (2 red dots for both shots in the upper arm), INJECTION SITE PAIN (Injection site hurts) and INJECTION SITE SWELLING (Has 2 red dots for both shots in upper arm; can feel them at touch) had not resolved and PAIN IN EXTREMITY (Sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use also included supplements (not specified).  Consent was given for Safety follow up.   This case was linked to MOD-2021-263790 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Chills, Cough, Feeding disorder
Clinical narrative: pressure headache; fever; throbbing/pressure headache; could not lie on her bath tub because of her back pain; cough; sweating; vomited; was not able to eat anything; real sharp pain on her upper and lower back, pain in lower back; pain on lower abdomen; numbness of the fingers on her right hand; nauseous; 2nd dose of the vaccine given beyond 36 days; arm hurt; chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back) and ABDOMINAL PAIN LOWER (pain on lower abdomen) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt) and CHILLS (chills). On 20-Jul-2021, the patient experienced FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), VOMITING (vomited) and NAUSEA (nauseous). On 21-Jul-2021, the patient experienced HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating) and HEADACHE (throbbing/pressure headache). On an unknown date, the patient experienced HEAD DISCOMFORT (pressure headache) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), HEAD DISCOMFORT (pressure headache), HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous) and HEADACHE (throbbing/pressure headache) outcome was unknown.            No Concomitant medications were provided. .
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Hyperhidrosis, Hypoaesthesia, Hypokinesia
Clinical narrative: pressure headache; fever; throbbing/pressure headache; could not lie on her bath tub because of her back pain; cough; sweating; vomited; was not able to eat anything; real sharp pain on her upper and lower back, pain in lower back; pain on lower abdomen; numbness of the fingers on her right hand; nauseous; 2nd dose of the vaccine given beyond 36 days; arm hurt; chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back) and ABDOMINAL PAIN LOWER (pain on lower abdomen) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt) and CHILLS (chills). On 20-Jul-2021, the patient experienced FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), VOMITING (vomited) and NAUSEA (nauseous). On 21-Jul-2021, the patient experienced HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating) and HEADACHE (throbbing/pressure headache). On an unknown date, the patient experienced HEAD DISCOMFORT (pressure headache) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), HEAD DISCOMFORT (pressure headache), HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous) and HEADACHE (throbbing/pressure headache) outcome was unknown.            No Concomitant medications were provided. .
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: pressure headache; fever; throbbing/pressure headache; could not lie on her bath tub because of her back pain; cough; sweating; vomited; was not able to eat anything; real sharp pain on her upper and lower back, pain in lower back; pain on lower abdomen; numbness of the fingers on her right hand; nauseous; 2nd dose of the vaccine given beyond 36 days; arm hurt; chills; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back) and ABDOMINAL PAIN LOWER (pain on lower abdomen) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt) and CHILLS (chills). On 20-Jul-2021, the patient experienced FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), VOMITING (vomited) and NAUSEA (nauseous). On 21-Jul-2021, the patient experienced HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating) and HEADACHE (throbbing/pressure headache). On an unknown date, the patient experienced HEAD DISCOMFORT (pressure headache) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of the vaccine given beyond 36 days), PAIN IN EXTREMITY (arm hurt), FEEDING DISORDER (was not able to eat anything), BACK PAIN (real sharp pain on her upper and lower back, pain in lower back), ABDOMINAL PAIN LOWER (pain on lower abdomen), HYPOAESTHESIA (numbness of the fingers on her right hand), HEAD DISCOMFORT (pressure headache), HYPOKINESIA (could not lie on her bath tub because of her back pain), COUGH (cough), HYPERHIDROSIS (sweating), VOMITING (vomited), CHILLS (chills), PYREXIA (fever), NAUSEA (nauseous) and HEADACHE (throbbing/pressure headache) outcome was unknown.            No Concomitant medications were provided. .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: heart fluttering happening several times a day lasting around 20 seconds; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030b21 and 024m21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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. In 2021, the patient experienced CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds). At the time of the report, CARDIAC FLUTTER (heart fluttering happening several times a day lasting around 20 seconds) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  Based on current available information and the temporal association between product use and the srtat date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the srtat date of the event a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Little fever for about one hour; Sore arm for a couple days; 1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jul-2021 and was forwarded to Moderna on 22-Jul-2021.    This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.), PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to sorghum), Food allergy (Allergic to sage), Rheumatoid arthritis since 1991 and Blood pressure high since 2004. Concomitant products included RAMIPRIL from 2004 to an unknown date and TAMSULOSIN from 2018 to an unknown date for Blood pressure high, METHOTREXATE from 1991 to an unknown date for Joint swelling, HYDROXYCHLOROQUINE SULFATE from 1991 to an unknown date and FOLIC ACID for Rheumatoid arthritis, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) from 2004 to an unknown date for Tachycardia.   On 04-Mar-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.). On an unknown date, the patient experienced PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days). On 05-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.) had resolved. At the time of the report, PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment details were not provided   This case was linked to MOD-2021-222134 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine). On 23-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old female patient was given the first dose of the Moderna Covid-19 vaccine instead of the Pfizer vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: both of us were deathley sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (both of us were deathley sick) in a 68-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (both of us were deathley sick). At the time of the report, ILLNESS (both of us were deathley sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-263840 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-263840:wife case
Sex: U
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, 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 IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines). At the time of the report, IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided. Concomitant medication information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion). On 22-Jul-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (1st dose of the Moderna Covid-19 vaccine given to 1 patient after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received and contains no new information
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Folks vaccinated in December and January who have now caught covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Folks vaccinated in December and January who have now caught covid) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Folks vaccinated in December and January who have now caught covid). At the time of the report, COVID-19 (Folks vaccinated in December and January who have now caught covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Ligament sprain, Muscle spasms
Clinical narrative: My husband had Moderna and he had leg cramps also very bad; He is sprainy; 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 MUSCLE SPASMS (My husband had Moderna and he had leg cramps also very bad) and LIGAMENT SPRAIN (He is sprainy) 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 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 MUSCLE SPASMS (My husband had Moderna and he had leg cramps also very bad) and LIGAMENT SPRAIN (He is sprainy). The patient was treated with MENTHOL (BIOFREEZE PAIN RELIEVING) for Leg cramps, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (My husband had Moderna and he had leg cramps also very bad) and LIGAMENT SPRAIN (He is sprainy) outcome was unknown.            No concomitant medication was provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Pyrexia
Clinical narrative: cannot get well; got very sick; fever 103F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (cannot get well), ILLNESS (got very sick) and PYREXIA (fever 103F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (cannot get well), ILLNESS (got very sick) and PYREXIA (fever 103F). At the time of the report, MALAISE (cannot get well), ILLNESS (got very sick) and PYREXIA (fever 103F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.   Reporter did not allow further contact