chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 09-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-253017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Email address added.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) in a 41-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   It was reported that patient didn't take any medication for COVID-19 Infection.   This case was linked to MOD-2021-253192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information included event and event outcome. Changed qualification of reporter.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. This is a case of lack of effect assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Further information is expected upon follow-up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Dizziness, Dysstasia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed) and DIZZINESS (Dizzy spells) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc (lower).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees). At the time of the report, PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees) outcome was unknown.            No concomitant product information was provided. No treatment information was provided. Patient reported that She had been to eye, hearing, and orthopedic specialists, and all said they could not find anything and her bloodwork was also fine. The neurologist was scheduled to do magnetic resonance imaging (MRI) scans of her head in Sep/2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added Patient demographics(date of birth), Medical history, Dose 1 information, Anatomical location for dose 2 and new events(Dizzy spells, pain in her knees, unsteady on her foot, could not walk without a walker). Updated dose 2 batch number and event verbatim (fall, balance disorder). On 25-Aug-2021: Follow up received contains no new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait inability, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed) and DIZZINESS (Dizzy spells) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc (lower).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees). At the time of the report, PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees) outcome was unknown.            No concomitant product information was provided. No treatment information was provided. Patient reported that She had been to eye, hearing, and orthopedic specialists, and all said they could not find anything and her bloodwork was also fine. The neurologist was scheduled to do magnetic resonance imaging (MRI) scans of her head in Sep/2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added Patient demographics(date of birth), Medical history, Dose 1 information, Anatomical location for dose 2 and new events(Dizzy spells, pain in her knees, unsteady on her foot, could not walk without a walker). Updated dose 2 batch number and event verbatim (fall, balance disorder). On 25-Aug-2021: Follow up received contains no new information
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Oropharyngeal pain, Vaccination site pruritus
Clinical narrative: lower back pain; sore throat; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, BACK PAIN (lower back pain), OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PRURITUS (Itchiness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: contains no new information and email id provided by reporter was not correct
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Slight pain in left arm where he received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight pain in left arm where he received the injection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Slight pain in left arm where he received the injection). At the time of the report, VACCINATION SITE PAIN (Slight pain in left arm where he received the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, SARS-CoV-2 test positive: positive Positive.     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 medication: AMLIDOPIN- 25mg 00-00-2020 ongoing. No treatment medication were reported.   This case was linked to MOD-2021-259995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Significant Follow-up includes patient age, height, weight, concomitant drugs and lab tests.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Fatigue, Headache
Clinical narrative: headache; Diarrhea; Nausea; kept falling in and out of sleep; talking continuously in her sleep; left arm was "on fire" and was red; sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore; "102 fever"; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache) and MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Pain. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Pain, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ESCITALOPRAM OXALATE (LEXAPRO), ALENDRONATE SODIUM (FOSAMAX OW), HYDROCHLOROTHIAZIDE, LABETALOL HYDROCHLORIDE (LABETALOL [LABETALOL HYDROCHLORIDE]), SPIRONOLACTONE (SPIRONOLACTONE A L), LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN D3, ALPRAZOLAM (XANAX SR) and ZOLPIDEM TARTRATE (AMBIEN CR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills) and FATIGUE (tired). On an unknown date, the patient experienced HEADACHE (headache), DIARRHEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills), FATIGUE (tired), DIARRHEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-294310 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Updated reporter address and new events diarrhea, nausea, and headache were added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Sleep disorder, Sleep talking
Clinical narrative: headache; Diarrhea; Nausea; kept falling in and out of sleep; talking continuously in her sleep; left arm was "on fire" and was red; sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore; "102 fever"; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache) and MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Pain. Concomitant products included HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) for Pain, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), ESCITALOPRAM OXALATE (LEXAPRO), ALENDRONATE SODIUM (FOSAMAX OW), HYDROCHLOROTHIAZIDE, LABETALOL HYDROCHLORIDE (LABETALOL [LABETALOL HYDROCHLORIDE]), SPIRONOLACTONE (SPIRONOLACTONE A L), LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN D3, ALPRAZOLAM (XANAX SR) and ZOLPIDEM TARTRATE (AMBIEN CR) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills) and FATIGUE (tired). On an unknown date, the patient experienced HEADACHE (headache), DIARRHEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCODONE BITARTRATE (HYDROCODONE [HYDROCODONE BITARTRATE]) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (kept falling in and out of sleep), SLEEP TALKING (talking continuously in her sleep), ERYTHEMA (left arm was "on fire" and was red), HEADACHE (headache), MYALGIA (sore left arm/left arm was "on fire/her left arm is "not as bad as last night but is still sore), PYREXIA ("102 fever"), CHILLS (chills), FATIGUE (tired), DIARRHEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-294310 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Updated reporter address and new events diarrhea, nausea, and headache were added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Heavy menstrual bleeding, Palpitations, Pyrexia
Clinical narrative: Bleeding (heavy flow); Palpitation; Severe headache; Fever (104 to 105 degrees Fahrenheit); This spontaneous case was reported by a nurse and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding (heavy flow)), PALPITATIONS (Palpitation), HEADACHE (Severe headache) and PYREXIA (Fever (104 to 105 degrees Fahrenheit)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078CZ1A and 033C21A) for COVID-19 vaccination.     The patient's past medical history included Menopause (6 years ago). Concurrent medical conditions included Allergy to antibiotic (Allergy to Levoquine), Allergy to antibiotic (Allergy to Ciprofloxacin), Sulfonamide allergy (Allergy to sulfur), Allergy to antibiotic (Allergy to Azithromycin) and Allergy to antibiotic (Allergy to Clindamycin).   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced PALPITATIONS (Palpitation), HEADACHE (Severe headache) and PYREXIA (Fever (104 to 105 degrees Fahrenheit)). On 11-Jul-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding (heavy flow)). On 05-Jul-2021, PYREXIA (Fever (104 to 105 degrees Fahrenheit)) had resolved. On 09-Jul-2021, PALPITATIONS (Palpitation) and HEADACHE (Severe headache) had resolved. In August 2021, HEAVY MENSTRUAL BLEEDING (Bleeding (heavy flow)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, Body temperature: 104 to 105 (High) 104 to 105 degrees Fahrenheit : fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Antidepressant and Supplements once a week. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: follow up received. added Reporter address, updated event outcome for heavy menstrual bleeding and palpitation, allergy added as medical history.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash
Clinical narrative: sleeping 3 hours a day; rash mostly all over back,neck to waist, upper arm,side of legs; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleeping 3 hours a day) and RASH (rash mostly all over back,neck to waist, upper arm,side of legs) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatitis since 23-Jul-2021. Concomitant products included LOSARTAN, LEVOTHYROXINE and ROSUVASTATIN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-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 INSOMNIA (sleeping 3 hours a day) and RASH (rash mostly all over back,neck to waist, upper arm,side of legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of 1 dosage form and CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Itching, at a dose of 1 dosage form. At the time of the report, INSOMNIA (sleeping 3 hours a day) outcome was unknown and RASH (rash mostly all over back,neck to waist, upper arm,side of legs) had not resolved.            The patient went to urgent care on 23 Jul 2021 finally diagnose the rash as "dermatitis unspecified and also said that to take 14 pills a day.  The patient also took ulcerative colitis medication and Hydrochloride.  The patient had an appointment with dermatologist on 17 Aug 2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus that is ongoing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus that is ongoing). At the time of the report, TINNITUS (tinnitus that is ongoing) had not resolved.            No concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: semi paralized; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (semi paralized) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (semi paralized) (seriousness criteria hospitalization and medically significant). At the time of the report, PARALYSIS (semi paralized) outcome was unknown.            Concomitant medication of the patient was not reported.  At the time of reporting, the patient was at 20th day of hospitalization.  No treatment information was provided by the reporter.  Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered today from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered today from a vial that was punctured more than 12 hours ago) had resolved.            No concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: With embryo in the womb received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (With embryo in the womb received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.; Sender's Comments: This is a case of product exposure during pregnancy with  associated no AE of   female (age not provided). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Really really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Really really sick) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, 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 (Really really sick). At the time of the report, ILLNESS (Really really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  Reporter/patient's spouse was a lead pharmacy technician. She did not have the vaccination card at the time of reporting and mentioned the date of vaccination as 23-Dec-2021.   This case was linked to MOD-2021-291688 .
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reactions; 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 VACCINATION COMPLICATION (bad reactions) 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 VACCINATION COMPLICATION (bad reactions). At the time of the report, VACCINATION COMPLICATION (bad reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Lipids normal, Musculoskeletal pain, Neck pain
Clinical narrative: musculoskeletal pain; Chest Pains; Neck Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pains), NECK PAIN (Neck Pain) and MUSCULOSKELETAL PAIN (musculoskeletal pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced CHEST PAIN (Chest Pains) and NECK PAIN (Neck Pain). On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (musculoskeletal pain). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest Pains) had not resolved, NECK PAIN (Neck Pain) had resolved and MUSCULOSKELETAL PAIN (musculoskeletal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Blood pressure measurement: normal (normal) good. On 18-Aug-2021, Lipids normal: normal (normal) good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  On 13-Aug-2021, the patient started getting neck and chest pains. the patient went to the local ED (emergency department), where they diagnosed with musculoskeletal pain. The patient was advised everything was normal by ED team and was discharged the same day without prolong hospitalization. The patient had also been advised by HCP to take ibuprofen and monitor the symptoms. The patient states that neck pain went away couple of days ago, but chest pain was still ongoing. The patient took blood pressure and cholesterol medications (unspecified).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: dizziness; sweats; sore body; chills; fever; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills) and PYREXIA (fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-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 DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications provided. No Treatment medications provided. The patient did not experienced cough. The patient received the second dose of the Moderna COVID-19 vaccine on 18-Aug-2021 and both doses were given in the patients left arm. The second doses lot number was 939901.   This case was linked to MOD-2021-292178 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: dizziness; sweats; sore body; chills; fever; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills) and PYREXIA (fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-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 DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), HYPERHIDROSIS (sweats), PAIN (sore body), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications provided. No Treatment medications provided. The patient did not experienced cough. The patient received the second dose of the Moderna COVID-19 vaccine on 18-Aug-2021 and both doses were given in the patients left arm. The second doses lot number was 939901.   This case was linked to MOD-2021-292178 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: Inflammation of knees; Pain in his knees; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees). The patient was treated with PREDNISONE for Inflammation, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had been having a problem with his knees for 6 months to a year before getting the vaccine.  Concomitant product use was not provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pruritus, Vaccination site scar, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Warm to the touch; Tingling; Dollar coin-size welt on my left arm where I received the vaccine; Itching; Small marking on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SCAR (Small marking on my arm) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced VACCINATION SITE SCAR (Small marking on my arm). On 18-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 19-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SCAR (Small marking on my arm) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Liver disorder
Clinical narrative: Liver problems; This spontaneous case was reported by an other health care professional and describes the occurrence of LIVER DISORDER (Liver problems) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (Liver problems). At the time of the report, LIVER DISORDER (Liver problems) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Hepatic enzyme increased: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER DISORDER (Liver problems) to be probably related.    No concomitant medications were reported. Treatment information was not provided. The patient had normal liver enzymes before. The patient  went for a routine visit to her PCP and she went for an ultrasound and after 13 vials of bloodwork and about 30 lab test they appeared  normal. The patient had a liver problem and it is probably  related to the immunization.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: Hair loss,it has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss,it has gotten worse) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, VILAZODONE HYDROCHLORIDE (VIIBRYD) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) and ZOLPIDEM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ALOPECIA (Hair loss,it has gotten worse). At the time of the report, ALOPECIA (Hair loss,it has gotten worse) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) A blood test came out fine..         The concomitant medication used for depression and anxiety. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Over 35 days since patient's 1st dose in Mid April) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 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 (Over 35 days since patient's 1st dose in Mid April). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Over 35 days since patient's 1st dose in Mid April) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) 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 VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose interval more than 42 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval more than 42 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (PCN).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval more than 42 days). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval more than 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Added second dose onset date Event Inappropriate schedule of vaccine administration and narrative was update accordingly.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Vision blurred
Clinical narrative: Dizziness; Weakness; Blurred vision/inability to focus; Headache; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) 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) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), VISION BLURRED (inability to focus ) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Reporter information of postal code and state added, patient details of age and gender added, in product, Date of vaccination added and events are added.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Continued to have wheezing; Could not sleep at night/unable to sleep; Having a hard time working; Felt fatigued/ chronic fatigue and slept constantly; Heart rate elevated; Blood pressure elevated; That night he had another psychotic episode; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (That night he had another psychotic episode), WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and HEART RATE INCREASED (Heart rate elevated) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (had asthma as a child).    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PSYCHOTIC DISORDER (That night he had another psychotic episode). On 31-Jul-2021, the patient experienced HEART RATE INCREASED (Heart rate elevated). 31-Jul-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure elevated). On an unknown date, the patient experienced WHEEZING (Continued to have wheezing), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PSYCHOTIC DISORDER (That night he had another psychotic episode), INSOMNIA (Could not sleep at night/unable to sleep), IMPAIRED WORK ABILITY (Having a hard time working), HEART RATE INCREASED (Heart rate elevated), BLOOD PRESSURE INCREASED (Blood pressure elevated) and FATIGUE (Felt fatigued/ chronic fatigue and slept constantly) outcome was unknown and WHEEZING (Continued to have wheezing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Blood pressure measurement: high (High) High. On 31-Jul-2021, Heart rate: high (High) High.         Concomitant medications were not reported.  Patient went to emergency room on 31-july-2021 and had more X-rays and breathing treatments. They suggested he had either asthma or pulmonary hypertension but not yet confirmed. On 02-Aug-2021 patient went to a pulmonologist who said it look like asthma and started breathing treatments but not the albuterol. Patient had still albuterol inhaler during night which caused him to be unable to sleep. He had blood work done on 19-Aug-2021   This case was linked to MOD-2021-293168 (Patient Link).