chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   NO CONCOMITANT AND TREATMENT DRUGS WERE GIVEN. CO-SUSPECT DRUG HUMIRA IS GIVEN   This case was linked to MOD-2021-165802 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Inner ear was dislodged; Head would go woo while turning in bed; Red spot , big red lump; A little tired; Bad episode of vertigo; Dizziness / "a little dizzy"; Headache; Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Bad episode of vertigo), VERTIGO (Head would go woo while turning in bed), DIZZINESS (Dizziness / "a little dizzy") and ERYTHEMA (Red spot , big red lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022IN20A and 022IN20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth extraction (bad episode of vertigo starting 12Mar2021 right before a dental extraction.).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Body aches). On 23-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Slight fever). On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness / "a little dizzy"). On 12-Mar-2021, the patient experienced VERTIGO (Bad episode of vertigo). On an unknown date, the patient experienced VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Vestibular Therapy) for Vertigo positional and Manual therapy (2 maneuvers were completed in vestibular therapy) for Vertigo. At the time of the report, VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump), HEADACHE (Headache), PYREXIA (Slight fever), MYALGIA (Body aches) and FATIGUE (A little tired) outcome was unknown, VERTIGO (Bad episode of vertigo) had resolved and DIZZINESS (Dizziness / "a little dizzy") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (normal) Reports having CT scan and other test that were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Patient  was seen at the emergency department, neurology specialist office and received vestibular therapy.  Action taken with mRNA-1273 in response to the event was not applicable.   Patient had 2 doses of vaccinations, reports episodes of dizziness have returned starting last week   This case was linked to MOD-2021-166578 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vertigo, Vertigo positional
Clinical narrative: Inner ear was dislodged; Head would go woo while turning in bed; Red spot , big red lump; A little tired; Bad episode of vertigo; Dizziness / "a little dizzy"; Headache; Slight fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Bad episode of vertigo), VERTIGO (Head would go woo while turning in bed), DIZZINESS (Dizziness / "a little dizzy") and ERYTHEMA (Red spot , big red lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022IN20A and 022IN20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tooth extraction (bad episode of vertigo starting 12Mar2021 right before a dental extraction.).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Body aches). On 23-Jan-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Slight fever). On 04-Mar-2021, the patient experienced DIZZINESS (Dizziness / "a little dizzy"). On 12-Mar-2021, the patient experienced VERTIGO (Bad episode of vertigo). On an unknown date, the patient experienced VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Vestibular Therapy) for Vertigo positional and Manual therapy (2 maneuvers were completed in vestibular therapy) for Vertigo. At the time of the report, VERTIGO POSITIONAL (Inner ear was dislodged), VERTIGO (Head would go woo while turning in bed), ERYTHEMA (Red spot , big red lump), HEADACHE (Headache), PYREXIA (Slight fever), MYALGIA (Body aches) and FATIGUE (A little tired) outcome was unknown, VERTIGO (Bad episode of vertigo) had resolved and DIZZINESS (Dizziness / "a little dizzy") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (normal) Reports having CT scan and other test that were normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Patient  was seen at the emergency department, neurology specialist office and received vestibular therapy.  Action taken with mRNA-1273 in response to the event was not applicable.   Patient had 2 doses of vaccinations, reports episodes of dizziness have returned starting last week   This case was linked to MOD-2021-166578 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm; adminstered to patient / had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (adminstered to patient / had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (adminstered to patient / had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm). At the time of the report, PRODUCT STORAGE ERROR (had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) and EXPIRED PRODUCT ADMINISTERED (adminstered to patient / had a temperature excursion where the highest the vials got was 10.6 degrees Celsius from about 7:30am-3:30pm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with the drug was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed getting my second dose by day 41; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed getting my second dose by day 41) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , no treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI follow up received on 25-may-2021
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test
Clinical narrative: "sore shoulder" (injection site) after 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified (Patient had two Open Heart surgeries) and Lupus syndrome. Concomitant products included LOSARTAN, METOPROLOL, HYDROXYCHLOROQUINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FUROSEMIDE and IRON for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine). The patient was treated with HYDROCODONE for Pain relief, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 800 mg, 2 tabs every four hours. At the time of the report, ARTHRALGIA ("sore shoulder" (injection site) after 1st vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Arthritis: elevated (High) elevated inflammation - arthritis test extremely high. On an unknown date, Blood test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-110157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feels awful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels awful) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOF) and Olanzatine for an unknown indication.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-May-2021, the patient experienced FEELING ABNORMAL (Feels awful). At the time of the report, FEELING ABNORMAL (Feels awful) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein increased, Red blood cell sedimentation rate increased
Clinical narrative: high levels of esr and crp; high levels of esr and crp; 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 RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp) outcome was unknown.            No concomitant medications were used. Treatment drugs used were unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and Unknown) for COVID-19 vaccination.     No medical history was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: have others reported skin rashes with Moderna?; This spontaneous case was reported by a consumer and describes the occurrence of RASH (have others reported skin rashes with Moderna?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (have others reported skin rashes with Moderna?). At the time of the report, RASH (have others reported skin rashes with Moderna?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: the 1st dose I became very ill; 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 ILLNESS (the 1st dose I became very ill) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (the 1st dose I became very ill). At the time of the report, ILLNESS (the 1st dose I became very ill) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: peeling of the skin on the hands; This spontaneous case was reported by a patient and describes the occurrence of SKIN EXFOLIATION (peeling of the skin on the hands) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unk dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (peeling of the skin on the hands). At the time of the report, SKIN EXFOLIATION (peeling of the skin on the hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Treatment information were not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Mild fever; Body ache; 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 PYREXIA (Mild fever) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Mild fever) and MYALGIA (Body ache). At the time of the report, PYREXIA (Mild fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21 Jul 2021 contains no significant information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Where i got the shot i have a ball; 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 SITE SWELLING (Where i got the shot i have a ball) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Where i got the shot i have a ball). At the time of the report, VACCINATION SITE SWELLING (Where i got the shot i have a ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No information about treatment medication was given
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Headache, Nausea
Clinical narrative: Tested positive for COVID-19; Dizziness; Headache; Chills; Slight fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Slight fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea). On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 after 1st dose..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Dizziness; Headache; Chills; Slight fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Slight fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea). On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19), DIZZINESS (Dizziness), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Slight fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 after 1st dose..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hangover
Clinical narrative: Feels like a really bad hangover; Still don't feel good; 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 FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover). At the time of the report, FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover) outcome was unknown.            No concomitant medication was reported , No treatment medication was reported . Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site movement impairment
Clinical narrative: couldn't lift her left arm; Terrible headache; Fever (recorded temperature of over 101 at noon); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history information was provided.  Concomitant products included CITALOPRAM for an unknown indication.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)). The patient was treated with IBUPROFEN on 28-May-2021 at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift her left arm), HEADACHE (Terrible headache) and PYREXIA (Fever (recorded temperature of over 101 at noon)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 1 June 2021 contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            The concomitant medications were not reported.  The patient had his last vaccination on Saturday. No treatment information was provided but the reporter was concerned about the drug to be administered for the event.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arms have been hurting for about3 weeks; 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 MYALGIA (arms have been hurting for about3 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced MYALGIA (arms have been hurting for about3 weeks). At the time of the report, MYALGIA (arms have been hurting for about3 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: serious hives in my upper chest area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (serious hives in my upper chest area) 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 URTICARIA (serious hives in my upper chest area). At the time of the report, URTICARIA (serious hives in my upper chest area) had not resolved.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: had bad itchy flare up; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (had bad itchy flare up) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 24-Dec-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 150 milligram per milliliter every two weeks. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (had bad itchy flare up). At the time of the report, RASH PRURITIC (had bad itchy flare up) outcome was unknown.            No relevant concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional  information regarding address was updated. On 07-Jul-2021: Additional information contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: my smell and taste have been off and different; my smell and taste have been off and different; 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 ANOSMIA (my smell and taste have been off and different) and AGEUSIA (my smell and taste have been off and different) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (my smell and taste have been off and different) and AGEUSIA (my smell and taste have been off and different). At the time of the report, ANOSMIA (my smell and taste have been off and different) and AGEUSIA (my smell and taste have been off and different) outcome was unknown.            No concomitant medication was reported , No treatment medication was reported .
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination complication
Clinical narrative: How long do side effects last before I should be worried; My side effect of weakness in my legs lasted about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long do side effects last before I should be worried) and MUSCULAR WEAKNESS (My side effect of weakness in my legs lasted about 5 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do side effects last before I should be worried) and MUSCULAR WEAKNESS (My side effect of weakness in my legs lasted about 5 days). At the time of the report, VACCINATION COMPLICATION (How long do side effects last before I should be worried) and MUSCULAR WEAKNESS (My side effect of weakness in my legs lasted about 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-jun-2021 contains significant information. Added New event: Weakness of lower extremities added. Outcome of the event updated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeding disorder, Hypersomnia
Clinical narrative: shakes; hard to eat/couldn't eat that much; kept sleeping; chills; body was sore; woke up throwing up that persisted and lasted through the night; diarrhea that persisted and lasted through the night.; felt fatigued which lasted the two days,still fatigued; Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again; felt like growing pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains), DIARRHOEA (diarrhea that persisted and lasted through the night.), TREMOR (shakes) and FEEDING DISORDER (hard to eat/couldn't eat that much) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued). On 29-May-2021, the patient experienced DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night). On 30-May-2021, the patient experienced TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore). On 21-May-2021, PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued) had resolved. On 30-May-2021, DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night) had resolved. On 02-Jun-2021, TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore) 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.   No relevant concomitant medications reported.  No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Tremor, Vomiting
Clinical narrative: shakes; hard to eat/couldn't eat that much; kept sleeping; chills; body was sore; woke up throwing up that persisted and lasted through the night; diarrhea that persisted and lasted through the night.; felt fatigued which lasted the two days,still fatigued; Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again; felt like growing pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains), DIARRHOEA (diarrhea that persisted and lasted through the night.), TREMOR (shakes) and FEEDING DISORDER (hard to eat/couldn't eat that much) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued). On 29-May-2021, the patient experienced DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night). On 30-May-2021, the patient experienced TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore). On 21-May-2021, PAIN IN EXTREMITY (Soreness in arms leg/with a weird soreness in my right leg/the same soreness in my legs started up again), PAIN (felt like growing pains) and FATIGUE (felt fatigued which lasted the two days,still fatigued) had resolved. On 30-May-2021, DIARRHOEA (diarrhea that persisted and lasted through the night.) and VOMITING (woke up throwing up that persisted and lasted through the night) had resolved. On 02-Jun-2021, TREMOR (shakes), FEEDING DISORDER (hard to eat/couldn't eat that much), HYPERSOMNIA (kept sleeping), CHILLS (chills) and MYALGIA (body was sore) 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.   No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today) 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 (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient wanting to get 2nd shot for covid of Moderna  at 89 days between 1st shot and today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extremely fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely fatigue). At the time of the report, FATIGUE (Extremely fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joints were sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints were sore) 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 ARTHRALGIA (joints were sore). At the time of the report, ARTHRALGIA (joints were sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Mouth swelling, Mouth ulceration, Myalgia
Clinical narrative: sore throat; Mouth sore; Mouth Red; Roof of Mouth swollen; Headache; feverish; Night sweats; Didn't feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and OROPHARYNGEAL PAIN (sore throat) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Sore arm). On 03-Jun-2021, the patient experienced PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen). On 09-May-2021, MYALGIA (Sore arm) had resolved. On 03-Jun-2021, PYREXIA (feverish) had resolved. On 04-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, MALAISE (Didn't feel well), OROPHARYNGEAL PAIN (sore throat), HEADACHE (Headache), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen) 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Oral pain, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; Mouth sore; Mouth Red; Roof of Mouth swollen; Headache; feverish; Night sweats; Didn't feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and OROPHARYNGEAL PAIN (sore throat) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  No concomitant medication reported.     On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Sore arm). On 03-Jun-2021, the patient experienced PYREXIA (feverish), NIGHT SWEATS (Night sweats), MALAISE (Didn't feel well) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen). On 09-May-2021, MYALGIA (Sore arm) had resolved. On 03-Jun-2021, PYREXIA (feverish) had resolved. On 04-Jun-2021, NIGHT SWEATS (Night sweats) had resolved. At the time of the report, MALAISE (Didn't feel well), OROPHARYNGEAL PAIN (sore throat), HEADACHE (Headache), ORAL PAIN (Mouth sore), MOUTH ULCERATION (Mouth Red) and MOUTH SWELLING (Roof of Mouth swollen) 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.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: can take any pain killer after vaccine?; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (can take any pain killer after vaccine?) 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 PAIN (can take any pain killer after vaccine?). At the time of the report, PAIN (can take any pain killer after vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed for 3-4 hours, it was an odd sensation; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed for 3-4 hours, it was an odd sensation) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and LEVOTHYROXINE SODIUM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (light headed for 3-4 hours, it was an odd sensation). On 13-Jan-2021, DIZZINESS (light headed for 3-4 hours, it was an odd sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-033172 (Patient Link).