chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported.On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication information was provided.No treatment medication were provided.The vial was exposed to room temperature range from 9:30AM 17Nov2021 to administration 18Nov2021.The expired booster dose was administered to a female patient 18Nov2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 012L20A and 012L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLUARIX QUADRIVALENT (Manufacturer - Seqirus, Lot number - 308455, Route - Intramuscular and Body site - Left Arm). Past adverse reactions to the above products included No adverse event with FLUARIX QUADRIVALENT. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), AMLODIPINE, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BACLOFEN, APIXABAN (ELIQUIS), ATORVASTATIN and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a booster from Moderna form , a vial that had been punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up document received: Added reported information, added historical vaccine information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever/ 103 F; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) and PYREXIA (Fever/ 103 F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 096B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure, VITAMIN B [VITAMIN B NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever/ 103 F). In 2021, the patient experienced FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA (Fever/ 103 F) had resolved. At the time of the report, FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 f (High) fever.         This case concerns a 64 year old female with no relevant medical history reported , who experienced Non-serious , expected event of fatigue which occurred on the same day  after  vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine )   and fever which occurred the day after vaccination with the 2nd dose.. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given and also the outcome of the event  fatigue is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-392001 (Patient Link).; Sender's Comments: This case concerns a 64 year old female with no relevant medical history reported , who experienced Non-serious , expected event of fatigue which occurred on the same day  after  vaccination with the 2nd dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine )   and fever which occurred the day after vaccination with the 2nd dose.. The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be given and also the outcome of the event  fatigue is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Erythema
Clinical narrative: armpit deep red; she was in bed 5 days; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (armpit deep red), BEDRIDDEN (she was in bed 5 days) and ARTHRALGIA (joint pain) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (armpit deep red), BEDRIDDEN (she was in bed 5 days) and ARTHRALGIA (joint pain). At the time of the report, ERYTHEMA (armpit deep red), BEDRIDDEN (she was in bed 5 days) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that she would like to know if with the Moderna COVID-19 booster shot the immunity works as with the first two doses, that you had to wait 2 weeks to get full immunity   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyskinesia, Pyrexia, Tremor
Clinical narrative: Severe shaking of whole body; Whole body was jerking; Had a bad reaction/very extreme reaction to the 2nd dose.; Shivers; Had a fever of 104F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F) 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, the patient experienced TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F). At the time of the report, TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) fever of 104F.         No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-392034 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe shaking of whole body; Whole body was jerking; Had a bad reaction/very extreme reaction to the 2nd dose.; Shivers; Had a fever of 104F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F) 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, the patient experienced TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F). At the time of the report, TREMOR (Severe shaking of whole body), DYSKINESIA (Whole body was jerking), VACCINATION COMPLICATION (Had a bad reaction/very extreme reaction to the 2nd dose.), CHILLS (Shivers) and PYREXIA (Had a fever of 104F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) fever of 104F.         No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-392034 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Chills, Myalgia, Nasal congestion
Clinical narrative: Really bad cold; Congestion; sore throat; Fever; Chills; Body aches; Joint aches/joint pain; tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (Fever) in a female patient of an unknown age 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 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 TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain). At the time of the report, TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) She had great high numbers of antibodies.         No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-392232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received on 24-NOV-2021. Events (Sore throat and Congestion) added. Outcome of events(Tinnitus, fever, chills, body aches, joint pain, sore throat and congestion) updated from unknown to recovered/resolved. On 24-Nov-2021: Follow up received on 24-NOV-2021 and does not contain any new information; Sender's Comments: Non-serious Case
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Tinnitus
Clinical narrative: Really bad cold; Congestion; sore throat; Fever; Chills; Body aches; Joint aches/joint pain; tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (Fever) in a female patient of an unknown age 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 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 TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain). At the time of the report, TINNITUS (tinnitus on her ear for 6 months, very annoying metallic clicking sounds/metallic clicking in her ears, more her right ear than the left.), NASOPHARYNGITIS (Really bad cold), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and ARTHRALGIA (Joint aches/joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: high (High) She had great high numbers of antibodies.         No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-392232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received on 24-NOV-2021. Events (Sore throat and Congestion) added. Outcome of events(Tinnitus, fever, chills, body aches, joint pain, sore throat and congestion) updated from unknown to recovered/resolved. On 24-Nov-2021: Follow up received on 24-NOV-2021 and does not contain any new information; Sender's Comments: Non-serious Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Product administration error; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported The patient phone number was 2093219692   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow Up received on 22-nov-2021 and patients initial and phone number updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow Up received: patient initials added
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: they saw other weird things with the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (they saw other weird things with the vaccination) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (they saw other weird things with the vaccination). At the time of the report, VACCINATION COMPLICATION (they saw other weird things with the vaccination) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up information received was contain no new information.; Sender's Comments: Non-serious Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. No excursion occurred. The Moderna vials were taken out of the freezer, thawed and administered as instructed. No delays occurred in administration of Moderna vaccine. On 01Nov2021, all vaccines were administered within 4-5 hours.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received includes updated Second reporter Information.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Myalgia, Pyrexia
Clinical narrative: dehydrated; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  Concurrent medical conditions included Latex allergy and Diabetes since 2010.Concomitant products included METFORMIN and PRAVASTATIN from 2021 to an unknown date for an unknown indication.On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with MELOXICAM ongoing from October 2021 at a dose of 15 mg once a day; LOSARTAN ongoing from June 2021 at a dose of 50 mg once a day and PROPRANOLOL ongoing from June 2021 at a dose of 10 mg four times per day. In May 2021, DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In May 2020, SARS-CoV-2 test: positive (Positive) Positive.mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.Treatment information was not provided.This case was linked to MOD-2021-272486 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: dehydrated; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.  Concurrent medical conditions included Latex allergy and Diabetes since 2010.Concomitant products included METFORMIN and PRAVASTATIN from 2021 to an unknown date for an unknown indication.On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). The patient was treated with MELOXICAM ongoing from October 2021 at a dose of 15 mg once a day; LOSARTAN ongoing from June 2021 at a dose of 50 mg once a day and PROPRANOLOL ongoing from June 2021 at a dose of 10 mg four times per day. In May 2021, DEHYDRATION (dehydrated), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In May 2020, SARS-CoV-2 test: positive (Positive) Positive.mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.Treatment information was not provided.This case was linked to MOD-2021-272486 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: Lips are swollen; Rash on the neck; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips are swollen) and RASH (Rash on the neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer BioNtech (lot no. EN6204) on 13-Mar-2021 and Pfizer BioNtech (Lot no. EW0151) on 03-Apr-2021.Past adverse reactions to the above products included No adverse event with Pfizer BioNtech and Pfizer BioNtech.Concurrent medical conditions included Allergy (Allegra). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced LIP SWELLING (Lips are swollen) and RASH (Rash on the neck). At the time of the report, LIP SWELLING (Lips are swollen) and RASH (Rash on the neck) outcome was unknown. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.- On an unknown date, the patient 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 19-Nov-2021, the patient experienced LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side). At the time of the report, LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.It was reported that patient had no reactions to first 2 vaccines.No relevant concomitant medications were reported.No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Interchange of vaccine products, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches after 3rd dose), PYREXIA (High temperature after 3rd dose), HEADACHE (Terrible headache after 3rd dose) and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 non-Moderna COVID-19 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 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches after 3rd dose), PYREXIA (High temperature after 3rd dose), HEADACHE (Terrible headache after 3rd dose) and INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 non-Moderna COVID-19 vaccine). On 20-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 non-Moderna COVID-19 vaccine) had resolved. At the time of the report, FEELING ABNORMAL (Feel terrible after having our 3rd dose/Felt like death all night after 3rd dose), PAIN (Aches after 3rd dose), PYREXIA (High temperature after 3rd dose) and HEADACHE (Terrible headache after 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.No concomitant medications reported.No treatment reported. This case was linked to MOD-2021-395575 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 012120A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia. Concomitant products included SIMVASTATIN and MEMANTINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.). At the time of the report, SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No treatment reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm at the injection was sore), VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced VACCINATION SITE PAIN (Left arm at the injection was sore). On 19-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site). At the time of the report, VACCINATION SITE PAIN (Left arm at the injection was sore), VACCINATION SITE SWELLING (Left shoulder near the injection site was swollen.), VACCINATION SITE ERYTHEMA (Developed a red rash at the injection site) and VACCINATION SITE RASH (Developed a red rash at the injection site) outcome was unknown. No concomitant medication details were reported.No treatment medication details were reported.Most recent FOLLOW-UP information incorporated above includes:On 21-Nov-2021: Follow-up information received contains no new information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE and URSODEOXYCHOLIC ACID (URSODIOL) for an unknown indication.On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)). On 21-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of an expired dose (12 Hours post puncture)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.Date the vial was initially stored in the refrigerator: 20 Nov 2021. Date(s) and time(S) vial was first punctured: 03:25 PM 20 Nov 2021.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever; Muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) 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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant and Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt bad after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. Concurrent medical conditions included Fibroids and Hypercholesterolemia. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced FEELING ABNORMAL (Felt bad after vaccination). At the time of the report, FEELING ABNORMAL (Felt bad after vaccination) outcome was unknown. Concomitant medication also include some fibroid medication and cholesterol medication.No treatment information were provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, had that with the first 2 doses) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036A21A) for COVID-19 vaccination. The patient's past medical history included Surgery in November 2019 and Surgery ((right leg) product of a clot for the previous surgery.) in January 2020.Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Anticoagulant therapy.On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm, had that with the first 2 doses). At the time of the report, PAIN IN EXTREMITY (sore arm, had that with the first 2 doses) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No treatment details were reported. The patient mentioned she got a surgery on Nov2019 and in Jan2020 got a leg surgery in right leg product of a clot for the previous surgery. And, in September or October she experience the same pain in the inner thigh. This case was linked to MOD-2021-395873, MOD-2021-395892 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (feel like death/feel dead) 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 FEELING ABNORMAL (feel like death/feel dead). At the time of the report, FEELING ABNORMAL (feel like death/feel dead) 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. Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Other side effects with the first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects with the first and second dose) 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 VACCINATION COMPLICATION (Other side effects with the first and second dose). At the time of the report, VACCINATION COMPLICATION (Other side effects with the first and second dose) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-396027, MOD-2021-396011, MOD-2021-396027 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (They have temperature excursion 57 degrees F), EXPIRED PRODUCT ADMINISTERED (they still continue to vaccinate people even after the temperature rise.) and PRODUCT STORAGE ERROR (temperature excursion where the vaccine went to 57 degrees F for 40mins. They noticed it around 4Pm PST but they still continue to vaccinate people) 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 medication and treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication was not provided. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (after second dose, her arm was tender for a day or two) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M204 and 041620A) for COVID-19 vaccination. No Medical History information was reported.On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TENDERNESS (after second dose, her arm was tender for a day or two). In February 2021, TENDERNESS (after second dose, her arm was tender for a day or two) had resolved. No concomitant information provided by the reporter,No treatment information provided by the reporter. This case was linked to MOD-2021-396212, MOD-2021-396346 (Patient Link).
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Limb discomfort
Clinical narrative: Discomfort and decreased range of motion in injected arm. Cannot lift arm above a certain point and with difficulty. Has currently lasted about 6 weeks. Unknown if considered disability/permanent.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Severe body aching for 36 hours; vomiting yellow bile; headache.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever, up to 101.5 Temporal, with violent shivering and chills, anorexia, severe fatigue. Tylenol 1000mg gradually helpful for 3 hours, then chills and fever returned. symptoms slowly resolving over the course of 48 hours. Continues with fatigue and poor appetite, as well as upset stomach. Not yet at baseline, but will continue to monitor.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Extra dose administered, Incorrect route of product administration, Insomnia, Pain
Clinical narrative: I got the booster shot on my left arm and the next day i was hurting alot i couldnt even sleep so when i was in the shower i notice i have a big ball shape underneath my armpit that hurts alot i went to pharmacy and they told me my shot was given to low and they took pictures and said they will call me in 2 days
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I got the booster shot on my left arm and the next day i was hurting alot i couldnt even sleep so when i was in the shower i notice i have a big ball shape underneath my armpit that hurts alot i went to pharmacy and they told me my shot was given to low and they took pictures and said they will call me in 2 days
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Tinnitus
Clinical narrative: One week after booster vaccine on 11/01/21 (Original was give on 03/06/2021 - Johnson & Johnson) I began to have ringing in both ears. They did not last for long duration but would come and go. Two weeks without any sign of frequency increasing of the episodes the ringing is now 24/7 in both ears.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I AM COVID POSITIVE  11/27/2021
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Tinnitus, whistling in right ear, hearing loss in left ear
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: about a month after the vaccination, I am having feeling uncomfortable/unpleasant left side chest pain, lasting 10-20 minutes at least 3 times per week. This left chest pain is continuously occurring as of now.  I had not had such left side chest pain before vaccination.