chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: terrible headache; slight fever; chills; body aches; she only felt sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she only felt sore arm), HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U58H212) for COVID-19 prophylaxis.     there was no  parental vaccine exposure.  The patient's past medical history included Sickness (On 3Jan2020 she was so sick for a week, she assumed was flu, but she never felt so sick in her life) on 03-Jan-2020. Concurrent medical conditions included Seasonal allergy.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (she only felt sore arm). On 05-Jan-2022, the patient experienced HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (she only felt sore arm), HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative and Negative.     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.   Patient received her 1st Moderna dose of the primary series on 02 Dec 2021, and she only felt sore arm during 1 day. On 4Jan 2022 her husband (not previously vaccinated) tested positive to COVID-19. On 5 Jan 2022 she experienced COVID symptoms like terrible headache, slight fever, chills and body aches during 3 days, but she tested negative to COVID-19 twice.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: terrible headache; slight fever; chills; body aches; she only felt sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she only felt sore arm), HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U58H212) for COVID-19 prophylaxis.     there was no  parental vaccine exposure.  The patient's past medical history included Sickness (On 3Jan2020 she was so sick for a week, she assumed was flu, but she never felt so sick in her life) on 03-Jan-2020. Concurrent medical conditions included Seasonal allergy.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (she only felt sore arm). On 05-Jan-2022, the patient experienced HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (she only felt sore arm), HEADACHE (terrible headache), PYREXIA (slight fever), CHILLS (chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative and Negative.     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.   Patient received her 1st Moderna dose of the primary series on 02 Dec 2021, and she only felt sore arm during 1 day. On 4Jan 2022 her husband (not previously vaccinated) tested positive to COVID-19. On 5 Jan 2022 she experienced COVID symptoms like terrible headache, slight fever, chills and body aches during 3 days, but she tested negative to COVID-19 twice.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     The patient's past medical history included Chronic kidney disease stage 2 since an unknown date. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Lot: DIU20A) on 15-Jan-2021, COVID-19 VACCINE on 12-Feb-2021, COVID-19 VACCINE (Lot: 031D21A) on 21-Oct-2021, COVID-19 VACCINE (Lot: 0833214) on 29-Mar-2022 and Influenza. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and Influenza.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022,  after starting , the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient had symptoms like, sore throat, cough and runny nose.  No treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     There was no parental vaccine exposure.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.). At the time of the report, COVID-19 (had COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccines.) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported patient tested positive for covid and has gone to doctor to get medication. Patient had all her Moderna vaccines.  Treatment medications were not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Rash, Rash pruritic
Clinical narrative: I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes; miserable; rash itches; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes), FEELING ABNORMAL (miserable), RASH PRURITIC (rash itches) and INSOMNIA (can't sleep) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Was there parental vaccine exposure?Answer:No.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes), FEELING ABNORMAL (miserable), RASH PRURITIC (rash itches) and INSOMNIA (can't sleep). At the time of the report, RASH (I've had a massive rash across my breast, the main one is between the breast, is the is the biggest one, 3 inches by 5, Across all the lower back to the top of the buttocks, my elbows, heels, A little bit in my scalp/ It dries and oozes) and FEELING ABNORMAL (miserable) had not resolved and RASH PRURITIC (rash itches) and INSOMNIA (can't sleep) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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. Patient received additional booster dose.  Patient had two  primary series and two booster dose. Patient treatment medication included product used for unknown indication for COVID pills for 5 days.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Covid vaccine interacted with Klonopin; This spontaneous case was reported by an other health care professional and describes the occurrence of DRUG INTERACTION (Covid vaccine interacted with Klonopin) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product CLONAZEPAM (KLONOPIN) for an unknown indication.    It was unknown that the patient had allergies to medication, food and other products. It was unknown that the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and CLONAZEPAM (KLONOPIN) (Oral) .5 milligram. On an unknown date, the patient experienced DRUG INTERACTION (Covid vaccine interacted with Klonopin). At the time of the report, DRUG INTERACTION (Covid vaccine interacted with Klonopin) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, there was an interaction between clonazepam and COVID-19 vaccine. They were doing some investigation work and read that the COVID vaccine interacted with Klonopin and it was similar to the RabAvert. If the COVID vaccine taken with clonazepam, they heard the T Cell did not proliferate the right way.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Followup received. Case updated as valid as specific patient identifier reported. Reporter details, co-suspect details and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Decreased appetite, Gastrointestinal hypermotility, Weight decreased
Clinical narrative: weight loss; inability to eat becuase they have to go to the bathroom right after eating; inability to eat becuase they have to go to the bathroom right after eating; decreased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure). At the time of the report, WEIGHT DECREASED (weight loss), DECREASED APPETITE (inability to eat becuase they have to go to the bathroom right after eating), GASTROINTESTINAL HYPERMOTILITY (inability to eat becuase they have to go to the bathroom right after eating) and BLOOD PRESSURE DECREASED (decreased blood pressure) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route) and mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states that patient has a friend who had the same side effects  after getting the Moderna Covid-19 vaccine inability to eat becuase they have to go to the bathroom right after eating, weight loss and decreased blood pressure. The friend has also been prescribed with Evushield to counter act the vaccine. Reporter does not have additional information about her friend's vaccination details. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: after 2 days began bed sweats during the night; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (after 2 days began bed sweats during the night) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (after 2 days began bed sweats during the night). At the time of the report, NIGHT SWEATS (after 2 days began bed sweats during the night) had not resolved.            Concomitant medication not reported.  Received latest vaccine for the variant recently and after 2 days began bed sweats during the night which appears to be continuing. Treatment medication not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Gastro-intestinal disorder NOS. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Gastro-intestinal disorder NOS.    On 19-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Nasal stuffiness, at an unspecified dose and frequency and PSEUDOEPHEDRINE for Nasal stuffiness, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Positive. On 19-Dec-2022, SARS-CoV-2 test: Positive.         Patient was fully vaccinated. Patient tested 3 to 4 days ago. Patient took Paxlovid the last one on the 17Dec2022 and the rebound started 5 days after patient completed treatment. Patient test positive on 19Dec2022 again. Patient did not have a fever but had the similar symptoms that stuffy nose, lot of secretions, coughing a little bit, not severely. The 19Dec2022 was the third day that patient got infected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (name of drug not reported).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 01-MAR-2021 and 2nd dose on 9-NOV-2021).    No concomitant medication was reported. The patient took the 4th dose of Moderna COVID-19 Vaccine on 10-Oct-2022. The patient received Lipitor and potassium citrate on 03-DEC-2022. On 14-Dec-2022, the patient had experienced COVID Rebound while on Pfizer drug for COVID 19 treatment from 05-Dec-2022 to 09-Dec-2022. Device Date : 18Dec2022 No treatment medication was reported.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 16-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture), POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients were administered a dose of the Moderna COVID-19 bivalent vaccine after more than 12 hours of vial puncture) and POOR QUALITY PRODUCT ADMINISTERED (The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM).    No concomitant medication was provided by reporter. The date vial was initially stored in the refrigerator: 14DEC2022. The date and time vial were first punctured: 15DEC2022, 2:00 PM and time of administration of vaccine: 16DEC2022, 9:42 AM How was the vial stored post puncture. The vial did not undergo any temperature excursions. No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Nutcracker syndrome; Bruising; Night sweat; Diarrhea; Nausea over a year; Vomiting; Headaches; Body aches; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of RENAL VEIN COMPRESSION (Nutcracker syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RENAL VEIN COMPRESSION (Nutcracker syndrome) (seriousness criterion medically significant), CONTUSION (Bruising), NIGHT SWEATS (Night sweat), DIARRHOEA (Diarrhea), NAUSEA (Nausea over a year), VOMITING (Vomiting), HEADACHE (Headaches), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, RENAL VEIN COMPRESSION (Nutcracker syndrome), CONTUSION (Bruising), NIGHT SWEATS (Night sweat), DIARRHOEA (Diarrhea), NAUSEA (Nausea over a year), VOMITING (Vomiting), HEADACHE (Headaches), PAIN (Body aches) and FATIGUE (Fatigue) 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 medication was not provided. Treatment information was not reported.  Company Comment: This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (medically significant) event of Renal vein compression which occurred on unknown interval after receiving an unknown dose number of mRNA-1273. It was reported that patient has been experiencing nutcracker syndrome along with non-serious events of diarrhea, night sweat, headaches, body aches, bruising, vomiting, nausea, and fatigue for more than a year since receiving the vaccine. The clinical course, diagnostic evaluation and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (medically significant) event of Renal vein compression which occurred on unknown interval after receiving an unknown dose number of mRNA-1273. It was reported that patient has been experiencing nutcracker syndrome along with non-serious events of diarrhea, night sweat, headaches, body aches, bruising, vomiting, nausea, and fatigue for more than a year since receiving the vaccine. The clinical course, diagnostic evaluation and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Renal vein compression, Vomiting
Clinical narrative: Nutcracker syndrome; Bruising; Night sweat; Diarrhea; Nausea over a year; Vomiting; Headaches; Body aches; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of RENAL VEIN COMPRESSION (Nutcracker syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced RENAL VEIN COMPRESSION (Nutcracker syndrome) (seriousness criterion medically significant), CONTUSION (Bruising), NIGHT SWEATS (Night sweat), DIARRHOEA (Diarrhea), NAUSEA (Nausea over a year), VOMITING (Vomiting), HEADACHE (Headaches), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, RENAL VEIN COMPRESSION (Nutcracker syndrome), CONTUSION (Bruising), NIGHT SWEATS (Night sweat), DIARRHOEA (Diarrhea), NAUSEA (Nausea over a year), VOMITING (Vomiting), HEADACHE (Headaches), PAIN (Body aches) and FATIGUE (Fatigue) 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 medication was not provided. Treatment information was not reported.  Company Comment: This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (medically significant) event of Renal vein compression which occurred on unknown interval after receiving an unknown dose number of mRNA-1273. It was reported that patient has been experiencing nutcracker syndrome along with non-serious events of diarrhea, night sweat, headaches, body aches, bruising, vomiting, nausea, and fatigue for more than a year since receiving the vaccine. The clinical course, diagnostic evaluation and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history information reported who experienced the unexpected, serious (medically significant) event of Renal vein compression which occurred on unknown interval after receiving an unknown dose number of mRNA-1273. It was reported that patient has been experiencing nutcracker syndrome along with non-serious events of diarrhea, night sweat, headaches, body aches, bruising, vomiting, nausea, and fatigue for more than a year since receiving the vaccine. The clinical course, diagnostic evaluation and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients).    Patient age was reported as 57 years and 5 months.  Concomitant medications details were not reported by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022. Additionally, In the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number.    Treatment details were not reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired administered to patient; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patient) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patient).    NDCID number was reported as 80777027398. Patient age was reported as 66 years and 08 months. Concomitant product use was not provided by the reporter. It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: 1 inch silver dolor size rash on the injection site; Rash on the injection site. It was itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (1 inch silver dolor size rash on the injection site) and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 041J21A, 026B21A and 046A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2022, received fourth 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 SITE RASH (1 inch silver color size rash on the injection site) and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching). At the time of the report, VACCINATION SITE RASH (1 inch silver dolor size rash on the injection site) was resolving and VACCINATION SITE PRURITUS (Rash on the injection site. It was itching) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2022-688233 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired administered to patients).    NDCID number was reported.  Patient age was reported as 64 years 10 months.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired that was administered to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patients). Number was reported as 80777027398.  Patient age was reported as 48 years 10 months.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A was administered to patient  between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).        No concomitant medications were reported.    Order date and completion date was reported as 05-May-2022.  The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired that was administered to Patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients).    NDCID number was reported.  Patient age was reported as 52 years 11 months.  No concomitant medications were reported. It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A this was administered to patient in between 08-Apr-2022 and 15-Dec-2022. No treatment medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).      Concomitant medications details were not reported by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022. Additionally, In the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number as 065F21A.    Treatment details were not reported by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired that was administered to Patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients).    NDCID number was reported.  Patient age was reported as 69 years 8 months.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A this was administered to patient in between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Past lot that had also been expired that was administered to Patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to Patients).    Patient's age was reported as 60 Year 4 Month.  Concomitant product use was not provided by the reporter.  It was reported that also another lot of vaccines lot number 065F21A was also expired and administered to patient and lot number O70H21A this was administered to patient in between 08-Apr-2022 and 15-Dec-2022.  Treatment information was not provided.  NDCID number was reported.