chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: From his 1ST dose he had soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (From his 1ST dose he had soreness in arm) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SB21A or 025B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 MYALGIA (From his 1ST dose he had soreness in arm) (seriousness criterion hospitalization). At the time of the report, MYALGIA (From his 1ST dose he had soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment-Based on the current available information and temporal association between the use of the product and the start date of the events noted in the narrative of the RA, a causal relationship cannot be excluded.  Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-277714 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received : dose regimen for first dose and second dose added. lot number added for both dosage.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events noted in the narrative of the RA, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Her husband contracted COVID; Got covid after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination). At the time of the report, COVID-19 (Her husband contracted COVID) and VACCINATION FAILURE (Got covid after vaccination) outcome was unknown.            On 06-Nov-2021 they had contact with their niece and patient contracted COVID. The patient started to show symptoms on 09-Nov-2021. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Concomitant medication was reported by reporter.  Company Comment:  This is a case concerning a 56-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19 and non-serious unexpected event of vaccination failure. The events occurred approximately 6 months after the second dose of mRNA-1273 vaccine administration. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Causality for the event of COVID-19 was not applicable to the product administration and related for vaccination failure event. The rechallenge was not applicable since the events occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Follow-up was received: Included no significant information.; Sender's Comments: This is a case concerning a 56-year-old male patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19 and non-serious unexpected event of vaccination failure. The events occurred approximately 6 months after the second dose of mRNA-1273 vaccine administration. The patient had mild symptoms of covid and did not need hospitalization, was treated at home. Causality for the event of COVID-19 was not applicable to the product administration and related for vaccination failure event. The rechallenge was not applicable since the events occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination) 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. In December 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination). On 28-Dec-2021, SARS-COV-2 TEST POSITIVE (Tested positive for COVID after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID after vaccination. On 28-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative with a home test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  Reporter stated that the son needs a booster to return to college. Does he have to wait 90 days before receiving the booster or can he get.  Company Comment - This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected event of SARS-CoV-2 test positive. The event occurred on a unknown date after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected event of SARS-CoV-2 test positive. The event occurred on a unknown date after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection.The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Diarrhoea, Flatulence, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No Appetite), AGEUSIA (no taste), FLATULENCE (Gas), VACCINATION COMPLICATION (Mild Other Symptoms) and DIARRHOEA (Diarrhea) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (No Appetite), AGEUSIA (no taste), FLATULENCE (Gas), VACCINATION COMPLICATION (Mild Other Symptoms) and DIARRHOEA (Diarrhea). At the time of the report, DECREASED APPETITE (No Appetite), AGEUSIA (no taste), FLATULENCE (Gas), VACCINATION COMPLICATION (Mild Other Symptoms) and DIARRHOEA (Diarrhea) outcome was unknown. No concomitant medications were reported. No treatment drugs were reported. No arm achiness experienced by patient. Company Comment: This case concerns a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious events of Decreased appetite, Ageusia, Flatulence, Vaccination complication and Diarrhoea. The patient received the third dose of COVID-19 Vaccine Moderna (mRNA-1273) on an unknown date and the events onset dates were not reported. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. This case was linked to MOD-2021-406637 (Patient Link). Sender's Comments: This case concerns a patient of an unknown age and gender with no previous medical history reported, who experienced the non-serious events of Decreased appetite, Ageusia, Flatulence, Vaccination complication and Diarrhoea. The patient received the third dose of COVID-19 Vaccine Moderna (mRNA-1273) on an unknown date and the events onset dates were not reported. No concomitant medication or treatment information was reported. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested covid positive recently; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested covid positive recently) 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 COVID-19 (Tested covid positive recently). At the time of the report, COVID-19 (Tested covid positive recently) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.     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 treatment and concomitant medications were provided.; Sender's Comments: This case concerns a patient (demographics not provided) with no relevant medical history, who experienced the unexpected Non-serious AESI event of COVID-19 (SARS-COV-2 test positive)). The event occurred at unknown interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Delivery (just gave birth) and Heart murmur.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The reporter thinks that the patient got COVID-19 from the patient's unvaccinated son who was not quite 2 years old and was in day care. No concomitant medication information was provided.  No treatment medication information was provided.  The patient tested positive for COVID after receiving the primary series of Moderna vaccine and the booster dose.   This case was linked to MOD-2022-450601 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected Non-serious event of COVID-19 (SARS-COV-2 test positive). The event occurred at unspecified interval after a booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after a booster dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid Positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive after vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01T21-2A) for COVID-19 vaccination.     Concomitant products included DEXAMETHASONE for an unknown indication.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2022, the patient experienced COVID-19 (Covid Positive after vaccination). At the time of the report, COVID-19 (Covid Positive after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Patient is taking Dexamethasone twice a day as maintenance dose. No further information given why he is taking that medication.; Sender's Comments: This is a spontaneous case concerning a 42-year-old male patient with medical history of concurrent use of dexamethasone, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred approximately 4 days after the first dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable. The rechallenge was not applicable. The concurrent use of dexamethasone considered as a confounding factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) 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 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. In December 2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) tested positive for covid.         No Treatment medications given No Concomitant medication given; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred on unknown day after the second dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Feeling abnormal, Haemolysis, Pyrexia
Clinical narrative: Hemolysis; Feeling miserable/feeling abnormal; Back pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Hemolysis) in a male 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.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) concentrate for solution for infusion for Paroxysmal nocturnal haemoglobinuria.    Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HAEMOLYSIS (Hemolysis) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling miserable/feeling abnormal), BACK PAIN (Back pain) and PYREXIA (Fever). At the time of the report, HAEMOLYSIS (Hemolysis), FEELING ABNORMAL (Feeling miserable/feeling abnormal), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved.            Company comment: This is a spontaneous case concerning a male patient of an unknown age with medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab), who experienced the serious (medically significant) unexpected event Hemolysis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is positive as patient experienced the same event after the third dose. The medical history of  Paroxysmal nocturnal hemoglobinuria remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   It was reported that  patient  resolved with all the symptoms after his infusion in Nov 2021.Also it was reported that the patient would be following up with physician in JAN 2022.  Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-451888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow-up received with no new information.; Sender's Comments: Company comment: This is a spontaneous case concerning a male patient of an unknown age with medical history of Paroxysmal nocturnal hemoglobinuria (in treatment with Ravulizumab), who experienced the serious (medically significant) unexpected event Hemolysis. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is positive as patient experienced the same event after the third dose. The medical history of  Paroxysmal nocturnal hemoglobinuria remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: went to get a booster dose from Moderna and got a full dose of 0.5ml.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 088D21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (First dose, lot EN6206, expiry date 30-JUN-2021, Injection) on 09-Mar-2021, Pfizer (Second dose, lot EP6955 and expiry date 30-JUN-2021) on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, GOLIMUMAB (SIMPONI), MESALAZINE (PENTASA), LAMOTRIGINE (LAMICTAL), FUROSEMIDE (LASIX [FUROSEMIDE]), OMEGA-3-ACID ETHYL ESTER (LOVAZA), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FAMOTIDINE (PEPCID [FAMOTIDINE]) and SODIUM for an unknown indication.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.). On 17-Jan-2022, ACCIDENTAL OVERDOSE (went to get a booster dose from Moderna and got a full dose of 0.5ml.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported This case pertains to the caller. Patient had 3 doses of primary series (first and second were Pfizer, third was Moderna)   This case was linked to MOD-2022-455754 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site itched after every shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itched after every shot) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESYLATE for Blood pressure high, FAMOTIDINE, TIMOLOL MALEATE (TIMOPTIC), BIMATOPROST (LUMIGAN) and PRAVASTATIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched after every shot). At the time of the report, VACCINATION SITE PRURITUS (injection site itched after every shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.  Every time, around the day of the injection or the next day patient´s injection site itched. It was not red nor had a rash. This lasted between 10 days and 2 weeks each time.   This case was linked to MOD-2022-454488, MOD-2022-454495 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site itched after every shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itched after every shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESYLATE for Blood pressure high, FAMOTIDINE for Hyperacidity, TIMOLOL MALEATE (TIMOPTIC), BIMATOPROST (LUMIGAN) and PRAVASTATIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 VACCINATION SITE PRURITUS (injection site itched after every shot). In 2021, VACCINATION SITE PRURITUS (injection site itched after every shot) had resolved.            No treatment information was provided. It was Reported, Every time, around the day of the injection or the next day patient´s injection site itched. It was not red nor had a rash.This lasted between 10 days and 2 weeks each time.   This case was linked to MOD-2022-454465, MOD-2022-454495 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus, Maternal exposure during pregnancy, Rubella, Toxoplasmosis
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) 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 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 15-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Diabetes mellitus: normal (normal) Normal. On an unknown date, Rubella: normal (normal) normal. On an unknown date, Toxoplasmosis: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. Patient fifth month of pregnancy, found out that her baby has a brain abnormality agenesis of the corpus callosum, asymmetrical and lack of brain structures. Patient wonder if the vaccination at the beginning of the first trimester could be the cause behind this abnormality?   This case was linked to MOD-2022-455707 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. The patient received their first dose of the Moderna Covid-19 vaccine on 19-Jan-2021and had a sore left arm. No treatment information was provided. This case was linked to MOD-2022-455271, MOD-2022-455275 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose 21 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose). On 14-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 21 days after 1st dose) had resolved.            No concomitant medication was reported No treatment medication was reported Patient was not experiencing any symptoms.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, SARS-CoV-2 test: positive (Positive) positive tested on morning..         No concomitant medications were reported.  Treatment medications were not provided by the reporter. Reporter is going through a divorce and suspects their spouse (patient) provided them with a counterfeit vaccine card.  Company Comment - This spontaneous case concerns a 46 year old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred 4 months and 13 days after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 46 year old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred 4 months and 13 days after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; Brown discharge, and it looked like a menstrual period; patient had received 1 dose of J and J vaccine and then received booster dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), VAGINAL DISCHARGE (Brown discharge, and it looked like a menstrual period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient had received 1 dose of J and J vaccine and then received booster dose of Moderna vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (J and J COVID-19 vaccine - one dose) in April 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included HIV disease (lived 40 years with HIV) and Menopause (patient had been in Menopause for so many years).    On 23-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient had received 1 dose of J and J vaccine and then received booster dose of Moderna vaccine). On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and VAGINAL DISCHARGE (Brown discharge, and it looked like a menstrual period). On 23-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient had received 1 dose of J and J vaccine and then received booster dose of Moderna vaccine) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) and VAGINAL DISCHARGE (Brown discharge, and it looked like a menstrual period) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  The patient had received a booster dose of Moderna vaccine and after one week, the patient had vaginal discharge and bleeding.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus
Clinical narrative: itching of both palms and both of feet; Itching of both palms of hands that gradually got worse; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching of both palms and both of feet) and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J212A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced PRURITUS (itching of both palms and both of feet) and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching of both palms and both of feet) had not resolved and CONDITION AGGRAVATED (Itching of both palms of hands that gradually got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. It was stated that patient went to doctor who did not prescribe anything as per patient.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore left injection site arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-455192, MOD-2022-455193 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients got a booster dose from an expired Moderna vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) 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 medications were reported.   This case was linked to MOD-2022-455209, MOD-2022-455278 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies). On 18-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered within 90 days of anti-SARS-CoV-2 monoclonal antibodies) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported. It was reported that patient had had anti-SARS-CoV-2 monoclonal antibodies treatment on 23-Nov-2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Tired/fatigue; A mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Tired/fatigue) and HEADACHE (A mild headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HEADACHE (A mild headache). On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Tired/fatigue). At the time of the report, CHILLS (Chills), FATIGUE (Tired/fatigue) and HEADACHE (A mild headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided.  No treatment medication was provided.  Patient experienced headache 4 to 5 days after the first dose.   This case was linked to MOD-2021-024870, MOD-2022-455317 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients got a booster dose from an expired Moderna vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) 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 information was reported.   This case was linked to MOD-2022-455195, MOD-2022-455207, MOD-2022-455269, MOD-2022-455277, MOD-2022-455278 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Palpitations, Stress
Clinical narrative: Felt a lot of chest pain/felt like she was going to have aheart attack; She was stressed about something but it felt really odd to experience that chest pain. felt really odd to experience that chest pain/she has never experienced anything like this before; Dizziness; I felt my heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I felt my heart racing), CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.), FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (I felt my heart racing) and DIZZINESS (Dizziness). On an unknown date, the patient experienced CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.) and FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 25-Apr-2021, PALPITATIONS (I felt my heart racing) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHEST PAIN (Felt a lot of chest pain/felt like she was going to have aheart attack), STRESS (She was stressed about something but it felt really odd to experience that chest pain.) and FEELING ABNORMAL (felt really odd to experience that chest pain/she has never experienced anything like this before) outcome was unknown.            No concomitant medications were reported   The patient stated that she had to go and talk to the healthcare provider on site and they asked her to be observed for an hour. They gave her water and kept checking in on her to make sure she was doing okay   This case was linked to MOD-2022-451533 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on his trunk) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on his trunk). At the time of the report, RASH (Rash on his trunk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (little fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little 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.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2022-455277, MOD-2022-455278, MOD-2022-455207, MOD-2022-455209 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore left injection site arm; Very tired after his second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose). On 17-Feb-2021, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Very tired after his second dose) had resolved.            No Concomitant product use was reported.  The patient received their second Moderna Covid-19 vaccine on 16-Feb-2021 and had a sore left injection site arm. The patient was very tired after their second dose. The patient went to bed at 6 pm on 17-Feb-2021 and when the patient woke up it was all over.  No treatment information was provided.   This case was linked to MOD-2022-455008, MOD-2022-455275 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Pre-diabetes. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, METFORMIN, LOSARTAN, PRAVASTATIN, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-455237 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection left arm site was sore for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection left arm site was sore for two days) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VACCINATION SITE PAIN (injection left arm site was sore for two days). On 21-Nov-2021, VACCINATION SITE PAIN (injection left arm site was sore for two days) had resolved.            No concomitant medication was reported. Treatment information was not reported.  The patient received the booster/third and first doses on the left arm shoulder deltoid muscle.   This case was linked to MOD-2022-455008, MOD-2022-455271 (Patient Link).