chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: felt like I had the flu; headache; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (felt like I had the flu), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INFLUENZA (felt like I had the flu), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches). In April 2021, INFLUENZA (felt like I had the flu), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) had resolved.            No relevant concomitant product were reported No treatment medication was provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: miserable; slight fever today; headache was much worse; got sick from the vaccine; Kind of tired/very tired; feeling weak/very very weak; not feeling well a few hours later/did not feel well/not feeling 100%; reaction to the vaccination; red mark on his right arm; red rash where the needle went in his arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable) and ERYTHEMA (red mark on his right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache (Before we went to get the vaccine, he had a headache.) and Stomachache. Concomitant products included WARFARIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (reaction to the vaccination), ERYTHEMA (red mark on his right arm) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm). On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired) and HEADACHE (headache was much worse). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (miserable) and PYREXIA (slight fever today). At the time of the report, ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable), ERYTHEMA (red mark on his right arm), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired), PYREXIA (slight fever today), HEADACHE (headache was much worse) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm) outcome was unknown.            No treatment medications provided by the reporter.   Reportedly, Patient daughter was thinking that patient already had COVID, and the vaccine just came at the time when patient had it.  Patient was not coughing and was not showing any respiratory signs. Patient had headache and stomachache, before went to get the vaccine,  but he got the Moderna booster anyway.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Pyrexia, Vaccination complication, Vaccination site erythema
Clinical narrative: miserable; slight fever today; headache was much worse; got sick from the vaccine; Kind of tired/very tired; feeling weak/very very weak; not feeling well a few hours later/did not feel well/not feeling 100%; reaction to the vaccination; red mark on his right arm; red rash where the needle went in his arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable) and ERYTHEMA (red mark on his right arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache (Before we went to get the vaccine, he had a headache.) and Stomachache. Concomitant products included WARFARIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (reaction to the vaccination), ERYTHEMA (red mark on his right arm) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm). On 21-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired) and HEADACHE (headache was much worse). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (miserable) and PYREXIA (slight fever today). At the time of the report, ASTHENIA (feeling weak/very very weak), MALAISE (not feeling well a few hours later/did not feel well/not feeling 100%), VACCINATION COMPLICATION (reaction to the vaccination), FEELING ABNORMAL (miserable), ERYTHEMA (red mark on his right arm), ILLNESS (got sick from the vaccine), FATIGUE (Kind of tired/very tired), PYREXIA (slight fever today), HEADACHE (headache was much worse) and VACCINATION SITE ERYTHEMA (red rash where the needle went in his arm) outcome was unknown.            No treatment medications provided by the reporter.   Reportedly, Patient daughter was thinking that patient already had COVID, and the vaccine just came at the time when patient had it.  Patient was not coughing and was not showing any respiratory signs. Patient had headache and stomachache, before went to get the vaccine,  but he got the Moderna booster anyway.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients received dose past viability time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for an unknown indication.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Got Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got Covid) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: present (Positive) Present.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: improperly stored (48.0F) and was administered; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Nurse reported that one dose of Bexsero was improperly stored on 18th November 2021 (at 48.0 degree F for 1 hour 26 minutes and 0 seconds) and was administered to the patient on 22nd November 2021, which led to incorrect storage of drug. Permission to contact the patient's physician was provided.  No further information was provided.  No product quality complaint was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them for quite a while, I had the shot both of them/suspected vaccination failure; I have them for quite a while; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles and having for quite a while and had the Shingles shot both of them. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: got Hiberix reconstituted with sterile water; got Hiberix reconstituted with sterile water; This case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination were not reported. The reporter reported that one of their nurses found just the diluent vial for Hiberix without the powder vial in their fridge, and the only other vaccine they kept in that fridge was from Merck. So the reporter thought one of their patient's got Hiberix reconstituted with a Merck sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administration.  The reporter ran a report and they know that it was one of 8 patients who possibly received Hiberix mixed with the wrong diluent.  These patients were all in valid age groups for receiving Hiberix and they haven't had any reported side effects from the patients since receiving their Hiberix dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243498:Same reporter
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Hypoaesthesia, Limb discomfort, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: Administration of the Shingrix vaccine was painful; Swollen glands underneath left arm pit; Tingling down her left shoulder; Felt pulsating pressure down her left arm; Stiffness in left hand; Numbness in left hand; This case was reported by a consumer via call center representative and described the occurrence of pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 15th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Influenza vaccine Quadrivalent 2021-2022 season. On 15th November 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand. On an unknown date, the outcome of the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand were not recovered/not resolved.   It was unknown if the reporter considered the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine into the left arm, at the same time she received her Flu vaccine in the right arm at pharmacy.  The patient reported that the administration of the Shingrix vaccine was painful. The patient also reported after the vaccination, she began to experienced swollen glands underneath her left arm pit and tingling down her left shoulder and she felt pulsating pressure down her left arm into her pinkie and ring finger and that she felts stiffness and numbness in her left hand. These above adverse events had been going on for over a week and they were currently unresolved. The patient stated that she had no effects in her right arm, the arm she received the Flu vaccine. The patient also received covid booster vaccine on 4th October 2021 and that was administered in her left arm. The reporter did not provide the lot or expiration date of the Shingrix vaccine. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Administration of the Shingrix vaccine was painful; Swollen glands underneath left arm pit; Tingling down her left shoulder; Felt pulsating pressure down her left arm; Stiffness in left hand; Numbness in left hand; This case was reported by a consumer via call center representative and described the occurrence of pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 15th November 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Influenza vaccine Quadrivalent 2021-2022 season. On 15th November 2021, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand. On an unknown date, the outcome of the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand were not recovered/not resolved.   It was unknown if the reporter considered the pain, swollen glands, tingling, pressure in limbs, limbs stiffness and numbness in hand to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine into the left arm, at the same time she received her Flu vaccine in the right arm at pharmacy.  The patient reported that the administration of the Shingrix vaccine was painful. The patient also reported after the vaccination, she began to experienced swollen glands underneath her left arm pit and tingling down her left shoulder and she felt pulsating pressure down her left arm into her pinkie and ring finger and that she felts stiffness and numbness in her left hand. These above adverse events had been going on for over a week and they were currently unresolved. The patient stated that she had no effects in her right arm, the arm she received the Flu vaccine. The patient also received covid booster vaccine on 4th October 2021 and that was administered in her left arm. The reporter did not provide the lot or expiration date of the Shingrix vaccine. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: inadvertently exposed to 55F / administered to patients.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report The nurse stated that Kinrix, Havrix, Engerix-B, Boostrix, Pediarix, and Infanrix was inadvertently exposed to 55 degree Fahrenhiet for as long as two weeks which led to incorrect storage of drug. Worst case scenario, some of the vaccines were administered to patients. No further details available at the time of this call, but nurse granted permission for safety to follow up via mail. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown ) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Dose number in series one. No concomitant medications were reported.  On an unspecified date, the patient had covid pneumonia and Suspected clinical vaccination failure. On SEP-2021, the patient died from covid pneumonia. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid pneumonia was fatal and outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000204396.; Sender's Comments: V0: 20211161441-Covid-19 vaccine ad26.cov2.s-Covid pneumonia. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 2021161441-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID PNEUMONIA
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; STILL GOT THE VIRUS AFTER VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, one total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and still got the virus after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the still got the virus after vaccine and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000204394.; Sender's Comments: V0: 20211161669-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: This spontaneous report received from a patient via a company representative via a social media concerned a patient of unspecified age, sex, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced myasthenia gravis and patient will visit neurologist in coming weeks. Dose number in series-1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myasthenia gravis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211162414-COVID-19 VACCINE AD26.COV2.S-myasthenia gravis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Peripheral swelling
Clinical narrative: Swollen arm; Bloody stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced HAEMATOCHEZIA (Bloody stool) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, HAEMATOCHEZIA (Bloody stool) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case concerns a 79-year- old male, with no relevant medical history reported in this case, who experienced the serious unexpected event of Haematochezia. The event occurred approximately 6 months after one dose of an unknown schedule of product administration of the mRNA-1273 vaccine. The rechallenge is unknown as the event happened after one dose of the vaccine and since no information on schedule of administration is provided. At the time of the report the outcome of the event is Unknown. The latency of 6 months remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. MR- General: For the event "Haematochezia" seriousness was manually overwritten. The event is considered medically significant per IME and per MSA medical judgement.; Sender's Comments: This case concerns a 79-year- old male, with no relevant medical history reported in this case, who experienced the serious unexpected event of Haematochezia. The event occurred approximately 6 months after one dose of an unknown schedule of product administration of the mRNA-1273 vaccine. The rechallenge is unknown as the event happened after one dose of the vaccine and since no information on schedule of administration is provided. At the time of the report the outcome of the event is Unknown. The latency of 6 months remains as a confounder for the event. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. MR- General: For the event "Haematochezia" seriousness was manually overwritten. The event is considered medically significant per IME and per MSA medical judgement.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered one dose to a patient that was expired on 29Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Fluzone (Lot number- UT356JA, Route of administration- Intramuscular, Body site - Left deltoid) on 17-Nov-2021 and pfizer (The patient had Pfizer as a primary series). Past adverse reactions to the above products included No adverse event with Fluzone and pfizer. Concurrent medical conditions included Depression, GERD and Seasonal allergy. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) from 2017 to an unknown date for Allergic reaction NOS, SERTRALINE from 2019 to an unknown date for Depression, FAMOTIDINE from 2021 to an unknown date for GERD, MELATONIN from 2020 to an unknown date for Sleep disorder NOS.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered one dose to a patient that was expired on 29Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. After administration of vaccine patient was closely monitored for 30 minutes, no adverse events occurred.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up received On 22-Nov-2021 contains Significant information. Patient demographics, medical history and Concomitant medications were added. Route of administration and anatomical location of Suspect product added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Keratitis, Ocular hyperaemia, Vision blurred
Clinical narrative: Left Cornea is inflamed again after booster dose; Vision is blurry out of her left eye; Left eye is red; Left eye is swollen; This spontaneous case was reported by a consumer and describes the occurrence of KERATITIS (Left Cornea is inflamed again after booster dose), VISION BLURRED (Vision is blurry out of her left eye), OCULAR HYPERAEMIA (Left eye is red) and EYE SWELLING (Left eye is swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     The patient's past medical history included Corneal disorder NOS (The patient reported that she had a history of Cornea problems starting 40 years ago due to a history of a virus in her eyes.) and Corneal transplant (The patient's past medical history included Corneal transplant two times). Concomitant products included ACICLOVIR and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced KERATITIS (Left Cornea is inflamed again after booster dose), VISION BLURRED (Vision is blurry out of her left eye), OCULAR HYPERAEMIA (Left eye is red) and EYE SWELLING (Left eye is swollen). At the time of the report, KERATITIS (Left Cornea is inflamed again after booster dose), VISION BLURRED (Vision is blurry out of her left eye), OCULAR HYPERAEMIA (Left eye is red) and EYE SWELLING (Left eye is swollen) outcome was unknown.            Treatment  information was not provided.   This case was linked to MOD-2021-391819, MOD-2021-391834 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Nov 9, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 9, 2021, patient administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine). On Nov 9, 2021, administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine) resolved. Per reporter, there were no symptoms or quality issue to report. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the expiration date of suspect product was on 25 Sep 2021. No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-392935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported no symptoms , and wanted to know if the booster dose and any testing was to be done.  No concomitant medications reported. No Treatment medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported.On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that expiration date of the vaccine was on 29-Sep-2021. No concomitant medications were reported.No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.     This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.    This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine used) and product administration error in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Oct 8, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 8, 2021, patient administered expired product (expired vaccine used) and product administration error. On Oct 8, 2021, administered expired product (expired vaccine used) and product administration error resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-392935 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.