chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome; Just a solid red rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient developed rash after becoming infected with COVID) and Viral infection NOS (patient developed rash after two non COVID viral infections).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash). At the time of the report, RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient has ongoing viral illnesses. No concomitant medication information was provided.  The rash was not itchy or bothersome just a solid red rash. Reporter assumes rash to be an immune response they have now developed toward ongoing viral illnesses. No treatment medication information was given.   This case was linked to MOD-2022-551296 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome; Just a solid red rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included ongoing viral illnesses.  The patient's past medical history included COVID-19 (Patient had developed the same rash after getting infected by COVID) and Viral infection NOS (Patient had also experienced same rash after getting two non COVID viral infections).   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, 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 RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash). At the time of the report, RASH (A patient developed a bilateral groin and armpit rash/The rash was not itchy or bothersome) and RASH ERYTHEMATOUS (Just a solid red rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  It was reported that the adverse events seemed to be an immune response the patient had developed towards an ongoing viral illnesses.   No treatment medications were reported.   This case was linked to MOD-2022-551282 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow-up received and contains no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Muscle spasms, Pyrexia
Clinical narrative: bad cramps; stomach aches; chills; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Retinal white dots syndrome (diagnosis right when COVID-19 virus hit (around November 2019)) since 2019 and Allergy to antibiotic. Concomitant products included FLECAINIDE, AMLODIPINE BESILATE (NORVASC) and VITAMINS NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, MUSCLE SPASMS (bad cramps), ABDOMINAL PAIN UPPER (stomach aches), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The first vaccination was the worst. The patient ended up in the emergency room from bad cramps, stomach aches, chills and fever. The patient stated that processes medications (unspecified) really slow.   This case was linked to MOD-2022-551312 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.; Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) and PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) and PRODUCT STORAGE ERROR (Administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Date the vial was initially stored in the refrigerator 24-Apr-2022.  The vial was first punctured on 25-Apr-2022 at 10:15 am, left out at room temperature all day and overnight and then administered a 2nd booster dose of the Moderna Covid-19 Vaccine from a vial that was 25 hours and 45 minutes post puncture and after 25 hours 45 minutes of room temperature storage. Vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck; Fever; swelling around the area of injection (left arm); Redness around the area of injection (left arm); Swelling hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Swelling hurts), SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck), PYREXIA (Fever), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, lot number - 8735) on 31-Mar-2021, Pfizer (2nd dose and lot number - 8731) on 23-Apr-2021. Past adverse reactions to the above products included Fever with Pfizer and Pfizer.    On 24-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PAIN (Swelling hurts), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)). On 24-Apr-2022, the patient experienced PYREXIA (Fever). On 26-Apr-2022, the patient experienced SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck). On 26-Apr-2022, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Swelling hurts), SWELLING (swelling under her left arm/swelling progressed to include the area under her left ear down to the collarbone/swelling of the left side of neck), VACCINATION SITE SWELLING (swelling around the area of injection (left arm)) and VACCINATION SITE ERYTHEMA (Redness around the area of injection (left arm)) outcome was unknown.            The patient had no history of allergies to medications, food and other products. Patient denied any COVID-19 diagnosis pre or post vaccination with COVID-19 vaccines. The patient did not have any concomitant medical conditions nor was she taking any medication except for vitamins. Patient received first booster dose on 24-Apr-2022. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (felt sick) in a patient, of an unknown age and gender who, received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 26, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 26, 2022, patient experienced malaise (felt sick). At the time of the report, malaise (felt sick) outcome: unknown. No concomitant medication or treatment information provided. The patient wanted to clarify if there is a laxative in the Moderna COVID-19 vaccine. She mentioned from the start she felt sick. This case linked to MOD-2022-552252 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: stored Moderna vaccine in their refrigerator and administered past the BUD date; BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021; BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021), PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) and POOR QUALITY PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021) and POOR QUALITY PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021), PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) and POOR QUALITY PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 17-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The BUD date was reported as 01-Nov-2022. and CDC expiration reported as 19-Mar-2022. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered past BUD date) and product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Dec 19, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Dec 19, 2021, patient administered expired product (administered past BUD date). On an unknown date, patient experienced product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date). At the time of the report, administered expired product (administered past BUD date) and product storage error (stored all Moderna vaccines in refrigerator and administered past BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021) and product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022; past the BUD date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 15, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 15, 2022, patient experienced administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021). On an unknown date, patient experienced product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022 past the BUD date of Nov 1, 2021). At the time of the report, administered expired product (administered vaccine Jan 15, 2022; past the BUD date of Nov 1, 2021) and product storage error (vaccine stored in refrigerator and administered on Jan 15, 2022 past the BUD date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. BUD date: Nov 1, 2022. Expiration date: Mar 19, 2022.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, HLA-B*27 assay, Myalgia, Tenderness
Clinical narrative: felt very uncomfortable; tenderness; muscle pain/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 032M20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy and Herniated disc. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Pain, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache). At the time of the report, FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) positive.         Concomitant medications also included Soloxide, anti inflammatory medications and birth control medications.  The patient did not experience any issues after receiving the first dose. The side effects lasted for 3 weeks. The symptoms were not as severe in nature as compared to the events experienced after the booster dose.  No treatment information was reported.   This case was linked to MOD-2022-551348 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Axillary pain, Chest pain, Feeling abnormal, HLA-B*27 assay
Clinical narrative: felt very uncomfortable; tenderness; muscle pain/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 032M20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy and Herniated disc. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Pain, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache). At the time of the report, FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) positive.         Concomitant medications also included Soloxide, anti inflammatory medications and birth control medications.  The patient did not experience any issues after receiving the first dose. The side effects lasted for 3 weeks. The symptoms were not as severe in nature as compared to the events experienced after the booster dose.  No treatment information was reported.   This case was linked to MOD-2022-551348 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling, Swelling, Weight increased
Clinical narrative: felt very uncomfortable; tenderness; muscle pain/muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 032M20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. No other vaccine was given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy and Herniated disc. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Pain, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache). At the time of the report, FEELING ABNORMAL (felt very uncomfortable), TENDERNESS (tenderness) and MYALGIA (muscle pain/muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) positive.         Concomitant medications also included Soloxide, anti inflammatory medications and birth control medications.  The patient did not experience any issues after receiving the first dose. The side effects lasted for 3 weeks. The symptoms were not as severe in nature as compared to the events experienced after the booster dose.  No treatment information was reported.   This case was linked to MOD-2022-551348 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, HLA-B*27 assay, Myalgia, Tenderness
Clinical narrative: Swelling of the arm; Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.; She was very afraid; Entire armpit area was swelling; Extremely painful chest pain; It was so uncomfortable; Gained some weight; Swelling of her lymph nodes under the armpit; Entire armpit area was painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling) and CHEST PAIN (Extremely painful chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 006C21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc and Penicillin allergy. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Herniated disc, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) Positive for HLA B27 Antigen.         Other concomitant medications included Soloxide, unspecified anti inflammatory and birth control medications. No treatment medications were reported.   This case was linked to MOD-2022-551334 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Axillary pain, Chest pain, Feeling abnormal, HLA-B*27 assay
Clinical narrative: Swelling of the arm; Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.; She was very afraid; Entire armpit area was swelling; Extremely painful chest pain; It was so uncomfortable; Gained some weight; Swelling of her lymph nodes under the armpit; Entire armpit area was painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling) and CHEST PAIN (Extremely painful chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 006C21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc and Penicillin allergy. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Herniated disc, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) Positive for HLA B27 Antigen.         Other concomitant medications included Soloxide, unspecified anti inflammatory and birth control medications. No treatment medications were reported.   This case was linked to MOD-2022-551334 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling, Swelling, Weight increased
Clinical narrative: Swelling of the arm; Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.; She was very afraid; Entire armpit area was swelling; Extremely painful chest pain; It was so uncomfortable; Gained some weight; Swelling of her lymph nodes under the armpit; Entire armpit area was painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling) and CHEST PAIN (Extremely painful chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 006C21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc and Penicillin allergy. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Herniated disc, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) Positive for HLA B27 Antigen.         Other concomitant medications included Soloxide, unspecified anti inflammatory and birth control medications. No treatment medications were reported.   This case was linked to MOD-2022-551334 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I'm exceptionally tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (I'm exceptionally tired) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 067E21A, 021B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (I'm exceptionally tired). At the time of the report, FATIGUE (I'm exceptionally tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 25-Oct-2021 patient took first booster dose. On 26-Apr-2022 patient took second booster dose. Patient did not experienced a similar event in the past. Patients allergies were unknown. The AE did not cause patient to seek medical care. No treatment details were reported.   This case was linked to MOD-2021-067305, MOD-2021-067552 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022) and product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 16, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 16, 2022, patient administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022). On an unknown date, patient experienced product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date). At the time of the report, administered expired product (BUD: Nov 1, 2021 but administered vaccine on Jan 16, 2022) and product storage error (stored all of the Moderna vaccines in refrigerator and administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, one of the providers stored all of the Moderna vaccines in their refrigerator and administered past the BUD date. BUD date: Nov 1, 2021. Expiration date: Mar 19, 2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was stored in the refrigerator and administered past the BUD date; Moderna vaccine was stored in the refrigerator and administered past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date) and PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date) and PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Beyond use date was reported as 01 Nov 2021. CDC expiration date reported as 19 Mar 2022. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) and product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Jan 28, 2022, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 28, 2022, patient administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021). On an unknown date, patient experienced product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021). At the time of the report, administered expired product (patient received vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) and product storage error (stored Moderna vaccine in the refrigerator and administered vaccine on Jan 28, 2022 past the beyond-use-date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Expiration date of the vaccine: Mar 19, 2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021; The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 01-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 01-Feb-2022 past the BUD date 01-Nov-2021 ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The BUD date was reported as 01-Nov-2022 and CDC expiration was reported as 19-Mar-2022. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient administered vaccine on Feb 4, 2022; past the BUD of Nov 1, 2021) and product storage error (Moderna vaccine stored in refrigerator; administered vaccine Feb 4, 2022; past the BUD date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Feb 4, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 4, 2022, patient administered expired product (patient administered vaccine on Feb 4, 2022; past the BUD of Nov 1, 2021). On an unknown date, patient experienced product storage error (Moderna vaccine stored in refrigerator; administered vaccine Feb 4, 2022; past the BUD date of Nov 1, 2021). At the time of the report, administered expired product (patient administered vaccine on Feb 4, 2022; past the BUD of Nov 1, 2021) and product storage error (Moderna vaccine stored in refrigerator; administered vaccine Feb 4, 2022; past the BUD date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The BUD date: Nov 1, 2022. Expiration reported as Mar 19, 2022.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (administered past the BUD date Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for immunization. No medical history reported. On Feb 13, 2022, patient received the  first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 13, 2022, patient administered expired product (administered past the BUD date Nov 1, 2021). On an unknown date, patient experienced product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date). At the time of the report, administered expired product (administered past the BUD date Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator, administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood cloth form groin to their ankle on their right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood cloth form groin to their ankle on their right leg) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient did not have Acute and Chronic illnesses at the time of vaccination.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ENALAPRIL, PRAVASTATIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), PANCREATIN (CREON), ALLOPURINOL and RIVAROXABAN (XARELTO) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood cloth form groin to their ankle on their right leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood cloth form groin to their ankle on their right leg) had not resolved.            Patient reported two months after getting their Second dose of the Moderna covid19 vaccine he got blood clot form groin to their ankle on their right leg. still there at the time of reporting, patient had been put on blood thinner for a year, and the blood cloth was still there, he don't know how he get it, because he was very active and takes aspirin everyday.  Patient also received the first booster on Nov2021, but could not provided date or lot number of the vaccine he took.  The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient never experienced a similar event in the past.  Company comment: This Spontaneous case concerns a 74-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of thrombosis after administration of the second dose of mRNA-1273 vaccine. He consulted to the emergency department and is under blood thinners. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 74-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of thrombosis after administration of the second dose of mRNA-1273 vaccine. He consulted to the emergency department and is under blood thinners. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient administered vaccine on Feb 17, 2022; past the BUD date of Nov 1, 2021) and product storage error (Moderna vaccine stored in refrigerator; administered vaccine on Feb 17, 2022 past the BUD date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, patient administered expired product (patient administered vaccine on Feb 17, 2022; past the BUD date of Nov 1, 2021). On an unknown date, patient experienced product storage error (Moderna vaccine stored in refrigerator; administered vaccine on Feb 17, 2022 past the BUD date of Nov 1, 2021). At the time of the report, administered expired product (patient administered vaccine on Feb 17, 2022; past the BUD date of Nov 1, 2021) and product storage error (Moderna vaccine stored in refrigerator; administered vaccine on Feb 17, 2022 past the BUD date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022) and product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Feb 18, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 18, 2022, patient administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022). On an unknown date, patient experienced product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date). At the time of the report, administered expired product (BUD was Nov 1, 2021 but vaccine administered on Feb 18, 2022) and product storage error (Moderna vaccine stored in refrigerator and administered past the BUD date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.