chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer, Colonoscopy
Clinical narrative: colon cancer; This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (colon cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Arthritis and Colon operation on 08-Jun-2021. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced COLON CANCER (colon cancer) (seriousness criterion medically significant). At the time of the report, COLON CANCER (colon cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Colonoscopy: abnormal (abnormal) diagnosed with colon cancer.  She stated she had no known drug or food allergies.  Company Comment - This spontaneous  case concerns a 74-year-old female patient with no relevant medical history who experienced serious unexpected event of colon cancer. The event occurred approximately less than a month after the second dose of the Moderna COVID-19 vaccine .The patient was diagnosed with colon cancer after a colonoscopy.  She had colon cancer surgery as a corrective treatment for the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-391946 (Patient Link).; Sender's Comments: This spontaneous  case concerns a 74-year-old female patient with no relevant medical history who experienced serious unexpected event of colon cancer. The event occurred approximately less than a month after the second dose of the Moderna COVID-19 vaccine .The patient was diagnosed with colon cancer after a colonoscopy.  She had colon cancer surgery as a corrective treatment for the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysgeusia, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Metallic taste/still experiencing intermittent of metallic taste; Brain fog; confusion; right arm went numb/still experiencing numbness in hand/right leg with numbness; right leg also went cold; right leg with tingling; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness) and PERIPHERAL COLDNESS (right leg also went cold) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and INFLUENZA VACCINE (FLU) from 19-Nov-2021 to an unknown date for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]) for Headache, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392012 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Metallic taste/still experiencing intermittent of metallic taste; Brain fog; confusion; right arm went numb/still experiencing numbness in hand/right leg with numbness; right leg also went cold; right leg with tingling; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness) and PERIPHERAL COLDNESS (right leg also went cold) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and INFLUENZA VACCINE (FLU) from 19-Nov-2021 to an unknown date for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at a dose of 1 dosage form and ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]) for Headache, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste/still experiencing intermittent of metallic taste), FEELING ABNORMAL (Brain fog), CONFUSIONAL STATE (confusion), HYPOAESTHESIA (right arm went numb/still experiencing numbness in hand/right leg with numbness), PERIPHERAL COLDNESS (right leg also went cold), PARAESTHESIA (right leg with tingling) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392012 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Haematochezia, Headache
Clinical narrative: Blood in stool; Loss of taste; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HAEMATOCHEZIA (Blood in stool), AGEUSIA (Loss of taste), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: This is a Spontaneous case concerning a 23-year-old, female patient with unknown medical history, who experienced the unexpected non serious (AESI) event of . The event occurred approximately 1 day after one dose of mRNA 1273 vaccine.  Patient also experience hematochezia with no more information. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 23-year-old, female patient with unknown medical history, who experienced the unexpected non serious (AESI) event of . The event occurred approximately 1 day after one dose of mRNA 1273 vaccine.  Patient also experience hematochezia with no more information. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: aches; sore arm after dose 1 and 2; fever; chills; vaccine breakthrough infection; COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) (seriousness criterion medically significant), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) outcome was unknown and COVID-19 (COVID), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills) had resolved.            Patient is taking concomitant for blood pressure , pill from having breast cancer  No concomitant medication was provided by reporter.  This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392113 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: aches; sore arm after dose 1 and 2; fever; chills; vaccine breakthrough infection; COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) (seriousness criterion medically significant), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (vaccine breakthrough infection) outcome was unknown and COVID-19 (COVID), PAIN (aches), VACCINATION SITE PAIN (sore arm after dose 1 and 2), PYREXIA (fever) and CHILLS (chills) had resolved.            Patient is taking concomitant for blood pressure , pill from having breast cancer  No concomitant medication was provided by reporter.  This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392113 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 68 years old, female patient with no clinical history who experienced the unexpected event of COVID-19 (AESI), PAIN, VACCINATION SITE PAIN, PYREXIA, CHILLS and VACCINE BREAKTHROUGH INFECTION The event occurred 120 days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Insomnia
Clinical narrative: hair loss; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) and INSOMNIA (lack of sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss) and INSOMNIA (lack of sleep). At the time of the report, ALOPECIA (hair loss) was resolving and INSOMNIA (lack of sleep) had resolved.        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.   Patient stated that after being admitted at the psychiatric facility he could sleep and rest and after that his hair started growing again. He stated that he lost his hair because of lack of sleep and not because of vaccine. He also mentioned that the doctor at the facility kept reminding him that he had first said it was the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Neck mass, Pyrexia
Clinical narrative: At 6:30pm that day, she started shaking; Heavy chills; Had fever of 101.6; Had a big knot in her muscle on the neck; Thought she is going to die; Felt throat was locked up; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (Felt throat was locked up), TREMOR (At 6:30pm that day, she started shaking), NECK MASS (Had a big knot in her muscle on the neck), FEELING ABNORMAL (Thought she is going to die) and CHILLS (Heavy chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, IRBESARTAN, PROPRANOLOL and LEVOTHYROXINE for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced THROAT TIGHTNESS (Felt throat was locked up), NECK MASS (Had a big knot in her muscle on the neck) and FEELING ABNORMAL (Thought she is going to die). On 17-Nov-2021, the patient experienced PYREXIA (Had fever of 101.6). On 17-Nov-2021 at 6:30 AM, the patient experienced TREMOR (At 6:30pm that day, she started shaking) and CHILLS (Heavy chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Felt throat was locked up), NECK MASS (Had a big knot in her muscle on the neck), FEELING ABNORMAL (Thought she is going to die), CHILLS (Heavy chills) and PYREXIA (Had fever of 101.6) outcome was unknown and TREMOR (At 6:30pm that day, she started shaking) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Body temperature: 101.6 (High) 101.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was afraid that it progressed to a point where she could not breath.    Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Event verbatim of neck mass was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: At 6:30pm that day, she started shaking; Heavy chills; Had fever of 101.6; Had a big knot in her muscle on the neck; Thought she is going to die; Felt throat was locked up; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (Felt throat was locked up), TREMOR (At 6:30pm that day, she started shaking), NECK MASS (Had a big knot in her muscle on the neck), FEELING ABNORMAL (Thought she is going to die) and CHILLS (Heavy chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, IRBESARTAN, PROPRANOLOL and LEVOTHYROXINE for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced THROAT TIGHTNESS (Felt throat was locked up), NECK MASS (Had a big knot in her muscle on the neck) and FEELING ABNORMAL (Thought she is going to die). On 17-Nov-2021, the patient experienced PYREXIA (Had fever of 101.6). On 17-Nov-2021 at 6:30 AM, the patient experienced TREMOR (At 6:30pm that day, she started shaking) and CHILLS (Heavy chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT TIGHTNESS (Felt throat was locked up), NECK MASS (Had a big knot in her muscle on the neck), FEELING ABNORMAL (Thought she is going to die), CHILLS (Heavy chills) and PYREXIA (Had fever of 101.6) outcome was unknown and TREMOR (At 6:30pm that day, she started shaking) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Body temperature: 101.6 (High) 101.6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was afraid that it progressed to a point where she could not breath.    Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Event verbatim of neck mass was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Pruritus, Rash
Clinical narrative: Itching; A biopsy was performed and it showed dermatitis.; Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching), DERMATITIS (A biopsy was performed and it showed dermatitis.) and RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms). On an unknown date, the patient experienced PRURITUS (Itching) and DERMATITIS (A biopsy was performed and it showed dermatitis.). At the time of the report, PRURITUS (Itching) and DERMATITIS (A biopsy was performed and it showed dermatitis.) outcome was unknown and RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included use of Aquaphor which seemed to provide a barrier to the spreading of rash  Patient reported that she had went to a walk in clinic because she was not able to stand the itching. Patient stated that a biopsy was performed which showed dermatitis. Patient also stated that the doctor told her that the immune system is fighting the vaccine just like it does in the case of pericarditis, but her body is attacking her skin. The patient reported that her sister developed the same events after receiving the vaccine, but it was on her back, chest, legs and arms and also the patient's granddaughter had the same rash, but only on her legs. Patient stated that the doctor at the walk in clinic told her that she had seen similar cases, specifically a (ethnicity given) (gender given) patient, but it was all over her body and big huge patches.   This case was linked to MOD-2021-392143, MOD-2021-391875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Reporter information added, Patient demographics updated, Patient's historical procedure hip replacement added, Dose 1 and dose 2 details updated, Events Pruritus and Dermatitis NOS added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Intense side effects/reactions more intense than with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Intense side effects/reactions more intense than with the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Intense side effects/reactions more intense than with the second dose). At the time of the report, VACCINATION COMPLICATION (Intense side effects/reactions more intense than with the second dose) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  It was reported that the patient had intense reactions with the second dose.   This case was linked to MOD-2021-392070 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains non-significant information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After the first dose she had only the sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After the first dose she had only the sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Breast cancer.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After the first dose she had only the sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (After the first dose she had only the sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included Blood pressure medication for blood pressure management and pills for breast cancer.  Treatment medication reported as reported as Tylenol, however the reporter was not sure.   This case was linked to MOD-2021-392060, MOD-2021-392132 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Event happened 6 months ago. No concomitant medication were given. No treatment information were given.   This case was linked to MOD-2021-392126 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist 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. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-May-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.   The concomitant medications information was not reported.  Treatment information was not provided.  Company Comment: This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 1 May -2021 patient received a dose of mRNA-1273  (028A21A expired date 28-April-2021).The benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 1 May -2021 patient received a dose of mRNA-1273  (028A21A expired date 28-April-2021).The benefit-risk relationship of mRNA-1273  is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain, Pyrexia
Clinical narrative: Aching after 2nd dose; Feverish after 2nd dose; feel aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching after 2nd dose), PYREXIA (Feverish after 2nd dose) and MYALGIA ( feel aching ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced PAIN (Aching after 2nd dose) and PYREXIA (Feverish after 2nd dose). 18-Nov-2021, the patient experienced MYALGIA ( feel aching ). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 2 Tylenol and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 Advil. At the time of the report, PAIN (Aching after 2nd dose), PYREXIA (Feverish after 2nd dose) and MYALGIA ( feel aching ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 101 (High) High, 101F at 14:30pm, 102.7 (High) High, 102.7F she and 101.6 (High) High, 101.6F..         The patient used v-safe as treatment. No concomitant medications were reported.   This case was linked to MOD-2021-392172 (Patient Link).; Sender's Comments: Non-serious Case.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction, Wrong technique in device usage process
Clinical narrative: I don't think a syringe was used to inject me. I think it was some kind of device that makes a 1/2 inch spot; I think it was some kind of device that makes a 1/2 inch spot; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I don't think a syringe was used to inject me. I think it was some kind of device that makes a 1/2 inch spot) and VACCINATION SITE REACTION (I think it was some kind of device that makes a 1/2 inch spot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I don't think a syringe was used to inject me. I think it was some kind of device that makes a 1/2 inch spot) and VACCINATION SITE REACTION (I think it was some kind of device that makes a 1/2 inch spot). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (I don't think a syringe was used to inject me. I think it was some kind of device that makes a 1/2 inch spot) had resolved and VACCINATION SITE REACTION (I think it was some kind of device that makes a 1/2 inch spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). In 2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Event happened 6 months ago. No concomitant medication were given. No treatment information were given.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours post initial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  The vial was initially stored in the refrigerator on 17-Nov-2021. The vial initially punctured on 17-Nov-2021. The vial had no temperature excursion.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aching after 1st dose; Feverish after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose). At the time of the report, PAIN (Aching after 1st dose) and PYREXIA (Feverish after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-392136 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patients may have received a vaccine which undergo a temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients may have received a vaccine which undergo a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Temperature went out of range several times for a total of 7 hours 20 minutes 50.7° F Max and 37°F Min. It was an hour here and an hour there at 49°F on 6 different days, all non consecutive days.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered beyond expiration date; 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 (Doses administered beyond expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). In November 2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Date(s) of administration of vaccine: Between 07Nov2021 and 18Nov2021. The vial didn't undergo any temperature excursions.; Sender's Comments: Non-serious case.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and tenderness at the injection site and on the left side of his throat to the collar bone; swelling at the injection site; tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling and tenderness at the injection site and on the left side of his throat to the collar bone), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PHARYNGEAL SWELLING (swelling and tenderness at the injection site and on the left side of his throat to the collar bone), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site). At the time of the report, PHARYNGEAL SWELLING (swelling and tenderness at the injection site and on the left side of his throat to the collar bone), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) had not resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient stated that tenderness refers to slightly painful without touching and more painful with touch. The armpit area was not affected. The symptoms had not worsened but it was not going away and it had been about 24 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: 4 days to get her energy back; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (4 days to get her energy back) and MYALGIA (Body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Asthma and Chronic bronchitis (She usually took a medication for Bronchitis, 6 doses.). Concomitant products included CETIRIZINE for Allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENIA (4 days to get her energy back) and MYALGIA (Body aches). The patient was treated with POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 22-Feb-2021, ASTHENIA (4 days to get her energy back) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient drank too much water with potassium and electrolytes and felt better.   This case was linked to MOD-2021-392451, MOD-2021-392574 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.            No concomitant medication were reported.   No treatment information was provided by the reporter.  Company comment: This case concerns a 62 year old male with no reported medical history, who experienced Serious ( Medically significant ,)  , unexpected event of Pneumonia , which occurred on an unknown date  with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The age of the patient  can be considered as a confounder for this case ( since elderly are vulnerable to infection ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 62 year old male with no reported medical history, who experienced Serious ( Medically significant ,)  , unexpected event of Pneumonia , which occurred on an unknown date  with an unknown dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the event is unknown. The age of the patient  can be considered as a confounder for this case ( since elderly are vulnerable to infection ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Somnolence
Clinical narrative: slept all day after the second dose; no appetite after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day after the second dose) and DECREASED APPETITE (no appetite after the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced SOMNOLENCE (slept all day after the second dose) and DECREASED APPETITE (no appetite after the second dose). At the time of the report, SOMNOLENCE (slept all day after the second dose) and DECREASED APPETITE (no appetite after the second dose) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-392215 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: severe thrombocytopenia.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (severe thrombocytopenia.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (severe thrombocytopenia.) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (severe thrombocytopenia.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender,  with no relevant medical history reported, who experienced serious unexpected event of severe thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was thus, not applicable.  The benefit-risk relationship of product is not affected by this report; Sender's Comments: This case concerns a patient of unknown age and gender,  with no relevant medical history reported, who experienced serious unexpected event of severe thrombocytopenia. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was thus, not applicable.  The benefit-risk relationship of product is not affected by this report