chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant live follow-up received. Reporter address updated.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported as unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: The recent follow-up received on 08-JUN-2022 contains non significant information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up document included non-significant information.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to 3 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 09-May-2022. HCP stated that they had Moderna at the facility which showed as expired on 17-May-2022 upon entering into the expiration look up tool on Moderna's website. It was reported that the vial did not undergo any temperature excursions. None of the patients have reported any adverse reactions to the expired dose. No treatment drug was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 3 doses of this expired vaccine on 20MAY2022 to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 09-May-2022. HCP stated that they had Moderna at the facility which showed as expired on 17-May-2022 upon entering into the expiration look up tool on Moderna's website. It was reported that the vial did not undergo any temperature excursions. None of the patients have reported any adverse reactions to the expired dose. No treatment drug was reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and treatment medication was not reported. Event start date was reported as 2022. Patient was not enrolled in clinical trial. Company Comment: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately more than 9 months after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately more than 9 months after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation reaction, Pruritus
Clinical narrative: covid arm from the shoulder to the elbow; it was red, very itchy and lasted a month; it was red, very itchy and lasted a month; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (covid arm from the shoulder to the elbow), ERYTHEMA (it was red, very itchy and lasted a month) and PRURITUS (it was red, very itchy and lasted a month) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 023M20A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified. Concomitant products included VERAPAMIL for Heart disease, unspecified.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (covid arm from the shoulder to the elbow), ERYTHEMA (it was red, very itchy and lasted a month) and PRURITUS (it was red, very itchy and lasted a month). At the time of the report, IMMUNISATION REACTION (covid arm from the shoulder to the elbow) outcome was unknown and ERYTHEMA (it was red, very itchy and lasted a month) and PRURITUS (it was red, very itchy and lasted a month) had resolved.            Patient did not have patient had positive COVID test or diagnosis. Treatment details was not reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Had a bad reaction to the three Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020b21a) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Allergy to nuts (Nuts), Allergy to grains (wheat) and Milk allergy (can not drink milk). Concomitant products included ESTRADIOL (DIVIGEL) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots). At the time of the report, IMMUNISATION REACTION (Had a bad reaction to the three Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2022-586557 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Body aches and pains; Severe headache; Body aches and pains; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not had allergies to (medications, food and other products).  It was reported that patient did not had any chronic illness at the time of vaccination.  They were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine  Patient did not had ever COVID positive test or did not diagnosed with COVID positive test.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains). At the time of the report, PAIN (Body aches and pains), HEADACHE (Severe headache) and MYALGIA (Body aches and pains) had not resolved.            On 08-Jun-2022, received fourth second booster dose of mRNA-1273 (Moderna COVID-19 Vaccine)  On 01-Nov-2021, the patient received first booster dose (no further information available)  There were no information about first primary and second primary dose  No concomitant medication information was provided.  It was reported that patient symptoms were not getting any better.  No treatment medication were provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pain
Clinical narrative: Condition aggravated; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Concomitant drugs were not reported. On 22-Oct-2021, patient received third dose/booster dose of Moderna vaccine. No treatment medication information was given
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine had stored at room temperature; Possibly expired dose administered; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possibly expired dose administered) and PRODUCT STORAGE ERROR (Vaccine had stored at room temperature) in a 23-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possibly expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had stored at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Possibly expired dose administered) and PRODUCT STORAGE ERROR (Vaccine had stored at room temperature) outcome was unknown.            Patient was not on any concomitant medications. Patient reports she not been experiencing side effects as of yet. No treatment medication was reported.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: SICK; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in December 2020.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In June 2021, the patient experienced ILLNESS (SICK). In 2021, ILLNESS (SICK) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included Xeljanz.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for co-suspect RINVOQ(UPADACITINIB) for the event of sick was not provided. opinion was that there was no reasonable possibility that the events of sick was related to RINVOQ(UPADACITINIB).  Treatment medications were not reported.   This case was linked to MOD-2022-586880, MOD-2022-586888 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, Pain assessment
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included TOFACITINIB CITRATE (XELJANZ) from May 2022 to an unknown date for Rheumatoid arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6 to 7 6 to 7 on scale of 10.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for RINVOQ(UPADACITINIB) with respect to the events of MIGRAINES and PAIN was not provided.  opinion was that there is no reasonable possibility that the events MIGRAINES and pain are related to RINVOQ(UPADACITINIB).  Treatment details were not given   This case was linked to MOD-2022-586870 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, Pain assessment
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No medical history was provided by the reporter.  Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6 to 7 pain was at 6 to 7 on scale of 10..         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for RINVOQ(UPADACITINIB) with respect to the events of MIGRAINES and PAIN was not provided.   opinion was that there is no reasonable possibility that the events MIGRAINES and pain are related to RINVOQ(UPADACITINIB). No treatment medications was provided by the reporter.   This case was linked to MOD-2022-586870 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feeling body aches after her first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine). At the time of the report, MYALGIA (feeling body aches after her first dose of the Moderna Covid-19 vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported.  The patient never went back to receive a second dose of Moderna COVID-19 vaccine. Patient received the vaccine in her left arm shoulder bicep muscle. No treatment details were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Number of doses or vials includes 1 dose from 1 vial. The vial was initially taken out from the freezer, thawed, and used on 10Jun2022. Never put in the refrigerator for storage. The vial did not undergo any temperature excursions. This was the patient's 2nd booster dose administered in their left arm. Patient was not experiencing any symptoms. No treatment was given. No treatment medication details was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second booster given 10 days after 1st; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second booster given 10 days after 1st) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter indicated that a family member took the patient to get the first booster dose and did not report it back to the nursing home where the patient was living. The patient was currently not experiencing any side effects.  No treatment information was provided by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm feels like it will fall off; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (arm feels like it will fall off) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was reported that patient had no allergies and medical history. .    On 09-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 and 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 LIMB DISCOMFORT (arm feels like it will fall off). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arm feels like it will fall off) outcome was unknown.            Patient height was 5'10.  Patient had no concomitant medications.  Patient was neither tested nor diagnosed with COVID in the past.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding; Burned, bubbled almost effervescent/Painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful). On 27-Nov-2021, VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 41,500 level of 41,500.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that patient took other medications. However, non of them were blood thinners that would had caused the bleeding and patient is due to get a MRI on 14 Jun2022.  No treatment medications were provided.   This case was linked to MOD-2022-587336 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding; Burned, bubbled almost effervescent/Painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A and 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful). On 27-Nov-2021, VACCINATION SITE HAEMORRHAGE (bleed to the point the person that gave the injection had to put pressure on the area for about a minute to get it to stop bleeding) and VACCINATION SITE PAIN (Burned, bubbled almost effervescent/Painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 41,500 level of 41,500.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that patient took other medications. However, non of them were blood thinners that would had caused the bleeding and patient is due to get a MRI on 14 Jun2022.  No treatment medications were provided.   This case was linked to MOD-2022-587336 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: large decrease in his ability to run/now he can only make it 200 Yards before getting tired and fatigued; pain in his legs and they just start to ache while sitting; sore left arm after the injection; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (large decrease in his ability to run/now he can only make it 200 Yards before getting tired and fatigued), PAIN IN EXTREMITY (pain in his legs and they just start to ache while sitting) and VACCINATION SITE PAIN (sore left arm after the injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced VACCINATION SITE PAIN (sore left arm after the injection). On an unknown date, the patient experienced FATIGUE (large decrease in his ability to run/now he can only make it 200 Yards before getting tired and fatigued) and PAIN IN EXTREMITY (pain in his legs and they just start to ache while sitting). At the time of the report, FATIGUE (large decrease in his ability to run/now he can only make it 200 Yards before getting tired and fatigued), PAIN IN EXTREMITY (pain in his legs and they just start to ache while sitting) and VACCINATION SITE PAIN (sore left arm after the injection) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial had been open for more than 24h; A patient was administered a dose from a vial that had been open for more 24h; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h) and PRODUCT STORAGE ERROR (the vial had been open for more than 24h) in a 65-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 10-Jun-2022 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial had been open for more than 24h). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a dose from a vial that had been open for more 24h) and PRODUCT STORAGE ERROR (the vial had been open for more than 24h) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. It was reported that there were no other AEs as a result of this misadministration. 1 dose expired after the 12h. On Monday 6 Jun 2022 the vial was initially stored in the refrigerator.  On 9 June 2022 9:30 am vial was first punctured.  The vial was stored post puncture in a fridge.  The vial did not  undergo any temperature excursions. The vial was exposed to room temperature range for 15 mins before administration.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Still having side effects after Moderna Vaccination; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Still having side effects after Moderna Vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (Still having side effects after Moderna Vaccination). At the time of the report, IMMUNISATION REACTION (Still having side effects after Moderna Vaccination) had not resolved.            No Concomitant product use was reported.  The patient stated that they had 1st, 2nd, and booster shots and was still having side effects from it.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just had slightly sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Just had slightly sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just had slightly sore arm). At the time of the report, PAIN IN EXTREMITY (Just had slightly sore arm) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-583896 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) in a 79-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was unknown. It was reported that vials had not undergone any temperature excursion. No treatment medication were reported.   This case was linked to MOD-2022-585393 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site granuloma
Clinical narrative: granulomas at the injection sites/ lumps have occurred, and they are exactly at the injection sites and above her lip; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE GRANULOMA (granulomas at the injection sites/ lumps have occurred, and they are exactly at the injection sites and above her lip) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product POLY-L-LACTIC ACID (SCULPTRA) injection for an unknown indication.    No Medical History information was reported.   On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started POLY-L-LACTIC ACID (SCULPTRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE GRANULOMA (granulomas at the injection sites/ lumps have occurred, and they are exactly at the injection sites and above her lip). At the time of the report, INJECTION SITE GRANULOMA (granulomas at the injection sites/ lumps have occurred, and they are exactly at the injection sites and above her lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 09-Jun-2021, it was reported that the patient was injected with Sculptra into the cheek area. The patient had granulomas at the injection sites and stated that the week after Easter 2022, 07-Apr-2022 or 08-Apr-2022, the patient noticed a lump on their lower right cheek. The consumer additionally reported that since then, other lumps had occurred, and they were exactly at the injection sites and above their lip. The patient had Radiesse in May-2021.~  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint range of motion decreased, Musculoskeletal discomfort, Pain, Pain in extremity
Clinical narrative: having a serious issue with my both shoulders, the left is much worse; also had little range of motion in my shoulder.; started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse; tired; had a sore arm; achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy), JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.), PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse), MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse) and FATIGUE (tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 505C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J (Lot: 1805020 and site: left arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced PAIN (achy), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm). In September 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.) and PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse). At the time of the report, PAIN (achy), JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.), PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse), MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm) outcome was unknown.            No allergies, cardiac issues history or COVID-19 history was reported. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-587494, MOD-2022-587536 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: having a serious issue with my both shoulders, the left is much worse; also had little range of motion in my shoulder.; started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse; tired; had a sore arm; achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy), JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.), PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse), MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse) and FATIGUE (tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 505C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J (Lot: 1805020 and site: left arm) on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced PAIN (achy), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm). In September 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.) and PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse). At the time of the report, PAIN (achy), JOINT RANGE OF MOTION DECREASED (also had little range of motion in my shoulder.), PAIN IN EXTREMITY (started having sharp pain in right arm with certain movements, started in my triceps area, then moved up in shoulder & bicep, progressively getting worse), MUSCULOSKELETAL DISCOMFORT (having a serious issue with my both shoulders, the left is much worse), FATIGUE (tired) and VACCINATION SITE PAIN (had a sore arm) outcome was unknown.            No allergies, cardiac issues history or COVID-19 history was reported. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-587494, MOD-2022-587536 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD-2022-571290. A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Single, Manufacturer: Unknown, Verbatim: we were both vaccinated and boosted), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Single, Manufacturer: Unknown, Verbatim: we were both vaccinated and boosted), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Single, Manufacturer: Unknown, Verbatim: we were both vaccinated and boosted), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My husband received Pfizer, and had the same exact result of a re-infection". The reporter stated that her husband got Pfizer, she got Moderna, both were vaccinated and boosted. Our doctor prescribed Paxlovid and explained the benefit of eliminating the symptoms that go along with Covid-19. The fact that Pfizer just sent this over to Moderna is insulting. Her husband received Pfizer, and had the same exact result of a re-infection. So they were 100% in her household and that was with 2 different brands of vaccine. They both had the foul taste. Pfizer says that less than 5% of people are re-infected, and less than 2% have the foul taste, she questioned that after reading all the other accounts online of people who experienced the same exact effects they did, also they were 100% of the people who took Paxlovid experienced both of those things. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.