chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 002M21A and 002M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jun-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022).    No concomitant drug information was provided.  On 21-Apr-2022, the vial was initially stored in the refrigerator and administered on 02-Jun-2022. The vial did not undergo any temperature excursions.  Patient did not experienced any symptoms following vaccination.  No additional doses, medications, or treatments have been administered at the time.   This case was linked to US-MODERNATX, INC.-MOD-2022-637070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637070:Same reporter (Patient C-A)
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Malaise, Musculoskeletal chest pain, Nasal congestion
Clinical narrative: coughed so hard that my ribs hurt; felt sick, Patient did not feel well; 2 days after booster patient got head congestion which then went away; Coughing kicked in; wheezing; As the week went on patient got more tired; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (2 days after booster patient got head congestion which then went away), COUGH (Coughing kicked in), MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing) and MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 050C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had a history or current diagnosis or pericarditis or myocarditis.  Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN FOR WOMEN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (2 days after booster patient got head congestion which then went away). On 12-Mar-2022, the patient experienced MALAISE (felt sick, Patient did not feel well). In March 2022, the patient experienced COUGH (Coughing kicked in), WHEEZING (wheezing) and FATIGUE (As the week went on patient got more tired). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt). At the time of the report, NASAL CONGESTION (2 days after booster patient got head congestion which then went away) and COUGH (Coughing kicked in) had resolved and MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing), MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) and FATIGUE (As the week went on patient got more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant products included Bausch and Lomb Preservision Areds, Womens Multivitamin and Prometh-D.  The patient received first booster dose of the Moderna Covid-19 vaccine. Cough lingered for 3 to 4 weeks despite the medication that her doctor gave her.  Reportedly, doctor put patient on 5 unspecified medications due to symptoms.   This case was linked to MOD-2022-637066 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Wheezing
Clinical narrative: coughed so hard that my ribs hurt; felt sick, Patient did not feel well; 2 days after booster patient got head congestion which then went away; Coughing kicked in; wheezing; As the week went on patient got more tired; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (2 days after booster patient got head congestion which then went away), COUGH (Coughing kicked in), MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing) and MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 050C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had a history or current diagnosis or pericarditis or myocarditis.  Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN FOR WOMEN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (2 days after booster patient got head congestion which then went away). On 12-Mar-2022, the patient experienced MALAISE (felt sick, Patient did not feel well). In March 2022, the patient experienced COUGH (Coughing kicked in), WHEEZING (wheezing) and FATIGUE (As the week went on patient got more tired). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt). At the time of the report, NASAL CONGESTION (2 days after booster patient got head congestion which then went away) and COUGH (Coughing kicked in) had resolved and MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing), MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) and FATIGUE (As the week went on patient got more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant products included Bausch and Lomb Preservision Areds, Womens Multivitamin and Prometh-D.  The patient received first booster dose of the Moderna Covid-19 vaccine. Cough lingered for 3 to 4 weeks despite the medication that her doctor gave her.  Reportedly, doctor put patient on 5 unspecified medications due to symptoms.   This case was linked to MOD-2022-637066 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: coughed so hard that my ribs hurt; felt sick, Patient did not feel well; 2 days after booster patient got head congestion which then went away; Coughing kicked in; wheezing; As the week went on patient got more tired; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (2 days after booster patient got head congestion which then went away), COUGH (Coughing kicked in), MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing) and MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 050C21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had a history or current diagnosis or pericarditis or myocarditis.  Concomitant products included MONTELUKAST, ALBUTEROL [SALBUTAMOL], PROMETHAZINE HYDROCHLORIDE (PROMETH), CEFUROXIME, METHYLPREDNISOLONE, COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN FOR WOMEN, IRBESARTAN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and AMLODIPINE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASAL CONGESTION (2 days after booster patient got head congestion which then went away). On 12-Mar-2022, the patient experienced MALAISE (felt sick, Patient did not feel well). In March 2022, the patient experienced COUGH (Coughing kicked in), WHEEZING (wheezing) and FATIGUE (As the week went on patient got more tired). On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt). At the time of the report, NASAL CONGESTION (2 days after booster patient got head congestion which then went away) and COUGH (Coughing kicked in) had resolved and MALAISE (felt sick, Patient did not feel well), WHEEZING (wheezing), MUSCULOSKELETAL CHEST PAIN (coughed so hard that my ribs hurt) and FATIGUE (As the week went on patient got more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant products included Bausch and Lomb Preservision Areds, Womens Multivitamin and Prometh-D.  The patient received first booster dose of the Moderna Covid-19 vaccine. Cough lingered for 3 to 4 weeks despite the medication that her doctor gave her.  Reportedly, doctor put patient on 5 unspecified medications due to symptoms.   This case was linked to MOD-2022-637066 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Gave a 0.25ml dose from the wrong vial (blue cap with a purple border); No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) in a child male patient 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) .25 milliliter. On an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Gave a 0.25ml dose from the wrong vial (blue cap with a purple border)).    No concomitant medication was provided.  The patient (child below 5 years) was given 0.25 ml from a vial that was meant for children 6 to 11 years old or as a booster dose to adults. The vial has a blue cap and a label with a purple border, not a magenta border. Treatment information was not provided.  This case was linked to MODERNATX, INC.-MOD-2022-637090 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637090:Crosslinked case CMOD22-03640
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Myalgia, Pain in extremity, Psoriasis, Stress
Clinical narrative: PLAQUE PSORIASIS FLARE UP; STRESS FLARE UPS; SICK; PAIN IN ARM; MUSCLE PAIN; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UP), STRESS (STRESS FLARE UPS), ILLNESS (SICK), PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UP), STRESS (STRESS FLARE UPS), ILLNESS (SICK), PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UP) had not resolved, STRESS (STRESS FLARE UPS) was resolving, ILLNESS (SICK) outcome was unknown and PAIN IN EXTREMITY (PAIN IN ARM) and MYALGIA (MUSCLE PAIN) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant product reported by reporter. No treatment medication reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pericardial effusion
Clinical narrative: fluid around the heart/inflammation; patient had a bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around the heart/inflammation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 PERICARDIAL EFFUSION (fluid around the heart/inflammation) (seriousness criterion medically significant) and IMMUNISATION REACTION (patient had a bad reaction). At the time of the report, PERICARDIAL EFFUSION (fluid around the heart/inflammation) and IMMUNISATION REACTION (patient had a bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment drug was provided by reporter.  Company comment: This spontaneous case concerns a unspecified age female patient, with no medical history reported, who experienced unexpected serious (medically significant) of pericardial effusion, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. At the time of reporting outcome of event is unknown. No further details about clinical course, lab test, treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female patient, with no medical history reported, who experienced unexpected serious (medically significant) of pericardial effusion, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. At the time of reporting outcome of event is unknown. No further details about clinical course, lab test, treatment received were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine; Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 03-Aug-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (Mixed COVID-19 primary series administered to patient/Patinet received 1st dose of Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Patinet received the Pfizer COVID-19 vaccine and then Moderna vaccine given as 2nd dose after 1st dose of Pfizer).    Concomitant product use was not provided by the reporter. Patient was five and a half years old. Patient was watched for 15 minutes and no adverse reactions were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Live Follow-up has been appended
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.; The patients did not report any adverse reactions; Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions) 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 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.) and NO ADVERSE EVENT (The patients did not report any adverse reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (The patients did not report any adverse reactions) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator, vaccines are usually put in refrigerator a week before administration.).    No concomitant medications were reported.  Dose administered after 30-day Use By Date or after manufacturer date of expiry.  Number of doses/vials were 7 doses/1 vial.  The Healthcare Professional was not knowing the date the vial was initially stored in the refrigerator but stated that vaccines were usually put in refrigerator a week before administration.  The vial had not undergone any temperature excursions.  The reporter wanted to know about the stability of this lot number and recommendation for next steps for the patients impacted due to this.  The patients had not reported any adverse reactions.  No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received vaccine pass 3 days of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine pass 3 days of expiry) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A and 018F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Tdap vaccine in 2021. Past adverse reactions to the above products included No adverse event with Tdap vaccine. Concurrent medical conditions included Asthma, Hypertension and Prediabetes. Concomitant products included GABAPENTIN, LOSARTAN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MONTELUKAST SODIUM (SINGULAIR), COLECALCIFEROL (VITAMIN D3) and PNEUMOCOCCAL VACCINE for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine pass 3 days of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine pass 3 days of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine pass 3 days of expiry).    Number of doses/vials were dose 1 and vial 1 vial did not undergo any temperature excursions. patient not had COVID positive test or diagnosis. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2022: Follow-up information received contains Contact Information updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vaccine kept in refrigerator; No adverse event; Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 61-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 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022) and PRODUCT STORAGE ERROR (expired vaccine kept in refrigerator).    No concomitant medications were reported.  Number of doses/vials were 7 doses/1 vial.  The Healthcare Professional (HCP) did not know the date the vial was initially stored in the refrigerator but stated that vaccines were usually put in refrigerator a week before administration.  The reporter wanted to know about the stability of this lot number and recommendation for next steps for the patients impacted due to this.  The patients had not reported any adverse reactions.  No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was kept in refrigerator; No adverse event; Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022/Patient received vaccine on 16-Jun-2022) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator).    No concomitant medications were reported.  The patient had received second booster dose. Number of doses/vials were 7 doses/1 vial. The vial did not undergo any temperature excursions. The Healthcare Professional (HCP) did not know the date the vial was initially stored in the refrigerator but stated that vaccines were usually put in refrigerator a week before administration. Patient had not reported any adverse reactions. No treatment details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Tremor
Clinical narrative: patient started shaking; she didn't feel well for 48 hours; Fever of 103 degree F; chills; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 prophylaxis.     Patient had no allergies Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Retired Nurse was reporting for herself. Patient was not under any concomitant or regular medication. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient had experienced a similar event in the past sometimes with flu shot and shingles with pneumonia shot she felt really bad. It was reported that symptoms resolved. Patient did not seek medical care.   This case was linked to MOD-2021-004180 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Myalgia, SARS-CoV-2 test
Clinical narrative: patient started shaking; she didn't feel well for 48 hours; Fever of 103 degree F; chills; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 prophylaxis.     Patient had no allergies Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, TREMOR (patient started shaking), MALAISE (she didn't feel well for 48 hours), PYREXIA (Fever of 103 degree F) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Retired Nurse was reporting for herself. Patient was not under any concomitant or regular medication. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient had experienced a similar event in the past sometimes with flu shot and shingles with pneumonia shot she felt really bad. It was reported that symptoms resolved. Patient did not seek medical care.   This case was linked to MOD-2021-004180 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Acquired haemophilia
Clinical narrative: Acquired hemophilia A; This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired hemophilia A) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (Acquired hemophilia A) (seriousness criterion medically significant). At the time of the report, ACQUIRED HAEMOPHILIA (Acquired hemophilia A) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACQUIRED HAEMOPHILIA (Acquired hemophilia A) to be related.    No concomitant medication and treatment medication were reported.  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (medically significant) event of Acquired hemophilia A, immediately after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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 literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (medically significant) event of Acquired hemophilia A, immediately after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got really sick with the Moderna; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got really sick with the Moderna) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Iron deficiency. Concomitant products included IRON for Iron deficiency, FISH OIL for an unknown indication.    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 ILLNESS (I got really sick with the Moderna). At the time of the report, ILLNESS (I got really sick with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's ethnicity was reported as white.  Patient got Pfizer booster instead of Moderna because she got really sick with the Moderna.  No treatment medications were reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Dysphonia, Influenza virus test, Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2022 at 11:00 as dose 1, single (Lot number: FT9142) at the age of 4 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "given incorrectly...The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syringe and not in the vial."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syrin"; ABDOMINAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown"; PYREXIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "fever 101-102"; DYSPHONIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, abdominal pain, pyrexia, dysphonia.  Additional Information: Caller was an office manager calling on behalf of a pediatric clinic. The product was given incorrectly. Caller was not sure if she had time to do a report. The mother of the patient was getting antsy and had already been there for 30 minutes. Caller clarified that she did not have time to do a report at that time. Caller clarified how it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. The patient did not receive prior vaccinations within 4 weeks. It was mixed in the syringe and not in the vial.   Follow-up (30Aug2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported in response to HCP letter sent. Updated information: Vaccine Information (dose number, lot number, route of administration), information on concomitant medication, lab test, treatment received, vaccine administration facility information and new adverse events added.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Pyrexia, Streptococcus test, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2022 at 11:00 as dose 1, single (Lot number: FT9142) at the age of 4 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "given incorrectly...The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syringe and not in the vial."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syrin"; ABDOMINAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown"; PYREXIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "fever 101-102"; DYSPHONIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, abdominal pain, pyrexia, dysphonia.  Additional Information: Caller was an office manager calling on behalf of a pediatric clinic. The product was given incorrectly. Caller was not sure if she had time to do a report. The mother of the patient was getting antsy and had already been there for 30 minutes. Caller clarified that she did not have time to do a report at that time. Caller clarified how it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. The patient did not receive prior vaccinations within 4 weeks. It was mixed in the syringe and not in the vial.   Follow-up (30Aug2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported in response to HCP letter sent. Updated information: Vaccine Information (dose number, lot number, route of administration), information on concomitant medication, lab test, treatment received, vaccine administration facility information and new adverse events added.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Disease recurrence; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive, notes: Day1- Wednesday 17Aug -tested positive; (21Aug2022) Positive, notes: Day Rapid antigen 5- Sunday 21Aug pm. faintly positive; (24Aug2022) Positive, notes: Day 8- 24Aug adverse event antigen faintly positive; (24Aug2022) Negative, notes: Day 8 24Aug Wednesday- Felt better- rapid antigen Negative; (27Aug2022) Positive, notes: Rapid antigen test brightly positive instantly. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: It was reported that the patient was not received other medication in 2 weeks. Day 0- Tuesday 16Aug - Symptom onset. Day1- Wednesday 17Aug -tested positive am -started Paxlovid pm 18Aug-23: severe light-headedness/dizziness. Took only 4 days Paxlovid. Stopped early due to dizziness. Last dose was day 5 on 21Aug Sunday morning. Day 5- Sunday 21Aug pm. Rapid antigen faintly positive. Day 8- 24Aug adverse event antigen faintly positive. Day 8 24Aug Wednesday- Felt better- rapid antigen Negative. Day10- pm hugged family without mask. Day 11-woke with rhinorrhea. Sneezing. Feeling of head cold. Spell of profound blurred vision/scotoma at work lasting 15 min. Upon return home- Rapid antigen test brightly positive instantly. Day 12-28Aug headache weak sinusitis dizzy fatigued.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE), COVID-19,disease recurrence cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 24Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (unspecified if ongoing); "asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 29Aug2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Aug2022) Negative, notes: Covid positive after testing negative; (29Aug2022) Positive, notes: Covid positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient had taken paxlovid treatment from 19Aug2022 to 24Aug2022 for the treatment of covid-19. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.