chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022; No adverse event; Patient used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administerd on 05-Aug-2022) 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 (Patient used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Jun-2022 and administered on 05-Aug-2022). No concomitant medications were reported. The patient received second booster dose. The vial was initially stored in the refrigerator on 30-Jun-2022. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis. It was unknown if patient had any allergies, any acute or chronic illnesses at the time of vaccination. It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient ever had COVID positive test or diagnosis. On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date.), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) 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 (Patient administered vaccine beyond its use by date.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022). No concomitant medications were reported. The patient had received second booster. The vial was initially stored in the refrigerator on 30-Jun-2022. Reportedly, the vial did not undergo any temperature excursions.  It was unknown if the adverse event caused patient to seek medical care. It was unknown if the patient experienced a similar event in the past. No treatment information was provided by the reporter.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Incorrect product formulation administered, No adverse event
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose), ACCIDENTAL UNDERDOSE (Received 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose) and ACCIDENTAL UNDERDOSE (Received 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose), ACCIDENTAL UNDERDOSE (Received 0.25 ml) 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 INCORRECT PRODUCT FORMULATION ADMINISTERED (7-Year-Old received 5-Month to 6-Year-old formulation vaccine for first dose/Received 0.25 ml of 5-Month to 6-Year-old formulation  for first dose) and ACCIDENTAL UNDERDOSE (Received 0.25 ml). No Concomitant medication was reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Follow-up received included non-significant information updated reporter's information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: After the vaccine, I felt bubbles in my veins; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins) 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 FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins). At the time of the report, FEELING ABNORMAL (After the vaccine, I felt bubbles in my veins) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was terrifying because patient figured out how reaction has stopped and started again. It was reported that It may be either with vaccine plus a chemical additive in the product which a patient used  a (strange combo phenomenon) that's causing bubbling or  a new chemical additive was manufactured with the same product. No treatment medications were reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 30-Jun-2022, the vial was administeed on 05-Aug-2022; No adverse event; used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 30-Jun-2022, the vial was administeed on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     It was unknown the patient had any allergies to (medications, food and other products).  It was unknown patient ever had COVID + test or diagnosis. Medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination was unknown. It was unknown recent change in status such as improvement or worsening. It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #).     On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 30-Jun-2022, the vial was administeed on 05-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 30-Jun-2022, the vial was administeed on 05-Aug-2022) 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 (used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 30-Jun-2022, the vial was administeed on 05-Aug-2022).    No concomitant drug was reported. It was reported that vial did not undergo temperature excursions. The patient received second booster dose.  It was unknown adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  It was unknown the patient has experienced a similar event in the past. No treatment drug was reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022; No adverse reaction; Patient administered vaccine beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine beyond its use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 30-Jun-2022 and administered on 05-Aug-2022).    No concomitant medication was reported.  It was reported that the vial was initially stored in the refrigerator on 30-Jun-2022. Number of doses or vials were unknown. The vial did not undergo any temperature excursions. The patient received second booster.  No treatment medication was reported.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022; No Adverse reaction; Used Moderna Covid-19 vaccine last week beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Used Moderna Covid-19 vaccine last week beyond its use by date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Jun-2022 and dose was administered on 05-Aug-2022).    No concomitant medications were reported. Patient received second booster. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown. Vial was initially stored in the refrigerator on 30-Jun-2022.Vial did not undergo any temperature excursions. Patient seeked medical care reported as unknown. No treatment information was provided.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022; No Adverse reaction; I used Moderna Covid-19 vaccine last week beyond its use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022) and NO ADVERSE EVENT (No Adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (I used Moderna Covid-19 vaccine last week beyond its use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30Jun2022 and administration of vaccine on AUG-2022).    Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid-19 vaccine used beyond its use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     It was unknown if patient was allergic to medications, food, and other products. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19. Acute and chronic illnesses at the time of vaccination were unknown. It was unknown if other vaccines were given to patient within 1 month prior to Moderna COVID-19 vaccine.     On 05-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine used beyond its use by date.) 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 (Moderna Covid-19 vaccine used beyond its use by date.).    No concomitant medications information was reported. Patient received the second booster.  It was unknown if the event caused the patient to seek medical care. It was unknown if the patient experienced a similar event in the past.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Sarcoidosis
Clinical narrative: Sarcoidosis to flare up; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of SARCOIDOSIS (Sarcoidosis to flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced SARCOIDOSIS (Sarcoidosis to flare up) (seriousness criterion medically significant) and ARTHRITIS (Arthritis). At the time of the report, SARCOIDOSIS (Sarcoidosis to flare up) and ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medication was reported.  Company comment: This is a spontaneous case concerning a elderly female patient with no reported medical history. Patient has reported co-suspect medication of Adalimumab (Humira) for unknown indication. Patient experienced the unexpected serious (medically significant) event of Sarcoidosis (Sarcoidosis to flare up), and the unexpected non-serious AESI event arthritis. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the event Sarcoidosis (Sarcoidosis to flare up). The patient being elderly and the unspecified indication of the co-suspect medication Adalimumab (Humira) may remain confounders for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a elderly female patient with no reported medical history. Patient has reported co-suspect medication of Adalimumab (Humira) for unknown indication. Patient experienced the unexpected serious (medically significant) event of Sarcoidosis (Sarcoidosis to flare up), and the unexpected non-serious AESI event arthritis. The events occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The co-suspect medication of Adalimumab (Humira) remain confounder for the event Sarcoidosis (Sarcoidosis to flare up). The patient being elderly and the unspecified indication of the co-suspect medication Adalimumab (Humira) may remain confounders for the event arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (hard time getting around) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (hard time getting around). At the time of the report, VACCINATION COMPLICATION (hard time getting around) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No treatment medication reported by reporter.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; 7 years old patient received a half dose of the Moderna COVID-19 vaccine by intramuscular injection as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 years old patient received a half dose of the Moderna COVID-19 vaccine by intramuscular injection as a booster) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine on 09-Nov-2021 and Pfizer COVID-19 Vaccine on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On 06-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 06-Aug-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 years old patient received a half dose of the Moderna COVID-19 vaccine by intramuscular injection as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 years old patient received a half dose of the Moderna COVID-19 vaccine by intramuscular injection as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (7 years old patient received a half dose of the Moderna COVID-19 vaccine by intramuscular injection as a booster).    It was reported that patient received half dose of Moderna COVID-19 vaccine as a booster. Concomitant drugs were not reported. It was also reported that patient did not experienced any symptoms after receiving this dose of the vaccine and no additional doses, medications, or treatments have been administered in response to this event.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 012H21B, 026C21A and 041B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 15-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2021 at 9:40 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:42 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (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 expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    No concomitant medication was provided. Date(s) of administration of vaccine were reported as  19-May-2022, 26-May-2022, 02-Jun2022, 07Jun2022 and 08-Jun-2022. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. No treatment medication was provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Illness, Palpitations
Clinical narrative: Sick; terribly weak; breathing impaired; heart pounding; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), ASTHENIA (terribly weak), DYSPNOEA (breathing impaired) and PALPITATIONS (heart pounding) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick), ASTHENIA (terribly weak), DYSPNOEA (breathing impaired) and PALPITATIONS (heart pounding). At the time of the report, ILLNESS (Sick) outcome was unknown and ASTHENIA (terribly weak), DYSPNOEA (breathing impaired) and PALPITATIONS (heart pounding) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       Concomitant products were not reported. It was reported that patient received primary two dose of Moderna and booster with Janssen vaccine. Patient had breathing impaired, heart pounding and terribly weak for a week. The patient was sick overnight after first J and J booster, second time drank a ton of water which may or may not be the reason that patient did not had terrible muscle pain. The event sickness was possible related to JNJ COVID-19 VACCINE. Treatment medications were not reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours; No adverse event; Administer a vaccine to a pediatric patient past 12 hours of first puncturing; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing), PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     Patient did not had any allergies or both Acute and Chronic illnesses at the time of vaccination. It was reported that patient has never been diagnosed/tested positive for COVID-19.     On 08-Aug-2022 at 8:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing), PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing) and PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours).    No concomitant medications was reported.  Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient has never experienced a similar event in the past.  The HCP administerd vaccine to a pediatric patient past 12 hours of first puncturing. The vial was expired on the 05-Aug-2022, and it was administer on the 08-Aug-2022. It was unknown, when the vial was initially stored in the refrigerator. The vial was first punctured on 05-Aug-2022 at 10:25 AM and for a total of 72 hours. It was unknown whether the vial was stored in room temperature or fridge post puncture. The vial did not undergo any temperature excursions.   No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Follow-up received contains updated batch number.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: SOME SPOTS; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (SOME SPOTS) in a 55-year-old female 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 Psoriasis.    No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-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) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (SOME SPOTS). At the time of the report, IMMUNISATION REACTION (SOME SPOTS) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event SOME SPOTS was not provided. No treatment medications were reported.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Pruritus, Swelling
Clinical narrative: SWELLING; Itching; BURNING AFTER INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING), PRURITUS (Itching) and INJECTION SITE PAIN (BURNING AFTER INJECTION) in an adult female 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 Crohn's disease.    No Medical History information was reported.   On 09-Apr-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF,solution for injection in pre-filled pen. On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (SWELLING), PRURITUS (Itching) and INJECTION SITE PAIN (BURNING AFTER INJECTION). At the time of the report, SWELLING (SWELLING) and PRURITUS (Itching) outcome was unknown and INJECTION SITE PAIN (BURNING AFTER INJECTION) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of burning after injection with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of swelling and itching with Humira (adalimumab) was no reasonable possibility.  No treatment medications were reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tremor
Clinical narrative: trembling; fever that got up to 106/ fever for 48hrs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer, The first dose he got the smaller dose because he was under 5 she thinks it was  0.3 mLs), when the patient was 4 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant), outcome "recovered", described as "fever that got up to 106/ fever for 48hrs"; TREMOR (non-serious), outcome "unknown", described as "trembling". The patient underwent the following laboratory tests and procedures: Body temperature: 106. The patient's mother reported that the patient had a bad reaction to the second dose of Pfizer COVID 19 Orange top vaccine. For the second dose he got the larger dose because he had turned 5. The patient's mother stated the patient is tiny so she thinks it was too much for him. His Reaction was fever that got up to 106, trembling, fever for 48hrs, it was horrendous. She will not give him, or her other kids the booster. She was done with the vaccine and she was not an anti-vaccine person. She does not understand why vaccines are not given by weight. The patient only weighs 30 lbs. She already made the report with the safety dept.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Pyrexia, Somnolence
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. A 5-year-old male patient received BNT162b2 (BNT162B2), on 04Aug2022 as dose 2 (orange cap), single (Lot number: FL8094, Expiration Date: 15Aug2022) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history included: "Hemophilia" (ongoing), notes: Bruises Easily. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid 19 Vaccine for 5-11 year olds Orange Cap; First Dose; Lot: FL8095; Expiration Date: 31Aug2022; 59267105504), administration date: 06Jul2022, when the patient was 5-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Fever"; SOMNOLENCE (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Sleeping all day"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 04Aug2022, outcome "unknown" and all described as "received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap". Therapeutic measures were not taken as a result of product preparation error, overdose, somnolence, pyrexia.  Additional information: Nurse called to request revaccination guidance for Pfizer BioNTech covid-19 vaccine (orange top) administered undiluted. Nurse stated that a 5 year old male patient received 1 undiluted dose of the Pfizer BioNTech covid-19 vaccine orange cap as the first dose. Had an incident today where the Pfizer 5 to 11 years old was administered without dilution. Concerned, reporter stated, "I am calling because I work for (Institution name (State name) and I am calling because we had an incident today where the Pfizer 5 to 11 years old was administered without dilution and they were wondering if there is a procedure or protocol or what is the apology regarding the administration of Pfizer (COVID-19 Vaccine) without dilution." QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default (as reported). Upon recent follow-up, they had an incident yesterday and she called yesterday and reported it and spoke to someone in Medical, but she was informed by a colleague at (Facility name Withheld) that it was the patient's first vaccine, when it was actually his second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (04Aug2022 and 05Aug2022): This is a spontaneous follow-up report from same contactable Nurse. Updated information included: patient information (height, weight); medical history; historical vaccine; concomitant medication; suspect drug details (lot number and expiration date); event details (new events: Sleeping all day and Fever); and additional information. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Dyspepsia, Dysphagia, Food allergy, Haemorrhage
Clinical narrative: Bleeding; Facial and lip swelling; Facial and lip swelling; Digestive issues; Allergic to most foods; Difficulty swallowing; Stool changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 16:00 as dose 1, single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Medication induced lupus" (unspecified if ongoing); "knownallergies: Multiple chemical" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; LISINOPRIL; METOPROLOL; OMEPRAZOLE.  The following information was reported: FOOD ALLERGY (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Allergic to most foods"; HAEMORRHAGE (medically significant) with onset 08Mar2022, outcome "not recovered", described as "Bleeding"; DYSPHAGIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Difficulty swallowing"; DYSPEPSIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Digestive issues"; SWELLING FACE (non-serious), LIP SWELLING (non-serious) all with onset 08Mar2022, outcome "not recovered" and all described as "Facial and lip swelling"; ABNORMAL FAECES (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Stool changes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of haemorrhage, swelling face, lip swelling, dyspepsia, food allergy, dysphagia, abnormal faeces.  Clinical course: The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks: Norvasc, Lisinopril, Metopolol, omeprazole. Covid was tested post vaccination.  Follow-Up (10Aug2022): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, SARS-CoV-2 test, Swelling face
Clinical narrative: Bleeding; Facial and lip swelling; Facial and lip swelling; Digestive issues; Allergic to most foods; Difficulty swallowing; Stool changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 at 16:00 as dose 1, single (Lot number: FK9895) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Medication induced lupus" (unspecified if ongoing); "knownallergies: Multiple chemical" (unspecified if ongoing). Concomitant medication(s) included: NORVASC; LISINOPRIL; METOPROLOL; OMEPRAZOLE.  The following information was reported: FOOD ALLERGY (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Allergic to most foods"; HAEMORRHAGE (medically significant) with onset 08Mar2022, outcome "not recovered", described as "Bleeding"; DYSPHAGIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Difficulty swallowing"; DYSPEPSIA (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Digestive issues"; SWELLING FACE (non-serious), LIP SWELLING (non-serious) all with onset 08Mar2022, outcome "not recovered" and all described as "Facial and lip swelling"; ABNORMAL FAECES (non-serious) with onset 08Mar2022, outcome "not recovered", described as "Stool changes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of haemorrhage, swelling face, lip swelling, dyspepsia, food allergy, dysphagia, abnormal faeces.  Clinical course: The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks: Norvasc, Lisinopril, Metopolol, omeprazole. Covid was tested post vaccination.  Follow-Up (10Aug2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive, notes: Treatment for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EK5730), in right arm, on 12Jan2021 at 16:45 as dose 2, single (Lot number: EL1283), in right arm, on 07Sep2021 at 10:30 as dose 3 (booster), single (Lot number: FC3181), in right leg and on 19Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in right arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no relevant medical history. Other medical history was reported as none and patient had no known allergies. The patient did previously receive a COVID-19 vaccine. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Patient did not take any medications within 2 weeks. Patient received anti-viral Paxlovid treatment from 26Jul2022 to 30Jul2022 for treatment of COVID-19. The reported seriousness of the events was non-serious.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 06Aug2022.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.