chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; A temperature excursion; vial beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion), EXPIRED PRODUCT ADMINISTERED (vial beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion) and EXPIRED PRODUCT ADMINISTERED (vial beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion), EXPIRED PRODUCT ADMINISTERED (vial beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (A temperature excursion) and EXPIRED PRODUCT ADMINISTERED (vial beyond use date).    Concomitant and treatment medications were not reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  A temperature excursion affected Moderna COVID-19 vaccines monovalent and bivalent lot #216K22A on 23-Jan-2023 - refrigerator - for only 15 minutes. 1 patient received a dose affected by a temperature excursion and after the vial beyond use date, on 25-Jan-2023. Date vial of monovalent was first thawed on 21-Dec-2022 with min temperature which reached 31°F  and max temperature which reached 42°F.  Duration of the excursion reported as 15 minutes.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines; No side effects reported by the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No side effects reported by the patient) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines. It was queried which dose should they get next and how long should they wait. No side effects reported by the patient.  No concomitant or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Non-significant follow up was received: case identifiers were added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: Temperature of vial reached to 24 °C; No adverse event; Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Jan-2023 at 9:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jan-2023 at 9:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C).    The vial was pulled out and 1 dose was administered on 24-Jan-2023 at 4 PM. The vial was left out overnight and the next day a dose from same vial was used at 9:30 am, not realizing the vial was past use time. The vial should have been used by 4 AM, 25-Jan-2023 and was therefore used 5.5 hours after beyond use time.  The temperature excursion happened for the first time, the minimum and the maximum temperature reached in this excursion were 2 °C and 24 °C respectively. The duration of the excursion was 18 hours and the 1 vial was affected by the excursion.  The vial is intended to be used in less than 3 days.  No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Significant live follow-up was appended : Event was added and iNarrative supplement was updated.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergy or disease on file.    On 17-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day 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 (Dose administered after 30-day Use By Date).    Concomitant and treatment medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to MOD-2023-704736 (Parent-Child Link).   See case MOD-2023-704736 for details regarding the child case.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered, No adverse event
Clinical narrative: 6 Patients received the vaccine past the beyond used date; Accidental underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medications were reported. No known allergies were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medication was reported.  This case pertains to the 1st child patient of the total 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-705188, US-MODERNATX, INC.-MOD-2023-705194, US-MODERNATX, INC.-MOD-2023-705203, US-MODERNATX, INC.-MOD-2023-705217, US-MODERNATX, INC.-MOD-2023-705220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705194:Master US-MODERNATX, INC.-MOD-2023-705188:Master US-MODERNATX, INC.-MOD-2023-705203:Master US-MODERNATX, INC.-MOD-2023-705217:Master US-MODERNATX, INC.-MOD-2023-705220:Master
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient received a booster without receiving any other vaccine) and NO ADVERSE EVENT (no adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced NO ADVERSE EVENT (no adverse event). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A patient received a booster without receiving any other vaccine). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient received a booster without receiving any other vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.          Concomitant and treatment medications were not reported.  A patient received a booster without receiving any other vaccine.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; a nurse gave a third dose of primary series of Moderna instead of the booster to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient) and NO ADVERSE EVENT (No adverse event) in a 14-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient was not immunocompromised.    On 26-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2023, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient) 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 WRONG PRODUCT ADMINISTERED (a nurse gave a third dose of primary series of Moderna instead of the booster to a patient).    Concomitant medication was not reported.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she was tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was tired) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FATIGUE (she was tired). At the time of the report, FATIGUE (she was tired) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient wanted to know the side effects because she was tired. She had vaccine two days ago.   Reporter did not allow further contact
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: running nose; Cough; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing) in a 2-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No allergy, concomitant diseases and risk factor were reported.  Concurrent medical conditions included Food allergy (Patient had anaphylactic to a few food).    On 11-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Jan-2023, the patient experienced RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing). At the time of the report, RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient was scheduled for Moderna Bivalent Booster, but he was sick with a runny nose, cough and sneezing all week, so his appointment was cancelled for tomorrow.   He first showed symptoms on Monday 1/23 and home COVID test was done on 1/24 but it was negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2023: Live follow up document received on 26-Jan-2023, which contains date of lab data and event information were updated. On 26-Jan-2023: Live follow up document received on 26-Jan-2023, which contains non significant information.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Dose administered more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jan-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) 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 (Dose administered more than 12 hours post puncture).    No relevant concomitant medications were reported.   The vial was initially stored in the refrigerator on 20-Jan-2023. Date and time vial was first punctured was 20-Jan-2023 at 9:20 am. Date and time of administration of vaccine was 23-Jan-2023 at 12:40-1:00 pm. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was left out an hour to thaw on 20-Jan-2023.  No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patients already received a previous bivalent booster on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In September 2022, the patient experienced EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patients already received a previous bivalent booster on Sep2022).  No concomitant medication was reported. No treatment medication was reported. HCP stated 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20Jan2023 but then they realized that patients already received a previous bivalent booster on Sep2022.
Age: 20.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breakthrough COVID-19, COVID-19 immunisation, Off label use, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID-19; very mild symptoms; tested positive for 2 weeks; Pfizer; Moderna; COVID-19; tested positive for 2 weeks; Sniffles; Had received the COVID-19 vaccine off label; 2nd booster dose; Congestion; This serious initial spontaneous safety report was received on 26-JAN-2023 from a consumer via the contact center.   A female of 20 year-old was vaccinated with intramuscular Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose (reported as a second booster) on 04-AUG-2022 in the upper arm at a health department vaccination site.  The following secondary suspect medications were reported: Pfizer Biontech Covid-19 Vaccine (tozinameran) dose 1 and dose 2 on unspecified dates in 2021, and Moderna Covid-19 Vaccine (elasomeran) dose 3 (first booster dose) on an unspecified date in 2021.  Medical history included Influenza like illness and Vaccination site pain after receiving Pfizer BioNTech COVID-19 vaccine (tozinameran)(on unspecified dates in 2021 for couple of days). It was reported the individual had no additional medical history or known allergies to report.  No concomitant medications were known by the reporter.  On 04-AUG-2022, the individual received her first dose as a second booster dose, after 3 previous doses of different COVID-19 vaccines (PT: Off label use) (PT: COVID-19 immunisation). Additionally, after vaccination, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant). On 04-JAN-2023, 5 months 1 day after vaccination, the individual got COVID-19 (PT: Breakthrough COVID-19) with very mild symptoms, no fever; just congestion (PT: Unevaluable event) and the sniffles (PT: Rhinorrhoea). She reportedly continued to test positive for about 2 weeks.   Relevant lab tests included: SARS-CoV-2 test (Result: Positive; Unspecified date in JAN-2023).  At the time of reporting, the event outcomes of Off label use, COVID-19 immunization, and Vaccination failure were recovered/resolved and event stop dates were 04-AUG-2022, and Breakthrough COVID-19, Unevaluable event, and Rhinorrhoea were recovered/resolved on unspecified dated in JAN-2023.; Sender's Comments: This 20 year-old female experienced: Vaccination failure, COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted and the reported event of Vaccination failure is considered Related and Covid-19 Vaccine, Adjuvanted and the other reported events is considered Possible.
Age: 20.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event, Vaccination failure
Clinical narrative: COVID-19; very mild symptoms; tested positive for 2 weeks; Pfizer; Moderna; COVID-19; tested positive for 2 weeks; Sniffles; Had received the COVID-19 vaccine off label; 2nd booster dose; Congestion; This serious initial spontaneous safety report was received on 26-JAN-2023 from a consumer via the contact center.   A female of 20 year-old was vaccinated with intramuscular Covid-19 Vaccine and Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose (reported as a second booster) on 04-AUG-2022 in the upper arm at a health department vaccination site.  The following secondary suspect medications were reported: Pfizer Biontech Covid-19 Vaccine (tozinameran) dose 1 and dose 2 on unspecified dates in 2021, and Moderna Covid-19 Vaccine (elasomeran) dose 3 (first booster dose) on an unspecified date in 2021.  Medical history included Influenza like illness and Vaccination site pain after receiving Pfizer BioNTech COVID-19 vaccine (tozinameran)(on unspecified dates in 2021 for couple of days). It was reported the individual had no additional medical history or known allergies to report.  No concomitant medications were known by the reporter.  On 04-AUG-2022, the individual received her first dose as a second booster dose, after 3 previous doses of different COVID-19 vaccines (PT: Off label use) (PT: COVID-19 immunisation). Additionally, after vaccination, the individual experienced vaccination failure (PT: Vaccination failure) (Serious: Medically Significant). On 04-JAN-2023, 5 months 1 day after vaccination, the individual got COVID-19 (PT: Breakthrough COVID-19) with very mild symptoms, no fever; just congestion (PT: Unevaluable event) and the sniffles (PT: Rhinorrhoea). She reportedly continued to test positive for about 2 weeks.   Relevant lab tests included: SARS-CoV-2 test (Result: Positive; Unspecified date in JAN-2023).  At the time of reporting, the event outcomes of Off label use, COVID-19 immunization, and Vaccination failure were recovered/resolved and event stop dates were 04-AUG-2022, and Breakthrough COVID-19, Unevaluable event, and Rhinorrhoea were recovered/resolved on unspecified dated in JAN-2023.; Sender's Comments: This 20 year-old female experienced: Vaccination failure, COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19 immunisation, Off label use, Breakthrough COVID-19, Rhinorrhoea and Unevaluable event were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted and the reported event of Vaccination failure is considered Related and Covid-19 Vaccine, Adjuvanted and the other reported events is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Loss of consciousness, Seizure
Clinical narrative: Blackouts; Seizures; Has no taste buds; has no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Blackouts"; SEIZURE (medically significant), outcome "unknown", described as "Seizures"; AGEUSIA (non-serious), outcome "unknown", described as "Has no taste buds"; DECREASED APPETITE (non-serious), outcome "unknown", described as "has no appetite". She is reporting an adverse event after having Pfizer Covid-19 Vaccine. She mentioned she is having blackouts and seizures. They clarified that they may file a lawsuit if it gets to that point. They clarified that this is not a life to live, they have blackouts or seizures or both or who knows what, nobody knows what they have. They have been calling numbers for 2 years. They have not had a taste of a hamburger, has no taste buds, has no appetite. She was not getting the booster and only got first and second dose of the Pfizer COVID Vaccine. She mentioned two different types of side effects, the adverse event and side effect from the vaccine and she wants information regarding those. Caller is stating that she is having "adverse event-side effect" from the vaccine. Caller narrated that she's been experiencing side effect/adverse event for 3 years and she has seen neurologist for the past 2 years, but they can't figure out what's wrong with her. She also mentioned that her healthcare providers don't have enough information whether what she is experiencing is side effect. Caller mentioned having blackout and seizures. She's been experiencing it for the past 3 years. She's been experiencing blackouts and siezures. Caller also mentioned that on 11Dec, she ended up on a lake (was not verified) and she didn't realize until she was anchored in the lake; stating her kids could have lost their mother. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient is 5 years old and received the 6month - 4year vaccine; patient is 5 years old and received the 6month - 4year vaccine; allergies; 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 18Jan2023 as dose 2 (maroon cap), single (Lot number: FX5095, Expiration Date: 30Jun2023) at the age of 5 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Lot number: GD1857, Expiry Date: 30Sep2023, Dose: 01), administration date: 16Dec2022, when the patient was 5-year-old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jan2023, outcome "unknown", described as "allergies"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious) all with onset 18Jan2023, outcome "unknown" and all described as "patient is 5 years old and received the 6month - 4year vaccine".  Additional information: Reporter stated that the patient is 5 years old and received the 6month to 4year vaccine on 18Jan2023. Reporter stated that this was the patients only dose of the 6month to 4years vaccine. Prior to this vaccine the patient had received one dose of the Pfizer COVID Vaccine for ages 5-11. Reporter stated denies any other medications, medical conditions, labs, testing, or treatments for the patient relevant to report. States that all she sees are some allergies, does not provide any further information. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was unknown; stated is uncertain about the time frame, if the vaccines the patient received on 16Dec2022 are within 4 weeks, Reporter states that the patient received that mentioned dose of the Pfizer COVID Vaccine for ages 5-11 on that day and also received a few other unspecified vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015929 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Two of my friends have ended up with heart problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Two of my friends have ended up with heart problems".  Additional information: Reporter stated to stop promoting this shot. Two of their friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300014834 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug, different patient/event;US-PFIZER INC-202300035011 same reporter/drug, different patient/event;
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: I am not feeling good; arms very sore; neck area sore; Muscle ache; Bad headache everyday since I have gotten the shot; Nausea; Vomiting; Fatigue; middle back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 20Jan2023 as dose number unknown, single (Lot number: FR2583) at the age of 64 years for covid-19 immunisation; vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), (Batch/Lot number: unknown). The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LOSARTAN taken for hypertension.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arms very sore"; NECK PAIN (non-serious), outcome "unknown", described as "neck area sore"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache everyday since I have gotten the shot"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "middle back pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pain in extremity, neck pain, myalgia, headache, nausea, vomiting, fatigue, back pain.  Additional information: Consumer stated that it going to be a long speech because she was not feeling good. she just heard a whole long speech about the COVID and everything. She asked should she continue or don't get any more shots. She just had my first dose on Friday (Clarified as 20Jan2023). Consumer stated that her arms very sore, neck area sore, muscle ache, bad headache every day since she has gotten the shot and nausea, vomiting, feeling fatigue and my middle back pain. Consumer stated her weight is About 240. She took vitamins, the day before she had a Vitamin B12 Shot and she take a lot of vitamins.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Neck pain, Pain in extremity, Vomiting, Weight
Clinical narrative: I am not feeling good; arms very sore; neck area sore; Muscle ache; Bad headache everyday since I have gotten the shot; Nausea; Vomiting; Fatigue; middle back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), on 20Jan2023 as dose number unknown, single (Lot number: FR2583) at the age of 64 years for covid-19 immunisation; vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), (Batch/Lot number: unknown). The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LOSARTAN taken for hypertension.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am not feeling good"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arms very sore"; NECK PAIN (non-serious), outcome "unknown", described as "neck area sore"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; HEADACHE (non-serious), outcome "unknown", described as "Bad headache everyday since I have gotten the shot"; NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "middle back pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pain in extremity, neck pain, myalgia, headache, nausea, vomiting, fatigue, back pain.  Additional information: Consumer stated that it going to be a long speech because she was not feeling good. she just heard a whole long speech about the COVID and everything. She asked should she continue or don't get any more shots. She just had my first dose on Friday (Clarified as 20Jan2023). Consumer stated that her arms very sore, neck area sore, muscle ache, bad headache every day since she has gotten the shot and nausea, vomiting, feeling fatigue and my middle back pain. Consumer stated her weight is About 240. She took vitamins, the day before she had a Vitamin B12 Shot and she take a lot of vitamins.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke-like symptoms: numbness in left fingers, unsteadiness on feet, speech abnormalities, confused thinking/diagnosed with a right MCA stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid prior vaccination yes" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing). No other medical history. Concomitant medication(s) included: OLMESARTAN; PROBIOTICS; FIBER. No other vaccine in four weeks. Medications in two weeks included Olmesartan, multivitamin/mineral, probiotic, fiber. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FJ4991, Location of injection: Arm Left), administration date: 28Jul2022, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FD7218, Location of injection: Arm Left), administration date: 13Dec2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER8728, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 53-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left), administration date: 17Mar2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 22Nov2022 at 08:00, outcome "recovering", described as "stroke-like symptoms: numbness in left fingers, unsteadiness on feet, speech abnormalities, confused thinking/diagnosed with a right MCA stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "stroke-like symptoms: numbness in left fingers, unsteadiness on feet, speech abnormalities, confused thinking/diagnosed with a right mca stroke" required emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident included medical testing and medications. Clinical course: On 22Nov2022, patient began having stroke-like symptoms: numbness in left fingers, unsteadiness on feet, speech abnormalities, confused thinking. Patient reported to the emergency room and was diagnosed with a right MCA stroke.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 screening, Drug ineffective, Interchange of vaccine products, Pneumonia
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; lost about 12 pounds; pneumonia; lungs were aching; Interchange of the vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: G52524) at the age of 81 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: Blood pressure diagnosed about 2 or 3 years ago, on BP medication for years. The patient took concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Interchange of the vaccine products"; PULMONARY PAIN (medically significant) with onset Jan2023, outcome "not recovered", described as "lungs were aching"; PNEUMONIA (medically significant) with onset 15Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost about 12 pounds". The event "pneumonia" required emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 screening: Negative; Weight decreased: lost about 12 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: On15Jan2023, she was in the ER because she thought she had pneumonia because her lungs were aching her, the ER visit was prior to Paxlovid. Reports her lungs are still aching.She has been taking her regular medication for years, such as blood pressure medication. She does not think its relevant. Has nothing to do with the way she feels. Testing: She did COVID at home testing, and all the tests showed negative. Even the day after being diagnosed she still showed negative.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Weight decreased
Clinical narrative: Diagnosed with COVID; Diagnosed with COVID; lost about 12 pounds; pneumonia; lungs were aching; Interchange of the vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: G52524) at the age of 81 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: Blood pressure diagnosed about 2 or 3 years ago, on BP medication for years. The patient took concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown", described as "Interchange of the vaccine products"; PULMONARY PAIN (medically significant) with onset Jan2023, outcome "not recovered", described as "lungs were aching"; PNEUMONIA (medically significant) with onset 15Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost about 12 pounds". The event "pneumonia" required emergency room visit. The patient underwent the following laboratory tests and procedures: COVID-19 screening: Negative; Weight decreased: lost about 12 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical information: On15Jan2023, she was in the ER because she thought she had pneumonia because her lungs were aching her, the ER visit was prior to Paxlovid. Reports her lungs are still aching.She has been taking her regular medication for years, such as blood pressure medication. She does not think its relevant. Has nothing to do with the way she feels. Testing: She did COVID at home testing, and all the tests showed negative. Even the day after being diagnosed she still showed negative.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vestibular disorder
Clinical narrative: Vestibular balance issues; Wrecked her truck when a bought of vertigo came on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VESTIBULAR DISORDER (non-serious), outcome "unknown", described as "Vestibular balance issues"; VERTIGO (non-serious), outcome "unknown", described as "Wrecked her truck when a bought of vertigo came on".  Additional information: The reporter was the brother of patient. The reporter stated he has had a serious and intense reaction that he can only trace back to the 2nd dose of the vaccine. It started with a lot of different symptoms. While competing a report on himself, caller stated that after his sister (the patient) got the vaccine she also experienced vestibular balance issues, but he doesn't know the manufacturer of the vaccine the patient received. The patient had an incident where she wrecked her truck when a bought of vertigo came on. The Caller declined to complete the report because he couldn't give detailed information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.