chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY ILL; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very ill was not reported. This report was non-serious. This case is a duplicate of 20230657808. This case, from the same reporter is linked to 20230657800.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Death, Dementia, Guillain-Barre syndrome
Clinical narrative: DEATH; DEMENTIA; GUILLAIN BARRE SYNDROME; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This solicited report received from a consumer via PPSCVM000196: Janssen Account concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre syndrome (dose number in series 2).  On an unspecified date, the patient experienced dementia. It was reported as broke through the blood brain barrier and she developed stage 5 dementia in months (dose number in series 2). On an unspecified date, the patient died from an unknown cause of death (dose number in series 2). It was unknown if an autopsy was performed. Reporter stated, "My Aunt died from this after 3 Vax shots. Broke through the blood brain barrier and she developed stage 5 dementia in months." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of dementia, Guillain-Barre syndrome and revaccination with different covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and death, dementia, and revaccination with different covid-19 vaccine was not related, and between covid-19 vaccine ad26.cov2.s, and Guillain-Barre syndrome was related. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20230658538- death, dementia. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered not related. 20230658538-Guillain-Barre syndrome. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Myalgia, Pyrexia
Clinical narrative: 2 days in bed so far; chills; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (2 days in bed so far), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (2 days in bed so far), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, BEDRIDDEN (2 days in bed so far), CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Upon internal review on 27-Jun-2023, significant correction performed to update report type from Regulatory authority to spontaneous. Case received from field updated to blank.
Age: 0.58
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; He ended up using the dark pink cap as the primary series; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series) and NO ADVERSE EVENT (No adverse event) in a 7-month-old 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. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series) 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 WRONG PRODUCT ADMINISTERED (He ended up using the dark pink cap as the primary series).    No concomitant information was reported. No treatment information was provided.
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Diarrhea developed 24 hours after the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Diarrhea developed 24 hours after the vaccine) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Moderna Covid-19 Monovalent booster dose, lot number 939902, Anatomica location-Left arm.) on 09-Sep-2021, Moderna COVID-19 Vaccine (Second Monovalent Moderna Covid-19 bivalent vaccine, lot number 022J21A expiration date 24-APR-22 and Anatomical location- Left arm. ) on 07-Feb-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DIARRHOEA (Diarrhea developed 24 hours after the vaccine). The patient was treated with GATIFLOXACIN (GATOR) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea developed 24 hours after the vaccine) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. It was reported that the patient had diarrhea each day since June 12, 2023. The patient was able to conduct daily of life activities such as going to work. Patient tried Immodium, Pepto-Bismol, and these medications were not working. The patient was taking energy drink for hydration. No dietary changes were noted in the patient during the time after the Moderna Covid-19 bivalent booster dose.
Age: 32.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration) and NO ADVERSE EVENT (No adverse event) in a 32-year-old 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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2023, 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 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration) 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 EXPIRED PRODUCT ADMINISTERED (6months and up Bivalent vaccine that expired June 18, 2023/Administered 3 days after expiration).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Age: 97.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient; The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and NO ADVERSE EVENT (no adverse event) in a 97-year-old 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. AS7643E) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient), PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) 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 (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient) and PRODUCT STORAGE ERROR (The vaccine was used after the puncture of the vaccine and was at room temperature overnight so the vaccine was out of range to long before being given to the patient).    Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
Age: 7.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired vaccine 6months and up that expired 18-Jun-2023.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 7-year-old 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. 069H22A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6months and up that expired 18-Jun-2023.).    Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. Expiry date of the vaccine was reported as 18-Jun-2023.  Treatment information was not provided.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) and NO ADVERSE EVENT (No adverse event) in an 8-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap) 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 WRONG PRODUCT ADMINISTERED (an 8 month old patient received a first dose of Moderna Bivalent COVID-19 vaccine from a vial with a dark pink cap).    Concomitant medication not reported.  Treatment medication not reported.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neoplasm malignant
Clinical narrative: have incurable cancer/ He also has a treatable form of cancer; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) (seriousness criterion medically significant). The patient was treated with Radiotherapy for Neoplasm malignant. At the time of the report, NEOPLASM MALIGNANT (have incurable cancer/ He also has a treatable form of cancer) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient was wondering if there was another shot out there that patient need to take. Patient have incurable cancer. He also had a treatable form of cancer and had been undergoing radiation treatment.  Company Comment: This is a spontaneous case concerning a 72 year-old, male patient no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred related to the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as the fifth dose of COVID-19 vaccination schedule. The outcome of the event was reported as unknown. The company considers the causality as not related due to lack of biological plausibility and known safety profile of the vaccine. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. Event´s seriousness assessed as reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No medical history was reported.  Previously administered products included for COVID-19 prophylaxis: spikevax (dose 1), spikevax (dose 3) and spikevax (dose 2). Past adverse reactions to the above products included No adverse event with spikevax, spikevax and spikevax. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.). At the time of the report, VACCINATION SITE PAIN (The Physician reports that the pain in his injection site from the Moderna Covid-19 vaccines is more intense than any other vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the pain in the injection site from the Moderna Covid-19 vaccines was more intense than any other vaccine. It was much more sore than when the patient received the flu shot. The patient did not wish to provide any additional information about his previous Moderna Covid-19 vaccine.  No treatment medication was reported.
Age: 34.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired vaccine 6 months and up vaccine that expired June 18, 2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6 months and up vaccine that expired June 18, 2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old 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. 069H22A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6 months and up vaccine that expired June 18, 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6 months and up vaccine that expired June 18, 2023) 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 EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 6 months and up vaccine that expired June 18, 2023).    No concomitant medication was reported.  No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction; Wrong dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Wrong dose administered) and NO ADVERSE EVENT (No adverse reaction) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 microgram. In December 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Wrong dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INCORRECT DOSE ADMINISTERED (Wrong dose administered) had resolved and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Wrong dose administered).   Concomitant medication was not provided. Treatment information was not reported.
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP; Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP; This non-serious spontaneous safety report, with reference number 2023SA105580 (and inquiry number 01560211), was received by the partner on 03-APR-2023 and forwarded to agency on 04-APR-2023, from a health care professional.   Due to the nature of the event, the causality between the event "Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP" and Vaxelis was not applicable.   Further information is expected.  Non-Significant Follow-up information was received by the partner on 03-APR-2023 and forwarded to agency on 05-APR-2023, from a health care professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "Student had received a dose of Vaxelis for their 11 year old vaccines instead of TDAP" and Vaxelis was not applicable.  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, HEPA, MMR, UNK, UNK
Symptoms: Extra dose administered
Clinical narrative: a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today; This non-serious spontaneous safety report with reference number 2023SA122541 (and inquiry number 01581087)  was received by a partner on 18-APR-2023 and forwarded to agency on 19-APR-2023 from a HCP.  Due to the nature of the event, the causality between Vaxelis and the reported event "a 15 month old child presented for their third dose of VAXELIS. However, the child may have received 2 doses today" was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PPV, RVX
Symptoms: Incorrect dose administered
Clinical narrative: Director for children's clinic reported a patient receiving only half the dose of the required dose of VAXELIS.; Director for clinic reported a patient receiving only half the dose of the required dose of VAXELIS.; This spontaneous safety report, with reference number 2023SA185923 (Interaction # 01657028), was received by the partner on 16-JUN-2023 and forwarded to agency on 19-JUN-2023, from a health professional.  Due to the nature of the event, the causality between the events "Director for children's clinic reported a patient receiving only half the dose of the required dose of VAXELIS." and Vaxelis was not applicable."  Further information is expected.
Sex: U
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023.; This spontaneous safety report, with reference number 02410179 (Interaction #02410170), was received by the partner on 19-JUN-2023 and forwarded to agency on 20-JUN-2023, from a health professional.  Due to the nature of the event, the causality between the events "Nurse reported that a patient received VAXELIS and VAXNEUVANCE by mouth on 6/15/2023." and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Patient experienced febrile seizure after receiving VAXELIS, ROTATEQ, and PREVNAR 13; This spontaneous safety report, with reference number 02411495 (Interaction # 02411489) was received by the partner on 20-JUN-2023 and forwarded to agency on 21-JUN-2023, from a health professional.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Patient experienced febrile seizure after receiving VAXELIS, ROTATEQ, and PREVNAR 13".   Further information is expected.
Age: 1.83
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Influenza like illness, Product preparation error
Clinical narrative: Patients mother was contacted this morning June 27, 2023 at approximately 8:15 am by a  certified translator for follow up after her daughter received 0.2 ml of undiluted Covid Pfizer vaccine on June 22, 2023 at 6:29pm. the mom stated that patient is doing fine and patient only had mild flu like symptoms after the vaccine. Patients mother denies any serious adverse reactions such as rashes, pain, shortness of breath. the mom advised if patient has any rashes, pain , shortness of breath or other concerning symptoms to call 911 or go to nearest emergency room. The mom verbalized understanding and thanked for care. The mom stated that she understands what happened and she has no questions or concerns.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Depressed level of consciousness, Fatigue, Hypotension, Pallor, Syncope
Clinical narrative: Patient received a seasonal influenza vaccine and fainted a few minutes after. She was pale and fatigued with low blood pressure for about 30 minutes and vomited after receiving a snack. Her color returned over the next hour and she was more alert, but fatigued for the rest of the day.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient received a seasonal influenza vaccine and fainted a few minutes after. She was pale and fatigued with low blood pressure for about 30 minutes and vomited after receiving a snack. Her color returned over the next hour and she was more alert, but fatigued for the rest of the day.
Age: 79.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Exercise tolerance decreased, Injection site pain, Mobility decreased
Clinical narrative: PATIENT BEGAN EXPERIENCING ARM PAIN RECENTLY (SPECIFIC TIME UNKNOWN) NEAR THE SITE OF MODERNA INJECTION RECEIVED 10/17/22.  HIS PAIN FEELS DEEP IN THE ARM AND HAS PROGRESSIVELY GOTTEN WORSE, WITH SEVERE PAIN AT NIGHT.  AT TIMES HE HAS TROUBLE LIFTING HIS ARM ABOVE HIS HEAD.  HE DOES NOT RECALL ANY UNUSUAL/SEVERE PAIN SHORTLY AFTER THE INJECTION, AND  ALSO RECEIVED FLUZONE HD IN THE OTHER ARM WITH NO ISSUES.  THERE ISN'T AND WAS NEVER A BRUISE OR LUMP AT THE SITE. HE DOES LIFT ARM WEIGHTS ON A DAILY BASIS  AND ONLY STOPPED FOR A COUPLE DAYS AFTER THE INJECTION.
Age: 65.0
Sex: M
Vaccine: HPV9, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patient received the first dose of Gardasil without meeting qualifying criteria. He is a 65 year old male. He had no reaction to the vaccination.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Body height abnormal, Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient height, it provided as 160cm, while the patient is only 3 years old; temperature excursion for Pfizer Covid 19 vaccine/it was administered; temperature excursion for Pfizer Covid 19 vaccine/it was administered; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 3-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Jun2023 at 15:00 as dose number unknown (maroon cap), 0.2 ml single (Lot number: GY5673, Expiration Date: 14Aug2023) at the age of 3 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 12Jun2023 at 15:00, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 12Jun2023 at 15:00, outcome "unknown" and all described as "temperature excursion for Pfizer Covid 19 vaccine/it was administered"; BODY HEIGHT ABNORMAL (non-serious), outcome "unknown", described as "patient height, it provided as 160cm, while the patient is only 3 years old".  Additional information: On 04Jun2023 the temperature reached 52.2 degrees Fahrenheit when restocking. It's not showing the total time. Just showed that day that is what it reached. went out on 3 other days. Not just for the 04Jun2023. Highest temperature reached on 17Jun2023 was 49.5 degrees Fahrenheit. Have time with no reading. It said-304 degrees Fahrenheit. Temperature provided as -304 was confirmed. Total time it was negative was at 10am and then stopped working and next reading wasn't until 2pm and was reading correctly after that. Not sure between that time what it was reading. On 19Jun2023 highest temperature she saw was 47.1 degrees Fahrenheit. Total time was about 1 hour and a half. On 20Jun2023 temperature was 47.7 degrees Fahrenheit. Thinks these are all from restocking. These 3 days had specific time. On 20Jun2023 was total of about 20 minutes. Total of about 9 patients for Pfizer Covid 19 vaccine maroon cap, bivalent. The reporter hasn't said anything so she would say not serious but isn't sure.  Follow (22Jun2023): This is a spontaneous follow-up report mail trail received in response to query sent regarding the confirmation below mentioned query. The response included: New event Body height abnormal added, response added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228860 same reporter/event, different patient/dose;US-PFIZER INC-202300228862 same reporter/event, different patient/dose;US-PFIZER INC-202300228866 same reporter/drug/event, different patient;US-PFIZER INC-202300228861 same reporter/event, different dose/patient;US-PFIZER INC-202300228962 same reporter/SD/AE, different patient;US-PFIZER INC-202300228963 same reporter/drug/event, different patient;US-PFIZER INC-202300229148 as same reporter/drug/event, different patient.;US-PFIZER INC-202300229256 Same reporter/drug/event, different patient.;
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HPV9, RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: I was ordered to give Pentacel, PCV13, and Rotavirus. On the encounter form, I put Pentacel, PCV13, and Rotavirus. Before grabbing the vaccines, I reverified what I needed to give and got the vaccines from the refrigerator and their respective VIS. I forgot to recheck if I had the correct vaccine and put the lot numbers of the vaccines that I had prepared. Once I sent the encounter form to Immunization Clinic, they called me the following day on 6/1/23 at around 10AM and informed me that the PCV13 I put on the form matched the lot number of HPV. Instead of giving the aforementioned vaccines, I gave Rotavirus #2, Pentacel #1, and HPV#1 instead of PCV13#2 on 5/31/23 @ 10AM. After realizing I probably gave the wrong vaccine, I called the patient's mother to see how she was doing. The mother informed me that the baby is fine and denied any adverse reactions. I also advised them to come back to the clinic to have the the correct vaccine administered, which is PCV13 #2. To prevent another error, I will reinforce the use of the 10 rights of medication administration and verify with another nurse before preparing and administering the vaccine.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Arthritis, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: 8/31/22 I went to pharmacy for the Prevnar 20 and the pharmacist cleaned the site and then injected particularly high on my arm. As soon as he injected it I had pain in my arm and shoulder. The pharmacist said it was normal. The pain persisted for weeks. When I saw my PCP in October with pain and low mobility in that left arm. I was prescribed physical therapy which I did in November and it slightly improved it. Pain still persisted, limited range of motion, it wakes me at night. I did see an orthopedic surgeon at the end of the year and he said it may have been injected into the Bursa. I was given a Cortisol Shot. I was fine for 5 months and then it came back with a vengeance. I went to my Rheumatologist who did X-rays. Nothing was significant besides mild arthritis. She did a cortisol injection but I had no relief with that cortisol shot. I got prescribed a new physical therapist regimen and I did that upon June this year. I am scheduled for an MRI next week (First week of July).
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Pain in extremity, Product administered at inappropriate site, Sleep disorder, X-ray abnormal
Clinical narrative: 8/31/22 I went to pharmacy for the Prevnar 20 and the pharmacist cleaned the site and then injected particularly high on my arm. As soon as he injected it I had pain in my arm and shoulder. The pharmacist said it was normal. The pain persisted for weeks. When I saw my PCP in October with pain and low mobility in that left arm. I was prescribed physical therapy which I did in November and it slightly improved it. Pain still persisted, limited range of motion, it wakes me at night. I did see an orthopedic surgeon at the end of the year and he said it may have been injected into the Bursa. I was given a Cortisol Shot. I was fine for 5 months and then it came back with a vengeance. I went to my Rheumatologist who did X-rays. Nothing was significant besides mild arthritis. She did a cortisol injection but I had no relief with that cortisol shot. I got prescribed a new physical therapist regimen and I did that upon June this year. I am scheduled for an MRI next week (First week of July).
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Mother of patient reports 29 days after dose of vaccination (on 6/23/23) the patient developed high fever and headaches. Temperatures ranged from 102.4-103.2 F. Fevers appeared resolved by later on 6/24/23 but patient did develop cough starting 6/26/23 (32 days post vaccination).
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Vestibular neuronitis
Clinical narrative: VESTIBULAR NEURITIS, TRANSPORTED TO ER AND SUBSEQUENTLY HOSPITALIZED FOR 7 DAYS. PATIENT HAS  REGAINED 80 % OF HER EQUILLIBRIUM. SHE IS HOME NOW.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Expired product administered, Pyrexia
Clinical narrative: We received the vaccine on 05/16/23, so the beyond use date was 06/15/23. I noticed it later when I was going through all my expired meds for the month. We administered the vaccine about 14 hours after the BUD. I notified Moderna (case number NA23-00033152) and the patient. There were no temperature excursions prior to vaccination. I spoke with the patient and she said she had typical adverse effects, such as fever and chills. She declined any further vaccination (if Moderna deems it necessary) since she feels like she received appropriate protection due to having typical side effects from the vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antibiotic therapy, Blood lactic acid increased, Culture negative, Encephalopathy, Haemofiltration
Clinical narrative: Encephalopathy with hypoglycemia progressing to multiorgan failure with shock require ventilator support, vasopressor support, and progressive refractory lactic acidosis despite CRRT and broad spectrum antibiotic therapy.  Most recent cultures negative so far.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoglycaemia, International normalised ratio increased, Lactic acidosis, Mechanical ventilation, Multiple organ dysfunction syndrome
Clinical narrative: Encephalopathy with hypoglycemia progressing to multiorgan failure with shock require ventilator support, vasopressor support, and progressive refractory lactic acidosis despite CRRT and broad spectrum antibiotic therapy.  Most recent cultures negative so far.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Shock
Clinical narrative: Encephalopathy with hypoglycemia progressing to multiorgan failure with shock require ventilator support, vasopressor support, and progressive refractory lactic acidosis despite CRRT and broad spectrum antibiotic therapy.  Most recent cultures negative so far.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pain
Clinical narrative: Patient reported having shoulder pain after injection. Pain goes away after but comes back when he used his shoulder or when exercising. He have consulted with his pcp.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Full blood count, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, persistent severe headache
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Tooth disorder, Tooth fracture
Clinical narrative: Dental problems, Teeth breaking
Age: 23.0
Sex: F
Vaccine: DTP
Symptoms: Pain
Clinical narrative: Reported Symptoms: 10033371:PAIN; Narrative:  Other Relevant HX:  Other:
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Anaphylactic reaction, Angioedema, Dizziness, Dyspnoea, Paraesthesia
Clinical narrative: Reported Symptoms: 10002218: ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10013573:DIZZINESS; 10037844:RASH; 10046735:URTICARIA; Narrative: Per 12/7 ED provider note: 62 yo male with the chief complaint of Possible allergic reaction.  The patient states that he received the pneumococcal vaccine in his primary clinic today, shortly after hebegan to have a "tingling" sensation all over his body, he feels as though he may have a rash, and feels as thought his tongue is "a little swollen." He denies nausea or vomiting, he denies abdominal pain, he is not wheezing but states he is mildly short of breath.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Reported Symptoms: 10002218: ANAPHYLAXIS; 10002424:ANGIOEDEMA; 10013573:DIZZINESS; 10037844:RASH; 10046735:URTICARIA; Narrative: Per 12/7 ED provider note: 62 yo male with the chief complaint of Possible allergic reaction.  The patient states that he received the pneumococcal vaccine in his primary clinic today, shortly after hebegan to have a "tingling" sensation all over his body, he feels as though he may have a rash, and feels as thought his tongue is "a little swollen." He denies nausea or vomiting, he denies abdominal pain, he is not wheezing but states he is mildly short of breath.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haemorrhage, Syncope
Clinical narrative: After injection, there was bleeding and it stopped after pressing a cotton. The patient fainted when she saw blood on cotton ball
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Angina unstable, Blood creatinine, Blood glucose normal, Blood potassium normal
Clinical narrative: Reported Symptoms:  10002391:ANGINAL PAIN; Narrative:  Pt reported unstable angina eventually requiring PCI approximately 3 months after 3rd dose of Pfizer Covid vaccine Other Relevant HX: No tobacco use
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood sodium normal, Glomerular filtration rate normal, Percutaneous coronary intervention
Clinical narrative: Reported Symptoms:  10002391:ANGINAL PAIN; Narrative:  Pt reported unstable angina eventually requiring PCI approximately 3 months after 3rd dose of Pfizer Covid vaccine Other Relevant HX: No tobacco use
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Pruritus; Pruritus; Rash; Rash;  Narrative: 68-year-old male reporting that he received flu shot in 12/2022 outside of facility. Per 01/31/2023 Chart Review Note Patient reported itching 24 hours after receiving vaccination and concurrent
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Reported Symptoms:  10043607:THROMBOSIS; Narrative:  Other Relevant HX:  Other:
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient was given wrong vaccine by mistake, np which ordered vaccine stated it was harmless and the pt will be fine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Affected area: back, itchy red, stinging - mild and unchanged Associated symptoms: erythema, painful rash and pruritus Treatment: gabapentin 600 mg 1 tb, PO, 2Xs/day counieling care, Valacyclovir 1 gram tab, PO. 5 days end: 6/26/23
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Face oedema
Clinical narrative: Reported Symptoms:  10014222:EDEMA FACE; Narrative:  Other Relevant HX:  Other:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: came down with shingles within 1 week of vaccination; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: came down with shingles within 1 week of vaccination). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 22-Jun-2023 The physician reported that the patient came down with shingles within 1 week after receiving Shingrix vaccine. Limited information was provided. It was unknown of the gender, age, name of patient. It was unknown after which dose (first or second) the patient came down with shingles. According to the GlaxoSmithKline agent, the reporter had a lengthy conversation about the events with MSL. The reporter did not consent to follow-up. This is 1 of 2 patients case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023087490:Same reporter, Report for 2 patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test, Computerised tomogram, Deafness unilateral, Dizziness
Clinical narrative: Lots of middle ear pain; balance issues; was completely deaf in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), on 19Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation series complete; Unknown Manufacturer), for COVID-19 immunisation. The following information was reported: DEAFNESS UNILATERAL (medically significant) with onset 21Dec2022, outcome "not recovered", described as "was completely deaf in my left ear"; EAR PAIN (medically significant), outcome "not recovered", described as "Lots of middle ear pain"; BALANCE DISORDER (medically significant), outcome "not recovered", described as "balance issues". The events "was completely deaf in my left ear", "lots of middle ear pain" and "balance issues" required physician office visit. Therapeutic measures were taken as a result of deafness unilateral, ear pain. Clinical course: Almost 6 months and patient had not regained any hearing after treatment from ENT's, Neurologists, and a Pain management doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.