chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Pediatric dose of Havrix; Adult received Pediatric dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 36-year-old male patient who received HAV (Havrix 720) (batch number 2X2EJ, expiry date 14-OCT-2024) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Havrix 720. On 20-APR-2023, an unknown time after receiving Havrix 720, the patient experienced adult use of a child product (Verbatim: Adult received Pediatric dose of Havrix) and underdose (Verbatim: Adult received Pediatric dose of Havrix). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 16-APR-2023 The reporter was a medical assistant. The reporter reported that the adult patient received pediatric dose of Havrix vaccine. The reporter did consent to follow up. The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product. This case had been linked with US2023058970 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023058970:Same reporter
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; TEMPERATURE EXCURSIONS FOR UNPUNCTURED VIALS ADMINISTERED TO THE PATIENTS; This spontaneous report received from a physician concerned a 30 year old male. 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 not reported, batch number: 216D21A expiry: 06-MAY-2023) dose was not reported, administered on 20-MAR-2023 for covid-19 prophylaxis. The drug was associated with Medication error. Temperature excursion occurred on 02-JAN-2023 0.2 C for 15 minutes and 0.4 C for 15 minutes then 1.5 C for 15 minutes then 1.5 C for 15 mins and on 02-APR-2023 Minimum 0.2 C and maximum 1.5 C for 1 hour total. Age at time of vaccination 30 years old. No concomitant medications were reported. On 20-MAR-2023, the patient experienced temperature excursions for unpunctured vials administered to the patients. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursions for unpunctured vials administered to the patients and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; EXCURSIONS FOR UNPUNCTURED VIALS ADMINISTERED TO PATIENT; This spontaneous report received from a physician concerned a 24 year old female. 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 not reported, batch number: 216D21A expiry: 06-MAY-2023) dose was not reported, administered on APR-2023 for covid-19 prophylaxis. The drug was associated with Medication error. excursions occurred on 02-JAN-2023: 0.2 C for 15 minutes and 0.4 C for 15 minutes then 1.5 C for 15 minutes then 1.5 C for 15 mins. and on 02-APR-2023: Minimum 0.2 C and maximum 1.5 C for 1 hour total. Age at time of vaccination 24 years old. No concomitant medications were reported. On APR-2023, the patient experienced excursions for unpunctured vials administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the excursions for unpunctured vials administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 82.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blister, Headache, Herpes zoster
Clinical narrative: Patient already had shingles but had not seen doctor yet; Patient has severe head pain after 4th shot; Blisters developed two weeks after shot 4; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (Patient already had shingles but had not seen doctor yet), BLISTER (Blisters developed two weeks after shot 4) and HEADACHE (Patient has severe head pain after 4th shot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053F22B, 004F21A, 026B21A and 036A219) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    It was reported that patient has never been diagnosed/tested positive for COVID-19.  Patient had no known allergies.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), SERTRALINE HYDROCHLORIDE (ZOLOFT), PREGABALIN (LYRICA), FUROSEMIDE, SIMVASTATIN, TRAZODONE and POTASSIUM CHLORIDE (K-TAB) for an unknown indication.   On 06-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Blisters developed two weeks after shot 4). On an unknown date, the patient experienced HERPES ZOSTER (Patient already had shingles but had not seen doctor yet) and HEADACHE (Patient has severe head pain after 4th shot). At the time of the report, HERPES ZOSTER (Patient already had shingles but had not seen doctor yet) outcome was unknown, BLISTER (Blisters developed two weeks after shot 4) had resolved and HEADACHE (Patient has severe head pain after 4th shot) had not resolved.            Concomitant products included KTAB6 10 milligram through oral route.  Blisters cleared but severe head pain still persists. so, far did not found medicine to help with the pain.  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-716112 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the vaccine was administered to 12 patients after the use by date of 06-Apr-2023. The vaccine was administered to 3 patients on 22-Apr-2023, 5 patients on 21-Apr-2023, 2 patients on 20-Apr-2023, 1 patient on 16-Apr-2023 and 1 patient on 12-Apr-2023. The patients involved were all over the age of 65. No other adverse events were reported.  Treatment medications were not provided.  This case was reported for patient 2 of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    It was reported that, the patients involved are all over the age of 65.  No concomitant medications was reported.  Date of administration of vaccine are 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  No other adverse events have been reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-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 (Patient received the Moderna Covid-19 vaccine after use by Date 6-Apr-2023).    No concomitant medications were provided. No other adverse events have been reported Date of administration of vaccine on 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient). The patients involved were all over the age of 65.  No treatment medication was provided. This case contains information for the 5th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (Patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the vaccine was administered to 12 patients after the use by date of 06-Apr-2023. The vaccine was administered to 3 patients on 22-Apr-2023, 5 patients on 21-Apr-2023, 2 patients on 20-Apr-2023, 1 patient on 16-Apr-2023 and 1 patient on 12-Apr-2023. The patients involved were all over the age of 65. No other adverse events were reported. This case is reported for patient 7 out of 12 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant medications was reported. It was reported that no other adverse events was reported. The vaccine was administration on 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients) and 0 16-Apr-2023 (1 patient), 12-Apr-2023 (1 patient).  All the patients involved are all over the age of 65. No treatment drug details was reported.  This case contains information for the 9th of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient - 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (patient received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    It was reported that, the patients involved are all over the age of 65.  No concomitant medications was reported.  Date of administration of vaccine are 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  No other adverse events have been reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date) 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 (patients received the Moderna Covid-19 vaccine after the 6-Apr-2023 use by Date).    No concomitant medication were reported.  Vaccine was administered on  22-Apr-2023 (3 patients) 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr- 2023 (1 patient) and 12-Apr-2023 (1 patient) The Pharmacist said that the patients involved are all over the age of 65. No other adverse events have been reported. No treatment information was provided by the reporter.  This case is of for patient 11 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly 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. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 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. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) 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 (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant medications were reported.  The patients involved were all over the age of 65.  Date(s) of administration of vaccine on 22-Apr-2023 (3 patients) 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient). No other adverse events had been reported.  No treatment medications were reported.  This case contains information for the 12th of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:patient 1
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Injection site pain, Pain, Pain in extremity
Clinical narrative: pain, throbbing throughout the arm, burning at injection site and shoulder. took aleve for 48 hours, rested and iced arm.
Age: 1.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, swelling, heat and rash at the injection site. this occured approximately 24 hrs after the injection.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Localized erythema around injection site, low grade fever - starting morning of 4/26/2023
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood glucose increased, Glucose tolerance impaired, Malaise, Myalgia
Clinical narrative: On May 22nd of 2022 I felt under the weather and tested positive for COVID-19.  My symptoms lasted until May 30th. Since August 2022 I have become pre-diabetic.  I have experienced random muscle aches and pains.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Basosquamous carcinoma, Biopsy skin abnormal, Impaired healing, Injection site erythema, Injection site irritation
Clinical narrative: Became red, irritated at injection site on right shoulder and eventually a small nonhealing wound appeared which slowly grew in size
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: Became red, irritated at injection site on right shoulder and eventually a small nonhealing wound appeared which slowly grew in size
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms
Clinical narrative: Right upper arm severely cramps occasionally at least a couple of times a week at various times.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging, Tinnitus
Clinical narrative: Tinnitus I have suffering from the first Pfizer shot which I received on 5/3/2021 and got worse after the second shot which I received on 6/3/2021I have been suffering from June 25 2021 still suffer from Tinnitus . There is no treatment for Tinnitus
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Immediate post-injection reaction, Pain in extremity, Vertigo
Clinical narrative: After the vaccination was administered, patient complained of a sore arm and then stated that she felt dizzy. She was asked to sit down. She then proceeded to lay down on the floor of the store and stated that she was having a vertigo episode. This happened immediately after the vaccine. Patient was doing well when i called her 4 hours later. She was still feeling dizzy but it was much better
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Heart rate irregular, Laboratory test, Malnutrition
Clinical narrative: Within a month (roughly around the time of the second dose), I started having extremely irregular heart rate, increased heart rate even while resting, and a lot of fatigue. Increased dietary issues have also come up and nothing has subsided since getting the vaccine, even though I?ve tried many things to get back to normal.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  and returned to clinic same day for additional dose of 0.25mL lot # AS7168B per vaccine provider recommendation.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  and returned to clinic same day for additional dose of 0.25mL lot # AS7168B per vaccine provider recommendation.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  and returned to clinic same day for additional dose of 0.25mL lot # AS7168B per vaccine provider recommendation.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  and returned to clinic same day for additional dose of 0.25mL lot # AS7168B per vaccine provider recommendation.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  and returned to clinic same day for additional dose of 0.25mL lot # AS7168B per vaccine provider recommendation.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Less than full dose of Bivalent Vaccine was given, patient received 0.25mL lot#024H22A initially at visit, patient called  left message that she is to return to clinic to receive additional 0.25 ml of same per vaccine provider recommendation.  She has been unavailable but her partner is aware that she should return or return call
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Anxiety, Asthma, Computerised tomogram, Condition aggravated
Clinical narrative: I woke up the day after my second vaccine with very loud ringing in my ears.  The loud ringing, high pich noise caused hearing, focus issues and anxiety My heart was acing casuing me to feel like I was falling after the heart beat slowed back to a normal pace.  AFter my heart stopped racing it caused me to cough.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Disturbance in attention, Electrocardiogram ambulatory, Feeling abnormal, Hypoacusis
Clinical narrative: I woke up the day after my second vaccine with very loud ringing in my ears.  The loud ringing, high pich noise caused hearing, focus issues and anxiety My heart was acing casuing me to feel like I was falling after the heart beat slowed back to a normal pace.  AFter my heart stopped racing it caused me to cough.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Palpitations, Tinnitus
Clinical narrative: I woke up the day after my second vaccine with very loud ringing in my ears.  The loud ringing, high pich noise caused hearing, focus issues and anxiety My heart was acing casuing me to feel like I was falling after the heart beat slowed back to a normal pace.  AFter my heart stopped racing it caused me to cough.
Age: 49.0
Sex: F
Vaccine: PNC15
Symptoms: Myalgia, Skin warm, Swelling
Clinical narrative: Left deltoid pain, swelling, and warmth.   Planned treatment is NSIADs and ice. Patient was seen today.   Outcome: TBD
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Tinnitus
Clinical narrative: Ringing in ears and rapid heart rate
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Capillary nail refill test, Grip strength decreased, Immediate post-injection reaction, Injection site pain
Clinical narrative: Rec'd Shingrix vaccine # 2 at clinic on 4/7/23 in her L deltoid.  Immediately afterward, her L deltoid was painful, but pain was c/w an IM injection, specifically c/w the 1st Shingrix vaccine that she rec'd in February.  The muscle pain was not out of the ordinary.  On 4/8, pt had fever 101.5, but that resolved.  Had nausea as well.  Reports a decreased ROM to L shoulder and L arm, which started on 4/8.  About 10 d ago, pt noticed a dull pain to her LH, L 3rd, 4th, & 5th finger and L wrist (dorsal and volar aspects), but the medial aspect of the LH and L wrist, as well as the L thumb are spared.  Pt has noticed a weakening of LH grip about 4-5 d, which she feels is worsening.  Pain exacerbated by gripping, extending wrist, fastening bra, waving, fastening seatbelt, and typing.  THese actions also cause her to notice the weakened grip more acutely.  She doesn't c/o n/t per se, but states that LH / L wrist feels 'heavy'.  Sometimes the pain radiates up her L lateral arm (w/ certain movements) up to the elbow and a little bit beyond the elbow.  Denies any hx of cardiac dz, HTN, HLD, or DM.  Denies previous issues w/ LH, LUE, L shoulder.  Denies neck problems.  She is RH-dominant.  Pt seen at Clinic for these LH/ LUE complaints on 4/26/23.  Phys exam conducted.  Grip is slightly weaker on L H, but strength is still 5/5.  No other weakness or decreased ROM noted to her LH, L wrist, L elbow, or L shoulder.  Neck is normal.  3+ L radial pulse, w/ + CSM to LH, w/ cap refill < 3 sec.  Referred to PCP for possible PT and possible imaging.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Limb discomfort, Nausea, Pain, Pain in extremity
Clinical narrative: Rec'd Shingrix vaccine # 2 at clinic on 4/7/23 in her L deltoid.  Immediately afterward, her L deltoid was painful, but pain was c/w an IM injection, specifically c/w the 1st Shingrix vaccine that she rec'd in February.  The muscle pain was not out of the ordinary.  On 4/8, pt had fever 101.5, but that resolved.  Had nausea as well.  Reports a decreased ROM to L shoulder and L arm, which started on 4/8.  About 10 d ago, pt noticed a dull pain to her LH, L 3rd, 4th, & 5th finger and L wrist (dorsal and volar aspects), but the medial aspect of the LH and L wrist, as well as the L thumb are spared.  Pt has noticed a weakening of LH grip about 4-5 d, which she feels is worsening.  Pain exacerbated by gripping, extending wrist, fastening bra, waving, fastening seatbelt, and typing.  THese actions also cause her to notice the weakened grip more acutely.  She doesn't c/o n/t per se, but states that LH / L wrist feels 'heavy'.  Sometimes the pain radiates up her L lateral arm (w/ certain movements) up to the elbow and a little bit beyond the elbow.  Denies any hx of cardiac dz, HTN, HLD, or DM.  Denies previous issues w/ LH, LUE, L shoulder.  Denies neck problems.  She is RH-dominant.  Pt seen at Clinic for these LH/ LUE complaints on 4/26/23.  Phys exam conducted.  Grip is slightly weaker on L H, but strength is still 5/5.  No other weakness or decreased ROM noted to her LH, L wrist, L elbow, or L shoulder.  Neck is normal.  3+ L radial pulse, w/ + CSM to LH, w/ cap refill < 3 sec.  Referred to PCP for possible PT and possible imaging.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Rec'd Shingrix vaccine # 2 at clinic on 4/7/23 in her L deltoid.  Immediately afterward, her L deltoid was painful, but pain was c/w an IM injection, specifically c/w the 1st Shingrix vaccine that she rec'd in February.  The muscle pain was not out of the ordinary.  On 4/8, pt had fever 101.5, but that resolved.  Had nausea as well.  Reports a decreased ROM to L shoulder and L arm, which started on 4/8.  About 10 d ago, pt noticed a dull pain to her LH, L 3rd, 4th, & 5th finger and L wrist (dorsal and volar aspects), but the medial aspect of the LH and L wrist, as well as the L thumb are spared.  Pt has noticed a weakening of LH grip about 4-5 d, which she feels is worsening.  Pain exacerbated by gripping, extending wrist, fastening bra, waving, fastening seatbelt, and typing.  THese actions also cause her to notice the weakened grip more acutely.  She doesn't c/o n/t per se, but states that LH / L wrist feels 'heavy'.  Sometimes the pain radiates up her L lateral arm (w/ certain movements) up to the elbow and a little bit beyond the elbow.  Denies any hx of cardiac dz, HTN, HLD, or DM.  Denies previous issues w/ LH, LUE, L shoulder.  Denies neck problems.  She is RH-dominant.  Pt seen at Clinic for these LH/ LUE complaints on 4/26/23.  Phys exam conducted.  Grip is slightly weaker on L H, but strength is still 5/5.  No other weakness or decreased ROM noted to her LH, L wrist, L elbow, or L shoulder.  Neck is normal.  3+ L radial pulse, w/ + CSM to LH, w/ cap refill < 3 sec.  Referred to PCP for possible PT and possible imaging.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Left chest internal vibration / buzzing
Age: 36.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Tinnitus
Clinical narrative: On or close to December 17, 2021 I started to hear ringing in my right ear. I made an appointment with my doctor. After informing him of my symptoms (vaccines were not part of discussion) he informed me that it could be tinnitus and that there was nothing he could do about it. I wasn't aware what tinnitus was and asked what could cause this? He informed me that although they didn't know exactly know the true cause of tinnitus but it could be caused by listening to loud music with headphone. I informed him that while I do wear headphone at times, I do not use them to listem to music. I usually use them for work where I have to listem to videos, it helps me focus better when listening to people talk. He gave me a prescription for Amox-Clav 500-125mg Tablets, 15 doses. There wno improvement. At next appointment he told me it was probably permanent and that I will have to learn to live with it.
Age: 25.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Condition aggravated, Endometriosis, Fibromyalgia, Hysterectomy, Idiopathic intracranial hypertension
Clinical narrative: Severe pelvic pain, endometriosis, hysterectomy, fibromyalgia, psuedotumor cerebri
Age: 25.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Pelvic pain
Clinical narrative: Severe pelvic pain, endometriosis, hysterectomy, fibromyalgia, psuedotumor cerebri
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus started 12/2021 approx. I thought it was related to another medicine, but that has been discontinued and the ringing in the ears is still there and constant.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Within 10 minutes of MMR vaccine administration patient turned very pale, started sweating. He drank some water. Did not faint. Recovered about 10 minutes later. Was observed for 30 min.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: pt seen on floor in prone position per staff pt lost consciouness for 9 secs. staff who witness the accident said pt slid down on chair and fell face forward vitals: 86/60 p-60 R-16 o2 98% offered food and fluids denied nausea vs bp 106/65 P-75 R-18 o2 98% RA t-98.1 at 337 pt verbalized no dizziness no headache able to move all extremitites without discomfort no vleedign on gums/mouth no change loc 347 BP104/63 P77 o2 99% pt parents will accompany pt to visit primary doc. clininc for further eval.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Bone pain, Decreased appetite, Fatigue
Clinical narrative: Muscle ache, Joint ache, pain mostly in upper pelvic bone area.  Feeling tired, loss of appetie, likely Polymyalgia Rheumatica
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Polymyalgia rheumatica, X-ray
Clinical narrative: Muscle ache, Joint ache, pain mostly in upper pelvic bone area.  Feeling tired, loss of appetie, likely Polymyalgia Rheumatica
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hyperlipidaemia, Hypertension, Loss of consciousness, Wrist fracture
Clinical narrative: Treatment for hypertension and hyperlipidemia under good control. Felt well prior to and following 3/25/21 vaccination. At 7:25 AM on 3/26/21 passed out on floor causing a closed distal radius fracture of the right wrist. After emergency treatment, PCP followed up with tests and specialists with no negative outcomes detected. Orthopedic treatment and Hand Rehabilitation ongoing.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Cold sweat, Formication
Clinical narrative: Crawling, cramps, numbness, chills, lots of sweaty cold, pain in he hips and body, strong pain in the chest, pangs in the chest.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain
Clinical narrative: Crawling, cramps, numbness, chills, lots of sweaty cold, pain in he hips and body, strong pain in the chest, pangs in the chest.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Pyrexia, Tinnitus
Clinical narrative: one hour after shot left arm went numb for twelve hours, and sixteen hours after shot ran a low grade fever for 24 hours, on 03/20/2021 a week after, both of my ears starting ring and have not stopped , and a pain above my right kidney started and has not went away
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Pain in extremity, Ultrasound scan
Clinical narrative: Pt reports that she had the vaccine 2 dose 5/10/2021  and she start having symptoms of general weakness at 6 am ,burning sensation at 1pm bilateral legs ,most painful in both feet.She called the PCP and they recommend her go to Urgent Care .Pt was sent to ER and US bilateral was performance ,no blood cot.Pt is scheduled with PCP for 5-20-2021. Prescribed Percocet and Benadryl
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Tremor
Clinical narrative: Tremors the morning after vaccine..ended up falling, also tremors every morning next two mornings. "Uncontrolled Tremors"
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Mobility decreased, Pain in extremity, Tinnitus
Clinical narrative: Since getting Moderna Vaccine the first week of April, I have suffered a significant loss in mobility, tinnitus in right ear, rapid inflammation response, especially in both legs and pain in left hip to spreading to left foot.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation issue, Wrong product administered
Clinical narrative: Clinic participated in a vaccination event on Sunday, May 9th. The event offered two vaccines Pfizer and Johnson and Johnson. The individual who was preparing the final syringes accidently took a J & J vial with 2 doses remaining thinking it was an undiluted Pfizer vial. They then added diluent to the vial and drew 6 syringes for vaccination. 5 were utilized. This non therapeutic doses were given to 5 patients that attended the event. Clinic has already contacted the patients following guidelines and each patient is being offered another vaccination as recommended by the CDC. All patients have been notified  Corrective Action Plan 1.  Root cause analysis completed 2.  New team transitioned to site 3.  Protocol and process gaps identified and updated 4.  Alignment of vaccine operations under clinical leadership
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing on face reported by pt after 10 mins from vaccination. No SOB or other sx noted. Pt waited in office for 50 mins after and Dr. examined her. Advised to take benadryl and go to ER if sx persisted or worsened.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Burning sensation, Chills
Clinical narrative: Chills, fever, dizzy, instability 3 weeks headache Limping/pain in left knee-ongoing Burning back pain - on going falling - hitting head - required stitches weakness - ongoing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Head injury, Headache
Clinical narrative: Chills, fever, dizzy, instability 3 weeks headache Limping/pain in left knee-ongoing Burning back pain - on going falling - hitting head - required stitches weakness - ongoing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suture insertion, X-ray
Clinical narrative: Chills, fever, dizzy, instability 3 weeks headache Limping/pain in left knee-ongoing Burning back pain - on going falling - hitting head - required stitches weakness - ongoing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: right side - swollen inguinal lymph nodes
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one dose Janssen
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Disorientation, Fall, Head injury, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Within 1 minute - loss of vision, syncope, loss of consciousness,  passed out - struck head against wall and then against the floor - medically diagnosed at Urgent Care Clinic with a  "Concussion" the following day. Dizziness, severe headaches for several days.   Erythrema and skin rash.  Pain around injection site and lymphadenopathy in axilla of left arm.  Generalized weakness, myalgia and arthralgia in joints for several days.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Within 1 minute - loss of vision, syncope, loss of consciousness,  passed out - struck head against wall and then against the floor - medically diagnosed at Urgent Care Clinic with a  "Concussion" the following day. Dizziness, severe headaches for several days.   Erythrema and skin rash.  Pain around injection site and lymphadenopathy in axilla of left arm.  Generalized weakness, myalgia and arthralgia in joints for several days.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Asthenia, Blindness, Concussion, Dizziness
Clinical narrative: Within 1 minute - loss of vision, syncope, loss of consciousness,  passed out - struck head against wall and then against the floor - medically diagnosed at Urgent Care Clinic with a  "Concussion" the following day. Dizziness, severe headaches for several days.   Erythrema and skin rash.  Pain around injection site and lymphadenopathy in axilla of left arm.  Generalized weakness, myalgia and arthralgia in joints for several days.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Erythema, Head injury, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Within 1 minute - loss of vision, syncope, loss of consciousness,  passed out - struck head against wall and then against the floor - medically diagnosed at Urgent Care Clinic with a  "Concussion" the following day. Dizziness, severe headaches for several days.   Erythrema and skin rash.  Pain around injection site and lymphadenopathy in axilla of left arm.  Generalized weakness, myalgia and arthralgia in joints for several days.
Age: 22.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Loss of consciousness, Lymphadenopathy, Myalgia, Rash, Syncope
Clinical narrative: Within 1 minute - loss of vision, syncope, loss of consciousness,  passed out - struck head against wall and then against the floor - medically diagnosed at Urgent Care Clinic with a  "Concussion" the following day. Dizziness, severe headaches for several days.   Erythrema and skin rash.  Pain around injection site and lymphadenopathy in axilla of left arm.  Generalized weakness, myalgia and arthralgia in joints for several days.
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AEs; HCP calling to report that GARDASIL 9 was inadvertently administered to 47 year old patient on 3/10/23. No further information available at time of call, no additional AEs, no PQCs.; This spontaneous report was received from a pharmacist, referring to a 47-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-MAR-2023, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). No additional adverse events (AEs).