chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: Medical assistant reported that an expired dose of Bexsero was administered to the patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date June 2022) for prophylaxis.   On 17th October 2022, the patient received Havrix. On 17th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that a administration of an expired dose of Havrix to a patient.  The reporter asked if the patient had to be re-vaccinated. The reporter did not provide the lot number but confirmed that the expiration date of the dose administered was June 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Laboratory test normal, Paraesthesia, Tremor
Clinical narrative: numbness, left feet worsens with position; Tingling in fingers, toes hands and feet; Episodes of shaking legs, shaking, not  seizure, taken to ER; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 72KJ4, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2022 11:00, the patient received FluLaval Quadrivalent 2022-2023 season (intramuscular). On 15th October 2022, the patient started Flulaval Tetra Pre-Filled Syringe Device. On 15th October 2022, 45 min after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced numbness, tingling of extremity and tremor limb. On an unknown date, the outcome of the numbness and tingling of extremity were not recovered/not resolved and the outcome of the tremor limb was recovered/resolved.   It was unknown if the reporter considered the numbness, tingling of extremity and tremor limb to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: The patient's mother reporter this case. Around 11 am, the patient was vaccinated with Flulaval into unknown arm and about 45 minutes later she experienced numbness and tingling in the fingers and toes that spread to her hands and feet (adverse events numbness and tingling were not recovered).  At that time her legs were shaking uncontrollably (adverse event shaking was recovered). She remained alert. The reporter denied it was a seizure.  The patient was taken to the emergency room that day. She had one more episode of shaking legs while in the ER (emergency room). Unknown tests were done and all were normal. The patient still had some numbness in her left foot today which worsens depending on her sitting position.  The reporter had nothing else to report. The reporter stated ER (emergency room) visit required. The reporter consented to follow-up with pediatrician.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: did not come back for second dose due to the COVID-19 pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15 October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.     Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's comment:  The pharmacist reported that the patient received first dose of Shingrix, but never received the second dose.  The pharmacist believed the patient did not come back for second dose due to the Covid-19 pandemic.  The pharmacist did not have the lot number and expiration date of the first dose.  At the time of reporting, the second dose had not been administered. The reporter did not consent to follow up.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 6th October 2022, the patient received Havrix. On 6th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 17-OCT-2022 Reporters comment:  The patient received the havrix vaccine which was expired on 18th June 2022. The reporter consent to follow-up. Additional Supportive information: The patient received Havrix, which was already expired in 18th June 2022, which led to expired vaccine used.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number 09cd9, expiry date 24th September 2023) for prophylaxis.   On 16th October 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: This case was reported by pharmacist. Pharmacist reported on October 18th, 2022 that Shingrix was exposed at a below temperature excursion reaching a minimum temperature of 29.2 degree F and it was administered to a patient on October 16th 2022. Reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter. Additional supportive information: As Shingrix was exposed below temperature excursion reaching temperature of 29.2 degree F which led to incorrect storage of vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 12th October 2022, the patient received Havrix. On 12th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: Medical assistance reported that a patient was administered expired dose of Havrix on different dates. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149858:Same reporter US-GSK-US2022149857:Same reporter US-GSK-US2022149860:Same reporter
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site was very sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR151190   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The reporter stated that a patient got her first Shingrix vaccine sometime in July 2022 in left arm.   The reporter stated that after her shot, the injection site was very sore for a few days and it was now resolved.   The reporter gave consent to follow up. For tolerance to the 2nd dose refer case US2022AMR151190.; Sender's Comments:  US-GSK-US2022AMR151190:Same reporter
Age: 2.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like reaction; This case was reported by a other health professional via sales rep and described the occurrence of seizure like phenomena in a 2-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number AJ3JX, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   On 6th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and PREVNAR 13. In October 2022, 30 hrs after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced seizure like phenomena (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure like phenomena was unknown.   It was unknown if the reporter considered the seizure like phenomena to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: The patient received doses of Flulaval and Prevnar 13 at the same visit into 2 different thighs (Flulaval in left thigh). The patient had a seizure-like reaction the following day, approximately 30 hours later.  The office that administered the vaccine was notified 5 days after the event by the patient's mother. They had not sought any face to face healthcare. It was unknown if the reporter considered the seizure to be related to Prevnar 13. The reporter consented to follow-up via postal.
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero reached 18 °F and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022 15:28, the patient received Bexsero. On 18th October 2022, the patient started Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The nurse reported that temperature excursion occurred with several vaccines reaching below freezing temperatures. After reviewing medical records, the nurse called and reported that the patient received the dose of Bexsero after dose had reached 18 degrees Fahrenheit.  The reporter did not have age or date of birth.  At the time of reporting, the dose had not been repeated.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  This case had been linked with US2022150652, reported by same reporter. Additional supportive information: The patient received Bexsero after this dose temperature excursion 18 degrees Fahrenheit, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022150652:same reporter
Age: 22.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received pediatric doses; received pediatric doses; received pediatric doses; received pediatric doses; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix 720) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix 720 and Havrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product, underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The reporter was practice manager. The reporter stated that a patient received pediatric doses of Havrix and Engerix-B. The reporter consented to follow up via postal. Additional Supportive Information: The reporter stated that, a patient received pediatric doses of Havrix and Engerix-B, which led to underdose and adult use of a child product.
Age: 0.08
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Boostrix instead of Hep B vaccine; boostrix administered to infant; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-week-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th October 2022, the patient received Boostrix .5 ml. On 24th October 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was a medical assistant from a medical office.   The reporter stated that, a patient received Boostrix instead of Hepatitis B vaccine. Lot number and expiration date of the Boostrix was not obtained Additional Supportive Information: The reporter stated that, a patient received Boostrix instead of Hepatitis B vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: BREAKTHROUGH INFECTIONS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a social media via a patient via a company representative concerned an unknown number of multiple patients with unknown age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Patient received multiple doses of non-company suspect vaccine included: covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infections, and revaccination with different covid-19 vaccine following vaccination with covid-19 vaccine (unspecified manufacturer) (Dose number in series 2). reported that  "I wish you would release data on the efficacy of your COVID-19 vaccine: Everyone I know who got 1xJNJ + multiple mRNA boosters has experienced breakthrough infections. I received 2xJNJ + multiple other platforms and have not been infected. Do you have data on us 2xJNJers?". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infections and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000256536
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 38 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A ,and expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 02-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (batch number: FJ8757, and expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered to the right arm on 27-NOV-2021 for covid-19 prophylaxis.  On 27-NOV-2021, the patient experienced revaccination with different covid-19 vaccine (Dose number in series 2). On 2022, the patient experienced suspected covid-19 infection following vaccination with tozinameran (Dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 05-OCT-2022 to 10-OCT-2022 for treatment of COVID-19. No concomitant medications were reported. On an unspecified date in OCT-2022, COVID returned 7-8 days after finishing patient's last dose of Paxlovid and testing negative two consecutive days. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and with Paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; REBOUND COVID INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sleep apnea, penicillin allergy, and drug allergy (quinine). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 in right arm for covid-19 prophylaxis. Age at time of vaccination 62 years old. Concomitant medications included acetylsalicylic acid, allopurinol, carvedilol, ergocalciferol, hydrochlorothiazide, krill oil, lisinopril, magnesium, rabeprazole, rosuvastatin, tamsulosin, testosterone, ubidecarenone, and vitamin b complex.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received two doses of non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 939906 expiry: UNKNOWN) dose was not reported, second dose administered on 23-OCT-2021 and (form of admin, and route of admin were not reported, batch number: 065K21A expiry: UNKNOWN) dose was not reported, third dose administered on 04-APR-2022 in right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with two doses of Moderna covid-19 vaccine (elasomeran) (dose number in series 2). The patient additionally received fourth dose of non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, and route of admin were not reported, batch number: AS7144B expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2022 14:00 in right arm for covid-19 prophylaxis. Patient was revaccinated with different covid-19 vaccine (dose number in series 3). On an unspecified date in 2022, the patient experienced covid-19 (dose number in series 3). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 08-OCT-2022 to 14-OCT-2022 for treatment of COVID-19. On 11-OCT-2022, Patient experienced rebound covid infection. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering from rebound covid infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSE BLEED; This spontaneous report received from a consumer concerned a female of unspecified age. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose bleed was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oedema
Clinical narrative: EDEMA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: male breast cancer (Patient was breast cancer survivor). 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced edema. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of edema was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: 213D21A expiry: AUG-2022) dose was not reported, administered on 24-OCT-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 24-OCT-2022, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 76-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 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster) 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 ACCIDENTAL UNDERDOSE (11 patients administered with doses of 0.25 mL instead of 0.50 mL of bivalent booster).    No concomitant medication information was provided. Reporter mentioned that no AEs were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662391, US-MODERNATX, INC.-MOD-2022-662390, US-MODERNATX, INC.-MOD-2022-662385 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662390:same reporter US-MODERNATX, INC.-MOD-2022-662385:same reporter US-MODERNATX, INC.-MOD-2022-662391:same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient just got over COVID. No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Acoustic stimulation tests, Deafness unilateral
Clinical narrative: Patient self reports he loss hearing in left ear 3 days after receiving 5th COVID-19 Pfizer booster
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Deafness unilateral
Clinical narrative: Patient self reports he loss hearing in left ear 3 days after receiving 5th COVID-19 Pfizer booster
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient experienced very mild sore arm during approximately 4 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (patient experienced very mild sore arm during approximately 4 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 017B21A and 048F21A) for COVID-19 vaccination.     Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not had history of COVID-19.  Concurrent medical conditions included Latex allergy, Food allergy (Corn products), Blood pressure high (since 4 years ago, no recent change in status such as improvement or worsening) and Depression (Antidepressant). Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Antidepressant therapy, LOSARTAN for Blood pressure high.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (patient experienced very mild sore arm during approximately 4 days). On 21-Mar-2021, PAIN IN EXTREMITY (patient experienced very mild sore arm during approximately 4 days) had resolved.            On 19Apr2021, patient experienced very mild sore arm  an d recovered on 23Apr2021 after second dose. On 21Sep2021, patient experienced very mild sore arm  an d recovered on 25Sep2021 after 1st booster dose. Treatment information was not provided.   This case was linked to MOD-2022-662403.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: seriously sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (seriously sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (seriously sick). At the time of the report, ILLNESS (seriously sick) outcome was unknown.    No relevant concomitant medications were reported.   Patient had all five Moderna and has been seriously sick, about a week or two weeks. On the fourth day, really really bad. Patient was not sure if he had to go to the hospital or not. He had his blood analysis and (unintelligible). The third vaccine from Moderna, he was concerned whether it was a life-or-death situation. It was that bad. The first flu shot that he got was the avian flu shot. He was concerned, but not as concerned as he was with Moderna.  No treatment information was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2022, 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 07-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine) 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 ACCIDENTAL UNDERDOSE (Accidentally received less than the authorized dose of the Moderna Covid 19 bivalent vaccine).    No concomitant medications were reported. HCP reported to accidentally administered less than the authorized dose of the Moderna Covid 19 bivalent vaccine and would like to know advice for same. Patient had no known allergies and no concomitant medication. No treatment information was reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: still having bad dizzy spells; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (still having bad dizzy spells) in a 66-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)) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetic. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 18-Oct-2022, 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 October 2022, the patient experienced DIZZINESS (still having bad dizzy spells). At the time of the report, DIZZINESS (still having bad dizzy spells) had not resolved. The patient received booster along with the flu shot on Tuesday and patient still had bad dizzy spells. Patient was asking if it was normal 5 days after vaccination. No treatment information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Pain in extremity, Pyrexia
Clinical narrative: had heart stent put in; sore arm; low-grade fever; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (had heart stent put in) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (low-grade fever). On 13-Jan-2022, the patient experienced CARDIAC DISORDER (had heart stent put in) (seriousness criterion medically significant). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) in January 2022 at an unspecified dose and frequency and Surgery (Patient had Stent Placement) for Cardiac disorder. At the time of the report, CARDIAC DISORDER (had heart stent put in), PAIN IN EXTREMITY (sore arm) and PYREXIA (low-grade fever) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had gotten all Moderna shots and received the 1st booster dose of Moderna Covid-19 vaccine (Monovalent).  Company Comment: This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Cardiac disorder and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The events Pain in extremity and Pyrexia occurred on the same day after the unspecified dose of mRNA-1273 Vaccine. The event Cardiac Disorder occurred 59 days after the unspecified dose of mRNA-1273 Vaccine. Patient was treated with Clopidogrel and Surgery. No further details on clinical course, lab test results were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   This case was linked to MOD-2022-662515 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Cardiac disorder and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The events Pain in extremity and Pyrexia occurred on the same day after the unspecified dose of mRNA-1273 Vaccine. The event Cardiac Disorder occurred 59 days after the unspecified dose of mRNA-1273 Vaccine. Patient was treated with Clopidogrel and Surgery. No further details on clinical course, lab test results were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematuria, Pain in extremity, Pyrexia, Transurethral prostatectomy
Clinical narrative: had heart stent put in; sore arm; low-grade fever; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (had heart stent put in) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (low-grade fever). On 13-Jan-2022, the patient experienced CARDIAC DISORDER (had heart stent put in) (seriousness criterion medically significant). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) in January 2022 at an unspecified dose and frequency and Surgery (Patient had Stent Placement) for Cardiac disorder. At the time of the report, CARDIAC DISORDER (had heart stent put in), PAIN IN EXTREMITY (sore arm) and PYREXIA (low-grade fever) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had gotten all Moderna shots and received the 1st booster dose of Moderna Covid-19 vaccine (Monovalent).  Company Comment: This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Cardiac disorder and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The events Pain in extremity and Pyrexia occurred on the same day after the unspecified dose of mRNA-1273 Vaccine. The event Cardiac Disorder occurred 59 days after the unspecified dose of mRNA-1273 Vaccine. Patient was treated with Clopidogrel and Surgery. No further details on clinical course, lab test results were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   This case was linked to MOD-2022-662515 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  67-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant) event of Cardiac disorder and unexpected non-serious event of Pain in extremity and expected non-serious event of Pyrexia. The events Pain in extremity and Pyrexia occurred on the same day after the unspecified dose of mRNA-1273 Vaccine. The event Cardiac Disorder occurred 59 days after the unspecified dose of mRNA-1273 Vaccine. Patient was treated with Clopidogrel and Surgery. No further details on clinical course, lab test results were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the "old" covid booster instead of the new bi-valent boost shot
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the "old" covid booster shot instead of the new bi-valent pfizer booster
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the "old" covid booster instead of the new bi-valent pfizer booster
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dermal filler reaction, Pain
Clinical narrative: Pain and swelling at dermal fillers site on left and right cheek bone area
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphasia, Memory impairment, Visual field defect
Clinical narrative: The event started around 11:30 am with a ?blind spot? in peripheral vision in my right eye. For example, when I was typing on the keyboard the keys on the edge of my right-side field of view would be in a ?blind spot?. Then immediately after during lunch with my mom, I was having trouble recalling specific names and terms during conversation, and if she referred to someone specific like a neighbor who I know, I would need to pause and think about who she was talking about (e.g., which neighbor is that, again?). Otherwise, my speech, hearing, and balance were normal, and my mom did not notice anything out of the ordinary. But I definitely noticed it.  I was back to ?normal? after about an hour.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dry skin, Injection site discolouration, Injection site dryness, Injection site erythema, Injection site induration
Clinical narrative: On my first day the site looked very nice. As a Nurse, the nurse did a really nice forearm intradermal injection. The site was a little bit red and continued to get more red till day three.  On day 4 the redness was reduced  but the site was swollen and a bit tender. The next day- day 5 the site was  hard and tender for about 1cm  from the site. This remained  till day 10 the site tenderness had reduced and  is now scabbing over?  Sort looks like it has dry skin around it and the site is darkened
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: On my first day the site looked very nice. As a Nurse, the nurse did a really nice forearm intradermal injection. The site was a little bit red and continued to get more red till day three.  On day 4 the redness was reduced  but the site was swollen and a bit tender. The next day- day 5 the site was  hard and tender for about 1cm  from the site. This remained  till day 10 the site tenderness had reduced and  is now scabbing over?  Sort looks like it has dry skin around it and the site is darkened
Age: 73.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Dizziness, Headache, Hypotension
Clinical narrative: Patient reports having low blood pressure, head aches, low energy, dizziness, and light headedness.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy
Clinical narrative: left axillary lymphadenopathy
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Wrong product administered
Clinical narrative: potentially given the monovalent dose as booster; potentially given 0.25ml instead of 0.5ml as booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (potentially given the monovalent dose as booster), ACCIDENTAL UNDERDOSE (potentially given 0.25ml instead of 0.5ml as booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (potentially given the monovalent dose as booster), ACCIDENTAL UNDERDOSE (potentially given 0.25ml instead of 0.5ml as booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (potentially given the monovalent dose as booster), ACCIDENTAL UNDERDOSE (potentially given 0.25ml instead of 0.5ml as booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (potentially given the monovalent dose as booster) and ACCIDENTAL UNDERDOSE (potentially given 0.25ml instead of 0.5ml as booster dose).    Concomitant medication was not reported.  Reporter stated that patient was administered with the "child booster dose". Agent clarified if the patient was given 0.25ml or 0.5ml but HCP did not have that information. HCP was also not aware if this were the bivalent booster dose or the monovalent dose that was given. Treatment details was not reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had rashes all over her back, rash was not raised, no pain, and not itchy
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over chest/neck