chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 12-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 02-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 0.67
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report inadvertent administration of GARDASIL 9 to an 8-month-old patient on 08JAN2024. Limited patient demographics provided. No additional AE/PQC.; This spontaneous report was received from medical assistant referring to an 8-months-old patient of unknown gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On 08-JAN-2024, the patient was inadvertent vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot # 1957405,expiration date 11-NOV-2025) 0.5 milliliter, once, (route of administration and anatomical locations were not reported) for prophylaxis (product administered to patient of inappropriate age).  No additional Adverse event or Product quality complaint was reported.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 6-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; Inapropriate age; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 12-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Inapprorpiate age of product administered). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Myoclonus, Tinnitus
Clinical narrative: 3 months after vaccine I developed Pulsatile Tinnitus, regular tinnitus & headaches. Worked very hard to find out what was wrong & finally found out I had a myoclonus that was manifesting between 2021 up until now 2024. I now have a permanent Palatal Myoclonus which is clicking of the soft palate only when turning my head or nodding my head up & down. Clicking ears & muscles around the soft palate that cause me headaches when moving for too long b/c the tensor vali palatini muscles never rest.
Age: 11.0
Sex: M
Vaccine: DTAPIPV, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: THE PATIENT WAS GIVEN THE QUADRACEL VACCINE INSTEAD OF THE HPV-9 VACCINE.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient signed up online via portal to receive a COVID-19 vaccination. Patient was called in to verify intake information, any adverse reactions to past COVID vaccines, or for recent positive COVID disease. After all information was verified, vaccine was administered. After administration, attempted to complete charting and was unable to continue. After multiple attempts to find out why charting was unable to be completed, I realized I provided patient with the incorrect COVID 19 funded dose. Patient signed up for BAP: Pfizer Comirnaty 12 yo+. However, supply from VFC: Pfizer Comirnaty 12 yo+ was given. Correct drug, dose, route, patient, time are noted. No adverse effects to patient related to event
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling of her feet below her ankle
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 7-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 04-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; Inappropriate age; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 12-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 02-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided)(Inappropriate age of product administration). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 4-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 10-OCT-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (recombinant Human albumin) (PROQUAD) injection, lot #X018584, expiration date: 05-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 1-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 02-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 1-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 30-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 43.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 43-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 29-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #W039689, expiration date: 13-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 29-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 27-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 5-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 10-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 16-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 07-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 36-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 30-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #W039689, expiration date: 13-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 14-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 04-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 14-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 10-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 15-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 27-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 1-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 03-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 16-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 26-SEP-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 8-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 04-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical Assistant called to report a temperature excursion and improperly stored VARIVAX and PROQUAD administered anywhere from 9/25/2023 until 10/10/2023 to multiple patients with unknown demographics. Confirmed no side effects or symptoms reported.; No additional AE/no PQC.; This spontaneous report was received from medical assistant and refers to a 12-years-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 10-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) rHa (recombinant Human albumin) (VARIVAX) injection, lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in -14 degree Celsius (can be up to -10 degree Celsius) for 10 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of expired MMR-II to a patient.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 24-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) (lot number W001520 has been verified to be a valid lot number, expiration date reported and validated as 13-JAN-2024) (expired product administered). No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A HCP called to report a TE for PEDVAX HIB and ROTATEQ in which the vaccines had also been administered to a patient; This spontaneous report was received from Other Health Professional and refers to a 9-week-old patient. The patient's medical history, concurrent and concomitant therapies were not reported.  On an 11-DEC-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1965644, expiration date: 02-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) and hib vaccine conj (ompc) (PEDVAXHIB), 0.5ml / once, lot #X003664, expiration date: 10-NOV-2025 (strength, formulation, route of administration, and indication were not provided).  The healthcare professional called to report a temperature excursion for hib vaccine conj (ompc) (PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in which the vaccines had also been administered to a patient on that day.  The patient did not report any adverse issues or side effects from the administration. No other adverse event information was able to be provided during the call. The following excursions were reported: 04-DEC-2023: 54.3F for 9 hours 32 minutes 0 seconds; 05-DEC-2023: 57.7F for 15 hours 30 minutes 0 seconds; 06-DEC-2023: 50.2F for 5 hours 43 minutes 0 seconds; 07-DEC-2023: 30.6F for 1 hour 55 minutes 0 seconds; 07-DEC-2023: 52.7F for 11 hours 3 minutes 0 seconds; 11-DEC-2023: 48.4F for 1 hour 47 minutes 0 seconds.  No other reported current or previous temperature excursions were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Large blister at injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site blisters in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site blisters (Verbatim: Large blister at injection site). The outcome of the injection site blisters was not reported.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.     It was unknown if the company considered the injection site blisters to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2024 The physician reported that the patient received Shingrix vaccine and experienced (injection site reaction) large blister at injection site. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: she developed sharp pain in the area that she received the vaccine sharp pain when she touches her arm and anytime that she; pain when she touches her arm; normal arm soreness after a vaccination; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 05-JAN-2024, the patient received Bexsero. In JAN-2024, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: she developed sharp pain in the area that she received the vaccine sharp pain when she touches her arm and anytime that she), pain in arm (Verbatim: normal arm soreness after a vaccination) and tenderness (Verbatim: pain when she touches her arm). In JAN-2024, the outcome of the pain in arm was resolved (duration 3 days). The outcome of the injection site pain was not resolved and the outcome of the tenderness was not reported.   It was unknown if the reporter considered the injection site pain, pain in arm and tenderness to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, pain in arm and tenderness to be related to Bexsero and Bexsero 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-Jan-2024 A reporter reported that we saw a patient in clinic today 19 January 2024 that received her vaccine on 05 January and she reports for three days she experienced normal arm soreness after a vaccination.  However, after that she developed sharp pain in the area that she received the vaccine that had persisted and now we are 2.5 weeks post vaccination, she reports sharp pain when she touches her arm and anytime that she moves her arm.  There are no signs of infection at the site. The reporter was GSK/ViiV field staff employee. The reporter did not agree to follow up from GSK.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Inappropriate drug; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Inappropriate drug). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 19-JAN-2024 The reporter stated that Arexvy was mistakenly administered to a pregnant woman, which led to vaccine exposure during pregnancy. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: He has not yet received his 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received first dose before the Covid pandemic For the tolerance of first dose refer case US2020187918.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He has not yet received his 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Linked case(s) involving the same patient:  US2020187918, US2021151570   Additional Information: GSK Receipt Date: 18-JAN-2024 The reporter was patient. The patient received his first Shingrix dose before the covid pandemic. Patient had not yet received his 2nd dose. The reporter requested to consent to follow-up. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151570:SAME PATIENT
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Will he need to redo the series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 23rd November 2020, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Will he need to redo the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-JAN-2024 The reporter reported via chat that he or she had patient who received first Shingrix vaccine in 2020. Reporter asked a question that would patient need to redo the series. Chat was abandoned after asking for demographics from the reporter. The reporter consented to follow-up. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling around the left deltoid injection site; Redness around injection site of left deltoid; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 3b2yj, expiry date 16-AUG-2025) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 14 October 2023 with no symptoms).   On 20-DEC-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 05-JAN-2024, 16 days after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swelling around the left deltoid injection site) and injection site erythema (Verbatim: Redness around injection site of left deltoid). The outcome of the injection site swelling and injection site erythema were not resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2024  The patient self-reported this case. The patient received both of his Shingrix Vaccinations. 2nd dose was received with the symptoms of redness and swelling to the left deltoid site of the injection that had not resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: nurse accidentally used Tenivac vaccine to reconstitute the solvent part of the Shingrix; nurse accidentally used Tenivac vaccine to reconstitute the solvent part of the Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: nurse accidentally used Tenivac vaccine to reconstitute the solvent part of the Shingrix) and inappropriate dose of vaccine administered (Verbatim: nurse accidentally used Tenivac vaccine to reconstitute the solvent part of the Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JAN-2024 The pharmacy intern reported that a nurse accidentally used Tenivac vaccine to reconstitute the solvent part of the Shingrix which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter declined to provide any further information.  The reporter did not consent to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Twinrix back in 2014; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (In 2014, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Twinrix back in 2014). The outcome of the incomplete course of vaccination 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-JAN-2024 A healthcare professional (HCP) reported that a patient received only the first dose of Twinrix back in 2014, which led to incomplete course of vaccination. The HCP asked if the patient needed to re-start the series or if the patient just needed two more doses. The reporter did not provide information about first dose given in 2014 (lot number, expiry date). The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the fever and chills were not reported.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     It was unknown if the company considered the fever and chills to be related to Shingrix.   Additional Information: GSK receipt date: 19-JAN-2024 The reporter was patient's wife. The reporter reported that the patient received Shingrix vaccine and experienced fever and chills. The reporter did not consent to follow-up. This case had been linked to US2024009502 the case reported by same reporter.; Sender's Comments:  US-GSK-US2024009502:FEMALE PATIENT
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation, Injection site pruritus, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Peeling at the injection site of left deltoid; Itchy at injection site; arm was swollen, and itchy within the first 24 hours; arm was swollen, and itchy within the first 24 hours; Swelling at the injection site of left deltoid; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 27-JUN-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swelling at the injection site of left deltoid). On 28-JUN-2023, the patient experienced itchy upper limbs (Verbatim: arm was swollen, and itchy within the first 24 hours) and swelling arm (Verbatim: arm was swollen, and itchy within the first 24 hours). On 10-JUL-2023, the patient experienced injection site exfoliation (Verbatim: Peeling at the injection site of left deltoid) and injection site itching (Verbatim: Itchy at injection site). On 15-JUL-2023, the outcome of the injection site swelling was resolved (duration 18 days). The outcome of the injection site exfoliation, injection site itching, itchy upper limbs and swelling arm were resolved.   It was unknown if the reporter considered the injection site swelling, injection site exfoliation, injection site itching, itchy upper limbs and swelling arm to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site exfoliation, injection site itching, itchy upper limbs and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2024 This case was self-reported by the patient. The patient noticed that her arm was swollen, and itchy within the first 24 hours after receiving the Shingrix vaccine, this had since resolved. The patient also complained of peeling at the injection site 10 days after being given the Shingrix vaccine. All symptoms had now subsided. The reporter consented to the follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In DEC-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the fever and chills were resolved (duration 1 day).   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     It was unknown if the company considered the fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JAN-2024 The caller was the wife of the patient who stated that her husband had a history of shingles. She stated that he received Shingrix in December 2023. She stated that evening he had a fever and chills that lasted 1 day. The reporter did not consent to follow up. This was Adverse event report 2 of 2.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema
Clinical narrative: redness on arm around the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness on arm around the injection site). The outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Arexvy.     It was unknown if the company considered the injection site erythema to be related to Arexvy.   Additional Information: GSK receipt date:19-JAN-2024 and 20-JAN-2024 The reporter reported that a patient was received Arexvy vaccine and developed redness on the arm around the injection site. The reporter did not consent to follow up.