chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vitreous floaters, Vomiting
Clinical narrative: Immediately upon injection I tasted a salty/metal taste in my mouth. My left side got tingly and my ears rang. That night had the worst menstrual cramps of my life. My arm hurt so mad it felt like there were a million knives stabbing it and I could not sleep, graze a shirt sleeve against it or shower for days. The following days felt sick with a severe headache and flu symptoms.  I then developed a giant red tender ring on my arm for 8 days. The morning the red arm rash disappeared I woke up with an extremely tight chest and it felt like someone was sitting on it and I could not breathe. I then started getting a racing pounding heart and my chest was in extreme pain as if someone poured cement in it, I had an elephant sitting on it, and my heart was being squeezed and stabbed at the same time and it would not slow down. These symptoms to this day are still here.  Extreme fatigue, weakness, dizziness, throwing up, fast inappropriate pounding heart, chest pain and chest pressure, shortness of breath, exertion  and out of breath with the slightest movement like my heart is non stop running a marathon. Loss of period for 9 months and now have been on my period for 3 months straight. Blacking out when standing, reactions to foods, tremors, joint pain, brain fog, non stop nausea, non stop vertigo, black floaters in my eyes.   Diagnosed with Myocarditis & Pericarditis - I still have symptoms (seen multiple cardiologists)  Diagnosed with POTS - I still have symptoms Diagnosed with more severe MCAS - I still have symptoms Diagnosed with Dysautonomia/Autonomic Dysfunction - I still have this Diagnosed with Chronic Fatigue syndrome - I still have this Diagnosed with Chronic Vertigo - I still have this  Diagnosed with a Positive ANA - I still have this (Autoimmune Antibodies) Diagnosed with Lactic Acidosis  Diagnosed with hypovolemia Diagnosed with Vaccine adverse reaction
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Eyelid function disorder, Gait disturbance, Muscular weakness, Sinus disorder
Clinical narrative: Day after eyes half closing all day like sinus problem. Then for next 5 days dizzy. The worst was a feeling of weakness in the arms and legs and a feeling that the arms were somehow internally shaking. Felt unsteady on feet.....off and on for 3 weeks after vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Day after eyes half closing all day like sinus problem. Then for next 5 days dizzy. The worst was a feeling of weakness in the arms and legs and a feeling that the arms were somehow internally shaking. Felt unsteady on feet.....off and on for 3 weeks after vaccination.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine 04 Oct 2022. No treatment medications were reported.  This case is for 1st patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported.  It was that moment they did not have the bivalent vaccine.   They received the bivalent vaccine on 04-Oct-2022.  No treatment medications were reported.  This case is for 2nd patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:Patient 1 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the monovalent booster instead of the bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine on 04-Oct-2022. No treatment medications were reported. This case was for 3rd patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:patient 1 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ).    No concomitant medications were reported.  The pharmacy received the bivalent vaccine on 04-Oct-2022.  No treatment medications were reported.  This case is for 4th patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:Patient 1 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine on 04-Oct-2022. No treatment medications were reported.. This case was for 5th patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656480 (E2B Linked Report). Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-655231:Patient 1
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; Improperly stored doses of RECOMBIVAX HB and VARIVAX were administered to the patient.; This spontaneous report has been received from a pharmacist referring a patient of unknown age and gender. The patient's concurrent conditions, medical history,drugs reactions or allergies and concomitant medications not reported.    On 05-AUG-2022, the patient was vaccinated with improperly stored doses of hepatitis B vaccine (recombinant)thimerosal-free (RECOMBIVAX HB) intramuscular injection, vial, lot number U008328 with expiration date: 16-DEC-2022 and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous Injection, lot number U028164 with expiration date: 09-SEP-2023, both of them administered for prophylaxis (strengths,doses, frequencies, routes of administration and anatomical sites of application were not provided) (product storage error).  The hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) had temperature excursion between 48.79 F for 2 hours and 43 minutes and 22.87 F for 3 hours and 36 minutes. Also, varicella virus vaccine live (oka/merck) (VARIVAX) had temperature excursion between 33.13 F for 14 hours and 55 minutes. It was reported that there were no previous temperature excursions. No additional adverse event reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information provided; accidentally been given PEDVAXHIB vaccine that was diluted; diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-SEP-2022, the patient was vaccinated with a second dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # W002453, expiration date 24-JUN-2024 for prophylaxis. The vaccine was accidentally diluted with 0.5mL of sodium chloride (NORMAL SALINE) and then 0.5mL was drawn up and administered (exact dose, route of administration, and anatomical location were not reported) (Product preparation error, Incorrect dose administered). No additional adverse event information provided (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA008125:02252011 US-009507513-2209USA008037:02251970 US-009507513-2209USA007893:02252094 US-009507513-2209USA007924:02252047 US-009507513-2209USA008290:02252078 US-009507513-2209USA008058:02252037 US-009507513-2209USA008275:02251979 US-009507513-2209USA008249:02251904 US-009507513-2209USA008273:02251935 US-009507513-2209USA007891:02251607
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: no additional AE have been reported at the time of call.; Nurse practitioner reports an AE for MMRII and VARIVAX. Caller states a 3 year-old patient was inadvertently administered 2 doses of MMRII and 2 doses of VARIVAX concomitantly on 9/28/2022. Caller states no additional AE have been reported at the tim; This spontaneous report was received from a Nurse Practitioner, referring to a 3-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medication was not provided.  On 28-SEP-2022, the patient was inadvertently administered 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # U022316, expiration date: 15-JUL-2023, 0 .5 milliliter for prophylaxis (dosage information and route of administration not informed), and 2 doses of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, Lot Number: W012164, expiration date: 12-APR-2024, for prophylaxis(dosage information and route of administration not informed); concomitantly, diluted with sterile diluent, product quantity 4, 0.5 mL (Accidental overdose). No additional adverse event had been reported at the time of call.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: The patient had not had any issue/No additional AE; Customer called to report that a patient was admin a expired dose of GARDASIL 9.  Caller did not have any other information at time of call.  No PQC.  Caller reported that the patient had not had any issues. LOT: Unknown by reporter EXP: Unknown by r; This non-valid spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot #, expiration date, dose, route of administration, anatomical location not provided) for prophylaxis (expired product administered). It was reported that the patient did not have any issue.   This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the pharmacist on 30-SEP-2022. The patient was female in her 20s. On 27-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, prefilled syringe, lot # 1659422, expiration date 04-SEP-2022. No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: The caller reported that her cousin was administered the HPV vaccine while pregnant.; No additional AE/PQC reported.; This spontaneous prospective pregnancy report was received from a patient's cousin concerning to a female patient of unknown age. The patient's medical history, current conditions, previous drug reactions/allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (reported as HPV vaccine) administered for prophylaxis (strength, dosage, lot number, expiration date, vaccination scheme frequency, route of administration and anatomical site of application were not provided) while pregnant (exposure during pregnancy).   The last menstrual period (LMP) and the estimated date of delivery (EDD) were not reported. No demographics were gathered for the patient or the reporter; therefore, no letter would be sent. The pregnancy outcome was lost to F/U. The fetal outcome was unknown. No additional adverse event was reported (no adverse event).
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: A consumer who is pregnant called to report that she was administered GARDASIL 9 on 9/29/2022.; No additional adverse events (AE's) were reported; This spontaneous prospective pregnancy report as received from a consumer refers to a 34 year old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.     On 29-SEP-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular, use as directed to prevent human papilloma virus infection.  The patient became pregnant with last menstrual period (LMP) of 15-MAR-2022 and estimated date of delivery (EDD) of 20-DEC-2022. The initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 28 week(s) (exposure during pregnancy). It was reported that the patient is scheduled to deliver the baby by caesarian section on 15-DEC-2022. No additional adverse event was provided. At the reporting time the outcome of the adverse event was reported as not recovered. The action taken of the adverse event as well as the causality assessment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting an improperly stored vaccine was administered to a patient.; No additional AE.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, for prophylaxis (anatomical location and route of administration were not provided), lot # W019623 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), expiration date upon internal validation established as 19-DEC-2023 (the same as reported)(product storage error). Administrated vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was stored at -11.8 Celsius degrees for 1 hour and 45 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 07-SEP-2022, the patient was vaccinated with improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, for prophylaxis (lot number: W016358, which was determined to be valid, with an expiration date on 16-NOV-2023) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 11.8 degrees Celsius (C), during a time frame of 1 hour and 45 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reporting an AE for PEDVAXHIB and ROTATEQ being administered after a temperature excursion that occurred on 05-OCT-2022.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 05-OCT-2022, the patient was vaccinated with improperly stored (product storage error) doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #: 1879874, expiration date: 19-OCT-2023; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot #: U039951, expiration date: 22-JUN-2024 (strengths, sites and routes of administration were not provided for both suspect vaccines) for prophylaxis. Temperature excursion information for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB): 47.4 degree Fahrenheit for 30 minutes; previous temperature excursion: approximately August 2022, 49.8 degree Fahrenheit for 2 hours 25 minutes. Temperature excursion information for rotavirus vaccine, live, oral, pentavalent (ROTATEQ): 47.4 degree Fahrenheit for 30 minutes; no previous temperature excursion. There was no additional adverse event reported.
Age: 0.17
Sex: U
Vaccine: HEP, UNK
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE details were provided.; the patient is a 2 month old infant who received a dose of VAXELIS and a dose of RECOMBIVAX HB on the same day on 3OCT2022.; This spontaneous report has been received from a medical assistant concerning to a 2-month-old infant patient of an unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On 03-OCT-2022, the patient received a dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) intramuscular injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme frequency, route of administration, and anatomical site of application were not provided; lot number T032918 that was verified to be valid for vial formulation with an expiration date reported and established as 12-NOV-2022) as prophylaxis; and on the same date, received a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, at a dose of 0.5 ml (strength, vaccination scheme frequency, route of administration, indication and anatomical site of application were not provided; lot number U7205AA that was verified to be valid with an expiration date reported as 24-OCT-2023 but upon internal validation established as 23-OCT-2024) (overdose).    By the reporting time, the patient did not have any adverse reactions. There was no additional adverse event (AE) reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Herpes zoster oticus, Oral herpes zoster, Pain
Clinical narrative: Bell's palsy; she got shingles,They were in her mouth,ear and the back of her head.; she got shingles,They were in her mouth,ear and the back of her head.; "she got shingles,They were in her mouth, ear and the back of her head."; Terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), oral herpes zoster, shingles and pain. On an unknown date, the outcome of the bell's palsy and pain were unknown and the outcome of the herpes zoster otitis externa, oral herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy, herpes zoster otitis externa, oral herpes zoster, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: This case was reported by a patient's child via interactive digital media. The patient got the Shingles shot and the week before her second one she got shingles. They were in her mouth, ear and the back of her head.  The patient was still trying to get over them. The patient also got Belles Palsy from them. The patient was in terrible pain.  The reporter stated that hope the patient feel better soon. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccine, had shingles again/suspected vaccination failure; shingles/had shingles again, this one is worse; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and had shingles and he/she had again now. The patient stated that this one was worse. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, 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: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Boostrix below temperature excursion, which led to incorrect storage of drug. This is 1 of 20 linked cases reported by same reporter for different patients.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness
Clinical narrative: Out of work (major/ terrilbe reactions); Felt like the flu (major/ terrible reactions); This case was reported by a consumer via interactive digital media and described the occurrence of inability to work in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced inability to work and influenza-like symptoms. On an unknown date, the outcome of the inability to work and influenza-like symptoms were unknown.   It was unknown if the reporter considered the inability to work and influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had major reaction to vaccine. The patient was out of work and felt like the flu with terrible reaction. The patient was scared of 2nd shot. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: was given a vaccine that expired; This case was reported by a other health professional via interactive digital media and described the occurrence of expired vaccine used in a patient who received Hepatitis B vaccine (batch number unknown, expiry date 12th August 2022) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Hepatitis B vaccine. On 1st September 2022, unknown after receiving Hepatitis B vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's comment: The reporter reported this case via interactive digital media.  The reporter stated that the patient received dose of Hepatitis B vaccine that was expired on 12th August 2022. The reporter asked could this be counted as a current dose or did it need to be repeated. Additional supportive information: The patient received a dose of Hepatitis B vaccine which was already expired, which led to expired vaccine used. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose12/2019 , no 2nd dose given yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose in December 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The case was reported by the patient via interactive digital media. The patient received his/her Shingles vaccine 1st dose, and 2nd dose was not given yet. The patient asked what to do. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Took me down for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she detests shot but this Shingles vaccine scares him more. The patient reported that the 2nd dose was a doozie and took him down for 24 hours. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Severe muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked if side effect of the Shingrix vaccine was severe muscle pain. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot 2 years ago, 2nd yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st first shingles shot 2 years ago).   On 1st October 2022, the patient received the 2nd dose of Shingles vaccine. On 1st October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of shingles vaccine 2 years ago.  The patient stated that, they did not tell him/her that, he/she needed a second shot of shingles vaccine. The day before reporting he/she got another shot of shingles vaccine. .  The patient wanted to know if he/she should get another in a few months. Additional Supportive Information: The patient received 2nd dose of shingles vaccine later than the recommended schedule which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness in my arm; Tired for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th September 2022, the patient received the 2nd dose of Shingles vaccine. On 30th September 2022, less than a day after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comments: This case was reported via interactive digital media. The patient got his/her second shingles shot.  He/she was very tired for 24 hours. A little soreness in my arm.  Additional supportive information: Follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: was horrible, Fever; was horrible, chills; was horrible severe, headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-OCT-2022 Reporter's comment: This case was reported by patient's wife via interactive digital media. The patient got the Shingles shots. Second one was horrible, fever and chills with severe headache. Additional supportive information: Follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: received two doses on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 29th September 2022, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK receipt date: 30-September-2022 Reporter's comment: Reporter stated that on Sep 29th, 2022, a patient received two doses of Shingrix on the same day. Additional supportive information:  As patient received 2 dose Shingrix on same day which led to overdose. The reporter did not consent to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix 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: 30-SEP-2022 Reporter's Comments: The health care provider called on 30th Sep 2022 to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree F from the period of 27th July 2022 until 22nd Sep 2022, due to a malfunction of their fridge. The HCP reported that during that period a total of 20 patients might had received these vaccines,15 patients received Boostrix and 5 patients received Shingrix. The expiration dates or any patients information was handy at the time was asked. The lot number was not provided. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional supportive information: The patient received Boostrix vaccine for which there was temperature excursion to 27 degree F which led to incorrect storage of drug. This case is 1 of 20 cases reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose was 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 Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 20th June 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 29th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th September 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: 30-SEP-2022 Reporter's comment: HCP (Health care professional) reported that an expired dose of Bexsero was administered to a patient. No details of the patient were available. 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: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo reconstituted with normal saline; Menveo reconstituted with normal saline; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA756A, expiry date 31st October 2023) for prophylaxis.   On 30th September 2022, the patient received Menveo. On 30th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's Comments: The health care professional (HCP) reported that patient received Menveo vaccine reconstituted with normal saline solution. The reporter consent to follow up. Additional Supportive Information: The patient received Menveo vaccine reconstituted with normal saline solution which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix B administered/Expired Drug Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HBV (Engerix B adult) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Engerix B adult. On 1st September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's comment: The licensed practical nurse reported that a dose of Engerix B adult given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B adult dose, which was already expired on 12th August 2022, which led to expired vaccine used.