chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Fatigue, Feeling abnormal, Injection site rash, Lip swelling
Clinical narrative: rash about 2 inches in diameter around the injection site.; fatigued.; felt really itchy.; light headed; eye lids got very puffy looking; lips also swelled up; "This was her third VARIVAX vaccine; This spontaneous report has been received from the patient's mother (reported as on behalf of her daughter), referring to a 18 years old female patient. The patient's historical condition and concomitant medication were not provided.  On 16-MAY-2022, the patient was vaccinated with her third doe of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, lot number and expiration date were unknown) for prophylaxis (Extra dose administered). She received the diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccine at the same time. She had a medical situation where she had to receive shots in her leg.  On the same day within a few minutes of her receiving the vaccine, the patient developed a rash about 2 inches in diameter around the injection site (Vaccination site rash). She felt really itchy (Pruritus). The reporter gave her 25mgs of diphenhydramine (BENADRYL) to try and help the itchy feeling.  Within about fifteen minutes of getting the vaccine, she started not feeling well. She felt light headed and fatigued (Dizziness and Fatigue). Within about twenty minutes after the injection, her eye lids got very puffy looking (Swelling of eyelid). Her lips also swelled up (Lip swelling). The reporter took her back to the doctors office and the nurse practitioner (NP) gave her another 25mgs of diphenhydramine (BENADRYL). After giving her more diphenhydramine (BENADRYL) the swelling went down. The NP told the reporter that it appeared the patient was not having an anaphylactic reaction. She felt better for a little while, but when the diphenhydramine (BENADRYL) ran out, she started to feel bad again. The reporter reached back out to the doctor and they suggested the reporter tried giving her cetirizine (ZYRTEC ) instead. So, the reporter had been giving her that every 12 hours for the past few days. She felt good in the morning, but when the cetirizine (ZYRTEC ) worn off she felt bad again. She was a vegan and had not had meat in a really long time. The reporter made an appointment with an allergist, but they had not been seen yet. The outcome of the events of vaccination site rash, lip swelling, swelling of eyelid, fatigue, dizziness and pruritus was considered as not recovered.  The causality assessment between the events of vaccination site rash, lip swelling, swelling of eyelid, fatigue, dizziness and pruritus and suspect vaccine was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pruritus, Rash, Swelling of eyelid
Clinical narrative: rash about 2 inches in diameter around the injection site.; fatigued.; felt really itchy.; light headed; eye lids got very puffy looking; lips also swelled up; "This was her third VARIVAX vaccine; This spontaneous report has been received from the patient's mother (reported as on behalf of her daughter), referring to a 18 years old female patient. The patient's historical condition and concomitant medication were not provided.  On 16-MAY-2022, the patient was vaccinated with her third doe of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, lot number and expiration date were unknown) for prophylaxis (Extra dose administered). She received the diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) vaccine at the same time. She had a medical situation where she had to receive shots in her leg.  On the same day within a few minutes of her receiving the vaccine, the patient developed a rash about 2 inches in diameter around the injection site (Vaccination site rash). She felt really itchy (Pruritus). The reporter gave her 25mgs of diphenhydramine (BENADRYL) to try and help the itchy feeling.  Within about fifteen minutes of getting the vaccine, she started not feeling well. She felt light headed and fatigued (Dizziness and Fatigue). Within about twenty minutes after the injection, her eye lids got very puffy looking (Swelling of eyelid). Her lips also swelled up (Lip swelling). The reporter took her back to the doctors office and the nurse practitioner (NP) gave her another 25mgs of diphenhydramine (BENADRYL). After giving her more diphenhydramine (BENADRYL) the swelling went down. The NP told the reporter that it appeared the patient was not having an anaphylactic reaction. She felt better for a little while, but when the diphenhydramine (BENADRYL) ran out, she started to feel bad again. The reporter reached back out to the doctor and they suggested the reporter tried giving her cetirizine (ZYRTEC ) instead. So, the reporter had been giving her that every 12 hours for the past few days. She felt good in the morning, but when the cetirizine (ZYRTEC ) worn off she felt bad again. She was a vegan and had not had meat in a really long time. The reporter made an appointment with an allergist, but they had not been seen yet. The outcome of the events of vaccination site rash, lip swelling, swelling of eyelid, fatigue, dizziness and pruritus was considered as not recovered.  The causality assessment between the events of vaccination site rash, lip swelling, swelling of eyelid, fatigue, dizziness and pruritus and suspect vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred.   This is one of 13 reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: No additional AE or PQC reported; only 0.4ml of GARDASIL 9 was administered to a patient; 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 31-MAY-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.4 ml, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (underdose).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired GARDASIL 9; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 26-MAY-2022, 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) lot #T026954, expiration date: 13-APR-2022, administered for prophylaxis (strength, dose, frequencyand route of administration were not provided)(expired product administered). No additional adverse events were reported. The vaccine did not undergone any previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; expired dose of MMR II was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and drug reactions or allergies were not reported.  On 02-JUN-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, was administered, lot #T018635 with expiration date: 29-MAY-2022, administered subcutaneously for prophylaxis (strength was not provided). No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Disseminated varicella zoster virus infection, Immunohistochemistry, Lymphocytic infiltration, Papule
Clinical narrative: Disseminated varicella zoster virus infection; Vaccination failure; Literature Report: This literature report has been received from authors of a published article, titled as above, regarding a 70 years old female patient.  The patient with a history of giant cell arteritis and resolved SARS-CoV-2 infection 10 months ago presented with a diffuse erythematous vesicular rash. Eighteen days ago, she completed a 20-week low-dose methylprednisolone taper for giant cell arteritis, initiated at 10 mg daily. Eight days prior to presentation, she received the first dose of the mRNA-1273 (Moderna) COVID-19 vaccine; 5 days later, a pruritic skin eruption with associated daily fevers developed in her. The examination demonstrated thin erythematous papules and vesicles over the forehead, trunk, and extremities. No antecedent dermatomal eruption was noted; of note, the patient had received zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis 10 years ago. Dermatopathology demonstrated papillary and mid-dermal lymphocytic infiltrate with admixed neutrophils and foci of lymphocytic vasculitis; findings of varicella zoster virus (VZV) immunohistochemistry were negative; however, findings of polymerase chain reaction from a sampled vesicle were positive for VZV DNA. The patient was initiated on oral valacyclovir 1000 mg 3 times daily; the following day, she was admitted to the hospital for intravenous acyclovir (10 mg/kg, every 8 hours for 5 days). One week after hospital discharge, she had a nearcomplete resolution of her infection with diffuse postinflammatory hyperpigmentation. One week after completing valacyclovir and 4 weeks after her first dose, she received the second vaccine dose without complications. The patient received adulthood VZV vaccination, yet presented with nondermatomal, acutely disseminated VZV (disseminated varicella zoster virus infection; vaccination failure). In the case, valacyclovir between vaccine doses may have been protective against a similar reaction following the second dose. Thus, it is our opinion that disseminated VZV reactivation should not be a contradiction to completing the mRNA-based SARS-CoV-2 vaccine regimens. The outcome of event disseminated varicella zoster virus infection was recovering. The outcome of vaccination failure was unknown.  The causality between both events and zoster vaccine live (ZOSTAVAX) was related.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: VARZOS
Symptoms: Pathology test, Post inflammatory pigmentation change, Pyrexia, Rash, Rash erythematous
Clinical narrative: Disseminated varicella zoster virus infection; Vaccination failure; Literature Report: This literature report has been received from authors of a published article, titled as above, regarding a 70 years old female patient.  The patient with a history of giant cell arteritis and resolved SARS-CoV-2 infection 10 months ago presented with a diffuse erythematous vesicular rash. Eighteen days ago, she completed a 20-week low-dose methylprednisolone taper for giant cell arteritis, initiated at 10 mg daily. Eight days prior to presentation, she received the first dose of the mRNA-1273 (Moderna) COVID-19 vaccine; 5 days later, a pruritic skin eruption with associated daily fevers developed in her. The examination demonstrated thin erythematous papules and vesicles over the forehead, trunk, and extremities. No antecedent dermatomal eruption was noted; of note, the patient had received zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis 10 years ago. Dermatopathology demonstrated papillary and mid-dermal lymphocytic infiltrate with admixed neutrophils and foci of lymphocytic vasculitis; findings of varicella zoster virus (VZV) immunohistochemistry were negative; however, findings of polymerase chain reaction from a sampled vesicle were positive for VZV DNA. The patient was initiated on oral valacyclovir 1000 mg 3 times daily; the following day, she was admitted to the hospital for intravenous acyclovir (10 mg/kg, every 8 hours for 5 days). One week after hospital discharge, she had a nearcomplete resolution of her infection with diffuse postinflammatory hyperpigmentation. One week after completing valacyclovir and 4 weeks after her first dose, she received the second vaccine dose without complications. The patient received adulthood VZV vaccination, yet presented with nondermatomal, acutely disseminated VZV (disseminated varicella zoster virus infection; vaccination failure). In the case, valacyclovir between vaccine doses may have been protective against a similar reaction following the second dose. Thus, it is our opinion that disseminated VZV reactivation should not be a contradiction to completing the mRNA-based SARS-CoV-2 vaccine regimens. The outcome of event disseminated varicella zoster virus infection was recovering. The outcome of vaccination failure was unknown.  The causality between both events and zoster vaccine live (ZOSTAVAX) was related.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular, Vaccination failure, Varicella virus test positive, Vasculitis
Clinical narrative: Disseminated varicella zoster virus infection; Vaccination failure; Literature Report: This literature report has been received from authors of a published article, titled as above, regarding a 70 years old female patient.  The patient with a history of giant cell arteritis and resolved SARS-CoV-2 infection 10 months ago presented with a diffuse erythematous vesicular rash. Eighteen days ago, she completed a 20-week low-dose methylprednisolone taper for giant cell arteritis, initiated at 10 mg daily. Eight days prior to presentation, she received the first dose of the mRNA-1273 (Moderna) COVID-19 vaccine; 5 days later, a pruritic skin eruption with associated daily fevers developed in her. The examination demonstrated thin erythematous papules and vesicles over the forehead, trunk, and extremities. No antecedent dermatomal eruption was noted; of note, the patient had received zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis 10 years ago. Dermatopathology demonstrated papillary and mid-dermal lymphocytic infiltrate with admixed neutrophils and foci of lymphocytic vasculitis; findings of varicella zoster virus (VZV) immunohistochemistry were negative; however, findings of polymerase chain reaction from a sampled vesicle were positive for VZV DNA. The patient was initiated on oral valacyclovir 1000 mg 3 times daily; the following day, she was admitted to the hospital for intravenous acyclovir (10 mg/kg, every 8 hours for 5 days). One week after hospital discharge, she had a nearcomplete resolution of her infection with diffuse postinflammatory hyperpigmentation. One week after completing valacyclovir and 4 weeks after her first dose, she received the second vaccine dose without complications. The patient received adulthood VZV vaccination, yet presented with nondermatomal, acutely disseminated VZV (disseminated varicella zoster virus infection; vaccination failure). In the case, valacyclovir between vaccine doses may have been protective against a similar reaction following the second dose. Thus, it is our opinion that disseminated VZV reactivation should not be a contradiction to completing the mRNA-based SARS-CoV-2 vaccine regimens. The outcome of event disseminated varicella zoster virus infection was recovering. The outcome of vaccination failure was unknown.  The causality between both events and zoster vaccine live (ZOSTAVAX) was related.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous report was received from a currently 64-year-old female patient who was a registered nurse referring to herself. Concurrent conditions included type 2 diabetes mellitus, allergic to oral hypoglycemic (sulfa based), allergic to fish and allergic to metformin. Historical drug included metformin. Medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported).  On an unknown date (reported as years ago), the patient experienced pneumonia. The outcome of pneumonia was unknown.  The causality between pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon internal review, pneumonia was determined to be medically significant.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events; Caller is nurse reporting extra dose of PROQUAD administered to 13 year old patient. Patient received doses of PROQUAD on 01JAN2011, 16JUN2014, and 03JUN2022.; Caller is nurse reporting extra dose of PROQUAD administered to 13 year old patient.; This spontaneous report was received from a registered nurse referring to a 13-year-old patient of unknown gender. The patient's historical vaccines included Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (administered twice). Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 03-JUN-2022, the patient was vaccinated with an extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) subcutaneous injection, third dose, lot number: W004694, expiration date: 08-AUG-2023 (dose, route of administration and anatomical location was not reported) for prophylaxis (extra dose administered, product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both shots months before I got this terrible painful thing/suspected vaccination failure; got this terrible painful thing; terrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had both Shingles shots months before patient got this terrible painful thing. The patient had Shingles 13 months ago. The patient still dealing with terrible pain.  Patient stated you did not want it, believe me. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses prior to the age of 6; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (BOOSTRIX).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 07-June-2022 Reporter's comment: The patient received two doses of Tdap - Boostrix (the patient received these doses outside of the country). Patient received both the doses of Boostrix at unknown ages, prior to the age of 6. These doses were administered at a different office. The reporter requested for guidance on how to move forward with immunizations. The reporter was unsure if the patient should receive a third Dtap, as it was required for school entry. The reporter requested data available on if the patient can/should get a third Dtap, if the previous two administrations were Tdap. The reporter consented to follow-up. Additional Supportive Information: As per official schedule 2nd dose of Boostrix should be taken after a gap of 10 years, however the patient received dose earlier than the recommended schedule, which led to drug dose administration interval too short. As patient received suspect vaccine outside this united states country, however the case was processed with the reporters country and follow up requested for more information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022090596:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of allergy in a 44-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included ankylosis, spondylitis, gastroesophageal reflux disease, cystitis interstitial and restless legs. Concurrent medical conditions included epilepsy, rheumatoid arthritis, drug allergy (allergy to Fursemide), drug allergy (allergy to Diltiazem) and drug allergy (allergy to Levofloxacin). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergy, hives and facial swelling. On an unknown date, the outcome of the allergy, hives and facial swelling were unknown. The reporter considered the allergy, hives and facial swelling to be related to Shingles vaccine. Linked case(s) involving the same patient: US2022AMR090272. Additional Information: GSK Receipt Date: 07-Jun-2022. Reporter's Comments: The patient was as allergic to the shingles shot, presented with sever Hives and facial swelling. Additional Supportive Information: This case has been linked to US2022AMR090272, reported by the same reporter, same patient. Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR090272:Same Reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: supected Vaccination failure; Internal shingles no rash but severe pain; severe pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient got both her shingles shots and still got internal shingles. The patient had no rash but severe pain. The vaccination did not work for her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: I felt unwell the next day; General body pain; 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.   The patient's past medical history included shingles (Family History) (Parents and sister).   On 8th June 2022, the patient received the 2nd dose of Shingles vaccine. On 9th June 2022, 1 days after receiving Shingles vaccine, the patient experienced malaise and general body pain. On an unknown date, the outcome of the malaise and general body pain were unknown.   It was unknown if the reporter considered the malaise and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-JUN-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient felt unwell the next day and had general pain in the body and stated it was preferable to acquiring this disease.  The patient stated about shingles as it was very painful and depending on the part of your body that hits, it was more complicated. The patient was happy to have the opportunity to be vaccinated now, since this disease was hereditary and the patient's parents and sister already had it and they suffered a lot, it was very painful.  Additional Supportive Information: Follow up would not be possible as no  contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: 1st dose in 2020 before Covid get the 2nd now; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on 2020 the patient received 1st dose of Shingrix.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 09-June-2022 Reporter's Comments: The patient had 1st dose of Shingrix in 2020 right before Covid.  The patient want to know do need to start it over again and get 2 vaccine within 6 month or just the 2nd vaccine. The patient couldn't get the 2nd shot on time due to Covid. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Even after getting the shot still get shingles; Still get shingles- I am one of those; The nerve pain is ridiculous; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Even after getting the shot, there were a select few that would still get shingles.  The patient was one of those, the physicians did not know why some still get it after the shot, but the patient would not wish this on my worst enemy. The nerve pain was ridiculous. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Ended up with a bruise the size of a half dollar/Had a bruise for 6 weeks, but survived.; This case was reported by a consumer via interactive digital media and described the occurrence of contusion 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, less than 6 months after receiving Shingles vaccine, the patient experienced contusion. On an unknown date, the outcome of the contusion was recovered/resolved.   It was unknown if the reporter considered the contusion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles vaccine shot and ended up with a bruise the size of a half dollar. The patient had bruise for 6 weeks but survived. The patient was worried about the second shot. The reporter stated that, it was two shots 2-6 months apart and he/she was due for 2nd one in next month. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got them twice once after had the shot/ suspected vaccination failure; got them twice once after had the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 08-JUN-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient was the reporter's husband. The patient got them twice once after he had the shot. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available. Note: narraative is not clear if the patient experienced shingles twice after vaccination or only once after vaccination and 1 episode before vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient got her 1st dose on 2019 and is just now requesting her second vaccine; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-JUN-2022 Reporter's comment:The case was received from the other healthcare professional via interactive digital media. The reporter enquired that he/she had a patient who got her first Shingrix vaccine in 2019 and was just now requesting her second vaccine.  The reporter asked did patient need to restart the series or just get her second shot. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 35 who is not  immunocompromised but doctors allowed to get it; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: The Shingrix had been approved for those who were immunocompromised less than 50. The reporter asked if someone who had shingles and was 35 and they did not qualify if this information was correct. They were not immunocompromised, but their doctors told them they were allowed to get it. The reporter consented to follow up. Additional supportive information: The patient of 35-year age to whom doctor told them they were allowed to get Shingrix, which led to inappropriate age at vaccine administration.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose of Engerix-B.; adult patient received a pediatric dose of Engerix-B.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old male patient who received HBV (Engerix B) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Engerix B. On 6th April 2022, unknown after receiving Engerix B, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: Medical Assistant reported that the adult patient received a pediatric dose of Engerix-B. The reporter consented to follow up. Additional Supportive Information: The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: The vaccines were exposed to a lowest temperature of -55°C for 4 minutes/administering these vaccines to patients.; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B and Boostrix. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B and Boostrix, the patient experienced product storage error. On an unknown date, the outcome of the product storage error 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: 8-JUN-2022 Reporter's Comment: The case was reported for group of people. The vaccines Boostrix, Engerix B, Havrix, Infanrix and Kinrix were exposed to lowest temperature of minus 55 degree C for 4 minutes due to equipment malfunction. The temperature went back in range and the vaccines were not frozen and were viable. These vaccines were administered to patient's and would be continued to administer as this was only a program issue. The reporter consented to follow up.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administered to a 9 month old.; Patient did not need the Hep B but needed the IPV component.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comment: This case was reported by the certified medical assistant (CMA). Kinrix was administered to a 9 month old patient. She stated that all they had in stock was the DTap-IPV-Hep B and the Dtap, but the patient did not need the Hep B but needed the IPV component.  Additional Suportive Information: The patient received Kinrix at 9 months age and did not need Hep B component, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inappropriate schedule of product administration, Incomplete course of vaccination, Pain in extremity, Peripheral swelling
Clinical narrative: first dose in October 2019, has not received second; swelling in arm; redness in arm; itchiness in arm; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, itchy upper limbs, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, erythema of extremities, itchy upper limbs and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, itchy upper limbs and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into the left arm and experienced swelling, redness, itchiness and pain in her left arm within 24 hours of receiving her first dose. The patient reported that the above symptoms were resolved after one month. The patient also stated that she had not received her second dose but planed on getting it soon (Inappropriate schedule of vaccine). The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: first dose in October 2019, has not received second; swelling in arm; redness in arm; itchiness in arm; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, itchy upper limbs, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, erythema of extremities, itchy upper limbs and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, itchy upper limbs and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 8-JUN-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into the left arm and experienced swelling, redness, itchiness and pain in her left arm within 24 hours of receiving her first dose. The patient reported that the above symptoms were resolved after one month. The patient also stated that she had not received her second dose but planed on getting it soon (Inappropriate schedule of vaccine). The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-b expired administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HBV (Engerix B) (batch number 5NY2K, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022 16:30, the patient received Engerix B. On 8th June 2022, the patient started Engerix B Pre-Filled Syringe Device. On 8th June 2022 16:30, unknown after receiving Engerix B and Engerix B 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: 08-JUN-2022 Reporter's Comment: The reporter reported that, the patient was administered with expired dose of Engerix-B. No reactions were reported. The reporter consented to follow up by email. Additional Supportive Information: The patient was administered with expired dose of Engerix-B, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a other health professional via call center representative and described the occurrence of expired drug used in a 17-month-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired drug used. On an unknown date, the outcome of the expired drug 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: 09-JUN-2022 Reporter's Comment: The reporter was office manager. The reporter reported that, they inadvertently administered an expired Infanrix to a patient. The reporter called to inquire to know about how to proceed. The reporter did not consent to follow-up. Additional Supportive Information: The patient was inadvertently administered with an expired dose of Infanrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of the vaccine in August 2020, the second dose in May 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (Received 1st dose of shingrix in August 2020).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, unknown after receiving Shingrix, 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 - 09th June 2022 Reporters comment: The reporter did not consent for follow-up. Additional Supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.