chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture, Movement disorder, Sensory loss
Clinical narrative: About 2 weeks later I had horrific pain in my back. A few days later I started to lose feeling in my legs and feet. I also was losing balance. I made 5 trips to the ER before they can even diagnosed. I had a spinal tap. I was diagnosed with Guillain-Barre syndrome. After 5 months of treatment and therapy I am treated.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Balance disorder, Guillain-Barre syndrome, Lumbar puncture, Sensory loss
Clinical narrative: About 2 weeks later I had horrific pain in my back. A few days later I started to lose feeling in my legs and feet. I also was losing balance. I made 5 trips to the ER before they can even diagnosed. I had a spinal tap. I was diagnosed with Guillain-Barre syndrome. After 5 months of treatment and therapy I am treated.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Immunisation reaction, Inappropriate schedule of product administration, Papule
Clinical narrative: Patient reported severe abdominal rash that extended to back after each dose of pfizer vaccine. Patient states rash began 24 hours after each vaccine and lasted approximately 10 days. Denies any other symptoms. Did not have a physician at this time and did not seek medical care. Patient states she called Pfizer to ask if she could obtain the new bivalent vaccine and they told her it was her choice. Patient decided to receive bivalent pfizer vaccine on 10/4/2022. I followed up with the patient today (10/5/22) to see if she has a rash again or other symptoms. So far, no rash. She has a doctor now and will follow up if needed.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient reported severe abdominal rash that extended to back after each dose of pfizer vaccine. Patient states rash began 24 hours after each vaccine and lasted approximately 10 days. Denies any other symptoms. Did not have a physician at this time and did not seek medical care. Patient states she called Pfizer to ask if she could obtain the new bivalent vaccine and they told her it was her choice. Patient decided to receive bivalent pfizer vaccine on 10/4/2022. I followed up with the patient today (10/5/22) to see if she has a rash again or other symptoms. So far, no rash. She has a doctor now and will follow up if needed.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient reported severe abdominal rash that extended to back after each dose of pfizer vaccine. Patient states rash began 24 hours after each vaccine and lasted approximately 10 days. Denies any other symptoms. Did not have a physician at this time and did not seek medical care. Patient states she called Pfizer to ask if she could obtain the new bivalent vaccine and they told her it was her choice. Patient decided to receive bivalent pfizer vaccine on 10/4/2022. I followed up with the patient today (10/5/22) to see if she has a rash again or other symptoms. So far, no rash. She has a doctor now and will follow up if needed.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Anaphylactic reaction, Hypersensitivity, Oropharyngeal discomfort, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Slight discomfort in side of neck-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reported having slightly strange feeling at the tip of his tongue and mild discomfort in the side of his neck approx 15 mins after vaccination but no difficulty breathing or other symptoms. Gave him water and asked for him to wait a little longer. Patient then reported that he felt better and RPh determined that epinephrine was not necessary. Patient insisted he was fine and left. Next day pt reported going to the ER due to arm numbness on the drive home.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Eye swelling, Hypoaesthesia, Mouth swelling, Musculoskeletal discomfort, Paraesthesia oral
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Slight discomfort in side of neck-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reported having slightly strange feeling at the tip of his tongue and mild discomfort in the side of his neck approx 15 mins after vaccination but no difficulty breathing or other symptoms. Gave him water and asked for him to wait a little longer. Patient then reported that he felt better and RPh determined that epinephrine was not necessary. Patient insisted he was fine and left. Next day pt reported going to the ER due to arm numbness on the drive home.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Slight discomfort in side of neck-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient reported having slightly strange feeling at the tip of his tongue and mild discomfort in the side of his neck approx 15 mins after vaccination but no difficulty breathing or other symptoms. Gave him water and asked for him to wait a little longer. Patient then reported that he felt better and RPh determined that epinephrine was not necessary. Patient insisted he was fine and left. Next day pt reported going to the ER due to arm numbness on the drive home.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chills, Dermatitis allergic, Fatigue, Headache, Pruritus
Clinical narrative: patient reported that her left arm , chest and back was full of red rash ( as seen per photo ) . she came to the pharmacy  on 10/03/2022 and reported the incident and showed me the pictures she took. she said tht he skin was full of welts, pustules and burning / itching.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: patient reported that her left arm , chest and back was full of red rash ( as seen per photo ) . she came to the pharmacy  on 10/03/2022 and reported the incident and showed me the pictures she took. she said tht he skin was full of welts, pustules and burning / itching.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Burning sensation, Pruritus, Pustule, Rash, Rash erythematous
Clinical narrative: patient reported that her left arm , chest and back was full of red rash ( as seen per photo ) . she came to the pharmacy  on 10/03/2022 and reported the incident and showed me the pictures she took. she said tht he skin was full of welts, pustules and burning / itching.
Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Urticaria
Clinical narrative: patient reported that her left arm , chest and back was full of red rash ( as seen per photo ) . she came to the pharmacy  on 10/03/2022 and reported the incident and showed me the pictures she took. she said tht he skin was full of welts, pustules and burning / itching.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21JUN2022, vaccine administered on 19Sep2022).    No concomitant medication information was provided. The vial size was reported as 2.5 ml. It was reported that Lot AS1414B was moved from the freezer to the refrigerator on 21-Jun-2022. It was reported that the vial did not undergo temperature excursions. None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654164, US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654167, US-MODERNATX, INC.-MOD-2022-654171 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654164:Patient 3 (same reporter) US-MODERNATX, INC.-MOD-2022-654159:Patient 2 (same reporter) US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654167:Patient 5 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6 (same reporter)
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; Medical assistant reported that an expired PROQUAD was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status: rHA (recombinant Human albumin) 1 dose, lot #u006312, expiration date: 24-AUG-2022 for prophylaxis (dose, route of administration and anatomical location were not provided) with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (expired product administered). No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; a dose of VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a "other" reporter described as "HBP" and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W002601, expiration date 24-JAN-2024 (dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was improperly stored for 30 minutes at a temperature of 5.7 Fahrenheit (F) degrees. The vaccine was also previously improperly stored at a temperature of 6 F degrees up to 14 F for 1 hour 6 minutes and at a temperature of 6 F degrees up to 14 F for 1 hour 8 minutes. No adverse events reported.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error, Underdose
Clinical narrative: No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product wadministering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing; This spontaneous report was received from the registered nurse and refers to a patient of unknown age, and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 31-AUG-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W002453, expiration date: 24-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  The suspect vaccine was diluted with 0.5ml of normal saline, and then the nurse after drawing up 0.5 ml, administered it to patient (product preparation error, accidental underdose). No additional adverse event information was provided.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008037:
Sex: U
Vaccine: HEP, HPV9
Symptoms: Fatigue
Clinical narrative: The patient had chronic fatigue; This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown gender, around 40 years of age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On an unknown date, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (product quantity, lot #, expiration date and route were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic fatigue.    At the time of the report, the outcome of chronic fatigue and the relationship between chronic fatigue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and hepatitis b vaccine (recombinant)(manufacturer unknown)  were not reported.    This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008265:
Sex: U
Vaccine: HEP, HPV9
Symptoms: Fatigue
Clinical narrative: The patient had chronic fatigue; This spontaneous report was received from a pharmacist via company representative and refers to a patient of unknown gender around 40 years of age. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On an unknown date, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) (product quantity, lot #, expiration date and route were not reported) for prophylaxis.   On an unknown date, the patient experienced chronic fatigue.    At the time of the report, the outcome of  chronic fatigue and the relationship between chronic fatigue and of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown)  were not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008263:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; product expired on 9/13/2022 and was administered; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 23-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U002528, expiration date: 13-SEP-2022, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (expired product administered). Customer confirms the product was stored appropriately and did not have any temperature excursions prior to administration. No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; 45 year old patient received a dose of PROQUAD; This spontaneous report as received from a nurse prescriber refers to a 45-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 mL, once (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (LLT: Inappropriate age at vaccine administration). No adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered, Incorrect route of product administration
Clinical narrative: did not have immunity; did not have immunity; Intramuscular; she originally received the series in 1995/She got a booster after that; This spontaneous report was received from the 31-year-old female patient, who refers to herself. The patient's medical history was not reported. The patient's concurrent conditions included drug reactions/ allergies to cefaclor (CECLOR). Historical drugs, and concomitant therapies were not provided.  On an unknown date in 1995, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered intramuscularly (incorrect route of product administration)(strength, lot #, expiry date, and indication were not provided).  However, in 2009, she received a titer test for work and was told that she did not have immunity (antibody test negative). She got a booster (extra dose administered) after that. However, she took another titer test in 2016, and which showed again, that she did not have immunity (antibody test negative). It is unknown, when she received her booster. No further information was provided. No additional adverse event reported.  The reporter considered antibody tests negative to be related to varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a state vaccine coordinator who reports a vaccines were administered following a temperature excursion; This spontaneous report has been received from a vaccine coordinator, concerning a 9-week-old (reported as 2-month-old) patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not provided.  On an unknown date, a temperature excursion occurred for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) in which a maximum temperature of 8.6 degrees Celsius were registered for a time frame of 18 minutes. Other previous temperature excursions was reported with maximum temperature of 11.5 degrees Celsius for 1 hour and 6 minutes, another with 8.8 degrees Celsius for 21 minutes and one with 9.6 degrees Celsius for 6 hours and 41 minutes.  On 27-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (lot # W004501, expiration date 20-APR-2023) (dose was not provided) for prophylaxis (product storage error), no other events were reported (no adverse event).  This is one of nine reports from the same reporter.; Sender's Comments:  US-009507513-2209USA010872: US-009507513-2209USA010921: US-009507513-2209USA010908:
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: The patient received his second dose of GARDASIL 9 and when he sat down next to his mom, he had convulsion.; This spontaneous report was received from a office manager via company representative regarding a 17-year-old male patient. The patient's medical history, drug reactions/allergies, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. Lot number U0368662 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and was reported with an expiration date: 10-AUG-2024. On the same day (reported as "when he sat down next to his mom"), the patient had a convulsion. When the nurses came to see him, he was already recovered. It was unknown whether the patient received treatment for the adverse event. He sought medical attention, he saw the physician.  The causal relationship between convulsion and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event of convulsion was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 09-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot #U028178, expiration date: 08-MAR-2023 (strength and route of administration were not provided) for prophylaxis (Product storage error).  On an unknown date, before the administration, the vaccine underwent temperature excursion at -12.5 Celsius degrees (C) for 1 hour. No previous temperature excursions were reported. No adverse event were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine. No additional AEs were reported,; a patient received improperly stored vaccine.; This spontaneous report was received from a physician and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, lot number U028178, expiration date: 08-MAR-2023, administered for prophylaxis (dose, strength, and route of administration were not provided). Before the administration, the vaccine was improperly stored (temperature: -12.5 Celsius degrees, time frame: 1 hour, no previous temperature excursion) (product storage error). No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Vaccination site rash
Clinical narrative: rash at the injection site; headache; feeling tired; This spontaneous report was received from nurse practitioner and refers to a 55-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 15-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #W005206, expiration date: 14-FEB-2024 (strength and route of administration were not provided) for immunisation.  On 29-SEP-2022, the patient experienced headache and feeling tired (Headache, Fatigue). The outcome of these events was unknown. On 30-SEP-2022, also reported as 15 days post vaccination, the patient experienced rash at the injection site (Vaccination site rash). The outcome of this event was reported as not recovered. Action taken was not applicable.  The causal relationship between feeling tired and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between headache and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between rash at the injection site and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (u024221   8/4/2023) Temperature: -12.5C Time frame:; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # u024221, expiration date 04-AUG-2023 (dose, route of administration and anatomical location were not reported). Administered vaccine was improperly stored in temperature of -12.5 degrees Celsius (product storage error, temperature too high) for 1 hour. There were no previous temperature excursion reported. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported.; The physician reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies or reactions and concomitant medications was not provided.  On 14-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number u024221 had been verified to be a valid number; expiration date 04-AUG-2023, and upon internal validation established as the same date, as prophylaxis (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) following a temperature excursion of minus 12.5 degrees Celsius (C), during a time frame of 1 hour, it was stated that no previous temperature excursion occurred. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Erythema, Herpes zoster, Paraesthesia
Clinical narrative: Goes to prove the vaccine is not 100%, still get/Suspected vaccination failure; Still get (shingles); Pain in back; Pain under arm; Rash/rash had gotten smaller; It feels more like Bee sting every once and while; Sometimes my back feels like sandpaper rubbing back and forth on it; Redness; 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, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation. On an unknown date, the outcome of the vaccination failure, shingles, tingling sensation and abnormal physical sensation were unknown and the outcome of the back pain, axillary pain and rash were recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient did not had itching. The patient had pain in back and under his/her arm. It was not as intense as it was when it started.  The patient felt more like bee sting every once and while.  Sometimes his/her back felt liked sandpaper rubbing back and forth on it.  After almost two months the redness was gone and the rash had gotten smaller.  The reporter went to prove the vaccine was not 100% effective and still got shingles. 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. This case has been linked with case US2022AMR139439 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139439:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Sensory disturbance, Vaccination failure
Clinical narrative: Goes to prove the vaccine is not 100%, still get/Suspected vaccination failure; Still get (shingles); Pain in back; Pain under arm; Rash/rash had gotten smaller; It feels more like Bee sting every once and while; Sometimes my back feels like sandpaper rubbing back and forth on it; Redness; 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, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation. On an unknown date, the outcome of the vaccination failure, shingles, tingling sensation and abnormal physical sensation were unknown and the outcome of the back pain, axillary pain and rash were recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient did not had itching. The patient had pain in back and under his/her arm. It was not as intense as it was when it started.  The patient felt more like bee sting every once and while.  Sometimes his/her back felt liked sandpaper rubbing back and forth on it.  After almost two months the redness was gone and the rash had gotten smaller.  The reporter went to prove the vaccine was not 100% effective and still got shingles. 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. This case has been linked with case US2022AMR139439 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139439:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Goes to prove the vaccine is not 100% [...] still get/Suspected vaccination failure; Some people still get (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients 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: 28-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that this gone to prove the vaccine was not 100 percent some people still get Shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2022AMR139418 reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR139418:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shots, the two new, still got shingles/Suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date).   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) 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she had 3 shots the old and then the two new and still got shingles. The patient also stated that it erupted in April (unspecified year) and he/she was still dealing with them in September (unspecified year). Not fun. Additional supportive information: This case was considered as suspected vaccination failure as details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both vaccines, got shingles again/ Suspected vaccination failure; Got shingles again; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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) 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had shingles, then patient got both the Shingles vaccines and got shingles again. 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: Herpes zoster, Pain, Vaccination failure
Clinical narrative: You can still get it, but much smaller chance . I did/Suspected vaccination failure; You can still get it, I did; Horrible pain; 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 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.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that after received Shingles vaccine you could still get the shingles but much smaller chance. The patient did and shingles was horrible pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary 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: Herpes zoster, Vaccination failure
Clinical narrative: Did (the vaccine) and now have had shingles for 2 months/Suspected vaccination failure; Have had shingles for 2 months; 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that do not get the vaccine. The reporter reported that the patient received Shingles vaccine and now patient have had Shingles for 2 months. 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, VARZOS
Symptoms: Herpes zoster, Insomnia, Pain, Vaccination failure
Clinical narrative: I am still in sirver pain; Can´'t sleep a night; I got the shingles april 30 2022. /suspected vaccination failure; I got the shingles april 30 2022.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 81-year-old 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 30th April 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and sleeplessness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and sleeplessness to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-SEP-2022 Reporter's comment: This case was reported via interactive digital media. The patient had got 1 shot and in a couple of days he/she got the 2nd one. The patient reported that he/she had got the shingles on 30th April 2022. He/she was still in severe pain. He/she could not sleep at night. Additional supportive information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles was reported at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Nerve injury, Pruritus, Vaccination failure
Clinical narrative: Had shot, had Shingles/Suspected vaccination failure; Shingles around eye, spread to ear, hairline, under jaw, nose, back of head; Itching; Burning; 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, pruritus and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and burning sensation to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, if you have them around or close to your eye, you need to see an eye specialist quickly because along with the nerve damage the damage to the eye could lead to blindness.  He/she had shingles shot several years ago, in June he/she got the shingles around left eye and was referred to an eye specialist and they did not get in his/her eye, they did spread to his/her left ear.  Two months later in August he/she started with the itching and burning again in left eye brow. This time they spread from the eye up to hairline and down to under jaw, from the complete left half of nose to about two inches on the back of head behind the left ear.  The patient was again referred to the eye specialist and they did not get into eye.  The doctor told him/her that in all his years of practicing medicine he had only seen about 15 patients got the shingles who had received the vaccination and that he had never seen a vaccinated person got them twice.  Both of his/her cases of shingles were mild cases since he/she had been vaccinated. Those mild cases were not anything he/she want to go through again, but he/she was fortunate that they were mild. All he/she could tell you was, if you have not had your shingles vaccination, please, please go get the vaccine as soon as possible.  By having both of those cases of shingles around his/her eye without the vaccination, there was a very good possibility that he/she could have lost the sight in that eye. 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. The follow up would not possible as no contact details were available. This case has been linked to the US2022AMR140778 case reported by the same reporter. Note: Onset date was not captured as year was not specified.; Sender's Comments:  US-GSK-US2022AMR140778:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: get Shingles, had received the vacillation/Suspected vaccination failure; get Shingles, had received the vacillation; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: 22-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that his/her doctor told him/her that in all his years of practicing medicine he had only saw about 15 patients got the Shingles who had received the vaccination and that he had never saw a vaccinated person got them twice. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with case US2022AMR140140, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140140:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine and had them 4 times after/Suspected vaccination failure; had them 4 times/has had them; 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.   The patient's past medical history included shingles (had shingles 2 times prior to the vaccination).   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 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: 30-Sept-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The patient has had them, a total of 6 times. The patient had the vaccine after the 2nd time and had them 4 times after. 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 unknown at the time of reporting. The follow-up could not be possible as no contact details were available.