chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Immunisation reaction, Pain, Pruritus, Swelling
Clinical narrative: PT SATES SHE EXPERIENCED COVID ARM AFTER BIVALENT BOOSTER. STATES SORENESS, SWELLING, ITCHING, AND PAIN. USED APAP AND BENADRYL TO TREAT. STILL EXPERIENCING MINOR SYMPTOMS
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: Headache which did not respond to analgesics and which lasted for almost a week.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood glucose increased, Headache, Hyperhidrosis, Influenza
Clinical narrative: Patient has cold and flu symptoms for 2-3 days after the vaccination, but 5 days after he still experiencing body ache, joint pain, headache, excessive sweating.  His blood glucose is >360 on day 5.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Patient has cold and flu symptoms for 2-3 days after the vaccination, but 5 days after he still experiencing body ache, joint pain, headache, excessive sweating.  His blood glucose is >360 on day 5.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, sore arm, body aches
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity, Pyrexia
Clinical narrative: 1. Fever for approx 16 hours 2. Sore arm for over 48 hours 3. redness, pain, injection site (still present 60 hours post injection) 4. Itching at injection site- started at 48 hours post injection
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13
Symptoms: Injection site erythema
Clinical narrative: don't know if it was a true reaction patient turned red at injection spots could be from when held down
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax abnormal, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Heart rate increased, Migraine, Pain, Pneumonia, Pruritus
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Anxiety, Body temperature fluctuation, Computerised tomogram thorax, Dizziness, Dyspnoea
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Early satiety, Electrocardiogram, Fatigue, Myalgia, Rash pruritic
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Tachycardia, Vision blurred, Vomiting
Clinical narrative: pt reported lightheadedness, fatigue, mild anxiety, early satiety, tachycardia, SOB, mild blurred vision, myalgias, vomiting, fluctuating temperatures, and itchy rash starting within 1 day of receiving covid booster
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MODERNA BIVALENT WAS APPROVED FOR PT<18 YEARS OLD AT TIME OF ADMIN; pt <18yo; no adverse effects noted or experienced per mom
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MODERNA BIVALENT WAS APPROVED FOR PT<18 YEARS OLD AT TIME OF ADMIN; pt <18yo; no adverse effects noted or experienced per mom
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: No adverse event; Patients received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication details was reported. It was reported that patient had 0.5 ml of a regular Moderna booster. No treatment medication details was reported.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patients received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication details was reported. It was reported that patient had 0.5 ml of a regular Moderna booster. No treatment medication details was reported.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient presented to office to recieve booster dose of Moderna Red cap. was not noticed until days after being given that the vaccine lot was expired
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19. Symptoms included stuffy nose, cough, muscle aches, metallic taste in mouth, fatigue.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dysgeusia, Fatigue, Myalgia
Clinical narrative: Positive for COVID-19. Symptoms included stuffy nose, cough, muscle aches, metallic taste in mouth, fatigue.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID-19. Symptoms included stuffy nose, cough, muscle aches, metallic taste in mouth, fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash
Clinical narrative: Day after the vaccination I felt tired and achy. Day 2 I developed a rash on my chest area that itched and burned. I called the Doctor who called me in a steroid and Pepcid.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Burning sensation, Fatigue, Pain, Rash, Rash pruritic
Clinical narrative: Day after the vaccination I felt tired and achy. Day 2 I developed a rash on my chest area that itched and burned. I called the Doctor who called me in a steroid and Pepcid.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Overdose
Clinical narrative: No additional AE reported.; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; concomitant administration of PROQUAD and VARIVAX to a patient on 7/28/2022; This spontaneous report was received from a nurse and referred to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUL-2022, the patient was administered concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot #U028164, expiration date: 09-SEP-2023; dose, strength and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (lot #U028178, expiration date: 08-MAR-2023; dose, strength and route were unknown) for prophylaxis (Overdose; Inappropriate schedule of product administration). No additional AE reported. No product quality compliant (PQC) reported.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: I have had 4 Shingrix shots yet I still get Shingles. Why?/Suspected vaccination failure; I have had 4 Shingrix shots yet I still get Shingles. Why?; I have had 4 Shingrix shots yet I still get Shingles. Why?; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingrix, the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had 4 Shingrix shots yet and he/she still got Shingles. The patient asked why. Additional supportive information: The patient had 4 Shingrix shots, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccine gave recurring shingles/ had recurring shingles ever since got the vaccine/ Suspected vaccination failure; Had recurring 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.   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: 02-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that the vaccine gave him/her recurring shingles ever since he/she had got the Shingles vaccine. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles twice, Got the two shots/Suspected vaccination failure; shingles twice; 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.   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: 02-OCT-2022 Reporter's Comments: The case was reported by the patient via interactive digital media. The patient got the two shots. The patient had shingles twice.  The patient said please get them. Much better than the alternative. Additional Supportive Information: This case was considered as suspected vaccination failure as time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had shots, still get them / suspected vaccination failure; had shots, still get them; hurt; 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: 02-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media.  The patient get them, but not like these folks. The patient reported that as he/she got older he/she would. The patient had his/her shots, but patient still got them and hurt no lie. 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: Herpes zoster, Vaccination failure
Clinical narrative: got the shot, still had 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.   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: 02-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingles shot and still had shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immediate post-injection reaction, Intensive care, Mechanical ventilation
Clinical narrative: Guillain-Barre Syndrome, in intensive care on a ventilator for a month; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got Guillain-Barre Syndrome shortly after a shingles vaccine. The patient was in intensive care on a ventilator for a month and in rehab for another 2 months and stated was one of the lucky ones. Still suffering effects after 5 years. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: suffered vision loss post vaccine/lost 50 percent of my vision; This case was reported by a consumer via interactive digital media and described the occurrence of loss of vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was unknown.   The reporter considered the loss of vision to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 02-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine and within 24 hours the patient lost 50 percent of her vision. The patient suffered vision loss post vaccine. The reporter reported that she remembered her friends had shingles, the pain and suffering they went through it was sounded unbearable the patient never wanted to experience that kind of pain, which made her want to learn more about this painful, blistering rash.  The patient educated herself about the risk for developing shingles especially for people 50 years or older, and what she could for prevention. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I took the shingles injection and it caused me shingles; shingles on the injection sight, below my elbow. It was bad.; 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.   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: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the shingles injection and it caused the patient to had shingles on the injection sight down elbow. The patient stated that it was so bad. The reporter denied to follow-up. 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.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took both of her shots and has shingles/suspected vaccination failure; horrible/bad case of shingles; 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, several weeks 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: 3-Oct-2022 Reporter's comment: The case was received from the patient's cousin via interactive digital media. The patient who was working in a hospital took her both shingles shots and still had a horrible case of shingles in a couple of weeks of her vaccines, that were supposed to prevent or make shingles milder did neither. The reporter asked that what's up with that. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shingle shot, got a small patch (shingles patch)/Suspected vaccination failure; Got a small patch (shingles patch) on my left shoulder; Painful; 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.   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: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingle shot and got a small patch (Shingles patch) on her left shoulder, was so painful. The patient mentioned that she could not imagine someone with more on them. The reporter denied to follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient broke out with shingles right after his/her 2nd shot. Terrible. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose two weeks after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 28-SEP-2022 Reporter's Comment: The patient received 2nd dose of Shingrix in 2 weeks after receiving the 1st dose. The patient made an appointment at the same place and got the second dose. The patient was told that, he/she should have waited at least a month. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt like a bigger; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's dad had Shingles 3 years).   In September 2022, the patient received the 2nd dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient's dad encouraged him/her to get the Shingles vaccine. The patient received dose of Shingles vaccine this week and it hurt like a bigger to the patient, but he/she certainly did not want shingles. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: I am sick today; it wiped me out; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (1st dose received on an unknown date, refer case US2022AMR140180).   On 27th September 2022, the patient received the 2nd dose of Shingles vaccine. On 28th September 2022, 1 days after receiving Shingles vaccine, the patient experienced sickness and malaise. On an unknown date, the outcome of the sickness and malaise were unknown.   It was unknown if the reporter considered the sickness and malaise to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR140180   Additional Information: GSK receipt date: 28-SEP-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated that he/she received the second dose of vaccine and experienced sickness and it wiped out both the times. Additional supportive information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR140180:Same reporter  1st  dose
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Pain, Skin lesion
Clinical narrative: mild shingles; lesion(s) on torso; pain in area; 1st dose on 11/12/18, 2nd dose on 6/24/19.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th November 2018).   On 24th June 2019, the patient received the 2nd dose of Shingrix. On 24th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles, skin lesion and pain. On an unknown date, the outcome of the shingles, skin lesion, pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles, skin lesion and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The patient received both the doses of Shingrix. The patient presented with mild shingles, lesion(s) on torso, pain in area on 27th Sep-2022. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: resident by mixing the lypophilized powder with sterile water for injection versus the diluent vial provided.; lypophilized powder mixed with sterile water was administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the first dose was given correctly on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.     Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter was a consultant pharmacist and had reported that Shingrix was administered to a resident patient of the nursing building by mixing the lyophilized powder with sterile water for injection versus the diluent vial provided. Note that the first dose was given correctly but the second dose was given as stated above. Reporter had inquired to ensure that the dose was properly absorbed when the incorrect diluent was used. The reporter had doubted if there were any studies or any definitive answer, but he/she had attempted to provide guidance to the nursing staff so that they can administer an additional vaccine (and at the right time/schedule) if a third dose would be required. The follow-up was not possible as per the process convention. Additional supportive information: The Shingrix dose was administered to a patient by mixing the lyophilized powder with sterile water for injection versus the diluent vial provided which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: Coughing; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced cough. On an unknown date, the outcome of the cough was unknown.   It was unknown if the reporter considered the cough to be related to Flu vaccine.     Additional Information: GSK receipt date: 29-Sep-2022 Reporter's comment: This case was reported via interactive digital media. Reporter reported that the patient had coughing. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 63-year-old 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The case was self-reported by the patient. The patient had allergic reaction to Shingles Vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got both doses went ahead and gave the second; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 28-SEP-2022 Reporter's Comments: The patient got a Shingrix shot and then thought he/she should get the second dose in two weeks.  The patient made an appointment at the same for the second dose and got it. The patient told I should had waited at least a month. The reporter understand that patient got second dose within 2 weeks of first dose. In the clinical trials, the 2nd dose was spaced out from the first by either 2 or 6 months. The reporter recommends that to speak with his/her healthcare provider to see how to proceed since second dose was early. The patient was kind of upset because the he/she got both doses went ahead and gave the second dose too early.  The patient had to pay per dose. Additional supportive information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient wanted to know how long the pain at the injection site from Shingrix vaccine continue. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 13 months ago, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose 13 months ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was wondering if he/she waited 13 months between doses if it was ok to just give the second dose. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Cough, Headache, Insomnia
Clinical narrative: can't sleep; keep coughing; joints in fingers hurt; headache; This case was reported by a consumer via interactive digital media and described the occurrence of insomnia in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On 28th September 2022, the patient received Flu vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Flu vaccine, the patient experienced insomnia, cough, joint pain and headache. On an unknown date, the outcome of the insomnia, cough, joint pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the insomnia, cough, joint pain and headache to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's comment: The patient self-reported this case via media. The patient got the flu and COVID booster yesterday (day before reporting) and he/she cannot sleep because he/she was keep coughing and his/her joints in his/her fingers hurt and he/she had a headache. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Boostrix below temperature excursion, which led to incorrect storage of drug. This is  1 of 20 linked cases reported by same reporter for different patients.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Shingrix below temperature excursion, which led to incorrect storage of drug. This is 1 of 20 linked cases reported by same reporter for different patients.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: went back to ER twice. Arm with Shingles; numbness n hand; pain n hand; I've lost 50 % use n my hand; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles, numbness in hand, pain in hand and injected limb mobility decreased. On an unknown date, the outcome of the shingles and injected limb mobility decreased were unknown and the outcome of the numbness in hand and pain in hand were not recovered/not resolved.   It was unknown if the reporter considered the shingles, numbness in hand, pain in hand and injected limb mobility decreased to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took shingles shot and went back to emergency department twice with her arm end up with shingles two weeks later. The patient had numbness and pain in hand now and had lost 50 percent use and her hand this all on the one side, where took shot in. The reporter denied to follow-up.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: needle gave resistance and only half dose was administered; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 13-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number ZC77G, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 28-Sep-2022 Reporter's comment: The pharmacist called to enquiry that should the dose be repeated.  The registered pharmacist reported the safety feature of the needle which gave resistance and only half Fluarix dose was administered to a 13 year old patient on 27th September 2022.  The registered pharmacist stated that it was not the Prefilled Syringe just the needle that screws on.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Incomplete course of vaccination, Nausea
Clinical narrative: Nausea; Upset stomach; Stomach Cramps; 1st dose years ago, not received his 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of nausea in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nausea, upset stomach, stomach cramps and incomplete course of vaccination. On an unknown date, the outcome of the nausea, upset stomach and stomach cramps were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the nausea, upset stomach and stomach cramps to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments:  The reporter states that he received his first dose of Shingrix about 2 years prior to the reporting and had not yet received his second dose. The reporter stated after the first dose, the patient experienced stomach cramps, upset stomach, and nausea which lasted many days. The reporter give consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.