chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Central venous catheterisation, Condition aggravated, Death, Decubitus ulcer, Depressed level of consciousness
Clinical narrative: after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think  this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dialysis, Fall, Fatigue, Gait inability, Myocardial necrosis marker increased
Clinical narrative: after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think  this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation immeasurable, Pulse absent, Renal impairment, Transfusion, Urinary retention
Clinical narrative: after first vaccine was given 4/08, patient became very weak, tired and slept almost the entire 3 weeks, when it was time to take the second dose, on 4/29 she drove herself to the hospital, got the shot and went home, that evening she becan to feel very weak and fell down, calling an ambulance for help, the following day, she fell down once again, called 911 and got help getting to her feet, she began to realize her body was too weak to carry herself and when she fell the 3rd time called 911 and asked to go to the hospital. arriving she was immediately give blood transfusions, being told her kidneys had somehow gotten much much worse out of no where and they were no longer producing red blood cells properly, within the first week she was in the hospital, she was given 4 total blood transfusions and was told her heart was not functioning properly, There were elevated enzymes. She was beginning to bloat as her kidneys were not working at all anymore, she was no longer urinating. she was scheduled to have a dialysis port put in and she started dialysis. she was given medication and was sent to a rehab facility for a few weeks where she made no progress at all, she was still weak and unable to walk. due to her inability to walk she was sent home from the rehab, our family had to rally around her to help keep her clean, no bed was sent to us, no commode, we had to find money for all of these things, she quickly got bed sores and we tried all we could do to care for her with little help there was home health coming to see her twice a week, and we repeatedly asked if someone could look into the vaccine doing this to her no one cared to hear our suspicions of the vaccine doing this to our mother, she went to the dialysis clinic 3 times a week all the while paying for her own 800 dollar a week gurney transportation due to her inability to walk, on july 15th she finally got to see her dr, upon taking her vital signs they found no pulse, no blood pressure and no pulse ox but the dr did not seem to think  this was a good reason to go to the hospital. we asked if the vaccine did this to her, the dr laughed it off, she went back home and was very tired, she went to sleep and the next morning when my father tried to wake her up for dialysis, she would not wake, 911 was called and she was once again rushed to the hospital, where her heart stopped within minutes of arriving.we asked the people in the ER if there was anyway we could talk to someone about the vaccine doing this to her. our mother is dead!! we were advised to call the health department, they told us to call the cdc, and i was directed to the compensation fund
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: The vaccine was administered into my upper left arm. At the time of administration I questioned the nurse about the extra pain that was noted during injection. I also noticed that the bandaid was placed rather high, above normal deltoid injection areas. Since the administration, my left arm has had increased pain with movement and decreased strength. My upper arm has pain when lifting above my head and also when rotating it. I have taken ibuprofen to help with the pain but it does not help. I sent a notification to my primary provider and have not heard back yet at this time. I have no history of left arm pain or trauma.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: The vaccine was administered into my upper left arm. At the time of administration I questioned the nurse about the extra pain that was noted during injection. I also noticed that the bandaid was placed rather high, above normal deltoid injection areas. Since the administration, my left arm has had increased pain with movement and decreased strength. My upper arm has pain when lifting above my head and also when rotating it. I have taken ibuprofen to help with the pain but it does not help. I sent a notification to my primary provider and have not heard back yet at this time. I have no history of left arm pain or trauma.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Urine analysis normal
Clinical narrative: Chest pain, intermittent, left-sided
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives- every morning and every night: legs, hips, arms, hands, feet.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chills, Diarrhoea, Dizziness
Clinical narrative: Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed.  I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS  Still having very achy joints all over my body. Diarrhea, sweats/chills
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram, Feeling abnormal, Heart rate increased, Hyperhidrosis, Metamorphopsia
Clinical narrative: Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed.  I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS  Still having very achy joints all over my body. Diarrhea, sweats/chills
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Nausea, Paraesthesia, Syncope, Tremor
Clinical narrative: Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed.  I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS  Still having very achy joints all over my body. Diarrhea, sweats/chills
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed.  I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS  Still having very achy joints all over my body. Diarrhea, sweats/chills
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: About 10-12 days after the second dose of the vaccination I began noticing a persistent foul odor. It is most pronounced when I smell particular food items like coffee and fried food, but it still manifests when there is no food present at all. It has also changed how I perceive my own body odor when I exercise from what I had previously experience to something like a garlic scent.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Limb discomfort, Vaccination site discomfort
Clinical narrative: Heaviness and discomfort left arm. Little bit of pain in the vaccinated area. July 27 2021 he said he was cold and axillary temperature was taken it was 37.66 Panadol was given and cream was applied on vaccinated area for discomfort. Since it is the first reaction and is early morning and is not a complication at the moment he will continue under my observation and then I will call his doctor.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Extreme chest pain (10/10). From shoulder to shoulder, neck to abdomen, front to back. Extreme pain lasted at least one hour.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Patient received dose of improperly stored VARIVAX; no other AE reported; This spontaneous report as received from a nurse referring to a patient of unknown age.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route of administration were not provided, lot # T020650 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-JUN-2022) as prophylaxis.  The vaccine was exposed to a temperature of 35°F, during a time frame of 16 hours which was not called by a data logger. No previous temperature excursions was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE reported; administered on 7/7/2021 that has a labeled expiry of 6/30/2021; 41 years old patient; This spontaneous report was received from a physician and refers to a 41-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), 0.5 milliliter, lot # S020161, expiry date: 30-JUN-2021 (formulation, route of administration, anatomical location were not reported) for prophylaxis. There were no known temperature excursions. No additional adverse events were reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Prophylaxis
Clinical narrative: No additional AE information reported; the patient received her second shot of GARDASIL 9 2 years later on 14-MAY-2021; This spontaneous report was received from a consumer referring to a currently 18-years-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 06-SEP-2019, at the age of 16-years-old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported). The patient's doctor refused to give the patient her second shot 2 months later, because it was during flu season. Then in March she didn't get her second shot because of the pandemic. Therefore the patient received her second shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported) 2 years later on 14-MAY-2021.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; VARIVAX that underwent a temperature excursion was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 12-JUL-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: T033166, expiration date: 29-SEP-2022; dose and route of administration not provided). The vaccine was stored in temperature 60 degrees Fahrenheit for 12 minutes. There was previous temperature excursion in temperatures from -10 to 8 degrees Celsius (-4.5 degrees Celsius) for 2 hours and 20 minutes. Digital data lodger was involved. No adverse event was reported.   This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2107USA004607:
Age: 26.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; dose of VAQTA with a labeled expiry of 7/11/2021 was inadvertently administered to a patient on 7/15/2021; This spontaneous report was received from a certified medical assistant and refers to a 26-year-old patient. of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-JUL-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # T018670 (lot # has ben verified to be valid for vial), expiration date 11-JUL-2021, 1 milliliter (route of administration and injection site were not provided) for prophylaxis. No known temperature excursions have occurred. No additional adverse event was reported.
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Product preparation issue
Clinical narrative: Product preparation error; Wrong technique in product usage process; No additional AE reported.; Information has been received from a medical assistant concerning a 21 month old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2021, the medical assistant added sterile diluent (lot number R033082, expiration date on 14-AUG-2021, dose 0.7 mL) to the hepatitis a vaccine, inactivated (VAQTA) vial (lot number T022333, expiration date on 11-DEC-2021, dose 0.5 mL) prior to administration for prophylaxis. Dose number, route of administration and anatomical location were not reported. She reported that they normally get the prefilled syringes but ordered the vials instead. She was not aware that she was not suppose to add diluent until after the product was administered (wrong technique in product usage process) (product preparation error). No adverse event. No product quality complaint. No additional information was reported.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient experienced no other AE.; administration of a dose of improperly stored VARlVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-JUL-2021 ,the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter one time, lot # T033166, expiration date was reported as 08-MAR-2023, but upon internal verification it was established as 29-SEP-2022 (route of administration and injection site were not reported) for prophylaxis.  The administered dose experienced a temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (6 degrees Fahrenheit) for 15 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.5 degrees Fahrenheit ) for 15 minutes; 14 degrees Fahrenheit to 46 degrees Fahrenheit (15.5 degrees Fahrenheit) for 15 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.5 degrees Fahrenheit ) for 15 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (5.5 degrees Fahrenheit ) for 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse events were reported.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: My son was injected with a 3 days expired MMR Vaccine; This spontaneous report was received from a consumer referring to their son - a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with 3 days expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (albumin status, exact dose, route of administration, injection site, lot # and expiration date were not reported) for prophylaxis. The reporter asked if for any advice if there was a possible negative effect and what should they do to counter the effect.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown gender whose age at vaccination was 68 years old. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On 01-FEB-2016, the pt was administered zoster vaccine live (ZOSTAVAX) by a pharmacist at a drug store (dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a physician at a hospital emergency department for shingles and other zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; Caller is a nurse who reports that a dose of ROT ATEQ was administered following a temperature excursion.; This spontaneous report has been received from  a Licensed Practical Nurse and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 19-JUL-2021, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number T028132, that was verified to be valid with an expiration date reported and established as 22-FEB-2022) (concentration, dose number and vaccination scheme frequency were not provided). It was reported that this vaccine was administered after experienced a temperature excursion of 49.69 degrees Fahrenheit during a time frame of 1 hour with 24 minutes and 0 seconds, which was detected by data logger (product storage error). No previous excursions were reported. No additional adverse events were reported.  This is one of several reports received from  the same reporter.; Sender's Comments:  US-009507513-2107USA006147: US-009507513-2107USA006252: US-009507513-2107USA006361: US-009507513-2107USA006509:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer referring to a currently 71 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at a medical office by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE or PQC was reported; a dose of MMRlI with a labeled expiry of 6/30/2021 was administered to a patient on 7/15/2021; This spontaneous report was received from a clinical manager (also was a medical assistant) referring to a 1 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (strength and route were not reported, lot # S020161, expiration date 30-JUN-2021) 0.5 milliliter for prophylaxis (expired product administered).         Agent utilized "Post Expiry Memo Vaccines and Biologics Administered" to evaluate the administered product and verbally provided supported disclaimer from attached article. No additional information was provided, no additional AE or PQC was reported at time of call.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Prophylaxis, Wrong product administered
Clinical narrative: GARDASIL 9 was inadvertently given to a 2 month old instead of Prevnar 13, the intended vaccine; No other AEs reported; Information has been received from a vaccine coordinator via a field-based employee referring to a 2 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.       On an unknown date, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(1 injection; strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis, instead of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13), the intended vaccine(wrong product administered). No other adverse events(AEs) were reported.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Blood test
Clinical narrative: patient had a blood titer drawn 1 week ago and the titer level came back less than 3.1; The patient received these vaccines on 8/12/1998, 10/16/1998, and 2/26/1999; This spontaneous report was received from a medical assistant and refers to a 23-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-AUG-1998, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (manufacturer unknown) for prevention of hepatitis B (exact dose, vaccination site, route of administration, lot # and expiration date were not provided). On 16-OCT-1998, she was vaccinated with the second dose of hepatitis B vaccine (recombinant) (manufacturer unknown). On 26-FEB-1999, she was vaccinated with the third dose of hepatitis B vaccine (recombinant) (manufacturer unknown).  On approximately 14-JUL-2021 (reported as 1 week ago), the patient had a blood titer drawn and the titer level came back less than 3.1 (units not provided). The reporter said the state health department wanted the patient to be revaccinated with another 3 dose series of hepatitis B vaccine (manufacturer unknown). The patient has not received a booster dose with hepatitis B vaccine (recombinant) (RECOMBIVAX HB), but the reporter said the patient was scheduled to come to the office for hepatitis B vaccine (recombinant) (RECOMBIVAX HB) administration on 22-JUL-2021. The patient sought medical attention. No treatment was given. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccine was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injury, Skin disorder
Clinical narrative: Vaccine injuries; Got the shingles vaxx and within 2 weeks I developed a skin problems that hasn't gotten any better; This case was reported by a consumer and described the occurrence of injury in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced injury and skin disorder. On an unknown date, the outcome of the injury was unknown and the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the injury and skin disorder to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got the shingles vaccine and within 2 weeks developed a skin problems that had not gotten any better. Also stated vaccine injuries.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: do they hurt!! Worst shots I've ever had; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, refer case US2021AMR156322).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/ herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced pain. The reporter stated that the patient might want to check to see if need a booster.  The patient reported that it was worst shot but better than getting shingles and it was a newer vaccine and was supposed to be much more effective than the previous shingles vaccine.  The reporter advised taking Tylenol or something like it before. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156322:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; fever-like aches; fever-like aches; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on an unknown date, refer case US2021AMR156348).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced fatigue, pain and fever. On an unknown date, the outcome of the fatigue, pain and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain and fever to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received the 2nd shot of shingles vaccine this year and experienced fatigue and fever-like aches for 24 hours. The patient was better on the next day and reported that it was so much better than getting shingles. No further information reported. For tolerance of 1st dose refer case US2021AMR156348; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156348:Same reporter,1 dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 2nd one really aches for several days; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient experienced pain after 2nd dose of shingrix vaccine and it was there for several days. No further information was reported. The follow up was not possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure/ I think I did, too / never get another shingles shot. Suffered too long after it / Never a shingles shot for me again; I think I did, too / never get another shingles shot. Suffered too long after it; This case was reported by a consumer via media and described the occurrence of suspected 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 details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that he/she suffered from shingles for long time after vaccination with shingles shot. The patient stated he/she would never get another shingles shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR156120, reported by same reporter for different patient.
Sex: U
Vaccine: VARZOS
Symptoms: Dyskinesia, Pyrexia, Seizure
Clinical narrative: seizure; uncontrollable jerking of my arms and torso; felt a little feverish; This case was reported by a consumer via media and described the occurrence of seizure in a 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 seizure (serious criteria GSK medically significant), jerkiness and fever. On an unknown date, the outcome of the seizure, jerkiness and fever were recovered/resolved.   It was unknown if the reporter considered the seizure, jerkiness and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and felt a little feverish and then had a seizure like system of uncontrollable jerking of arms and torso and lasted about 15 seconds. The reporter asked could that be a reaction to shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles 2 weeks after. I got the shot; 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 Shingles vaccine. On an unknown date, 2 weeks 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 details were provided as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. The patient had received shingles vaccine and 2 weeks after got shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I got sicker with the second shot than the first; This case was reported by a consumer via interactive digital media described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient got sick with the 1st dose of Shingles vaccine. For tolerance to 2nd dose refer case US2021AMR158035. No contact details were provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158035:Same reporter US-GLAXOSMITHKLINE-US2021AMR158052:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I got sicker with the second shot than the first; 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 illness (1st dose received on an unknown date and experienced sick refer case US2021AMR158025).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient got sicker with the 2nd shot than the 1st shots, It was still better than shingles. No contact details were provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158025:Same reporter US-GLAXOSMITHKLINE-US2021AMR158052:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: worse flu I ever had after a flu shot/suspected vaccination failure; worse flu I ever had; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shot and experienced worse flu the patient ever had. The patient still feel like negative reactions are not the norm and staying well was getting tougher.  The patient stated if a pandemic did not get the patient, the weather would. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for Flu and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: between my 1st & 2nd shingles vaccines / I had active shingles; This case was reported by a consumer via call center representative 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 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. There was 18 months elapsed between 1st and 2nd shingles vaccines because the patient had active shingles.  Pharmacist was recommending a 3rd dose but company's literature does not. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient / received the second dose / 1 week after receiving the first dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vacination was not reported. The physician reported that, the patient received dose 2, 1 week after 1st dose of Bexsero, which led to shortening of vaccination schedule. No further details were available as health care professional was hurry. The health care professional was provided with phone number to get in touch with them. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue, Prophylaxis
Clinical narrative: received / first dose on 2018 / never received / second dose due /out of stock.; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose due to out of stock, which led to product supply issue. The patient never received Shingrix second dose. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Twinrix in July 2020 and the second dose in July 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old male patient who received HAB (Twinrix adult) (batch number GG3S5, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received in July 2020, batch number 3Y7NL, expiry date 24th May 2022).   In July 2021, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. In July 2021, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Muscle spasms, Myalgia
Clinical narrative: usual symptoms from the vaccine/ myalgia; leg cramps; received a third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 94-year-old female patient who received Herpes zoster (Shingrix) (batch number 75X82, expiry date 28th January 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 13th May 2021, the patient received the 3rd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced myalgia and leg cramps. On an unknown date, the outcome of the myalgia, leg cramps and extra dose administered were unknown.   It was unknown if the reporter considered the myalgia and leg cramps to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, the patient received 3rd dose of Shingrix,which led to extra dose administered. Less than 3 months after vaccination with 3rd dose of Shingrix, the patient had myalgia, leg cramps. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: administered only the liquid component of Menveo; administered only the liquid component of Menveo; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa419a, expiry date 30th August 2022) for prophylaxis.   On 21st June 2021, the patient received Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The registered pharmacist stated the patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The call center representative did not obtain consent to follow up from the reporter. This case has been linked to US2021151045, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151045:Same reporter