chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 05-MAY-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-MAY-2016, a week after being vaccinated with ZOSTAVAX, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as shingles. On or about 19-MAY-2016, the patient sought subsequent treatment at a clinic for ongoing and worsening episodes of shingles outbreaks. The patient has been prescribed LYRICA, TYLENOL, carbamazepine, gabapentin and lidocaine for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JAN-2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical facility for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 24-JUL-2012, the patient was inoculated with ZOSTAVAX (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a physician office (by an unspecified health care professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 20-JUN-2016, the patient was treated at a medical center (by an unspecified health care professional) for a blistering vesicular outbreak, which was diagnosed as shingles. On or about 30-JUN-2016, the patient sought subsequent treatment at an eye physicians office, for a persistent vesicular rash interfering with her eyes, which was diagnosed as herpes zoster eye disease. On or about 11-JUL-2016, the patient was further treated at the eye physicians office for ongoing and worsening interference of herpes zoster eye disease. The patient has been prescribed acyclovir for management of here painful and persistent condition. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, the events of Herpes zoster eye disease and Further treated for ongoing and worsening interference of herpes zoster eye disease were determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Face oedema, Swelling face
Clinical narrative: PT HAD SWELLING/EDEMA ON THE LEFT SIDE OF HIS FACE WHERE HE PREVIOUSLY HAD SHINGLES (1 YEAR AGO).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nerve compression, Pain
Clinical narrative: I received the Tdap shot and just felt a little soreness for a few days. After 2 weeks, my arm was extremely painful at the site. I took ADVIL, but it didn't help. Then it went away for a few days. Now, 3 weeks later, I'm in extreme pain at my left arm where the shot was given and radiating down my arm to my elbow. It is very painful. After the 2 weeks, I got a pinched nerve, I think, but don't know if it was related to the shot or not. No redness. No swelling. No fever. The pain is about a 6/10.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Chills, Influenza like illness, Myalgia
Clinical narrative: 16 hrs post dose, I had chills, followed by temp of 99.9 at 21 hours. Normal temp for me is 97.8. Some muscle aches & joint aches similar to flu. No treatment at this time (now).
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Decreased appetite, Injection site pain, Irritability, Pyrexia
Clinical narrative: Here today with mom with c/o of right leg pain. Mom states patient was here 5/2/18 and got his 15 month shots. Mom states since the shots patient has been crying when he puts weight on his right leg. Mom states patient has been eating less and fussier. Mom states patient has had fevers off and on from 101-102. Right thigh pain right anterior thigh where he got his PREVNAR, started 4 hrs after the vaccine. No bruise, not hot, moves joints well. Mom said a few days didn't bear wt.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Here today with mom with c/o of right leg pain. Mom states patient was here 5/2/18 and got his 15 month shots. Mom states since the shots patient has been crying when he puts weight on his right leg. Mom states patient has been eating less and fussier. Mom states patient has had fevers off and on from 101-102. Right thigh pain right anterior thigh where he got his PREVNAR, started 4 hrs after the vaccine. No bruise, not hot, moves joints well. Mom said a few days didn't bear wt.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Approximately 5-6 hours after injection, experienced flu-like muscle/body aches, fatigue, slight fever for 36 hours. Some improvement each day (less aches and less fatigue). After 4 days, feeling back to normal, except for a little less energy. Appears I had the reaction as stated in the Vaccine Information Statement, part 4: Reaction Risks.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Neck pain, Paraesthesia, Pharyngeal oedema
Clinical narrative: Headache, Neck pain, tingling in hands and feet, subjective report of "throat swollen".
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Skin warm, Swelling
Clinical narrative: Patient noticed a little swelling the first night after vaccine. The next morning her arm was red,swollen and warm. Patient felt ill that day (day after injection). Patient feels better today, but arm is still red and swollen.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Allergy test negative, Cold sweat, Lethargy, Pallor, Pyrexia
Clinical narrative: Fever, pale in color, clammy, local hives and lethargic.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Fever, pale in color, clammy, local hives and lethargic.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient received the SHINGRIX vaccine on 05/14/18. On 05/16/18, patient called in the morning to report that there was an adverse reaction at the site of injection. Her arm is swollen at the site of injection, it feels heated/warm, there is a rash, and her arm feels sore. She has also experienced chills. Patient has been taking pain medication to help and putting cool compress on the area. She says it is not getting worse, but it hasn't resolved yet. Pharmacy will follow up in a few days to see how patient is doing.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient received the SHINGRIX vaccine on 05/14/18. On 05/16/18, patient called in the morning to report that there was an adverse reaction at the site of injection. Her arm is swollen at the site of injection, it feels heated/warm, there is a rash, and her arm feels sore. She has also experienced chills. Patient has been taking pain medication to help and putting cool compress on the area. She says it is not getting worse, but it hasn't resolved yet. Pharmacy will follow up in a few days to see how patient is doing.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: While shopping after getting my shot, I felt fatigued & experienced severe joint & muscle pain. It got so bad that I had to call out sick the next day. As the week went on, my side effects slowly eased. There also was pain & swelling (the size of a golf ball) at the injection site which faded as the week went on. On Saturday, I absentmindedly scratched the site & it was like scratching open a mosquito bite. I've never had side effects from a shot before.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Intense soreness at injection site, red mark approx. 3" around at injection site, warmness at injection site. Extremely mild itching, but I didn't notice any detectable rash, swelling nor did I ever feel any tightness of breath, wheezing or anything else related to injection. It was at least a week that I experienced these above symptoms.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient got PREVNAR-13 IMZ on 5/7/18. She returned to pharmacy 5/16/18 for a refill on a medication and asked if she should take her follow-up pneumonia shot after the reaction that occurred with this shot. She showed us a picture of her left arm. It was badly swollen from injection site to elbow. Color was bright red with what looked like a bruise at the injection site. She said that her arm had been hot to the touch (it was still hot at injection site on 5/16/18) and that the injection site had been hard...that it felt like it had a core (it still felt like this on 5/16/18). She stated that her body temp had been 101 degrees for about 5 days post injection. She took TYLENOL to keep fever down. She did not mention any swelling of face or problems breathing.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient got PREVNAR-13 IMZ on 5/7/18. She returned to pharmacy 5/16/18 for a refill on a medication and asked if she should take her follow-up pneumonia shot after the reaction that occurred with this shot. She showed us a picture of her left arm. It was badly swollen from injection site to elbow. Color was bright red with what looked like a bruise at the injection site. She said that her arm had been hot to the touch (it was still hot at injection site on 5/16/18) and that the injection site had been hard...that it felt like it had a core (it still felt like this on 5/16/18). She stated that her body temp had been 101 degrees for about 5 days post injection. She took TYLENOL to keep fever down. She did not mention any swelling of face or problems breathing.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Myalgia, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Sore arm, fever, myalgias, worsening of urticaria. 1 day of symptoms.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Fall, Haemorrhage, Joint injury, Lip injury, Loss of consciousness
Clinical narrative: Passed out on sidewalk in parking lot of the clinic about 15 min after vaccine was administered, immediately came to but hit nose and lip causing bleeding and elbow during fall, did not try to catch herself. Went back into clinic, saw a nurse who took name and number, no ice pack or treatment was given, patient stayed for about 10 min before nurse told her she could leave, and patient drove herself home.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Nasal injury
Clinical narrative: Passed out on sidewalk in parking lot of the clinic about 15 min after vaccine was administered, immediately came to but hit nose and lip causing bleeding and elbow during fall, did not try to catch herself. Went back into clinic, saw a nurse who took name and number, no ice pack or treatment was given, patient stayed for about 10 min before nurse told her she could leave, and patient drove herself home.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome where patient is being hospitalized currently.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Morning after vaccination, patient woke up feeling very weak and nauseated for the entire day. One episode of vomiting in the morning. Diarrhea later in the day. By the following day, the patient's symptoms had subsided.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Nausea
Clinical narrative: Morning after vaccination, patient woke up feeling very weak and nauseated for the entire day. No episodes of vomiting. Few episodes of diarrhea in the afternoon. By the following day, the patient's symptoms had subsided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Side effects as follows: nausea- muscle aches- fatigue- shivering- overheated- headache-body aches head to toe including teeth- injection site pain.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Toothache
Clinical narrative: Side effects as follows: nausea- muscle aches- fatigue- shivering- overheated- headache-body aches head to toe including teeth- injection site pain.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Gait disturbance, Malaise, Nausea
Clinical narrative: Pt. came in today and described the adverse event. He received the vaccine on Wednesday, 4-4-18. On Monday, 4-9, he was speaking on the phone with his son that evening when he started feeling ill. After he hung up, he tried to walk to the door and fell in the floor, could not get up due to extreme dizziness, nausea, etc. An ambulance was called and transported him to the hospital where he remained for 2 days. His family physician did not think the vaccine was responsible, but apparently a specialist, after being told of the vaccine administration, said he was sure that that was the cause of the problem, diagnosing it as Vestibular Neuritis. Patient complained of dizziness, vision disturbances and trouble walking. He is still receiving physical therapy and says his vision has not returned to normal.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Vestibular neuronitis, Visual impairment
Clinical narrative: Pt. came in today and described the adverse event. He received the vaccine on Wednesday, 4-4-18. On Monday, 4-9, he was speaking on the phone with his son that evening when he started feeling ill. After he hung up, he tried to walk to the door and fell in the floor, could not get up due to extreme dizziness, nausea, etc. An ambulance was called and transported him to the hospital where he remained for 2 days. His family physician did not think the vaccine was responsible, but apparently a specialist, after being told of the vaccine administration, said he was sure that that was the cause of the problem, diagnosing it as Vestibular Neuritis. Patient complained of dizziness, vision disturbances and trouble walking. He is still receiving physical therapy and says his vision has not returned to normal.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Patient said that all of a certain he got loose diarrhea and kept on going till 5/14/18, which was when he notified us, however, it's resolved yesterday 5/15/18.
Sex: U
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Guillain Barre syndrome after receiving the flu vaccine (manufacturer not confirmed). The call got disconnected before any additional information could be obtained. The contact information for reporter was not obtained before call disconnected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Hypermetabolism
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shivering in a 84-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown). On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering (serious criteria hospitalization), hypermetabolism and dehydration. On an unknown date, the outcome of the shivering, hypermetabolism and dehydration were recovered/resolved. It was unknown if the reporter considered the shivering, hypermetabolism and dehydration to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced uncontrollable shivering after vaccination, she could not stop and was admitted to the hospital for several days. The patient was fine, pharmacist did not know how soon these events occurred after vaccination. The patient's primary physician recommended that the patient should not receive second dose due to the severity of the reaction.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 53-year-old female patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). Concomitant products included prasugrel, Montelukast, CRESTOR, KOMBIGLYZE XR, MYRBETRIQ, TRULICITY, cyclobenzaprine, glipizide, lisinopril and metoprolol succinate. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th May 2018, 1 hr after receiving SHINGRIX, the patient experienced nausea (serious criteria disability) and vomiting (serious criteria disability). On an unknown date, the outcome of the nausea and vomiting were not recovered/not resolved. The reporter considered the nausea and vomiting to be possibly related to SHINGRIX. Additional information was received as follows: The patient visited Healthcare Professional office for a regular visit earlier morning of 11th May 2018, and received SHINGRIX on left deltoid afterwards at 12:30. The patient was not sick at the time of vaccination. The vomiting was severe enough that the patient would stop to vomit while speaking with the pharmacist on the phone.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a elderly male patient who received Influenza vaccine Quadrivalent. Concomitant products included PNEUMOVAX. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 14 days after receiving Influenza vaccine Quadrivalent, 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 unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient received a flu vaccine a few years ago. The patient also received another vaccine, PNEUMOVAX, on the same day with the flu vaccine. The patient developed Guillain Barre Syndrome about 2-3 weeks after receiving the vaccine. The healthcare professional stated that the vaccine was administered at another facility so, the brand of influenza vaccine administered was unknown. The reporter also stated that, the patient reports the hospitalized for a period of 4 days in Intensive care unit during this event. No further information was reported regarding the event.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Discomfort, Herpes zoster, Pain in extremity, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 75-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 2 years before the reporting date, without any adverse event). Concomitant products included pneumococcal vaccine. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In April 2018, the patient experienced itchy rash, discomfort, painful rash, maculopapular rash and shingles. On 12th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the itchy rash, discomfort, painful rash, maculopapular rash and shingles were unchanged. The reporter considered the itchy rash, discomfort, pain in arm, painful rash and maculopapular rash to be related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: On 11th April 2018, the patient received Pneumonia vaccine (name unknown) intramuscularly on the left arm. At 14:00 hours, the patient received SHINGRIX on right arm. Less than a day after receiving SHINGRIX, the patient had right arm pain lasted overnight. Approximately a week after receiving SHINGRIX, the patient experienced a rash that progressively spread over his back, chest, and abdomen. The patient described the rash as red, raised dots, that are itchy, uncomfortable, and sometimes hurt. The rash had not spread since a week before the reporting date. The patient's wife told him that it could be Shingles. The patient gave permission to contact his physician. The patient was referred to his healthcare professional.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 75-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received 2 years before the reporting date, without any adverse event). Concomitant products included pneumococcal vaccine. On 11th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In April 2018, the patient experienced itchy rash, discomfort, painful rash, maculopapular rash and shingles. On 12th April 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the itchy rash, discomfort, painful rash, maculopapular rash and shingles were unchanged. The reporter considered the itchy rash, discomfort, pain in arm, painful rash and maculopapular rash to be related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: On 11th April 2018, the patient received Pneumonia vaccine (name unknown) intramuscularly on the left arm. At 14:00 hours, the patient received SHINGRIX on right arm. Less than a day after receiving SHINGRIX, the patient had right arm pain lasted overnight. Approximately a week after receiving SHINGRIX, the patient experienced a rash that progressively spread over his back, chest, and abdomen. The patient described the rash as red, raised dots, that are itchy, uncomfortable, and sometimes hurt. The rash had not spread since a week before the reporting date. The patient's wife told him that it could be Shingles. The patient gave permission to contact his physician. The patient was referred to his healthcare professional.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized urticarial in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced generalized urticarial. On an unknown date, the outcome of the generalized urticarial was unknown. It was unknown if the reporter considered the generalized urticarial to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that a patient broke out in generalized hives. The reporter declined to provide any further information because he did not administer the vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 71-year-old female patient who received SHINGRIX. On 5th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than year after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of their patients received the SHINGRIX vaccine at their pharmacy. The patient developed a blister on the opposite side where she had the injection.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was immunized at the pharmacy and experienced significant myalgias. The physician did not have any additional details regarding the patient. The reporter did not agree to receive mails of follow up from the GlaxoSmithKline. This case has been linked with the case US2018GSK082079 reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 3rd May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort. On an unknown date, the outcome of the injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort were not recovered/not resolved. The reporter considered the injection site erythema, insomnia, injection site itching, injection site swelling and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on last Wednesday. The patient had experienced redness at the injection site which was the size of a baseball, swollen at the injection site, hot at the injection site and itches at the injection site. The patient stated, she did not sleep because it was so uncomfortable. The patient started having these side effects the day after the vaccination and she still had the symptoms persisted at the time of reporting.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 3rd May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort. On an unknown date, the outcome of the injection site erythema, insomnia, injection site itching, injection site swelling, injection site warmth and discomfort were not recovered/not resolved. The reporter considered the injection site erythema, insomnia, injection site itching, injection site swelling and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on last Wednesday. The patient had experienced redness at the injection site which was the size of a baseball, swollen at the injection site, hot at the injection site and itches at the injection site. The patient stated, she did not sleep because it was so uncomfortable. The patient started having these side effects the day after the vaccination and she still had the symptoms persisted at the time of reporting.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received SHINGRIX. Concurrent medical conditions included penicillin allergy. Concomitant products included vitamin d, magnesium, TURMERIC and zinc. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, feeling abnormal, fatigue and headache. On an unknown date, the outcome of the pain in arm, feeling abnormal, fatigue and headache were not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. The reporter considered the feeling abnormal, fatigue and headache to be possibly related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medications included unspecified supplements. The patient received SHINGRIX in the left deltoid. The patient felt blah (feeling abnormal).
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a 53-year-old male patient who received SHINGRIX. Concomitant products included Furosemide and Lisinopril. On 9th May 2018 10:00, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, 8 hrs after receiving SHINGRIX, the patient experienced tingling, general body pain and malaise. On an unknown date, the outcome of the tingling, general body pain and malaise. On an unknown date, the outcome of the tingling, general pain and malaise were recovering/resolving. The reporter considered the tingling, general body pain and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: Eight hours after receiving the vaccination, the patient had tingling on his right side in his thigh, chin, orbit of his eye, his ankle and a finger (all on the right side). Less than a day after receiving vaccination, the patient also was sore and achy all over and had slight malaise. The patient had denied permission to contact their physician. The vaccination was done by the pharmacist so patient did not see the need for his doctor to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX. On 1st May 2018, the patient received SHINGRIX. In May 2018, 5 days after receiving SHINGRIX, the patient experienced muscle pain and shooting pain. On an unknown date, the outcome of the muscle pain and shooting pain were unknown. The reporter considered the muscle pain and shooting pain to be possibly related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine last week before the date of reporting and she developed severe muscle pain and shooting pain. The reporter commended that she could not hear and that she would call back, she then disconnected the call.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain localized in a 69-year-old female patient who received HAVRIX 1440 adult (batch number TB995, expiry date 25th October 2020). On 3rd May 2018, the patient received the 1st dose of HAVRIX 1440 adult (intramuscular) 1 ml. On 7th May 2018, 4 days after receiving HAVRIX 1440 adult, the patient experienced pain localized. In May 2018, less than a week after vaccination, the patient experienced fatigue and fever. On 7th May 2018, the outcome of the fatigue and fever were recovered/resolved. On an unknown date, the outcome of the pain localized was not recovered/not resolved. The reporter considered the pain localized, fatigue and fever to be probably related to HAVRIX 1440 adult. Additional details were provided as follows: The patient reported to the licensed practical nurse (LPN) that she had a stabbing pain 2 inches below the injection site (local pain). The pain was on and off. The patient also reported feeling fatigued and believed she might have had a fever (possible fever), but did not get confirmation.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details reported as follows: This case was not previously reported to anyone. The age at vaccination was not applicable for this report. Thar pharmacist stated that several patients reported experiencing body aches and injection site pain after getting SHINGRIX. The pharmacist stated that generally the symptoms started on the same day, usually later that evening, that they receive the injection. The pharmacist stated that most of the patient's symptoms resolved in 2 to 3 days. The pharmacist did not have specifics for this group of patients, but they were all adult patients.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 53-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 5th February 2018, the patient received the 1st dose of SHINGRIX. On 5th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In February 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 53 or 52 years old. Pain at the injection site lasted for 3 days. On 21st April 2018, the patient received 2nd dose of SHINGRIX in the left deltoid (batch number XC534, expiry date 4th July 2020).
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased, Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a adult male patient who received ENGERIX B (batch number EB993, expiry date 13th March 2019). Co-suspect products included ENGERIX B (batch number EB993, expiry date 13th March 2019 and ENGERIX B (batch number EB993, expiry date 13th March 2019). On an unknown date, the patient received the 1st dose of ENGERIX B, he 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy  non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The health care professional had a patient who received 3 doses of ENGERIX B and did not develop an immune response, which led to therapeutic response decreased. It was reported that all 3 doses had same batch number, two doses had the same expiry date, third dose was documented as 31st March 2018 but health care professional thought it was a transcription error and should have been the same as the first two doses as 13th March 2019.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On 7th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced fever, light headedness and headache. On an unknown date, the outcome of the fever, light headedness and headache were unknown. It was unknown if the reporter considered the fever, light headedness and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced low grade fever. The pharmacist refused to provide further information regarding the adverse events as she was the only pharmacist at the pharmacy and she had to get off the phone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported. The age at vaccination was not reported. No further details were provided.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose, Dizziness, Gait disturbance, Haemoglobin, Sensory loss
Clinical narrative: Pt received TDAP vaccine on 4/25/18 and returned to facility on 5/16/18 with complaints of: dizziness, altered gait, decreased sensation but all tests and examination showed no deficits.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pruritus generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache and generalized pruritus. On an unknown date, the outcome of the headache and generalized pruritus were unknown. It was unknown if the reporter considered the headache and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced an adverse reaction to the SHINGRIX vaccine including severe headache and severe systemic itching (per patient, every part of her body above her knees were affected). No other signs of an allergic reaction were identified.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concomitant products included SINGULAIR. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site rash and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site rash and injection site erythema were unchanged. The reporter considered the injection site swelling, injection site rash and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced redness, swelling and rash at the injection site which was about the size of a palm. All questions were asked.
Age: 1.83
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: 5-16-18 4:10pm After receiving 2 injections was standing at Front Desk- verbalize feeling faint - Assisted to Floor by Nurse - no loss of consciousness. In about 5 min assisted to exam table - stating she feeling better BP 106/76 Drank 8oz regular coke, ate cookies. 4:30pm stating feeling ok, no lightheadedness. Ambulated to car with nurse by side- mother present.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Erythema, Rash
Clinical narrative: Mother reported slight rash and redness to face about 15 min after pt received vaccines. Nurse practitioner, RN, and MD were notified. V/S taken and were stable. Providers determined there was no harm to pt.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of polymyalgia in a 60-year-old female patient who received SHINGRIX. Concurrent medical conditions included rheumatoid arthritis (prior to SHINGRIX vaccination). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced polymyalgia and joint pain. On an unknown date, the outcome of the polymyalgia and joint pain were unknown. It was unknown if the reporter considered the polymyalgia and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The GlaxoSmithKline field representative was notified today by the reporter. The patient experienced general myalgia and specifically greater joint pain than her usual joint pain associated with her preexisting rheumatoid arthritis, after having received the SHINGRIX vaccine. The reporter said the vaccination was administered at the patient's rheumatologist's office and that the reporter is not the responsible doctor but was the patient's primary care physician. No further details were provided by the reporter to the GlaxoSmithKline field representative. It was unknown if the reporter gives permission to be contacted by GCSP.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a elderly female patient who received SHINGRIX. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced abdominal pain, vomiting, diarrhea, fever and shivering. On an unknown date, the outcome of the abdominal pain, vomiting, diarrhea, fever and shivering were not recovered/not resolved. It was unknown if the reporter considered the abdominal pain, vomiting, diarrhea, fever and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Limited information was provided. During conversation, the patient disconnected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-OCT-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 20-OCT-2014, the patient was treated by a physician, which was diagnosed as shingles along with an additional diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient has been prescribed VALTREX and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer had also reported that the patient was inoculated with the ZOSTAVAX vaccine for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX vaccine and suffered serious physical, emotional and economic damages as a result of her shingles and associated injuries. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.