chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with sweats. Nausea and vomiting. Left arm deltoid measuring 11.5". Vaccine reaction and medication info. I wanted to let you know that I had a severe reaction to the pneumonia vaccine I received Tuesday. About three hours after receiving the vaccine I began having severe pain in my left arm. It became so bad by late afternoon that I could not use my arm. Also that night I experienced cold sweats, chills, dizziness and vomiting. Someone called a personal friend as it was after hours. He recommended taking an antihistamine. I did and all the symptoms except the pain and soreness began to subside. Yesterday was better but I was still unable to use my arm due to pain. I still have pain this morning but not to the same degree as I am able to use my arm. Adverse reaction after PNEUMOVAX adm on 6/19/18. Pt sent message via portal on 6/21/18 that had had reaction after PNEUMOVAX given in left arm in office on 6/19. Had chills/nausea and vomiting and could not move arm from left elbow to shoulder and exquisite pain that she compare to childbirth. There is swelling below the injection site today 3 days later-size of left upper arm 11.5 inches compared to 11 inches on right. There is mild erythema of the area below the injection site. She grimaces with movement of left shoulder. Has been taking 2 ALEVE BID and not helping much but feels movement is much better. I will send in meloxicam as well as gabapentin and she will let me know if not improved-will order MRI. Patient-I am on call this weekend. Please let me know how you are doing tomorrow. I might want to start prednisone to settle this faster.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with sweats. Nausea and vomiting. Left arm deltoid measuring 11.5". Vaccine reaction and medication info. I wanted to let you know that I had a severe reaction to the pneumonia vaccine I received Tuesday. About three hours after receiving the vaccine I began having severe pain in my left arm. It became so bad by late afternoon that I could not use my arm. Also that night I experienced cold sweats, chills, dizziness and vomiting. Someone called a personal friend as it was after hours. He recommended taking an antihistamine. I did and all the symptoms except the pain and soreness began to subside. Yesterday was better but I was still unable to use my arm due to pain. I still have pain this morning but not to the same degree as I am able to use my arm. Adverse reaction after PNEUMOVAX adm on 6/19/18. Pt sent message via portal on 6/21/18 that had had reaction after PNEUMOVAX given in left arm in office on 6/19. Had chills/nausea and vomiting and could not move arm from left elbow to shoulder and exquisite pain that she compare to childbirth. There is swelling below the injection site today 3 days later-size of left upper arm 11.5 inches compared to 11 inches on right. There is mild erythema of the area below the injection site. She grimaces with movement of left shoulder. Has been taking 2 ALEVE BID and not helping much but feels movement is much better. I will send in meloxicam as well as gabapentin and she will let me know if not improved-will order MRI. Patient-I am on call this weekend. Please let me know how you are doing tomorrow. I might want to start prednisone to settle this faster.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Shivering, Fever, Pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Discomfort, Erythema, Fatigue, Headache
Clinical narrative: Left arm became very red, swollen, hard to the touch, hot, and painful, almost down to the wrist, and all the way up to the shoulder, almost all around the arm. This lasted for 4 days when it gradually went away. On the 3rd day I felt feverish and took my temp - 100. That night I woke up every two hours wringing wet with sweat. 4th day temp was down to 99.8. All this time I had body aches and pains all over, especially in my left shoulder blade. Upon the least little exertion of even a few steps I became weak, fatigued, and had a headache. I also had nausea and thought I was going to have emesis several times, but didn't. By the 5th day I was feeling better, although still not well. However, on the 7th day I suddenly started feeling much worse again, in a lot of pain, feverish, and had a fever that night of 101! The next day I went to the doctor who prescribed me 4 days of a low prednisone dosage. This helped, and after about another week I felt almost back to my old self. During this entire time the pain in my left shoulder blade interrupted with sleeping. It hurt when I sat up, stood, or laid-couldn't get comfortable.  ALEVE helped a little, but not much.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Left arm became very red, swollen, hard to the touch, hot, and painful, almost down to the wrist, and all the way up to the shoulder, almost all around the arm. This lasted for 4 days when it gradually went away. On the 3rd day I felt feverish and took my temp - 100. That night I woke up every two hours wringing wet with sweat. 4th day temp was down to 99.8. All this time I had body aches and pains all over, especially in my left shoulder blade. Upon the least little exertion of even a few steps I became weak, fatigued, and had a headache. I also had nausea and thought I was going to have emesis several times, but didn't. By the 5th day I was feeling better, although still not well. However, on the 7th day I suddenly started feeling much worse again, in a lot of pain, feverish, and had a fever that night of 101! The next day I went to the doctor who prescribed me 4 days of a low prednisone dosage. This helped, and after about another week I felt almost back to my old self. During this entire time the pain in my left shoulder blade interrupted with sleeping. It hurt when I sat up, stood, or laid-couldn't get comfortable.  ALEVE helped a little, but not much.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Middle insomnia, Musculoskeletal pain, Nausea, Night sweats
Clinical narrative: Left arm became very red, swollen, hard to the touch, hot, and painful, almost down to the wrist, and all the way up to the shoulder, almost all around the arm. This lasted for 4 days when it gradually went away. On the 3rd day I felt feverish and took my temp - 100. That night I woke up every two hours wringing wet with sweat. 4th day temp was down to 99.8. All this time I had body aches and pains all over, especially in my left shoulder blade. Upon the least little exertion of even a few steps I became weak, fatigued, and had a headache. I also had nausea and thought I was going to have emesis several times, but didn't. By the 5th day I was feeling better, although still not well. However, on the 7th day I suddenly started feeling much worse again, in a lot of pain, feverish, and had a fever that night of 101! The next day I went to the doctor who prescribed me 4 days of a low prednisone dosage. This helped, and after about another week I felt almost back to my old self. During this entire time the pain in my left shoulder blade interrupted with sleeping. It hurt when I sat up, stood, or laid-couldn't get comfortable.  ALEVE helped a little, but not much.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Left arm became very red, swollen, hard to the touch, hot, and painful, almost down to the wrist, and all the way up to the shoulder, almost all around the arm. This lasted for 4 days when it gradually went away. On the 3rd day I felt feverish and took my temp - 100. That night I woke up every two hours wringing wet with sweat. 4th day temp was down to 99.8. All this time I had body aches and pains all over, especially in my left shoulder blade. Upon the least little exertion of even a few steps I became weak, fatigued, and had a headache. I also had nausea and thought I was going to have emesis several times, but didn't. By the 5th day I was feeling better, although still not well. However, on the 7th day I suddenly started feeling much worse again, in a lot of pain, feverish, and had a fever that night of 101! The next day I went to the doctor who prescribed me 4 days of a low prednisone dosage. This helped, and after about another week I felt almost back to my old self. During this entire time the pain in my left shoulder blade interrupted with sleeping. It hurt when I sat up, stood, or laid-couldn't get comfortable.  ALEVE helped a little, but not much.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Vaccination complication
Clinical narrative: Patient came to office on 6/11/18 with less than 50 vesicles on body. Dxd vaccine adverse reaction.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Yesterday patient told me before taking this IMZ she seems to get exaggerated responses to IMZ and preferred only 1 at a time. Today she calls me and discusses side effects. She said her side effects seem to match the literature she was given by us. She is having fatigue, muscle pain, neck pain, head ache, chills and shaking, decreased appetite. Patient has arm tenderness at the injection site. She asked for me to report these effects. I told her to contact her doctor if needed.  She responded that she felt most likely a doctor would not be necessary. I told her I would contact her later today or in the morning to check on her. I cannot adequately fill out Item 20 or 21 at this time.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Neck pain, Tremor
Clinical narrative: Yesterday patient told me before taking this IMZ she seems to get exaggerated responses to IMZ and preferred only 1 at a time. Today she calls me and discusses side effects. She said her side effects seem to match the literature she was given by us. She is having fatigue, muscle pain, neck pain, head ache, chills and shaking, decreased appetite. Patient has arm tenderness at the injection site. She asked for me to report these effects. I told her to contact her doctor if needed.  She responded that she felt most likely a doctor would not be necessary. I told her I would contact her later today or in the morning to check on her. I cannot adequately fill out Item 20 or 21 at this time.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: All over body aches, headache, malaise, and fatigue. I took 4 ADVIL shortly after getting the shot, which is my second dose of two doses, because I had such pain with the first shot. I have taken 800 mg of ADVIL every 4-6 since getting the shot and it has not helped ease the achiness and pain considerably. I hurt with rest, I hurt with movement, and I am easily fatigued.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenitis, Lymphadenopathy, Tenderness
Clinical narrative: This spontaneous report was received from a physician and refers to 11-year-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, after receiving the GARDASIL 9, the patient experienced axillary lymphadenitis. The outcome of axillary lymphadenitis was reported as recovered in one week. The relatedness between axillary lymphadenitis and GARDASIL 9 was not reported. On 11-JUN-2018, follow-up information was received from a physician. On 29-JAN-2018, the patient was vaccinated with the first dose of MENACTRA. On 19-FEB-2018, the patient was vaccinated with a first dose of GARDASIL 9 1 dose, lot # N020353, expiration date: 28-APR-2020 in left deltoid. On 21-FEB-2018 (also reported as within 48 hours), the patient developed a peanut size lymph node, mild tenderness in left axilla and above mid left clavicle. No fever, no local swelling or redness on site injection was reported. The physician also reported that the patient developed a peanut size firm mildly tender swelling in left axilla and just above mid left clavicle. Swelling was mobile with no overlying redness or warmth. The patient was given ibuprofen for 3 days and advised to be observed for fever worsening. On 05-MAR-2018, the patient was seen at physician office and it was reported that swelling was stable. On 16-APR-2018, the patient again was seen at physician office and it was reported that swelling completely resolved.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist, who is also a patient's mother, refers to a currently 11-year-old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and concomitant therapies. On an unknown date in November 2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (dose, lot# and expiration date were not reported) for prevention of HPV. On an unknown date (reported as 48 hours after the vaccination), the patient developed erythema, swelling and pain at the injection site. The patient was given ibuprofen for the adverse events. The patient did not seek medical attention and her physician was unaware of the adverse effects. The events of erythema, swelling and pain at the injection site resolved after 3 days. The relatedness between the events and vaccination with GARDASIL 9 was not reported.
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Erythema, Inflammation, Skin tightness
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a female patient of unknown age. Past medical history, drug allergies/reactions and concomitant medications were not reported. On an unknown date in 2016 (reported as 2 years ago), the patient received a dose of GARDASIL or GARDASIL 9 for prophylaxis. The nurse practitioner didn't know if the product was GARDASIL or HPV GARDASIL 9, since she was not the person who administered it. The patient had received the vaccine from a different healthcare provider. On unknown date, the patient's arm became red, inflamed and very tight. It was not specified which arm was affected. The patient's mother questioned the nurse practitioner if the patient should receive another dose of GARDASIL. It was not specified if the patient received any further doses of Quadrivalent GARDASIL. Outcome and causality of the events was not reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Polyneuropathy
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 23-JUN-2016, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), (by an unspecified healthcare professional) at a public health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed pain on her torso. On 05-OCT-2016, the patient presented to the physician, her primary care physician, and was diagnosed as suffering from polyneuropathy. Shortly thereafter, the patient returned to the physician and was diagnosed as suffering from internal shingles. As a direct and proximate result of these malfunctions, 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. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of the ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. The events of Polyneuropathy and internal shingles were considered disabling. Upon internal review, Polyneuropathy was considered to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: This spontaneous report was received from an unspecified source in a website via company representative, and refers to an adult female patient of unknown age (reported as "55 to 64 years old"). Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date in January 2012, the patient was vaccinated with a dose of ZOSTAVAX Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date were not reported). The reporter informed that on an unspecified date in 2012, 24 hours after being vaccinated, the patient experienced joint pain and flu-like symptoms. The patient sought medical attention, and received an unspecified treatment. The outcome of the events, and their relationship with the vaccination with ZOSTAVAX were not provided by the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 12-JUN-2018, the patient was vaccinated with VAQTA lot # N002921 with expiration date 08-APR-2018, at a dose of 1 ml, intramuscularly for prophylaxis. No adverse effects reported. No further information provided.
Age: 0.83
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 10 month old patient. On 28-JUN-2018, the patient was vaccinated with Oka/Merck VARIVAX lot # R002056, expiration date 22-JAN-2020, and (wistar ra 27-3) M-M-R I) lot # N025889, expiration date 18-APR-2019, both subcutaneous for prophylaxis. Sterile diluent was used for vaccine reconstitution. No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 28-JUN-2018, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M018810 with expiration date 28-MAY-2018, intramuscularly, for prophylaxis. No adverse effect was reported.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Previously administered products included SHINGRIX (received 1st dose). On 19th April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 10th May 2018, 21 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. The reporter considered the shingles to be unlikely related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reporting that one of their patients who received 2nd dose of SHINGRIX and developed shingles infection on for which he was being treated with oral antiviral medication. The caller was unable to provide any concomitant medications since patient does not get medications regularly from their pharmacy. Follow up information received from the pharmacist on 21st June 2018: The patient received SHINGRIX intramuscularly. The reporter's details were updated. The VAERS details were updated. Sender's Comments: US2018091654: Previous VAERS submission in paper format.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported the adverse event via web form. The healthcare professional reported that the patient came back on the day of reporting with a rash (red, size of 2 into 3 inches) at the side of the injection. The patient was informed that it was very common adverse effect and should be resolved soon but she would like to know how long it would typically take to get resolved and what could done to help it resolve faster and to manage overall itching and redness. No additional information was provided.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hepatitis b surface antigen positive in a 65-year-old male patient who received ENGERIX B adult for prophylaxis. On 8th June 2018, the patient received ENGERIX B adult. On 15th June 2018, 7 days after receiving ENGERIX B adult, the patient experienced hepatitis b surface antigen positive. On an unknown date, the outcome of the hepatitis b surface antigen positive was unknown. It was unknown if the reporter considered the hepatitis b surface antigen positive to be related to ENGERIX B adult. Additional details were reported as follows: The age at vaccination was not applicable for this report. On 15th June 2018, the patient came to the emergency room for other reasons and had a Liver Function test. The patient tested positive for the Hepatitis Surface Antigen. The patient was negative prior. No additional information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivers in a elderly female patient who received SHINGRIX for prophylaxis. 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 shivers. On an unknown date, the outcome of the shivers was recovered/resolved. It was unknown if the reporter considered the shivers to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that, after taking the vaccine she had shivers for three nights and then the shivers stopped.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site discoloration in a 18-year-old female patient who received BEXSERO for prophylaxis. On 16th May 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site discoloration and injection site swelling. On an unknown date, the outcome of the injection site discoloration and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The health care professional reported that 18 year old patient received the 1st dose of BEXSERO and when they came in for their doctor visit 1 month later, the patient still had injection site skin darkening as well as injection site swelling. The doctor decided to hold the 2nd dose and to wait 1 month and see if the reaction resolves before giving the 2nd dose. The patient went to the doctor at the 1 month mark to receive the 2nd dose, they did not go because of their symptoms but the doctor decided to hold the dose and see how patient does after 1 month.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, 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 pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site swelling, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site warmth was unknown and the outcome of the injection site swelling, injection site inflammation and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site inflammation and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient declined to provide concomitant medications. In 2018, the patient received SHINGRIX in left upper arm. At some unknown time after receiving the SHINGRIX, he had absolute tenderness and soreness with warmth at the site of injection by the next day following the day when the vaccine had been administered. There was swelling, inflammation, slight redness, and warmth at the injection site of which tenderness and soreness at the injection site was described to have been extended in that those symptoms lasted for at least a week. The swelling and redness were gone with no apparent evidence of any symptoms seen by just looking at that injection site. When the patient pressed his arm, he still had soreness and slight tenderness with the tenderness described as being deeper into the muscle. He had no doctor's office or emergency room (ER) visit for any of the symptoms.  He was referred to his healthcare professional (HCP) before the call ended. The patient had denied permission to contact their physician. The patient said it would be okay to contact him by phone for further related questions. The patient declined to provide the facility of vaccination or his date of birth. No further information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included back surgery. Concomitant products included MELOXICAM. On 5th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, headache, fever and general body pain. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved and the outcome of the tiredness, headache, fever and general body pain were unknown. The reporter considered the influenza-like symptoms, tiredness, headache, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: No additional details about medical history provided. The reporter denied any other vaccines were administered at the time of the SHINGRIX. In between 15:00 hours to 17:00 hours, the patient received SHINGRIX in left arm. After 2 to 3 days (no exact date provided after injection), the patient experienced flu like symptoms. The patient had three bouts of two day flu like symptoms over the past sixteen days and she described flu like as tired, headache, fever, and aching all over. Flu like symptom bouts had not worsened or improved with each bout.  No hospitalization for treatment of flu like symptoms. The patient spoke with her primary care physician and pharmacist about her flu like symptoms. The reporter could not recall pharmacist who administered vaccine. The reporter did not have lot number, expiration date, dose, or strength of SHINGRIX. No addiitonal details were provided.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, fever and chills. On an unknown date, the outcome of the injection site pain, injection site itching, fever and chills were recovering/resolving. The reporter considered the injection site pain, injection site itching, fever and chills to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccination, the patient experienced pain and itching at the injection site, fever and chills and worsened overnight. The patient went to urgent care four days later to be evaluated. The events had gotten better but had not resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). 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: The patient received SHINGRIX in left deltoid and experienced rash on both shoulders that went to the patient's hands.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site warmth in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The primary reporter stated to field representative that patient experienced warmth and redness at the injection site which was 4 to 5 inch in diameter just like a size of soft ball. No further details were provided by the field representative.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, tingling and rash. On an unknown date, the outcome of the shingles, tingling and rash were unknown. It was unknown if the reporter considered the shingles, tingling and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The patient developed tingling 24 hours after receiving a dose of SHINGRIX, which escalated to full rash and shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 16th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site burning. On 16th June 2018, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the injection site burning was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient went to pharmacy to receive Shingles vaccination, she was given a bandage to cover the injection site after removing the bandage that evening on 16th June 2018, the patient's upper arm was extremely red and itchy. The patient stated that at the time of reporting had a tattoo like burn on her arm and it seems to be getting worse. The patient claims she would now seek the care of a dermatologist.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: I took the second dose of the SHINGRIX shingles vaccine yesterday at 4 o'clock. Woke up today with a fever of 100.4, severe muscle and joint aches, chills, headache, mild stomach cramps. I had no reaction except some soreness to the first dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I took the second dose of the SHINGRIX shingles vaccine yesterday at 4 o'clock. Woke up today with a fever of 100.4, severe muscle and joint aches, chills, headache, mild stomach cramps. I had no reaction except some soreness to the first dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: About 1 hr after vaccination patient felt sick to her stomach, chills, and shooting pain in head. All symptoms she had with an active case of shingles previously. Took 3 days for symptoms to resolve completely.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash (approx 10 cm diameter) and soreness at injection site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Eczema, Eye swelling, Eyelid oedema, Flushing, Injection site erythema
Clinical narrative: FLUSHING AND REDNESS STARTED NEAR ADMINISTRATION SITE FIRST. IN 2 DAYS SHE DEVELOPED SWELLING AND REDNESS OF RIGHT EYE, WITH RASH FROM WRISTS TO ELBOW TOO. UPPER STERNUM ALSO SHOWING RASH. BENADRYL 50 MG GIVEN BUT TOO SLEEPY. FACE STILL BROKEN OUT ON 3RD DAY (TODAY), AND NOW LEFT EYE ALSO PUFFY. RASH NOW DOWN ARM TOO AND ECZEMA OF HANDS IS WORSENING. CONTINUES TO BE ITCHY.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: FLUSHING AND REDNESS STARTED NEAR ADMINISTRATION SITE FIRST. IN 2 DAYS SHE DEVELOPED SWELLING AND REDNESS OF RIGHT EYE, WITH RASH FROM WRISTS TO ELBOW TOO. UPPER STERNUM ALSO SHOWING RASH. BENADRYL 50 MG GIVEN BUT TOO SLEEPY. FACE STILL BROKEN OUT ON 3RD DAY (TODAY), AND NOW LEFT EYE ALSO PUFFY. RASH NOW DOWN ARM TOO AND ECZEMA OF HANDS IS WORSENING. CONTINUES TO BE ITCHY.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cyst, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: About 5-7 PM that evening started to feel cold/chills. That night felt like worse day of my life, chills, bad body pains/ache and sweaty hot, next day like bad flu, second night not as bad, 2nd day better. After about 48 hrs back to normal. Also on 2nd day a cyst formed on my right front neck by throat, fever.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: About 5-7 PM that evening started to feel cold/chills. That night felt like worse day of my life, chills, bad body pains/ache and sweaty hot, next day like bad flu, second night not as bad, 2nd day better. After about 48 hrs back to normal. Also on 2nd day a cyst formed on my right front neck by throat, fever.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Confusional state, Dizziness, Eye movement disorder, Loss of consciousness
Clinical narrative: Eyes rolled to back of head, hands to side and convulsed for 17-20 seconds, clammy, unconscious, pt unaware of surroundings post convulsions and or name, pt urinated on self, pt was nauseous and dizzy, symptoms began 5 minutes after vaccination and pt was discharged one hour later.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Seizure, Urinary incontinence
Clinical narrative: Eyes rolled to back of head, hands to side and convulsed for 17-20 seconds, clammy, unconscious, pt unaware of surroundings post convulsions and or name, pt urinated on self, pt was nauseous and dizzy, symptoms began 5 minutes after vaccination and pt was discharged one hour later.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity, Pyrexia
Clinical narrative: Patient said her arm was sore and hard and she felt she had a slight fever since she got the shingles shot. The symptoms started the day after she got the shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Urticaria
Clinical narrative: WHEN THE PT. CAME IN TO PICK UP A MEDICATION, SHE ASKED ABOUT WHEN THE 2ND SHINGRIX SHOULD BE ADMINISTERED. AFTER THE TECHNICIAN TOLD HER THE TIMEFRAME, SHE MENTIONED THAT SHE HAD A SLIGHT REACTION TO THE FIRST SHOT. I WENT DOWN TO THE PICK UP WINDOW TO INQUIRE ABOUT THE REACTION, AND THE PT. TOLD ME THAT SHE BROKE OUT IN HIVES APPROXIMATELY 24 HOURS AFTER RECEIVING THE SHOT. SHE DID SAY THAT THE REACTION WAS LOCAL ONLY AND THAT IT CLEARED UP IN A FEW DAYS, AFTER TAKING BENADRYL.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Crying, Wheezing
Clinical narrative: Patient cried for a prolonged peroid of time, and cried hard, after his injections. Dad was unable to console him. Dad reported the next day that Patient began to wheeze about an hour after his injections and he took him to the Hospital E.R. and Patient received a breathing treatment and was started on steroids. Dad reported no further problems and I am unable to reach him today by phone. Dad stated on June 27, 2018 when he called in the E.R. information that Patient was not having any further difficulties.
Age: 1.25
Sex: F
Vaccine: DT
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient inadvertently received DT instead of DTaP. No adverse reactions occurred
Age: 5.0
Sex: M
Vaccine: DT, IPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient inadvertently received DT instead of Dtap. No adverse events occurred.
Age: 23.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: DTap was administerd rather than a Tdap which was ordered by the provider.
Age: 1.5
Sex: M
Vaccine: DT, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Inadvertently received DT instead of DTaP. No adverse events occurred
Age: 1.58
Sex: M
Vaccine: DT, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Inadvertently received DT instead of DTaP. No adverse events occurred.
Age: 1.42
Sex: F
Vaccine: DT
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Inadvertently received DT instead of DTaP. No adverse events occurred.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising
Clinical narrative: Monday 6/25 at 2:44 she got her 2nd SHINGRIX shot. It was in her left upper arm. Immediately after the shot the arm was sore. Around 6 PM that night she developed full body muscle aches. She vomited multiple times that night. The next day Tuesday she continued to have extreme generalized pain, and soreness in the left arm. She did not have an appetite, could not drink. She developed a fever and chills. Wednesday she continued to feel sick with fever and chills and body aches. Thursday she felt a little better, but still had excruciating left arm pain and decrease ROM of the left arm. Today Friday she comes in to be evaluated. She has bruising at the site of injection. A few inches below the injection site she has an area of redness and warmth on her arm. Her arm is still painful and cannot fully extend it.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Malaise, Myalgia, Pain
Clinical narrative: Monday 6/25 at 2:44 she got her 2nd SHINGRIX shot. It was in her left upper arm. Immediately after the shot the arm was sore. Around 6 PM that night she developed full body muscle aches. She vomited multiple times that night. The next day Tuesday she continued to have extreme generalized pain, and soreness in the left arm. She did not have an appetite, could not drink. She developed a fever and chills. Wednesday she continued to feel sick with fever and chills and body aches. Thursday she felt a little better, but still had excruciating left arm pain and decrease ROM of the left arm. Today Friday she comes in to be evaluated. She has bruising at the site of injection. A few inches below the injection site she has an area of redness and warmth on her arm. Her arm is still painful and cannot fully extend it.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Monday 6/25 at 2:44 she got her 2nd SHINGRIX shot. It was in her left upper arm. Immediately after the shot the arm was sore. Around 6 PM that night she developed full body muscle aches. She vomited multiple times that night. The next day Tuesday she continued to have extreme generalized pain, and soreness in the left arm. She did not have an appetite, could not drink. She developed a fever and chills. Wednesday she continued to feel sick with fever and chills and body aches. Thursday she felt a little better, but still had excruciating left arm pain and decrease ROM of the left arm. Today Friday she comes in to be evaluated. She has bruising at the site of injection. A few inches below the injection site she has an area of redness and warmth on her arm. Her arm is still painful and cannot fully extend it.
Age: 58.0
Sex: M
Vaccine: HEP, MMR, VARZOS
Symptoms: Rash
Clinical narrative: Rash on lower arms (left and right), and left side of body. Symptoms started 1 day after vaccination was given. No rash or redness at local injection site. No other systemic side effects.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Chills, Fall, Feeling cold, Tremor
Clinical narrative: At 4AM I had severe cold/chills to the point of shaking. Around 7AM I got up to use rest room and went to my knees, then rolled onto my back to prevent passing out.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: Pt had reaction at injection site of left arm with swelling, edema, radiation of site swelling to elbow that lasted 48 hours before starting to subside.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Injection site pain, Neck pain, Rash
Clinical narrative: Received 1st shot of SHINGRIX on 5/26/2018. The next morning awoke with severe pain in (R) shoulder and under center of my neck. Pain without relief lasted until 6/6/18 when a rash started in neck in the fold on (R) side. Pain subsided when rash started. Went to ER and Dr. diagnosed me with shingles. Went for PT for 2 wks thinking it was my neck. Went to spine spec. Dr. did 4 x rays - not from neck. Rash increased every day spreading all over my upper back. Dermatologist ordered oral cortisone. (Prednisone 20 mg tab, 2 tabs every morning with food) and topical cortisone (Betamethasone DP 0.05% crm) applied to neck and back 3 x day for 2 wks. Rash lasted for 23 days. My husband took many pictures one each day so I could see how the rash was progressing. I know Dr.'s say shingles ordinarily doesn't cross the spine but the key word here is ordinarily. This was no ordinary rash. I had nothing before the vaccine. No one will ever convince me to get the second shot of SHINGRIX.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal X-ray
Clinical narrative: Received 1st shot of SHINGRIX on 5/26/2018. The next morning awoke with severe pain in (R) shoulder and under center of my neck. Pain without relief lasted until 6/6/18 when a rash started in neck in the fold on (R) side. Pain subsided when rash started. Went to ER and Dr. diagnosed me with shingles. Went for PT for 2 wks thinking it was my neck. Went to spine spec. Dr. did 4 x rays - not from neck. Rash increased every day spreading all over my upper back. Dermatologist ordered oral cortisone. (Prednisone 20 mg tab, 2 tabs every morning with food) and topical cortisone (Betamethasone DP 0.05% crm) applied to neck and back 3 x day for 2 wks. Rash lasted for 23 days. My husband took many pictures one each day so I could see how the rash was progressing. I know Dr.'s say shingles ordinarily doesn't cross the spine but the key word here is ordinarily. This was no ordinary rash. I had nothing before the vaccine. No one will ever convince me to get the second shot of SHINGRIX.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Loss of personal independence in daily activities, Pain in extremity, X-ray limb
Clinical narrative: Day 2 arm started to be sore from injection site, became worse every day and debilitatingly sore for 3 1/2 weeks. My Dr. ordered x rays to detect fluid. Very difficult to put on my clothes, aches in legs first week. No doubt that it was the shot.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Abscess limb, Induration, Limb mass, Nasopharyngitis, Secretion discharge
Clinical narrative: Hard lump in arm, with a abscess that patient stated she drained fluid out herself. Mild cold like symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: The itchy red dots started 1 day after the vaccine was administered. 1 itching dot on rib area and 1 itchy dot around navel. She tried BENADRYL to relieve the itch without success.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling from top of arm going down to right above the elbow. Redness and heat as well, soreness. Patient is to use cold compress, ZYRTEC 10 mg daily and use either ZANTAC 150 mg or PEPCID complete along with the ZYRTEC. Patient is to go the ER, if he starts to have trouble breathing, urgent care if the reaction continues to get worse.