chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure high, cough and difficulty breathing. Concomitant products included fluticasone propionate, ADVAIR DISKUS, Calcium, FLONASE, SINGULAIR, Celapram, fish oil, lisinopril, MVI, TOPROL XL, verapamil and NORVASC. On 25th April 2018, the patient received SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach. On 25th April 2018, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness, headache, fever, chills and upset stomach were unknown. The reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, headache, fever, chills and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX shot on Wednesday. The patient experienced soreness immediately that day.  The next morning, the patient's husband saw her arm was redness and swelling. The patient received the shot on the back side of her arm up toward her shoulder blade. The patient stated that her arm was increased about 2 by 2 to 3 by 4 areas, but it was not as sore. The patient also stated that the day after later in the evening experienced upset stomach, fever, chills, headache and tiredness. The patient began taking lisinopril the day before the vaccination and that day had trouble breathing and cough. The patient took it for about 2 days then contacted the physician's office, who instructed her to stop the Lisinopril. The patient denied the cough and breathing trouble being related to her SHINGRIX and she had the same issue with two other blood pressure medications verapamil and NORVASC. She was being started on another medication but had not picked it up yet. She was encouraged to notify her physician about the experience she had with the SHINGRIX, since she had not already.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 66-year-old female patient who received SHINGRIX. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. In 2018, the patient experienced left arm achiness, which lasted for 2 days after injection. This is 1 of the 2 cases reported by same reporter.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on side of arm opposite of injection.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a 60-year-old male patient who received SHINGRIX. Concomitant products included FLONASE, omeprazole, Rosuvastatin and lisinopril. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 days after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The caller was the patient who received a dose of SHINGRIX approximately 2 weeks before the time of reporting. The caller reported that 2 days after the vaccine received, the patient had routine blood work done and his white blood cells were slightly elevated at a value of 15. The patient reported that all other labs drawn were normal. The patient did not have lot number available and was not able to provide phone number for the pharmacy. The patient had denied permission to contact their physician.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Migraine
Clinical narrative: This case was reported by a contact and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX. The patient's past medical history included migraine headache. On 23rd February 2018, the patient received the 1st dose of SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced migraine headache and floating feeling. The patient was treated with IMITREX, Steroid Pack (NOS) and TOPAMAX. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the migraine headache was recovering/resolving and the outcome of the floating feeling was unknown. The reporter considered the injection site pain, migraine headache and floating feeling to be related to SHINGRIX. Additional details were provided as follows: The caller was patient who received SHINGRIX on left arm. The patient experienced arm pain at injection site that lasted for about one week after the dose was given. The caller reported that the 1 day after receiving the dose of SHINGRIX she experienced debilitating migraine headache for which she took IMITREX. This did not resolve and she went to her doctor and was prescribed TOPAMAX which also did not resolve and was later prescribed a steroid pack. The caller reported that the headaches had improved and she felt better but had not completely resolved as she still had slight feeling of floatiness in the area where she had the headache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. The reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The reporter received the 1st SHINGRIX vaccine approximately three weeks ago on left arm. The patient arm was very sore and red for the first 4 to 5 after receiving the vaccine. Then the events were slowly resolved. The patient had denied permission to contact their physician. The reporter would not provide her address and did not want her information used to contact her and unable to obtain additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of herpes simplex in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The patient reported to a physician about an outbreak of herpes simplex experienced approximately 1 week following vaccination with SHINGRIX. The physician did not have details of lot number/expiry or any specific patient details.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms, joint pain, muscle pain and headache. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the influenza-like symptoms, joint pain, muscle pain and headache were unknown. The reporter considered the injection site pain, influenza-like symptoms, joint pain, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. A pharmacist reported that in general, the younger recipients of SHINGRIX were reporting local reactions such as pain that resolve within a day. The older age recipients were reporting flu like symptoms which include muscle and joint pain. Older patients also had reported a severe headache. The pharmacist called with an unrelated question. Whenever they had administered SHINGRIX, they had the recipient call them the next day to let them know if they are experiencing any side effects. The pharmacist wasn't sure if she should be reporting this events, as they are common and listed in the prescribing information. She had not logged the patient specific information, so unable to provide these details. This case has been linked with US2018GSK080146, reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness both arms 3-24-18. Redness with swelling and warmth on right arm on 3-25-18 also c/o pain in both knees starting 3-25-18. Today 3-26-18 large area about midnight of upper arm of redness and swelling in Rt upper arm with warmth to touch. Just mild redness left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Redness both arms 3-24-18. Redness with swelling and warmth on right arm on 3-25-18 also c/o pain in both knees starting 3-25-18. Today 3-26-18 large area about midnight of upper arm of redness and swelling in Rt upper arm with warmth to touch. Just mild redness left arm.
Age: 45.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Client received Typhoid Vaccine at 1020. Returned to immunization  RM at 10:30 walking around, verbalizing. Pt wanted to walk out, but instructed to sit down. She began rubbing her chest and C/O SOB. Medic was called and EPI PEN administered at 1055 at (L) anterior thigh. 9-1-1 called. Transferred to Hospital 11:10.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: On 5/2/2018 mom reported he had fever and the skin near the injection site became erythematous, edematous and tender. Mom returned to the clinic 05/04/2018 with erythematous, edematous, tenderness measuring 13cm X 8cm in right thigh. Cellulitis was treated with Cephalexin 250mg/5ml 5ml twice a day for 10 days, returned the following morning 5/5/2018 cellulitis improved and erythema, edema and tenderness decreased.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: He wanted to let us know about the complications of his PREVNAR vaccine from 4/9/18. Pt states the shot immediately hurt and gave him severe pain in his arm. This severe pain lasted for a month. He also had so much joint pain that he could not walk without a cane. Pt states he remained in this condition of severe pain for a month. Pt states he was never warned of side effects or that the immunization would hurt- states he would never have received if he knew this. I apologized to the patient and said that there are some unknown complications with vaccines and medications because nobody reacts the same way. I apologized for not reviewing this enough with him prior. I notified him if he were ever in this condition to please contact us immediately so we can address the condition. (As we were in contact with him for a medication and pt never mentioned the reaction).
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Walking aid user
Clinical narrative: He wanted to let us know about the complications of his PREVNAR vaccine from 4/9/18. Pt states the shot immediately hurt and gave him severe pain in his arm. This severe pain lasted for a month. He also had so much joint pain that he could not walk without a cane. Pt states he remained in this condition of severe pain for a month. Pt states he was never warned of side effects or that the immunization would hurt- states he would never have received if he knew this. I apologized to the patient and said that there are some unknown complications with vaccines and medications because nobody reacts the same way. I apologized for not reviewing this enough with him prior. I notified him if he were ever in this condition to please contact us immediately so we can address the condition. (As we were in contact with him for a medication and pt never mentioned the reaction).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe soreness and pain at injection site. So painfull cannot raise rt. arm (arm of injection site).
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Feeling abnormal, Headache, Post herpetic neuralgia
Clinical narrative: Patient called reported feeling horrible worse than when had the flu with headache and dizziness that cause fall.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Patient stated the day she received vax she developed flu like symptoms. Including extreme fatigue, chills, fever-like symptoms. She also stated she had extreme pain in her arm at the injection site. She also had a red, bumpy, very itchy rash. All of these symptoms developed the day of vax and resolved within 3 - 5 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Patient stated the day she received vax she developed flu like symptoms. Including extreme fatigue, chills, fever-like symptoms. She also stated she had extreme pain in her arm at the injection site. She also had a red, bumpy, very itchy rash. All of these symptoms developed the day of vax and resolved within 3 - 5 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: On Monday 4/30/18 at 8:30 am I received first of two injection dosed of SHINGRIX 50MCG SUSR. On Wednesday 5/2/18 during the evening my wife noticed significant area of redness on my upper arm and took a picture to send to my doctor. The area was a bit swollen, hot, and tender to the touch. My doctor's office contacted me Friday indicating that the picture indicated a possible cellulitis, which my wife was concerned about. By Friday afternoon the swelling and redness had subsided but the area was still tender.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Headache
Clinical narrative: Experienced multiple health issues after receiving SHINGRIX 50MCG INJ. Nausea, fever, weakness, chills, joint pain, headache, stomach irritation, swelling and rash at injection site. As of today 5/4 symptoms are slowly dissipating.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Experienced multiple health issues after receiving SHINGRIX 50MCG INJ. Nausea, fever, weakness, chills, joint pain, headache, stomach irritation, swelling and rash at injection site. As of today 5/4 symptoms are slowly dissipating.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Influenza like illness, Malaise, Myalgia
Clinical narrative: I was sick for 6 days after receiving the 1st dose of SHINGRIX (zoster vaccine) 50mcg shingles vaccine. Pain, swelling, muscle ache, tired, upset stomach. I felt like I had the flu. I will be hard pressed to get the 2nd dose given my first reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: I was sick for 6 days after receiving the 1st dose of SHINGRIX (zoster vaccine) 50mcg shingles vaccine. Pain, swelling, muscle ache, tired, upset stomach. I felt like I had the flu. I will be hard pressed to get the 2nd dose given my first reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine, Myoglobin urine present, Pyrexia
Clinical narrative: Patient received SHINGRIX vaccine. Shortly after expired high fever and bloody urine that persisted for 5 weeks off and on.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). Concomitant products included allopurinol and alprazolam. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th April 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On 17th April 2018, the patient experienced fatigue. In April 2018, the outcome of the pain in arm, fatigue and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain in arm, fatigue and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX in the left deltoid. The patient experienced extreme pain and soreness in his arm, such that he could barely move his arm. One day after vaccination, the patient experienced fatigue. The symptoms were lasted for 3 days. The reported lot number (Y553Y) for SHINGRIX did not exist and was updated to YS53Y, according to sales database.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discomfort, Myalgia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a adult male patient who received SHINGRIX. On 25th April 2018, the patient received SHINGRIX. On 26th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site discomfort, joint pain, muscle pain and erythematous rash. On an unknown date, the outcome of the injection site discomfort, joint pain, muscle pain and erythematous rash were unknown. It was unknown if the reporter considered the injection site discomfort, joint pain, muscle pain and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 25th April 2018 (Wednesday afternoon), the received SHINGRIX and the next day, he experienced some discomfort at the injection site as well as muscle aches and joint pain on that same day in the evening the patient noticed what might be a rash on his chest, on both sides, on the day of reporting (in the morning), it was on his back as well. At the time of reporting the patient reported that the rash was not raised at all, it was just redness.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Discomfort, Rash, Viral test positive
Clinical narrative: Patient presented to the Clinic on 4/20/2018 stating that he felt some burning and bumps on his right side the day before in the shower. Noticed discomfort during the night also prior to presenting to the clinic. Physical exam on the right T5 dermatome reveals a group of vesicles on the posterior and anterior aspect. It does not cross the mid-line, no streaking noted. Culture of the vesicles was performed that returned positive for Herpes Zoster.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt. tolerated vaccines well in office. The next day went to ER with C/O redness and swelling in (R) leg-knee-area. I spoke with ER Nurse, she states it was a localized reaction from Dtap. 05/03 08:59 This 5 yrs old Male presents to Ed via POV with complaints of Allergic Reaction. 5 yo male received 4 vaccines yesterday morning at 0900, two in right leg and two in left leg. Patient acted normally all day, then began complaining of right leg pain yesterday evening. He can walk on his leg, but it hurts. The pain is located near the injection site and in his knee. He has associated swelling in this knee and entire leg. There is a small red rash at the injection site. No other assoc Sx including F/C, N/V/D, cough, SOB, or other rashes. He has never had reactions to vaccines before.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Local reaction, Rash erythematous
Clinical narrative: Pt. tolerated vaccines well in office. The next day went to ER with C/O redness and swelling in (R) leg-knee-area. I spoke with ER Nurse, she states it was a localized reaction from Dtap. 05/03 08:59 This 5 yrs old Male presents to Ed via POV with complaints of Allergic Reaction. 5 yo male received 4 vaccines yesterday morning at 0900, two in right leg and two in left leg. Patient acted normally all day, then began complaining of right leg pain yesterday evening. He can walk on his leg, but it hurts. The pain is located near the injection site and in his knee. He has associated swelling in this knee and entire leg. There is a small red rash at the injection site. No other assoc Sx including F/C, N/V/D, cough, SOB, or other rashes. He has never had reactions to vaccines before.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling. Advised to take BENADRYL, ice, elevate. On 5/4/18 swelling decreased, advised to continue BENADRYL, ice if needed, worsens over weekend go to ER.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized itching in a adult patient who received SHINGRIX. The patient's past medical history included skin lesion. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced localized itching. On an unknown date, the outcome of the localized itching was unknown. The reporter considered the localized itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had itching at the site of a previous shingles lesion. The case has been linked with US2018074652, reported by the same reporter. The pharmacist called with an unrelated question. Whenever they had administered SHINGRIX, they had the recipient call them the next day to let them know if they are experiencing any side effects. The pharmacist was not sure if she should be reporting this events, as they were common and listed in the prescribing information. She had not logged the patient specific information, so unable to provide these details.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HPV9
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: Patient was given 1 dose of HPV 9 (mistakenly for his sister). He is doing fine - no reaction at all.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Day after receiving injection, arm painful and swollen. Febrile. Diagnosed with cellulitis and put on antibiotics.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Thursday - injection. Pain upon injection. A couple of hours it was swelling, hot, tender to touch, no appetite, sluggish, achy. Began taking ADVIL. The swelling and redness began to creep down my upper arm. Friday - called the doctor the day after the injection and the nurse said these items are side effects. Saturday - soreness. Redness, hot and swelling was 6 inches below the injection site.  Sunday the redness, hot and swelling was getting better from the injection site to about 3 inches below, but still tender to touch, but below the injection site about 2 inches  the redness, hot and swelling is still a concern. Monday - the injection site to 3 inches below is itchy and still tender, and the lower part is still red, hot, swelling and tender. I've never experienced this type of reaction to an injection. Made me think it could be cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Sluggishness
Clinical narrative: Thursday - injection. Pain upon injection. A couple of hours it was swelling, hot, tender to touch, no appetite, sluggish, achy. Began taking ADVIL. The swelling and redness began to creep down my upper arm. Friday - called the doctor the day after the injection and the nurse said these items are side effects. Saturday - soreness. Redness, hot and swelling was 6 inches below the injection site.  Sunday the redness, hot and swelling was getting better from the injection site to about 3 inches below, but still tender to touch, but below the injection site about 2 inches  the redness, hot and swelling is still a concern. Monday - the injection site to 3 inches below is itchy and still tender, and the lower part is still red, hot, swelling and tender. I've never experienced this type of reaction to an injection. Made me think it could be cellulitis.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Loss of consciousness, Malaise, Nausea
Clinical narrative: Patient describes after receiving the vaccine around noon she started not feeling well later on in the evening. In the middle of the night she was experiencing extreme flu like symptoms and severe nausea (no vomiting reported) around this time she reported "passing out" and needing to be taken to the emergency room via ambulance. Patient was feeling better and I believe discharged from the hospital. No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Dehydration, Diarrhoea, Enzyme level test, Feeling abnormal
Clinical narrative: Patient describes after receiving the vaccine around noon she started not feeling well later on in the evening. In the middle of the night she was experiencing extreme flu like symptoms and severe nausea (no vomiting reported) around this time she reported "passing out" and needing to be taken to the emergency room via ambulance. Patient was feeling better and I believe discharged from the hospital. No treatment information was reported.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Loss of consciousness, Nausea, Syncope, Weight decreased
Clinical narrative: Patient describes after receiving the vaccine around noon she started not feeling well later on in the evening. In the middle of the night she was experiencing extreme flu like symptoms and severe nausea (no vomiting reported) around this time she reported "passing out" and needing to be taken to the emergency room via ambulance. Patient was feeling better and I believe discharged from the hospital. No treatment information was reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Zoster rash to R forehead extending down to eyelid/nasal bridge, worsening over the course of 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling and bruising at site for 3 weeks and still hard not....did see doc.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Blood test, Chest X-ray, Pityriasis rosea, Rash
Clinical narrative: As of 4/11/18 I noticed a rash under my left breast, which looked like eczema, or ringworm. About a week later at PM I noticed several bumps on my abdomen. As each day went by there were new bumps forming on my lower back, arm pits, cervical neck area and groin. There was no itching or fever. Taking BENADRYL did help! So eventually I email my Dermatologist for advice. He requested pictures to be sent via email. Finally on 5/4/18 I was seen by derm. A biopsy was taken of a few of the bumps, which is pending. I was also told that I had something called Pityriasis Rosea, possibly caused by a virus in the HERPES 6 family the same virus that cause roseola in babies and cause the chicken pox virus. I am pretty much a healthy 61 year hold, recently divorced, but not sexually active for 6 years. I do not easily get colds, or even the flu! I am very concerned that the Zoster Vaccine may have triggered my break out, even though it's a year later. Ironically it is almost a year to date that I received the vaccine and had the break out. I thank you for your attention to this matter.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient stated arm sore one to two days after injection. Then 8 days after initial injection arm sore and slightly edematous apprx golf ball size. Patient took Ibuprofen and swelling subsided. Continues to complain of soreness at the time of todays visit "5-7-18".
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site warmth, Myalgia
Clinical narrative: Headache, muscle/joint aches, fatigue, and nausea-no swelling at injection just mild warmth-denies fever or other sx.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Headache, muscle/joint aches, fatigue, and nausea-no swelling at injection just mild warmth-denies fever or other sx.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Pt reported extreme fatigue for 2-3 days, pain and redness at injection site, and joint pain (especially in hips).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension
Clinical narrative: Patient noted very low blood pressure that evening after having the vaccination. Felt very dizzy. Took blood pressure and it was 54/45. No recent changes in medication dosing.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Insomnia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Around 4pm patient felt weak and was unable to lift arms in order to get a drink from  kitchen sink and legs were also very weak. Patient went directly to bed. After about an hour she couldn't even have the strength to roll over or put arms up under pillow so she laid there all night. Patient states muscles were sore all night and she didn't sleep all night as well. In the morning she was able to get up and made it to the sofa where she stayed from 7am til 3pm laying on side and maybe slept 2 hours. Around 3 she felt better and was able to roll over and then got up and was able to get a drink, finally and started doing better. She was feeling stronger and able to eat a little bit. That evening she went to bed as normal and then woke up on the next day feeling normal.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large, red swollen area about 3 inches in diameter located below her deltoid muscle. She said she was experiencing pain 05/05/2018 Saturday after receiving the shot, but the pain had improved some. She also stated that it feels hot.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash papular
Clinical narrative: PT DEVELOPED RASH (RAISED RED SPOTS) ON LEFT SHOULDER GOING ABOUT 4-6 INCHES DOWN TO HIS CHEST. PATIENT WAS INSTRUCTED TO CONSULT HIS PCP AND SEE IF HE SHOULD STILL RECEIVE THE SECOND DOSE OF THE SERIES. UPON FOLLOW-UP PT SAID THE RASH HAS RESOLVED AND HE NEVER WENT TO SEE THE PCP.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Heart rate increased, Injection site pain, Limb discomfort
Clinical narrative: Injection site pain, discomfort down left arm, weakness, increased heart rate, tired.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Discomfort, Ear pain, Ear, nose and throat examination normal, Erythema
Clinical narrative: In the early morning after the injection the injection site was hurting so badly that I could not sleep and had to get up and take ibuprofen. The next morning I started with chills and then ran a high fever around 102 degrees. I took Ibuprofen to reduce my fever. My left arm hurt badly and the entire top of my arm was red for 4 days. Seven days after the injection I had pain in my left ear with pain and stiffness up the left side of my neck and left side of my head, giving me a headache.  I went to my primary care physician on Tuesday, April 3rd and asked her to look into my left ear, thinking I had an ear infection. She said my ear looked okay. I had a dentist appt. the same day and my xrays looked fine, because I thought maybe I had an abscessed tooth. My xrays were fine, also. The following week after continual pain in my left ear, side of my head and neck, I went to an ENT.  He did a thorough examination, even inserting a camera in my nostril to look around and he didn't find a cause for my pain and discomfort. He put me on muscle relaxers and steroids for a week. After I finished the meds, the pain came back. The Dr. then sent me for physical therapy for my neck pain.  I believe all of this was caused by the PREVNAR 13 vaccination. Since then, I have been trying to detox and get the meds out of my system. This has been a huge inconvenience for me as well as expensive. I regret getting the vaccine and will never get another vaccination. I just hope I can flush this stuff out of my system!
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Insomnia, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: In the early morning after the injection the injection site was hurting so badly that I could not sleep and had to get up and take ibuprofen. The next morning I started with chills and then ran a high fever around 102 degrees. I took Ibuprofen to reduce my fever. My left arm hurt badly and the entire top of my arm was red for 4 days. Seven days after the injection I had pain in my left ear with pain and stiffness up the left side of my neck and left side of my head, giving me a headache.  I went to my primary care physician on Tuesday, April 3rd and asked her to look into my left ear, thinking I had an ear infection. She said my ear looked okay. I had a dentist appt. the same day and my xrays looked fine, because I thought maybe I had an abscessed tooth. My xrays were fine, also. The following week after continual pain in my left ear, side of my head and neck, I went to an ENT.  He did a thorough examination, even inserting a camera in my nostril to look around and he didn't find a cause for my pain and discomfort. He put me on muscle relaxers and steroids for a week. After I finished the meds, the pain came back. The Dr. then sent me for physical therapy for my neck pain.  I believe all of this was caused by the PREVNAR 13 vaccination. Since then, I have been trying to detox and get the meds out of my system. This has been a huge inconvenience for me as well as expensive. I regret getting the vaccine and will never get another vaccination. I just hope I can flush this stuff out of my system!
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nasoendoscopy, Neck pain, Pain in extremity, Pyrexia, X-ray dental normal
Clinical narrative: In the early morning after the injection the injection site was hurting so badly that I could not sleep and had to get up and take ibuprofen. The next morning I started with chills and then ran a high fever around 102 degrees. I took Ibuprofen to reduce my fever. My left arm hurt badly and the entire top of my arm was red for 4 days. Seven days after the injection I had pain in my left ear with pain and stiffness up the left side of my neck and left side of my head, giving me a headache.  I went to my primary care physician on Tuesday, April 3rd and asked her to look into my left ear, thinking I had an ear infection. She said my ear looked okay. I had a dentist appt. the same day and my xrays looked fine, because I thought maybe I had an abscessed tooth. My xrays were fine, also. The following week after continual pain in my left ear, side of my head and neck, I went to an ENT.  He did a thorough examination, even inserting a camera in my nostril to look around and he didn't find a cause for my pain and discomfort. He put me on muscle relaxers and steroids for a week. After I finished the meds, the pain came back. The Dr. then sent me for physical therapy for my neck pain.  I believe all of this was caused by the PREVNAR 13 vaccination. Since then, I have been trying to detox and get the meds out of my system. This has been a huge inconvenience for me as well as expensive. I regret getting the vaccine and will never get another vaccination. I just hope I can flush this stuff out of my system!
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site reaction, Vaccination complication
Clinical narrative: Patient presented in the afternoon of 05/07/2018 with redness radiating out from site. Band radiating medially from site. Two small satellite lesions surrounding smallpox inoculation site. Possible auto inoculation underneath bilateral eyes. No local lymphadenopathy noted. Patient was treated with BACTRIM 800/160 mg- 1 tab orally twice a day for 7 days, instructed to follow-up with emergency room or his local healthcare provider if symptoms worsen or do not improve.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Vaccination complication
Clinical narrative: Weakness, headache from the vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: According to the patient, she woke up while sleeping to severe tingling of the nerves, backache, body pain, slight fever and upset stomach. She started feeling better by morning. Symptoms progressively got better by day 2.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Disturbance in attention, Headache
Clinical narrative: My arm became increasingly sore the first day- hard to raise by late evening. The next morning when I woke up about 24 hours from when I got the shot, it was a bit puffy and soreness increased- I could not touch it w/out significant pain nor raise it above my ear (to brush hair/shower). It was a bit warm but not too bad. I was nauseated all day - unable to eat more than a bowl of cereal. Throughout the day I had an intermittent high fever with chills and some shaking.i had increasing body aches, headache, and limited focus. By evening the nausea was worse. The pain in my arm woke me several times during the night and my fever increased (not sure of the number but I was hot to the touch and very pink.. On Sunday the temperature went down but the nausea remained as did the aching.  I also got a patch red rash that looked like a hand slap around the injection site. That night I had diarrhea throughout the night and intense stomach cramps. On Monday, I am better but my arm is still a bit puffy and the re patchiness is now itchy.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hyperaesthesia, Hypophagia, Injection site erythema, Injection site rash, Middle insomnia
Clinical narrative: My arm became increasingly sore the first day- hard to raise by late evening. The next morning when I woke up about 24 hours from when I got the shot, it was a bit puffy and soreness increased- I could not touch it w/out significant pain nor raise it above my ear (to brush hair/shower). It was a bit warm but not too bad. I was nauseated all day - unable to eat more than a bowl of cereal. Throughout the day I had an intermittent high fever with chills and some shaking.i had increasing body aches, headache, and limited focus. By evening the nausea was worse. The pain in my arm woke me several times during the night and my fever increased (not sure of the number but I was hot to the touch and very pink.. On Sunday the temperature went down but the nausea remained as did the aching.  I also got a patch red rash that looked like a hand slap around the injection site. That night I had diarrhea throughout the night and intense stomach cramps. On Monday, I am better but my arm is still a bit puffy and the re patchiness is now itchy.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: My arm became increasingly sore the first day- hard to raise by late evening. The next morning when I woke up about 24 hours from when I got the shot, it was a bit puffy and soreness increased- I could not touch it w/out significant pain nor raise it above my ear (to brush hair/shower). It was a bit warm but not too bad. I was nauseated all day - unable to eat more than a bowl of cereal. Throughout the day I had an intermittent high fever with chills and some shaking.i had increasing body aches, headache, and limited focus. By evening the nausea was worse. The pain in my arm woke me several times during the night and my fever increased (not sure of the number but I was hot to the touch and very pink.. On Sunday the temperature went down but the nausea remained as did the aching.  I also got a patch red rash that looked like a hand slap around the injection site. That night I had diarrhea throughout the night and intense stomach cramps. On Monday, I am better but my arm is still a bit puffy and the re patchiness is now itchy.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: My arm became increasingly sore the first day- hard to raise by late evening. The next morning when I woke up about 24 hours from when I got the shot, it was a bit puffy and soreness increased- I could not touch it w/out significant pain nor raise it above my ear (to brush hair/shower). It was a bit warm but not too bad. I was nauseated all day - unable to eat more than a bowl of cereal. Throughout the day I had an intermittent high fever with chills and some shaking.i had increasing body aches, headache, and limited focus. By evening the nausea was worse. The pain in my arm woke me several times during the night and my fever increased (not sure of the number but I was hot to the touch and very pink.. On Sunday the temperature went down but the nausea remained as did the aching.  I also got a patch red rash that looked like a hand slap around the injection site. That night I had diarrhea throughout the night and intense stomach cramps. On Monday, I am better but my arm is still a bit puffy and the re patchiness is now itchy.
Age: 20.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, TYP, VARCEL, YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives began on 05/02/2018. They started on the chest and spread to the stomach. They continued to spread over her body and continue spreading as of today, 05/07/2018. No difficulty breathing, throat swelling, nausea, vomiting, headaches, fevers. Patient has not sought care as of this time. She has been taking BENADRYL tabs to help with the itching. There is no resolution at this time.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Skin reaction
Clinical narrative: This spontaneous report was received from a a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unspecified date in 2008 (also reported as "about 10 years ago"), the patient was vaccinated with a one shot once of ZOSTAVAX (lot # and expiration date were not provided) route reported as injection, for prophylaxis. Patient reported "about one week after she got the vaccine, her arm blistered, burned, itched and the skin reaction kinda moved through her arm and then to her legs." The patient talked to her doctor who told her he felt "due to the nature of the reaction and the timing, it was likely unrelated to the vaccine." The patient took BENADRYL for the itching. If further treatments were provided they were not discussed. The patient has recovered. No further information is available. There was no product quality complaint (PQC) involved. The reporter did not assess the causality between the events and ZOSTAVAX.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Erythema, Fatigue, Pain, Swelling
Clinical narrative: Per patient that night he got home from getting the vaccine he was very tired and felt "run down". That continued for a total of 48 hours. Also had severe pain (still has moderate pain today 5/7/18), redness, swelling, and stated that the day after he got the shot he had post nasal drip/cough start (however, patient also stated that he has seasonal allergies and had some mild sinus symptoms the day before getting the vaccine).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Upper-airway cough syndrome
Clinical narrative: Per patient that night he got home from getting the vaccine he was very tired and felt "run down". That continued for a total of 48 hours. Also had severe pain (still has moderate pain today 5/7/18), redness, swelling, and stated that the day after he got the shot he had post nasal drip/cough start (however, patient also stated that he has seasonal allergies and had some mild sinus symptoms the day before getting the vaccine).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: By the evening of the shot (Thursday) my arm became sore. The following day, Friday, I had muscle aches and shivers; by the time I got home from work, about 5:30 p.m., I had a fever of 100, along with fatigue, muscle aches, and now the whole of my upper arm where the shot had been injected was extremely sore. By the third day after the shot, Saturday, I still had great fatigue, sore arm and by evening I felt feverish again. By Sunday I still had fatigue and my arm was sore, but less so. By Monday I was mostly feeling well. I self-treated with ibuprofen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: By the evening of the shot (Thursday) my arm became sore. The following day, Friday, I had muscle aches and shivers; by the time I got home from work, about 5:30 p.m., I had a fever of 100, along with fatigue, muscle aches, and now the whole of my upper arm where the shot had been injected was extremely sore. By the third day after the shot, Saturday, I still had great fatigue, sore arm and by evening I felt feverish again. By Sunday I still had fatigue and my arm was sore, but less so. By Monday I was mostly feeling well. I self-treated with ibuprofen.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Nausea, severe muscle/joint pain, feelings of impending doom, redness at injection site, hot to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: Nausea, severe muscle/joint pain, feelings of impending doom, redness at injection site, hot to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Headache, Heart rate increased, Injection site erythema
Clinical narrative: Nausea, severe muscle/joint pain, feelings of impending doom, redness at injection site, hot to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: Nausea, severe muscle/joint pain, feelings of impending doom, redness at injection site, hot to touch.