chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX. Concurrent medical conditions included rheumatoid arthritis. On 16th April 2018, the patient received SHINGRIX. On 16th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 17th April 2018, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was hoping to talk to someone other than 2 days from now. The patient has Rheumatoid Arthritis and had to take the non virus vaccine. The patient had her my first shot yesterday of SHINGRIX and she received it under her arm, which led to vaccine administered at inappropriate site, and it was so swollen today had a huge red raised area and her arm was so sore she queried if it was common, and is she could take to help it. The patient also queried if she should really get the 2nd shot, and if she does not would she be still covered and is 2nd dose a booster.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Rash, Rash papular
Clinical narrative: Rash located on upper back, upper R arm, forehead, Less amount on L upper arm. Tiny, papules, slightly erythema.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Nausea, Pharyngeal oedema
Clinical narrative: Patient was seen at Hospital ER around 11:15 am. on 4/23/18. Patients C/O- mild SOB, throat swelling, lightheadedness, and nausea 1 hr. after injection No apparent distress, otherwise, otherwise healthy patient. Medication given at ER BENADRYL oral 25mg, PEPCID oral 40mg, and Prednisone oral 60mg. Prescriptions - Prednisone 10 mg, BENADRYL 25 mg, PEPCID 20 mg, EPIPEN x 2. Pt. was discharged home and condition stable. Follow up in 1-2 weeks. Pt. states she received Tdap week before and had a reaction to that injection also. Pt. did not received the Tdap at the health department.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Experienced rigor throughout the night after vaccination. Also experienced swelling, rash, pain and erythema at the injection site from day 2 thru day 10.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Mouth/jaw tingling.
Age: 78.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Headache, Injection site rash, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Rash appeared at the injection site of PREVNAR 13 after 24 hours, later it spread to the other parts of the arm. Arms are sore, painful and difficulty in lifting the arm. Headache and fever for 2 days after receiving vaccine. Mild rash at the injection site of SHINGRIX. Disappeared after few days.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Audiogram abnormal, Dizziness, Ear discomfort, Ear pain, Hyperacusis
Clinical narrative: Within hour of receiving Flu shot noticed remarkable ringing in left ear that never have experienced. The ringing became worse followed by pain & pressure and partial hearing loss within two to three hours. Additionally, dizzy spells (vertigo followed). After pain and ringing in left ear didn't stop consulted an Ear doctor (Otolaryngologist). Several test were done including MRI and Audiology test that determined suffered partial hearing loss. Given low dose of Prednisone which did not work. As of 5/1/18 I have continuous ringing in left ear and occasional strong pain and pulsating in ear. I never had any ringing in ear prior to vaccination and had FLU shot every year for 25 years with no symptoms. I am 100% that the Flu shot caused my condition. I am now sensitive to noise especially high pitch noises.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoacusis, Nuclear magnetic resonance imaging brain normal, Tinnitus, Vertigo
Clinical narrative: Within hour of receiving Flu shot noticed remarkable ringing in left ear that never have experienced. The ringing became worse followed by pain & pressure and partial hearing loss within two to three hours. Additionally, dizzy spells (vertigo followed). After pain and ringing in left ear didn't stop consulted an Ear doctor (Otolaryngologist). Several test were done including MRI and Audiology test that determined suffered partial hearing loss. Given low dose of Prednisone which did not work. As of 5/1/18 I have continuous ringing in left ear and occasional strong pain and pulsating in ear. I never had any ringing in ear prior to vaccination and had FLU shot every year for 25 years with no symptoms. I am 100% that the Flu shot caused my condition. I am now sensitive to noise especially high pitch noises.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient noted the next day (Saturday 4-28-18) that her right arm was swollen, red, stinging and hurting.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: ARM IS INFLAMED AND ITCHY. IT IS VERY RED AND HOT TO THE TOUCH.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given less than 28 days after dose I.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Ear swelling, Rash, Rash erythematous, Urticaria
Clinical narrative: Ears swollen, red rash on face, rash/hives on bilateral arms.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states pain in arm started about 12 hrs after she got the shot. On day 3 after shot pt states the pain increased and she had difficulty moving her arm. Day 4 she took Aleve for the pain. Day 5 she presented to clinic to see provider. She was prescribed a Medrol dose pack. Spoke with pt on Day 6 and she states the pain is much improved, but still has decreased range of motion.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient received TDAP vaccine on 4/19/2018 during office visit. On 4/20/2018 the patient noticed a large lump where the vaccine was administered. She was seen on 4/24/2018 for another office visit. The lump was reported as painful, hot, and increasing in size. Warm compresses and cold compresses offered no relief.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Rash
Clinical narrative: 60 hours post vaccine developed severe muscle spasms. Left arm, back and neck which lasted for about 24 hours. Also developed rash on back.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: I have an employee who works in the Surgery center in an office by herself with no patient contact. Vaccinated with 1st Varicella vaccine of the series due to low immunity, level 0.78 on 4/10/18. Reports low grade fever 99.8 begun Sunday night 4/22/18. Reported to work on Monday, went straight to closed door office right off the front entrance of Surgery, worked 8-9 hrs yesterday and only came out to use the rest room. Otherwise remained in closed office from visitors and staff. Monday night, noticed sporadic red spots on face, arms, neck, and thighs. No clustering, no open lesions but itchy. Called off today, fever 100.0, contacted PCP, they explained the potential of rash, fever post vaccination. Called me, Recommendation/policy, must be fever free for 24 hrs without fever-reducer, and lesions must be dry and crusted. Informed she will need to call me to set up RTW prior to reporting back. Employee is able to work from home, if Leader approves. Treatment recommendation conservative, fever reducer, AVEENO bath for itch. Adverse risk.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Inconsolable crying, fussiness x 5 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Nausea, chills, fever, sore arm, tired.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Headache, Lymph node pain, Pain
Clinical narrative: Patient states that 10 days after injection (3/12/18), she had decreased appetite, headache, painful lymph nodes, body aches, fatigue, fever up to 101.0. No prior history of MMR as a child. Took Ibuprofen 400 mg BID. On 3/17/18 patient developed a macular rash on neck, torso, back, upper arms, proximal thighs with slight itching and low-grade temp 99.5, but otherwise feels improved. Was evaluated by nurse on 3/14, physician on 3/16, 3/17 (home visit), and 4/10. Unknown duration of rash, but was advised to self-quarantine for 5 days. Verified husband was vaccinated as a child.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash macular
Clinical narrative: Patient states that 10 days after injection (3/12/18), she had decreased appetite, headache, painful lymph nodes, body aches, fatigue, fever up to 101.0. No prior history of MMR as a child. Took Ibuprofen 400 mg BID. On 3/17/18 patient developed a macular rash on neck, torso, back, upper arms, proximal thighs with slight itching and low-grade temp 99.5, but otherwise feels improved. Was evaluated by nurse on 3/14, physician on 3/16, 3/17 (home visit), and 4/10. Unknown duration of rash, but was advised to self-quarantine for 5 days. Verified husband was vaccinated as a child.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Immunizations were given early. No known adverse reaction.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Exposure during pregnancy, Pericarditis
Clinical narrative: C/o chest pain 9d following vaccination. Discovered at that time to be pregnant. Currently d/w pericarditis.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Cardiovascular evaluation, Laboratory test, Pericarditis, Vaccination complication
Clinical narrative: C/o chest pain 9d following vaccination. Discovered at that time to be pregnant. Currently d/w pericarditis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Tenderness & soreness at injection site within a couple of hours dissipating by 04/30/2018. Flu like symptoms (chills & mild sweating) during very early AM on 04/27/2018- self limiting. Redness noted at injection site with a 2 inch diameter approximately 10 PM on 04/27/218, dissipating by AM on 05/01/2018. At no time did I run a fever or need to take Tylenol or ibuprofen. No impact on diet. Had full range or motion with left arm and shoulder.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Patient received vaccine at noon, in the evening reported Nausea and Fever for 3 days. Her arm was swollen, red, hard and warm to touch for 4 days. She used cold compress to arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient received vaccine at noon, in the evening reported Nausea and Fever for 3 days. Her arm was swollen, red, hard and warm to touch for 4 days. She used cold compress to arm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Blood culture negative, Culture urine negative, Diarrhoea haemorrhagic, Dyskinesia
Clinical narrative: 2 days after the vaccines started with bloody diarrhea, decreased intake and fever. 4-5 episodes of bloody diarrhea and fever up to 101. Due to the symptoms and age was hospitalized. He required IVF, abdominal US (normal), XR(normal), stool studies( PCR positive for EAE coli PCR -aggregate and Rota PCR), blood culture (negative), and urine culture (negative). After the initial 4-5 episodes of bloody diarrhea it resolved. He started to tolerate foods better. While in the hospital he became quite neutropenic, down to 70. Trended labs there and then at her hospital f/u here repeated a CBC and CMP. ANC now 1133 which is back at normal. Has continued to be more sleepy than normal, no quite acting himself per Mom. Had an episode in the hospital of 30-40 seconds of robotic type movements which concerned Mom. No further episodes since then. Will follow up next week to see how he is doing, overall looked good on exam, gaining weight and eating.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Escherichia test positive, Full blood count, Hypophagia, Metabolic function test, Neutropenia
Clinical narrative: 2 days after the vaccines started with bloody diarrhea, decreased intake and fever. 4-5 episodes of bloody diarrhea and fever up to 101. Due to the symptoms and age was hospitalized. He required IVF, abdominal US (normal), XR(normal), stool studies( PCR positive for EAE coli PCR -aggregate and Rota PCR), blood culture (negative), and urine culture (negative). After the initial 4-5 episodes of bloody diarrhea it resolved. He started to tolerate foods better. While in the hospital he became quite neutropenic, down to 70. Trended labs there and then at her hospital f/u here repeated a CBC and CMP. ANC now 1133 which is back at normal. Has continued to be more sleepy than normal, no quite acting himself per Mom. Had an episode in the hospital of 30-40 seconds of robotic type movements which concerned Mom. No further episodes since then. Will follow up next week to see how he is doing, overall looked good on exam, gaining weight and eating.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil count decreased, Polymerase chain reaction positive, Pyrexia, Rotavirus test positive, Somnolence
Clinical narrative: 2 days after the vaccines started with bloody diarrhea, decreased intake and fever. 4-5 episodes of bloody diarrhea and fever up to 101. Due to the symptoms and age was hospitalized. He required IVF, abdominal US (normal), XR(normal), stool studies( PCR positive for EAE coli PCR -aggregate and Rota PCR), blood culture (negative), and urine culture (negative). After the initial 4-5 episodes of bloody diarrhea it resolved. He started to tolerate foods better. While in the hospital he became quite neutropenic, down to 70. Trended labs there and then at her hospital f/u here repeated a CBC and CMP. ANC now 1133 which is back at normal. Has continued to be more sleepy than normal, no quite acting himself per Mom. Had an episode in the hospital of 30-40 seconds of robotic type movements which concerned Mom. No further episodes since then. Will follow up next week to see how he is doing, overall looked good on exam, gaining weight and eating.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen normal, X-ray normal
Clinical narrative: 2 days after the vaccines started with bloody diarrhea, decreased intake and fever. 4-5 episodes of bloody diarrhea and fever up to 101. Due to the symptoms and age was hospitalized. He required IVF, abdominal US (normal), XR(normal), stool studies( PCR positive for EAE coli PCR -aggregate and Rota PCR), blood culture (negative), and urine culture (negative). After the initial 4-5 episodes of bloody diarrhea it resolved. He started to tolerate foods better. While in the hospital he became quite neutropenic, down to 70. Trended labs there and then at her hospital f/u here repeated a CBC and CMP. ANC now 1133 which is back at normal. Has continued to be more sleepy than normal, no quite acting himself per Mom. Had an episode in the hospital of 30-40 seconds of robotic type movements which concerned Mom. No further episodes since then. Will follow up next week to see how he is doing, overall looked good on exam, gaining weight and eating.
Age: 20.0
Sex: F
Vaccine: HEP, IPV, TYP
Symptoms: Lip swelling, Pruritus, Rash, Rash pruritic
Clinical narrative: Pt states they got vaccinated with Typhoid, Hep B and IPV vaccines a little after noon on 30 April 2018 and felt nothing different after. Pt reports around 7pm they went to the movies and while there, they ate the only meal of the day, some popcorn and a soda. Pt reported they went home after the movies and it was after they got in bed that they had first symptoms of itching in the face. Pt states they took some over the count BENADRYL and was able to go to sleep but woke the next morning with swollen lips and itchy bumps on abdomen. Pt recalled during VAERS counseling that they just washed their bed sheets and uniform on Monday morning with a new detergent. Pt reports they now suspect detergent might have been cause of reaction as well. Pt. reports no history of allergic reaction or anything similar to current symptoms and allergic reactions.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient reported a red, itchy rash about 6 inches in diameter around the injection site starting the day after patient received vaccination. Patient reported adverse event to the pharmacy. Pharmacist recommended patient take BENADRYL if needed, but it is unclear if patient took BENADRYL or not. Six days following the vaccination, pharmacy contacted the patient and patient reported that the rash was receding and improving.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient started to get swelling and redness and itching of the arm about 3 to 4 hours after immunizations. Guardian stated that the area was very firm 24 hours after vaccination. The area was about 5 inches by 3 inches in erythema and warmth. Child was given some MOTRIN and BENADRYL. Also used cold compress. Started to feel better after 48 hours. Was seen in clinic on 4/30 for the symptoms. Improving symptoms at the time of the doctors visit. Recommended continued BENADRYL and MOTRIN and cold compresses and to watch the redness and swelling if no improvement in 48 to return to clinic.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: INJECTION SITE RED INFLAMED AND ITCH.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Extra dose administered, Herpes zoster, Rash, Wrong drug administered
Clinical narrative: I had received my original dose of ZOSTAVAX 11-17-2011, I was told 3-28-2018 that needed a booster. I questioned it because of my immune problem and they said it was just fine. I did not remember that one needed a booster for ZOSTAVAX, but I did not want a herpes zoster infection and went with it. Then a few days later I discovered that there is not booster for the ZOSTAVAX and that SHINGRIX was what I should have had. I contacted the Public Health Nurse and Clinic.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Syncope
Clinical narrative: Collapsed - fainting or weakness, did not pass out.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received immunization on 4/30/18 at approximately 4:30pm. On 5/1/18 she called the pharmacy at approximately 5:30pm to report her arm was red and swollen around the injection site and that it had spread down her arm toward her elbow. We discussed her putting ice on it which she was going to do. I suggested an otc antihistamine but she declined the use of that. I advised her to seek medical attention if the swelling/redness worsened or continued to spread.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient exhibited symptom of severe heat, swelling, pain and itchiness at and around injection site.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site reaction started an hour after leaving appointment. By the next day (5/1/18) per mom the area was very red and warm, with potential for cellulitis if left untreated. No fevers. Normal activity otherwise. Mom came in to have it checked, and NP prescribed KEFLEX x 7 days and gave child 5 mg dexamethasone in Ibuprofen (3.75 ml) as preventative measures.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient received vaccine 4/24 and called 5/1 stating she has had diarrhea, soreness at site, shivering, then 4/30 she started with a stiff neck and sore left leg, called her MD and MD suggested she take APAP.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pt complained of injection hurting for more than 2 weeks, at knot at the site of injection, redness, swelling, but no bruising, felt like a residual "phantom" pain. No fever though.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: Chills and flu like symptoms for 72 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site plaque
Clinical narrative: Note: she developed extremely painful red plaques near the injection site. The next day a second plaque appeared, without edema, just redness and pain. I treated these with prednisone 40mg a day for 2 days and they slowly disappeared.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling and painful.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient had soreness at the injection site and states that he still cannot lift his arm above his shoulder and does not have normal range of motion of the left arm.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging
Clinical narrative: The night of the vaccine, patient began having terrible headaches. She has missed almost seven weeks of school. They vary in intensity but do not go away. To date, we have been to our pediatrician, the ER, a neurologist, and had an MRI. So far, no medicine has worked to stop the headaches.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chills, Headache, Pyrexia
Clinical narrative: Low grade fever, chills, headache back of head, lower back pain. One whole day after injection.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Headache, Malaise, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: Low grade fever, chills, headache back of head, lower back pain. One whole day after injection.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever, chills, headache back of head, lower back pain. One whole day after injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Pyrexia, Tremor
Clinical narrative: Patient reports flu like symptoms: chills, fever, shaking, took ADVIL and stayed home from work one day. Felt fine after 1 day.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient experienced redness on left lower bicep that turned into rash. No itching or pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Swelling
Clinical narrative: Started out as a small red bump and over several days it measured 8" long by 3" wide. Within a few days it faded. At times the site was itchy. No treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Diplopia, Headache, Hyperhidrosis
Clinical narrative: Double vision, entire body sweated profusely, higher body temperature than usual 102, aches in all joint area, especially the hips and knees, nausea, headache.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Double vision, entire body sweated profusely, higher body temperature than usual 102, aches in all joint area, especially the hips and knees, nausea, headache.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Injection site induration, Injection site mass, Injection site pain, Irritability
Clinical narrative: Projectile vomiting and rectal fever of 101.7  the night of the vaccine. Crankiness and decreased appetite for about 4 days following vaccine. Hard lumps in thighs at injection sites which appeared to be painful and cause discomfort when touched.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Projectile vomiting and rectal fever of 101.7  the night of the vaccine. Crankiness and decreased appetite for about 4 days following vaccine. Hard lumps in thighs at injection sites which appeared to be painful and cause discomfort when touched.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient described over the phone reaction starting a few days after injection. She has hives, rash and itching. It is down her arm to her wrist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful redness at injection site evening of 4-25-18. Developed nausea, H/A, joint pain, fever of 100 degrees, redness and swelling at site on 4-26-18. Margins marked on 4-26-18. Went to U.C. 4-27-18. Redness, swelling beyond margins. Heat to site recommended at U.C. Symptoms resolved 5-1-18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: Painful redness at injection site evening of 4-25-18. Developed nausea, H/A, joint pain, fever of 100 degrees, redness and swelling at site on 4-26-18. Margins marked on 4-26-18. Went to U.C. 4-27-18. Redness, swelling beyond margins. Heat to site recommended at U.C. Symptoms resolved 5-1-18.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red bump and ring around site of PEDIARIX mild warmth to the area, swelling and pain.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports arm became red, swollen and painful. Patient reports he was told by physicians at medical center he had cellulitis in this arm. Admitted to hospital and given IV antibiotics.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Blister, Blood test normal, Burning sensation, Discomfort
Clinical narrative: I had a SHINGRIX shingles inoculation on the above date, the first in the two part series. About five days after the injection, about the time that the usual 'kick' in arm the feeling at an injection site had passed, I started to have all over aching muscles, stiffness and generally feeling unwell. I also developed a burning sensation over the surface of the right side of my stomach and an area down from the groin spreading into the inside of my right thigh. Ten days after the injection, feeling pretty generally miserable, I saw a primary care physician who investigated my response to physician physical prodding of organs located in the area of discomfort, sent me for a stomach x-ray x-ray, and an array of blood and urine tests. The results were all negative: in the office I had no fever, regular low blood pressure, no pain from physical investigation; the lab results were all within the normal range including a negative result for inflammation. But brushing across the surface of my stomach rather than prodding was uncomfortable and I began feeling rather sharp jabs in my right side and a whole central body 'jolt' - a sensation I'm afraid I can't properly describe. The following morning, the 24th 24th, I woke up to find two red blisters center and right, low on my stomach and over the following four days my lower right stomach area and a band just below my waist waist, around my right side to mid back has broken out with a blistery red rash. It's truly painful rather than simply uncomfortable, deeply felt pain as well as a shocking surface jolt whenever just carelessly grazed. Confirmed by my doctor yesterday, this is indeed shingles and I think that it would be too great a coincidence not to conclude that it's my body's reaction to the SHINGRIX injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Herpes zoster, Hypotension, Inflammatory marker test
Clinical narrative: I had a SHINGRIX shingles inoculation on the above date, the first in the two part series. About five days after the injection, about the time that the usual 'kick' in arm the feeling at an injection site had passed, I started to have all over aching muscles, stiffness and generally feeling unwell. I also developed a burning sensation over the surface of the right side of my stomach and an area down from the groin spreading into the inside of my right thigh. Ten days after the injection, feeling pretty generally miserable, I saw a primary care physician who investigated my response to physician physical prodding of organs located in the area of discomfort, sent me for a stomach x-ray x-ray, and an array of blood and urine tests. The results were all negative: in the office I had no fever, regular low blood pressure, no pain from physical investigation; the lab results were all within the normal range including a negative result for inflammation. But brushing across the surface of my stomach rather than prodding was uncomfortable and I began feeling rather sharp jabs in my right side and a whole central body 'jolt' - a sensation I'm afraid I can't properly describe. The following morning, the 24th 24th, I woke up to find two red blisters center and right, low on my stomach and over the following four days my lower right stomach area and a band just below my waist waist, around my right side to mid back has broken out with a blistery red rash. It's truly painful rather than simply uncomfortable, deeply felt pain as well as a shocking surface jolt whenever just carelessly grazed. Confirmed by my doctor yesterday, this is indeed shingles and I think that it would be too great a coincidence not to conclude that it's my body's reaction to the SHINGRIX injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Laboratory test normal, Malaise, Musculoskeletal stiffness, Myalgia
Clinical narrative: I had a SHINGRIX shingles inoculation on the above date, the first in the two part series. About five days after the injection, about the time that the usual 'kick' in arm the feeling at an injection site had passed, I started to have all over aching muscles, stiffness and generally feeling unwell. I also developed a burning sensation over the surface of the right side of my stomach and an area down from the groin spreading into the inside of my right thigh. Ten days after the injection, feeling pretty generally miserable, I saw a primary care physician who investigated my response to physician physical prodding of organs located in the area of discomfort, sent me for a stomach x-ray x-ray, and an array of blood and urine tests. The results were all negative: in the office I had no fever, regular low blood pressure, no pain from physical investigation; the lab results were all within the normal range including a negative result for inflammation. But brushing across the surface of my stomach rather than prodding was uncomfortable and I began feeling rather sharp jabs in my right side and a whole central body 'jolt' - a sensation I'm afraid I can't properly describe. The following morning, the 24th 24th, I woke up to find two red blisters center and right, low on my stomach and over the following four days my lower right stomach area and a band just below my waist waist, around my right side to mid back has broken out with a blistery red rash. It's truly painful rather than simply uncomfortable, deeply felt pain as well as a shocking surface jolt whenever just carelessly grazed. Confirmed by my doctor yesterday, this is indeed shingles and I think that it would be too great a coincidence not to conclude that it's my body's reaction to the SHINGRIX injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Urine analysis normal, X-ray normal
Clinical narrative: I had a SHINGRIX shingles inoculation on the above date, the first in the two part series. About five days after the injection, about the time that the usual 'kick' in arm the feeling at an injection site had passed, I started to have all over aching muscles, stiffness and generally feeling unwell. I also developed a burning sensation over the surface of the right side of my stomach and an area down from the groin spreading into the inside of my right thigh. Ten days after the injection, feeling pretty generally miserable, I saw a primary care physician who investigated my response to physician physical prodding of organs located in the area of discomfort, sent me for a stomach x-ray x-ray, and an array of blood and urine tests. The results were all negative: in the office I had no fever, regular low blood pressure, no pain from physical investigation; the lab results were all within the normal range including a negative result for inflammation. But brushing across the surface of my stomach rather than prodding was uncomfortable and I began feeling rather sharp jabs in my right side and a whole central body 'jolt' - a sensation I'm afraid I can't properly describe. The following morning, the 24th 24th, I woke up to find two red blisters center and right, low on my stomach and over the following four days my lower right stomach area and a band just below my waist waist, around my right side to mid back has broken out with a blistery red rash. It's truly painful rather than simply uncomfortable, deeply felt pain as well as a shocking surface jolt whenever just carelessly grazed. Confirmed by my doctor yesterday, this is indeed shingles and I think that it would be too great a coincidence not to conclude that it's my body's reaction to the SHINGRIX injection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythromacular rash in a 60-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 26th March 2018 11:18, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 1 day after receiving SHINGRIX, the patient experienced erythromacular rash. On an unknown date, the outcome of the erythromacular rash was not recovered/not resolved. It was unknown if the reporter considered the erythromacular rash to be related to SHINGRIX. Additional information was received as follows: The reporter stated that the patient developed red spots on her chest the day after receiving the SHINGRIX. The spots appeared to be enlarging but the number of spots had not increased. At the time of reporting, they were fingertip size red spots that did not itch or cause pain.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain a adult female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRX, the patient experienced injection site pain, injection site bruising and wrong injection technique. On an unknown date, the outcome of the injection site pain, injection site bruising and wrong injection technique were unknown. The reporter considered the injection site pain and injection site bruising to be unlikely related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional called to make sure he was preparing the SHINGRIX vaccine correctly. The healthcare professional stated that he gave SHINGRIX to the patient 2 weeks before the date of reporting and the patient had bruising and some soreness at the injection site. The healthcare professional felt that was related to his technique and not to the SHINGRIX vaccine itself. The healthcare professional did not want to report this as an adverse event or be contacted further about it. The patient had denied permission to contact their physician.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 80-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 14th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 14th April 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, general body pain and headache. In April 2018, the outcome of the shivering and general body pain were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving. It was unknown if the reporter considered the shivering, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm.
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 adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, the dose was an unknown dose. 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that his doctor's wife experienced pain in her arm after receiving the SHINGRIX injection. The reporter stated that his doctor just mentioned this to him and he did not have any additional information regarding this event.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 56-year-old male patient who received SHINGRIX. Concurrent medical conditions included knee pain (work related - prior to receiving vaccine) and blood cholesterol increased. Concomitant products included sertraline, simvastatin, Testosterone Shot and TRILIPIX. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, several hours after receiving SHINGRIX, the patient experienced nausea. On 17th April 2018, the patient experienced injection site pain. On 18th April 2018, the patient experienced facial flushing. On an unknown date, the outcome of the nausea was recovering/resolving and the outcome of the injection site pain and facial flushing were recovered/resolved. It was unknown if the reporter considered the nausea, injection site pain and facial flushing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The before the day of reporting, at around 1:30 or 2 pm, the patient received the SHINGRIX vaccine. The patient stated that during the injection, he felt pain immediately, but that this pain went away after the injection was completed. The night of the day of reporting, the patient experienced waves of nausea. The patient experienced it a little on the day of reporting, in morning as well every so often. The patient stated that he took ginger ale and it seemed to have resolved. The patient also stated that on the day of reporting, in morning, (1 day after receiving SHINGRIX), the patient experienced flushing of his face and he took some ibuprofen and that has resolved as well.
Age: 92.0
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 92-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 24th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The reporter did not have all event details because another healthcare professional administered SHINGRIX to the patient (in an unknown deltoid). The reporter did not know how long after SHINGRIX that the patient developed the shingles. The patient was treated by their physician for shingles. The batch number reported for SHINGRIX (53982), did not exist and was updated to 539A2, as per sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: This case was reported by other health professional via sales rep and described the occurrence of local swelling in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling and hives. On an unknown date, the outcome of the local swelling and hives were recovered/resolved. The reporter considered the local swelling and hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his case for herself. The patient received SHINGRIX in an unknown deltoid and experienced swelling from shoulder to elbow and hives on skin. Follow up would be conducted to provide more information.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vitreous floaters
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling of feet in a 69-year-old male patient who received SHINGRIX (batch number ZX3YA, expiry date 28th April 2020). The patient's past medical history included heart disorder. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 11th April 2018, 14 days after receiving SHINGRIX, the patient experienced swelling of feet and eye floaters. On an unknown date, the outcome of the swelling of feet was recovering/resolving and the outcome of the eye floaters was not recovered/not resolved. It was unknown if the reporter considered the swelling of feet and eye floaters to be related to SHINGRIX. Additional details were provided as follows: The patient experienced toe swelling and feeling of 'lint' in eye. The pharmacist stated more in likely it was a floater. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Influenza, Injection site erythema, Malaise
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient also experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a physician via interactive digital media and described the occurrence of general body pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint. On an unknown date, the outcome of the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema, unwell and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the general body pain, fever, pain in arm, flu syndrome, diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient also experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea, fatigue, injection site erythema and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician purchased a dose of SHINGRIX and had a patient with bad side effects. The patient experienced sore arm, redness around injection site, flu syndrome, fever, fatigue, and diarrhea. The physician also posted on social media, SHINGRIX made the patient ill and he would not give SHINGRIX to another human. The physician was requesting reimbursement for these doses of SHINGRIX. The Vaccine Service Center (VSC) said that, they could only reimburse for a product complaint. His main thought was to get reimbursed. He would like to talk to someone. He was requesting to speak with the vice president of the company. He reached out to his sales representative who had not gotten back to him. The physician would like a call back to resolve this situation. The physician was not willing to provide more information about the adverse event's because he had already reported the events. This is 1 of 13 cases, reported by the same reporter for the patient's who experienced adverse events after receiving SHINGRIX.