chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: I got up to use the bathroom at around midnight and because very dizzy and faint. I was able to get back into bed without falling. At about 3:30, I awoke and was extremely hot and uncomfortable. Both arms were sore, the right one was very swollen. I got up to have a drink of water, felt dizzy and began to knee down on the floor. I awoke some time later, on the floor, feeling extremely dizzy, hot and nauseous. I vomited several times. I was unable to get up for quite a while but my husband brought me some ibuprofen and water and after a time, I felt well enough to get up and use the bathroom. After that, I was still dizzy, but made it back to bed. When I awoke around 9am, I felt better than I had the previous night and sat up in bed for several minutes but became dizzy and nauseous and lay down again. By noon, I was able to get up for the bathroom and felt lightheaded but not as much as before. I continue to feel lightheaded, slightly nauseous, and my right arm is still painful and swollen.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Crying, Dyskinesia, Electroencephalogram, Eye movement disorder
Clinical narrative: Verbally called by RN in influenza vaccination clinic that child was in distress. I came immediately to room and encountered child in RNs arms, having seizure activity consisting of rhythmic jerking of limbs, eyes rolling upward repeatedly, hands clenched. Color normal. Child was placed on exam table in decubitus position and I called for oxygen and emergency kit and asked staff to activate EMS. Child with strong femoral pulse and normal respirations during seizure, no color change. 5L O2 by FM was placed on baby, O2 sat 98-100%, HRs 150s throughout. Seizure lasted approximately 2-3 minutes. Baby was bulb suctioned x 3 during episode to help clear secretions. No vomiting. HR and respirations normal throughout episode. At conclusion of seizure baby remained in post-ictal state for approx 2-3 min at which time EMS arrived. Glucose normal, saturations normal, baby vigorous and crying with normal exam. Baby transported via EMS.  I discussed seizure with parents before transport and let them know I would also communicate with PMD.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Joint contracture, Postictal state, Seizure, Ultrasound bladder, Ultrasound kidney
Clinical narrative: Verbally called by RN in influenza vaccination clinic that child was in distress. I came immediately to room and encountered child in RNs arms, having seizure activity consisting of rhythmic jerking of limbs, eyes rolling upward repeatedly, hands clenched. Color normal. Child was placed on exam table in decubitus position and I called for oxygen and emergency kit and asked staff to activate EMS. Child with strong femoral pulse and normal respirations during seizure, no color change. 5L O2 by FM was placed on baby, O2 sat 98-100%, HRs 150s throughout. Seizure lasted approximately 2-3 minutes. Baby was bulb suctioned x 3 during episode to help clear secretions. No vomiting. HR and respirations normal throughout episode. At conclusion of seizure baby remained in post-ictal state for approx 2-3 min at which time EMS arrived. Glucose normal, saturations normal, baby vigorous and crying with normal exam. Baby transported via EMS.  I discussed seizure with parents before transport and let them know I would also communicate with PMD.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Myalgia
Clinical narrative: Shingles rash, myalgias, severe headache
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Induration, Pyrexia, Vomiting
Clinical narrative: Throwing up and fever on Sunday Now Red hard arm
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Decreased appetite, Diplopia, Magnetic resonance imaging
Clinical narrative: Double vision with nausea and loss of appetite.   Went to ER had CT scan and MRI.  Diagnosed with Sixth nerve palsy with no known cause.    I don't know which flu vaccine was given, but it was not the double dose for age over 65.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Urine analysis, VIth nerve paralysis
Clinical narrative: Double vision with nausea and loss of appetite.   Went to ER had CT scan and MRI.  Diagnosed with Sixth nerve palsy with no known cause.    I don't know which flu vaccine was given, but it was not the double dose for age over 65.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt has received two doses of the Fluad high dose flu vaccine within one month. Pt not experiencing any adverse events
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Headache, Loss of personal independence in daily activities, Mechanical urticaria
Clinical narrative: I received the Flu Vaccination on 10/11/19 at approximately 3pm. By approximately 7pm I began to have a headache, whole body aching, a low grade fever, and chest pain. I took Ibuprofen and went to bed. I was awake frequently due to the pain. Saturday I also began to develop an itch throughout my body. Everywhere I scratched became red and swollen with hives, and increasingly itchy. I took a shower, applied lotion, and even tried applying vicks vapor rub which momentarily relieved the itching. I eventually took Zyrtec before going to bed which helped to alleviate the itching and allowed me to sleep. Monday Morning (10/14/19) I was feeling much better, and went to work. I found myself itching throughout the day and the red marks continued to develop everywhere that I scratched. I scheduled an appointment with my Primary Care Provider for that evening. After meeting with my Dr. I was prescribed Benadryl and Zyrtec and was told that I should stay home from work the next day (today 10/15/19) due to the effects of the Medications. I was diagnosed with Dermatographia which they believe was caused by the Flue Vaccination.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Poor quality sleep, Pruritus, Pyrexia, Swelling
Clinical narrative: I received the Flu Vaccination on 10/11/19 at approximately 3pm. By approximately 7pm I began to have a headache, whole body aching, a low grade fever, and chest pain. I took Ibuprofen and went to bed. I was awake frequently due to the pain. Saturday I also began to develop an itch throughout my body. Everywhere I scratched became red and swollen with hives, and increasingly itchy. I took a shower, applied lotion, and even tried applying vicks vapor rub which momentarily relieved the itching. I eventually took Zyrtec before going to bed which helped to alleviate the itching and allowed me to sleep. Monday Morning (10/14/19) I was feeling much better, and went to work. I found myself itching throughout the day and the red marks continued to develop everywhere that I scratched. I scheduled an appointment with my Primary Care Provider for that evening. After meeting with my Dr. I was prescribed Benadryl and Zyrtec and was told that I should stay home from work the next day (today 10/15/19) due to the effects of the Medications. I was diagnosed with Dermatographia which they believe was caused by the Flue Vaccination.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Vaccination complication
Clinical narrative: I received the Flu Vaccination on 10/11/19 at approximately 3pm. By approximately 7pm I began to have a headache, whole body aching, a low grade fever, and chest pain. I took Ibuprofen and went to bed. I was awake frequently due to the pain. Saturday I also began to develop an itch throughout my body. Everywhere I scratched became red and swollen with hives, and increasingly itchy. I took a shower, applied lotion, and even tried applying vicks vapor rub which momentarily relieved the itching. I eventually took Zyrtec before going to bed which helped to alleviate the itching and allowed me to sleep. Monday Morning (10/14/19) I was feeling much better, and went to work. I found myself itching throughout the day and the red marks continued to develop everywhere that I scratched. I scheduled an appointment with my Primary Care Provider for that evening. After meeting with my Dr. I was prescribed Benadryl and Zyrtec and was told that I should stay home from work the next day (today 10/15/19) due to the effects of the Medications. I was diagnosed with Dermatographia which they believe was caused by the Flue Vaccination.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient states arm soreness never went away after shot. She went to Dr's office yesterday 10/14 and was told that the flu shot potentially hit a nerve from being injected too deep in the arm which resulted in a radiated pain in the upper shoulder. There was no sign of the flu shot being administered into the bursae around the shoulder, it was the Dr's opinion that it was administered too deeply into the arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever since 2:00 pm today.  Going to bed.
Age: 71.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Burning sensation, Pain, Parosmia
Clinical narrative: After administering flu vaccine pt stated to smell something strong, then administered the shingrix vaccine. Pt felt burning sensation on back and throughout body. Pt could breathe, but pain was unbearable. Gave patient water. Denied ambulance. Pt stated that she felt it was the influenza vaccine. Checked BP after pt was calm 137/67 with pulse of 83. Patient sat for about 45 more minutes, checked BP again 127/73 w/ pulse 73. Pt felt fine to leave.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Fatigue, Heart rate increased, Paraesthesia, Vision blurred
Clinical narrative: increased heart rate, tingling, metalic taste, blurry vision night following having Shingrix and fatigue for the next day, reported her symptoms to dr who advised her not to receive another dose.
Age: 75.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain in extremity
Clinical narrative: large area of redness and pain in arm below where the shot was given
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: shortness of breath, increased heart rate, chest pain
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site bruising, Insomnia, Pain in extremity
Clinical narrative: Patient states she's had soreness in the injection arm with a bruise at the site of injection. She states has been unable to lift her arm up or sleep, and so she had to go to the ER for treatment
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: tight chest, problems breathing
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Starting 1 day after the administration, patient started experiencing left arm pain and swelling. Patient had also received a flu vaccine in the other arm during the same visit. Patient reported her symptoms in the left arm got progressively worse and included heat, pain, itching and the appearance of a rash which the patient described as "bumps". 2 days later, the patient developed a low grade intermittent fever and chills. About 4 days ago from the date of this report, patient started developing a rash on her left side which extended to her stomach. Patient visited her PCP who concluded that it may be shingles but did not prescribe any treatments.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Starting 1 day after the administration, patient started experiencing left arm pain and swelling. Patient had also received a flu vaccine in the other arm during the same visit. Patient reported her symptoms in the left arm got progressively worse and included heat, pain, itching and the appearance of a rash which the patient described as "bumps". 2 days later, the patient developed a low grade intermittent fever and chills. About 4 days ago from the date of this report, patient started developing a rash on her left side which extended to her stomach. Patient visited her PCP who concluded that it may be shingles but did not prescribe any treatments.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called on 10/15 saying her arm still hurt.  She said that her arm normally hurts for extended period of times after her flu shot.  She said it hurts when she lays down and something if holding phones etc.  I called the MD for her but they wanted her to call the doctor.  I relayed information to pt.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: patient had some pain when she got the injection and she has pain continuing after 5 days in the injection site sometines radiating to the sfoulder and sone times to the neck. No rash or swelling and injection site looks normal
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Injection site erythema, Myalgia, Rash, Rash erythematous
Clinical narrative: Big red ring around injection site, raised red/pink spotted rash on back, back of neck up ears around hair line, on the face ( face swollen) down to chest. Instructed to tKe Benadryl by Dr seen on 10/15/2019. Feeling weak with muscle aches.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Rash papular, Swelling face
Clinical narrative: Big red ring around injection site, raised red/pink spotted rash on back, back of neck up ears around hair line, on the face ( face swollen) down to chest. Instructed to tKe Benadryl by Dr seen on 10/15/2019. Feeling weak with muscle aches.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Malaise, Tachycardia
Clinical narrative: Patient reported tachycardia, chills, and malaise. Patient stated that she treated her rapid heartbeat with some nitro tablets that she had.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient stated that she got hives one day after the vaccine and that it cleared up the same day with diphenhydramine
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient is complaining about continuous muscle pain.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient had red inflamed swollen area NOT at the actual injection site (lateral), but medially (on the inside of her arm basically from her armpit to her elbow). She said it happened very shortly after getting the vaccine and she said it feels tender to the touch. It is not swollen, red, or inflamed at the site of injection, but the she does have the usual post injection soreness at the injections site.
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: swollen site of injection, red about 3cm by day 3, bigger by day 7. Hot to the touch and very painful
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: pain and soreness at the injection site lasting 3 days, he did not seek medical attention and it is no longer causing pain.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: patient had severe arm pain could not lift arm till Monday 10-14-2019 also reported neck and shoulder pain I suggested Ibuprofen every 8 hours and add Acetaminophen 1000mg if Ibuprofen does not handle the pain and also suggested ice on and off every 20 minutes when she can.  Spoke to patient today 10-15-2019 and she stated all back to normal. no pain.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Headache, chills, aching, legs hurting, lower abdomen hurting
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient developed itching approximately one hour after receiving the flu vaccine at the fire house. He took some Benadryl. Approximately 12 hours later the sx recurred and were accompanied by some hives on the upper left arm.  He does not know which flu vaccine he received.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on trunk
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain, Paraesthesia
Clinical narrative: The patient described that he experienced a severe neuropathy from his head to toes, that caused tingling pain and numbness. He stated that he was seen by a specialist and the symptoms are just now starting to resolve.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Burning sensation, Food allergy, Nerve conduction studies normal, Neuropathy peripheral
Clinical narrative: The patient described that he experienced a severe neuropathy from his head to toes, that caused tingling pain and numbness. He stated that he was seen by a specialist and the symptoms are just now starting to resolve.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: The patient described that he experienced a severe neuropathy from his head to toes, that caused tingling pain and numbness. He stated that he was seen by a specialist and the symptoms are just now starting to resolve.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Local reaction at left arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Patient developed erythema and pain to bilateral thighs one day after vaccines. Since then the redness has improved, but discoloration noted. Not painful, no induration, just purple discoloration.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Patient developed a raised, splotchy, red rash on her chest that spans across her upper chest from armpit to armpit. She says it does not hurt, burn, or itch. She says she does not know when it occurred, outside of the fact that it started after she received her first dose of her Shingrix vaccine series. It has been two months since her first dose and the rash is still present.
Age: 85.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Voicemail received and passed to nurse 10.15.2019. Nurse called to follow up with patient. Patient reported: After his visit on 09.23.2019 around 6pm that evening he started to feel feverish, bodyaches, his left arm became painful and swollen from his shoulder down to his elbow, and he passed out for a bit. When he came to he called EMS with his life alert and was taken to Hospital ER. Hospital kept him there for the night and discharged him the next day.   Patient stated his arm is no longer swollen nor painful anymore.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Electrocardiogram, Sensation of foreign body
Clinical narrative: Pt into office 10-14-19 0921AM - Given Influenza High Dose Trivalent vaccine 0.5mL IM 10:00AM. Pt Returned to office 10-14-19 1422 c/o feeling like a lump was in his throat becoming difficult to swallow. Admin 0.3 mL Epi 1mg/mL. Prednisolone 60mg, Albuterol Neb 2.5mg/3mL, EKG and transported to ED via EMS
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: 48 hours after vaccine given in (L) deltoid, pt reported pain/aching in (L) deltoid/upper arm. Next day had radiation to elbow, forearm-still present in upper arm. On 10-11-19-seen in CLINIC w/her pain in (L) arm 6/10 with use, 4/10 @ rest. Exam: no inflammation seen, possible tingling sensation/strength.
Age: 84.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Peripheral swelling, Somnolence
Clinical narrative: Severe soreness, swelling of arm, excessive sleepiness for next day antibiotic prescribed by MD
Age: 73.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Rash
Clinical narrative: lump; itchy; large red lump; cold; joint pain; runny eyes; stuffy nose; throat issues; soreness; history of joint pain but it has much worse after vaccination; miserable; This case was reported by a nurse via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (had many years ago). Previously administered products included Hepatitis B vaccine with an associated reaction of injection site pain (received many years ago, refer linked case US2019AMR182433). Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), herpes zoster, diabetes and arthralgia.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced cold, joint pain, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated and feeling miserable. On 3rd October 2019, the patient experienced skin mass, pruritus and erythema. The patient was treated with non-drug therapy (Cold Compress) and non-drug therapy (Wet Compress). On an unknown date, the outcome of the cold, skin mass, eye discharge, nasal stuffiness, throat discomfort, pain in arm and erythema were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the pruritus, condition aggravated and feeling miserable were unknown.   It was unknown if the reporter considered the cold, joint pain, skin mass, pruritus, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated, feeling miserable and erythema to be related to Shingrix.  Additional information received were as follows: The retired nurse practitioner reported that she received her first dose of Shingrix on left deltoid. In that night, the patient's arm really hurt and she was miserable. The patient described the arm as sore.  The patient also felt like she had a cold which she described as runny eyes, stuffy nose and throat issues. The patient also experienced joint pain that has not resolved.  The patient had a history of joint pain but it had been much worse after the vaccination.  Three days later, the patient experienced a large red lump two inches below the injection site and it made her arm look like she was a muscle builder. The patient said that the area was painful and itchy and she put a cold wet compress on it and within 2 to 3 days, things got better but the red lump moved lower to her elbow and then resolved.  The reporter consented to follow up. The patient stated that the Shingrix issue cleared up in a couple of days.
Age: 73.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Arthralgia, Condition aggravated, Erythema, Eye discharge, Feeling abnormal
Clinical narrative: lump; itchy; large red lump; cold; joint pain; runny eyes; stuffy nose; throat issues; soreness; history of joint pain but it has much worse after vaccination; miserable; This case was reported by a nurse via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (had many years ago). Previously administered products included Hepatitis B vaccine with an associated reaction of injection site pain (received many years ago, refer linked case US2019AMR182433). Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), herpes zoster, diabetes and arthralgia.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced cold, joint pain, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated and feeling miserable. On 3rd October 2019, the patient experienced skin mass, pruritus and erythema. The patient was treated with non-drug therapy (Cold Compress) and non-drug therapy (Wet Compress). On an unknown date, the outcome of the cold, skin mass, eye discharge, nasal stuffiness, throat discomfort, pain in arm and erythema were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the pruritus, condition aggravated and feeling miserable were unknown.   It was unknown if the reporter considered the cold, joint pain, skin mass, pruritus, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated, feeling miserable and erythema to be related to Shingrix.  Additional information received were as follows: The retired nurse practitioner reported that she received her first dose of Shingrix on left deltoid. In that night, the patient's arm really hurt and she was miserable. The patient described the arm as sore.  The patient also felt like she had a cold which she described as runny eyes, stuffy nose and throat issues. The patient also experienced joint pain that has not resolved.  The patient had a history of joint pain but it had been much worse after the vaccination.  Three days later, the patient experienced a large red lump two inches below the injection site and it made her arm look like she was a muscle builder. The patient said that the area was painful and itchy and she put a cold wet compress on it and within 2 to 3 days, things got better but the red lump moved lower to her elbow and then resolved.  The reporter consented to follow up. The patient stated that the Shingrix issue cleared up in a couple of days.
Age: 73.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Nasal congestion
Clinical narrative: lump; itchy; large red lump; cold; joint pain; runny eyes; stuffy nose; throat issues; soreness; history of joint pain but it has much worse after vaccination; miserable; This case was reported by a nurse via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (had many years ago). Previously administered products included Hepatitis B vaccine with an associated reaction of injection site pain (received many years ago, refer linked case US2019AMR182433). Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), herpes zoster, diabetes and arthralgia.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced cold, joint pain, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated and feeling miserable. On 3rd October 2019, the patient experienced skin mass, pruritus and erythema. The patient was treated with non-drug therapy (Cold Compress) and non-drug therapy (Wet Compress). On an unknown date, the outcome of the cold, skin mass, eye discharge, nasal stuffiness, throat discomfort, pain in arm and erythema were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the pruritus, condition aggravated and feeling miserable were unknown.   It was unknown if the reporter considered the cold, joint pain, skin mass, pruritus, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated, feeling miserable and erythema to be related to Shingrix.  Additional information received were as follows: The retired nurse practitioner reported that she received her first dose of Shingrix on left deltoid. In that night, the patient's arm really hurt and she was miserable. The patient described the arm as sore.  The patient also felt like she had a cold which she described as runny eyes, stuffy nose and throat issues. The patient also experienced joint pain that has not resolved.  The patient had a history of joint pain but it had been much worse after the vaccination.  Three days later, the patient experienced a large red lump two inches below the injection site and it made her arm look like she was a muscle builder. The patient said that the area was painful and itchy and she put a cold wet compress on it and within 2 to 3 days, things got better but the red lump moved lower to her elbow and then resolved.  The reporter consented to follow up. The patient stated that the Shingrix issue cleared up in a couple of days.
Age: 73.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal discomfort, Pain in extremity, Pruritus, Skin mass
Clinical narrative: lump; itchy; large red lump; cold; joint pain; runny eyes; stuffy nose; throat issues; soreness; history of joint pain but it has much worse after vaccination; miserable; This case was reported by a nurse via call center representative and described the occurrence of cold in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (had many years ago). Previously administered products included Hepatitis B vaccine with an associated reaction of injection site pain (received many years ago, refer linked case US2019AMR182433). Concurrent medical conditions included immunocompromised (Compromised immune system diagnosed in 2003), herpes zoster, diabetes and arthralgia.   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, less than a day after receiving Shingrix, the patient experienced cold, joint pain, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated and feeling miserable. On 3rd October 2019, the patient experienced skin mass, pruritus and erythema. The patient was treated with non-drug therapy (Cold Compress) and non-drug therapy (Wet Compress). On an unknown date, the outcome of the cold, skin mass, eye discharge, nasal stuffiness, throat discomfort, pain in arm and erythema were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the pruritus, condition aggravated and feeling miserable were unknown.   It was unknown if the reporter considered the cold, joint pain, skin mass, pruritus, eye discharge, nasal stuffiness, throat discomfort, pain in arm, condition aggravated, feeling miserable and erythema to be related to Shingrix.  Additional information received were as follows: The retired nurse practitioner reported that she received her first dose of Shingrix on left deltoid. In that night, the patient's arm really hurt and she was miserable. The patient described the arm as sore.  The patient also felt like she had a cold which she described as runny eyes, stuffy nose and throat issues. The patient also experienced joint pain that has not resolved.  The patient had a history of joint pain but it had been much worse after the vaccination.  Three days later, the patient experienced a large red lump two inches below the injection site and it made her arm look like she was a muscle builder. The patient said that the area was painful and itchy and she put a cold wet compress on it and within 2 to 3 days, things got better but the red lump moved lower to her elbow and then resolved.  The reporter consented to follow up. The patient stated that the Shingrix issue cleared up in a couple of days.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Facial pain, Injection site pain, Myalgia, Nausea
Clinical narrative: Blistered; spot on the bridge of his nose; Rash on nose; shingles; Nose getting red; Nose started being painful; Nose sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of nasal pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 1st case of shingles in 10 to 12 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced nasal pain, nasal soreness, shingles and erythema. On 10th September 2019, the patient experienced red rash and spot-like rash. On 12th September 2019, the patient experienced blister. On an unknown date, the outcome of the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash to be related to Shingrix.  Additional details were reported as follows: The patient received dos eof Shingrix in the local pharmacy at around noon. The reporter stated that, in the same evening after vaccination, the patient experienced painful nose, sore to touch and getting red. The next day after vaccination , the patient had red rash on his noseand 2 days later it blistered. The patient visited his phisician on 3rd October 2019 and was told it was shingles. Till the time of reporting, the patient still had it. The patient had a spot on the bridge of his nose that he was afraid might get a scar. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Blistered; spot on the bridge of his nose; Rash on nose; shingles; Nose getting red; Nose started being painful; Nose sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of nasal pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 1st case of shingles in 10 to 12 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced nasal pain, nasal soreness, shingles and erythema. On 10th September 2019, the patient experienced red rash and spot-like rash. On 12th September 2019, the patient experienced blister. On an unknown date, the outcome of the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash to be related to Shingrix.  Additional details were reported as follows: The patient received dos eof Shingrix in the local pharmacy at around noon. The reporter stated that, in the same evening after vaccination, the patient experienced painful nose, sore to touch and getting red. The next day after vaccination , the patient had red rash on his noseand 2 days later it blistered. The patient visited his phisician on 3rd October 2019 and was told it was shingles. Till the time of reporting, the patient still had it. The patient had a spot on the bridge of his nose that he was afraid might get a scar. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Rash erythematous, Rash macular
Clinical narrative: Blistered; spot on the bridge of his nose; Rash on nose; shingles; Nose getting red; Nose started being painful; Nose sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of nasal pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 1st case of shingles in 10 to 12 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced nasal pain, nasal soreness, shingles and erythema. On 10th September 2019, the patient experienced red rash and spot-like rash. On 12th September 2019, the patient experienced blister. On an unknown date, the outcome of the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash to be related to Shingrix.  Additional details were reported as follows: The patient received dos eof Shingrix in the local pharmacy at around noon. The reporter stated that, in the same evening after vaccination, the patient experienced painful nose, sore to touch and getting red. The next day after vaccination , the patient had red rash on his noseand 2 days later it blistered. The patient visited his phisician on 3rd October 2019 and was told it was shingles. Till the time of reporting, the patient still had it. The patient had a spot on the bridge of his nose that he was afraid might get a scar. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rhinalgia
Clinical narrative: Blistered; spot on the bridge of his nose; Rash on nose; shingles; Nose getting red; Nose started being painful; Nose sore to the touch; This case was reported by a consumer via call center representative and described the occurrence of nasal pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 1st case of shingles in 10 to 12 years ago).   On 9th September 2019, the patient received the 1st dose of Shingrix. On 9th September 2019, less than a day after receiving Shingrix, the patient experienced nasal pain, nasal soreness, shingles and erythema. On 10th September 2019, the patient experienced red rash and spot-like rash. On 12th September 2019, the patient experienced blister. On an unknown date, the outcome of the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash were not recovered/not resolved.   It was unknown if the reporter considered the nasal pain, nasal soreness, red rash, shingles, erythema, blister and spot-like rash to be related to Shingrix.  Additional details were reported as follows: The patient received dos eof Shingrix in the local pharmacy at around noon. The reporter stated that, in the same evening after vaccination, the patient experienced painful nose, sore to touch and getting red. The next day after vaccination , the patient had red rash on his noseand 2 days later it blistered. The patient visited his phisician on 3rd October 2019 and was told it was shingles. Till the time of reporting, the patient still had it. The patient had a spot on the bridge of his nose that he was afraid might get a scar. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Myalgia
Clinical narrative: difficult or impossible to lift things in a certain way, to wash/dry my back when showering, to fasten/unfasten bra straps; Have lost movement; Issues with the arm; Bit of pain with certain movements; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, arm discomfort and pain upon movement. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the injected limb mobility decreased, arm discomfort, pain upon movement and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, arm discomfort, pain upon movement and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine. The patient had issues with the arm it was given in since then. The patient lost movement and had quite a bit of pain with certain movements.  The patient find it difficult or impossible to lift things in a certain way, to wash/dry her back when showering, to fasten/unfasten bra straps, put on a seat belt, open a car door from inside. These were just a few of the problems. The patient did see her NP and was treated with an anti-inflammatory (NSAID) for 2 weeks.  The patient did work from home on the computer and it was becoming difficult to hold left arm in position to type.  The patient asked if GSK had any other reports of this type of side effect, any recommendations for treating it? The patient was waiting to return arm to full function.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Loss of personal independence in daily activities, Pain
Clinical narrative: difficult or impossible to lift things in a certain way, to wash/dry my back when showering, to fasten/unfasten bra straps; Have lost movement; Issues with the arm; Bit of pain with certain movements; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, arm discomfort and pain upon movement. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the injected limb mobility decreased, arm discomfort, pain upon movement and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, arm discomfort, pain upon movement and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine. The patient had issues with the arm it was given in since then. The patient lost movement and had quite a bit of pain with certain movements.  The patient find it difficult or impossible to lift things in a certain way, to wash/dry her back when showering, to fasten/unfasten bra straps, put on a seat belt, open a car door from inside. These were just a few of the problems. The patient did see her NP and was treated with an anti-inflammatory (NSAID) for 2 weeks.  The patient did work from home on the computer and it was becoming difficult to hold left arm in position to type.  The patient asked if GSK had any other reports of this type of side effect, any recommendations for treating it? The patient was waiting to return arm to full function.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: bruising at the injection site; a rash on the inside of his right elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th October 2019, 20 days after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The patient developed bruising at the injection site sometime after receiving the vaccine. At the time of reporting, the patient developed a rash on the inside of his right elbow. The rash was the size of a baseball.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Rash
Clinical narrative: bruising at the injection site; a rash on the inside of his right elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 7th October 2019, 20 days after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising and rash to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The patient developed bruising at the injection site sometime after receiving the vaccine. At the time of reporting, the patient developed a rash on the inside of his right elbow. The rash was the size of a baseball.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Varicella virus test positive
Clinical narrative: Pharmaceutical product complaint; Shingles around ear and scalp; Rash; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and cefalexin (Cephalexin). On an unknown date, the outcome of the shingles, rash and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and then broke out with Shingles around his ear and scalp. The rash measured about 3 inches long at the top of his ear by 1 inch wide at the end. He went to urgent care on 25th September 2019 and they said it was an infection. After Cephalexin antibiotics, the rash got worsened and spread to his torso with 7 more spots. The patient went to the dermatologist on 30th September 2019, and had a scraping done which turned out as positive for Shingles. The reporter consented for follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Product complaint, Rash
Clinical narrative: Pharmaceutical product complaint; Shingles around ear and scalp; Rash; This case was reported by a consumer via patient support programs and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced pharmaceutical product complaint. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and cefalexin (Cephalexin). On an unknown date, the outcome of the shingles, rash and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and then broke out with Shingles around his ear and scalp. The rash measured about 3 inches long at the top of his ear by 1 inch wide at the end. He went to urgent care on 25th September 2019 and they said it was an infection. After Cephalexin antibiotics, the rash got worsened and spread to his torso with 7 more spots. The patient went to the dermatologist on 30th September 2019, and had a scraping done which turned out as positive for Shingles. The reporter consented for follow up.