chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Dizziness, migraine headache for 30 hours. Body ache, sore neck and arms, sore sides. Unable to work for 27+ hours. Rash on arm 4 days. Unable to concentrate, dizziness. Severe migraine for over 30 hours. Aching in neck, back, sides (both). Whole body was aching. Red rash about 4 inches in diameter around injection site (on arm) (4 days). Unable to work for 27 hours. Unable to keep any commitments for this length of time or leave my home.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Disturbance in attention, Dizziness, Impaired work ability, Injection site erythema
Clinical narrative: Dizziness, migraine headache for 30 hours. Body ache, sore neck and arms, sore sides. Unable to work for 27+ hours. Rash on arm 4 days. Unable to concentrate, dizziness. Severe migraine for over 30 hours. Aching in neck, back, sides (both). Whole body was aching. Red rash about 4 inches in diameter around injection site (on arm) (4 days). Unable to work for 27 hours. Unable to keep any commitments for this length of time or leave my home.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Loss of personal independence in daily activities, Migraine, Neck pain, Pain
Clinical narrative: Dizziness, migraine headache for 30 hours. Body ache, sore neck and arms, sore sides. Unable to work for 27+ hours. Rash on arm 4 days. Unable to concentrate, dizziness. Severe migraine for over 30 hours. Aching in neck, back, sides (both). Whole body was aching. Red rash about 4 inches in diameter around injection site (on arm) (4 days). Unable to work for 27 hours. Unable to keep any commitments for this length of time or leave my home.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Dizziness, migraine headache for 30 hours. Body ache, sore neck and arms, sore sides. Unable to work for 27+ hours. Rash on arm 4 days. Unable to concentrate, dizziness. Severe migraine for over 30 hours. Aching in neck, back, sides (both). Whole body was aching. Red rash about 4 inches in diameter around injection site (on arm) (4 days). Unable to work for 27 hours. Unable to keep any commitments for this length of time or leave my home.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain in extremity
Clinical narrative: The patient did notice the sore arm and general malaise that is to be noticed the morning after the administration of the injection. The patient did have increase swelling and soreness at the injection site. The swelling and soreness has continued for 3 days now. Patient will start taking an NSAID to help with the pain and swelling and will alternate between warm and cool compress. Will follow up with the patient the next several days to see if symptoms improve.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient stated she noticed redness, pain and warmth to the area 5 hours post injection. She presented for a nurse only visit 2 days later (4-11-18) and was asked to see a provider who marked the area and discussed comfort plan. Patient presented 2 days later again (4-13-18) for recheck as area worse, so seen by same provider as 4/11/18 and antibiotics were ordered for a diagnosis of Cellulitis. Patient to follow up with this provider on 4/18/18.
Age: 54.0
Sex: F
Vaccine: HEPA, TDAP, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: On 4/10/18 patient received three vaccines in our pharmacy. In her right arm (lower) she received HAVRIX (NDC 58160-0826-43), and upper she got SHINGRIX (NDC 58160-0829-03). In her left arm she got ADACEL (NDC 49281-0400-88). On Friday 4/13/18 patient called and spoke with pharmacist. She was complaining that her right arm is raised and swollen since receiving the vaccines on 4/10/18. Our pharmacists told her that these types of skin reactions are normal as part of the vaccination process. He recommended she try OTC TYLENOL and it should go away within a few days. Patient was satisfied with this information.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Abnormal behaviour, Diarrhoea, Feeling abnormal
Clinical narrative: Normal mild pain at injection site beginning night of vaccine and extending to a swollen, hot upper arm that lasted four days. Woke day after injection with strong flu-like symptoms that lasted about 54 hours. Symptoms included muscular aches and pains, lethargy, a feeling that I had been hit by a truck as well as feeling very swollen and bloated. It resulted in doing nothing other than watching TV for two days. I am a runner, healthy eater and very active so this behavior is very unusual. I felt a mild fever during this time and had a severe headache. The headache continued for 5 days following the vaccine. In addition, I had GI distress consisting of loose, frequent stools for about 5 days. I have never had a reaction to a vaccine nor but felt compelled as the pharmacy people seemed to think this must be something else since it never happens but it was not. My sister manages pharmacies and asked her pharmacist to speak to the drug rep. Again, it was portrayed that this must not be true. Your website indicating my reactions and that younger people may have more response is what saved my sanity. I will get the follow-up part two vaccine as this is certainly better than getting shingles, I just believe the side-effects need to be more accurately portrayed by the company and its reps so that the pharmacy dispensing can alert people (as well as websites). My husband had the vaccine at the same time and had almost identical symptoms; therefore he is reporting as well.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Frequent bowel movements, Headache, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Normal mild pain at injection site beginning night of vaccine and extending to a swollen, hot upper arm that lasted four days. Woke day after injection with strong flu-like symptoms that lasted about 54 hours. Symptoms included muscular aches and pains, lethargy, a feeling that I had been hit by a truck as well as feeling very swollen and bloated. It resulted in doing nothing other than watching TV for two days. I am a runner, healthy eater and very active so this behavior is very unusual. I felt a mild fever during this time and had a severe headache. The headache continued for 5 days following the vaccine. In addition, I had GI distress consisting of loose, frequent stools for about 5 days. I have never had a reaction to a vaccine nor but felt compelled as the pharmacy people seemed to think this must be something else since it never happens but it was not. My sister manages pharmacies and asked her pharmacist to speak to the drug rep. Again, it was portrayed that this must not be true. Your website indicating my reactions and that younger people may have more response is what saved my sanity. I will get the follow-up part two vaccine as this is certainly better than getting shingles, I just believe the side-effects need to be more accurately portrayed by the company and its reps so that the pharmacy dispensing can alert people (as well as websites). My husband had the vaccine at the same time and had almost identical symptoms; therefore he is reporting as well.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lethargy, Myalgia, Pyrexia, Swelling
Clinical narrative: Normal mild pain at injection site beginning night of vaccine and extending to a swollen, hot upper arm that lasted four days. Woke day after injection with strong flu-like symptoms that lasted about 54 hours. Symptoms included muscular aches and pains, lethargy, a feeling that I had been hit by a truck as well as feeling very swollen and bloated. It resulted in doing nothing other than watching TV for two days. I am a runner, healthy eater and very active so this behavior is very unusual. I felt a mild fever during this time and had a severe headache. The headache continued for 5 days following the vaccine. In addition, I had GI distress consisting of loose, frequent stools for about 5 days. I have never had a reaction to a vaccine nor but felt compelled as the pharmacy people seemed to think this must be something else since it never happens but it was not. My sister manages pharmacies and asked her pharmacist to speak to the drug rep. Again, it was portrayed that this must not be true. Your website indicating my reactions and that younger people may have more response is what saved my sanity. I will get the follow-up part two vaccine as this is certainly better than getting shingles, I just believe the side-effects need to be more accurately portrayed by the company and its reps so that the pharmacy dispensing can alert people (as well as websites). My husband had the vaccine at the same time and had almost identical symptoms; therefore he is reporting as well.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: March 6, 2015 got shingles.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pruritus
Clinical narrative: A few minutes after giving ADACEL on patient's right deltoid, she stated she felt some itchiness and there was a small bump forming at injection site. Dr. was informed and took a look at site. He advised to put ice on injection site. Ice was given to patient.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Auto-inoculation to neck, chin, face.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Myalgia, Post vaccination autoinoculation, Pyrexia, Skin lesion
Clinical narrative: Auto-inoculation to neck, chin, face.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: PATIENT DEVELOPED A BLOTCHY, ITCHY RASH ON UPPER ARM.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness, rested, better the next day.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, chills, fever.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site reaction, Localised oedema, Pain in extremity
Clinical narrative: Patient got PREVNAR last year all ok came back today for PNEUMOVAX 23 and decided to add the SHINGRIX on my recommendation all was fine we talked for a while and she called me at 7:00 and said she got a sore red swollen spot on arm I told her this is an expected injection site reaction and that I would report it for her and to talk to her doctor if she feels the need to.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Eyelid oedema, Gingival pruritus, Pruritus, Swelling face
Clinical narrative: Within 30 to 40 minutes intense itching in left eye, left cheek and left gum. Left eye swelled shut and left cheek swollen with 1 hour of injection. Minor itching of right eye and cheek. Patient took diphenhydramine for itching and swelling. No shortness of breath or swelling of tongue. Next morning left eye reopened, swelling of left cheek reduced. Over course of next 24 hours, itching and swelling pretty much resolved although lingered a bit through 48 hours particularly swelling of left cheek.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Headache, Lip blister, Lip swelling
Clinical narrative: 10.5 hours after receiving SHINGRIX vaccine patient was awaken out of sleep C/O HA, Fever, Chills, and swelling on nose and upper lip. The next day (approximately 24 hours after vaccine) she had blisters on upper lip, nose, and buccal mucosa. Patient states she took TYLENOL 500 mg 1 tablet PO each day since symptoms started.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal oedema, Oral mucosal blistering, Pyrexia
Clinical narrative: 10.5 hours after receiving SHINGRIX vaccine patient was awaken out of sleep C/O HA, Fever, Chills, and swelling on nose and upper lip. The next day (approximately 24 hours after vaccine) she had blisters on upper lip, nose, and buccal mucosa. Patient states she took TYLENOL 500 mg 1 tablet PO each day since symptoms started.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There wasn't an adverse reaction to the vaccination, the vaccine was administered outside of the ACIP guideline recommended age range, the patient is only 46 years old.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incomplete course of vaccination
Clinical narrative: Patient arm got red and the area is increasing every day. Patient went to the ER and is put on antibiotics and still taking. Decided to not give the 2nd dose of the series.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Immediate post-injection reaction, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Pain immediately after given the shot, took ibuprofen, used warm and cold compression's, massaged the area, nothing worked, the pain hasn't gone away, the pain has increased involving the shoulder, arm and upper back. I now have reduced range of motion, and my arm is weak. It's been more than 5 months now, and I haven't been able to sleep well due to the pain I feel when I move while sleeping.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Pain immediately after given the shot, took ibuprofen, used warm and cold compression's, massaged the area, nothing worked, the pain hasn't gone away, the pain has increased involving the shoulder, arm and upper back. I now have reduced range of motion, and my arm is weak. It's been more than 5 months now, and I haven't been able to sleep well due to the pain I feel when I move while sleeping.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain, swelling and redness at the site of the injection lasting at least three days. Pain radiating towards the neck and the leg on the side of the injection lasting for about two days post-injection. Malaise and weakness lasting for about 24 hours following injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain, swelling and redness at the site of the injection lasting at least three days. Pain radiating towards the neck and the leg on the side of the injection lasting for about two days post-injection. Malaise and weakness lasting for about 24 hours following injection.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase increased, Blood creatinine increased
Clinical narrative: The night of vaccine-chills weakness, body ache. 12/28 Swollen joints-knees, elbows, wrists, thumbs. Took ibuprofen. Seen in office 12/30, obvious swollen joints. Lab creatinine 3.2, AST 156, 368-ALT, ALK 0332. Admitted to hospital treated with prednisone, hydration.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Joint swelling, Pain, Peripheral swelling
Clinical narrative: The night of vaccine-chills weakness, body ache. 12/28 Swollen joints-knees, elbows, wrists, thumbs. Took ibuprofen. Seen in office 12/30, obvious swollen joints. Lab creatinine 3.2, AST 156, 368-ALT, ALK 0332. Admitted to hospital treated with prednisone, hydration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Rash, Rash pruritic
Clinical narrative: Rash started on (L) side, just below breast on rig cage. Noticed about 1 hour after vaccine. Scaly, itchy, raised small white bumps. About 9 hours after vaccine noticed rash on other side of ribs. Put hydrocortisone on both and they went away.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Late Entry 04/13/18 1400 Patient received Walk In immunizations at the Mobile clinic. 15 minutes after receiving KINRIX, MMR and VAR, patient started with itching on the legs, arms, anterior and posterior trunk of the body. Noted red flat smooth patches to the legs, abdomen and arms. Lungs clear to auscultate x 4 lobes. No resp. distress noted. Unable to look at the throat due to fighting however able to swallow without difficulty. BENADRYL 12mg/5ml, 8ml orally given and tolerated well. Observed for 15 more minutes. Explained ER precautions to mother. Go to ER with SOB, difficulty swallowing, rash getting worse. Mother verbalize good understanding. Patient discharged home with red patches going away denies itching.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: 04/12/2018 Mild Rash within 14 days of dose. Rash/fever developed after 1st varicella vaccine given - noted rash and a few red spots on left lateral thigh by injection site from mother report. Also has had fever on/off from 99-101 degrees; improved some since 4/12/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a 64-year-old female patient who received SHINGRIX. Concomitant products included LEVOXYL. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, 9 hrs after receiving SHINGRIX, the patient experienced nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting. In April 2018, the outcome of the nausea, general body pain, malaise, fever, chills and vomiting were recovered/resolved. On an unknown date, the outcome of the decreased appetite and fatigue were recovering/resolving. It was unknown if the reporter considered the nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting to be related to SHINGRIX. Additional details were reported as follows: The patient was a retired physician. The patient received SHINGRIX at 14:00 hours. Less than a day after receiving SHINGRIX, the patient experienced decreased appetite and vomiting. The patient planned to follow-up with her physician on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a 64-year-old female patient who received SHINGRIX. Concomitant products included LEVOXYL. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, 9 hrs after receiving SHINGRIX, the patient experienced nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting. In April 2018, the outcome of the nausea, general body pain, malaise, fever, chills and vomiting were recovered/resolved. On an unknown date, the outcome of the decreased appetite and fatigue were recovering/resolving. It was unknown if the reporter considered the nausea, decreased appetite, general body pain, malaise, fever, chills, fatigue and vomiting to be related to SHINGRIX. Additional details were reported as follows: The patient was a retired physician. The patient received SHINGRIX at 14:00 hours. Less than a day after receiving SHINGRIX, the patient experienced decreased appetite and vomiting. The patient planned to follow-up with her physician on an unknown date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, itchy upper limbs, pain in arm, erythema of extremities and rash. On an unknown date, the outcome of the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities were not recovered/not resolved and the outcome of the rash was unknown. The reporter considered the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not received any concomitant vaccine. The patient received SHINGRIX vaccine on her right deltoid. The pharmacist reported that the patient came in on the reporting date and had a circular red rash a couple inches below the injection site that was red, itching and tender that appeared the same day as the injection in the right bicep per the pharmacist. The appearance had not changed since last week as per the pharmacist.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, itchy upper limbs, pain in arm, erythema of extremities and rash. On an unknown date, the outcome of the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities were not recovered/not resolved and the outcome of the rash was unknown. The reporter considered the allergic reaction, itchy upper limbs, pain in arm and erythema of extremities to be related to SHINGRIX. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient did not received any concomitant vaccine. The patient received SHINGRIX vaccine on her right deltoid. The pharmacist reported that the patient came in on the reporting date and had a circular red rash a couple inches below the injection site that was red, itching and tender that appeared the same day as the injection in the right bicep per the pharmacist. The appearance had not changed since last week as per the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. Concomitant products included Valacyclovir. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, influenza-like symptoms and injection site erythema. On an unknown date, the outcome of the injection site swelling, influenza-like symptoms and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, approximately two months ago, the patient received a dose of SHINGRIX vaccine in right deltoid and experienced redness and swelling at the injection site and flu like symptoms that all lasted for three days and then resolved without need for any treatment or intervention. The patient notified her physician of the events and was counseled by the physician to call them back if symptoms had not resolved within the week. The limited report was filed with available information. The reporter declined to provide further details for the report.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 50-year-old female patient who received SHINGRIX. On 8th April 2018, the patient received the 1st dose of SHINGRIX. On 8th April 2018, 9 hrs after receiving SHINGRIX, the patient experienced chills, headache and pain. On an unknown date, the outcome of the chills, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the chills, headache and pain to be related to SHINGRIX. Additional details were provided as follows: On 8th April 2018 at 14.00, the patient received SHINGRIX. Limited information was provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported body aches, flu-like symptoms, redness, pain and swelling at injection site, joint pain/aches in opposite side of body that injection was given. Severe body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reported body aches, flu-like symptoms, redness, pain and swelling at injection site, joint pain/aches in opposite side of body that injection was given. Severe body aches.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 73-year-old female patient who received SHINGRIX (batch number T5242, expiry date 3rd March 2020). On 5th April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, injection site erythema, malaise and fatigue. On an unknown date, the outcome of the injection site tenderness, injection site erythema, malaise and fatigue were unknown. The reporter considered the injection site tenderness, injection site erythema, malaise and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist did not want to give medication or medical history during call. Within 24 hours of receiving SHINGRIX in the left arm, the patient experienced malaise, fatigue, redness at the injection site and tenderness at the injection site. The reporting pharmacist stated that she had spoken to patient twice since the patient received the vaccine, and was not aware of any medical intervention taken. The reporting pharmacist stated this was very likely to have been caused by SHINGRIX. The reported lot number (T5252) for SHINGRIX did not exist and was updated to T5242, according to sales database.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included SHINGRIX. On 6th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX and an unknown time after starting MOTRIN, the patient experienced pain in arm, headache, general body pain, fever, injection site swelling, injection site wheal and drug dose administration interval too short. The patient was treated with MORTIN and TYLENOL. On an unknown date, the outcome of the pain in arm, headache, general body pain and injection site swelling were not recovered/not resolve and the outcome of the fever was recovering/resolving and the outcome of the injection site wheal and drug dose administration interval too short were unknown. The reporter considered the pain in arm, headache, general body pain, fever and injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were provided as follows: On 7th March 2018, the patient received 1st dose of SHINGRIX. One month after receiving 1st dose the patient received 2nd dose of SHINGRIX in an unknown arm, which led to shortening of vaccination schedule. The patient experienced adverse events same night of vaccination, unknown how may hours after injection. It was reported that the arm in which the vaccination was received was described as really sore and site of injection swollen the size of a fist. Injection site was also welting up. The patient described her fever as high. Achiness was described as being full body. On 7th April 2018, the patient's body temperature was recorded as 102.1 degree F and on 9th April 2018, it was recorded as 99 degree F. The patient was managing issues by alternation TYLENOL and MOTRIN.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included SHINGRIX. On 6th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2018, less than a day after receiving SHINGRIX and an unknown time after starting MOTRIN, the patient experienced pain in arm, headache, general body pain, fever, injection site swelling, injection site wheal and drug dose administration interval too short. The patient was treated with MORTIN and TYLENOL. On an unknown date, the outcome of the pain in arm, headache, general body pain and injection site swelling were not recovered/not resolve and the outcome of the fever was recovering/resolving and the outcome of the injection site wheal and drug dose administration interval too short were unknown. The reporter considered the pain in arm, headache, general body pain, fever and injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were provided as follows: On 7th March 2018, the patient received 1st dose of SHINGRIX. One month after receiving 1st dose the patient received 2nd dose of SHINGRIX in an unknown arm, which led to shortening of vaccination schedule. The patient experienced adverse events same night of vaccination, unknown how may hours after injection. It was reported that the arm in which the vaccination was received was described as really sore and site of injection swollen the size of a fist. Injection site was also welting up. The patient described her fever as high. Achiness was described as being full body. On 7th April 2018, the patient's body temperature was recorded as 102.1 degree F and on 9th April 2018, it was recorded as 99 degree F. The patient was managing issues by alternation TYLENOL and MOTRIN.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Vomiting
Clinical narrative: I woke up with dizziness and I had a stomach ache I felt like I needed to go but could not. I got up several times and had to go. I had the runs most of the night. I took two IMODIUM and went back to bed. I stayed in bed most of Wed 4-3-18. I started to vomit bile as I had nothing to eat and only drank water.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX. Concomitant products included Aspirin, Magnesium, METAMUCIL, Metformin, Probiotic, Vitamin B12, calcium citrate, Citracel Plus D, CENTRUM SILVER, SYNTHROID, Tumeric and TYLENOL. On 1st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovered/resolved. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were reported as follows: The reported stated in evening on the day of vaccination or by the next day the patient was experiencing joints hurting. The joint hurt resolved after a couple of days. The patient noted that she had that from time to time with the flu vaccine (manufacturer unknown) and she got a flu shot every year but it did not happen every year. Refer case US2018GSK065048. The reporter planned to get the 2nd dose on 1st May 2018. The reporter called today as her Dermatologist wanted her to start methotrexate, but her pharmacist was concerned with the vaccine. She was provided the information from the prescribing information on use of vaccine with immunosuppressive medications and decrease of efficacy of the vaccine with such drugs. She was referred to her Dermatologist for discussion. The primary care physician had retired and would accept authorization form and provide healthcare professional if one known at the time of follow up. This case has been linked with case US2018GSK065048 same patient.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Achy, fever approximately 102 degrees F for 12-18 hrs. -took ADVIL.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Herpes simplex, Herpes simplex test negative, Herpes simplex test positive
Clinical narrative: This case was reported by a other health professional and described the occurrence of herpes simples type I in a adult female healthcare professional who intended to vaccinate the patient with SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced herpes simples type I, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the herpes simplex type I, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the herpes simplex type I to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The reporter was a health care provider and during reconstitution while removing the needle, the vacuum suction caused it to splash on her hands, which led to inadvertent exposure to vaccine and exposure via skin contact. Four days after vaccination, the healthcare provider was tested positive for herpes simplex virus type type I (HSV1 and she had negative antibodies so that means it was new virus to her). The healthcare provider had not had any exposure to contract the virus in the 14 day window for a new first time outbreak. The reporter was asking if the SHINGRIX could cause the HSV virus if the vaccine came in contact with skin.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Pt given Tdap (L) deltoid 4-10-18. Pt had pain afterward. Day later pt had swelling lymph node under (L) arm. Next day 4-12 woke up with substantial swelling. (L) supraclavicular lymph node. Tender, no fever, some fatigue. Pt has never had reaction like this in past. Assessment/Plan: Lymph node swelling likely due to robust immune response to vaccine. Will give oral Prednisone 40 mg daily x 5 days for pain, swelling. Educate use of Ibuprofen prn pain. Return precautions given.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site rash, Injection site warmth, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 2nd April 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced throbbing pain, injection site warmth, allergic reaction, fever and muscle pain. In April 2018, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the throbbing pain, injection site warmth, allergic reaction, fever and muscle pain were unknown. The reporter considered the injection site rash, throbbing pain, injection site warmth, allergic reaction, fever and muscle pain to be related to SHINGRIX. Additional details were provided as follows: By the evening, on the day of vaccination, the patient felt fever coming on, experienced muscle pain and the injection site was radiating heat and throbbing pain. The patient developed rash below the injection site about 3 to 4 inches in diameter. The patient did visit her doctor. On 5th April 2018, the pharmacist was last spoken to the patient and at that time, the rash had faded slightly. The pharmacist stated that as per nurse practitioner, the patient might have experienced an allergic reaction to SHINGRIX. The reporter was transferred to medical information for assistance in determining if patient should receive the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 2nd April 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced throbbing pain, injection site warmth, allergic reaction, fever and muscle pain. In April 2018, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving and the outcome of the throbbing pain, injection site warmth, allergic reaction, fever and muscle pain were unknown. The reporter considered the injection site rash, throbbing pain, injection site warmth, allergic reaction, fever and muscle pain to be related to SHINGRIX. Additional details were provided as follows: By the evening, on the day of vaccination, the patient felt fever coming on, experienced muscle pain and the injection site was radiating heat and throbbing pain. The patient developed rash below the injection site about 3 to 4 inches in diameter. The patient did visit her doctor. On 5th April 2018, the pharmacist was last spoken to the patient and at that time, the rash had faded slightly. The pharmacist stated that as per nurse practitioner, the patient might have experienced an allergic reaction to SHINGRIX. The reporter was transferred to medical information for assistance in determining if patient should receive the 2nd dose.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received Influenza vaccine quadrivalent. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season. On an unknown date, less than a year after receiving influenza vaccine quadrivalent unspecified season, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to Influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The patient noted that she experienced joint hurt time to time with the flu vaccine (manufacturer unknown). The patient got flu shot every year but it did not happen every year. The primary care physician had retired and would accept authorization form and provide healthcare professional if one known at the time of follow up. This case has been linked with case US2018060700, reported for the same patient, by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incomplete course of vaccination, Injection site discolouration, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX. Concomitant products included hydroxychloroquine. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling and fever. On 26th March 2018, the patient experienced injection site erythema, pain in arm, headache, queasy, erythema urticarial and exhaustion. SHINGRIX was discontinued. In March 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever, headache, queasy, erythema urticarial and exhaustion were recovered/resolved and the outcome of the injection site discoloration and injection site swelling were unknown. The reporter considered the injection site erythema, pain in arm, fever, headache, queasy, erythema urticarial and exhaustion to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to SHINGRIX. Additional information was received as follows: The patient reported that she experienced pain in her left arm which started on the same day of vaccination and lasted for 5 days. The patient also reported that she had a red hot welt at the injection site which also started on the same day of injection and it was continued to grow and was 2 inches in length x 2 1/4 inch breadth. The patient started taking hydrocortisone cream to stop welt and stated that the cream helped to stop the welt from growing. The welt and redness was gone away. However, there was a raised darker area on her arm where the welt was located. The patient experienced headache that lasted all day first day and some of the next day. The patient was queasy for first couple of days following vaccination and queasiness was on and off. The suggested that patient should not get second SHINGRIX injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX. Concomitant products included hydroxychloroquine. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling and fever. On 26th March 2018, the patient experienced injection site erythema, pain in arm, headache, queasy, erythema urticarial and exhaustion. SHINGRIX was discontinued. In March 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever, headache, queasy, erythema urticarial and exhaustion were recovered/resolved and the outcome of the injection site discoloration and injection site swelling were unknown. The reporter considered the injection site erythema, pain in arm, fever, headache, queasy, erythema urticarial and exhaustion to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to SHINGRIX. Additional information was received as follows: The patient reported that she experienced pain in her left arm which started on the same day of vaccination and lasted for 5 days. The patient also reported that she had a red hot welt at the injection site which also started on the same day of injection and it was continued to grow and was 2 inches in length x 2 1/4 inch breadth. The patient started taking hydrocortisone cream to stop welt and stated that the cream helped to stop the welt from growing. The welt and redness was gone away. However, there was a raised darker area on her arm where the welt was located. The patient experienced headache that lasted all day first day and some of the next day. The patient was queasy for first couple of days following vaccination and queasiness was on and off. The suggested that patient should not get second SHINGRIX injection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX. Concomitant products included hydroxychloroquine. On 26th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site discoloration, injection site swelling and fever. On 26th March 2018, the patient experienced injection site erythema, pain in arm, headache, queasy, erythema urticarial and exhaustion. SHINGRIX was discontinued. In March 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever, headache, queasy, erythema urticarial and exhaustion were recovered/resolved and the outcome of the injection site discoloration and injection site swelling were unknown. The reporter considered the injection site erythema, pain in arm, fever, headache, queasy, erythema urticarial and exhaustion to be related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to SHINGRIX. Additional information was received as follows: The patient reported that she experienced pain in her left arm which started on the same day of vaccination and lasted for 5 days. The patient also reported that she had a red hot welt at the injection site which also started on the same day of injection and it was continued to grow and was 2 inches in length x 2 1/4 inch breadth. The patient started taking hydrocortisone cream to stop welt and stated that the cream helped to stop the welt from growing. The welt and redness was gone away. However, there was a raised darker area on her arm where the welt was located. The patient experienced headache that lasted all day first day and some of the next day. The patient was queasy for first couple of days following vaccination and queasiness was on and off. The suggested that patient should not get second SHINGRIX injection.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 91-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 30th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unchanged. The reporter considered the injected limb mobility decrease to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The patient experienced lack of arm mobility in the vaccinated arm. The reporter was unable to provide additional details and stated that he filed a VAERS report regarding this information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (patient had a similar reaction to ZOSTAVAX 2 years prior). On 9th April 2018, the patient received SHINGRIX. On 10th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient was feeling febrile. No additional information was reported.