chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Axillary Lymphadenopathy that started after the vaccine was given (7/17/18) and still present when pt was seen again on 7/30/18.
Age: 29.0
Sex: M
Vaccine: ANTH, HPV9
Symptoms: Feeling abnormal, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Member presented to staff immunizations with orders requesting Anthrax, and needed 2nd dose of HPV. Member received HPV in right arm and Anthrax in left arm at 1200. At 1203, pt stated he "wasn't feeling good". Member became pale, slid down into chair, and was unresponsive. Staff was called and became overseeing provider. 1207, pt vitals were taken with BP: 80/54 and HR: 57 with SPO2 98%. At 1208, pt began to wake up and respond fully. 1209, vitals retaken BP: 96/64 and HR: 73 with SPO2 at 99%. Pt states he is feeling much better, and has color returned to his face. Pt walked back to treatment room by staff for vitals and observation. At 1245 pt was discharged and went home with no complaints.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Tremor
Clinical narrative: Headache, shivers, and shakes for the entire evening of Aug 1. Upon awakening the next day the shivers and shakes subsided. Headache finally went away in the afternoon on Aug 2.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Erythema, Injection site bruising, Injection site discolouration, Injection site oedema
Clinical narrative: Elevated temperature 102-103.0 about 5 hours after receiving MENACTRA and TDaP  vaccination at the clinic during pts KBH. Injection site at right deltoid has golf-ball size edema with discoloration that mother states looks bruised. Pt came into clinic on 8/2/18 and was evaluated from physician and swelling had decreased, but still had redness and warmth. Will continue to monitor.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Elevated temperature 102-103.0 about 5 hours after receiving MENACTRA and TDaP  vaccination at the clinic during pts KBH. Injection site at right deltoid has golf-ball size edema with discoloration that mother states looks bruised. Pt came into clinic on 8/2/18 and was evaluated from physician and swelling had decreased, but still had redness and warmth. Will continue to monitor.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash, Rash vesicular
Clinical narrative: Allergic reaction to SHINGRIX 2 - 3 days after his shot on 07-26-2018 at pharmacy. Rash vesicular and ulcerative rash on his neck (mimicking chickenpox) head and face. DEPO MEDROL 40 mg and BENADRYL 50 mg IM; (Given) patient is doing well but is advised to go to ER if feels bad, (i.e., SOB, difficulty breathing, etc.).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: Evening after vaccine, complaint of stiff neck and malaise. Two days after vaccine still complaining of stiff neck, malaise & sore throat. Denies fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: General overall achiness, tired, flu-like headache. One day.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Headache, Influenza like illness, Pyrexia
Clinical narrative: Patient had a fever, headache and difficulty breathing which started about 5 hours after the shot. He also had extreme joint pain and a rash which lasted for about a week. According to the patient, the symptoms felt like a bad case of flu for a week. He feels fine at the time of contacting the pharmacy. Patient did not see the doctor regarding the symptoms but has an appointment in a few days and will talk to the doctor about it.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a fever, headache and difficulty breathing which started about 5 hours after the shot. He also had extreme joint pain and a rash which lasted for about a week. According to the patient, the symptoms felt like a bad case of flu for a week. He feels fine at the time of contacting the pharmacy. Patient did not see the doctor regarding the symptoms but has an appointment in a few days and will talk to the doctor about it.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient experiencing muscle aches/pain over entire body not localized to injection site (arm).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Golf ball sized swelling in shoulder, redness, and pain.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Pain in jaw, Pyrexia
Clinical narrative: Complained of having fever, chills and jaw pain 3-4 hours after receiving vaccine on 7-23-18. Temperature was not taken per mother at onset of fever or through the night. Mother reported fever of 100.9 F on 7-24-18 and managed with acetaminophen and ibuprofen. Mother's main concern was the complaint of jaw pain by client. Mother was instructed to see PCP for evaluation on 7-25-18 or ER visit for on 7-24-18. Nursing followed-up with Mother on 7-25-18 and reported that jaw pain and fever had resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site which eventually spread down half the arm and lasting about 2 weeks. No fever reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin swelling, Skin warm
Clinical narrative: Skin redness, swelling and warmth.
Age: 25.0
Sex: M
Vaccine: HEPAB, MNQ, VARCEL
Symptoms: Auditory disorder, Chills, Dizziness, Flushing, Heart rate decreased
Clinical narrative: FOLLOWING THE ADMINISTRATION OF THE THIRD VACCINE (VARIVAX), PATIENT STATED THAT HE WAS FEELING DIZZY, FLUSHED, CHILLS, NAUSEA, VISUAL AND AUDITORY DISTURBANCE. PATIENT'S HEART RATE HAD DROPPED TO THE MID 50S AND DID LOOK PALE. HE ALSO STATED THAT HE DID NOT EAT ALL DAY, HE WAS GIVEN FOOD/WATER TILL THE PARAMEDICS ARRIVED AND WAS "FEELING MUCH BETTER" AT THAT TIME (15 MINUTES LATER). HE WAS THEN CLEARED BY PARAMEDICS AND RECOMMENDED TO FOLLOW UP WITH PRIMARY CARE PROVIDER.
Age: 25.0
Sex: M
Vaccine: HEPAB, MNQ, VARCEL
Symptoms: Nausea, Pallor, Visual impairment
Clinical narrative: FOLLOWING THE ADMINISTRATION OF THE THIRD VACCINE (VARIVAX), PATIENT STATED THAT HE WAS FEELING DIZZY, FLUSHED, CHILLS, NAUSEA, VISUAL AND AUDITORY DISTURBANCE. PATIENT'S HEART RATE HAD DROPPED TO THE MID 50S AND DID LOOK PALE. HE ALSO STATED THAT HE DID NOT EAT ALL DAY, HE WAS GIVEN FOOD/WATER TILL THE PARAMEDICS ARRIVED AND WAS "FEELING MUCH BETTER" AT THAT TIME (15 MINUTES LATER). HE WAS THEN CLEARED BY PARAMEDICS AND RECOMMENDED TO FOLLOW UP WITH PRIMARY CARE PROVIDER.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Paraesthesia, Swelling
Clinical narrative: Following 2nd vaccination administered on July 18, 2018. On July 31, 2018, I began to have redness, swelling, tingling and burning symptoms on the right side of my forehead, above the right eye, approximately one-half inch inside the hairline. Two photos were taken of the affected area on August 1 and 2, 2018.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: By the afternoon patient had swelling and redness on her arm of injection site. The next day it was extremely painful and she had red welts at the injection site and down her arm as well. The pain has started to resolve but she still has the welts. Denies any trouble breathing.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient called to report the area of injection to be red, swollen and painful. She reported a fever of 104 F, with chills and fever. She was advised to take TYLENOL 500mg, place a cool compress on the site and call her doctor if it became worse. She is feeling a little better after 2 days and the area is not as painful. She has not contacted her doctor so we will call her on Fri Aug 3, 2018. She is continuing to take TYLENOL at the recommended dosage on the label.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal distension, Anxiety, Colitis ulcerative, Constipation
Clinical narrative: On February 4, 2016 I received the hepatitis B vaccination series shot number one. Several days later I started to experience a headaches, mental distortion, fogginess, tingling and muscle weakness. The muscle weakness started in my arms then eventually moved down to my hands. A couple of days later I started having muscle weakness in my legs down to my feet. So much so that I felt uncomfortable walking by myself at times. I've always struggled with constipation and digestion issues (having UC) however during this time, the excessive bloating and constipation/pain became so unbearable that on February 8 I made an appointment to have an ultrasound of my abdomen. Results came back normal. I had made an additional three doctors appointments (1 phone/2 in office) in hopes of a diagnosis as my quality of living was declining. I was told by one of the Doctors that it was probably a tension headache or anxiety I was experiencing and that it had nothing to do with the hepatitis B vaccination. Though I was advised not to continue the last 2 shots in the series?
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Gait disturbance, Headache, Mental disorder, Muscular weakness
Clinical narrative: On February 4, 2016 I received the hepatitis B vaccination series shot number one. Several days later I started to experience a headaches, mental distortion, fogginess, tingling and muscle weakness. The muscle weakness started in my arms then eventually moved down to my hands. A couple of days later I started having muscle weakness in my legs down to my feet. So much so that I felt uncomfortable walking by myself at times. I've always struggled with constipation and digestion issues (having UC) however during this time, the excessive bloating and constipation/pain became so unbearable that on February 8 I made an appointment to have an ultrasound of my abdomen. Results came back normal. I had made an additional three doctors appointments (1 phone/2 in office) in hopes of a diagnosis as my quality of living was declining. I was told by one of the Doctors that it was probably a tension headache or anxiety I was experiencing and that it had nothing to do with the hepatitis B vaccination. Though I was advised not to continue the last 2 shots in the series?
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Paraesthesia, Quality of life decreased, Tension headache, Ultrasound abdomen normal
Clinical narrative: On February 4, 2016 I received the hepatitis B vaccination series shot number one. Several days later I started to experience a headaches, mental distortion, fogginess, tingling and muscle weakness. The muscle weakness started in my arms then eventually moved down to my hands. A couple of days later I started having muscle weakness in my legs down to my feet. So much so that I felt uncomfortable walking by myself at times. I've always struggled with constipation and digestion issues (having UC) however during this time, the excessive bloating and constipation/pain became so unbearable that on February 8 I made an appointment to have an ultrasound of my abdomen. Results came back normal. I had made an additional three doctors appointments (1 phone/2 in office) in hopes of a diagnosis as my quality of living was declining. I was told by one of the Doctors that it was probably a tension headache or anxiety I was experiencing and that it had nothing to do with the hepatitis B vaccination. Though I was advised not to continue the last 2 shots in the series?
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Fluid retention, Peripheral swelling, Skin warm
Clinical narrative: Around 6 pm on 7/31/18; pt noticed her right arm swelling, red, hot tender to touch. She ignored it at first and decided it would go away by next day. On 8/1/18, (morning), Sx still persisted and did not resolve. Still her arm was hot to touch, swollen, red and fluid accumulation on 8/1/18, she went to urgent care and was Dx w/cellulitis and was prescribed an antibiotic (KEFLEX) filled at pharmacy.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Tenderness
Clinical narrative: Around 6 pm on 7/31/18; pt noticed her right arm swelling, red, hot tender to touch. She ignored it at first and decided it would go away by next day. On 8/1/18, (morning), Sx still persisted and did not resolve. Still her arm was hot to touch, swollen, red and fluid accumulation on 8/1/18, she went to urgent care and was Dx w/cellulitis and was prescribed an antibiotic (KEFLEX) filled at pharmacy.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspepsia, Nausea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Scalp tingling following injection slight nausea heartburn, thick feeling in back of throat. 50mg BENADRYL IM - Symptoms improved/resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Pt received DTap-IPV, MMRV vaccine on 07-30-18. Father noticed red area following day. Pt was seen 08-01-18 11x6.5 cm local reaction on (R) thigh. Minimal warmth, no tenderness, no drainage, central clearing, minimal induration at points of injection.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Blood culture, Blood test, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: 1st ER visit 7/18/18 (13:54 - 15:57) Complaints of dizziness, and vomiting. At ED visit patient given BENADRYL, PEPCID, SOLU-MEDROL and ZOFRAN. As well as Home medications of prednisone, ZOFRAN, and BENADRYL on discharge. Adverse reaction to mixed bacterial vaccine diagnosis upon DC. 2nd ER visit 7/18/18 (18:30 - 20:12) Complaints of dizziness and stating throat swelling. Stated since the time she had received the vaccine she felt dizzy, like her throat was swelling, and difficulty breathing. She also felt nauseous, no vomiting today. She was given prednisone and BENADRYL earlier in the day at the ED, but is not improving. Upon reassessment in the ER client began to feel better, discomfort in throat resolved. Airway patent, dizziness resolved, and client able to eat. Lungs clear with no respiratory distress.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Electrocardiogram abnormal, Nausea, Pharyngeal oedema, Sinus arrhythmia, Vomiting
Clinical narrative: 1st ER visit 7/18/18 (13:54 - 15:57) Complaints of dizziness, and vomiting. At ED visit patient given BENADRYL, PEPCID, SOLU-MEDROL and ZOFRAN. As well as Home medications of prednisone, ZOFRAN, and BENADRYL on discharge. Adverse reaction to mixed bacterial vaccine diagnosis upon DC. 2nd ER visit 7/18/18 (18:30 - 20:12) Complaints of dizziness and stating throat swelling. Stated since the time she had received the vaccine she felt dizzy, like her throat was swelling, and difficulty breathing. She also felt nauseous, no vomiting today. She was given prednisone and BENADRYL earlier in the day at the ED, but is not improving. Upon reassessment in the ER client began to feel better, discomfort in throat resolved. Airway patent, dizziness resolved, and client able to eat. Lungs clear with no respiratory distress.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Injected limb mobility decreased, Pain in extremity, Rash, Skin warm
Clinical narrative: (L) arm became hot, rash, and painful, After shot given. Next day he slept all day and he didn't move his arm due to pain. Wed night (8/1/18), he had sharp shooting pains under his (L) axillary area. He went to PMD 8/2/18 in pm and was ordered to take MOTRIN, BENADRYL and warm compresses. He is to follow-up Friday by PMD if not better and start antibiotics.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Secondary eruption at 1000 and 1400, Left arm.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Peripheral swelling
Clinical narrative: On 07/17/2018, patient received the PPSV23 vaccine 0.5 ml IM into his left deltoid while at a VA primary care clinic appointment. The following morning, 07/18/208, patient presented to walk-in clinic C/P swollen red arm near injection site. Symptoms began that morning when he woke up. No redness or heat was seen at the injection site. The upper left arm was slightly swollen but not tender to palpation. Patient was instructed to ice the area and then use moist heat, and to contact the clinic if he noticed any increased swelling, redness, heat, or streaking. Patient did not have any further issues and this was considered a mild reaction to the PPSV23 (PNEUMOVAX) vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: 3" diameter whelp (red and warm to touch) 2" below site of injection 2 days later. Recommended Pharmacy minute clinic or Urgent Care for possible infection.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt. went in for routine MRI and was told she had swollen lymph nodes on left armpit - (when questioned about vaccine use) - she said she got a SHINGRIX shot. Dr. said it was probably due to vaccine because SHINGRIX causes swollen lymph nodes.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Nuclear magnetic resonance imaging abnormal, Vaccination complication
Clinical narrative: Pt. went in for routine MRI and was told she had swollen lymph nodes on left armpit - (when questioned about vaccine use) - she said she got a SHINGRIX shot. Dr. said it was probably due to vaccine because SHINGRIX causes swollen lymph nodes.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swelling, firm, redness, warm to touch around injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pain left upper arm 8/10 and body aches onset night vaccine given 7/12/18. Seen office 7/19/18 given VICODIN for pain. 8 days localized pain lasted.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted in hallway after vaccination while waiting for physical form to be copied. Patient seemed fine when receiving vaccination and after vaccine was administered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient complains of pain in all joints the day after first SHINGRIX dose, but pain has continued in both shoulders since then.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Cough, Erythema, Respiratory tract congestion, Wheezing
Clinical narrative: Gave vaccine, patient left then returned a few min later with cough, congestion, audible wheezing, and redness on skin. Reassessed patient and gave BENADRYL/ORAPRED. Patient was taken to hospital EMS. Sent to ER for observation.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Face injury, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Several hours after vaccination-she fainted and hit face on floor nausea/chills/shaking/arm hurting/sweats.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Syncope, Tremor
Clinical narrative: Several hours after vaccination-she fainted and hit face on floor nausea/chills/shaking/arm hurting/sweats.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Confusional state, Fatigue, Headache
Clinical narrative: I was advised to get the new SHINGRIX two part vaccination, being told it was "safe" for sufferers of rheumatoid arthritis. I had the first dose in May, and simply had moderate pain at the injection site for three days. I had the second dose last night and within an hour I could lift arm as the injection site hurt so much. This morning I woke in full RA flare with fatigue, confusion, headache, fever, chills, and the injection site is still painful at 5 out of 10. There is slight redness and swelling at the injection site. 400 of ibuprofen every five hours and 3 mg. prednisone seem to knock the edge off the severity of the symptoms. I called my rheumatologist, and his nurse suggested I try and even higher dose of prednisone. If it's not necessary, I won't do it.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Rheumatoid arthritis
Clinical narrative: I was advised to get the new SHINGRIX two part vaccination, being told it was "safe" for sufferers of rheumatoid arthritis. I had the first dose in May, and simply had moderate pain at the injection site for three days. I had the second dose last night and within an hour I could lift arm as the injection site hurt so much. This morning I woke in full RA flare with fatigue, confusion, headache, fever, chills, and the injection site is still painful at 5 out of 10. There is slight redness and swelling at the injection site. 400 of ibuprofen every five hours and 3 mg. prednisone seem to knock the edge off the severity of the symptoms. I called my rheumatologist, and his nurse suggested I try and even higher dose of prednisone. If it's not necessary, I won't do it.
Sex: F
Vaccine: FLUX
Symptoms: Full blood count normal, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Laboratory test normal
Clinical narrative: This is a serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 59-year-old, adult female patient. On an unspecified date, the patient was administered Influenza vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date after vaccination (reported as one month after vaccination), the patient experienced severe shoulder pain with restricted range of motion. The patient denied any trauma to the left shoulder, fever or chills. The patient took unspecified over the counter pain relief medications, but that did not help. The patient's serum chemistry and complete blood count were within normal limit. Physical examination was significant for 5/10 pain at the rest and 8/10 pain upon abduction of the left shoulder. There was also continued tenderness directly over the posterolateral border of the acromion and over the infraspinatus insertion. X-ray of the patient's left shoulder showed degenerative subcortical cystic change in the distal clavicle. Magnetic resonance imaging (MRI) of the left shoulder joint showed abnormal marrow signal within the humeral head and neck laterally, especially at the location of the teres minor insertion and edema at my myotendinous junction. Based on those MRI findings, timing of the symptoms after flu vaccine administration, the patient was diagnosed with shoulder injury related to vaccine administration (SIRVA). Six months later, during the follow-up, the patient complained of the left shoulder pain and severe restriction of the left shoulder movement. It was reported that, the needle used to administer the vaccine was longer and the vaccine was administered into the bursa. At the time of this report, the patient had not recovered from the event SIRVA. The report assessed the event as related to suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: This is a serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 59-year-old, adult female patient. On an unspecified date, the patient was administered Influenza vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date after vaccination (reported as one month after vaccination), the patient experienced severe shoulder pain with restricted range of motion. The patient denied any trauma to the left shoulder, fever or chills. The patient took unspecified over the counter pain relief medications, but that did not help. The patient's serum chemistry and complete blood count were within normal limit. Physical examination was significant for 5/10 pain at the rest and 8/10 pain upon abduction of the left shoulder. There was also continued tenderness directly over the posterolateral border of the acromion and over the infraspinatus insertion. X-ray of the patient's left shoulder showed degenerative subcortical cystic change in the distal clavicle. Magnetic resonance imaging (MRI) of the left shoulder joint showed abnormal marrow signal within the humeral head and neck laterally, especially at the location of the teres minor insertion and edema at my myotendinous junction. Based on those MRI findings, timing of the symptoms after flu vaccine administration, the patient was diagnosed with shoulder injury related to vaccine administration (SIRVA). Six months later, during the follow-up, the patient complained of the left shoulder pain and severe restriction of the left shoulder movement. It was reported that, the needle used to administer the vaccine was longer and the vaccine was administered into the bursa. At the time of this report, the patient had not recovered from the event SIRVA. The report assessed the event as related to suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: X-ray limb abnormal
Clinical narrative: This is a serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 59-year-old, adult female patient. On an unspecified date, the patient was administered Influenza vaccine, (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date after vaccination (reported as one month after vaccination), the patient experienced severe shoulder pain with restricted range of motion. The patient denied any trauma to the left shoulder, fever or chills. The patient took unspecified over the counter pain relief medications, but that did not help. The patient's serum chemistry and complete blood count were within normal limit. Physical examination was significant for 5/10 pain at the rest and 8/10 pain upon abduction of the left shoulder. There was also continued tenderness directly over the posterolateral border of the acromion and over the infraspinatus insertion. X-ray of the patient's left shoulder showed degenerative subcortical cystic change in the distal clavicle. Magnetic resonance imaging (MRI) of the left shoulder joint showed abnormal marrow signal within the humeral head and neck laterally, especially at the location of the teres minor insertion and edema at my myotendinous junction. Based on those MRI findings, timing of the symptoms after flu vaccine administration, the patient was diagnosed with shoulder injury related to vaccine administration (SIRVA). Six months later, during the follow-up, the patient complained of the left shoulder pain and severe restriction of the left shoulder movement. It was reported that, the needle used to administer the vaccine was longer and the vaccine was administered into the bursa. At the time of this report, the patient had not recovered from the event SIRVA. The report assessed the event as related to suspect vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt stated about 1-2 months ago she started to notice a sharp pain in her upper arm but can't remember exactly when. The vaccine was given about 3 months ago and she feels it is the cause. It is a sharp pain that only occurs typically at bedtime and sometimes only lasts about a few minutes and sometimes longer 10-15 minutes and it occurs randomly.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Endoscopy, Flatulence, Gastric disorder, Gastrooesophageal reflux disease
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastric ulcer in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastric ulcer (serious criteria GSK medically significant), weight loss, gastrointestinal disorder and inflammation localized. On an unknown date, the outcome of the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized were unknown. It was unknown if the reporter considered the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. The healthcare professional (HCP) reported that after receiving the dose of SHINGRIX, the patient experienced gastrointestinal problems and inflammation around abdomen. The patient had to go to the emergency room. The patient was treated for an ulcer and lost 18 pounds. The patient received a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018GSK138513, reported for same patient for 2nd dose of SHINGRIX.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenitis, Nuclear magnetic resonance imaging, Ulcer, Ultrasound scan, Weight decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastric ulcer in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastric ulcer (serious criteria GSK medically significant), weight loss, gastrointestinal disorder and inflammation localized. On an unknown date, the outcome of the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized were unknown. It was unknown if the reporter considered the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. The healthcare professional (HCP) reported that after receiving the dose of SHINGRIX, the patient experienced gastrointestinal problems and inflammation around abdomen. The patient had to go to the emergency room. The patient was treated for an ulcer and lost 18 pounds. The patient received a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018GSK138513, reported for same patient for 2nd dose of SHINGRIX.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: X-ray
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastric ulcer in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastric ulcer (serious criteria GSK medically significant), weight loss, gastrointestinal disorder and inflammation localized. On an unknown date, the outcome of the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized were unknown. It was unknown if the reporter considered the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. The healthcare professional (HCP) reported that after receiving the dose of SHINGRIX, the patient experienced gastrointestinal problems and inflammation around abdomen. The patient had to go to the emergency room. The patient was treated for an ulcer and lost 18 pounds. The patient received a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018GSK138513, reported for same patient for 2nd dose of SHINGRIX.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gastric ulcer, Gastrointestinal disorder, Inflammation, Nuclear magnetic resonance imaging, Weight decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastric ulcer in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced gastric ulcer (serious criteria GSK medically significant), weight loss, gastrointestinal disorder and inflammation localized. On an unknown date, the outcome of the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized were unknown. It was unknown if the reporter considered the gastric ulcer, weight loss, gastrointestinal disorder and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. The healthcare professional (HCP) reported that after receiving the dose of SHINGRIX, the patient experienced gastrointestinal problems and inflammation around abdomen. The patient had to go to the emergency room. The patient was treated for an ulcer and lost 18 pounds. The patient received a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018GSK138513, reported for same patient for 2nd dose of SHINGRIX.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Erythema, Injection site abscess, Injection site extravasation, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report was received from a registered nurse and who was referring to a currently 56-year-old female patient. Her pertinent medical history was not reported. Concomitant therapies were not provided. The patient did not have any known drug reaction or allergies. On an unknown date, reported as "the patient believed that years ago", she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not reported). However it was also reported that there was no documentation of the vaccination. On an unknown date, the patient's titer was drawn and the patient was not immune. Consequently, on 13-JUN-2018, the patient was vaccinated with M-M-R II lot # N014482 with an expiration date: 10-MAY-2019, for prophylaxis along with sterile diluent (dose, route of administration, lot# and expiration date were not provided). In June, about 5 to 7 days after vaccination, the patient experienced localized arm reactions (unspecified) with a maximum fever of 102.7 degrees Fahrenheit. On an unspecified date in 2018, she was seen by her primary care provider (unspecified) and diagnosed with cellulitis at the injection site. On an unspecified date in 2018, the patient was given a course of antibiotics (unspecified) and the fever resolved. According to the reporter, the reaction site was not as tender, the swelling went down but the lump was still there. On 23-JUL-2018, the patient's the lump opened up and oozing fluid. On the same day, the patient went to their primary care provider (unspecified) and was referred to a wound care center (unspecified), since the wound was tunneling. On an unspecified date in 2018, the patient told the nurse via phone call that, the wound on the arm was, which was an abscess, being cared for by the wound care center where it was "packed ". At the reporting time, the patient did not experienced fever. The outcome of the other events was unknown. The relatedness between the events and suspect therapies was not reported. Upon internal review, the event of wound abscess was determined to be medically significant.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse and who was referring to a currently 56-year-old female patient. Her pertinent medical history was not reported. Concomitant therapies were not provided. The patient did not have any known drug reaction or allergies. On an unknown date, reported as "the patient believed that years ago", she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not reported). However it was also reported that there was no documentation of the vaccination. On an unknown date, the patient's titer was drawn and the patient was not immune. Consequently, on 13-JUN-2018, the patient was vaccinated with M-M-R II lot # N014482 with an expiration date: 10-MAY-2019, for prophylaxis along with sterile diluent (dose, route of administration, lot# and expiration date were not provided). In June, about 5 to 7 days after vaccination, the patient experienced localized arm reactions (unspecified) with a maximum fever of 102.7 degrees Fahrenheit. On an unspecified date in 2018, she was seen by her primary care provider (unspecified) and diagnosed with cellulitis at the injection site. On an unspecified date in 2018, the patient was given a course of antibiotics (unspecified) and the fever resolved. According to the reporter, the reaction site was not as tender, the swelling went down but the lump was still there. On 23-JUL-2018, the patient's the lump opened up and oozing fluid. On the same day, the patient went to their primary care provider (unspecified) and was referred to a wound care center (unspecified), since the wound was tunneling. On an unspecified date in 2018, the patient told the nurse via phone call that, the wound on the arm was, which was an abscess, being cared for by the wound care center where it was "packed ". At the reporting time, the patient did not experienced fever. The outcome of the other events was unknown. The relatedness between the events and suspect therapies was not reported. Upon internal review, the event of wound abscess was determined to be medically significant.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site cellulitis, Injection site discharge, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a registered nurse and who was referring to a currently 56-year-old female patient. Her pertinent medical history was not reported. Concomitant therapies were not provided. The patient did not have any known drug reaction or allergies. On an unknown date, reported as "the patient believed that years ago", she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not reported). However it was also reported that there was no documentation of the vaccination. On an unknown date, the patient's titer was drawn and the patient was not immune. Consequently, on 13-JUN-2018, the patient was vaccinated with M-M-R II lot # N014482 with an expiration date: 10-MAY-2019, for prophylaxis along with sterile diluent (dose, route of administration, lot# and expiration date were not provided). In June, about 5 to 7 days after vaccination, the patient experienced localized arm reactions (unspecified) with a maximum fever of 102.7 degrees Fahrenheit. On an unspecified date in 2018, she was seen by her primary care provider (unspecified) and diagnosed with cellulitis at the injection site. On an unspecified date in 2018, the patient was given a course of antibiotics (unspecified) and the fever resolved. According to the reporter, the reaction site was not as tender, the swelling went down but the lump was still there. On 23-JUL-2018, the patient's the lump opened up and oozing fluid. On the same day, the patient went to their primary care provider (unspecified) and was referred to a wound care center (unspecified), since the wound was tunneling. On an unspecified date in 2018, the patient told the nurse via phone call that, the wound on the arm was, which was an abscess, being cared for by the wound care center where it was "packed ". At the reporting time, the patient did not experienced fever. The outcome of the other events was unknown. The relatedness between the events and suspect therapies was not reported. Upon internal review, the event of wound abscess was determined to be medically significant.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site swelling, Local reaction, Measles antibody negative, Pyrexia, Wound abscess
Clinical narrative: This spontaneous report was received from a registered nurse and who was referring to a currently 56-year-old female patient. Her pertinent medical history was not reported. Concomitant therapies were not provided. The patient did not have any known drug reaction or allergies. On an unknown date, reported as "the patient believed that years ago", she was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, anatomical location, lot# and expiration date were not reported). However it was also reported that there was no documentation of the vaccination. On an unknown date, the patient's titer was drawn and the patient was not immune. Consequently, on 13-JUN-2018, the patient was vaccinated with M-M-R II lot # N014482 with an expiration date: 10-MAY-2019, for prophylaxis along with sterile diluent (dose, route of administration, lot# and expiration date were not provided). In June, about 5 to 7 days after vaccination, the patient experienced localized arm reactions (unspecified) with a maximum fever of 102.7 degrees Fahrenheit. On an unspecified date in 2018, she was seen by her primary care provider (unspecified) and diagnosed with cellulitis at the injection site. On an unspecified date in 2018, the patient was given a course of antibiotics (unspecified) and the fever resolved. According to the reporter, the reaction site was not as tender, the swelling went down but the lump was still there. On 23-JUL-2018, the patient's the lump opened up and oozing fluid. On the same day, the patient went to their primary care provider (unspecified) and was referred to a wound care center (unspecified), since the wound was tunneling. On an unspecified date in 2018, the patient told the nurse via phone call that, the wound on the arm was, which was an abscess, being cared for by the wound care center where it was "packed ". At the reporting time, the patient did not experienced fever. The outcome of the other events was unknown. The relatedness between the events and suspect therapies was not reported. Upon internal review, the event of wound abscess was determined to be medically significant.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Asthenia, Chills, Erythema, Fatigue
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Initial insomnia, Injected limb mobility decreased, Injection site pain, Injection site rash
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Limb discomfort, Neck pain, Pain in extremity, Rash erythematous
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Thirst
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Neck pain, Pyrexia
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Rash, Pain all the way to the neck and arm, low grade fever, thirsty, weakness and tiredness in the body.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Erythema, Irritability
Clinical narrative: He got a large red spot on his leg and has been very fussy and not himself since.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: No pain during injection. Aproximately 3-4 hours later significant discomfort and pain in the area of arm. Then later when took shirt off the upper arm was very swollen from top of arm almost down to elbow. It was significant and could be easily seen by spouse. It was quite sore to touch, and very swollen. I called primary doctor and was told it was very unsually and to put ice on it. The ice seem to help.
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a currently 36-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II (lot #, expiration date, dose and frequency and route of administration were not provided) for prophylaxis. On an unknown date post-vaccination, the patient had titers drawn and the result showed low titers, specifically less than 9 (units not provided) for mumps. No clarifying information was provided. At the time of this report, the outcome of the event was unknown. The reporter did not provide the causality between the event and the M-M-R II vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in February 2010, the patient was vaccinated with the first dose of GARDASIL for prophylaxis. On an unknown date in November 2011, the patient was vaccinated with GARDASIL for prophylaxis. The patient experienced no adverse event.