chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Injection site reaction, Injection site warmth, Nuclear magnetic resonance imaging brain
Clinical narrative: 7/25/18: Bright red, warm to the touch (no blisters) rash surrounding injection site. Resolved in approximately 3 days. 7/31/18: Awoke at approximately 2 AM to new onset pounding head pain located in back of right side head. Reported to Urgent care. Blood pressure elevated (178/106). Dr diagnosed Herpes Zoster. Started course of VALTREX 1000 mg. 8/8/18: Follow-up visit with PAC. Blood pressure elevated (167/91). Reported only way to stop the 2 AM headaches was to maintain therapy of MOTRIN 400 mg every 6 hours. Removed MOTRIN therapy and started continual therapy of INDOCIN SR 75 mg. Brain MRI ordered. 8/15/18: Return visit with PAC presenting with new onset vaginal sore and elevated blood pressure (156/92). Sore swabbed for HSV. Test returned negative for HSV Type 1 and 2. Started therapy of HYDRODIURIL 25 mg tabs daily. 8/17/18: Brain MRI conducted. Awaiting results. 8/19/18: Awoke approximately 7 AM to numbness in both hands and dull head pain located in back of right side of head.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Thyroid function test normal, Vaginal ulceration
Clinical narrative: 7/25/18: Bright red, warm to the touch (no blisters) rash surrounding injection site. Resolved in approximately 3 days. 7/31/18: Awoke at approximately 2 AM to new onset pounding head pain located in back of right side head. Reported to Urgent care. Blood pressure elevated (178/106). Dr diagnosed Herpes Zoster. Started course of VALTREX 1000 mg. 8/8/18: Follow-up visit with PAC. Blood pressure elevated (167/91). Reported only way to stop the 2 AM headaches was to maintain therapy of MOTRIN 400 mg every 6 hours. Removed MOTRIN therapy and started continual therapy of INDOCIN SR 75 mg. Brain MRI ordered. 8/15/18: Return visit with PAC presenting with new onset vaginal sore and elevated blood pressure (156/92). Sore swabbed for HSV. Test returned negative for HSV Type 1 and 2. Started therapy of HYDRODIURIL 25 mg tabs daily. 8/17/18: Brain MRI conducted. Awaiting results. 8/19/18: Awoke approximately 7 AM to numbness in both hands and dull head pain located in back of right side of head.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Patient experienced a sore arm at the injection site, flu like symptoms (chills and fever) 08-18-2018, and resting heart rate over 120. Patient has not received treatment to date, he feels better today than yesterday, but not nearly as good as Friday prior to the immunization. I instructed to seek medical care if necessary.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Allergy test positive, Anaphylactic reaction, Hypersensitivity
Clinical narrative: My son had eaten peanut butter and almonds several times with no reaction and also had healthy skin. Not even one month after receiving his vaccines he developed severe allergies and went into anaphylactic shock and was allergy tested after that showing allergies to many different things.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash, Sensory disturbance, Skin warm
Clinical narrative: Friday (evening) patient experienced "nerve sensations" randomly and intermittently. Rash began Friday evening as well. Sunday, the rash has enlarged, does not itch, is warm. Extreme fatigue on Saturday.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Fatigue, Pain in extremity, Pruritus
Clinical narrative: Began with very severe fatigue that lasted from 15th through 18th; obvious bruising/redness that looked like someone had grabbed arm leaving prints - but they did not press hard when giving shot. Bruising hurt for about 3 days, then began itching by 19th. Took BENADRYL to relieve. Could not do anything but lie down on 15th, 17th and 18th; 19th finally felt normal except for itching on arm.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: For flu vaccine - redness, itchiness, swelling, sore arm, feverish, achy, headache. For SHINGRIX- redness, swelling, sore arm.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: For flu vaccine - redness, itchiness, swelling, sore arm, feverish, achy, headache. For SHINGRIX- redness, swelling, sore arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Gingival pain, Injection site pain
Clinical narrative: FEVER OF 101.5. CHILLS. DIZINESS AND FEELING FAINT--HAD TO STOP WHILE SHOWERING TO SIT AND LOWER HEAD 2 DIFFERENT TIME FOR 15 MINUTES. EXTREME FATIGUE. SORE MOUTH, PALATE, GUMS, AND THROAT AS OF DAY 5 AFTER SHOT. CONTINUED FOR 4 TO 5 DAYS....THROAT WAS EXTREMELY PAINFUL. PAIN AT INJECTION SITE AND TINGLING IN LEFT ARM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Oropharyngeal pain, Paraesthesia, Pyrexia
Clinical narrative: FEVER OF 101.5. CHILLS. DIZINESS AND FEELING FAINT--HAD TO STOP WHILE SHOWERING TO SIT AND LOWER HEAD 2 DIFFERENT TIME FOR 15 MINUTES. EXTREME FATIGUE. SORE MOUTH, PALATE, GUMS, AND THROAT AS OF DAY 5 AFTER SHOT. CONTINUED FOR 4 TO 5 DAYS....THROAT WAS EXTREMELY PAINFUL. PAIN AT INJECTION SITE AND TINGLING IN LEFT ARM.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Eye pain, Fibromyalgia, Headache, Myalgia
Clinical narrative: I have been having ongoing headaches for years. Just recently when I received the last shot on 9/13/2017 I started to experience more headaches, eye pain, jaw pain, muscle pain and chest pains. Last month I was diagnosed with fibromyalgia.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in jaw
Clinical narrative: I have been having ongoing headaches for years. Just recently when I received the last shot on 9/13/2017 I started to experience more headaches, eye pain, jaw pain, muscle pain and chest pains. Last month I was diagnosed with fibromyalgia.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Rash
Clinical narrative: Felt tired all day, and at night developed a painful rash around the shot area, treated with Tylenol and hydrocortisone cream.
Age: 0.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This shot was giving to me, while I was pregnant with my daughter.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site nodule, Injection site swelling, Myalgia
Clinical narrative: Patient came in today 8-19-18 and showed me his right arm where he received the PNEUMOVAX 23 from 8-16-18, it was reddened and swollen to his elbow, and a hard nodule at injection site and had chills and muscle aches, he also received a flu vaccine at the same time in left arm. Patient put an ice pack on it the following morning and took some ibuprofen for the pain, he said he day it is starting to feel better and is still sore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: Severe headache, fever, shivering, body achy all over, no appetite.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: FEVER.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Impaired work ability, Influenza, Nausea, Pyrexia
Clinical narrative: Patient states the evening following her vaccinations she experienced "every flu symptom imaginable." She states she was nauseous, had chills and a fever, and even had to miss work the following day. She didn't start to feel better until 2 days later.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient states her arm started hurting immediately after the pneumonia vaccine and stayed sore for approximately 2.5 months. Then this past April it started hurting in the exact same spot and she had difficulties lifting her arm and doing daily task such as clip her bra, etc. The right arm is the arm that has been giving her the problem all along. She decided to go to the doctor this week about it. She used ice and it intially helped her but from October but when it started bothering her in April ice didnt help and she resorted to SALONPAS patches to see if they would numb the area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Inflammatory marker increased, Mobility decreased, Pain in extremity
Clinical narrative: Pt reports fatigue and inability to get up, accompanied by severe "traveling" pain, primarily in legs and feet. Required meloxicam to treat, which she is still on as of August 18, 2018. States that MD drew labs and confirmed significantly increased inflammatory mediators and has told pt not to complete SHINGRIX series.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient presented to pharmacy on 8/19/18 with redness across her entire upper arm that she stated felt hot and had been spreading over the last two days. She said that the day prior, 8/18/18, she had experienced a great deal of swelling and her elbow was "messed up", but that had resolved. She reported that she is unable to take antihistamines, so I advised her to monitor the rash and seek medical attention if it worsens. I suggested trying to get in touch with her physician to determine if she should take a course of steroids.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching reported on 8/19/2018 advised BENADRYL and to monitor reaction.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Urticaria
Clinical narrative: On 8/18/2018 at around 6:15pm patient received FLUZONE QUADRIVALENT into her left deltoid, overnight she developed dime size burning hives on her lower abdomen, lower hands, and at inner thighs, she noticed this in the early morning, she also took 25mg BENADRYL tablet at 9 pm for sleep.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: FEVER.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Fatigue, Headache, Impaired work ability, Myalgia
Clinical narrative: Patient reports low grade fever 24 hours after admin that lasted approx 12 hours. Headache, decreased concentration, fatigue and muscle aches. Pt took 1/2 day off from work as result.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports low grade fever 24 hours after admin that lasted approx 12 hours. Headache, decreased concentration, fatigue and muscle aches. Pt took 1/2 day off from work as result.
Sex: U
Vaccine: TYP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Site reaction.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reports extreme soreness later on the first day. Over the next few days..her arm was red with swelling across upper arm and slight warmness. By Friday, the redness had moved downward along with swelling and was still a little sore/sensitive. Patient says that it was subsiding as time went on though.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Decreased appetite, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Same day (day 1) restless sleep and irritability. Day 2 irritability, swollen red/tenderness at injection site. Day 3 irritability, swollen red injection site, tenderness/pain at injection site, restless sleep. Day 4 loss of appetite, irritability, crying and wailing during night time every few hours, hard lump under skin of injection site including redness/bruising, tenderness/pain. Day 5 loss of appetite, irritability, crying and wailing during night every couple hours, hard lump under skin of injection site including bruising, tenderness/pain. Day 6 runny nose, mild fever less than 101.0 irritability, loss of appetite, hard lump under injection site with pain at injection site. Doesn't want to drink fluids.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Irritability, Poor quality sleep
Clinical narrative: Same day (day 1) restless sleep and irritability. Day 2 irritability, swollen red/tenderness at injection site. Day 3 irritability, swollen red injection site, tenderness/pain at injection site, restless sleep. Day 4 loss of appetite, irritability, crying and wailing during night time every few hours, hard lump under skin of injection site including redness/bruising, tenderness/pain. Day 5 loss of appetite, irritability, crying and wailing during night every couple hours, hard lump under skin of injection site including bruising, tenderness/pain. Day 6 runny nose, mild fever less than 101.0 irritability, loss of appetite, hard lump under injection site with pain at injection site. Doesn't want to drink fluids.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Same day (day 1) restless sleep and irritability. Day 2 irritability, swollen red/tenderness at injection site. Day 3 irritability, swollen red injection site, tenderness/pain at injection site, restless sleep. Day 4 loss of appetite, irritability, crying and wailing during night time every few hours, hard lump under skin of injection site including redness/bruising, tenderness/pain. Day 5 loss of appetite, irritability, crying and wailing during night every couple hours, hard lump under skin of injection site including bruising, tenderness/pain. Day 6 runny nose, mild fever less than 101.0 irritability, loss of appetite, hard lump under injection site with pain at injection site. Doesn't want to drink fluids.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pruritus, Swelling
Clinical narrative: Patient reported body aches for 3 days. There was a bump and itchiness at first also. Patient just overall was not feeling well post-vaccine...primarily with the overall body aching.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Haematochezia, Pyrexia, Rotavirus infection, Salmonellosis
Clinical narrative: Blood in stool at 2am after the vaccination. He continued to have bloody stools. Was taking to urgent care. He had fever of 102.2. He continued to have bloody diapers and was sent to the main hospital. He was dehydrated and was diagnosed with rotavirus and salmonella. He was perfectly healthy and fine before the immunizations.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Stool analysis
Clinical narrative: Blood in stool at 2am after the vaccination. He continued to have bloody stools. Was taking to urgent care. He had fever of 102.2. He continued to have bloody diapers and was sent to the main hospital. He was dehydrated and was diagnosed with rotavirus and salmonella. He was perfectly healthy and fine before the immunizations.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Gastroenteritis salmonella, Salmonella test positive
Clinical narrative: Blood in stool at 2am after the vaccination. He continued to have bloody stools. Was taking to urgent care. He had fever of 102.2. He continued to have bloody diapers and was sent to the main hospital. He was dehydrated and was diagnosed with rotavirus and salmonella. He was perfectly healthy and fine before the immunizations.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient came in with large welts/hives on his face and arms. Patient stated that he noticed this morning and that they were very itchy.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pruritus
Clinical narrative: Pt was immunized with MENACTRA vaccine at approximately 4:45pm. Rph evaluated all the DUR for immunization, and found no reason not to proceed with the vaccine. Rph had patient wait in the area for 15-20 minute to observe. Pt had no signs or symptoms of allergic reaction at that time. Pt reported back to pharmacy at approximately 5:45pm with redness in upper chest area and complained of moderate itchiness. Pt reported no problems breathing, etc. Pt stated no prior history of no allergic reaction to a drug or vaccine. Pt advised to take an antihistamine and counseled on sign/symptoms of anaphylaxis reaction. Pt advised to get medical attention if symptoms worsen or are of a concern to her.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient expressed her arm got swollen at injection site and hard. She reported no pain and also not warm to touch.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient was inadvertently given Tdap when Dtap was ordered along with MMR, Varicella, and IPV as part of child's 4-6 year old booster vaccinations. Mother of child was immediately made aware  error with instructions to bring in if any adverse reactions were noted. Child was re-evaluated by myself PA-C on 8-16-2018 with an 7.0 cm X 5.5 cm erythematous and mildly edematous and left anterior thigh where the Tdap was given 48 hours prior. I recommended Cetirizine 5mg/mL 2.5mL-5mL PO Q/day along with Hydrocortisone 2.5% cream applied BID until resolved with introductions to use no longer and 7 days. Child was recommended for follow up visit on 8-2018 or to the emergency room if symptoms worsen. Patient's PCP Dr. and our office manager were made aware of event.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL, IPV, MMR, TDAP
Symptoms: Injection site erythema, Injection site warmth, Wrong product administered
Clinical narrative: Patient was inadvertently given Tdap when Dtap was ordered along with MMR, Varicella, and IPV as part of child's 4-6 year old booster vaccinations. Mother of child was immediately made aware  error with instructions to bring in if any adverse reactions were noted. Child was re-evaluated by myself PA-C on 8-16-2018 with an 7.0 cm X 5.5 cm erythematous and mildly edematous and left anterior thigh where the Tdap was given 48 hours prior. I recommended Cetirizine 5mg/mL 2.5mL-5mL PO Q/day along with Hydrocortisone 2.5% cream applied BID until resolved with introductions to use no longer and 7 days. Child was recommended for follow up visit on 8-2018 or to the emergency room if symptoms worsen. Patient's PCP Dr. and our office manager were made aware of event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Eyelid function disorder, Headache, Lacrimation increased
Clinical narrative: Pt called on 8/19/18 stating she is having watery eyes, can't stand light, can't open her eyes. She stated that these symptoms started on 8/18/18. Pt has been advised to go to ER. Pt also stated that she had Fever, chills, headache, dizziness on 8/15/18 which lasted for 3 days and then resolved. Pt also stated that she could not raise her arm for 2 days. After Pt stated that the eye issues started on 8/18/18 after she got a cold. Pt also stated that maybe she got cream in her eyes. Pt has been advised to go to ER right away. Pt stated that she doesn't want to go and is waiting for the doctor covering her MD to call her back. This is the 2nd shot in series. First time Pt didn't have any SE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nasopharyngitis, Photophobia, Pyrexia
Clinical narrative: Pt called on 8/19/18 stating she is having watery eyes, can't stand light, can't open her eyes. She stated that these symptoms started on 8/18/18. Pt has been advised to go to ER. Pt also stated that she had Fever, chills, headache, dizziness on 8/15/18 which lasted for 3 days and then resolved. Pt also stated that she could not raise her arm for 2 days. After Pt stated that the eye issues started on 8/18/18 after she got a cold. Pt also stated that maybe she got cream in her eyes. Pt has been advised to go to ER right away. Pt stated that she doesn't want to go and is waiting for the doctor covering her MD to call her back. This is the 2nd shot in series. First time Pt didn't have any SE.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Injection site hot/red/swollen/hard 3-days after injection Patient experienced low grade fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Patient stated she had extreme itching on her hands (palms) and her legs, that started shortly after receiving vaccine. She also stated she got a mild case of shingles as well. Took and antihistamine to help with the itching.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated she had redness, swelling, soreness and warmth at injection site and arm shot was administered.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The customer came in for a SHINGRIX vaccine 8/17/18 and came back 8/18/18 stating his arm opposite the injection site became red and swollen. The time course was 24 hours. His arm appeared red mostly opposite the injection site on the same arm.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Nausea, Peripheral swelling, Pruritus
Clinical narrative: The patient reported swelling, itchy arm/hands, the day after. Seven days out patient is reporting itchiness on site along with headache, nausea, and vomiting.
Age: 80.0
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: The patient reported swelling, itchy arm/hands, the day after. Seven days out patient is reporting itchiness on site along with headache, nausea, and vomiting.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of insomnia in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 14th March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation. On an unknown date, the outcome of the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation were not recovered/not resolved. It was unknown if the reporter considered the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient reported on the voicemail that he was seen by his physician.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Impaired work ability, Insomnia, Loss of personal independence in daily activities, Malaise
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of insomnia in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 14th March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation. On an unknown date, the outcome of the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation were not recovered/not resolved. It was unknown if the reporter considered the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient reported on the voicemail that he was seen by his physician.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of insomnia in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 14th March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation. On an unknown date, the outcome of the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation were not recovered/not resolved. It was unknown if the reporter considered the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient reported on the voicemail that he was seen by his physician.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Formication, Insomnia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of insomnia in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 14th March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation. On an unknown date, the outcome of the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation were not recovered/not resolved. It was unknown if the reporter considered the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient reported on the voicemail that he was seen by his physician.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Paraesthesia, Urinary retention
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of insomnia in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 14th March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation. On an unknown date, the outcome of the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation were not recovered/not resolved. It was unknown if the reporter considered the insomnia, tingling skin, fuzzy, fatigue, malaise, appetite lost and crawling sensation to be related to SHINGRIX. Additional details were provided as follows: The patient reported on the voicemail that he was seen by his physician.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding 2 patients of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On two unspecified dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # N034525, expiry date: 13-SEP-2019, intramuscularly for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided).  On 12-JUL-2018, both patients developed cellulitis at injection site and were admitted on unspecified dates to the hospital for unspecified intravenous antibiotics treatment. It was unknown by the reporter if lab diagnostics/studies performed and patients' present status. It was reported that the patients sought medical attention and that they had been seen by a physician. The outcome of injection site cellulitis was not reported. The reporter's causality assessment between PNEUMOVAX 23 and injection site cellulitis was not reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because of availability of patient identifier. Follow-up information was received from the nurse on 10-AUG-2018. The patient was a 71 year 10 months old male. The patient's concurrent conditions included hypertension (HTN), benign prostatic hyperplasia (BPH), osteoarthritis, and hyperlipidaemia. The patient's concomitant therapies included PROSCAR, COZAAR, CRESTOR, FLOMAX, and VERELAN. The patient had no known allergies. The patient had no illnesses at the time of vaccination and up to one month prior. On 05-JUL-2018 at 08:42, the patient was vaccinated with first dose of PNEUMOVAX 23, in the left arm for prophylaxis. On 06-JUL-2018 at 14:43, the patient experienced erythema, swelling, pain, heat left arm and forearm diagnosed as injection site cellulitis, sepsis and acute kidney injury. The patient underwent blood cultures, computerized tomogram (CT) scan arm and ultrasound arm related to the events. The patient visited doctor's office and was hospitalized for two days in July 2018. The patient did not experience these events previously. The outcome of events was reported as recovered in July 2018. The reporter did not provide any causality assessment. Upon internal review, sepsis and acute kidney injury were determined to be medically significant. This is one of two reports received from the same reporter (1808USA007168). Sender's Comments:  US-009507513-1808USA007168.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Acute kidney injury, Blood culture, Computerised tomogram, Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding 2 patients of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On two unspecified dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # N034525, expiry date: 13-SEP-2019, intramuscularly for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided).  On 12-JUL-2018, both patients developed cellulitis at injection site and were admitted on unspecified dates to the hospital for unspecified intravenous antibiotics treatment. It was unknown by the reporter if lab diagnostics/studies performed and patients' present status. It was reported that the patients sought medical attention and that they had been seen by a physician. The outcome of injection site cellulitis was not reported. The reporter's causality assessment between PNEUMOVAX 23 and injection site cellulitis was not reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because of availability of patient identifier. Follow-up information was received from the nurse on 10-AUG-2018. The patient was a 71 year 10 months old male. The patient's concurrent conditions included hypertension (HTN), benign prostatic hyperplasia (BPH), osteoarthritis, and hyperlipidaemia. The patient's concomitant therapies included PROSCAR, COZAAR, CRESTOR, FLOMAX, and VERELAN. The patient had no known allergies. The patient had no illnesses at the time of vaccination and up to one month prior. On 05-JUL-2018 at 08:42, the patient was vaccinated with first dose of PNEUMOVAX 23, in the left arm for prophylaxis. On 06-JUL-2018 at 14:43, the patient experienced erythema, swelling, pain, heat left arm and forearm diagnosed as injection site cellulitis, sepsis and acute kidney injury. The patient underwent blood cultures, computerized tomogram (CT) scan arm and ultrasound arm related to the events. The patient visited doctor's office and was hospitalized for two days in July 2018. The patient did not experience these events previously. The outcome of events was reported as recovered in July 2018. The reporter did not provide any causality assessment. Upon internal review, sepsis and acute kidney injury were determined to be medically significant. This is one of two reports received from the same reporter (1808USA007168). Sender's Comments:  US-009507513-1808USA007168.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling, Sepsis
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding 2 patients of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On two unspecified dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # N034525, expiry date: 13-SEP-2019, intramuscularly for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided).  On 12-JUL-2018, both patients developed cellulitis at injection site and were admitted on unspecified dates to the hospital for unspecified intravenous antibiotics treatment. It was unknown by the reporter if lab diagnostics/studies performed and patients' present status. It was reported that the patients sought medical attention and that they had been seen by a physician. The outcome of injection site cellulitis was not reported. The reporter's causality assessment between PNEUMOVAX 23 and injection site cellulitis was not reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because of availability of patient identifier. Follow-up information was received from the nurse on 10-AUG-2018. The patient was a 71 year 10 months old male. The patient's concurrent conditions included hypertension (HTN), benign prostatic hyperplasia (BPH), osteoarthritis, and hyperlipidaemia. The patient's concomitant therapies included PROSCAR, COZAAR, CRESTOR, FLOMAX, and VERELAN. The patient had no known allergies. The patient had no illnesses at the time of vaccination and up to one month prior. On 05-JUL-2018 at 08:42, the patient was vaccinated with first dose of PNEUMOVAX 23, in the left arm for prophylaxis. On 06-JUL-2018 at 14:43, the patient experienced erythema, swelling, pain, heat left arm and forearm diagnosed as injection site cellulitis, sepsis and acute kidney injury. The patient underwent blood cultures, computerized tomogram (CT) scan arm and ultrasound arm related to the events. The patient visited doctor's office and was hospitalized for two days in July 2018. The patient did not experience these events previously. The outcome of events was reported as recovered in July 2018. The reporter did not provide any causality assessment. Upon internal review, sepsis and acute kidney injury were determined to be medically significant. This is one of two reports received from the same reporter (1808USA007168). Sender's Comments:  US-009507513-1808USA007168.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: This spontaneous report was received from a licensed vocational nurse regarding 2 patients of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reporter. On two unspecified dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # N034525, expiry date: 13-SEP-2019, intramuscularly for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided).  On 12-JUL-2018, both patients developed cellulitis at injection site and were admitted on unspecified dates to the hospital for unspecified intravenous antibiotics treatment. It was unknown by the reporter if lab diagnostics/studies performed and patients' present status. It was reported that the patients sought medical attention and that they had been seen by a physician. The outcome of injection site cellulitis was not reported. The reporter's causality assessment between PNEUMOVAX 23 and injection site cellulitis was not reported. This is a non-valid case due to lack of patient identifiers. Upon receipt of follow-up information, it was determined that this case is now valid because of availability of patient identifier. Follow-up information was received from the nurse on 10-AUG-2018. The patient was a 71 year 10 months old male. The patient's concurrent conditions included hypertension (HTN), benign prostatic hyperplasia (BPH), osteoarthritis, and hyperlipidaemia. The patient's concomitant therapies included PROSCAR, COZAAR, CRESTOR, FLOMAX, and VERELAN. The patient had no known allergies. The patient had no illnesses at the time of vaccination and up to one month prior. On 05-JUL-2018 at 08:42, the patient was vaccinated with first dose of PNEUMOVAX 23, in the left arm for prophylaxis. On 06-JUL-2018 at 14:43, the patient experienced erythema, swelling, pain, heat left arm and forearm diagnosed as injection site cellulitis, sepsis and acute kidney injury. The patient underwent blood cultures, computerized tomogram (CT) scan arm and ultrasound arm related to the events. The patient visited doctor's office and was hospitalized for two days in July 2018. The patient did not experience these events previously. The outcome of events was reported as recovered in July 2018. The reporter did not provide any causality assessment. Upon internal review, sepsis and acute kidney injury were determined to be medically significant. This is one of two reports received from the same reporter (1808USA007168). Sender's Comments:  US-009507513-1808USA007168.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Cellulitis, Erythema, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included allopurinol, acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), fluticasone propionate, polyethylene glycol (Miralax), ubidecarenone (Coq10), fish oil and verapamil. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort. On 12th July 2018, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, the patient experienced fever. On 17th July 2018, the patient experienced injection site pain and injection site itching. On 16th July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site discomfort, injection site warmth, injection site pain, injection site cellulitis, injection site itching, injection site erythema and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, injection site warmth, injection site pain, fever, injection site cellulitis, injection site itching, injection site erythema and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her physician had reported adverse events to VAERS. Concomitant medication included move free joint pill (over the counter), multivitamins and probiotic. The patient received SHINGRIX vaccine in the right deltoid. On 12th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 17th July 2018, 6 days after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. The patient reported that his fever went as high as 100.5. The patient planned to continue follow-up with his physician on an unknown date. The patient provided contact details of the physician.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included allopurinol, acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), fluticasone propionate, polyethylene glycol (Miralax), ubidecarenone (Coq10), fish oil and verapamil. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort. On 12th July 2018, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, the patient experienced fever. On 17th July 2018, the patient experienced injection site pain and injection site itching. On 16th July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site discomfort, injection site warmth, injection site pain, injection site cellulitis, injection site itching, injection site erythema and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, injection site warmth, injection site pain, fever, injection site cellulitis, injection site itching, injection site erythema and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her physician had reported adverse events to VAERS. Concomitant medication included move free joint pill (over the counter), multivitamins and probiotic. The patient received SHINGRIX vaccine in the right deltoid. On 12th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 17th July 2018, 6 days after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. The patient reported that his fever went as high as 100.5. The patient planned to continue follow-up with his physician on an unknown date. The patient provided contact details of the physician.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included allopurinol, acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), fluticasone propionate, polyethylene glycol (Miralax), ubidecarenone (Coq10), fish oil and verapamil. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort. On 12th July 2018, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, the patient experienced fever. On 17th July 2018, the patient experienced injection site pain and injection site itching. On 16th July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site discomfort, injection site warmth, injection site pain, injection site cellulitis, injection site itching, injection site erythema and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, injection site warmth, injection site pain, fever, injection site cellulitis, injection site itching, injection site erythema and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her physician had reported adverse events to VAERS. Concomitant medication included move free joint pill (over the counter), multivitamins and probiotic. The patient received SHINGRIX vaccine in the right deltoid. On 12th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 17th July 2018, 6 days after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. The patient reported that his fever went as high as 100.5. The patient planned to continue follow-up with his physician on an unknown date. The patient provided contact details of the physician.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included allopurinol, acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), fluticasone propionate, polyethylene glycol (Miralax), ubidecarenone (Coq10), fish oil and verapamil. On 11th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort. On 12th July 2018, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, the patient experienced fever. On 17th July 2018, the patient experienced injection site pain and injection site itching. On 16th July 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site discomfort, injection site warmth, injection site pain, injection site cellulitis, injection site itching, injection site erythema and joint pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, injection site warmth, injection site pain, fever, injection site cellulitis, injection site itching, injection site erythema and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated that her physician had reported adverse events to VAERS. Concomitant medication included move free joint pill (over the counter), multivitamins and probiotic. The patient received SHINGRIX vaccine in the right deltoid. On 12th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site warmth, injection site cellulitis, injection site erythema and joint pain. On 13th July 2018, 2 days after receiving SHINGRIX, the patient experienced fever. On 17th July 2018, 6 days after receiving SHINGRIX, the patient experienced injection site pain and injection site itching. The patient reported that his fever went as high as 100.5. The patient planned to continue follow-up with his physician on an unknown date. The patient provided contact details of the physician.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Dermatitis allergic, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 75-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included CRESTOR, FLONASE Nasal Spray, LINZESS and ZETIA. On 25th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th July 2018, less than a day after receiving SHINGRIX, the patient experienced itchy rash, arm discomfort, blistery rash and raised rash. On an unknown date, the outcome of the itchy rash, arm discomfort, blistery rash and raised rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, arm discomfort, blistery rash and raised rash to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a rash with blisters that were raised and weeping, itchy and also experienced discomfort on both arms from his upper arm to his elbow. The pharmacist reported that the patient followed-up with the physician on 8th August 2018. The pharmacist reported that he reported this to VAERS.