chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER CHILLS BODY ACHES
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Urticaria
Clinical narrative: hives on both lower arms.  First on the left vaccinated arm, then the other ( right) arm.  Still having a reaction.  Not affecting breathing.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash
Clinical narrative: Patient had flu like symptoms and rash (approx 2 inch circle) around the injection site for 2 days following the vaccination
Age: 2.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Aphasia, Eye discharge, Human metapneumovirus test positive, Intentional self-injury, Pyrexia
Clinical narrative: On March 28TH he started with a fever and runny nose and eye puss. He had a fever for 4 days and got sent to the hospital, and tested positive for human metapneumovirus. He was not speaking and tapping on his face with his fists.
Age: 2.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: On March 28TH he started with a fever and runny nose and eye puss. He had a fever for 4 days and got sent to the hospital, and tested positive for human metapneumovirus. He was not speaking and tapping on his face with his fists.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Vaccine given at 1:40pm on 6/4/19. Patient states that when she woke up on 6/5/19 her arm was sore, swollen and warm to the touch. She stated she applied ice packs to it. She came into the pharmacy at 6:40 on 6/6/19. The vaccinated arm was red and swollen on the underside of the arm down past her elbow. There did not appear to be any swelling at the site of the injection (you could see where the bandaid had been). I advised her to go to the emergency care center to have it looked at by a physician (to make sure it was not cellulitis).  Patient did receive Prevnar 13 from myself on 10/6/2015 without any adverse effects.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Lethargy, Myalgia, Nausea
Clinical narrative: Nausea, headache, lethargic, muscle aches, mild chills, that lasted 11 hrs.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Culture negative, Headache, Meningitis, Mental status changes, Seizure
Clinical narrative: Vaccines administered on May 30, 2019.  Seen in ED and admitted to hospital on Jun 3, 2019 for headache, altered mental status, and seizures.  Meningitis as preliminary diagnosis, culture negative.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient had a syncopal event immediately following administration of vaccine Resolved instantaneously
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Herpes zoster, Impaired work ability, Muscular weakness, Rash
Clinical narrative: The Patient had a shingles symptom and rash appear. Patient states was very weeks knees and had difficulty walking and was not able to work for 3 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Lethargy, Mental status changes
Clinical narrative: Temp 101.8, lethargic for 2-3 days, decreased mental status
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Decreased appetite, Lethargy, Pyrexia, Seizure, Tremor
Clinical narrative: 2-230pm temp of 104. Went to 105. Tylenol would not work.   Stopped accepting food starting 2am-10am Very lethargic from 6am-9am when normally up  Shaking and convulsing
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: Unable to give lot number, given in health dept
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness, swelling at injection site and distal;  Patient saw doctor and received prescription for clindamycin.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported red, warm, swollen area below injection sight. It was painful for a couple days but is now only painful if touched or bumped.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Hyperhidrosis, Nausea
Clinical narrative: headache, nausia, retlessness, uncomfortable, chills, sweating
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: headache, nausia, retlessness, uncomfortable, chills, sweating
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymph node pain, Pain, Tenderness
Clinical narrative: Patient reported tenderness and soreness.  She also had a red circle about 3 inches in diameter where the vaccine was given and her lymph nodes in her left armpit were very tender and sore.
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 6/2/19 4pm patient received 1 dose of Boostrix on right arm and 1 dose of Shingrex on left arm. At around 9pm 6/2/19, patient experienced pain on left arm. On 6/4/19, patient experienced redness and swelling on left arm. On 6/6/19, patient states pain and swelling improved, but there is itchiness near injection site on left arm.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Rash
Clinical narrative: Rash on waistline right side of body.  Rash is getting better as of 12 hours later.  Patient reports feeling achy and had chills this morning at onset of rash.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Crying, Injection site mass, Injection site pain
Clinical narrative: She had Hib (PedvaxHIB), PCV13 and Hepb (Engerix-B) at the same time. This was her second dose (first dose at 9 weeks) of all 3. She received the PCV13 on the right thigh, with no reaction. On her left thigh, she received the Hib and Hepb. I am not sure which of these two injections caused it, but she had a bump under the skin that was bigger than her nose in size and lasted one month. It was extremely painful when I touched it and if any time I accidentally barely touched her leg she would cry. It slowly decreased in size and was gone in a month.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Heart rate increased, Pain
Clinical narrative: We both took our second Shingrix Shingles shot. During the night had chills. In the morning had headaches, 101.5 fever, fast heart rates ranging from 88 to 95 bpm. Light headed, body aches. We both had these symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: We both took our second Shingrix Shingles shot. During the night had chills. In the morning had headaches, 101.5 fever, fast heart rates ranging from 88 to 95 bpm. Light headed, body aches. We both had these symptoms.
Sex: M
Vaccine: PPV
Symptoms: Blindness unilateral, Blood glucose normal, Borrelia test negative, C-reactive protein normal, Full blood count
Clinical narrative: Patient was in the office and received a pneumovax on 4/10/19. Later that night he started to lose vision in his right eye and has since lost full vision in his right eye.
Sex: M
Vaccine: PPV
Symptoms: Glomerular filtration rate normal, Metabolic function test, Red blood cell sedimentation rate, Treponema test negative, Troponin T normal
Clinical narrative: Patient was in the office and received a pneumovax on 4/10/19. Later that night he started to lose vision in his right eye and has since lost full vision in his right eye.
Sex: M
Vaccine: PPV
Symptoms: Vitamin B12
Clinical narrative: Patient was in the office and received a pneumovax on 4/10/19. Later that night he started to lose vision in his right eye and has since lost full vision in his right eye.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Intussusception, Vomiting
Clinical narrative: My son received the MMR vaccine on 04/27/2019 and was perfectly fine and healthy up until this point. On 04/29/2019 my son began to throw up and showed signs of exhaustion. A few hours later he was diagnosed with intussusception.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received a Shingrix vaccination on 3/28/19, and got rashes on her upper arm. The rash persisted and spread on her arm. Her physician told her to take 3 Cetirizine 10mg tablets three times daily for 1 week, and the rash became smaller, but is still present.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: I had a Pneumovax 23 vaccine 6/1/19. I got a high fever 101.7 was shivering and my arm was very sore. I went to urgent care 6/2/19. They determined it was the Pneumovax vaccine and not the Shingrix vaccine that I also received on 6/1/19. I rec'd the first Shingrix vaccine 3/30/19 with no problems. My fever went down 6/2/19 to 100.5 and I kept taking Tylenol and slept most the day and night. Today 6/3/19 I feel better and don't have a fever. I rec'd the vaccines at pharmacy. The pharmacist checked the website and stated I could receive both vaccines at the same time. Urgent care confirmed this. I have never had a bad reaction to a vaccine before other than a sore or red arm. I have a pdf of the two vaccines but not a photo. The NCD number was 00006-4837-03 for the Pneumovax 23. Rx number 6996891. The Shingrix (not the problem) was NCD 58160-0823-11, Rx number 6996890.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site exfoliation, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Received Tdap vaccination on 4/16/19. On 4/17/19 noticed area was red, itchy, and swollen (to be expected, but severity new reaction for me). Over next several days/weeks, developed a large lump under skin that was approx. 3x3. Area of redness continued with itchiness, and lump/abscess. Physician notified but was told she didn't need to examine to just put ice on site. The abscess or lump is still present under skin as of today 5/6/19 with redness and peeling skin at injection site. I have pictures if needed of my arm since day after vaccination.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: Proquad #1 given on 5/15/19 on 5/31 he had fever 102 degrees - went to urgent care and put on cefdinir - received 2 doses - then mom noticed a diffuse macular rash on face, trunk, extremities - the child was not having other symptoms - the rash was most consistent with mild exanthem or vaccine related rash not drug related rash
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: 4x3 cm left delta ... Mother states that patient complained once or twice about the pain after administration. Swelling and pain started one day after administration. Mother gave patient ibuprofen for pain, which helped, and applied Neosporin to the area of concern. Mother states that patient possibly scratched the area of administration as it caused redness, which is why Neosporin was applied, and a scab formed. Swelling and pain was gone after 2-3 days of administration. During that time, area was sensitive to touch and there was a possible bruise?
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left Deltoid - Erythema - edema - pain
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Erythema, Nodule, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Patient came to pharmacy 6/6/19 around 7pm to pick up a copy of her flu shot form b/c she said she's still have pain from the vaccine and her md told her it was given incorrectly.  The patient states she always has a reaction to vaccines.  So when her arm first was very red and hurt she didn't think anything of it b/c this always happens to her. The patient states that it appeared to be like a "red strip" from the back to the front of her left shoulder. Today she is feeling joint pain in the area. Patient states received vaccine 9.22.18 and followed up with her PCP office about 3 weeks after the shot. She said after her first follow up she saw staff at the PCP office about 2 weeks later. After seeing staff she went back one more time to see Dr. who order xrays and she recommended to see an orthopedic doctor. She went to see Dr. around Jan 2019. The orthopedic doctor did a cortisone injection in her left shoulder and was recommended to do therapy. She states he told her that the flu shot was given in the incorret area and he could see that on a MRI she had after visiting him in Jan 2019. She plans to go for a follow up with the Dr b/c she's still stating she has pain now (joint pain and pain from the back top of her shoulder to the front top of her shoulder). She just saw Dr, her PCP, last week, who's in the same office as orthopedic Dr. and staff. The patient states that her md says she now has another nodule forming at her shoulder area and the Dr is thinking she has a torn rotator cuff from the shot. Again the patient wants to see the orthopedic doctor one more then and then follow up again with her PCP to see if they are on the same page with these findings.  The patient reports still feeling pain in her arm. She states she feels it in her joints mostly when she's moving.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site, X-ray
Clinical narrative: Patient came to pharmacy 6/6/19 around 7pm to pick up a copy of her flu shot form b/c she said she's still have pain from the vaccine and her md told her it was given incorrectly.  The patient states she always has a reaction to vaccines.  So when her arm first was very red and hurt she didn't think anything of it b/c this always happens to her. The patient states that it appeared to be like a "red strip" from the back to the front of her left shoulder. Today she is feeling joint pain in the area. Patient states received vaccine 9.22.18 and followed up with her PCP office about 3 weeks after the shot. She said after her first follow up she saw staff at the PCP office about 2 weeks later. After seeing staff she went back one more time to see Dr. who order xrays and she recommended to see an orthopedic doctor. She went to see Dr. around Jan 2019. The orthopedic doctor did a cortisone injection in her left shoulder and was recommended to do therapy. She states he told her that the flu shot was given in the incorret area and he could see that on a MRI she had after visiting him in Jan 2019. She plans to go for a follow up with the Dr b/c she's still stating she has pain now (joint pain and pain from the back top of her shoulder to the front top of her shoulder). She just saw Dr, her PCP, last week, who's in the same office as orthopedic Dr. and staff. The patient states that her md says she now has another nodule forming at her shoulder area and the Dr is thinking she has a torn rotator cuff from the shot. Again the patient wants to see the orthopedic doctor one more then and then follow up again with her PCP to see if they are on the same page with these findings.  The patient reports still feeling pain in her arm. She states she feels it in her joints mostly when she's moving.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came to pharmacy 6/6/19 around 7pm to pick up a copy of her flu shot form b/c she said she's still have pain from the vaccine and her md told her it was given incorrectly.  The patient states she always has a reaction to vaccines.  So when her arm first was very red and hurt she didn't think anything of it b/c this always happens to her. The patient states that it appeared to be like a "red strip" from the back to the front of her left shoulder. Today she is feeling joint pain in the area. Patient states received vaccine 9.22.18 and followed up with her PCP office about 3 weeks after the shot. She said after her first follow up she saw staff at the PCP office about 2 weeks later. After seeing staff she went back one more time to see Dr. who order xrays and she recommended to see an orthopedic doctor. She went to see Dr. around Jan 2019. The orthopedic doctor did a cortisone injection in her left shoulder and was recommended to do therapy. She states he told her that the flu shot was given in the incorret area and he could see that on a MRI she had after visiting him in Jan 2019. She plans to go for a follow up with the Dr b/c she's still stating she has pain now (joint pain and pain from the back top of her shoulder to the front top of her shoulder). She just saw Dr, her PCP, last week, who's in the same office as orthopedic Dr. and staff. The patient states that her md says she now has another nodule forming at her shoulder area and the Dr is thinking she has a torn rotator cuff from the shot. Again the patient wants to see the orthopedic doctor one more then and then follow up again with her PCP to see if they are on the same page with these findings.  The patient reports still feeling pain in her arm. She states she feels it in her joints mostly when she's moving.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Patient came to pharmacy 6/6/19 around 7pm to pick up a copy of her flu shot form b/c she said she's still have pain from the vaccine and her md told her it was given incorrectly.  The patient states she always has a reaction to vaccines.  So when her arm first was very red and hurt she didn't think anything of it b/c this always happens to her. The patient states that it appeared to be like a "red strip" from the back to the front of her left shoulder. Today she is feeling joint pain in the area. Patient states received vaccine 9.22.18 and followed up with her PCP office about 3 weeks after the shot. She said after her first follow up she saw staff at the PCP office about 2 weeks later. After seeing staff she went back one more time to see Dr. who order xrays and she recommended to see an orthopedic doctor. She went to see Dr. around Jan 2019. The orthopedic doctor did a cortisone injection in her left shoulder and was recommended to do therapy. She states he told her that the flu shot was given in the incorret area and he could see that on a MRI she had after visiting him in Jan 2019. She plans to go for a follow up with the Dr b/c she's still stating she has pain now (joint pain and pain from the back top of her shoulder to the front top of her shoulder). She just saw Dr, her PCP, last week, who's in the same office as orthopedic Dr. and staff. The patient states that her md says she now has another nodule forming at her shoulder area and the Dr is thinking she has a torn rotator cuff from the shot. Again the patient wants to see the orthopedic doctor one more then and then follow up again with her PCP to see if they are on the same page with these findings.  The patient reports still feeling pain in her arm. She states she feels it in her joints mostly when she's moving.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Redness at site of vaccine with warmth and tenderness of (L) thigh Treated with Keflex.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site urticaria
Clinical narrative: Hives within days at injection site then systemically x weeks 0 Anaphylaxis
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: An area of redness & subcutaneous lump noted in (L) deltoid reg measuring 1.5x2in & an area of induration & tenderness noted in the (R) deltoid reg measuring 2.2x3cm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient describes rash on injection site that still exists 16 days after receiving injection. Rash descipates
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Chest X-ray, Electroencephalogram normal, Febrile convulsion, Seizure like phenomena
Clinical narrative: 5/22/19 - AM, well child visit - Dtap administered  5/22/19 - PM - ER for Temp 105, febrile seizure 5/25/19 - Admitted to hospital. Seizure-like activity. 30 hr EEG - normal. Discharged 5/26/19 6/6/19 - PCP office visit.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Urine analysis
Clinical narrative: 5/22/19 - AM, well child visit - Dtap administered  5/22/19 - PM - ER for Temp 105, febrile seizure 5/25/19 - Admitted to hospital. Seizure-like activity. 30 hr EEG - normal. Discharged 5/26/19 6/6/19 - PCP office visit.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Pruritus generalised
Clinical narrative: Patient said as she was walking out of store after shot - she felt itchy all over. She went home - put a cold pack on her sore arm & took a pain reliever. Was still itchy - took a Benadryl. She also had redness & pain 3 1/2" down & 1" forward from injection site. Pt. informed me 6-6-19 of adverse event. Felt better next day.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Neurodermatitis, Pruritus
Clinical narrative: Unknown exact date of vaccine and reaction, but in Oct pt had 2nd Shingrix, then days later had very pruritic eczematous eruption on most of her trunk. Seen 6/5/19 and has few spots of lichen simplex chronicus that remain, but rest has started to resolve without treatment.
Age: 15.0
Sex: F
Vaccine: HEPA, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: According to mom, itchy body rash has occured Tuesday at pm after receiving injections at am. Denied fever or any other symptoms. Rash are individual bumps with out pustules (under bra area on right side of chest).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: sore shoulder; stiff neck; slight headache; hives/red and hives on top of hives; quite red; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shoulder soreness, stiff neck, headache, hives and erythema. On an unknown date, the outcome of the shoulder soreness, stiff neck, headache, hives and erythema were unknown.   It was unknown if the reporter considered the shoulder soreness, stiff neck, headache, hives and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shringrix injection a month before the date of reporting and had side effects including sore shoulder, stiff neck, slight headache and hives.  The hives were not unusual for the patient to have, but these were quite red and hives on top of hives. Not really itchy though. The patient was wondering if this injection contains any sulfa which the patient was very allergic to and was aking if the patient should go ahead with the second injection.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Musculoskeletal pain, Musculoskeletal stiffness, Urticaria
Clinical narrative: sore shoulder; stiff neck; slight headache; hives/red and hives on top of hives; quite red; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shoulder soreness, stiff neck, headache, hives and erythema. On an unknown date, the outcome of the shoulder soreness, stiff neck, headache, hives and erythema were unknown.   It was unknown if the reporter considered the shoulder soreness, stiff neck, headache, hives and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shringrix injection a month before the date of reporting and had side effects including sore shoulder, stiff neck, slight headache and hives.  The hives were not unusual for the patient to have, but these were quite red and hives on top of hives. Not really itchy though. The patient was wondering if this injection contains any sulfa which the patient was very allergic to and was aking if the patient should go ahead with the second injection.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Lymphadenopathy, Oral herpes, Peripheral swelling
Clinical narrative: pink cheek; cheek scabbed over; shingles; fever of 99.0; swollen face on right side; swollen glands on right side; Rash; cold sore broke out to inside the right cheek; swelling of left arm; Injection site redness; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 4th April 2019, the patient received Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On 5th April 2019, the patient experienced injection site swelling. On 10th April 2019, the patient experienced shingles, fever, facial swelling, swollen glands, rash and cold sores. On 13th April 2019, the patient experienced red face and scab. On an unknown date, the outcome of the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Public Health Nurse. The patient experienced redness where the vaccine was administered. On 5th April 2019, 1 day after receiving a dose of Shingrix the patient experienced swelling of left arm, where the vaccine was administered. On 10th April 2019 at 10 AM, 6 days after receiving a dose of shingrix, the patient had fever, swollen face and glands on right side, started in right corner of mouth. On the same day the patient questioned a cold sore but by the evening it broke out to inside the right cheek. On 13th April 2019, 9 days after receiving a dose of shingrix, the patient had pink on cheek and by the 17th April 2019 it was mostly scabbed over. On 17th April 2019, the patient visited to primary care physician and was told that he had shingles, but no testing was done.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Scab, Swelling face
Clinical narrative: pink cheek; cheek scabbed over; shingles; fever of 99.0; swollen face on right side; swollen glands on right side; Rash; cold sore broke out to inside the right cheek; swelling of left arm; Injection site redness; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 4th April 2019, the patient received Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On 5th April 2019, the patient experienced injection site swelling. On 10th April 2019, the patient experienced shingles, fever, facial swelling, swollen glands, rash and cold sores. On 13th April 2019, the patient experienced red face and scab. On an unknown date, the outcome of the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Public Health Nurse. The patient experienced redness where the vaccine was administered. On 5th April 2019, 1 day after receiving a dose of Shingrix the patient experienced swelling of left arm, where the vaccine was administered. On 10th April 2019 at 10 AM, 6 days after receiving a dose of shingrix, the patient had fever, swollen face and glands on right side, started in right corner of mouth. On the same day the patient questioned a cold sore but by the evening it broke out to inside the right cheek. On 13th April 2019, 9 days after receiving a dose of shingrix, the patient had pink on cheek and by the 17th April 2019 it was mostly scabbed over. On 17th April 2019, the patient visited to primary care physician and was told that he had shingles, but no testing was done.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: pink cheek; cheek scabbed over; shingles; fever of 99.0; swollen face on right side; swollen glands on right side; Rash; cold sore broke out to inside the right cheek; swelling of left arm; Injection site redness; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 4th April 2019, the patient received Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On 5th April 2019, the patient experienced injection site swelling. On 10th April 2019, the patient experienced shingles, fever, facial swelling, swollen glands, rash and cold sores. On 13th April 2019, the patient experienced red face and scab. On an unknown date, the outcome of the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Public Health Nurse. The patient experienced redness where the vaccine was administered. On 5th April 2019, 1 day after receiving a dose of Shingrix the patient experienced swelling of left arm, where the vaccine was administered. On 10th April 2019 at 10 AM, 6 days after receiving a dose of shingrix, the patient had fever, swollen face and glands on right side, started in right corner of mouth. On the same day the patient questioned a cold sore but by the evening it broke out to inside the right cheek. On 13th April 2019, 9 days after receiving a dose of shingrix, the patient had pink on cheek and by the 17th April 2019 it was mostly scabbed over. On 17th April 2019, the patient visited to primary care physician and was told that he had shingles, but no testing was done.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Pyrexia, Rash, Scab, Swelling face
Clinical narrative: pink cheek; cheek scabbed over; shingles; fever of 99.0; swollen face on right side; swollen glands on right side; Rash; cold sore broke out to inside the right cheek; swelling of left arm; Injection site redness; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox.   On 4th April 2019, the patient received Shingrix. On 4th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On 5th April 2019, the patient experienced injection site swelling. On 10th April 2019, the patient experienced shingles, fever, facial swelling, swollen glands, rash and cold sores. On 13th April 2019, the patient experienced red face and scab. On an unknown date, the outcome of the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site swelling, fever, facial swelling, swollen glands, rash, cold sores, red face and scab to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Public Health Nurse. The patient experienced redness where the vaccine was administered. On 5th April 2019, 1 day after receiving a dose of Shingrix the patient experienced swelling of left arm, where the vaccine was administered. On 10th April 2019 at 10 AM, 6 days after receiving a dose of shingrix, the patient had fever, swollen face and glands on right side, started in right corner of mouth. On the same day the patient questioned a cold sore but by the evening it broke out to inside the right cheek. On 13th April 2019, 9 days after receiving a dose of shingrix, the patient had pink on cheek and by the 17th April 2019 it was mostly scabbed over. On 17th April 2019, the patient visited to primary care physician and was told that he had shingles, but no testing was done.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling cold, Injection site rash
Clinical narrative: shingles-like sores; damage to skin; Pain; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash, skin injury, pain and discomfort. On an unknown date, the outcome of the vesicular rash, skin injury, pain and discomfort were unknown.   It was unknown if the reporter considered the vesicular rash, skin injury, pain and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had horrible reaction to the 2nd shingrix shot. The patient wish could include pictures of the damage to Skin. The patient had a horrible experience with the shingrix and have spent the last month in considerable pain and discomfort.  The patient covered with shingles-like sores, and frankly the patient would have rather risked actual shingles than this experience. The patient has endured.  The patient would do everything can to alert family members friends and even age appropriate acquaintances to the risk involved in partaking of the shingrix vaccine.  The patient was a huge supporter of vaccines in general, but this one was potentially very damaging, the patient regret that ever heard of shingrix, much less allowed or agreed to the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia, Rash, Rash vesicular, Vomiting
Clinical narrative: shingles-like sores; damage to skin; Pain; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash, skin injury, pain and discomfort. On an unknown date, the outcome of the vesicular rash, skin injury, pain and discomfort were unknown.   It was unknown if the reporter considered the vesicular rash, skin injury, pain and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had horrible reaction to the 2nd shingrix shot. The patient wish could include pictures of the damage to Skin. The patient had a horrible experience with the shingrix and have spent the last month in considerable pain and discomfort.  The patient covered with shingles-like sores, and frankly the patient would have rather risked actual shingles than this experience. The patient has endured.  The patient would do everything can to alert family members friends and even age appropriate acquaintances to the risk involved in partaking of the shingrix vaccine.  The patient was a huge supporter of vaccines in general, but this one was potentially very damaging, the patient regret that ever heard of shingrix, much less allowed or agreed to the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Pain, Rash vesicular, Skin injury
Clinical narrative: shingles-like sores; damage to skin; Pain; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash, skin injury, pain and discomfort. On an unknown date, the outcome of the vesicular rash, skin injury, pain and discomfort were unknown.   It was unknown if the reporter considered the vesicular rash, skin injury, pain and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had horrible reaction to the 2nd shingrix shot. The patient wish could include pictures of the damage to Skin. The patient had a horrible experience with the shingrix and have spent the last month in considerable pain and discomfort.  The patient covered with shingles-like sores, and frankly the patient would have rather risked actual shingles than this experience. The patient has endured.  The patient would do everything can to alert family members friends and even age appropriate acquaintances to the risk involved in partaking of the shingrix vaccine.  The patient was a huge supporter of vaccines in general, but this one was potentially very damaging, the patient regret that ever heard of shingrix, much less allowed or agreed to the vaccine.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient were each administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse referring to two unspecified patients of unknown ages and unknown genders. Information of concurrent condition, medical history and concomitant therapy were not provided.    On 24-OCT-2018, patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017635 with expiration date 20-JUN-2020 (strength, dose and route were not reported) for prophylaxis and sterile diluent (STERILE DILUENT). The varicella virus vaccine live (oka/merck)(VARIVAX) vaccines experienced temperature excursion and were stored at 6 to 14 Fahrenheit degrees (9.1 Fahrenheit degrees ) for 50 minutes (Product storage error). There was no previous temperature excursion. No adverse events were reported in any patients. A data logger was involved. The outcome of the event was not reported.  Follow-up information was received from the reporting nurse on 05-JUN-2019.  The nurse reported the patient's demographics and were updated in the case. It was also reported that on 24-OCT-2018, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, route of administration, anatomical site of injection, lot # and expiration date were not reported). There was no information regarding storage of this vaccine.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002233: US-009507513-1906USA002234:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; On 29-MAY-2019, the patient was inadvertently administered an expired dose of MMRII (Lot N013869 exp. 04-MAY-2019); Information has been received from a nurse, referring to a 13 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N013869 (expiration date on 04-MAY-2019) for prophylaxis. That was reconstituted with properly stored sterile diluent. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Expired dose of ZOSTAVAX administered to 12 month old patient; This spontaneous report was received from a physician, concerning a 12-month old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 30-MAY-2019, an expired dose of Zoster Vaccine Live (ZOSTAVAX) (19400 plaque-forming units (PFU) vial) lot # N025703with expiration date 16-DEC-2018 (dose, frequency and anatomical location were not provided; route of administration was unknown by the reporter) was administered to the patient for prophylaxis.  No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.    On or about 07-JUL-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration not specified), as prescribed and/or administered by a healthcare provider at a pharmacy, for the long-term prevention of herpes zoster or shingles.  On an unspecified date, reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at a physician's office for herpes zoster. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX)  vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the event is not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; On 03-JUN-2019, 1 dose of VAQTA (lot R011952 and expiration date 27-MAY-2019) was administered to 1 patient; This spontaneous report was received from a medical assistant and refers to a 16 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug allergies/reactions were not reported.  On 03-JUN-2019, the patient was vaccinated with an expire dose of hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (units not reported) (route of administration and anatomical site of vaccination were not reported; lot number R011952 and expiration date on 27-MAY-2019) (experienced expired product administered). Additionally, no adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: At the age of 18 years old the patient was accidentally re-vaccinated and given another dose of GARDASIL 9. The patient is now 19 years old and was given yet another GARDASIL 9 shot; no adverse event; This spontaneous report was received from the patient's mother and refers to a 19 year old female patient. The patient's medical history included thyroid disorder.  The patient's concomitant medications and drug reactions or allergies were not reported.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 5,  via intramuscular, for prophylaxis (dosage schedule, anatomical location, lot number and expiration date were not reported).     On an unknown date, it was reported that at the age of 18 years old the patient was accidentally re-vaccinated and given another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The patient was now19 years old and was given yet another hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot (extra dose administered ). The patient did not experience any reaction.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects; in removing the needle from the patient's right thigh, some product spilled out of the syringe and the patient subsequently had an inadvertent low or invalid dose; This spontaneous report as received from a registered nurse refers to a 12-months-old patient of an unknown gender.  The patient's medical history, concurrent conditions, concomitant medications, past drugs and allergies were unknown.  On 30-MAY-2019, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), via subcutaneous route in right thigh (therapy type: rHA, lot # R028225 and expiration date 02-OCT-2020) for prophylaxis. It was reported that while removing the needle from the patient's right thigh, some product spilled out of the syringe and the patient subsequently had an inadvertent lowor invalid dose (underdose). No adverse effects and product quality complaint reported. It was also reported that the therapy was not discontinued.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, Pyrexia
Clinical narrative: Patient developed fever after receiving an expired dose of MMR II; receiving an expired dose of MMR II; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. The patient did not have pertinent medical history, concomitant medications, drug reactions and allergies.   On 22-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), subcutaneously (strength, dose, anatomical location, and lot # were not reported) expiration date of lot was on 18-MAY-2019, indicated for prophylaxis.  The lot# and expiration of the sterile diluent was unknown by the reporter.  On 04-JUN-2019, the patient developed fever (pyrexia) after receiving the expired vaccine, therefore a treatment was given for it. The patient did not seek medical attention. Laboratory test and studies were not performed.    The outcome of pyrexia was reported as resolving. The reporter did not assess the causal relationship between fever and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).    The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as well as the sterile diluent did not have temperature excursions.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Nurse reports one expired dose of MMR II was administered to patient; This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unknown age and gender.  The patient's pertinent medical history, previous drug reactions, allergies, and concomitant therapies were not reported.     On 05-JUN-2019, the patient was vaccinated with one expired dose of and recombinant human albumin (rHA) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route of administration were not reported; lot # N008366 with expiration date 13-MAR-2019) for prophylaxis. No adverse effects reported.         Lot number and expiration date were reported in the source document. But, when entering the lot number in database the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.