chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Swelling of lip and part of tongue, hive on chest.  Symptoms lasted about 2 hours.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Right upper arm. Redness and warmth, itchy.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: The patient experienced extreme fatigue, some body aches, and a fever of 101F approximately 24 hours after receiving the second dose of the Shingrix vaccine. Her first dose was 2/16/19 and she experienced no adverse effects with that dose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Rash, Type III immune complex mediated reaction
Clinical narrative: - Our daughters first two DTaP vaccines were Pentacel. Following a move, our new provider did not carry, and would not obtain, Pentacel to continue the vaccine series.  - We informed our provider of the manufacturer/ACIP recommendation against switching vaccine manufacturers mid-series whereverpossible and where the vaccine history is known. We had our daughters vaccine record with us at the appointment, complete with vaccine brand and lot numbers.  - In spite of the our concerns, our provider insisted that there was no risk whatsoever to switching manufacturers.  - We were unaware that there are three brands of Glaxo DTaP vaccines, and our provider elected to administer Kinrix as the third dose. We later found out that Kinrix is contraindicated as the 3rd/4th dose, and is only licensed as the 5th dose, according to the manufacturer's FDA insert. - On the day of the injection, our daughter had a red lump/bruising at the injection site and wouldn't put weight on her leg.  - 6 days after the injection, she developed a 4.5" diameter rash, with the red lump/bruising remaining in the center. The school nurse called us out of concern when she noticed the rash at school. We later found out that the rash is a rare (delayed) Type 3 hypersensitivity reaction. We called the doctor's office immediately when we saw the reaction, but no one was willing to see her, and instead told us to giver her benadryl and take her to urgent care if necessary. We documented the timeline, took photographs, and filed one with her provider for inclusion in her medical record.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Weight bearing difficulty
Clinical narrative: - Our daughters first two DTaP vaccines were Pentacel. Following a move, our new provider did not carry, and would not obtain, Pentacel to continue the vaccine series.  - We informed our provider of the manufacturer/ACIP recommendation against switching vaccine manufacturers mid-series whereverpossible and where the vaccine history is known. We had our daughters vaccine record with us at the appointment, complete with vaccine brand and lot numbers.  - In spite of the our concerns, our provider insisted that there was no risk whatsoever to switching manufacturers.  - We were unaware that there are three brands of Glaxo DTaP vaccines, and our provider elected to administer Kinrix as the third dose. We later found out that Kinrix is contraindicated as the 3rd/4th dose, and is only licensed as the 5th dose, according to the manufacturer's FDA insert. - On the day of the injection, our daughter had a red lump/bruising at the injection site and wouldn't put weight on her leg.  - 6 days after the injection, she developed a 4.5" diameter rash, with the red lump/bruising remaining in the center. The school nurse called us out of concern when she noticed the rash at school. We later found out that the rash is a rare (delayed) Type 3 hypersensitivity reaction. We called the doctor's office immediately when we saw the reaction, but no one was willing to see her, and instead told us to giver her benadryl and take her to urgent care if necessary. We documented the timeline, took photographs, and filed one with her provider for inclusion in her medical record.
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Rash all over the body, last like 1 day it was a non authorized vaccine, so everything was manage in silence by the hospital until last day, no treatment that I had known
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Allergy test positive, Blood test, Choking, Chronic spontaneous urticaria
Clinical narrative: After receiving my flu shot in December, I began to notice stomach pain after eating and occasional small hives. I thought it was nothing and expected it to go away in time. The stomach pain began to get worse and worse. The hives remained as well but the seemingly allergic reaction began to worsen to swelling at the mouth, uvula, and various muscles. The uvula swelling was so bad that I would choke at night. My first appointments with the doctor were in Feb 2017 to attempt to diagnose what was going on. After many other blood tests, the doctor tested me for gluten sensitivity at my request. This came back positive and celiac disease was later confirmed by endoscopy/colonoscopy on June 29, 2017. I had hoped this would solve my chronic urticaria as well. However, it did not. An allergist diagnosed me with delayed idiopathic urticaria on 22 Sept 2017. I have suffered from chronic urticaria for the last 2+ years triggered by physical stimulus of the skin including cold, heat, vibration, and pressure. In the pamphlet for the vaccine, urticaria is a known potential adverse event. The flu shot may have been the triggering agent for celiac disease as well.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Coeliac disease, Colonoscopy abnormal, Endoscopy abnormal, Enlarged uvula, Hypersensitivity
Clinical narrative: After receiving my flu shot in December, I began to notice stomach pain after eating and occasional small hives. I thought it was nothing and expected it to go away in time. The stomach pain began to get worse and worse. The hives remained as well but the seemingly allergic reaction began to worsen to swelling at the mouth, uvula, and various muscles. The uvula swelling was so bad that I would choke at night. My first appointments with the doctor were in Feb 2017 to attempt to diagnose what was going on. After many other blood tests, the doctor tested me for gluten sensitivity at my request. This came back positive and celiac disease was later confirmed by endoscopy/colonoscopy on June 29, 2017. I had hoped this would solve my chronic urticaria as well. However, it did not. An allergist diagnosed me with delayed idiopathic urticaria on 22 Sept 2017. I have suffered from chronic urticaria for the last 2+ years triggered by physical stimulus of the skin including cold, heat, vibration, and pressure. In the pamphlet for the vaccine, urticaria is a known potential adverse event. The flu shot may have been the triggering agent for celiac disease as well.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Mouth swelling, Muscle swelling, Urticaria
Clinical narrative: After receiving my flu shot in December, I began to notice stomach pain after eating and occasional small hives. I thought it was nothing and expected it to go away in time. The stomach pain began to get worse and worse. The hives remained as well but the seemingly allergic reaction began to worsen to swelling at the mouth, uvula, and various muscles. The uvula swelling was so bad that I would choke at night. My first appointments with the doctor were in Feb 2017 to attempt to diagnose what was going on. After many other blood tests, the doctor tested me for gluten sensitivity at my request. This came back positive and celiac disease was later confirmed by endoscopy/colonoscopy on June 29, 2017. I had hoped this would solve my chronic urticaria as well. However, it did not. An allergist diagnosed me with delayed idiopathic urticaria on 22 Sept 2017. I have suffered from chronic urticaria for the last 2+ years triggered by physical stimulus of the skin including cold, heat, vibration, and pressure. In the pamphlet for the vaccine, urticaria is a known potential adverse event. The flu shot may have been the triggering agent for celiac disease as well.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Influenza like illness, Malaise
Clinical narrative: Cold feeling, extreme muscle pain, extreme joint pain, flu like sick feeling, extreme fatigue for 30 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Cold feeling, extreme muscle pain, extreme joint pain, flu like sick feeling, extreme fatigue for 30 hours.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Neck pain, Pain, Pain in extremity, X-ray limb
Clinical narrative: L arm pain throbbing into neck & down arm, decreased ROM Pt continues with significant pain and decreased ROM in affected extremity. It has improved minimally but not resolved as of 5/1/2019.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Gingival pain, Headache, Impaired work ability, Injection site erythema
Clinical narrative: She received shingrix IM injection left deltoid on 4/29/2019.  First shingrix 8/9/2018-she describes a typical local reaction to the injection the first time-about 4cm area of redness at the site with mild tenderness and mild itch all of which resolved in a few days.  Yesterday she started with pain in the left upper arm and shoulder and had trouble changing her clothes to go to sleep, husband helped her. She had pain with movement of the left arm in the shoulder and upper arm area this am so got ready using right hand and tried to go to work but was sent home since she could not work with both arms. She has had some left upper chest pain, dull and sore to the touch as well as left neck with a small node at the left base of neck anteriorly. No fevers, some pain on and off in "gums" but points to the TMJs, no swelling, no itch. Some headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Local reaction, Loss of personal independence in daily activities, Nodule
Clinical narrative: She received shingrix IM injection left deltoid on 4/29/2019.  First shingrix 8/9/2018-she describes a typical local reaction to the injection the first time-about 4cm area of redness at the site with mild tenderness and mild itch all of which resolved in a few days.  Yesterday she started with pain in the left upper arm and shoulder and had trouble changing her clothes to go to sleep, husband helped her. She had pain with movement of the left arm in the shoulder and upper arm area this am so got ready using right hand and tried to go to work but was sent home since she could not work with both arms. She has had some left upper chest pain, dull and sore to the touch as well as left neck with a small node at the left base of neck anteriorly. No fevers, some pain on and off in "gums" but points to the TMJs, no swelling, no itch. Some headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: She received shingrix IM injection left deltoid on 4/29/2019.  First shingrix 8/9/2018-she describes a typical local reaction to the injection the first time-about 4cm area of redness at the site with mild tenderness and mild itch all of which resolved in a few days.  Yesterday she started with pain in the left upper arm and shoulder and had trouble changing her clothes to go to sleep, husband helped her. She had pain with movement of the left arm in the shoulder and upper arm area this am so got ready using right hand and tried to go to work but was sent home since she could not work with both arms. She has had some left upper chest pain, dull and sore to the touch as well as left neck with a small node at the left base of neck anteriorly. No fevers, some pain on and off in "gums" but points to the TMJs, no swelling, no itch. Some headache.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Facial pain, Musculoskeletal pain, Myalgia
Clinical narrative: ExtReme muscle pain. WoRst at Low back and buddocks. FaciaL muscle pain and uppeR body pain as well. FeveR and stomach pain. ExtReme symptoms lasted 24 to 36 hRouRs. DuRing second day weRe slightly mildeR. All symptoms gone by day five. Tylenol did not help the pain. I will not take the 2nd dose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: ExtReme muscle pain. WoRst at Low back and buddocks. FaciaL muscle pain and uppeR body pain as well. FeveR and stomach pain. ExtReme symptoms lasted 24 to 36 hRouRs. DuRing second day weRe slightly mildeR. All symptoms gone by day five. Tylenol did not help the pain. I will not take the 2nd dose.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Urticaria, Vaccination site reaction
Clinical narrative: Patient Broke out in whelps around site of the vaccine an hour after the vaccine was given. Patient went to urgent care the same day and received a steroid shot and the whelps disappeared the next day. The whelps returned 5/1/19 and were worse than before. This time the rash spread to both arms and down the patient's sides and groin area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: Pt has a approximately 5x5 size rash on left upper arm. Pt complains of lots of pain, swollen + hot to touch arm + also rash. Pt states that she feels fine except for her arm. States she "hasn't done much of anything at all". I, called PCP. Person from office called me back to let us know pt is going to be seen in the office today. Pt came back through drive through. MD gave her Clindamycin + is checking in with her. Patient has antibiotic now + will follow up with doctor. Pts arm is outlined by MD so that they will be able to identify if the rash is spreading.   - called manufacturer (closed) will follow up this week (Friday) + let staff RPH aware thursday (512).   - pt states she received this Monday April 29th around 9pm. Started noticing a reaction the next morning Tuesday April 30th.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Escherichia infection, Feeling abnormal
Clinical narrative: Pain, fever, loss of weight and appetite, dizzyness. Had to stay in bed for over a week. Didn't really feel like myself for over 4 weeks. Now much weaker. UTI & e. coli infection. No prior symptoms
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urinary tract infection, Urine analysis, Weight decreased
Clinical narrative: Pain, fever, loss of weight and appetite, dizzyness. Had to stay in bed for over a week. Didn't really feel like myself for over 4 weeks. Now much weaker. UTI & e. coli infection. No prior symptoms
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Eye swelling, Nasal oedema, Pruritus, Rash
Clinical narrative: eye swollen; Nose swelling; allergic reaction; papular rash; hives; itchy; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 28-year-old female patient who received HBV (Engerix B adult) (batch number 924TJ, expiry date 19th February 2019) for prophylaxis.   The patient's past medical history included eczema (10 to 15 years prior, which has resolved).   On 10th April 2019, the patient received the 1st dose of Engerix B adult. On 10th April 2019, less than a day after receiving Engerix B adult, the patient experienced allergic reaction, papular rash, hives and itchy rash. On 12th April 2019, the patient experienced eye swelling and nasal edema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, eye swelling and nasal edema were unknown and the outcome of the papular rash, hives and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, papular rash, hives, itchy rash, eye swelling and nasal edema to be related to Engerix B adult.  Additional details were provided as follows: The physician was told by her staff that the patient developed a rash and hives later that day. The physician had not seen the patient herself yet. The patient took Benadryl but the rash was still present and itchy. On 24th April 2019, the healthcare professional called back to add that the rash was on both arms and legs, the eyes were swollen and the bridge of the nose was swollen. On 24th April 2019, the physician called back to add that the rash was a fine papular rash on the distal arms and legs of the patient, and that the patient's eyes and bridge of the nose was swollen. The onset of the rash, including itchiness, happened the night after the receiving the vaccine. 2 days later, the swelling began and the rash persisted. It appears like an allergic reaction to the physician. The reporter gave consent to follow up.
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Eye swelling, Hypersensitivity, Nasal oedema, Rash papular, Rash pruritic
Clinical narrative: eye swollen; Nose swelling; allergic reaction; papular rash; hives; itchy; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 28-year-old female patient who received HBV (Engerix B adult) (batch number 924TJ, expiry date 19th February 2019) for prophylaxis.   The patient's past medical history included eczema (10 to 15 years prior, which has resolved).   On 10th April 2019, the patient received the 1st dose of Engerix B adult. On 10th April 2019, less than a day after receiving Engerix B adult, the patient experienced allergic reaction, papular rash, hives and itchy rash. On 12th April 2019, the patient experienced eye swelling and nasal edema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, eye swelling and nasal edema were unknown and the outcome of the papular rash, hives and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, papular rash, hives, itchy rash, eye swelling and nasal edema to be related to Engerix B adult.  Additional details were provided as follows: The physician was told by her staff that the patient developed a rash and hives later that day. The physician had not seen the patient herself yet. The patient took Benadryl but the rash was still present and itchy. On 24th April 2019, the healthcare professional called back to add that the rash was on both arms and legs, the eyes were swollen and the bridge of the nose was swollen. On 24th April 2019, the physician called back to add that the rash was a fine papular rash on the distal arms and legs of the patient, and that the patient's eyes and bridge of the nose was swollen. The onset of the rash, including itchiness, happened the night after the receiving the vaccine. 2 days later, the swelling began and the rash persisted. It appears like an allergic reaction to the physician. The reporter gave consent to follow up.
Age: 28.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: eye swollen; Nose swelling; allergic reaction; papular rash; hives; itchy; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 28-year-old female patient who received HBV (Engerix B adult) (batch number 924TJ, expiry date 19th February 2019) for prophylaxis.   The patient's past medical history included eczema (10 to 15 years prior, which has resolved).   On 10th April 2019, the patient received the 1st dose of Engerix B adult. On 10th April 2019, less than a day after receiving Engerix B adult, the patient experienced allergic reaction, papular rash, hives and itchy rash. On 12th April 2019, the patient experienced eye swelling and nasal edema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, eye swelling and nasal edema were unknown and the outcome of the papular rash, hives and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, papular rash, hives, itchy rash, eye swelling and nasal edema to be related to Engerix B adult.  Additional details were provided as follows: The physician was told by her staff that the patient developed a rash and hives later that day. The physician had not seen the patient herself yet. The patient took Benadryl but the rash was still present and itchy. On 24th April 2019, the healthcare professional called back to add that the rash was on both arms and legs, the eyes were swollen and the bridge of the nose was swollen. On 24th April 2019, the physician called back to add that the rash was a fine papular rash on the distal arms and legs of the patient, and that the patient's eyes and bridge of the nose was swollen. The onset of the rash, including itchiness, happened the night after the receiving the vaccine. 2 days later, the swelling began and the rash persisted. It appears like an allergic reaction to the physician. The reporter gave consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: feeling nausea; shingles; pain; burning sensations; knee pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in the past.).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, 6 days after receiving Shingrix, the patient experienced shingles, pain, burning sensation and knee pain. On 24th April 2019, the patient experienced nausea. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the burning sensation, knee pain and nausea were unknown.   It was unknown if the reporter considered the shingles, pain, burning sensation, knee pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced burning, stabbing pain in her knee, exactly where she had shingles in the past.  On 24th April 2019, the patient visited her physician who agreed that it was the start of another shingles outbreak. The patient was prescribed antivirals that made her feel nauseated. The pain seemed to be ebbing, though it was sitll present at the time of reporting and it had not yet erupted into a rash or blisters. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Herpes zoster, Nausea, Pain
Clinical narrative: feeling nausea; shingles; pain; burning sensations; knee pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in the past.).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, 6 days after receiving Shingrix, the patient experienced shingles, pain, burning sensation and knee pain. On 24th April 2019, the patient experienced nausea. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved and the outcome of the burning sensation, knee pain and nausea were unknown.   It was unknown if the reporter considered the shingles, pain, burning sensation, knee pain and nausea to be related to Shingrix.  Additional details were provided as follows: The patient experienced burning, stabbing pain in her knee, exactly where she had shingles in the past.  On 24th April 2019, the patient visited her physician who agreed that it was the start of another shingles outbreak. The patient was prescribed antivirals that made her feel nauseated. The pain seemed to be ebbing, though it was sitll present at the time of reporting and it had not yet erupted into a rash or blisters. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Dry skin, Eczema, Erythema, Haemorrhage, Pruritus
Clinical narrative: Redness, bleeding, scabbing, flaky, dry, itchy skin - eczema
Age: 24.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Scab, Skin exfoliation
Clinical narrative: Redness, bleeding, scabbing, flaky, dry, itchy skin - eczema
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site induration, Injection site movement impairment
Clinical narrative: Patient experienced LLR less than 24 hours after injection. Patient presented with significant discomfort, decreased mobility, and hardening of the area surrounding the injection site.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dry skin, Eczema, Food allergy, Haemorrhage, Pruritus
Clinical narrative: Extreme itching in hands, arms, legs, scalp,  neck etc. Eczema- scabbing, bleeding, dry skin. Sensitivity to wheat.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Scab
Clinical narrative: Extreme itching in hands, arms, legs, scalp,  neck etc. Eczema- scabbing, bleeding, dry skin. Sensitivity to wheat.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Diarrhoea, Eczema, Faeces discoloured, Food allergy
Clinical narrative: Chronic diarrhea, chronic itchiness- eczema worsened, wheat sensitivities, bile in stool, worsening of gallbladder symptoms
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Gallbladder disorder, Pruritus
Clinical narrative: Chronic diarrhea, chronic itchiness- eczema worsened, wheat sensitivities, bile in stool, worsening of gallbladder symptoms
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Abnormal behaviour, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Headache, Myalgia
Clinical narrative: After vaccine headaches, nausea, muscle pain, after 45 days significant change of behavior later child has been diagnosed with Autism.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Nausea, Psychiatric evaluation abnormal
Clinical narrative: After vaccine headaches, nausea, muscle pain, after 45 days significant change of behavior later child has been diagnosed with Autism.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal mucosal blistering, Oral mucosal blistering, Urinary tract infection
Clinical narrative: Patient reported blisters in nose started Thursday night and blisters in mouth started Friday morning.  Went to hospital.  Patient reports being diagnosed with urinary tract infection and blisters.
Age: 1.08
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia, Rash papular
Clinical narrative: Left anterior thigh at sight of injection with irregularly shaped lesion with raised erythematous borders with 2 central papules. Rash lesion was tender to palpation. Patient also had fever along with this rash on 1May, 9 days after the injection. This rash on the left leg started with small bumps a few days after the vaccine administration of the right thigh on which she also received Hib, Influenza and MMR. But those small bumps resolved and did not grow like the one on the left thigh.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; to receive VARIVAX and M-M-R II; however, patient received VARIVAX and PROQUAD; to receive VARIVAX and M-M-R II; however, patient received VARIVAX and PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-APR-2019, the patient was in office to receive varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported), however, patient received varicella virus vaccine live (Oka/Merck) (VARIVAX) (formulation, strength, dose, frequency and route of administration were not reported) lot# R021377 with expiration date: 25-JUL-2020 and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA), lot# R017629 with expiration date:18-DEC-2019, 0.5 milliliter once, subcutaneously for prophylaxis. Both vaccines were reconstituted with sterile diluent lot# N030572 with expiration date 20-APR-2020. Both vaccines and sterile diluent were properly stored. No adverse effects were reported. No further information was provided.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from two physicians referring to sever unspecified female patients of unknown age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Approximately in October 2018, reported as within the last 6 months, the patients had finger sticks at their doctor visits in order to check their cholesterol levels. The same patients then were vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis at the same office visit. The same patients fainted (syncope) after receiving dose of GARDASIL 9. The patients sought medical attention in the doctor's office. The outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. Upon internal review, the event of  fainted (syncope) was considered as medically significant. The causality between the event and the suspect vaccine was not reported by the reporter. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1904USA013123.
Sex: F
Vaccine: MMR
Symptoms: Immunodeficiency, Micturition urgency, Multiple sclerosis, Stem cell transplant, Urinary incontinence
Clinical narrative: This spontaneous report was received from a currently 48-year-old female patient who was a pharmacist and who referred to herself. The patient's medical history included receiving natalizumab (TYSABRI) and hypersensitivity to this drug. The concomitant therapies included multiple unspecified medications. On unknown dates, when the patient was a child, she was vaccinated with unspecified number of doses of M-M-R II (reported as an unknown MMR series, manufacturer unknown, but M-M-R II could not be ruled out) (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as routine vaccination). On an unknown date in 2008, the patient developed multiple sclerosis. On an unknown date in 2008, the patient was given a treatment for multiple sclerosis, which included stem cell transplant. It was reported that this treatment wiped out the patient's immunity to everything. On an unknown date, the patient developed urinary incontinence and urinary urgency. The patient sought medical attention. Health Care Professional stated that revaccination was not necessary at that time. It was reported that no treatment was given for the events. No laboratory diagnostics and studies were performed. The outcome of the events multiple sclerosis, wiped out the patient's immunity to everything was reported as not recovered. The outcome of the events urinary incontinence and urinary urgency was not provided. The relatedness between the events and M-M-R II was not provided. Upon internal review, the event of multiple sclerosis was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the patient was vaccinated with M-M-R II intramuscularly; No adverse symptoms reported; This spontaneous report was received from a pharmacist referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly (dose detail, lot # and expiration date were not reported) for prophylaxis (incorrect route of product administration). No adverse symptoms were reported.
Age: 74.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; 74 year old patient received first dose of GARDASIL 9; This spontaneous report was received from a pharmacist regarding a 74-year-old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 27-SEP-2018, the patient was vaccinated with first dose in hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Dose, frequency, route, lot# and expiry date were not reported) series for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported (no adverse event). The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Bedridden, Loss of personal independence in daily activities, Malaise
Clinical narrative: unable to get on with life for 6 months; illness; bedridden; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included fibromyalgia. Previously administered products included TUBERCULOSIS VACCINE with an associated reaction of malaise (received vaccine when the patient was child) and Influenza virus vaccine with an associated reaction of malaise (For tolerability of the previous dose of influenza vaccine, refer case US2019GSK077261).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced activities of daily living impaired, unwell and bedridden. On an unknown date, the outcome of the activities of daily living impaired, unwell and bedridden were unknown.   It was unknown if the reporter considered the activities of daily living impaired, unwell and bedridden to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient received the flu jab and became ill, bedridden or unable to get on with life for 6 months to be told not one of chosen virus were correct for that year not had again. The patient also reported that her daughter had ASD (Autism spectrum disorder) and they both had fits after the MMR (measles mumps rubella) jabs. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Tachycardia/Heart rate was 105 thru the night; Have fever 99.7deg F, myalgia, chills; myalgia, neck muscles hurt; Have fever 99.7deg F, myalgia, chills; a bad headache; slight dizziness; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced tachycardia, fever, myalgia, chills, headache and dizziness. On an unknown date, the outcome of the tachycardia, fever, myalgia, chills, headache and dizziness were unknown.   It was unknown if the reporter considered the tachycardia, fever, myalgia, chills, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine the night before reporting. The patient's heart rate was 105 through the night, at the time of reporting it was 97.  The patient had fever 99.7 degree F, myalgia, chills and neck muscles hurt. The patient had a bad headache and slight dizziness when the patient got out of bed in the morning of reporting day. The patient inquired if there was a situation down the road when they would need to get a booster. The patient also stated that a search revealed that tachycardia was a form of severe allergic reaction and their doctor would likely to advocate Tylenol.  The patient was resting in the bed at the time of reporting. The patient provided the consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Tachycardia/Heart rate was 105 thru the night; Have fever 99.7deg F, myalgia, chills; myalgia, neck muscles hurt; Have fever 99.7deg F, myalgia, chills; a bad headache; slight dizziness; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 2nd dose of Shingrix. In April 2019, less than a day after receiving Shingrix, the patient experienced tachycardia, fever, myalgia, chills, headache and dizziness. On an unknown date, the outcome of the tachycardia, fever, myalgia, chills, headache and dizziness were unknown.   It was unknown if the reporter considered the tachycardia, fever, myalgia, chills, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine the night before reporting. The patient's heart rate was 105 through the night, at the time of reporting it was 97.  The patient had fever 99.7 degree F, myalgia, chills and neck muscles hurt. The patient had a bad headache and slight dizziness when the patient got out of bed in the morning of reporting day. The patient inquired if there was a situation down the road when they would need to get a booster. The patient also stated that a search revealed that tachycardia was a form of severe allergic reaction and their doctor would likely to advocate Tylenol.  The patient was resting in the bed at the time of reporting. The patient provided the consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by an other health professional via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3Z53C, expiry date unknown) for prophylaxis.   On 8th April 2019, the patient received the 1st dose of Shingrix. On 13th April 2019, 5 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient presented with a case of shingles on 15th April 2019, symptoms began on 13th April 2019.  The patient came to office where the physician diagnosed shingles.  The reporter could not rule out if the event is related to the receiving the shot a week earlier. The reporter did agree to follow up from GlaxoSmithKline.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Pain
Clinical narrative: body pain; Bone pain; This case was reported by a pharmacist via patient support programs and described the occurrence of general body pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hmg coa reductase inhibitors (nos) (Statins).   On 15th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain and bone pain. On an unknown date, the outcome of the general body pain and bone pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and bone pain to be related to Shingrix.  Additional details were provided as follows: The patient reported body pain all over and in bones for 3 days. The pain subsided after 3 days and did not return.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix at the minute clinic. The patient experienced flu- like symptoms, which was lasted for 1 week. The patient mentioned that, a case was legal. The reporter consented to follow up. For tolerance to next dose, refer case US2019072365.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: illness; This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included fibromyalgia. Previously administered products included Tuberculosis vaccine with an associated reaction of malaise (received vaccine when the patient was child).   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself. The patient received the flu jab and became ill. The patient also reported that her daughter had ASD (Autism spectrum disorder) and they both had fits after the MMR (measles mumps rubella) jabs. The follow up was not required. For tolerability of the subsequent dose of influenza vaccine, refer case US2019AMR072979.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2018, the patient received the 1st dose of Shingrix. On 16th May 2018, 1 hr after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that after receiving Shingrix vaccine she experienced soreness at the injection site on her left arm. The soreness started approximately one hour after receiving the vaccination and resolved with one and half days. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information. For tolerances of 2nd dose, refer case US2019074225.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by husband of patient.  The age at vaccination was not reported.  The patient developed shingles some time after receiving the first dose of Shingrix.   The patient was currently under the care of her physician. There was consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash/painful rash'; This case was reported by a physician via call center representative and described the occurrence of painful rash in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was recovered/resolved.   It was unknown if the reporter considered the painful rash to be related to Shingrix.  Additional details were provided as follows: The patient developed a painful rash on his trunk.  The patient reported that the rash lasted for two weeks.  No additional details were provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak from nect to breast area; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis.   On 30th November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received of Shingrix and one week later was diagnosed with Shingles outbreak from neck to breast area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in October 2018). On 4th February 2019, the patient received SHINGRIX. On 15th April 2019, 70 days after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The retired pediatrician reported that his wife developed bell's palsy after receiving SHINGRIX vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st April 2019, 9 hrs after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the patient's husband. The patient received Shingrix vaccine in right arm. The reporter did not consent to follow up.