chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Patient has muscle aches, fever, fatigue, chills.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: 24 hrs post injection pt experienced redness, swelling, pain and itching greater than 100 mm below injection site. (down to elbow) Pt also experienced full body muscle aches. Treated with MOTRIN and ice. Consulted GSK and advised to continue treatment with ice, MOTRIN and BENADRYL and to monitor for fever and worsening of reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Myalgia, Pain, Skin warm
Clinical narrative: 24 hrs post injection pt experienced redness, swelling, pain and itching greater than 100 mm below injection site. (down to elbow) Pt also experienced full body muscle aches. Treated with MOTRIN and ice. Consulted GSK and advised to continue treatment with ice, MOTRIN and BENADRYL and to monitor for fever and worsening of reaction.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Shoulder injury related to vaccine administration
Clinical narrative: 5-29-2018 client called HD to report onset of right shoulder blade pain starting 2/16/2018, day after Flu injection received. Reports had slight pain at injection site. States no injury to area at that time. Reports she thought it would get better and waited one month before seeing her physician. Reports pain under shoulder blade was getting worse and more frequent. 4-10-18 physical therapy started to present. Stated Physical Therapist told her she has SIRVA. Client reports right shoulder aches when sitting or standing with arm unsupported, has difficulty sleeping due to pain waking her up. Heat helps relieve pain. Denies decrease range of motion. Flu injection was administered in left deltoid per record, not in right arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased, Pain
Clinical narrative: Reported flu-like symptoms 24 hrs after the vaccine and reported soreness and slight inability to move arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain
Clinical narrative: Patient reported pain in the left armpit after injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Body aches, fatigue, headache, dry cough, chest tightness, sore throat.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, fatigue, headache, dry cough, chest tightness, sore throat.
Age: 0.08
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MA accidentally given Hep A to 4 week old instead of first Hep B dose. No adverse signs to report, patient reported today to clinic, had no symptoms, received 2 month vaccinations with no adverse reactions.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Rash pustular
Clinical narrative: Two days after receiving vaccine, patient reported an outbreak of pustules to her arms bilaterally and her lower legs, below the knee bilaterally. She also reported general malaise and body aches.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Dyskinesia, Fatigue, Headache, Incoherent
Clinical narrative: Patient was given both the Meningococcal and HPV vaccine. Within several minutes he passed out and had a seizure. Seizure lasted approximately 1-1.5 minutes. He lost consciousness and awareness, was rigid and shaking, not coherent and unable to control body. Once he seizure stopped he was dizzy, had a headache that was localized to the right side, the same side as the arm that got the shot. Headache went away by morning, but is left feeling tired and slightly dizzy.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Loss of consciousness, Muscle rigidity, Seizure, Tremor
Clinical narrative: Patient was given both the Meningococcal and HPV vaccine. Within several minutes he passed out and had a seizure. Seizure lasted approximately 1-1.5 minutes. He lost consciousness and awareness, was rigid and shaking, not coherent and unable to control body. Once he seizure stopped he was dizzy, had a headache that was localized to the right side, the same side as the arm that got the shot. Headache went away by morning, but is left feeling tired and slightly dizzy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Cough, Nasal congestion, Nasopharyngitis
Clinical narrative: Patient received SHINGRIX (herpes zoster) vaccine on 4/24/18. On 4/26/18 patient developed cold-like symptoms - stuffy nose, sore throat, cough, etc. During the cold the patient could not smell or taste. Nasal symptoms ceased on 5/10/18, but taste and small sensations have still not returned. Patient also still has persistent productive cough.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Productive cough
Clinical narrative: Patient received SHINGRIX (herpes zoster) vaccine on 4/24/18. On 4/26/18 patient developed cold-like symptoms - stuffy nose, sore throat, cough, etc. During the cold the patient could not smell or taste. Nasal symptoms ceased on 5/10/18, but taste and small sensations have still not returned. Patient also still has persistent productive cough.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Burning sensation, Decreased appetite, Dizziness, Erythema
Clinical narrative: Felt dizzy getting out of elevator following vaccination. That evening arm sore, burning at injection site.  Next morning 4" x 3" red raised, burning sensation, nausea, achiness, Temp = 100.6, no appetite.  2 days after vaccination "a little better". That night (4 am) woke up "drenched". Next day much better. 5 days after vaccination still red, raised 2" x 2" but much better.  Advised MD appt if persists or worse.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Swelling
Clinical narrative: Felt dizzy getting out of elevator following vaccination. That evening arm sore, burning at injection site.  Next morning 4" x 3" red raised, burning sensation, nausea, achiness, Temp = 100.6, no appetite.  2 days after vaccination "a little better". That night (4 am) woke up "drenched". Next day much better. 5 days after vaccination still red, raised 2" x 2" but much better.  Advised MD appt if persists or worse.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Mother called to report vomiting x1 episode, headache and tiredness. Fever 100.7F, occurring 1 day after injection. Mom to monitor at this time.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Blood glucose normal, Contusion, Fatigue, Head injury, Somnolence
Clinical narrative: Syncope without loss of consciousness. Lasted 25 minutes until back to baseline. Patient hit head against wall while fainting causing a superficial bruise without evidence of intracranial injury. Patient was tired, and somnolent but oriented to person, place, time and condition. All vitals were normal including HR and BP. A POCT glucose was normal. Patient was kept in a supine position until back to baseline and was able to walk out of the clinic unassisted.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Syncope without loss of consciousness. Lasted 25 minutes until back to baseline. Patient hit head against wall while fainting causing a superficial bruise without evidence of intracranial injury. Patient was tired, and somnolent but oriented to person, place, time and condition. All vitals were normal including HR and BP. A POCT glucose was normal. Patient was kept in a supine position until back to baseline and was able to walk out of the clinic unassisted.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: 8 hours after Shot 1, fever, chills, headache and light sensitive. Fever lasted 2 days and got up to 101.  Headache and light sensitivity never got better. After consultation with my Primary Care MD, I went to the ER on May 23, 2018. I had a Spinal Tap and MRI. My doctor was concerned about Meningitis, but I tested clear. I was treated with Migrane injection which did not help at all. Then a Steroid injection which helped a good deal. I got major relief from the Steroid injection. My Dr. put me on Valtrex and a MEDROL pack (steroids). After finishing the oral steroids, the symptoms returned. My Dr. prescribed more steroids yesterday. So now I am taking 2 MG of Dexamethasone Twice daily. This Vaccine has changed my life for the worse.....I can not go out in the sun or keep my blinds open and have live in a darkened room since the original injection of SHINGRIX. I wrote to GSK, the manufacturer, but they offered NO help, other than telling me to see my doctor.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: 8 hours after Shot 1, fever, chills, headache and light sensitive. Fever lasted 2 days and got up to 101.  Headache and light sensitivity never got better. After consultation with my Primary Care MD, I went to the ER on May 23, 2018. I had a Spinal Tap and MRI. My doctor was concerned about Meningitis, but I tested clear. I was treated with Migrane injection which did not help at all. Then a Steroid injection which helped a good deal. I got major relief from the Steroid injection. My Dr. put me on Valtrex and a MEDROL pack (steroids). After finishing the oral steroids, the symptoms returned. My Dr. prescribed more steroids yesterday. So now I am taking 2 MG of Dexamethasone Twice daily. This Vaccine has changed my life for the worse.....I can not go out in the sun or keep my blinds open and have live in a darkened room since the original injection of SHINGRIX. I wrote to GSK, the manufacturer, but they offered NO help, other than telling me to see my doctor.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye pain, Headache, Hyperhidrosis, Ocular discomfort
Clinical narrative: 8 hours after Shot 1, fever, chills, headache and light sensitive. Fever lasted 2 days and got up to 101.  Headache and light sensitivity never got better. After consultation with my Primary Care MD, I went to the ER on May 23, 2018. I had a Spinal Tap and MRI. My doctor was concerned about Meningitis, but I tested clear. I was treated with Migrane injection which did not help at all. Then a Steroid injection which helped a good deal. I got major relief from the Steroid injection. My Dr. put me on Valtrex and a MEDROL pack (steroids). After finishing the oral steroids, the symptoms returned. My Dr. prescribed more steroids yesterday. So now I am taking 2 MG of Dexamethasone Twice daily. This Vaccine has changed my life for the worse.....I can not go out in the sun or keep my blinds open and have live in a darkened room since the original injection of SHINGRIX. I wrote to GSK, the manufacturer, but they offered NO help, other than telling me to see my doctor.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Optic nerve injury, Photophobia, Pyrexia
Clinical narrative: 8 hours after Shot 1, fever, chills, headache and light sensitive. Fever lasted 2 days and got up to 101.  Headache and light sensitivity never got better. After consultation with my Primary Care MD, I went to the ER on May 23, 2018. I had a Spinal Tap and MRI. My doctor was concerned about Meningitis, but I tested clear. I was treated with Migrane injection which did not help at all. Then a Steroid injection which helped a good deal. I got major relief from the Steroid injection. My Dr. put me on Valtrex and a MEDROL pack (steroids). After finishing the oral steroids, the symptoms returned. My Dr. prescribed more steroids yesterday. So now I am taking 2 MG of Dexamethasone Twice daily. This Vaccine has changed my life for the worse.....I can not go out in the sun or keep my blinds open and have live in a darkened room since the original injection of SHINGRIX. I wrote to GSK, the manufacturer, but they offered NO help, other than telling me to see my doctor.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: HEART PALPITATIONS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Influenza like illness
Clinical narrative: About 5:30 PM, an hour after receiving the shot, a section of my lip started to swell. After going to bed I woke up Around midnight with severe chills, a fever, and headache. The next morning at 7 AM I was still lethargic, weak and lightheaded. I took two Bayer aspirin to help with the headache that did alleviate that portion of the symptoms. Currently it?s 9:12 AM and I?m still feeling As if I have the flu, lethargic, weak and lightheaded.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Lip swelling, Pyrexia
Clinical narrative: About 5:30 PM, an hour after receiving the shot, a section of my lip started to swell. After going to bed I woke up Around midnight with severe chills, a fever, and headache. The next morning at 7 AM I was still lethargic, weak and lightheaded. I took two Bayer aspirin to help with the headache that did alleviate that portion of the symptoms. Currently it?s 9:12 AM and I?m still feeling As if I have the flu, lethargic, weak and lightheaded.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Injection site pain, Pain
Clinical narrative: PATIENT REPORTED THE NEXT DAY HER ARM WAS RED, HOT, AND SWOLLEN. SHE ALSO REPORTED FEELING FATIGUED. THIS IS A NORMAL VACCINE RESPONSE AND SHE WAS COUNSELED TO MONITOR THE EFFECTS AND TO SEE HER PHYSICIAN IF SYMPTOMS WORSENED AND PERSISTED. THE PATIENT DID NOT REPORT WORSENED SYMPTOMS FOR SEVERAL WEEKS. THE PATIENT SPOKE TO THE PHARMACIST ON 5/25/2018 THAT SHE STILL HAD PAIN IN HER ARM AT THE INJECTION SITE AND COMPLAINED OF ALL OVER BODY PAIN AND JOINT PAIN. SHE DESCRIBES FATIGUE WHICH WORSENS WITH WORK AND ACTIVITY AND CAUSES HER TO SLEEP WHENEVER NOT WORKING. THE PHARMACIST COUNSELED THE PATIENT TO SEE HER PHYSICIAN WHICH SHE SAID SHE WOULD DO.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Somnolence
Clinical narrative: PATIENT REPORTED THE NEXT DAY HER ARM WAS RED, HOT, AND SWOLLEN. SHE ALSO REPORTED FEELING FATIGUED. THIS IS A NORMAL VACCINE RESPONSE AND SHE WAS COUNSELED TO MONITOR THE EFFECTS AND TO SEE HER PHYSICIAN IF SYMPTOMS WORSENED AND PERSISTED. THE PATIENT DID NOT REPORT WORSENED SYMPTOMS FOR SEVERAL WEEKS. THE PATIENT SPOKE TO THE PHARMACIST ON 5/25/2018 THAT SHE STILL HAD PAIN IN HER ARM AT THE INJECTION SITE AND COMPLAINED OF ALL OVER BODY PAIN AND JOINT PAIN. SHE DESCRIBES FATIGUE WHICH WORSENS WITH WORK AND ACTIVITY AND CAUSES HER TO SLEEP WHENEVER NOT WORKING. THE PHARMACIST COUNSELED THE PATIENT TO SEE HER PHYSICIAN WHICH SHE SAID SHE WOULD DO.
Age: 71.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neuralgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nerve pain in a 71-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Co-suspect products included HAVRIX (batch number 4H37Y, expiry date 8th November 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and HAVRIX. On 14th May 2018, less than a day after receiving SHINGRIX and HAVRIX, the patient experienced injection site swelling (serious criteria other: As per reporter), injection site erythema (serious criteria other: As per reporter) and injection site pain (serious criteria other: As per reporter). In May 2018, the patient experienced nerve pain (serious criteria other: As per reporter). The patient was treated with TYLENOL and prednisone. On an unknown date, the outcome of the nerve pain was not recovered/not resolved and the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the nerve pain, injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX and HAVRIX. Additional details were provided as follows: The case was reported by the Medical Assistant. The patient was administered SHINGRIX and HAVRIX in the right arm. The patient reported that her arm was swollen, red and sore at the injection site and that reaction started later that same day and it was resolved within 3 days. Less than a week after receiving vaccination, the patient also experienced a nerve pain in her hands and fingers as well as a spot that when she touched it, it radiates and feels like a lateral line was going down the arm where she received the vaccine. This had not been resolved. The patient called the doctor's office and the doctor recommended TYLENOL, heating pad, and Prednisone 40mg daily for 7 days. The reporter stated the patient would not get the 2nd dose because of this reaction. The patient would follow up with the doctor. The batch number of the HAVRIX was reported as 4A37Y, however it was changed to 4H37Y as per latest sales data sheet.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Joint range of motion decreased, Joint swelling, Musculoskeletal pain, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 63-year-old female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain (serious criteria disability), rash (serious criteria disability), joint range of motion decreased (serious criteria disability), tendonitis (serious criteria disability) and swollen joints. on an unknown date, the outcome of the shoulder pain and joint range of motion decreased were unchanged and the outcome of the rash, tendonitis and swollen joints were unknown. The reporter considered the shoulder pain, joint range of motion decreased and swollen joints to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the rash and tendonitis to be related to SHINGRIX. Additional information was received as follows: The health care professional (HCP) stated that the patient received SHINGRIX two weeks before the date of reporting, below the deltoid region. The patient experienced severe pain at shoulder, the site was swollen and it was looked like tendonitis. The patient had limited range of motion and constant pain. The vaccine was administered by local pharmacy and the HCP did not have additional information to provide.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendonitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 63-year-old female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain (serious criteria disability), rash (serious criteria disability), joint range of motion decreased (serious criteria disability), tendonitis (serious criteria disability) and swollen joints. on an unknown date, the outcome of the shoulder pain and joint range of motion decreased were unchanged and the outcome of the rash, tendonitis and swollen joints were unknown. The reporter considered the shoulder pain, joint range of motion decreased and swollen joints to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the rash and tendonitis to be related to SHINGRIX. Additional information was received as follows: The health care professional (HCP) stated that the patient received SHINGRIX two weeks before the date of reporting, below the deltoid region. The patient experienced severe pain at shoulder, the site was swollen and it was looked like tendonitis. The patient had limited range of motion and constant pain. The vaccine was administered by local pharmacy and the HCP did not have additional information to provide.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes simplex test, Rash, Stomatitis
Clinical narrative: Rigors - approximately 3 wks after the shot. Rash on chin and stomatitis 6 wks after the shot.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 5 months old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD lot # N022972 with expiration date on 19-FEB-2019 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was considered as a drug administered to patient of inappropriate age. No adverse were effects reported.
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An elderly male patient who was more than 65 years, received PREVNAR 13 on 22May2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness at his whole upper arm on an unspecified date with outcome of unknown. Information on the batch number has been requested.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Myalgia
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative.  A 16-year-old male patient received TRUMENBA (lot S26986) in right deltoid, at single dose and MENACTRA in left deltoid, both on an unspecified date, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, a couple of hours after vaccinations, the patient experienced pain at the injection site, fatigue, malaise, chills and myalgia. These events lasted approximately 24 hours and resolved on an unspecified date.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 73-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. The reporter considered the injection site reaction to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown arm. The healthcare professional was unable to provide further details regarding the nature of the reaction as she had not seen the patient at the time of report. No additional information was provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: My wife and I got our second SHINGRIX vaccination at about noon today at our pharmacy. After approx. two hours my wife began having significant pain in her shoulder above the injection site. The pain was radiating up her shoulder into her lower neck and was throbbing. We went to the ER as it about 5 PM at that point. The ER Dr prescribed 1 grain of TYLENOL followed by alternating ADVIL ever four to six hours. Her pain began to diminish after an hour. I felt no great discomfort initially but at about 6 PM I began to feel very bad with flu like symptoms (body ache, headache, soreness in shoulder and general malaise). The symptoms I experienced closely mirror what I had after the first injection two months ago. Neither of us can remember any vaccination causing this many and disturbing side effects. I have only taken TYLENOL (2 at 500 mg) and alternating ADVIL with little relief.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a adult female patient who received SHINGRIX. On 15th May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was not recovered/not resolved. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local injection site reactions. The patient received an inbound cell phone call and hung up abruptly to answer that call. No additional details were gathered.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Injection site erythema, Lymph node pain, Pain, Pyrexia
Clinical narrative: Rash on my arms, back and front. I have a fever of 103. Rash is slightly raised, started today. Red spots. Not really pimple like. No itching, not painful. No lesions in mouth, or hands or feet. Never had anything like this before. Denies chest pain or sob. Arm around vaccination site is red, swollen and hot. Lymph nodes in armpit tender. Feeling tired and worn out. Little achy. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash erythematous, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Rash on my arms, back and front. I have a fever of 103. Rash is slightly raised, started today. Red spots. Not really pimple like. No itching, not painful. No lesions in mouth, or hands or feet. Never had anything like this before. Denies chest pain or sob. Arm around vaccination site is red, swollen and hot. Lymph nodes in armpit tender. Feeling tired and worn out. Little achy. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Patient broke out in a rash. Red and itchy. Rash is on patient's back. Hurts to scratch.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Eyelid ptosis, Myasthenia gravis, Vertigo
Clinical narrative: The patient reported a sudden worsening of her Myasthenia Gravis, which had been well controlled on MESTINON 60 mg bid for years prior to vaccination. She reported R ptosis/eyelid droop and difficulty focusing her vision the day after the vaccination. She later had dizziness and vertigo. She has been under the care of a neuro-ophthalmologist, Dr. who has placed her on prednisone (has titrated up to 7.5 mg daily) and has increased her MESTINON to 60 mg 3-4 times daily (a tolerated). Despite these measures her symptoms remain uncontrolled. The patient and I wonder if the flu shot may have triggered this worsening of symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: The patient reported a sudden worsening of her Myasthenia Gravis, which had been well controlled on MESTINON 60 mg bid for years prior to vaccination. She reported R ptosis/eyelid droop and difficulty focusing her vision the day after the vaccination. She later had dizziness and vertigo. She has been under the care of a neuro-ophthalmologist, Dr. who has placed her on prednisone (has titrated up to 7.5 mg daily) and has increased her MESTINON to 60 mg 3-4 times daily (a tolerated). Despite these measures her symptoms remain uncontrolled. The patient and I wonder if the flu shot may have triggered this worsening of symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: My PCP, MD asked me to contact my pharmacist to report the following vaccination reaction so that the pharmacist could notify the manufacturer and also to find out if there are any recommendations related to the second shot in the series. I contacted Pharmacist on 5/30/18 declined to submit a notification to the manufacturer because the symptoms are on the list of side effects & advised me that personally he would not recommend that I get the second vaccination. I am an RN and am aware of the agony shingles can cause but my PCP & I are concerned about the severity of the reaction I had & would like advice: I had my initial SHINGRIX vaccination around 2:00 PM on Sunday 5/27/18. Right after  receiving the injection I felt briefly nauseous & started perspiring but that passed quickly and I was fine other than a sore arm until around midnight. By midnight I had a pounding headache, fever, nausea/vomiting. I was bed bound/sleeping with fever, headache & nausea/vomiting/dry heaves for about 20 hours after which I began to improve. I was lightheaded all day 5/29 but continued to improve. All symptoms were gone by around 11:00 PM on 5/29. I've never had a vaccination reaction to anything in the past aside from a sore arm. Should I receive the 2nd injection in 2-6 months & if so are there any recommendations/precautions.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Retching, Vomiting
Clinical narrative: My PCP, MD asked me to contact my pharmacist to report the following vaccination reaction so that the pharmacist could notify the manufacturer and also to find out if there are any recommendations related to the second shot in the series. I contacted Pharmacist on 5/30/18 declined to submit a notification to the manufacturer because the symptoms are on the list of side effects & advised me that personally he would not recommend that I get the second vaccination. I am an RN and am aware of the agony shingles can cause but my PCP & I are concerned about the severity of the reaction I had & would like advice: I had my initial SHINGRIX vaccination around 2:00 PM on Sunday 5/27/18. Right after  receiving the injection I felt briefly nauseous & started perspiring but that passed quickly and I was fine other than a sore arm until around midnight. By midnight I had a pounding headache, fever, nausea/vomiting. I was bed bound/sleeping with fever, headache & nausea/vomiting/dry heaves for about 20 hours after which I began to improve. I was lightheaded all day 5/29 but continued to improve. All symptoms were gone by around 11:00 PM on 5/29. I've never had a vaccination reaction to anything in the past aside from a sore arm. Should I receive the 2nd injection in 2-6 months & if so are there any recommendations/precautions.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Arrhythmia, Electrocardiogram normal, Muscular weakness, Stress echocardiogram abnormal, X-ray normal
Clinical narrative: In June 2015 started noticing weaker legs riding bicycle, 12-1-15 - EKG and XRay recommended at Heart Doctor, everything checked out ok. Dr., cardiology - stress test and cardio-gram Heart out of rhythm. Said everything looked ok, wanted me to take succinate ER 25 mg one daily. After finishing bike ride (25miles) took my own blood pressure about-15 minutes after finishing ride 66 over 62 and 100 pulse heart rate. When I told Doctor about what happen, he said it was impossible for vaccine to cause that reaction, so did heart Dr. I still have, take nothing for it.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red and tenderness at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called office on 5/24/18 and stated she received a vaccine at her visit on 5/22/18 and that her arm was swollen. Patient states swelling starts at injection site and goes down into her forearm. Sore at injection site. Patient stated she took a BENADRYL and the swelling seemed to be getting better. I spoke to patient on 5/29/18 and the swelling has resolved.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: BODY ACHES, TIRED, HEADACHE.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event has taken place.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Contusion, Erythema, Injection site reaction
Clinical narrative: Almost immediately after receiving vaccine welted up and arm was swollen around injection site. Arm continued to get more red and bruised as evening continued on. Pt also had very achy joints to the point was hard to move around, developed a fever around 100 even after taking an aspirin and had body chills.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Mobility decreased, Pyrexia, Urticaria
Clinical narrative: Almost immediately after receiving vaccine welted up and arm was swollen around injection site. Arm continued to get more red and bruised as evening continued on. Pt also had very achy joints to the point was hard to move around, developed a fever around 100 even after taking an aspirin and had body chills.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Blood test normal, Computerised tomogram head normal, Electroencephalogram normal, Moaning, Neurological examination normal
Clinical narrative: On 3/8/18, 8 days after vaccination, patient had a seizure: while sleeping at 7am, Mother describes clenched fists, whimpering for 2 minutes; post-ictal phase afterwards.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Postictal state, Seizure
Clinical narrative: On 3/8/18, 8 days after vaccination, patient had a seizure: while sleeping at 7am, Mother describes clenched fists, whimpering for 2 minutes; post-ictal phase afterwards.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Rash
Clinical narrative: Patient reported rash to right ring finger four days after Shingrex vaccine administration. Nurse practitioner diagnosed lesion as herpetic whitlow.
Age: 45.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Dehydration, Fatigue, Injection site pruritus
Clinical narrative: 5/25/18 - hours after administration patient felt mild itching at vaccine site, resolved. 5/26/18 - 5/29/18: exhaustion, fatigue, malaise, lack of energy, need for increase in hours of sleep at night; also, myalgia, arthralgia, soreness/tenderness at site of vaccination. 5/27/18: dehydration 5/30/18: seen at same clinic, treatment is supportive.
Age: 45.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Myalgia, Somnolence, Vaccination site pain
Clinical narrative: 5/25/18 - hours after administration patient felt mild itching at vaccine site, resolved. 5/26/18 - 5/29/18: exhaustion, fatigue, malaise, lack of energy, need for increase in hours of sleep at night; also, myalgia, arthralgia, soreness/tenderness at site of vaccination. 5/27/18: dehydration 5/30/18: seen at same clinic, treatment is supportive.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: Pt reported "flu-like symptoms" aches and pains, chills, fatigue, light headedness, chest tightness (shortness of breath) after exertion, injection site pain, pain on underside of arm (swollen lymph node?). Symptoms most severe on day after immunization and continuing the following day, but all but fatigue and arm pain resolved after 2 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea exertional, Fatigue, Influenza like illness, Injection site pain, Lymphadenopathy
Clinical narrative: Pt reported "flu-like symptoms" aches and pains, chills, fatigue, light headedness, chest tightness (shortness of breath) after exertion, injection site pain, pain on underside of arm (swollen lymph node?). Symptoms most severe on day after immunization and continuing the following day, but all but fatigue and arm pain resolved after 2 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reported "flu-like symptoms" aches and pains, chills, fatigue, light headedness, chest tightness (shortness of breath) after exertion, injection site pain, pain on underside of arm (swollen lymph node?). Symptoms most severe on day after immunization and continuing the following day, but all but fatigue and arm pain resolved after 2 days.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Neck pain
Clinical narrative: Over the last 2 months I suffer from pain in my upper arm where shot was given-pain is now traveling up to neck and head.
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 8 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Nurse and refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2018, the patient was vaccinated with VARIVAX lot number M035141, expiration date 01-AUG-2018, subcutaneously for prophylaxis. On the same date, while vaccination, the patient moved when it was being administered and some leaked out at the injection site on the leg. The patient was supposed to be vaccinated with 0.5ml subcutaneously, but it was not sure how much was administered (underdose). No adverse events were reported.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Cellulitis
Clinical narrative: This case was reported by a physician and described the occurrence of cellulitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown arm. The patient experienced cellulitis. The patient received another vaccine (details not provided) in the same arm but in different anatomical location. This case is one of the case reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site discolouration, Injection site erythema, Injection site haemorrhage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. Concomitants products included COZAAR, LIPITOR, SYNTHROID and XANAX. On 15th May 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash. In May 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site itching and injection site erythema were unchanged and the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the injection site macule was recovering/resolving and the outcome of the injection site rash was unknown. The reporter considered the pain in arm, injection site itching and injection site erythema to be related to SHINGRIX. The reporter considered the injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient stated that on the same evening she received the vaccine or day after, she developed pain in her arm along with redness and itching right below the site of administration. The patient had denied permission to contact their physician. All questions were asked. Limited information provided due to time constraint. On 24th May 2018, the Reporter called back to indicate that the patient developed a brown spot at the injection site which smaller than a dime about the size of a button after approximately 1-2 days after receiving the SHINGRIX vaccine. The event appeared to be resolving as it was getting lighter in color but she noticed for the first time yesterday that there were four red spots in the brown area. The patient had flu-like symptoms that resolved. She said that she still had slight rash below the injection site which was surrounding half of the left arm. The patient said that it might itch at the most twice daily and noted that there was not lot of bleeding from the injection site at the time of the initial injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site macule, Injection site pruritus, Injection site rash, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX. Concomitants products included COZAAR, LIPITOR, SYNTHROID and XANAX. On 15th May 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash. In May 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site itching and injection site erythema were unchanged and the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the injection site macule was recovering/resolving and the outcome of the injection site rash was unknown. The reporter considered the pain in arm, injection site itching and injection site erythema to be related to SHINGRIX. The reporter considered the injection site hemorrhage, injection site macule, influenza-like symptoms and injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The patient stated that on the same evening she received the vaccine or day after, she developed pain in her arm along with redness and itching right below the site of administration. The patient had denied permission to contact their physician. All questions were asked. Limited information provided due to time constraint. On 24th May 2018, the Reporter called back to indicate that the patient developed a brown spot at the injection site which smaller than a dime about the size of a button after approximately 1-2 days after receiving the SHINGRIX vaccine. The event appeared to be resolving as it was getting lighter in color but she noticed for the first time yesterday that there were four red spots in the brown area. The patient had flu-like symptoms that resolved. She said that she still had slight rash below the injection site which was surrounding half of the left arm. The patient said that it might itch at the most twice daily and noted that there was not lot of bleeding from the injection site at the time of the initial injection.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: I received the GARDASIL shot on Wednesday 5/23/2018 and on 5/25/2018 I noticed rash (raised bumps) area on my stomach on the right hand side. As of 5/26/2018 it has gotten worse.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4/30/18 Afternoon of vaccination: sore L arm at injection, became swollen. Next day 5/1/18: nausea, cold sweat, chills, very pale at breakfast so had to lie down; muscle aches throughout day; low grade fever in evening; injection site swollen, red and hot to touch. 5/2/18: fever, muscle aches gone; arm still significantly sore, swollen, red and hot. 5/3/18: arm soreness and swelling improving; redness migrating downward. About 5/5/18: swelling down and soreness gone.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pain in extremity, Pallor
Clinical narrative: 4/30/18 Afternoon of vaccination: sore L arm at injection, became swollen. Next day 5/1/18: nausea, cold sweat, chills, very pale at breakfast so had to lie down; muscle aches throughout day; low grade fever in evening; injection site swollen, red and hot to touch. 5/2/18: fever, muscle aches gone; arm still significantly sore, swollen, red and hot. 5/3/18: arm soreness and swelling improving; redness migrating downward. About 5/5/18: swelling down and soreness gone.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: 4/30/18 Afternoon of vaccination: sore L arm at injection, became swollen. Next day 5/1/18: nausea, cold sweat, chills, very pale at breakfast so had to lie down; muscle aches throughout day; low grade fever in evening; injection site swollen, red and hot to touch. 5/2/18: fever, muscle aches gone; arm still significantly sore, swollen, red and hot. 5/3/18: arm soreness and swelling improving; redness migrating downward. About 5/5/18: swelling down and soreness gone.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Gait inability, Muscular weakness
Clinical narrative: PATIENT HAD LOWER BACK PAIN 10 MINUTES AFTER IMMUNIZATION...RIGHT LEG WAS WEAK & WAS TEMPORARILY UNABLE TO WALK.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Chills, bodyaches,leg cramps - no appetite, arm sore for 3 days- symtoms from friday to sunday- 3 days.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: The patient stated that she got mouth sores that lasted for about 1 day.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Increased tendency to bruise
Clinical narrative: Patient developed dark bruising and redness near injection site. Patient expressed no pain, itching, or aggravation other than discoloration. Patient is taking Xarelto and endorsed frequent/easy bruising while on blood thinner. Advised patient that his bruising is likely a result of his chronic anticoagulation, but assured him that we would submit a adverse event report.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash pruritic
Clinical narrative: She had pain at site of injection for 1st 36 hours. On Sat 5/26/18 she developed an itchy rash in her left hip area. She said it wasn't bothering her too bad. I told her to see her PCP is it gets worse or hot feeling or swollen.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: His arm was very sore and he was very tired. He went to his PCP and was told these are normal SE's.  He was not prescribed any medicine.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Influenza like illness, Injection site pain, Presyncope
Clinical narrative: Patient came in the next morning, 5/30/2018, complaining about his experience following the flu shot.  Complaints included lightheadedness and near syncopal episode starting roughly a half hour after the immunization and lasting 3 to 4 hours later. Patient also complained of severe flu-like symptoms with several episodes diarrhea through the evening and vomiting once in the morning during breakfast.  Complaints also included arm pain at the injection site. All protocols were followed during the immunization process. Patient also received a testosterone injection from a nurse at 10:05AM  before going to the pharmacy for the SHINGRIX vaccine.