chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: achy arm; achy shoulder; headache; neck pain; back pain; Inappropiate schedule of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2018).   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th June 2019, the patient experienced pain in arm, shoulder pain, headache, neck pain and back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, headache, neck pain and back pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache, neck pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in arm, shoulder pain, headache, neck pain and back pain after receiving 2nd dose of Shingrix. The patient received 2nd dose of Shingrix 10 months after receiving 1st dose, which led to lengthening of vaccination schedule. This case is linked to case US2019101097, reported by same reporter
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: achy arm; achy shoulder; headache; neck pain; back pain; flu like symptoms; tired; achy; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2018).   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th June 2019, the patient experienced pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness and pain. On an unknown date, the outcome of the pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness and pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness, pain and drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. On the day of reporting, the patient woke up with achy arm, achy shoulder, headache, neck pain and back pain. The patient also experienced flu like symptoms, feeling tired and achy. This case had been linked with case US2019101070 (wife's case), reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: achy arm; achy shoulder; headache; neck pain; back pain; flu like symptoms; tired; achy; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2018).   On 3rd June 2019, the patient received the 2nd dose of Shingrix. On 3rd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 4th June 2019, the patient experienced pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness and pain. On an unknown date, the outcome of the pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness and pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache, neck pain, back pain, influenza-like symptoms, tiredness, pain and drug dose administration interval too long to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. On the day of reporting, the patient woke up with achy arm, achy shoulder, headache, neck pain and back pain. The patient also experienced flu like symptoms, feeling tired and achy. This case had been linked with case US2019101070 (wife's case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day 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 age at vaccination was not reported. The patient was in her late 60s or early 70s. About a month ago, the patient received 1st dose of Shingrix . The next day, the patient presented in the office with active shingles.  The patient had no signs of shingles at the time of vaccination.  Limited details available at the time of reporting, as physician was unable to access patient data in the system and the vaccination was not administered at the office.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, X-ray normal
Clinical narrative: Injection site pain; pain travels from injection site up to neck; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and neck pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the neck pain was unknown.   It was unknown if the reporter considered the injection site pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on left arm. The patient experienced injection site pain that lasted really bad for 3 days. The pain travels from injection site upto the neck. The patient had an X-ray and it showed nothing. The patient said that shw will not be taking 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain in left upper arm; pain radiating to left side of neck; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and neck pain. The patient was treated with oxycodone and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the injection site pain and neck pain were not recovered/not resolved.   The reporter considered the injection site pain and neck pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 89 years or 90 years. The patient received Shingrix in her left upper arm at the local pharmacy. Within 24 hours of receiving the vaccine, the patient started to experience this pain. The patient had been suffering from excruciating pain in her left upper arm which radiated up the left side of her neck on occasion.  The patient had been seen by her physician several times since the initial vaccine and her physician prescribed Oxycodone for the pain which helped but she was concerned about taking the medication long term. Her physician recently prescribed a round of physical therapy to help with her pain.  The patient reported that, she would definitely not getting the 2nd vaccine and also would not obtained the 1st one if she knew, she would be at an increased risk for this type of pain.  On the day of reporting, the patient was following up with her physician. She consented to follow up and provided details of her physician. In source document, the outcome was reported as recovering/ resolving for all the symptoms, however as per narrative description it was not recovered/ not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Lip pain, Pigmentation lip, Skin indentation
Clinical narrative: lip sore; lip spot; painful on her lips with indentations; lip indentation/ painful on her lips with indentations; This case was reported by a consumer via call center representative and described the occurrence of sores lip in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st March 2019, 1 days after receiving Shingrix, the patient experienced sores lip, lip pigmental spot, lip soreness and skin indentation. On an unknown date, the outcome of the sores lip, lip pigmental spot, lip soreness and skin indentation were not recovered/not resolved.   It was unknown if the reporter considered the sores lip, lip pigmental spot, lip soreness and skin indentation to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm. The following day she had sores on her lips. The patient stated that, these sores were different from the cold sores which she had in past. She described the area as painful on her lips with indentations. The patient had sores on the top and bottom but mostly on the bottom lip. She had a white spot on her bottom lip and then half of her bottom lip turned white. The patient had sores for two and half months and the area was still unresolved. The patient consented to follow up. Outcome of the events sores lip, lip pigmental spot and lip soreness was discrepantly reported as recovering/ resolving in source document while in database and narrative description it was reported as not recovered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness; itchy; warm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 3rd May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd May 2019, immediately after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site warmth. In May 2019, the outcome of the injection site erythema, injection site itching and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a red arm at the injection site immediately which the patient described as the size of a hot dog bun.  Less than a day after vaccination, the area was not inflamed but it was red, itchy and a little warm. The symptoms resolved after a week. The reporter had consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: patient only received the 0.4 Sodium Chloride diluent portion, the powdered ActHIB was not added to it; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional via phone.  This case involves a patient of an unknown demographics who only received the 0.4 Sodium Chloride diluent portion, while he/she received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique because patient only received the 0.4 Sodium Chloride diluent portion, the powdered ActHIB was not added to it.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Sex: F
Vaccine: UNK
Symptoms: Skin discolouration
Clinical narrative: Got a black mark on the arm; This is a spontaneous case initially received from pharmacist on 30-Nov-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for influenza prophylaxis.  On an unspecified date, after vaccination, the developed a black mark on the arm.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.; Reporter's Comments: A female patient of unspecified age developed black mark on the arm after administration of (INN Flu Vaccine Seasonal). The causality of the event was unassessable due to lack of onset latency with the suspect vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded after receiving the shingrix shot.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Productive cough, fatigue, left arm pain at injection site with soreness, myalgia, arthralgia, headache.  Injection was on June 12. Today is June 14 and I am still symptomatic. Incidentally, I am a healthcare provider (MD, board certified Family Medicine).  I have taken ibuprofen (800 mg on June 13 and acetaminophen 1000 mg on June 14).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Productive cough
Clinical narrative: Productive cough, fatigue, left arm pain at injection site with soreness, myalgia, arthralgia, headache.  Injection was on June 12. Today is June 14 and I am still symptomatic. Incidentally, I am a healthcare provider (MD, board certified Family Medicine).  I have taken ibuprofen (800 mg on June 13 and acetaminophen 1000 mg on June 14).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: lower left arm swollen and red at the elbow area
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Injection site extravasation
Clinical narrative: an unspecified amount of fluid was leaking out of the injection site; This spontaneous report was received from a pharmacist and refers to a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.   On 03-JUN-2019, the patient was vaccinated with on dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number S000132 with expiration date on 02-JAN-2021 (strength, frequency and route of administration were not reported) for prophylaxis. Other suspect therapy includes sterile diluent lot number S000977 with expiration date on 14-SEP-2021.  On the same date, during the administration of the vaccine an unspecified amount of fluid was leaking out of the injection site (vaccination site extravasation). The outcome of vaccination site extravasation was unknown.  The relatedness between the event occurrence and varicella virus vaccine live (Oka/Merck) (VARIVAX) administration was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Vaccination site pain; Vaccination site swelling; Vaccination site erythema; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included steroid injections. Concurrent medical conditions included sciatica (Chronic pain).   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and muscle pain. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix approximately 2 months before. The patient states that the symptoms injection site pain, injection site swelling, injection site erythema and severe muscle pain lasted for approximately 1 to 2 weeks. The reporter did not consented to follow-up. The patient did not wish to provide any additional details or contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash; Tenderness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 20th May 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and injection site tenderness. On an unknown date, the outcome of the injection site rash and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site rash and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter stated that, the patient experienced rash around injection site, down her arm, and tenderness. The reporter declined to give patient information. This case has been linked with case US2019GSK105365, reported by the same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Guillain-Barre syndrome
Clinical narrative: GuillainBarre syndrome; patient received seasonal influenza vaccine early in the first trimester of pregnancy; Initial information received on 07-Jun-2019 regarding an unsolicited valid serious pregnancy case issued from a literature article.   Abstract: Guillain-Barré syndrome (GBS) is an adverse event of interest after vaccination, yet few data are available for background rates during pregnancy. We confirmed 2 cases of incident GBS and estimated an incidence of 2.8 confirmed GBS cases per million person-years (95% confidence interval, 0.5-9.3), indicating rare occurrence. Our findings will help inform safety assessments of Zika vaccines in pregnant populations.  This case involves a 26 years old female patient who developed Guillain-Barre Syndrome, while she received vaccine INFLUENZA VACCINE, while she was pregnant.   Data regarding this pregnancy were received retrospectively, i.e. after pregnancy outcome was known. The reported Guillain-Barre syndrome occurred at 22 Weeks of pregnancy.  The date of last menstrual period and actual date of delivery were not reported.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had previous pregnancies.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (formulation: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient presented with a serious Guillain-Barre Syndrome (guillain-barre syndrome) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was case of vaccine exposure during pregnancy. The patient was 22 weeks pregnant when she received vaccine.  (Other relevant tests included No lab data.) Final diagnosis was guillain-barre syndrome.   It was not reported if the patient received a corrective treatment.  The reporter did not believe that this represents a case of vaccine-associated GBS.  Outcome of the event GBS was not reported.  Additionally, at time of reporting, the birth type and delivery type were not reported. Gestation period at delivery: 39 weeks.  There will be no information available on the batch number for this case.  List of document held by sender; none; Sender's Comments: This case concerns a 26 years old pregnant female patient who presented with Guillain-barre syndrome after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Injected limb mobility decreased, Injection site swelling, Pain
Clinical narrative: Patient received the vaccine on 5/17/2019 or after (not sure of the date) but called the office on 5/20/2019 with complaints that her right arm is red, warm, and the area of the injection raised. She was advised to take Benadryl and use an ice pack in 15 minute cycles by one of our triage medical assistants. She didn't report any hives or breathing issues and doctor was okay with what the medical assistant advised and stated to have the patient  come back in if it gets any worse.   On 5/24/2019, patient called back with the swelling now persisting and the redness not going away. Doctor stated he will work her in if needed to address today and advised OTC Benadryl still with hydrocortisone cream. Our after hours team reported to the patient what do advised going to an urgent care or ER if the symptoms worsened over Holiday Weekend.  On 6/7/2019, Patient called back in the morning with complaints of shortness of breath as well as the swelling still ongoing. She came in on that day to follow with Dr for the reaction. He noticed at that time the arm was swollen and that she was having pain in that arm when it came to moving it. If she swelling wasn't going down, Dr was going to order imaging on her arm.  On 6/11/2019, another Medical Assistant was asked to follow up with the patient to see how she was doing and to verify the symptoms in order to report. She still notes she cannot fully move her right arm still and that it is still swollen and warm to touch even after nearly 4 weeks since she got the vaccine..
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Patient received the vaccine on 5/17/2019 or after (not sure of the date) but called the office on 5/20/2019 with complaints that her right arm is red, warm, and the area of the injection raised. She was advised to take Benadryl and use an ice pack in 15 minute cycles by one of our triage medical assistants. She didn't report any hives or breathing issues and doctor was okay with what the medical assistant advised and stated to have the patient  come back in if it gets any worse.   On 5/24/2019, patient called back with the swelling now persisting and the redness not going away. Doctor stated he will work her in if needed to address today and advised OTC Benadryl still with hydrocortisone cream. Our after hours team reported to the patient what do advised going to an urgent care or ER if the symptoms worsened over Holiday Weekend.  On 6/7/2019, Patient called back in the morning with complaints of shortness of breath as well as the swelling still ongoing. She came in on that day to follow with Dr for the reaction. He noticed at that time the arm was swollen and that she was having pain in that arm when it came to moving it. If she swelling wasn't going down, Dr was going to order imaging on her arm.  On 6/11/2019, another Medical Assistant was asked to follow up with the patient to see how she was doing and to verify the symptoms in order to report. She still notes she cannot fully move her right arm still and that it is still swollen and warm to touch even after nearly 4 weeks since she got the vaccine..
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient presented to walk in with swelling, redness and warmth to left deltoid area from vaccine given on 6/11/19.  Immunization was documented as being given in right arm on record.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Condition aggravated, Feeling abnormal, Headache
Clinical narrative: Patient noticed symptoms when she awoke the morning following her injection. She c/o chills with low grade fever, low BP, nausea, headache, increased back pain, and  body aches. She had swelling to her right upper arm. There was localized erythematous area to right deltoid at injection site. Warmth and tenderness with palpation. Pt reports she felt real bad Tuesday and Wednesday. Symptoms began to improve Thursday, which is when she was able to come to clinic for evaluation. Pt had been taking ibuprofen as needed. She was advised by provider to continue taking ibuprofen as needed for pain/swelling and can alternate with Tylenol. Advised she may apply ice pack to injection site. Advised to call or return to clinic if symptoms do not resolve or if they worsen.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Patient noticed symptoms when she awoke the morning following her injection. She c/o chills with low grade fever, low BP, nausea, headache, increased back pain, and  body aches. She had swelling to her right upper arm. There was localized erythematous area to right deltoid at injection site. Warmth and tenderness with palpation. Pt reports she felt real bad Tuesday and Wednesday. Symptoms began to improve Thursday, which is when she was able to come to clinic for evaluation. Pt had been taking ibuprofen as needed. She was advised by provider to continue taking ibuprofen as needed for pain/swelling and can alternate with Tylenol. Advised she may apply ice pack to injection site. Advised to call or return to clinic if symptoms do not resolve or if they worsen.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient noticed symptoms when she awoke the morning following her injection. She c/o chills with low grade fever, low BP, nausea, headache, increased back pain, and  body aches. She had swelling to her right upper arm. There was localized erythematous area to right deltoid at injection site. Warmth and tenderness with palpation. Pt reports she felt real bad Tuesday and Wednesday. Symptoms began to improve Thursday, which is when she was able to come to clinic for evaluation. Pt had been taking ibuprofen as needed. She was advised by provider to continue taking ibuprofen as needed for pain/swelling and can alternate with Tylenol. Advised she may apply ice pack to injection site. Advised to call or return to clinic if symptoms do not resolve or if they worsen.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Developed a mild case of the chicken pox 12 days after injection. Started developing blisters, about 10 on back, head and arms.  Otherwise no other symptoms and acted normally.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Patient started experiencing flu like symptoms, body ache, chills, fatigue, etc., about a day after receiving the first dose of his Shingrix vaccine, he does not want to receive the second dose due to feeling so awful after receiving the first dose.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Administration site erythema, Administration site pain, Administration site swelling
Clinical narrative: RED, SWOLLEN, AND TENDER AREA AT SITE OF ADMINISTRATION. PATIENT STARTED TREATMENT OF ANTIHISTAMINE (BENADRYL)
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Chest pain, Wheezing
Clinical narrative: complaining of chest hurting, wheezing , heart beat was fine BP was 190911 was called for ambulance and client was taken to hospital unknown whether vaccine was cause.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Antiphospholipid antibodies negative, C-reactive protein increased, Rheumatoid factor negative, Synovitis
Clinical narrative: bilateral synovitis of the hands bilaterally, starting 4 days after the 2nd dose of the Shingrix.  Gradually worsening at 6 weeks post dose
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Vaccine was given in the joint space of the right arm. Patient has been having right shoulder pain since last week. Pain is dull and achy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Patient experienced flu like symptoms, muscle aches, chills, fatigue, etc. about a day after receiving the vaccine. He did not experience these symptoms with the first dose of the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Patient had experienced flu-like symptoms, muscle aches, chills, fatigue, etc. about a day after receiving the vaccine. She had not experienced these symptoms with the first dose of the vaccine.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Lip swelling
Clinical narrative: Upon waking next day,  patient had a swollen lip
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site joint pain, Nausea, Neck pain
Clinical narrative: contemporaneous severe neck pain, later pain in upper shot  arm joint, nausea, headache for several days
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Blepharospasm, Dyskinesia, Excessive eye blinking, Head titubation, Speech disorder
Clinical narrative: Patient begin an involuntary and uncontrollable eye blinking / twitch within 12 hours of the vaccine.  Also developed an uncontrollable throat clearing tic, interrupting continuing speech to clear throat. Will also occasionally involuntarily nod head in a jerky way with eye blinking. Has not resolved nine months after vaccine.  Severity waxes and wanes, but has not resolved.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Throat clearing, Tic
Clinical narrative: Patient begin an involuntary and uncontrollable eye blinking / twitch within 12 hours of the vaccine.  Also developed an uncontrollable throat clearing tic, interrupting continuing speech to clear throat. Will also occasionally involuntarily nod head in a jerky way with eye blinking. Has not resolved nine months after vaccine.  Severity waxes and wanes, but has not resolved.
Age: 68.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Chills, Fatigue, Insomnia, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient stated that later that day he began to feel tired and chills. Later that night he felt his shoulder swelling with severe pain. The swelling moved all the way down his arm and swelled like a balloon. This lasted 6 days until 6/13 when nearly all of the swelling was resolved. He couldn't sleep at all during the height of the incident and said it was some of the worst pain he has ever experienced.
Age: 68.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Swelling
Clinical narrative: Patient stated that later that day he began to feel tired and chills. Later that night he felt his shoulder swelling with severe pain. The swelling moved all the way down his arm and swelled like a balloon. This lasted 6 days until 6/13 when nearly all of the swelling was resolved. He couldn't sleep at all during the height of the incident and said it was some of the worst pain he has ever experienced.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: pt says she had severe pain in the muscle unable to lift arm and put on shirt. did not go to er did not start treatment till 2/6/2019 per pt
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal pain, Crying, Faeces discoloured, Irritability, Screaming
Clinical narrative: Neon green poop. Non stop screaming and crying. Belly pain. Fussiness days later.
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Pain
Clinical narrative: soreness; felt nodule; This case was reported by a nurse via sales rep and described the occurrence of pain in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced pain and injection site nodule. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the injection site nodule was not recovered/not resolved.   It was unknown if the reporter considered the pain and injection site nodule to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After an unknown period, the patient experienced initial soreness. The soreness went away, but the patient felt nodule. The nodule was still there after 2 weeks, but no more soreness was present. The reporter agreed to follow up from GSK. The description did not include that the nodule is at injection site, whereas injection site was retained as per the reported information in Argus core.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: pain in arm, where vaccine was administered; This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date on the arm at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  It was reported on an unspecified date that the patient experienced pain in arm, where vaccine was administered. The outcome of the event was unknown.   Information on the batch number has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Patient came in 2 days post vaccination complaining of a red rash, inflammation, and skin hot to the touch at injection site. She also had a bad reaction the day after the vaccination that lasted 24 hours including chills, fever, aches, and fatigue but this is common with this vaccintion. Patient was counseled to watch the rash to ensure it did not continue to grow or get worse. Also counseled to take ibuprofen for pain and swelling. Patient cam e in again 4 days post vaccination where the rash has resolved but was still swollen. This was likely an injection site reaction to the vaccine based on resolution but patient still wanted to report side effect to VAERS.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient came in 2 days post vaccination complaining of a red rash, inflammation, and skin hot to the touch at injection site. She also had a bad reaction the day after the vaccination that lasted 24 hours including chills, fever, aches, and fatigue but this is common with this vaccintion. Patient was counseled to watch the rash to ensure it did not continue to grow or get worse. Also counseled to take ibuprofen for pain and swelling. Patient cam e in again 4 days post vaccination where the rash has resolved but was still swollen. This was likely an injection site reaction to the vaccine based on resolution but patient still wanted to report side effect to VAERS.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Standard reaction that CDC and Dr. forewarned was possible:   flu like symptoms for 2-3 days:  low grade fever, chills, extreme joint and muscle pain of entire body - particularly both shoulder areas (trapezius and spinatus muscles), mild nausea, extreme fatigue, bad headache, etc and the common red swollen injection area
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Standard reaction that CDC and Dr. forewarned was possible:   flu like symptoms for 2-3 days:  low grade fever, chills, extreme joint and muscle pain of entire body - particularly both shoulder areas (trapezius and spinatus muscles), mild nausea, extreme fatigue, bad headache, etc and the common red swollen injection area
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Eye disorder, Feeling abnormal, Gait disturbance
Clinical narrative: Standard reaction that CDC and Dr. forewarned was possible:   flu like symptoms for 2-3 days:  low grade fever, chills, extreme joint and muscle pain of entire body - particularly both shoulder areas (trapezius and spinatus muscles), mild nausea, extreme fatigue, bad headache, etc and the common red swollen injection area
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Ophthalmic herpes zoster, Pain, Pyrexia, Vestibular neuronitis
Clinical narrative: Standard reaction that CDC and Dr. forewarned was possible:   flu like symptoms for 2-3 days:  low grade fever, chills, extreme joint and muscle pain of entire body - particularly both shoulder areas (trapezius and spinatus muscles), mild nausea, extreme fatigue, bad headache, etc and the common red swollen injection area
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: EXTREME MUSCLE AND JOINT PAIN THROUGHOUT MY BODY DURING THE NIGHT AND INTO THE MORNING.
Age: 18.0
Sex: M
Vaccine: HEP, MENB, MNQ
Symptoms: Nodule
Clinical narrative: Client came to clinic on 05-14-19 to report of complaint of nodules to right clavicular area. Client states he did not feel them before having vaccines. Client also complained of fever for two days that he managed with Tylenol. Client did not check temperature with a thermometer. Clavicular area was palpated by this Nurse and nodules were palpated to right clavicular area. Client had a schedules appt with his doctor on 05-14-19 at 1345 hrs. Client was instructed to call this Nurse for update and to complete a VAERS report. Multiple attempts have been made to contact client without succesClient has been lost to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling hot, Herpes zoster, Hypoaesthesia, Hypokinesia
Clinical narrative: shingles; stomach disconfort; leg numb; could hardly walk/barely move; arm swollen; arm  hot; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 31st May 2019, 1 days after receiving Shingrix, the patient experienced swelling arm and extremities hot feeling of. On 1st June 2019, the patient experienced numbness in leg and movements reduced. On 4th June 2019, the patient experienced shingles and stomach discomfort. On an unknown date, the outcome of the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort were unknown.   It was unknown if the reporter considered the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient's arm was very swollen and hot. The patient said she could barely move and her leg was numb. The patient was feeling sick to her stomach and thoughts she may have shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: shingles; stomach disconfort; leg numb; could hardly walk/barely move; arm swollen; arm  hot; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. On 31st May 2019, 1 days after receiving Shingrix, the patient experienced swelling arm and extremities hot feeling of. On 1st June 2019, the patient experienced numbness in leg and movements reduced. On 4th June 2019, the patient experienced shingles and stomach discomfort. On an unknown date, the outcome of the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort were unknown.   It was unknown if the reporter considered the shingles, swelling arm, extremities hot feeling of, numbness in leg, movements reduced and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient's arm was very swollen and hot. The patient said she could barely move and her leg was numb. The patient was feeling sick to her stomach and thoughts she may have shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: redness at injection site and upper arm/redness of upper arm; Swelling at injection site and upper arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the right deltoid and experienced swelling, redness at injection site and upper arm. The reporter asked, how to processed with 2nd dose of Shingrix. The patient information was gathered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Bronchitis, Dyspnoea, Expired product administered, Malaise, Pain in extremity
Clinical narrative: Expired Drug Used; bronchitis; malaise/sick; breathing problems; soreness left arm; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number M17058, expiry date 30th April 2019) for prophylaxis.   The patient's past medical history included scoliosis surgery.   On 20th May 2019, the patient received Menveo (intramuscular). In May 2019, 1 day after receiving Menveo, the patient experienced bronchitis, malaise, difficulty breathing and pain in arm. On 20th May 2019, the patient experienced expired vaccine used. On an unknown date, the outcome of the bronchitis, malaise and difficulty breathing were not recovered/not resolved and the outcome of the pain in arm and expired vaccine used were unknown.   It was unknown if the reporter considered the bronchitis, malaise, difficulty breathing and pain in arm to be related to Menveo.  Additional details were provided as follows: This case was reported by the patient's mother. The patient received Menveo which was expired already. The caller stated that the patient has been sick for 24 hours after receiving the vaccine.  The patient has experienced malaise and breathing problems and was diagnosed with bronchitis. The reporter consented to follow up. Emergency room visit required.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Pain
Clinical narrative: lumbar pain; Muscle pain; aches; This case was reported by a nurse via call center representative and described the occurrence of lumbar pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced lumbar pain, muscle pain and pain. On an unknown date, the outcome of the lumbar pain, muscle pain and pain were unknown.   It was unknown if the reporter considered the lumbar pain, muscle pain and pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The nurse reported through online chat that the patient had Shingrx vaccine before the date of reporting. The patient know muscle pain was a common side effect. Since last PM the patient had symptoms, including pronounced lumbar pain.  The patient asked was that to be expected. Some other aches intermittently. But, constant lumbar pain. The reporter did not consent to follow up. Related to Patient.  The reporter reporting about herself.  The reported declined to provide address at time of online chat.