chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a 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 case was reported by the patient's son. The age at vaccination was not reported, but it could be 71 or 72 years. The patient experienced shingles within 24 hours after receiving Shingrix. Diagnosis was provided by the patient's doctor and no contact details was provided. No start date of shingles was provided. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Frequent bowel movements, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Entire upper arm very sore, fever, nausea, muscle aches,frequent bowel movements, overall ill feeling lasting approximately 36 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Entire upper arm very sore, fever, nausea, muscle aches,frequent bowel movements, overall ill feeling lasting approximately 36 hours.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: short periods of dizziness when moving from horizontal to vertical or from lying on one side to the other side.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Fever with "body twitching" that began around 5pm & lasted appx 8 hours. Twitching not rhythmic and present for duration of the entire 8 hour period. Mom concerned w/seizure activity d/t hx.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and erythema of site which led to a follow up office visit
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Large left arm swelling at injection site.  Stiffness, upper arm pain left arm.  Headache.  Fatigue.  Too painful to use left arm.  Slept most of day 10/20/2019.  Tried acetaminophen for relief, not helpful, for headache or arm pain.  Still very sore left arm and mildly fatigued on 10/21/2019 but improving.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Large left arm swelling at injection site.  Stiffness, upper arm pain left arm.  Headache.  Fatigue.  Too painful to use left arm.  Slept most of day 10/20/2019.  Tried acetaminophen for relief, not helpful, for headache or arm pain.  Still very sore left arm and mildly fatigued on 10/21/2019 but improving.
Age: 53.0
Sex: M
Vaccine: FLUR4, VARZOS
Symptoms: Abdominal pain, Mesenteric panniculitis
Clinical narrative: Patient presented with abdominal pain two days following administration of vaccines, later to be diagnosed with mesenteric panniculitis.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Rash
Clinical narrative: Pt. had dizziness upon receiving vaccine and then developed a rash on right torso 30 minutes after vaccination.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, Swelling, Warmth.  About the 6 inches in length
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth.  About 6 inches in length
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is to report accidental administration of 2 flu shots for the patient 10/11/2019 and 10/20/2019. The patient has not reported any adverse events yet
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA left arm
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Eating disorder, Hypotonia, Pyrexia, Rash macular, Screaming
Clinical narrative: 103.7 degree Fever High Pitch Screaming Could not calm or settle baby for hours Splotchy looking skin on abdomin Baby could/would not sleep Baby could/would not sit steady like he  typically does (almost like he was "floopy" like a noodle. We pages the emergency docotr on call she advised to give advil, we did. A few hours later Patient fell asleep and calmed Since this eppisode Patient has not been eating or sleeping like he typically does and his daycare reported him not as happy go lucky,
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: 103.7 degree Fever High Pitch Screaming Could not calm or settle baby for hours Splotchy looking skin on abdomin Baby could/would not sleep Baby could/would not sit steady like he  typically does (almost like he was "floopy" like a noodle. We pages the emergency docotr on call she advised to give advil, we did. A few hours later Patient fell asleep and calmed Since this eppisode Patient has not been eating or sleeping like he typically does and his daycare reported him not as happy go lucky,
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; patient inadvertently received first dose of MMA II that was past its expiry; This spontaneous report was received from a nurse and refers to a 3-year and 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 26-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), lot # N025898, expiration date 19-SEP-2019, (dose, route of administration and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent, hepatitis A vaccine and inactivated and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL). No adverse effects were reported.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Pain in extremity, Renal pain
Clinical narrative: Back pain / Feels like kidney pain; Radiating leg pain; kidney pain; This case was reported by a nurse via call center representative and described the occurrence of back pain in a 58-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season. On 9th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced back pain, pain in extremity and renal pain. On an unknown date, the outcome of the back pain, pain in extremity and renal pain were not recovered/not resolved.   It was unknown if the reporter considered the back pain, pain in extremity and renal pain to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The patient experienced low back pain with radiating leg pain. The patient felt like kidney pain. The reporter consented to follow up. This is 1 of the 4 cases reported by the same reporter.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pink raised lump at injection site left arm. Afebrile.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee developed pruritis and widespread hives over the trunk of his body including upper thighs, lower abdomen and buttocks after flu vaccination on 10/18/19.  He did not have any other systemic symptoms.  He alerted his primary care provider and took 50 mg of Benadryl to treat the pruritis.  The hives lasted for 48 hours and all symptoms resolved on 10/20/19.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Tremor
Clinical narrative: severe muscle contractions  and tremors all night following vaccine
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Blindness unilateral, Ophthalmological examination, Retinal vein occlusion, Visual impairment
Clinical narrative: Patient states saw "fireworks" in left eye shortly after vaccination (maybe 30 mins). After 24 hours could not see out of left eye
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: employee complained of pain and tingling going down to fingers in same arm day after injection. Continued with pain and moved to not able to move arm. Saw Worker comp provider was placed on NSAIDs without relief. was placed out of work and sent for physical therapy.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Fall, Pain in extremity, Rhinorrhoea
Clinical narrative: PATIENT'S ARM BECAME MORE PAINFUL THAT USUAL THE FOLLOWING DAY. PATIENT'S NOSE ALSO BEGAN RUNNING UNCONROLLABLE. THE FOLLOWING NIGHT THE PATIENT LOST BALANCE, MAY HAVE BLACKED OUT AND LAID ON HIS BATHROOM FLOOR FOR A WHILE BEFORE HE COULD REGAIN STRENGTH TO GET BACK UP. STILL FEELING WEAK BUT GRADUALLY FEELING BETTER.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Cerebrovascular accident, Coagulation test, Computerised tomogram normal, Dysarthria, Facial paralysis
Clinical narrative: Patient presented with stroke-like symptoms and headache. Right-sided leg numbness that ascended to right arm and eventually face with facial droop and slurred speech.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Patient presented with stroke-like symptoms and headache. Right-sided leg numbness that ascended to right arm and eventually face with facial droop and slurred speech.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored PEDVAX was administered to the patient on an unknown date; no adverse effect; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number: N024570, expiration date: 01-MAY-2020) (dose and route of administration were not provided). The vaccine was stored in temperature below 36 degrees Fahrenheit (32.1 degrees Fahrenheit) for 8 hours. There was no previous temperature excursion. Digital data lodger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Thimerosal Free) lot # S007075, expiration date 06-SEP-2020 (injection site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit for 8 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. The outcome of event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 27-AUG-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician's office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was reported as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at injection site; Low grade fever; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 56-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 26th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fever to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the Practice Manager. The patient received dose of Fluarix Quadrivalent 2019-2020 season in left arm. The reporter stated that, after vaccination, the patient had injection site pain and low grade fever. The health care professional reported that the injection site pain and low grade fever resolved in 24 hours. The reporter denied consent to be followed up.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Patient complains of tingling in face, ears, & head, after flu injection in the left deltoid @1530. Notified the Clinics Physician. The physician assessed the patient - @1600.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: I received the two-part shingrix shot on 1/15/19 and 5/29/19. After the first shot I had soreness for a couple of weeks, which lessened somewhat, but I periodically had pain in that arm until and including the time of the second shot. The initial pain with the second shot was worse, and it got better within three days, but I still have pain in my left arm. It is a dull, achy pain most of the time, but it gets worse when I am NOT using that arm and when I lie down at night. Tylenol helps, and I have used some topical ointments which help somewhat, but the dull, achy pain is there most of the time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Fatigue, Pallor, Somnolence
Clinical narrative: Client presented for flu shot.  Flu Shot administered but afterwards complained of feeling faint and client looked slightly pale and clammy.  Nurse instructed client to put her head down between her knees which client did.  After a few moments she sat back up and said "I fell asleep." Had client remain in chair and encouraged to drink some water.  She said she had not eaten anything since lunch and did not eat much at lunch.  Dad said they lived about a block away and that he wanted to take her home.  Father volunteered that client's mother occasionally faints from shots. After about 10 minutes client was able to stand without feeling faint but she said she felt tired so her dad carried her from clinic site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Headache, Influenza like illness, Myalgia
Clinical narrative: Full flu-like symptoms that include high fever, shakes, bone and muscle pain, headache, all over weakness
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Full flu-like symptoms that include high fever, shakes, bone and muscle pain, headache, all over weakness
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Decreased activity, Incorrect route of product administration, Injected limb mobility decreased, Musculoskeletal disorder
Clinical narrative: The vaccine was incorrectly administered - it was not injected Intramuscular as required - it was injected directly into the bursa of my shoulder, causing what my Physical Therapist refers to as SIRVA (shoulder injury resulting from vaccination administration) and/or frozen shoulder.  Approximately 4-5 hours after receiving the incorrectly administered vaccine, I was unable to lift or move or use my left arm at all.  Two months down the line I am requiring physical therapy 3x/week in order to regain strength, stability, range of motion and general normal use of my left arm & shoulder.  Because of the strain on my shoulder, my neck and collarbone are also negatively affected.  This has been one of the most painful episodes I have ever experienced and has caused quite a loss of activity.  I do not fully understand if this is a VAERS reportable injury or not, as it appears to have been an error in administration of the vaccine, rather than something in the actual vaccine that injured me.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: BILATERAL HANDS REDNESS, ITCHING AND SWELLING.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Head discomfort, Impaired work ability, Retching, Tinnitus
Clinical narrative: At 3:30am, woke up and felt a lot of pressure on head, banging noise on right ear and hissing on the left.   Sat up and threw up vile, had dry heaves--no food came up. Patient was shivering from waist up.   Experienced another episode with similar symptoms around 7am.   Emesis continued until 8pm next night. If had 4-5 sips of a drink dry heaves would start. Episodes were scary; patient wanted to call an ambulance but could not get out of bed.  Patient laid in bed all day long.  On 9/28 went to doctor to get a note, to take the day off.  Ate only easy foods and Pedialyte. Provider in agreement to continue with rest and replacing fluids.  On same day went to pharmacist to let them know what happened.  On Sunday, recovered completely and went to work.  With previous vaccinations patient has been sore on the 2nd day but nothing out of norm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: At 3:30am, woke up and felt a lot of pressure on head, banging noise on right ear and hissing on the left.   Sat up and threw up vile, had dry heaves--no food came up. Patient was shivering from waist up.   Experienced another episode with similar symptoms around 7am.   Emesis continued until 8pm next night. If had 4-5 sips of a drink dry heaves would start. Episodes were scary; patient wanted to call an ambulance but could not get out of bed.  Patient laid in bed all day long.  On 9/28 went to doctor to get a note, to take the day off.  Ate only easy foods and Pedialyte. Provider in agreement to continue with rest and replacing fluids.  On same day went to pharmacist to let them know what happened.  On Sunday, recovered completely and went to work.  With previous vaccinations patient has been sore on the 2nd day but nothing out of norm.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: sore arm has not gone away.  maybe an administration error into the nerve
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states his arm is still sore and it is difficult to lift
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Total arm down to hand is swollen and warm to touch
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Influenza, Pain, Pyrexia
Clinical narrative: flu symptoms, fever (100.3),body ache, substantial breathing difficulties.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB
Symptoms: Asthenia, Fall, Head injury, Pallor
Clinical narrative: Approx 10 mins after vaccines administered, thump was heard coming from patients room.  MA entered and Patient stated he fell backwards and hit head on wall, did not fall off table,  No visible injury noted, patient never lost consciousness, appeared pale and weak.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Lip swelling, Pruritus
Clinical narrative: numbness to both arms, swelling to lips, itchiness to legs, chest and abdomen.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Feeling hot, Headache, Vision blurred
Clinical narrative: Shortness of breath, headache, blurry vision, felt hot
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: body itching, rash, hives in forehead 30 min after vaccine was administrated
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness
Clinical narrative: Patient reported becoming dizzy the morning after the shot (Monday). Lasted till the following Sunday.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Patient developed pneumonia during the first week of June in 2019; This spontaneous report as received from pharmacist via company representative refers to an 85-year-old male patient. The patient's concurrent conditions included colon cancer.The patient was allergic to lidocaine. Historical vaccine included pneumococcal 13v conj vaccine (PREVNAR 13) on an unspecified date in 2014. The patient's concomitant medication was not reported.     On an unspecified date in 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose, route, frequency, lot # and expiry date were not reported) for immunisation. On an unknown date in June 2019 (reported as "during the 1st week of June in 2019"), the patient experienced pneumonia. The patient was admitted to an unspecified hospital for one week and received unspecified treatment. It was unknown whether any lab diagnostics/studies were performed. The patient sought medical attention. The outcome of pneumonia was reported as recovered. The causality assesement was not provided by the reporter. No product quality complaint was reported.         Upon internal review, the event pneumonia was determined to be medically significant.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Skin lesion
Clinical narrative: painful blistering rash and skin lesions; painful blistering rash and skin lesions; painful blistering rash and skin lesions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On or about 22-MAR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, route of administration, lot # and expiration date, were not reported) for the long-term prevention of shingles and zoster related conditions. On an unspecified date, the patient experienced painful blistering rash and skin lesions. The outcome of the events was not reported.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Post Herpetic Neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 29-MAY-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster related conditions. On an unspecified date, the patient experienced Herpes Zoster and Post Herpetic Neuralgia. The outcome of the events was not reported.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; a 14 year old patient received a dose of Proquad; This spontaneous report was received from a nurse and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions of allergies and concomitant therapies was provided. On 08-MAY-2019, the patient of inappropriate age was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # R023499 and expiration date 13-FEB-2020 (dose and route of administration were not reported) for prophylaxis. There was no known adverse effects.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervix carcinoma, Cervix carcinoma recurrent, Pelvic exenteration, Vaccination failure
Clinical narrative: Cervical dysplasia and malignancy after HPV vaccination; This literature marketed report has been received from the authors of a published literature article and refers to female patient of unknown age.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) (route and site of administration, lot # and expiration date were not reported) as prophylaxis. She received at least 2 doses of the vaccine.  On an unknown date, between 2007- 2017, after immunization, the patient was treated for cervical dysplasia or invasive carcinoma (vaccination failure). At the time of the last follow-up, she had recurrence carcinoma treated with pelvic exenteration. The outcome of vaccination failure was not reported.  The authors considered vaccination failure to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown).      This is one of two reports derived from the same literature article (cross referenced with US-009507513-1910USA009632); Sender's Comments:  US-009507513-1910USA009632:
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Intense lower back pain; Pain radiating down to her leg; Problems lifting her leg; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced low back pain, leg pain and mobility decreased. On an unknown date, the outcome of the low back pain, leg pain and mobility decreased were unknown.   It was unknown if the reporter considered the low back pain, leg pain and mobility decreased to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The nurse reported that one of her patients work at their institution. The patient was complaining of intense lower back pain with pain radiating down to her leg. The patient had problems lifting her leg to get into the car because of the patient. This patient also spoke to her coworkers that received the same vaccine on the same day and some of them experienced the same symptom. This is report 2 out of 2 adverse events on the patient's coworkers. No additional information provided. This case is 1 of the 4 linked cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a physician via call center representative and described the occurrence of facial rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial rash. On an unknown date, the outcome of the facial rash was unknown.   It was unknown if the reporter considered the facial rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and now the patient experienced rash on the face.  This is 1 of 4 cases reported by same reporter.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3BS44, expiry date 30th June 2020) for prophylaxis.   On 25th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than 3 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Fluarix Quadrivalent 2019-2020 season in the right deltoid. The reporter stated that, after vacination, the patient complained for injection site pain for 48 hours. It was unknown, if the patient took any analgesic. The reporter denied consent to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; Fever; This case was reported by a nurse via sales rep and described the occurrence of pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 mg. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional information received were as follows: The nurse reported the case for the father. The age at vaccination was not reported. The patient had pain and fever following Shingrix shot. The adverse event disappeared after 2 days. This case has been linked with US2019AMR188737, reported by the same reporter.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Cellulitis; Itchy at the injection site; Redness at the injection site; Puffy at the injection site; Warmth at the injection site; Fatigue; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 72-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 10th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever. The patient was treated with cefalexin (Cephalexin). On an unknown date, the outcome of the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever were unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2019-2020 season in right deltoid. On Thursday, the patient started to develop cellulitis which included redness, puffy, warmth with itching at the injection site and also had fatigue along with low grade fever. He was in bed on Thursday, Friday and Saturday. On Sunday, he started to feel better. He saw the physician on 14th October 2019, and was started on due to cellulitis of the injection site. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Cellulitis; Itchy at the injection site; Redness at the injection site; Puffy at the injection site; Warmth at the injection site; Fatigue; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 72-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 10th October 2019, 1 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever. The patient was treated with cefalexin (Cephalexin). On an unknown date, the outcome of the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever were unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site itching, injection site erythema, injection site swelling, injection site warmth, fatigue and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received FluLaval Tetra 2019-2020 season in right deltoid. On Thursday, the patient started to develop cellulitis which included redness, puffy, warmth with itching at the injection site and also had fatigue along with low grade fever. He was in bed on Thursday, Friday and Saturday. On Sunday, he started to feel better. He saw the physician on 14th October 2019, and was started on due to cellulitis of the injection site. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Still being paralyzed; Guillian Barre syndrome; Losing all muscle strength; Dizziness; Severe numbness all over; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number JC9EM, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 1st October 2019, 7 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), generalized muscle weakness (serious criteria hospitalization), dizziness (serious criteria hospitalization), numbness (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 Season and was ultimately being diagnosed with Guillian-Barre syndrome. Two weeks ago from the day of reporting, the patient was admitted into hospital where he spent 5 days and reports being administered IVIG to counteract reaction. The patient was losing all muscle strength and experiencing dizziness and sever numbness all over. The patient was still being paralyzed although he was currently home. The reporter consented to follow up. The patient was enquiring whether how to submit request for medical bill payments and mentions there was no way the VA hospital will cover current hospital bills.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Paralysis
Clinical narrative: Still being paralyzed; Guillian Barre syndrome; Losing all muscle strength; Dizziness; Severe numbness all over; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number JC9EM, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 1st October 2019, 7 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), generalized muscle weakness (serious criteria hospitalization), dizziness (serious criteria hospitalization), numbness (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 Season and was ultimately being diagnosed with Guillian-Barre syndrome. Two weeks ago from the day of reporting, the patient was admitted into hospital where he spent 5 days and reports being administered IVIG to counteract reaction. The patient was losing all muscle strength and experiencing dizziness and sever numbness all over. The patient was still being paralyzed although he was currently home. The reporter consented to follow up. The patient was enquiring whether how to submit request for medical bill payments and mentions there was no way the VA hospital will cover current hospital bills.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction on injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 5-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 95RZ3, expiry date 5th June 2020) for prophylaxis.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The nurse reported that the patient experienced a local reaction on injection site after Flulaval Quadrivalent vaccination. Th reporter consented to follow up. No other details provided at time of initial report.  The nurse also did not wish to provide her full last name.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Lower back pain; Leg pain; Mobility decreased; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 45-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 97S5T, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced low back pain, leg pain and mobility decreased. On an unknown date, the outcome of the low back pain and leg pain were not recovered/not resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the low back pain, leg pain and mobility decreased to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The patient experienced low back pain and leg pain. The outcome of low back pain and leg pain reported in the system did not match with that reported in the source document. This case is 1 of the 4 linked cases, reported by the same reporter.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 16th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were received as follows: Wife calling on behalf of her husband reported that the patient received 2nd dose less than recommended interval, which led to shortening of vaccination schedule. He received the second dose in his left arm. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dysstasia, Ear infection viral, Impaired work ability, Laboratory test
Clinical narrative: Viral ear infection; Nystagmus; Could not stand; trouble with balance; Vomiting; Vertigo; was a test pilot and is unable to do that now; This case was reported by a nurse via call center representative and described the occurrence of ear infection viral in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknwon date received older shingles vaccine). Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On 1st October 2019, between 1 and 2 weeks after receiving Shingrix, the patient experienced ear infection viral (serious criteria hospitalization), nystagmus (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), vomiting (serious criteria hospitalization), vertigo (serious criteria hospitalization) and impaired work ability. On an unknown date, the outcome of the ear infection viral, nystagmus, difficulty in standing, balance difficulty and impaired work ability were unknown and the outcome of the vomiting and vertigo were recovered/resolved.   The reporter considered the ear infection viral, nystagmus, difficulty in standing, balance difficulty, vomiting, vertigo and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced vertigo, could not stand, vomiting around 1:00 PM and had to be dragged to an ambulance and taken to the hospital. The patient was in the hospital for two days. The final diagnosis was a viral infection in his left ear. As per reporter, the patient was a test pilot and was unable to do that now. The patient He had two hours of testing and the audiologist thinks it is related to the vaccine. The patient was no longer vomiting, this stopped in the emergency room, but he still had trouble with his balance, nystagmus when it is dark out. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Nystagmus, Vertigo, Vomiting
Clinical narrative: Viral ear infection; Nystagmus; Could not stand; trouble with balance; Vomiting; Vertigo; was a test pilot and is unable to do that now; This case was reported by a nurse via call center representative and described the occurrence of ear infection viral in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknwon date received older shingles vaccine). Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On 1st October 2019, between 1 and 2 weeks after receiving Shingrix, the patient experienced ear infection viral (serious criteria hospitalization), nystagmus (serious criteria hospitalization), difficulty in standing (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), vomiting (serious criteria hospitalization), vertigo (serious criteria hospitalization) and impaired work ability. On an unknown date, the outcome of the ear infection viral, nystagmus, difficulty in standing, balance difficulty and impaired work ability were unknown and the outcome of the vomiting and vertigo were recovered/resolved.   The reporter considered the ear infection viral, nystagmus, difficulty in standing, balance difficulty, vomiting, vertigo and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced vertigo, could not stand, vomiting around 1:00 PM and had to be dragged to an ambulance and taken to the hospital. The patient was in the hospital for two days. The final diagnosis was a viral infection in his left ear. As per reporter, the patient was a test pilot and was unable to do that now. The patient He had two hours of testing and the audiologist thinks it is related to the vaccine. The patient was no longer vomiting, this stopped in the emergency room, but he still had trouble with his balance, nystagmus when it is dark out. The reporter consented to follow up.
Age: 1.5
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever 3-4 days with 104.2 rectal temp checked at home being the highest according to FOC  Maculopapular rash on face, chest and abdomen area  Doctor visit 09/10/2019. Vital signs WNL. Temperature 97.9 F, route: ear
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient was administered flu shot at the time of the rash on Monday  (10/7/2019) Denies any new medicines. No recent Abx or supplements Denies chemical exposures or irritants. She was outdoors with her husband, who did not have a rash  Denies tongue swelling, lip swelling, throat closing, dyspnea or wheezing   Feels well otherwise No other bleeding, painful or concerning skin lesions
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Peripheral swelling, Pyrexia
Clinical narrative: I had the same shots last year - same location, both together, and only experienced localized pain. This year my arm swelled by that evening, pain was such that I couldn't put any weight on or touch that area; it also reddened with what looked like a rash;  there was some itchiness; I had fever of 101 degrees two days later. On 3rd day symptoms abated.