chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dizziness postural, Fatigue, Full blood count normal, Hypersomnia
Clinical narrative: Mandatory flu vaccine for employees. I received injection around 1:45pm on 9/29/2020. Approximately 45 minutes later, I felt a little light headed. Continued job. Went to bed at 8pm and felt really exhausted. Woke up on 9/30/2020 at 1:30am with uncontrollable shaking. I was very disoriented. My husband (who is a nurse) took my temp and it was 104.8. My blood pressure was 156/82. He gave me a tylenol and took my temp 20 minutes later and it was 102,6. He then took me to ER. I was put in a  negative pressure room. They did a rapid Covid test, CBC and CRP. Covid was negative and lab work was within normal limits. The injection sight was swollen and warm to the touch. Every bone and muscle in my body was hurting. My throat was sore and scratchy but no shortness of breath. I had a temp of 100.7 in the ER and still very disoriented. Dr informed me that I was having a sever auto immune reaction to the flu vaccination. He stated rest, fluids and to return if symptoms persisted on 9/30/2020. My husband brought me home and I slept for almost 24 hours. I am still experiencing body aches and dizzy to stand or ambulate on 10/01/2020. I am fever free at this time. I have been told by my employer that I cannot return to work until I am fever free for 24 hours. Again, the body and bone aches persist.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injection site swelling, Injection site warmth, Myalgia, Oropharyngeal pain
Clinical narrative: Mandatory flu vaccine for employees. I received injection around 1:45pm on 9/29/2020. Approximately 45 minutes later, I felt a little light headed. Continued job. Went to bed at 8pm and felt really exhausted. Woke up on 9/30/2020 at 1:30am with uncontrollable shaking. I was very disoriented. My husband (who is a nurse) took my temp and it was 104.8. My blood pressure was 156/82. He gave me a tylenol and took my temp 20 minutes later and it was 102,6. He then took me to ER. I was put in a  negative pressure room. They did a rapid Covid test, CBC and CRP. Covid was negative and lab work was within normal limits. The injection sight was swollen and warm to the touch. Every bone and muscle in my body was hurting. My throat was sore and scratchy but no shortness of breath. I had a temp of 100.7 in the ER and still very disoriented. Dr informed me that I was having a sever auto immune reaction to the flu vaccination. He stated rest, fluids and to return if symptoms persisted on 9/30/2020. My husband brought me home and I slept for almost 24 hours. I am still experiencing body aches and dizzy to stand or ambulate on 10/01/2020. I am fever free at this time. I have been told by my employer that I cannot return to work until I am fever free for 24 hours. Again, the body and bone aches persist.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, SARS-CoV-2 test negative, Throat irritation, Tremor
Clinical narrative: Mandatory flu vaccine for employees. I received injection around 1:45pm on 9/29/2020. Approximately 45 minutes later, I felt a little light headed. Continued job. Went to bed at 8pm and felt really exhausted. Woke up on 9/30/2020 at 1:30am with uncontrollable shaking. I was very disoriented. My husband (who is a nurse) took my temp and it was 104.8. My blood pressure was 156/82. He gave me a tylenol and took my temp 20 minutes later and it was 102,6. He then took me to ER. I was put in a  negative pressure room. They did a rapid Covid test, CBC and CRP. Covid was negative and lab work was within normal limits. The injection sight was swollen and warm to the touch. Every bone and muscle in my body was hurting. My throat was sore and scratchy but no shortness of breath. I had a temp of 100.7 in the ER and still very disoriented. Dr informed me that I was having a sever auto immune reaction to the flu vaccination. He stated rest, fluids and to return if symptoms persisted on 9/30/2020. My husband brought me home and I slept for almost 24 hours. I am still experiencing body aches and dizzy to stand or ambulate on 10/01/2020. I am fever free at this time. I have been told by my employer that I cannot return to work until I am fever free for 24 hours. Again, the body and bone aches persist.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Off label use
Clinical narrative: lndication reducing risk of serious infection with Covid 19; No AE reported.; This spontaneous report was received from a company representative and refers to a 56-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for covid-19 prophylaxis. On an unknown date, the patient experienced off label use (indication: reducing risk of serious infection with Covid 19) and no adverse event. The action taken with the suspect vaccine and the outcome of the events was unknown. Causality assessment was not provided.
Sex: F
Vaccine: MENB
Symptoms: Injection site vesicles
Clinical narrative: "feeling liquid" at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site blisters in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Reporter started that the patient received the Bexsero vaccine and experienced feeling liquid at the injection site, which led to injection site blisters. The reporter consented to follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: fever; swollen arm; fatigue; NAUSEA; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 3 times before starting the vaccine). Concurrent medical conditions included immunocompromised.   On 5th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced fever, swelling arm, fatigue and nausea. On an unknown date, the outcome of the fever, swelling arm, fatigue and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, swelling arm, fatigue and nausea to be related to Shingrix.  Additional information was provided as follows: The patient experienced fever, swollen arm, fatigue and nausea after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: having  a fever of 101.3; This case was reported by a physician via call center representative and described the occurrence of fever in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter was patient itself. The patient had fever of 101.3 degree F. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Inappropriate schedule of product administration, Injection site pain, Malaise
Clinical narrative: second dose of Shingrix 30 days after her first; pain at the injection site / after receipt of the second dose.; malaise / after receipt of the second dose.; dizziness after receipt of the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 12th September 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 19th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain, malaise and dizziness. On 19th September 2020, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the injection site pain, malaise, dizziness and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, malaise and dizziness to be related to Shingrix.  Additional details were provided as follows:  The patient received second dose of Shingrix 30 days after her first, which lead to shortening of vaccination schedule. The patient experienced malaise, pain at the injection site and dizziness.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: mistakenly gave a 2nd dose of Fluzone 3 days from the first one on a 5 year old, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5-years-old male patient who received a 0.5 mL first and second dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 3 days from the first one (lot: UT7041MA, expiry date: 30-Jun-2021) via an unknown route at an unknown administration site as prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation at the time of first dose.  It was an actual medication error due to Drug dose administration interval too short (Inappropriate schedule of product administration) on same day.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Age: 18.0
Sex: M
Vaccine: FLUR4
Symptoms: Seizure
Clinical narrative: Per patient's mother: approximately 10 minutes post-vaccination, the patient slumped out of the chair onto the floor and experienced a seizure that lasted 10 to 15 seconds.  Our technician noticed the patient on the floor in the waiting area and notified the pharmacists on duty, but the patient was no longer actively seizing.  Pharmacists checked in with the patient and mother and he was conscious and able to answer basic questions( date, location...) and expressed that he felt completely fine.  Mother was still concerned and stated that she wanted to take him to a local pediatric hospital but that she did not feel it necessary to call EMT/ambulance.
Age: 49.0
Sex: F
Vaccine: FLUR4
Symptoms: Angioedema, Dysphagia
Clinical narrative: Angioedema, difficulty swallowing
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Received flu vaccine 9/3/20 in left arm from medical center.  Patient reports normal pain associated with vaccine initially for 1-2 days, then laid on his harm and pain increased. Pain reduced to mild pain for a while, but pain increased around 9/23/20. 9/29 & 9/30  patient experienced increased pain, rates pain 6/10. Pt reports he feels the pain at the joint. No redness or pain in the area. Pain has improved a little bit as of 9/30, as he reports taking ibuprofen. No weakness in the left arm or hand, but notices some pain if he's doing certain movements.  No hx of recent shoulder injuries, pt did say he had some shoulder issues >15 years ago. Came in to Health Clinic on 9/30/20 to be assessed by health provider. X-ray ordered, PT started.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, body aches, sore arm
Age: 64.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Shivers and Chills, pain in right arm, headache, fatigue
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Dizziness, Headache, Impaired driving ability
Clinical narrative: Extreme, continuous shivering began at 10:00 pm the day I received the shot, and continued off and on throughout the next two days.  It has lessened on the fourth day (today). Nerve sensitivity (tingling) began the day I received the shot and continues through today (beginning to lessen today).  Locations:  both feet and shin areas, right hand, mouth area including tongue and lips. Some random tingling was felt in both legs and both arms on Day 2 & 3, which has now lessened.) Lymph node sensitivity in left underarm area was noticed on Wednesday, but is gone today (Thursday). Injection site was very painful, swollen and hot.  I experienced difficulty in using that arm each day since receiving the injection.  Today it is beginning to lessen. Headache began on Day 2, was worse on Day 3, and is lessening today.  Advil was not helpful to stop the headache. I experience dizziness frequently due to my Vestibular Imbalance condition, but the dizziness became worse after I received this vaccine.  I wasn't able to drive or ride in a car without taking Dramamine since Day 2, which prior to the shot I was mostly able to do. I experienced nausea at an increased level on Day 2 & 3.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Loss of personal independence in daily activities
Clinical narrative: Extreme, continuous shivering began at 10:00 pm the day I received the shot, and continued off and on throughout the next two days.  It has lessened on the fourth day (today). Nerve sensitivity (tingling) began the day I received the shot and continues through today (beginning to lessen today).  Locations:  both feet and shin areas, right hand, mouth area including tongue and lips. Some random tingling was felt in both legs and both arms on Day 2 & 3, which has now lessened.) Lymph node sensitivity in left underarm area was noticed on Wednesday, but is gone today (Thursday). Injection site was very painful, swollen and hot.  I experienced difficulty in using that arm each day since receiving the injection.  Today it is beginning to lessen. Headache began on Day 2, was worse on Day 3, and is lessening today.  Advil was not helpful to stop the headache. I experience dizziness frequently due to my Vestibular Imbalance condition, but the dizziness became worse after I received this vaccine.  I wasn't able to drive or ride in a car without taking Dramamine since Day 2, which prior to the shot I was mostly able to do. I experienced nausea at an increased level on Day 2 & 3.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Nausea, Paraesthesia, Paraesthesia oral, Vestibular disorder
Clinical narrative: Extreme, continuous shivering began at 10:00 pm the day I received the shot, and continued off and on throughout the next two days.  It has lessened on the fourth day (today). Nerve sensitivity (tingling) began the day I received the shot and continues through today (beginning to lessen today).  Locations:  both feet and shin areas, right hand, mouth area including tongue and lips. Some random tingling was felt in both legs and both arms on Day 2 & 3, which has now lessened.) Lymph node sensitivity in left underarm area was noticed on Wednesday, but is gone today (Thursday). Injection site was very painful, swollen and hot.  I experienced difficulty in using that arm each day since receiving the injection.  Today it is beginning to lessen. Headache began on Day 2, was worse on Day 3, and is lessening today.  Advil was not helpful to stop the headache. I experience dizziness frequently due to my Vestibular Imbalance condition, but the dizziness became worse after I received this vaccine.  I wasn't able to drive or ride in a car without taking Dramamine since Day 2, which prior to the shot I was mostly able to do. I experienced nausea at an increased level on Day 2 & 3.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: About 7 hours after administration of vaccine patient started experiencing flu like symptoms body aches fatigue mild fever chills headache as well as reported a very sore arm at injection site that has lasted into the next day he feels he can barely lift his arm and it is very painful. He has taken tylenol and ibuprofen and tried to apply ice to the injection site. Will follow up when symptoms resolve.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 7 hours after administration of vaccine patient started experiencing flu like symptoms body aches fatigue mild fever chills headache as well as reported a very sore arm at injection site that has lasted into the next day he feels he can barely lift his arm and it is very painful. He has taken tylenol and ibuprofen and tried to apply ice to the injection site. Will follow up when symptoms resolve.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Facial paralysis, Facial paresis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Metallic taste in mouth, progressing to numbness and weakness in right side of face with noticeable droop in smile and right side facial muscles, numb tongue.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient reported extensive redness and swelling. went to drs office.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: Pt was given Flublok instead of regular flu.   Health Dept was called.  Parent was notified.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Urticaria
Clinical narrative: Second day after shot I experienced fatigue, slight nausea for 24 hours.  Injection site was sore for approx. 3 days.    5 days after injection I woke up with hives on both legs.  7 on left leg and 4 on right leg.  They are not itchy.
Age: 62.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Fatigue, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Soreness throughout body, injection site soreness, tiredness that did not allow me to do my normal routing.  Resolve after 2 to 3 days.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm profuse redness, warmth, and swelling posteriorly from shoulder to just above elbow
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Full body aches Fatigue Nausea
Age: 28.0
Sex: F
Vaccine: FLUR4, PPV, TDAP
Symptoms: Body temperature increased, Dizziness, Erythema, Fatigue, Peripheral swelling
Clinical narrative: 09/25/20 LEFT arm - red splotches, swelling; RIGHT arm - tender, pink, swelling size of golf ball; temp 99.3, fatigue, dizziness. Pt denies s/sx of anaphylaxis reaction. 09/28/2020 - Pt reports improvement in symptoms. ( R arm symptoms resolved and L arm symptoms resolving)
Age: 28.0
Sex: F
Vaccine: FLUR4, PPV, TDAP
Symptoms: Rash macular, Tenderness
Clinical narrative: 09/25/20 LEFT arm - red splotches, swelling; RIGHT arm - tender, pink, swelling size of golf ball; temp 99.3, fatigue, dizziness. Pt denies s/sx of anaphylaxis reaction. 09/28/2020 - Pt reports improvement in symptoms. ( R arm symptoms resolved and L arm symptoms resolving)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Eye pain, Fatigue, Headache
Clinical narrative: Low-grade fever (99.4),  body aches, pain/pressure in eyes, bloodshot eyes, ache in upper back and chest, tiredness, headache, sore throat, minor congestion
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular discomfort, Ocular hyperaemia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Low-grade fever (99.4),  body aches, pain/pressure in eyes, bloodshot eyes, ache in upper back and chest, tiredness, headache, sore throat, minor congestion
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Low-grade fever (99.4),  body aches, pain/pressure in eyes, bloodshot eyes, ache in upper back and chest, tiredness, headache, sore throat, minor congestion
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Migraine, Pyrexia
Clinical narrative: Severe fatigue, mild fever (about 100°), loss of appetite, migraine headaches, lasting roughly two days from onset, fully recovered on third day
Age: 77.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Contusion, Inflammation
Clinical narrative: PATIENT RETURNED TO PHARMACY ON 10/1/2020 WITH INFLAMMATION AND BRUISING IN HER LEFT ARM BELOW THE INJECTION SITE. SHE SAID SHE NOTICED TO ISSUE ON THE MORNING OF 10/1/2020. WE RECOMMENDED THAT SHE FOLLOW UP WITH HER PCP
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Lumbar puncture, Seizure, Skin warm
Clinical narrative: Mom reports "hot to touch" Seizure was observed. Taken to the ER
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus infection, Rash
Clinical narrative: pt underwent 1 of the two Shingerix vaccines, roughly 48-72 hrs later developed painful herpteic rash along T1 dermatomal distribution.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Extreme tiredness, joint pain - especially in both hands, muscle pain, stiff neck and shivering
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Administred expired vaccine; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 10-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, lot # R024903, expiration date: 30-AUG-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On or about 02-SEP-2016, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, at his local pharmacy. Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. The causality was related.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: She too experienced increased pain at the injection site; This spontaneous report was received from a consumer (the patient's mother) via a company representative and referring to a 15-years-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications, and previous drug reactions or allergies were unknown by the reporter.  In September 2017, also reported as approximately three years ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination scheme frequency, anatomical location, route of administration, lot number, and expiration date were not provided) as prophylaxis.  On an unspecified date in September 2017, the patient experienced increased pain at the injection site. It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or studies were performed or if any treatment was given to the patient. At the time of this report, the outcome of the event was unknown by the reporter.   The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the increased pain at the injection site was not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2009USA010525:
Sex: U
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: FLU; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal), via nasal route, on an unknown date.     On an unknown date, the patient experienced flu (preferred term: Influenza).     The outcome of the event was unknown.    The event was considered non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Incomplete course of vaccination, Rash, Rash erythematous
Clinical narrative: Reaction that looked like a sunburn and then blistered; Redness; Rash; Sunburn like reaction; First dose of Shingrix 2 years ago; This case was reported by a nurse via sales rep and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blister, erythema, rash, sunburn-like rash and incomplete course of vaccination. On an unknown date, the outcome of the blister, erythema, rash, sunburn-like rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the blister, erythema, rash and sunburn-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccinationwas not reported for 1st dose. The age at vaccination was not applicable for this report for 2nd dose. The patient received 1st dose on an unknown arm. The reporter stated that, thye patient received 1st dose of Shingrix 2 years ago and experienced reaction that looked like a sunburn and then blistered and redness and rash on vaccine arm. Till the trime of reporting, the patient did not receive dose 2 of Shingrix, which led to incomplete course of vaccination. The provider was unsure if the patient should recommend getting the second dose to complete the series. The reporter stated that, patient cut grass in the sun the day after received her first dose of Shingrix.
Sex: M
Vaccine: FLUX
Symptoms: Blindness unilateral
Clinical narrative: blind in one eye; This case was reported by a consumer via interactive digital media and described the occurrence of blind in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced blind (serious criteria GSK medically significant). On an unknown date, the outcome of the blind was recovered/resolved.   It was unknown if the reporter considered the blind to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Influenza vaccine, the patient became blind in one eye.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick from my first flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient got sick from first flu shot.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Injection site redness; Injection site  welt; Injection site hot to touch; Injection site raised; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 31st August 2021) for prophylaxis.   Concurrent medical conditions included eosinophilic esophagitis and celiac disease.   On 16th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 18th September 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema, injection site wheal, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site wheal, injection site warmth and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site wheal, injection site warmth and injection site swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: After receiving dose of Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site reactions redness, a welt, hot to touch and raised. The reporter was the patient's mother. The patient received the vaccine on Wednesday and on Friday the injection site reactions presented and progressed. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189737:same reporter US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189737:same reporter US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189741:same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after the 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189737:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Myalgia; Fatigue; Headache; Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2020, the patient received the 1st dose of Shingrix (injection). On 9th June 2020, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, headache and influenza-like symptoms. On 11th June 2020, the outcome of the myalgia, fatigue, headache and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the myalgia, fatigue, headache and influenza-like symptoms to be related to Shingrix.  Additional details were as follows: The patient received 1st dose of Shingrix in right arm. After receiving 1st dose of Shingrix, the patient experienced myalgia, fatigue, headache and influenza-like symptoms. The symptoms lasted approximately 36 hours. On 11th June 2020, she had no other symptoms. The patient called to ask if she should get the next injection and to report the first adverse events. I provided the caller with the Medical Disclaimer, encouraging her to speak with her HCP and information in PI in content. The reporter did not consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Illness
Clinical narrative: experiencing / episode of herpes in her eye after the injection; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of herpes ophthalmic in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes ophthalmic.   On 3rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and sickness. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the herpes ophthalmic and sickness were recovering/resolving.   It was unknown if the reporter considered the herpes ophthalmic and sickness to be related to Shingrix.  Additional information was provided as follows: The patient experienced an episode of herpes in her eye after the injection. Patient also reported feeling sick so she took a motrin and took a three hour nap, she then felt fine after the nap. The reporter consented to follow up. Pharmacist did not have access to the Shingrix Lot at time of the call. Provided pharmacist MI for additional information.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: pain of the left upper arm and numbness; pain of the left upper arm and numbness; heaviness in left wrist/ hand; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 29Sep2020 morning in left upper arm at a single dose for immunization. The patient's medical history was not reported. Concomitant medications included influenza vaccine (FLU) in right upper arm at the same time on 29Sep2020 for immunization. On 29Sep2020, the patient experienced pain of the left upper arm and numbness, heaviness in left wrist/ hand. The outcome of events was unknown.   No follow-up attempts are needed. Information on lot/batch cannot be obtained.
Age: 64.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient has an active outbreak of shingles on his left temple and around eye after receiving dose of Shingrix on 9/22/2020. He is being treated for the shingles. Unknown if this is related to the vaccine but we are reporting the event as it is on the same side as his vaccine was administered and so close to the date administration.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeding disorder, Feeling abnormal, Malaise, Nausea
Clinical narrative: Patient called office and stated they received the flu shot for the first time yesterday (9/29/30) in a long time and when patient got home patient started not feeling well and could not eat dinner. Patient then got fever/nausea/vomiting/chills. Patient still does not feel like herself on 9/30/20 but no longer has fever/achy/chills, only some mild nausea.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient called office and stated they received the flu shot for the first time yesterday (9/29/30) in a long time and when patient got home patient started not feeling well and could not eat dinner. Patient then got fever/nausea/vomiting/chills. Patient still does not feel like herself on 9/30/20 but no longer has fever/achy/chills, only some mild nausea.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness at injection site lasting more than one week
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Mobility decreased, Pain, Posture abnormal, Swelling
Clinical narrative: Neck swelling at dinner, feeling of swelling over entire left side by the end of the evening.  Severe pain.  I'd been told reaction may be minor, lasting 24-48 hours, nothing like what ensued.  By that evening I was unable to move or lift my head.  My husband had to hold my head and accompany me in order for me to get out of bed and go to the bathroom.  Pain severe.  Notified primary care physician.  Nothing I could take that I wasn't already taking.  Slept for 5 days with this pain.  Today, 9 days later, I still have residual neck pain and am unable to drive because of limited neck movement.  My research indicates I never should have been given this vaccine, having had RA, and telling the nurse this.  I even asked her why I needed the vaccine if I've had shingles as well as chicken pox, and she said there's a debate about that.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Facial pain, Headache, Injection site pain, Periorbital pain
Clinical narrative: Approximately 12 hours after the injections (about 3 a.m.) , i developed a severe headache - behind my ear, shivering, and of course site injection pain.   This continued for several hours even after ibuprofen.  By that night at 8:30 p.m. (approximately 29 hours after the injection), my face started to swell.  When I woke the next morning, my face was extremely swollen - around my eyes - and hot to the touch.   I reported to my physician.  Went to the physician.  Obviously an allergic reaction - had an injection of steriods, taking ibuprofen and antihistamines.  As I report this, approximately 72 hours after injection, my face and periorbital area is still extremely swollen and slightly painful and still a headache.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Periorbital swelling, Skin warm, Swelling face
Clinical narrative: Approximately 12 hours after the injections (about 3 a.m.) , i developed a severe headache - behind my ear, shivering, and of course site injection pain.   This continued for several hours even after ibuprofen.  By that night at 8:30 p.m. (approximately 29 hours after the injection), my face started to swell.  When I woke the next morning, my face was extremely swollen - around my eyes - and hot to the touch.   I reported to my physician.  Went to the physician.  Obviously an allergic reaction - had an injection of steriods, taking ibuprofen and antihistamines.  As I report this, approximately 72 hours after injection, my face and periorbital area is still extremely swollen and slightly painful and still a headache.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Asthenia, Back pain, Musculoskeletal pain
Clinical narrative: Severe lower backache and into buttock, similar to sciatica. Debilitation almost complete for about 48 hours. Moved from initially on right side to left side of lower back. After initially noticed Friday, by Monday marked improvement. Now, 8 days after flu shot, back pain greatly reduced but not gone. Now have serious weakness/ache in right knee, unknown if related.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Audiogram, Deafness neurosensory, Dizziness, Immediate post-injection reaction, Malaise
Clinical narrative: Patient reports immediate "ill" feeling with Dizziness, vertigo, fever. Today presents with sudden onset moderate right sided sensorineural hearing loss
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Sudden hearing loss, Vertigo
Clinical narrative: Patient reports immediate "ill" feeling with Dizziness, vertigo, fever. Today presents with sudden onset moderate right sided sensorineural hearing loss
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Burning sensation, C-reactive protein increased, Dizziness, Neuropathy peripheral
Clinical narrative: First reaction occurred earlier about 1 week after the injection consisted of generalized dizziness.  Lasted for about a month. Second and more serious reaction began around 8-20-20,  of burning of the bottom of both feet. It has progressively gotten worse and radiates up the side of both lower legs.  This is  Peripheral Neuropathy.   I am schedule to consult with a neurologist on Oct 6, 2020;  Dr. I have discovered on a clinic connect that there are multiple number of other people that have experienced the same sequela.  This needs to be fully investigated.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Burning sensation, Disease susceptibility, Dizziness, Neuropathy peripheral
Clinical narrative: First reaction occurred earlier about 1 week after the injection consisted of generalized dizziness.  Lasted for about a month. Second and more serious reaction began around 8-20-20,  of burning of the bottom of both feet. It has progressively gotten worse and radiates up the side of both lower legs.  This is  Peripheral Neuropathy.   I am schedule to consult with a neurologist on Oct 6, 2020;  Dr. I have discovered on a clinic connect that there are multiple number of other people that have experienced the same sequela.  This needs to be fully investigated.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Orthostatic hypotension, Small fibre neuropathy
Clinical narrative: First reaction occurred earlier about 1 week after the injection consisted of generalized dizziness.  Lasted for about a month. Second and more serious reaction began around 8-20-20,  of burning of the bottom of both feet. It has progressively gotten worse and radiates up the side of both lower legs.  This is  Peripheral Neuropathy.   I am schedule to consult with a neurologist on Oct 6, 2020;  Dr. I have discovered on a clinic connect that there are multiple number of other people that have experienced the same sequela.  This needs to be fully investigated.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough
Clinical narrative: Developed severe cough and mucous production approx. 2 hours after receiving the vaccine. (Same symptoms occured last year after the flu vaccine while pregnant)  Self medicated with Benaddryl oral.
Age: 78.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an influenza-Fluzone High Dose on 09/23/2020 in the Left Arm-Lot # UJ461AA, and was given another Fluzone High Dose today, 10/01/2020, as described above. Patient was notified of the error. Physician was also notified. Patient is not experiencing any adverse events at the time of the administration of the vaccine.
Sex: M
Vaccine: PPV
Symptoms: Product packaging confusion
Clinical narrative: Patient "feels fine" / patient is not currently experiencing side effects; accidental overdose; Product packaging confusion; Wrong product administered; This spontaneous report was received from a physician concerning a 69-year-old male patient with dementia. The patient's medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 28-SEP-2020, the patient received by mistake pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot number S017429 and expiration date 28-MAR-2021 (route of administration was not provided). The patient was supposed to received a different medication, and additionally he was given 4 times the recommended dosage (Accidental overdose). The patient is not currently experiencing side effects, but caller is requesting a  consult.  The physician stated the vials were confused with epoetin alfa-epbx (RETACRIT) by the office staff due to having a similar vial size and top color (Product packaging confusion). The patient was sent home and lives with a family member so he is being monitored.