chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient accidently vaccinated with two doses of quadracel within 34-day time frame/no AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional (practice manager).  This case involves a 6 years old male patient who was accidently vaccinated with two doses of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] within a 34-day time frame (inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  It was of actual medication error due to drug dose administration interval too short.  At the time of reporting, no adverse event 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: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Extreme fatigue (unable to engage in daily activities), all-over muscle aches, chills, headache, injection site soreness
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Extreme fatigue (unable to engage in daily activities), all-over muscle aches, chills, headache, injection site soreness
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Gait inability, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: By night on 9/5/2020 the patient had itching, area was red and swollen to the elbow, fever, couldn't walk, and was shaking.  She applied an ice pack overnight.  On 9/8 the area was red, swollen, hard and pink. On 9/9 the area was still affected, but improving.   I called the doctor's office.  They advised for her to reach out to the office is no improvement or worsening.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: By night on 9/5/2020 the patient had itching, area was red and swollen to the elbow, fever, couldn't walk, and was shaking.  She applied an ice pack overnight.  On 9/8 the area was red, swollen, hard and pink. On 9/9 the area was still affected, but improving.   I called the doctor's office.  They advised for her to reach out to the office is no improvement or worsening.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: very sore left arm, achy body,  weakness, 12 hours + after vaccination.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no adverse effects; vaccine administered after temperature excursion and before temperature excursion evaluation occurred; This spontaneous report was received from a medical assistant and refers to a 5-year-old male patient. No information regarding the patient's concurrent conditions, medical history and drug reactions or allergies was provided. His concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX).  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) dose 1, subcutaneously, lot # S006830, expiration date 02-SEP-2020 in the right thigh (exact dose was not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 5 degrees Celsius for 12 hours. There was a previous temperature excursion of 8.4 degrees Fahrenheit for 60 hours. Digital Data Logger was involved. No additional adverse effects were reported.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous report was received from a medical assistant and refers to a 43-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-SEP-2020 the patient was vaccinated with expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0.5 milliliter (expiration date reported as 26-SEP-2020) (strength, dose, route of administration and lot # were not reported) for prophylaxis.
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut; multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 06-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut. These injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter determined the events to be disabling.  Upon internal review, the event of herpes zoster ophthalmicus was considered to be medically significant.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 100.5 fever; Achy; Flu-like symptoms; This case was reported by a consumer via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 15th September 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, pain and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever (100.5 degree F), ache and flu like symptoms after the doses of Shingrix and Flu vaccine. The reporter stated that, she received 2 vaccines at the same time and had a reaction to one of them. The patient also had a Covid test which turned out to be negative.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Within 4 days I got the Shingles  on left upper arm & left shoulder near my neck   The rash disappeared within a month, but it's  over a year and I have pain ever day where the rash was on arm & shoulder.  Note ( Had the Shingles vaccine about 15 years ago with no adverse problems )
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Hypersomnia, Injection site pain, Limb discomfort
Clinical narrative: Symptoms developed over about 36 hours. Started with injection site pain, followed by that arm feeling very heavy. Overnight, the bottom half of my body also felt very heavy -- I had difficulty moving my legs. The following morning, I had a slight fever (99.5 vs my normal 97.5), was nauseated and extremely tired. I slept most of that day. The following day, I was still fatigued (but functional) and the other symptoms had dissipated.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nausea, Pyrexia
Clinical narrative: Symptoms developed over about 36 hours. Started with injection site pain, followed by that arm feeling very heavy. Overnight, the bottom half of my body also felt very heavy -- I had difficulty moving my legs. The following morning, I had a slight fever (99.5 vs my normal 97.5), was nauseated and extremely tired. I slept most of that day. The following day, I was still fatigued (but functional) and the other symptoms had dissipated.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Evening of 10/1/20 mom noticed large red area surrounding injection site on right thigh. Area is warm to touch. It is red, raised and blotchy.   Mom brought child to clinic on 10/2/20 for evaluation. Confirmed 9cm area of erythema to right thigh. Area is warm to touch. Child does not appear in any distress and denies pain. No changes in appetite or day to day activities. Mom did give Children's Benadryl the night of the shot. Will treat with benadryl and prednisolone daily for 5 days. Also use cool packs to area for short periods of time.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Pain
Clinical narrative: flu vaccine given on 09/02/2020 in the LUE; spoke w/ WFM states had some pain to the LUE, states the pain has not gone away and has worsened; denies redness, states there is a slight lump at the sight of the injection, denies warmness to touch; states has decreased range of motion, states that when lifting LUE it causes some pain 6/10, when at rest has 4/10 pain, states has used topical NSAIDS, cannot take oral NSAIDs d/t Chron's dz, states has tried Tylenol without relief;
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: later in the evening of the day of vaccination, pt noted redness, swelling, tenderness of the area around the injection site. the area had spread more the following morning. she also felt dizzy and hot the subsequent day VSS, cortisone cream and cold pack applied to the area. pt already takes daily allergy medication.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Fever, numbness, body aches, chills, shortness of breath, vomiting, dizziness, headache, rapid breathing
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Fever, numbness, body aches, chills, shortness of breath, vomiting, dizziness, headache, rapid breathing
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Chest pain, Chills, Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: Patient experienced vomiting, fever, chills, and shaking the evening of vaccinations (9/28/20). The next morning (9/29/20) her skin was hurting, legs were sore, and her chest was hurting. Patient stated she never experienced injection site reactions on either arm. After alternating acetaminophen and ibuprofen for 2 days, her symptoms have completely resolved as of 9/30/20.
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Patient experienced vomiting, fever, chills, and shaking the evening of vaccinations (9/28/20). The next morning (9/29/20) her skin was hurting, legs were sore, and her chest was hurting. Patient stated she never experienced injection site reactions on either arm. After alternating acetaminophen and ibuprofen for 2 days, her symptoms have completely resolved as of 9/30/20.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Approximately 7 hours after vaccine- I started a fever of 100 degrees,  my body ached,  I had a head ache, and stomach ache/nausea.
Age: 42.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: within 30 minutes of administration hives on torso, bilateral arms, and upper legs bilateral.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, tired
Age: 23.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Migraine, Pyrexia
Clinical narrative: fever, weakness, migraine
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: pain redness at the injection site, headache, muscle pain, fever, and upset stomach starting in the afternoon after injection on 9/30/2020. Mother treated at home with alternating tylenol and ibuprofen. Keflex 500 mg tablet started at office visit on 10/2/2020.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: pain redness at the injection site, headache, muscle pain, fever, and upset stomach starting in the afternoon after injection on 9/30/2020. Mother treated at home with alternating tylenol and ibuprofen. Keflex 500 mg tablet started at office visit on 10/2/2020.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Headache Severe chills Fever No energy Symptoms still after 2 days!
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Blood potassium decreased, Erythema, Injected limb mobility decreased, Pain
Clinical narrative: Redness, soreness, unable to lift arm (Lt.), red, splotches in chest area, Rt. arm and down Rt. side. Low Potassium Level at ER.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Redness, soreness, unable to lift arm (Lt.), red, splotches in chest area, Rt. arm and down Rt. side. Low Potassium Level at ER.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: On 091920 received Flu vaccine. At 2000 that night developed Hives below the sight. Gave Benadryl, no other symptoms followed
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: on administration of improperly stored vaccines; This spontaneous report as received from a certified medical assistant refers to a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 31-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin (rHA); dose and route of administration were not reported, lot # S021326, expiration date 05-JAN-2021) for prophylaxis. Previously, the vaccine had experienced temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. The current temperature excursion was from 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. Digital data logger was used.  This is one of the multiple reports received the same reporter.; Sender's Comments:  US-009507513-2009USA000931:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a layer regarding a case in litigation, concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and rote of administration ere not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, he patient had and will continue 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, including but not limited to medical losses and costs include 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 will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was not provided. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: postherpetic polyneuropathy; This spontaneous report has been received from a layer regarding a case in litigation, concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 02-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and rote of administration ere not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician for postherpetic polyneuropathy (PHN). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, he patient had and will continue 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, including but not limited to medical losses and costs include 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 will continue to suffer such losses, and damages in the future. The outcome for postherpetic polyneuropathy was not provided. The lawyer considered postherpetic polyneuropathy to be related to zoster vaccine live (ZOSTAVAX).
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; large welts; This case was reported by a nurse via sales rep and described the occurrence of pruritus in a 69-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   The patient's past medical history included adverse reaction (took a medication that may had caused the reaction which he had a reaction to in the past).   On an unknown date, the patient received Fluarix. On an unknown date, less than a day after receiving Fluarix, the patient experienced pruritus and welts. On an unknown date, the outcome of the pruritus and welts were unknown.   It was unknown if the reporter considered the pruritus to be related to Fluarix. The reporter considered the welts to be unrelated to Fluarix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix and woke up in the night with itching and large welts.  The patient went to urgent care and took a medication that may had caused the reaction which had a reaction to in the past, but patient felt the reaction was due to the Fluarix. The reporter tested him to the vaccine, and it was negative and thinks that he had underlying urticaria not related to the vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: her arm as there was significant redness; swelling at injection site; was given "below the deltoid not in muscle"; This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. On 21st September 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the wrong route of administration was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information was provided as follows: The patient experienced significant redness and swelling at the injection site after the 1st dose of Shingrix. The reporter mentioned that, the dose was given below the deltoid and not in the muscle, which led to incorrect route of product administration. The reporter wanted to know if the dose was still valid. No other information was provided. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: The two times i took flu shots i contracted the flu/suspected vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of influenza (received Influenza vaccine on an unknown date, refer case US2020AMR193663).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the patient took flu shots and contracted the flu. No shots, no flu. This case was considered as suspected vaccination failure, since the information regarding time to onset and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR193663:same reporter
Sex: F
Vaccine: MEN
Symptoms: Death, Seizure
Clinical narrative: having seizures that were uncontrollable; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 21-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 4 months after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the seizure was fatal. The reported cause of death was seizure.   It was unknown if the reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were provided as follows:  The age at vaccination was reported. The patient was only 21 years old. The patient received Meningococcal B vaccine and after 4 months experienced horrible seizures and was died in sleep. The patient did not had seizures before. The reporter mentioned that,  she continued having seizures and were uncontrollable.; Reported Cause(s) of Death: Seizure
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Big round circle around the injection site. It was puffed up; Big round circle around the injection site. It was puffed up and red; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 17th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site swelling and injection site erythema. In September 2020, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2020-2021 season in right arm and experienced big round circle around the injection site and it was puffed up and red. The reaction lasted for 4 day. This case has been linked with US2020189733 and US2020189735 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189733:same reporter US-GLAXOSMITHKLINE-US2020189735:same reporter
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Big round circle around the injection site. It was puffed up; Big round circle around the injection site. It was puffed up and red; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z5N5G, expiry date 30th June 2021) for prophylaxis.   On 17th September 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. The patient received Fluarix Quadrivalent 2020-2021 season in her left arm and experienced big round circle around the injection site and it was puffed up and red. The reaction lasted for 1 day. This case has been linked with US2020189720 and US2020189735 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189720:same reporter US-GLAXOSMITHKLINE-US2020189735:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Wrong technique in product usage process
Clinical narrative: "strong reaction" redness and swelling / at the injection site; "strong reaction" redness / at the injection site; is not sure if they were both in the muscle because; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and wrong technique in drug usage process. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved and the outcome of the wrong technique in drug usage process was unknown.   The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Addtional deatils provided as follows: The patient was vaccinated with 1st shot of Shingrix. After vaccination patient had strong reaction" redness and swelling which was quite uncomfortable at the injection site. The patient  received the Shingrix two shot series. They were both given at the same pharmacy but were administered by two different pharmacists. The pharmacy should have that information on file.  The both shots were  in the deltoid but patient was  not sure if they were both in the muscle because "one was deeper and one was shallower" which led to wrong injection technique. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR191352:same patient same reporter 2nd dose
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Inappropriate schedule of product administration, Pain in extremity, Vaccination site erythema
Clinical narrative: It was sore then next day it turned into size of a saucer on his; Big huge bump that turned red/he got a great big huge bump that turned; Pain in arm; First Shingrix shot on 12 AUG 2020 / Second Shingrix shot on 19 SEP 2020; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 18th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, vaccination site erythema, pain in arm and drug dose administration interval too short. On an unknown date, the outcome of the extensive swelling of vaccinated limb and drug dose administration interval too short were unknown and the outcome of the vaccination site erythema was recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, vaccination site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The first shot didn't hurt. The second shot he got a great big huge bump that turned red. It was sore then next day it turned into size of a saucer on his arm. The bump went down it was still a little sore at the time of reporting but mostly ok. The patient received his first Shingrix shot on 12th August 2020 and his second Shingrix shot on 18th September 2020 which led to drug dose administration interval too short. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product storage error
Clinical narrative: Left arm hurts; Froze the vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and incorrect product storage. On an unknown date, the outcome of the pain in arm and incorrect product storage were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient's husband was reporter. The reporter went to the pharmacy to get her first dose of Shingrix and the pharmacist didn't have a license to administer the vaccine, so they referred her to her physician's office. The Pharmacist said to keep the vaccine refrigerated.  When they went to the physician's office, the nurse in the office said to freeze the vaccine and thaw it prior to administration.   The patient froze the vaccine for one week and then it was thawed prior to administration at the physician's office. The patient received the dose in her left arm intramuscular and her left arm hurts now. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Acne, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: the injection site.  The area also began to hurt; Red area described as looking like a pimple, presented at the injection site; arm became weaker than normal/hand is weaker; hand is weaker and gets numb; Pain in her shoulder above the injection site; Injection site pimple; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received HBV (Engerix B adult) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Engerix B adult (intramuscular). In August 2020, 1 week after receiving Engerix B adult, the patient experienced injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples. On an unknown date, the outcome of the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples to be related to Engerix B adult.  Additional details were provided as follows: The age at vaccination was not reported. A week following the vaccination, a red area described as looking like a pimple, presented at the injection site. The area also began to hurt and the arm became weaker than normal. It hurts when pressure was applied and the hand was weaker and get numb after a while when hold a cell phone in her hand. There was pain in her shoulder above the injection site. All symptoms presented a week after vaccination and have not resolved. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Tenderness
Clinical narrative: the injection site.  The area also began to hurt; Red area described as looking like a pimple, presented at the injection site; arm became weaker than normal/hand is weaker; hand is weaker and gets numb; Pain in her shoulder above the injection site; Injection site pimple; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received HBV (Engerix B adult) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Engerix B adult (intramuscular). In August 2020, 1 week after receiving Engerix B adult, the patient experienced injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples. On an unknown date, the outcome of the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples to be related to Engerix B adult.  Additional details were provided as follows: The age at vaccination was not reported. A week following the vaccination, a red area described as looking like a pimple, presented at the injection site. The area also began to hurt and the arm became weaker than normal. It hurts when pressure was applied and the hand was weaker and get numb after a while when hold a cell phone in her hand. There was pain in her shoulder above the injection site. All symptoms presented a week after vaccination and have not resolved. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Bone pain, Chest pain, Pain, Pain in extremity
Clinical narrative: Pain and soreness to Left Arm; Pain and soreness to her left arm, left chest, left armpit and collarbone; Pain and soreness to left armpit; Pain and soreness to collarbone; Swelling to her left arm, left chest, left armpit and collarbone; Swelling to her left arm, left chest, left armpit and collarbone; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On an unknown date, unknown after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling. On an unknown date, the outcome of the pain in arm, chest pain with radiation to left arm, bone pain, swelling arm and swelling were recovered/resolved and the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Quadrivalent 2018-2019 season on left arm intramuscularly. The caller wanted to know what ingredients were in the Fluarix vaccine from 2018 and 2019. The patient had pain, swelling, and soreness to her left arm, left chest, left armpit and collarbone.  The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Pain and soreness to Left Arm; Pain and soreness to her left arm, left chest, left armpit and collarbone; Pain and soreness to left armpit; Pain and soreness to collarbone; Swelling to her left arm, left chest, left armpit and collarbone; Swelling to her left arm, left chest, left armpit and collarbone; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On an unknown date, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular). On an unknown date, unknown after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling. On an unknown date, the outcome of the pain in arm, chest pain with radiation to left arm, bone pain, swelling arm and swelling were recovered/resolved and the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the pain in arm, chest pain with radiation to left arm, axillary pain, bone pain, swelling arm and swelling to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Quadrivalent 2018-2019 season on left arm intramuscularly. The caller wanted to know what ingredients were in the Fluarix vaccine from 2018 and 2019. The patient had pain, swelling, and soreness to her left arm, left chest, left armpit and collarbone.  The reporter did not consent to follow-up.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Biopsy tongue, Condition aggravated, Dermatitis bullous, Erythema
Clinical narrative: WITHIN 40 MINUTES OF RECEIVING VACCINE REDNESS AND ITCHING TO ARMS BEGAN - URTICARIA DEVELOPED OVER ARM - ADVISED ORAL BENADRYL. SEEN 9/18/2020 IN OFFICE WITH URTICARIAL AND BULLOUS LESIONS OVER BOTH ARMS - PRESCRIBED ORAL PREDNISONE AND ORAL BENADRYL. LESIONS CONTINUED TO WORSEN AND SPREAD OVER ALL LIMBS - 9/25/2020 SEEN AT HOSPITAL ED. STABLE AND DISCHARGED. 9/27/2020 - SEEN AGAIN AT HOSPITAL ED, THEN TAKEN TO ANOTHER HOSPITAL. ADMITTED 9/27-9/29/2020. DIAGNOSIS RASH, ADVERSE REACTION TO VACCINE, BULLOUS RASH, TONGUE LESION, ANXIETY. BIOPSY TAKEN OF LESION, TREATED WITH ORAL AND TOPICAL STEROIDS. DISCHARGE HOME STABLE.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Tongue disorder, Urticaria, Vaccination complication
Clinical narrative: WITHIN 40 MINUTES OF RECEIVING VACCINE REDNESS AND ITCHING TO ARMS BEGAN - URTICARIA DEVELOPED OVER ARM - ADVISED ORAL BENADRYL. SEEN 9/18/2020 IN OFFICE WITH URTICARIAL AND BULLOUS LESIONS OVER BOTH ARMS - PRESCRIBED ORAL PREDNISONE AND ORAL BENADRYL. LESIONS CONTINUED TO WORSEN AND SPREAD OVER ALL LIMBS - 9/25/2020 SEEN AT HOSPITAL ED. STABLE AND DISCHARGED. 9/27/2020 - SEEN AGAIN AT HOSPITAL ED, THEN TAKEN TO ANOTHER HOSPITAL. ADMITTED 9/27-9/29/2020. DIAGNOSIS RASH, ADVERSE REACTION TO VACCINE, BULLOUS RASH, TONGUE LESION, ANXIETY. BIOPSY TAKEN OF LESION, TREATED WITH ORAL AND TOPICAL STEROIDS. DISCHARGE HOME STABLE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Peripheral swelling
Clinical narrative: Patient had severe chills, swollen arm, redness
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Employee received Flucelvax, single dose, (Seqirus, Lot #276539) via employee flu clinic on Wed. 9/30 at approx. 8 am. States she's receives flu vaccine every year  and denies any issues/reactions with vaccines in years past. At about 8-9 pm that same evening, developed sudden onset of hives on bilateral thighs and bilateral arms with mild pruritus. Denies prior history of allergies, allergic reactions or hives.  Next morning on 10/1, reports hives were more defined with increased pruritus. Took one dose Zyrtec and hives resolved. On night of 10/1, urticaria had sudden reappearance on face, neck, abdomen, back, arms, and legs. Reports increased pruritus. States she went to bed without sleep disturbances. Hives remained today and repeated dose of Zyrtec. Denies allergies to medications, food, animals or environmental. Denies new soap, detergent, lotion, environmental changes, or new foods.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Fatigue, Injection site urticaria
Clinical narrative: hives on arm where vaccine was given, plus dizziness and fatigue
Age: 50.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Chills, Injection site mass, Injection site pain, Paraesthesia
Clinical narrative: Soreness and lunp at injection site (even 4 days later). Tingling in arm that received injection.  Chills and weakness.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: pt said she experienced pain in the arm and was diagnosed with cellulitis
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: The patient reported soreness at the injection site which initially improved the following day, but then increased beyond the injection site.  The patient stated that it radiated down his arm and has been consistently sore/painful since it started.  He cannot lift his arm straight up in the air without extreme discomfort/pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Chest pain, Rash
Clinical narrative: Pain from right breast bone - under arm to spine. Rash started after 2 days of just pain with spreading from breast bone on upper abdomen under arm to spine along the same plane.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination error
Clinical narrative: PATIENT WAS IN OFFICE WITH SIBLINGS, PT, WAS LAST TO BE VACCINATED, DID NOT VERIFY PATIENT NAME BEFORE GIVING VACCINES, PT. RECEIVED IMMUNIZATIONS THAT BROTHER WAS SUPPOSED TO RECEIVE. PATIENT HAD ALREADY RECEIVED THESE IMMUNIZATIONS BEFORE. MOM STATED THIS WAS NOT THAT PATIENT AFTER PT. WAS GIVEN VACCINES. NOTIFIED MOM THAT HE DID RECEIVE THE DTAP-IPV AND MMRV AND THIS WAS NOT WHAT HE WAS DUE FOR. NOTIFIED PHYSICIAN ABOUT VACCINE ERROR. NOTIFIED MOM TO CALL IF ANY CONCERNS.
Age: 6.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction at time of this report.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pain
Clinical narrative: 8 hrs of fatigue and chills and mild body aches
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Vaccine positive rechallenge
Clinical narrative: Inconsolable  crying for 3 hours after injection. Happened @ 2 mo vaccination also, same Injection with Lot # K7TF9 7/20/2020
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chest discomfort, Chest pain, Muscle twitching, Muscular weakness
Clinical narrative: After getting the flu vaccine on Monday September 14, starting that evening I began to feel multiple twitching, spasms  on my chest, and triceps. I felt chest pains on both sides of my body, I felt muscle weakness and my chest and arm felt hot.   I previously was recovering from a right arm and shoulder injury which occurred in a local bar which I was feeling discomfort and pain from, however after the flu vaccine the pain and discomfort around my right shoulder increased, with new symptoms including my neck hurting. Although several days ago the twitching and spasms stopped, I continued feeling heat around my chest and shoulder and neck discomfort which I didn?t feel before the flu vaccine.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Neck pain
Clinical narrative: After getting the flu vaccine on Monday September 14, starting that evening I began to feel multiple twitching, spasms  on my chest, and triceps. I felt chest pains on both sides of my body, I felt muscle weakness and my chest and arm felt hot.   I previously was recovering from a right arm and shoulder injury which occurred in a local bar which I was feeling discomfort and pain from, however after the flu vaccine the pain and discomfort around my right shoulder increased, with new symptoms including my neck hurting. Although several days ago the twitching and spasms stopped, I continued feeling heat around my chest and shoulder and neck discomfort which I didn?t feel before the flu vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Patient experienced adverse events such as fever, vomiting, rash and went to the ER 2 days after receiving the vaccine