chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had the flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case is linked to case 2020SA291942 (same reporter).  This case involves female patient (age unspecified) who had the flu (influenza), while she received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing diabetic.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu (influenza) (non-serious) within 5 days following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got the flu shot and got sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer and transmitted to Sanofi on 10-Oct-2020.  This case was linked to cases 2020SA294125, 2020SA294157, 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294164, 2020SA294165, 2020SA294166, 2020SA294167, 2020SA294168, 2020SA294169, 2020SA294170, 2020SA294171, 2020SA294172, 2020SA294173, 2020SA294174, 2020SA294175, 2020SA294142, 2020SA294143, 2020SA294144, 2020SA294145, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294149, 2020SA294150, 2020SA294151, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same source).  This case involved a patient of unknown demographics who experienced got the INFLUENZA VACCINE shot and got sick (illness).  Relevant medical history, medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was patient got the flu shot and got sick.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally administered two injections of Fluzone HD to patient(with no ae); Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who was accidentally administered with two injections of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), concomitant medication , vaccination(s) and family history were not provided.  On an unknown date, the patient received two doses of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: it gave the flu; not feeling well; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional (internal employee) via Medical Information (MI) via call center (Reference number- 00339572) and transmitted to Sanofi on 30-Oct-2020.  This case involves a female patient (age not reported) who experienced flu (influenza) and was not feeling well (malaise), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and was not feeling well (malaise) unknown latency following the administration of INFLUENZA VACCINE.  The caller does not know any details about the flu vaccine she had received.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Tues, Dec 1, 2020 after 8 pm. Arm sore; chills and shivering; eyes and head felt hot, but cool to touch; diarrhea. Wed, Dec 2, 2020 wake up around 7 pm. Feeling bad, like having the flu; ears ringing; aches and chills/can't get warm; joints achy (hands and knees); light headed (feels like sinus stuffed up, but not). Drink tea, scrambled eggs and toast. Keep it down. Thought I was going to throw up with the tea by itself as first thing in mouth, but didn't.  I have been working from home since April, wife and I wear masks everywhere, and rarely go out. Wife tested for COVID with negative results on Tues, Dec 1, 2020. I am healthy. I noticed on CDC site that younger people get these symbols more than older people, may because they have a stronger immune system fighting the foreign material. Just curious.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: Tues, Dec 1, 2020 after 8 pm. Arm sore; chills and shivering; eyes and head felt hot, but cool to touch; diarrhea. Wed, Dec 2, 2020 wake up around 7 pm. Feeling bad, like having the flu; ears ringing; aches and chills/can't get warm; joints achy (hands and knees); light headed (feels like sinus stuffed up, but not). Drink tea, scrambled eggs and toast. Keep it down. Thought I was going to throw up with the tea by itself as first thing in mouth, but didn't.  I have been working from home since April, wife and I wear masks everywhere, and rarely go out. Wife tested for COVID with negative results on Tues, Dec 1, 2020. I am healthy. I noticed on CDC site that younger people get these symbols more than older people, may because they have a stronger immune system fighting the foreign material. Just curious.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tues, Dec 1, 2020 after 8 pm. Arm sore; chills and shivering; eyes and head felt hot, but cool to touch; diarrhea. Wed, Dec 2, 2020 wake up around 7 pm. Feeling bad, like having the flu; ears ringing; aches and chills/can't get warm; joints achy (hands and knees); light headed (feels like sinus stuffed up, but not). Drink tea, scrambled eggs and toast. Keep it down. Thought I was going to throw up with the tea by itself as first thing in mouth, but didn't.  I have been working from home since April, wife and I wear masks everywhere, and rarely go out. Wife tested for COVID with negative results on Tues, Dec 1, 2020. I am healthy. I noticed on CDC site that younger people get these symbols more than older people, may because they have a stronger immune system fighting the foreign material. Just curious.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: About 8pm I started having muscle aches and an headache. At 2am I woke up I had chills, 6am woke up I had a fever of 99.6 along with chills and weakness. Went to the screening clinic at 11am for COVID 19 test. Went back home and MD asked her to purchase pulse ox to monitor myself for shortness of breath. Went back to bed. By 230-3pm 24 hours later after the shot I was about 90% recovered and fever 3wqas gone.
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test
Clinical narrative: About 8pm I started having muscle aches and an headache. At 2am I woke up I had chills, 6am woke up I had a fever of 99.6 along with chills and weakness. Went to the screening clinic at 11am for COVID 19 test. Went back home and MD asked her to purchase pulse ox to monitor myself for shortness of breath. Went back to bed. By 230-3pm 24 hours later after the shot I was about 90% recovered and fever 3wqas gone.
Age: 36.0
Sex: M
Vaccine: MMR
Symptoms: Injection site bruising, Injection site erythema, Swelling
Clinical narrative: HPI: Noticed new bump just above clavicle's lateral edge. Denies trauma, injury, or any event to cause it. States received MMR booster in L arm SC on 11/20; states he tolerated well without any local reaction or swelling, erythema, or heat at injection site. Noticed deformity on 11/26. Denies pain, erythema, heat, edema, impeding ROM. EE state he has no PMH. Denies he's immunocompromised, recent infection or illness, fever, chills, night sweats, or unexplained weight loss.  EXAM: L SHOULDER/CLAVICLE: 1.5-2" in diameter fixed, raised mass above lateral edge of clavicle; rubbery to feel. Pigmentation same as surrounding skin. No erythema, heat, edema. No TTP. FROM of shoulder without discomfort. L ARM: small 0.5 cm bruise/erythema on posterior upper arm corresponding to SC injection. Flat. No heat and no TTP.  Evaluated in-person at WWC on 11/30. Referred to PCP, who diagnosed with supraclavicular lymphadenitis via telehealth visit 12/2. Will monitor and order US if no resolution or enlarges in next 3 months.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Swelling, Swelling face
Clinical narrative: Swelling and redness at injection site and face. Some swelling at other sites. Patient went to ER, given Benadryl, which resolved the problem. No respiratory involvement at any time.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Lethargy, Rash, Rash pruritic
Clinical narrative: Symptoms started 11.29.20. Felt lathargic, had stomach issues. Then on 12.01.20, had red large spot, size of orange in area where vaccine was given. Then rash on left hand was itching appeared, then rash with little bumps appeared on hand and arm. Symptoms are all on left hand and left arm. Still redness, with little bumps filled with puss like fluids.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: fever, nausea, severe headache
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: After I got the flu shot 3-4 days My right rotator cuff started hurting, I could not lay on it and it was very painful. The pain lasted for 8 weeks. I asked the pharmacist about the pain and asked of this was a symptom of the vaccine and they stated it could be. I'm about 90% recovered.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, fatigue
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Headache, Influenza A virus test negative, Influenza B virus test, Myalgia, Nausea
Clinical narrative: muscle aches, headache nausea and vomiting
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: muscle aches, headache nausea and vomiting
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient kicked during vaccination. received scratch to thigh as result. mom reported next day patient with swelling and redness to site which has since resolved. mother had telehealth appointment with doctor day after vaccination and advised to take tylenol / motrin PRN and ice site as needed.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Shock, Tremor
Clinical narrative: Shock violent shaking of entire body
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Autoimmune thyroiditis, Dysphagia, Hypothyroidism, Laboratory test
Clinical narrative: Received Tdap on 04/27, delivered baby via C-section, one day prior to due date. Baby weighed 8lbs.  Few months after delivery my throat was extremely swollen, difficulty swallowing and my neck and shoulder muscles were extremely tight and sore causing extreme discomfort. My energy level was at an all time low and could barely stay awake  in the afternoon / evening time. Waited a few months hoping it would go away on it's own but it became unbearable to hold my head up. Contacted Family Medicine and got blood work and a neck ultrasound completed.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle tightness, Nodule, Pharyngeal swelling, Ultrasound scan
Clinical narrative: Received Tdap on 04/27, delivered baby via C-section, one day prior to due date. Baby weighed 8lbs.  Few months after delivery my throat was extremely swollen, difficulty swallowing and my neck and shoulder muscles were extremely tight and sore causing extreme discomfort. My energy level was at an all time low and could barely stay awake  in the afternoon / evening time. Waited a few months hoping it would go away on it's own but it became unbearable to hold my head up. Contacted Family Medicine and got blood work and a neck ultrasound completed.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of product; This spontaneous report has been received from a pharmacist referring to a 43 years old female patient. Concurrent condition, historical condition and concomitant therapy were not reported.   On 17-JUL-2020, the patient received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot# and expiration date were not reported) for prophylaxis.   The patient wanted the pharmacist to have two doses total. The second dose had not yet been administrated. The patient dosed outside of recommended dosing schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster and postherpetic neuralgia; multiple outbreaks of herpes zoster and postherpetic neuralgia; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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 pt had 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/not resolved. The reporter considered the events of herpes zoster and post herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster and post herpetic neuralgia were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: difficulty breathing/coughing/sore throat/dyspnea/diagnosed with pneumonia; difficulty breathing/dyspnea/diagnosed with acute chronic obstructive pulmonary disease exacerbation; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history and concomitant medications was provided. His concurrent conditions included chronic obstructive pulmonary disease. On or around 20-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an acute onset of difficulty breathing, coughing, sore throat, dyspnea. He was diagnosed with acute chronic obstructive pulmonary disease exacerbation and pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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 pt had 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/not resolved. The reporter considered the events of pneumonia and chronic obstructive pulmonary disease exacerbation to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia and chronic obstructive pulmonary disease exacerbation were considered to be disabling.  Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: difficulty breathing/coughing/sore throat/dyspnea/diagnosed with pneumonia; difficulty breathing/dyspnea/diagnosed with acute chronic obstructive pulmonary disease exacerbation; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history and concomitant medications was provided. His concurrent conditions included chronic obstructive pulmonary disease. On or around 20-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an acute onset of difficulty breathing, coughing, sore throat, dyspnea. He was diagnosed with acute chronic obstructive pulmonary disease exacerbation and pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt 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 pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt 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 pt had 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/not resolved. The reporter considered the events of pneumonia and chronic obstructive pulmonary disease exacerbation to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia and chronic obstructive pulmonary disease exacerbation were considered to be disabling.  Upon internal review, the event of pneumonia was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes ophthalmic, Vaccination failure
Clinical narrative: Shingles on 25th October 2020 in his right eye; Suspected vaccination failure; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 2nd dose of Shingrix. In February 2020, the patient received the 1st dose of Shingrix. On 25th October 2020, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and herpes ophthalmic (serious criteria hospitalization and GSK medically significant). The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and herpes ophthalmic were unknown.   It was unknown if the reporter considered the vaccination failure and herpes ophthalmic to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was diagnosed with Shingles on 25th October 2020 in his right eye and was in the hospital from 29th October 2020 to 4th November 2020. The patient was receiving the antiviral drug Acyclovir. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpez zoster were unknown at the time of reporting.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A medical assistant administer a influenza vaccine to patient on 12/01/2020. Patient is only 2 months and does not qualify to get influenza until 6 months of age. Provider checked patient after the administration of the vaccine and stated to medical assistant that the patient was ok and she did not have any immediate reaction to the vaccine. I will be following up with the mother of the patient on 12/02/2020.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Periarthritis, Product administered at inappropriate site, Screaming
Clinical narrative: The pharmacist, injected the vaccine into my right shoulder instead of my deltoid at 8:30 pm.  At 1;30 am I woke up screaming in pain and with a frozen right shoulder.  My shoulder did not begin to improve till 1//28/2020.  The injury is now fully resolved and I now have full range of motion.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Severe headache - 48 hours Chills - 48 hours Low Grade Fever of 99 - 24 hours Body Aches - 48 hours Severe fatigue - 48 hours Nausea - 48 hours
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe headache - 48 hours Chills - 48 hours Low Grade Fever of 99 - 24 hours Body Aches - 48 hours Severe fatigue - 48 hours Nausea - 48 hours
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: Patient complained of pain and paralysis in arm.  She sought medical attention that night or next morning.  At first they though it could be SIRVA, however 3 days after event, patient is still in pain but mobility has returned and pain is getting better.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Angiogram, Angiogram cerebral normal, Arteriogram carotid normal, Computerised tomogram head abnormal, Guillain-Barre syndrome
Clinical narrative: Patient was hospitalized 11/9/20-11/27/20 with probable Guillain-Barre Syndrome. He was discharged to long-term care for rehab.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Lumbar spinal stenosis, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Vertebral foraminal stenosis
Clinical narrative: Patient was hospitalized 11/9/20-11/27/20 with probable Guillain-Barre Syndrome. He was discharged to long-term care for rehab.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient got painful rash on face and opposite hand. Patient was not seen at the time and rash was beginning to resolve by time reports about one month later.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dehydration, Fatigue, Feeling abnormal, Headache
Clinical narrative: Fatigue, poor sleep, achy muscles, dehydration, head ache. Chills. Generally feeling crummy.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Poor quality sleep
Clinical narrative: Fatigue, poor sleep, achy muscles, dehydration, head ache. Chills. Generally feeling crummy.
Age: 93.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pain in extremity
Clinical narrative: Soreness in arm for 3 days. Headache for 2nd and 3rd days (still experiencing slight headache). Took Tylenol both days. Swelling at the injection site about 3" in diameter still after 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches and pain, significant headache, fever and chills, exhaustion 5 days later follow-up call with PCP to discuss symptoms and COVID 19 test. Patient unsure which arm vaccine was received.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Muscle aches and pain, significant headache, fever and chills, exhaustion 5 days later follow-up call with PCP to discuss symptoms and COVID 19 test. Patient unsure which arm vaccine was received.
Age: 22.0
Sex: F
Vaccine: FLUR4
Symptoms: Eye swelling, Lip swelling, Periorbital swelling
Clinical narrative: Swollen/puffy eyes and lips
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: muscle weakness in injection spot
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: injection site soreness, fever, chills, whole body aches
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Normal pain in arm, but tinnitus (bilateral, nonpulsitile) developed within 24 hours of injection and is still present continuously at the date of this report.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Exercise tolerance decreased, Injection site pain
Clinical narrative: The day the vaccination was administered the patient developed pain in his left arm near the site of the injection. Pain has not radiated to any other site. It has remained within 3 inches of initial shot location. The pain lasted approximately 2 weeks, then subsided to a constant dull ache. When the patient exercises and lift weights the pain intensifies again. It has now been 2  months since his vaccination, so he should not be experiencing pain any longer.   The patient has not taken any medication to treat the pain
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling around collar bone; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a adult 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 swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After received Shingrix patient experienced swelling around collar bone.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient received your hepatitis b vaccine twice within one day; This case was reported by a other health professional and described the occurrence of accidental overdose in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On 22nd November 2020, the patient received the 1st dose of Pediarix. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device. On 22nd November 2020, the patient received Engerix B. On 22nd November 2020, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Engerix B, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Infant received hepatitis b vaccine twice within one day, which led to accidental overdose .  The reporter was concerned about this.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Myalgia, Pain, Sleep disorder
Clinical narrative: Pain after pneumococcal 13-val conj vac (dipht crm197 protein) injection/ pain on the same side of injection, left arm, near shoulder, forearm/ pain in his muscle; difficulty sleeping on his left side; This is a spontaneous report from a contactable pharmacist (patient). A 73-year-old-male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) solution for injection in pre-filled syringe (Batch/lot number: DL2861, NDC number of Prevnar 13: 00005-1971-02) intramuscularly in the left deltoid on 19Nov2020 12:00 around noon at 0.5ml single as routine pneumonia vaccine. Medical history was none. Concomitant medications were none. Patient reported that previously in 2014 he took an unknown pneumonia vaccine (states he is not sure what the name was) and a zoster shingles vaccine in separate arms. He took the flu vaccine in 2014 not at the same time but around that time. He had a flu vaccine last year (2019). He never had any pain reaction from the previous vaccines he had administered. Patient took pneumococcal 13-val conj vac (dipht crm197 protein) at a Pharmacy. He was told by the pharmacist to follow up and take a dose of pneumonia vaccine 23, pneumovax 23 a year after receiving the pneumococcal 13-val conj vac (dipht crm197 protein). Patient experienced pain after pneumococcal 13-val conj vac (dipht crm197 protein) injection on 19Nov2020. The pain started 3 or 4 hours after the injection. The pain had lasted more than 3 weeks. He did not know if his bone was hit from the injection. The pain was on the same side of injection, left arm, near shoulder, forearm. It was painful, not serious, not life threatening. He had never had this happen with any prior vaccine. He was really shock that the pain in his muscle continued this long. He had difficulty sleeping on his left side for many days due to the pain (Nov2020). He tried to do hand movement exercise for days and when there was more pain he took one tablet of prescription ibuprofen (MOTRIN) 600mg twice a day. Pain has gradually improved. No emergency room visit and no physician office visit. Investigation assessment was no. The outcome of event "Pain after pneumococcal 13-val conj vac (dipht crm197 protein) injection/ pain on the same side of injection, left arm, near shoulder, forearm/ pain in his muscle" was recovering. The outcome of event "difficulty sleeping on his left side" was unknown. The patient considered the event was related to pneumococcal 13-val conj vac (dipht crm197 protein).  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: getting sick; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced getting sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious getting sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got flu; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves patient of unknown demographics who got flu (influenza),while patient received vaccine INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got non serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Allergic Reaction - Throat closed up. needed and epi pen
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Induration
Clinical narrative: Fatigue, Tired feeling, Headache, Muscle pain, Decreased appetite, Pain on the left arm, swelling,  tenderness, hard lump, chills, fever for 2 nights (Saturday 28th & Sunday 29th), drowsiness, sleepy, fatigue.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Mass, Myalgia, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Fatigue, Tired feeling, Headache, Muscle pain, Decreased appetite, Pain on the left arm, swelling,  tenderness, hard lump, chills, fever for 2 nights (Saturday 28th & Sunday 29th), drowsiness, sleepy, fatigue.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: Fatigue, Tired feeling, Headache, Muscle pain, Decreased appetite, Pain on the left arm, swelling,  tenderness, hard lump, chills, fever for 2 nights (Saturday 28th & Sunday 29th), drowsiness, sleepy, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Very tired, muscle aches, light fever for approximately 24 - 36 hours Arm was sore Two red splotches on my upper left arm beneath the vaccination site which lasted for several days
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dysphagia, Injection site erythema, Rash, Skin warm
Clinical narrative: Patient reported left arm was burning within 10 minutes of receiving vaccine. Visible redness observed around injection site. Healthcare providers monitored closely -- noted left arm with developing rash, increasing warmth to touch, redness / rash on left upper arm spreading to neck and chest. Patient reported scratchy throat, onset of throat tightness and difficulty swallowing. EPI Pen administered in left thigh at 1128am. EMS activated. Patient remained awake and alert.  EMS arrived at 1139am, transported patient to ER via stretcher. Patient released from ER same day.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Patient reported left arm was burning within 10 minutes of receiving vaccine. Visible redness observed around injection site. Healthcare providers monitored closely -- noted left arm with developing rash, increasing warmth to touch, redness / rash on left upper arm spreading to neck and chest. Patient reported scratchy throat, onset of throat tightness and difficulty swallowing. EPI Pen administered in left thigh at 1128am. EMS activated. Patient remained awake and alert.  EMS arrived at 1139am, transported patient to ER via stretcher. Patient released from ER same day.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called the pharmacy on 12/1/2020 to report that her arm has been sore since the administration of the vaccine on 10/6/2020.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  The dose was not injected into the muscle as recommended.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Brain injury, Deafness unilateral, Magnetic resonance imaging brain abnormal
Clinical narrative: pt experienced hearing loss in left ear the morning following their flu shot. has had MRI since and patient has permanent hearing damage in left ear and brain damage. neurolgist said the flu shot likely may have triggered her autoimmune system to overreact
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommend.
Sex: U
Vaccine: FLUX
Symptoms: Psoriasis
Clinical narrative: Causing psoriasis to flare; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case was linked to case 2020SA290167 (same reporter).  This case involved an unknown demographic patient who experienced psoriasis flare (psoriasis), after receiving INFLUENZA VACCINE.  The patient had received flu vaccine since last three years which caused his/her psoriasis to flare.  The patient's past medical treatment(s), family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing Psoriasis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious psoriasis flare (psoriasis), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had broken out 2 weeks after taking these shots.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There would be no information available on the batch number for this case.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommend.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at the injection site. She presented to the emergency department on 11/12/20 and again to an urgent care center on 11/14/20. She was discharged on antibiotics without being admitted.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 65.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Arthralgia, Bone pain, Chest pain, Myalgia
Clinical narrative: Two days post-vax felt muscle/bone pain from elbow to shoulder, shoulder blade and upper breastplate pain. Still experiencing symptoms to date. Have not sought medical attention as of yet.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills
Clinical narrative: Temperature of 99.7 Severe chills
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu Vaccine was not administered correctly.  the dose was not injected into the muscle of the arm as recommended.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Fever, chills, felt blah,
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Product administration error
Clinical narrative: Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.