chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eye pruritus, Fatigue, Influenza like illness, Ocular hyperaemia
Clinical narrative: Red, burning, itchy left eye where she had previously (years prior) had a shingles outbreak. Reaction not confirmed as shingles.  Also had significant flu-like symptoms that lasted 7 days and fatigue still at day 10.  No reactions to first shot in series.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered at inappropriate site
Clinical narrative: Shot was given too high up in arm cause pain
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Cough, Fatigue, Feeling cold, Laryngitis
Clinical narrative: In the about 12 hr - severe joints pain, esp. large joints; chills, fatigue, generalized itching. On the third day - dry cough, sore throat, tracheolaryngitis.  On the fifth day (today, Monday) missed work due to feeling sick and noticed rash.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: In the about 12 hr - severe joints pain, esp. large joints; chills, fatigue, generalized itching. On the third day - dry cough, sore throat, tracheolaryngitis.  On the fifth day (today, Monday) missed work due to feeling sick and noticed rash.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: vaccine given on 9/14/2019....patient came to the pharmacy and reported that her shoulder has been sore since the vaccination and has a hard time lifting her arm.... i told the patient to contact her Dr. to determine if she needs to get the second dose....
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: patient developed rash in the injected area after 2 days, reported to a pharmacy
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: PATIENT DEVELOPED SHINGLE INFECTION AFTER GETTING SHINGRIX. SYMPTOMS WERE CONFIRMED BY MD. RASHES WITH BLISTERS ON CHEST/BACK/NECK
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dysphonia, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient reported that day of vaccine, she felt sick and had pain. 4 days later (day she reported it to pharmacy) she reported having a lot of pain at site, swollen, slight red lines; she also reported that day of reporting, she felt feverish, had hoarse voice, pain on shoulder that feels like "pounding".
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: Patient reported that day of vaccine, she felt sick and had pain. 4 days later (day she reported it to pharmacy) she reported having a lot of pain at site, swollen, slight red lines; she also reported that day of reporting, she felt feverish, had hoarse voice, pain on shoulder that feels like "pounding".
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient states she experience severe soreness ( swollen and tingling ) in arm, which caused generalized malaise and ER visit
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Shot on Thurs by Sat am itching in left arm progressing to burning sensation and redness by Sat pm.  Sunday itching and burning persisted with addition of intermittent sharp pain in area with rash and redness size of an orange.  Pain has persisted today, Monday.  Visited immediate care facility and they prescribed Valacyclovir 1000 mg, 3 times per day.  Am waiting another day before getting prescription to see if systems persist.  In the meantime using cold compress, baking soda and water paste, and lidocaine patch.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Insomnia, Myalgia, Nausea
Clinical narrative: Loss of appetite several hours after vaccination; nausea; insomnia; extreme fatigue; muscle aches.  Lasted from approximately 5:00 p.m. on 11/01/2019 through 11/03/2019.  Stayed in bed and slept intermittently all day 11/02/2019 and 11/03/2019.  All symptoms resolved 11/04/2019.
Age: 23.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Confusional state, Disorientation, Loss of consciousness, Presyncope
Clinical narrative: Member had vasovagal response and completely blacked out. episode lasted appx 3 seconds. member was disoriented and slightly confused upon coming to. member was treated by laying him on his back on the exam table, bending his knees, and placing a cold pack behind his neck. member stated after about 5 minutes that he felt back to normal and like himself again.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 11pm Itching began,  along with massive amount of Large and small hives and rash on back and chest, buttocks;  face, arms, stomach and legs milder rash
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10/31/2019 My left at became increasingly sore and painful and seemed to be radiating out of the deltoid muscle area.  11/1/2019 In the morning my left upper arm was visibly swollen as compared to the right. I noticed it while standing in front of the mirror. There was a reddened circle about 4-5 inches in diameter about 2 inches below the injection site. In the center of the reddened circle was an even redder circle about 2 inches in diameter. It was hot to the touch. After several hours the pain began to radiate into my clavicle area and I began to feel very warm (I did not think to take my temperature) Mid-day, I called agency to document the event and to find out what I should do. No one answered so I left a voice mail )work number). About 5:00pm I showed my boss and she took a photo of it but by this time the red circle in the center was gone and although still swollen did not appear as red but it was still warm to the touch.  11/2/2019 to 11/3/2019 The inflammation continued to improve (redness, pain and swelling) 11/4/2019 I had received an e-mail (work address) with this form and instructions.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: 10/31/2019 My left at became increasingly sore and painful and seemed to be radiating out of the deltoid muscle area.  11/1/2019 In the morning my left upper arm was visibly swollen as compared to the right. I noticed it while standing in front of the mirror. There was a reddened circle about 4-5 inches in diameter about 2 inches below the injection site. In the center of the reddened circle was an even redder circle about 2 inches in diameter. It was hot to the touch. After several hours the pain began to radiate into my clavicle area and I began to feel very warm (I did not think to take my temperature) Mid-day, I called agency to document the event and to find out what I should do. No one answered so I left a voice mail )work number). About 5:00pm I showed my boss and she took a photo of it but by this time the red circle in the center was gone and although still swollen did not appear as red but it was still warm to the touch.  11/2/2019 to 11/3/2019 The inflammation continued to improve (redness, pain and swelling) 11/4/2019 I had received an e-mail (work address) with this form and instructions.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV1
Symptoms: Wrong product administered
Clinical narrative: Provider ordered Pediarix, Hib, Rotarix, and Prevnar 13 on 10-29-19 at well baby. Nurse administered Pediarix, Hib, Rotarix and HPV9. On 10-29-19 at well baby exam
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Dyspnoea, Nausea, Throat irritation, Urticaria
Clinical narrative: Got flu + HPV vaccines today, within minutes, felt dizzy + nauseous. Then got hives on face, c/o trouble breathing and felt like "frog in throat". Had started to improve but went ahead and gave Benadryl. O wheezing. Vitals/BP stable. Hives resolved after ~45 min.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Back pain, Erythema, Foot fracture, Foot operation
Clinical narrative: Very swollen and inflamed (L) arm redness, headache Treatment: Icing or cool compress prn Benedry/liquid: Take 2 tsp every 6hrs to reduce inflammation Tylenol 650mg every 6hrs as needed
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hyperthyroidism, Hysterectomy, Inflammation, Intestinal adhesion lysis
Clinical narrative: Very swollen and inflamed (L) arm redness, headache Treatment: Icing or cool compress prn Benedry/liquid: Take 2 tsp every 6hrs to reduce inflammation Tylenol 650mg every 6hrs as needed
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Osteoarthritis, Paraesthesia, Peripheral swelling, Premature delivery, Spinal decompression
Clinical narrative: Very swollen and inflamed (L) arm redness, headache Treatment: Icing or cool compress prn Benedry/liquid: Take 2 tsp every 6hrs to reduce inflammation Tylenol 650mg every 6hrs as needed
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Tonsillectomy, Uterine cancer
Clinical narrative: Very swollen and inflamed (L) arm redness, headache Treatment: Icing or cool compress prn Benedry/liquid: Take 2 tsp every 6hrs to reduce inflammation Tylenol 650mg every 6hrs as needed
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis @ injection site
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm size of grapefruit fever - 103 degrees x 2 days -
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Dyspnoea, Vision blurred
Clinical narrative: Pt. received vaccine few minutes later Pt complainted of blurred vision light headedness, dizziness. initial diff. breath took BP 130/75 HR 70 Took 1 tab Benadryl gave water
Age: 4.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Abnormal behaviour, Confusional state, Nausea, Pyrexia, Skin warm
Clinical narrative: Pt. comes in with  mom, low grade fever last night and seemed confused after immunizations yesterday Patient was his usual self prior to receiving vaccines yesterday. He received Hep A and MMR #2. She stated upon leaving him and when putting him in his carseat and seemed confused. He was saying things that were not making sense and he was acting out of it. He was asking her to bring him back in clinic and how much he liked it here. He felt warm to her and temp at home was 99. While driving he fell asleep so she pulled over and he immediately woke up. She stopped to feed him and he ate well and then he was his normal self again. He had a good breakfast morning of vaccines. When he got home he complained of feeling like he was going to vomit. She recalls speaking with his previous pediatrician about similar experience following his one year vaccines. She also recalls him having fever and rash 2 weeks after those vaccines. Reviewed his chart and called 2 days after his vaccines with fever. Then phone call couple weeks later on 3/11/16 with rash.
Age: 21.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: On 10/03/2019 a few hours after receiving vaccines patient reports that her right arm swollen up, and was extremely painful, to the point she was unable to raise arm to put on steering wheel of car to drive. Did not take any medication, used a heating pad on arm. Started getting relief on the morning of 10/06/2019. On 10/07/2019 very little and no swelling.
Age: 84.0
Sex: U
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Malaise, Pyrexia
Clinical narrative: Before I started shopping at store. I got my flu and pneumonia vaccines. Very shortly after I felt dizzy and not well while shopping. The next day I had a fever + chills and spent 1 day in bed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms muscle aches, extreme fatigue
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Chapped lips, Glossitis, Glossodynia, Lip dry
Clinical narrative: Swelling of my throat, tongue and lips -fisure on center of my tongue became inflamed and very sore. Lasted about a week - my lips became very dry, cracked so when I smiled they bled some. My tongue has lost most taste buds so now I can barely taste my food.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Lip haemorrhage, Lip swelling, Pharyngeal swelling, Plicated tongue
Clinical narrative: Swelling of my throat, tongue and lips -fisure on center of my tongue became inflamed and very sore. Lasted about a week - my lips became very dry, cracked so when I smiled they bled some. My tongue has lost most taste buds so now I can barely taste my food.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Rash on torso treatment - Elocon cream 40mg
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient entered Health Center at approx. 9 am during non-clinic hours and reported to Office Assistant that he had itchiness and rash at flu injection area from immunization he received on 10/23/19. she asked if felt in medical distress, he denied any distress. OA provided with a called client later same day on 10/29/19 to provide follow up assessment. He denied pain, headache, fever, and had no other symptoms. Stated he continued to have rash on posterior and anterior of left arm. Reports he was seen by a provider at Health Center and prescribed acyclovi
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Polymyalgia rheumatica
Clinical narrative: patient reported aching joints after the shot (generalized joint aches) persisting weeks later. He recently informed me that he went to the MD & was diagnosed with PMR (polymyalgia rheumatica) & was prescribed with steroid which helped him per patient.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: On 10-21-19 patient reported prolonged soreness in left arm with some restriction in range of motion. Vaccine administered 9-20-19.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: hivEs/Rash at site and all ovER
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: her (left) arm got swollen, red and warm  if it got worse she was going to  go to MD otherwise just  leave it
Age: 2.92
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Mom noticed redness/rash on left thigh one day after vaccines were administered. Treated with Benadryl/ibuprofen.
Age: 27.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Onset swell, itchy, induration within 24' after SQ varicella vaccine. Examination revels 3cm induration, 5cm and tender, minimum erythema - (R) arm
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dysstasia, Gait disturbance, Inflammation, Injection site pain
Clinical narrative: Starting within 20 minutes of injection, arm pain and swelling from injection site in top of shoulder began. Over the next 24 hours the pain and swelling increased down the left afrm to just below the elbow. The elbow joint felt stiff. Skin itched. I used a cool compress on the inflamed area of my arm. At about 1:00pm on 10/24/209 while working in my compute I got extremely dizzy. I had trouble getting out of the chair. It was difficuplt to get my legs to walk. I had to support myself on the wall and furniture to get the living room chair. On 10/24/2019 I saw P/A at Health clinic. recommended rest and cool compress and intake of fluids. The reaction cleared up as of 10/27/2019.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Joint stiffness, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Starting within 20 minutes of injection, arm pain and swelling from injection site in top of shoulder began. Over the next 24 hours the pain and swelling increased down the left afrm to just below the elbow. The elbow joint felt stiff. Skin itched. I used a cool compress on the inflamed area of my arm. At about 1:00pm on 10/24/209 while working in my compute I got extremely dizzy. I had trouble getting out of the chair. It was difficuplt to get my legs to walk. I had to support myself on the wall and furniture to get the living room chair. On 10/24/2019 I saw P/A at Health clinic. recommended rest and cool compress and intake of fluids. The reaction cleared up as of 10/27/2019.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Eating disorder, Eye injury, Facial paralysis, Gait disturbance
Clinical narrative: shingles; Bell's palsy; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 17-MAY-2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).   On 08-JUN-2013, the patient suffered debilitating injuries including an outbreak of painful shingles, facial paralysis, eye injuries, and was diagnosed with Bell's palsy. Since these initial injuries manifested, the patient still experienced facial paralysis, problems with speech, eating, walking, pain, vision loss and other limitations still today (as reported). The patient did not recover from all the events. As per the reporter, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.  The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Speech disorder
Clinical narrative: shingles; Bell's palsy; Information has been received from a lawyer referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 17-MAY-2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).   On 08-JUN-2013, the patient suffered debilitating injuries including an outbreak of painful shingles, facial paralysis, eye injuries, and was diagnosed with Bell's palsy. Since these initial injuries manifested, the patient still experienced facial paralysis, problems with speech, eating, walking, pain, vision loss and other limitations still today (as reported). The patient did not recover from all the events. As per the reporter, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.  The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was determined to be medically significant.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Bladder dysfunction, Coronavirus test positive, Full blood count, Functional gastrointestinal disorder, Gait disturbance
Clinical narrative: Transverse Myletis characterlsted Initially by Intense pain In think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness In lower extremities and numbness; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Act (VAERS # 801379-1) on 26-SEP-2018 and refers to a 11-year-old female patient. The patient's illness at the time of vaccination included Coronavirus infection (Also reported as Coronavirus positive). The patient had no chronic or long-standing health conditions or no known allergies (NKA). She did not take any prescription or over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination.  On 18-JAN-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, intramuscularly in arm, lot # R005341 and expiration date: 06-DEC-2020 (Exact dose and frequency were not reported) for prophylaxis, a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 dose, intramuscularly in arm, lot # U6128AA (Exact dose, frequency and expiration date were not reported) for prophylaxis, and a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) 1 dose, intramuscularly in arm, lot # U6002CA (Exact dose, frequency and expiration date were not reported) for prophylaxis.  On 28-JAN-2019, the patient experienced transverse myelitis characterized initially by intense pain "in think" and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness. She sought doctor or other health professional office/clinic visit and emergency room/department or unit care on unknown dates. On an unknown date, approximately in January 2019, the patient was hospitalized due to the event for 7 days. On unknown dates, the patient had urinalysis (UA), infectious studies, complete blood count (CBC), renal ultrasound, magnetic resonance imaging (MRI), and unspecified tests named NLM and Anti-Maug performed, but no results for those studies were provided. On an unknown date, the patient had Coronavirus test with a positive result. The event of transverse myelitis caused the patient's disability or permanent damage. On an unknown date in 2019, the patient recovered from the event. The causality was not assessed by the primary reporter.  The Agency assessed the report to be serious.  Follow up information has been received from an admin on 01-NOV-2019. The admin enquired if there were any additional patient details available. It was reported that no additional patient details had been included in the report. The name of the health care professional (HCP) who reported the adverse event (AE) was provided to the admin. The admin stated that the form would be passed on to the physician to fill out if they were able to recall the patient who was involved in that AE.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Laboratory test, Mood altered, Muscular weakness, Myelitis transverse
Clinical narrative: Transverse Myletis characterlsted Initially by Intense pain In think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness In lower extremities and numbness; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Act (VAERS # 801379-1) on 26-SEP-2018 and refers to a 11-year-old female patient. The patient's illness at the time of vaccination included Coronavirus infection (Also reported as Coronavirus positive). The patient had no chronic or long-standing health conditions or no known allergies (NKA). She did not take any prescription or over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination.  On 18-JAN-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, intramuscularly in arm, lot # R005341 and expiration date: 06-DEC-2020 (Exact dose and frequency were not reported) for prophylaxis, a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 dose, intramuscularly in arm, lot # U6128AA (Exact dose, frequency and expiration date were not reported) for prophylaxis, and a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) 1 dose, intramuscularly in arm, lot # U6002CA (Exact dose, frequency and expiration date were not reported) for prophylaxis.  On 28-JAN-2019, the patient experienced transverse myelitis characterized initially by intense pain "in think" and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness. She sought doctor or other health professional office/clinic visit and emergency room/department or unit care on unknown dates. On an unknown date, approximately in January 2019, the patient was hospitalized due to the event for 7 days. On unknown dates, the patient had urinalysis (UA), infectious studies, complete blood count (CBC), renal ultrasound, magnetic resonance imaging (MRI), and unspecified tests named NLM and Anti-Maug performed, but no results for those studies were provided. On an unknown date, the patient had Coronavirus test with a positive result. The event of transverse myelitis caused the patient's disability or permanent damage. On an unknown date in 2019, the patient recovered from the event. The causality was not assessed by the primary reporter.  The Agency assessed the report to be serious.  Follow up information has been received from an admin on 01-NOV-2019. The admin enquired if there were any additional patient details available. It was reported that no additional patient details had been included in the report. The name of the health care professional (HCP) who reported the adverse event (AE) was provided to the admin. The admin stated that the form would be passed on to the physician to fill out if they were able to recall the patient who was involved in that AE.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain, Ultrasound kidney, Urine analysis
Clinical narrative: Transverse Myletis characterlsted Initially by Intense pain In think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness In lower extremities and numbness; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Act (VAERS # 801379-1) on 26-SEP-2018 and refers to a 11-year-old female patient. The patient's illness at the time of vaccination included Coronavirus infection (Also reported as Coronavirus positive). The patient had no chronic or long-standing health conditions or no known allergies (NKA). She did not take any prescription or over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination.  On 18-JAN-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, intramuscularly in arm, lot # R005341 and expiration date: 06-DEC-2020 (Exact dose and frequency were not reported) for prophylaxis, a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 dose, intramuscularly in arm, lot # U6128AA (Exact dose, frequency and expiration date were not reported) for prophylaxis, and a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) 1 dose, intramuscularly in arm, lot # U6002CA (Exact dose, frequency and expiration date were not reported) for prophylaxis.  On 28-JAN-2019, the patient experienced transverse myelitis characterized initially by intense pain "in think" and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness. She sought doctor or other health professional office/clinic visit and emergency room/department or unit care on unknown dates. On an unknown date, approximately in January 2019, the patient was hospitalized due to the event for 7 days. On unknown dates, the patient had urinalysis (UA), infectious studies, complete blood count (CBC), renal ultrasound, magnetic resonance imaging (MRI), and unspecified tests named NLM and Anti-Maug performed, but no results for those studies were provided. On an unknown date, the patient had Coronavirus test with a positive result. The event of transverse myelitis caused the patient's disability or permanent damage. On an unknown date in 2019, the patient recovered from the event. The causality was not assessed by the primary reporter.  The Agency assessed the report to be serious.  Follow up information has been received from an admin on 01-NOV-2019. The admin enquired if there were any additional patient details available. It was reported that no additional patient details had been included in the report. The name of the health care professional (HCP) who reported the adverse event (AE) was provided to the admin. The admin stated that the form would be passed on to the physician to fill out if they were able to recall the patient who was involved in that AE.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Hypoaesthesia, Laboratory test, Magnetic resonance imaging, Mood altered, Muscular weakness
Clinical narrative: Transverse Myletis characterlsted Initially by Intense pain In think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness In lower extremities and numbness; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Act (VAERS # 801379-1) on 26-SEP-2018 and refers to a 11-year-old female patient. The patient's illness at the time of vaccination included Coronavirus infection (Also reported as Coronavirus positive). The patient had no chronic or long-standing health conditions or no known allergies (NKA). She did not take any prescription or over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination.  On 18-JAN-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, intramuscularly in arm, lot # R005341 and expiration date: 06-DEC-2020 (Exact dose and frequency were not reported) for prophylaxis, a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 dose, intramuscularly in arm, lot # U6128AA (Exact dose, frequency and expiration date were not reported) for prophylaxis, and a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) 1 dose, intramuscularly in arm, lot # U6002CA (Exact dose, frequency and expiration date were not reported) for prophylaxis.  On 28-JAN-2019, the patient experienced transverse myelitis characterized initially by intense pain "in think" and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness. She sought doctor or other health professional office/clinic visit and emergency room/department or unit care on unknown dates. On an unknown date, approximately in January 2019, the patient was hospitalized due to the event for 7 days. On unknown dates, the patient had urinalysis (UA), infectious studies, complete blood count (CBC), renal ultrasound, magnetic resonance imaging (MRI), and unspecified tests named NLM and Anti-Maug performed, but no results for those studies were provided. On an unknown date, the patient had Coronavirus test with a positive result. The event of transverse myelitis caused the patient's disability or permanent damage. On an unknown date in 2019, the patient recovered from the event. The causality was not assessed by the primary reporter.  The Agency assessed the report to be serious.  Follow up information has been received from an admin on 01-NOV-2019. The admin enquired if there were any additional patient details available. It was reported that no additional patient details had been included in the report. The name of the health care professional (HCP) who reported the adverse event (AE) was provided to the admin. The admin stated that the form would be passed on to the physician to fill out if they were able to recall the patient who was involved in that AE.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Myelitis transverse, Pain, Ultrasound kidney, Urine analysis
Clinical narrative: Transverse Myletis characterlsted Initially by Intense pain In think and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness In lower extremities and numbness; This report was obtained on request by the Company from the Food and Drug Administration (FDA) under the Act (VAERS # 801379-1) on 26-SEP-2018 and refers to a 11-year-old female patient. The patient's illness at the time of vaccination included Coronavirus infection (Also reported as Coronavirus positive). The patient had no chronic or long-standing health conditions or no known allergies (NKA). She did not take any prescription or over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination.  On 18-JAN-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, intramuscularly in arm, lot # R005341 and expiration date: 06-DEC-2020 (Exact dose and frequency were not reported) for prophylaxis, a dose of diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) 1 dose, intramuscularly in arm, lot # U6128AA (Exact dose, frequency and expiration date were not reported) for prophylaxis, and a dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) 1 dose, intramuscularly in arm, lot # U6002CA (Exact dose, frequency and expiration date were not reported) for prophylaxis.  On 28-JAN-2019, the patient experienced transverse myelitis characterized initially by intense pain "in think" and low pain, gait changes, bowel/bladder dysfunction, mood changes progressing to weakness in lower extremities and numbness. She sought doctor or other health professional office/clinic visit and emergency room/department or unit care on unknown dates. On an unknown date, approximately in January 2019, the patient was hospitalized due to the event for 7 days. On unknown dates, the patient had urinalysis (UA), infectious studies, complete blood count (CBC), renal ultrasound, magnetic resonance imaging (MRI), and unspecified tests named NLM and Anti-Maug performed, but no results for those studies were provided. On an unknown date, the patient had Coronavirus test with a positive result. The event of transverse myelitis caused the patient's disability or permanent damage. On an unknown date in 2019, the patient recovered from the event. The causality was not assessed by the primary reporter.  The Agency assessed the report to be serious.  Follow up information has been received from an admin on 01-NOV-2019. The admin enquired if there were any additional patient details available. It was reported that no additional patient details had been included in the report. The name of the health care professional (HCP) who reported the adverse event (AE) was provided to the admin. The admin stated that the form would be passed on to the physician to fill out if they were able to recall the patient who was involved in that AE.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Lip swelling, Pruritus, Rash generalised, Swelling face
Clinical narrative: The patient woke up around 0200 Friday morning complaining with itching and hives on trunk; the patient woke up with itching and hives on trunk/ the patient presented again with worsening itching; Patient presented rash head to toe; Swelling in lips and face; shortness of breath; This spontaneous report as received from a healthcare professional, via Food and Drug Administration (FDA), referring to a 12-years-old male patient. The patient's concurrent conditions included asthma; Illness at time of vaccionation included possible scabies; previous allergies to medications, food or other products were unknown by the reporter; and concomitant medications were not reported.  On 21-FEB-2019 at 17:00hrs, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (IM), in an unspecified arm, for prophylaxis. On 22-FEB-2019 around 02:00hrs, he woke up complaining with itching (pruritus) and hives (urticaria) on trunk.  On unknown date in 2019, the patient presented to emergency department (ED) with worsening hives.   The patient was discharged on dexamethasone (DECADRON), diphenhydramine hydrochloride (BENADRYL) and "ap epi pen". He presented again with worsening itching and rash head to toe (rash generalised), swelling in lips and face (swelling face) and shortness of breath (dyspnoea). The patient received diphenhydramine hydrochloride (BENADRYL) (reported as Bendaryl), famotidine (PEPCID), dexamethasone (DECADRON), ibuprofen (MOTRIN), albuterol sulfate (+) ipratropium bromide (DUONEBS) and epi 0.3 with some improvement. Therefore the outcome was considered as recovering/resolving.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events, was not reported.  The agency considered the event(s) to be serious for the following reason: medically significant.  Follow up information was received on 30-OCT-2019.  A phone call was placed to the immunization manager. The call was answered by receptionist and was transferred to the office manager. No assistance was received as the patient could not be located with incomplete identifiers.  This is an amended report, the 'Received from Agency' field was un-checked.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: The patient woke up around 0200 Friday morning complaining with itching and hives on trunk; the patient woke up with itching and hives on trunk/ the patient presented again with worsening itching; Patient presented rash head to toe; Swelling in lips and face; shortness of breath; This spontaneous report as received from a healthcare professional, via Food and Drug Administration (FDA), referring to a 12-years-old male patient. The patient's concurrent conditions included asthma; Illness at time of vaccionation included possible scabies; previous allergies to medications, food or other products were unknown by the reporter; and concomitant medications were not reported.  On 21-FEB-2019 at 17:00hrs, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (IM), in an unspecified arm, for prophylaxis. On 22-FEB-2019 around 02:00hrs, he woke up complaining with itching (pruritus) and hives (urticaria) on trunk.  On unknown date in 2019, the patient presented to emergency department (ED) with worsening hives.   The patient was discharged on dexamethasone (DECADRON), diphenhydramine hydrochloride (BENADRYL) and "ap epi pen". He presented again with worsening itching and rash head to toe (rash generalised), swelling in lips and face (swelling face) and shortness of breath (dyspnoea). The patient received diphenhydramine hydrochloride (BENADRYL) (reported as Bendaryl), famotidine (PEPCID), dexamethasone (DECADRON), ibuprofen (MOTRIN), albuterol sulfate (+) ipratropium bromide (DUONEBS) and epi 0.3 with some improvement. Therefore the outcome was considered as recovering/resolving.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events, was not reported.  The agency considered the event(s) to be serious for the following reason: medically significant.  Follow up information was received on 30-OCT-2019.  A phone call was placed to the immunization manager. The call was answered by receptionist and was transferred to the office manager. No assistance was received as the patient could not be located with incomplete identifiers.  This is an amended report, the 'Received from Agency' field was un-checked.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: The patient woke up around 0200 Friday morning complaining with itching and hives on trunk; the patient woke up with itching and hives on trunk/ the patient presented again with worsening itching; Patient presented rash head to toe; Swelling in lips and face; shortness of breath; This spontaneous report as received from a healthcare professional, via Food and Drug Administration (FDA), referring to a 12-years-old male patient. The patient's concurrent conditions included asthma; Illness at time of vaccionation included possible scabies; previous allergies to medications, food or other products were unknown by the reporter; and concomitant medications were not reported.  On 21-FEB-2019 at 17:00hrs, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (IM), in an unspecified arm, for prophylaxis. On 22-FEB-2019 around 02:00hrs, he woke up complaining with itching (pruritus) and hives (urticaria) on trunk.  On unknown date in 2019, the patient presented to emergency department (ED) with worsening hives.   The patient was discharged on dexamethasone (DECADRON), diphenhydramine hydrochloride (BENADRYL) and "ap epi pen". He presented again with worsening itching and rash head to toe (rash generalised), swelling in lips and face (swelling face) and shortness of breath (dyspnoea). The patient received diphenhydramine hydrochloride (BENADRYL) (reported as Bendaryl), famotidine (PEPCID), dexamethasone (DECADRON), ibuprofen (MOTRIN), albuterol sulfate (+) ipratropium bromide (DUONEBS) and epi 0.3 with some improvement. Therefore the outcome was considered as recovering/resolving.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events, was not reported.  The agency considered the event(s) to be serious for the following reason: medically significant.  Follow up information was received on 30-OCT-2019.  A phone call was placed to the immunization manager. The call was answered by receptionist and was transferred to the office manager. No assistance was received as the patient could not be located with incomplete identifiers.  This is an amended report, the 'Received from Agency' field was un-checked.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: The patient woke up around 0200 Friday morning complaining with itching and hives on trunk; the patient woke up with itching and hives on trunk/ the patient presented again with worsening itching; Patient presented rash head to toe; Swelling in lips and face; shortness of breath; This spontaneous report as received from a healthcare professional, via Food and Drug Administration (FDA), referring to a 12-years-old male patient. The patient's concurrent conditions included asthma; Illness at time of vaccionation included possible scabies; previous allergies to medications, food or other products were unknown by the reporter; and concomitant medications were not reported.  On 21-FEB-2019 at 17:00hrs, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (IM), in an unspecified arm, for prophylaxis. On 22-FEB-2019 around 02:00hrs, he woke up complaining with itching (pruritus) and hives (urticaria) on trunk.  On unknown date in 2019, the patient presented to emergency department (ED) with worsening hives.   The patient was discharged on dexamethasone (DECADRON), diphenhydramine hydrochloride (BENADRYL) and "ap epi pen". He presented again with worsening itching and rash head to toe (rash generalised), swelling in lips and face (swelling face) and shortness of breath (dyspnoea). The patient received diphenhydramine hydrochloride (BENADRYL) (reported as Bendaryl), famotidine (PEPCID), dexamethasone (DECADRON), ibuprofen (MOTRIN), albuterol sulfate (+) ipratropium bromide (DUONEBS) and epi 0.3 with some improvement. Therefore the outcome was considered as recovering/resolving.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events, was not reported.  The agency considered the event(s) to be serious for the following reason: medically significant.  Follow up information was received on 30-OCT-2019.  A phone call was placed to the immunization manager. The call was answered by receptionist and was transferred to the office manager. No assistance was received as the patient could not be located with incomplete identifiers.  This is an amended report, the 'Received from Agency' field was un-checked.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This case was reported by a consumer and described the occurrence of bell's palsy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lyme disease.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, 2 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was unaware if he had experienced lyme's disease before or after receiving Shingrix. The patient was diagnosed with Bell's Palsy after receiving Shingrix. The patient asked whether she can receive the 2nd dose of Shingrix and was concerned if she may again experience Bell's Palsy symptoms again from receiving the 2nd dose of Shingrix.
Age: 74.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3
Symptoms: Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Extreme pain when shot was given.  It felt like syrup going into the left arm.  The shot was very high.  Extreme pain in arm within 10 minutes where I could not lift my left elbow without severe pain
Age: 74.0
Sex: M
Vaccine: FLUA3, TDAP, FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain, Nerve injury, Product administered at inappropriate site, Ultrasound scan normal
Clinical narrative: Extreme pain when shot was given.  It felt like syrup going into the left arm.  The shot was very high.  Extreme pain in arm within 10 minutes where I could not lift my left elbow without severe pain
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Felt bad; General malaise; fever; headache; joint ache; nausea; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 10 days after receiving Shingrix, the patient experienced feeling bad, malaise, fever, headache, joint pain and nausea. On an unknown date, the outcome of the feeling bad, malaise, fever, headache, joint pain and nausea were recovered/resolved.   The reporter considered the feeling bad, malaise, fever, headache, joint pain and nausea to be probably related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 10 days later he felt bad. He experienced general malaise with fever, headache, joint ache and nausea. His doctors said it was probably from the Shingrix vaccine. All his symptoms resolved after two weeks.The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field of database (recovered) and the outcome reported in the source document (recovered with sequel).