chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Asthenia, Contraindication to vaccination, Influenza
Clinical narrative: pneumonia; Initial information received on 17-Sep-2020 regarding an unsolicited valid serious case received from a consumer non-healthcare professional.  This case is linked to case 2020SA257965 (same reporter).  This case involves a 72-years-old female patient who experienced pneumonia, while she received INFLUENZA VACCINE.  The patient's medical history included smallpox, pneumonia and allergy to eggs due to which she had the reactions of abdominal pain, peripheral swelling and rash macular.  The patient's past vaccination included smallpox vaccine (when studied abroad and came down with cowpox) and Influenza vaccine (unknown manufacturer).  The patient's past medical treatment and family history were not provided.  At the time of the event, the patient had ongoing food allergy.  Concomitant medications included two part and booster PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  On an unknown date, the patient received a once 0.5 mL 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 serious pneumonia unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from pneumonia.  Batch number has been requested for suspect product for this case.; Sender's Comments: An 72-years-old female patient who presented with pneumonia following the vaccination with INFLUENZA VACCINE (unknown manufacturer).Time to onset is not clearly defined. Medical history include smallpox, pneumonia, abdominal pain, peripheral swelling and rash macular. Patient also had ongoing food allergy. Concomitant medication include PNEUMOCOCCAL VACCINE. Patient's past vaccination included smallpox vaccine and Influenza vaccine. Precise etiological diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received vaccine after it had been exposed to temperatures below the recommended range for 2 hours at a low temperature of 30.9 degrees, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from the other healthcare professional.   This case involves a 85 year old female patient who was vaccinated with a 0.5 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Prefilled syringe, lot UJ453AB and expiration date was 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 22-Sep-2020 after it had been exposed to temperature at 30.9 degrees F (Fahrenheit), due to refrigerator malfunction for 2 hours on an unknown date.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive concomitant vaccines.  It was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was inadvertently administered an expired dose of Daptacel, no AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional .  This case involves a 15-month-old female patient who was vaccinated with an expired 0.5 mL fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] once (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination on 11-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and INFLUENZA VACCINE (FLU) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; 63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; 63-year-old patient inadvertently administered the Fluzone High-Dose Quadrivalent rather than Fluzone Quadrivalent vaccine, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other care health professional.  This case involves a 63 year old female patient who was vaccinated with a 0.5 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ478AA and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 22-Sep-2020.   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient did not receive concomitant vaccines.  It was an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 88.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site bruising, Seizure, Vertigo
Clinical narrative: Patient started to feel faintness almost immediately upon receiving the vaccine. She then continued to experience a light headed feeling, vertigo, and then had a seizure.  Sought medical advice from PCP, but doctor did not indicate that the seizure was caused by immunization.  Patient has experienced seizures before.  Patient also experienced bruising at the site of the injection that has lasted over 14 days now.
Age: 60.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Fever that started around 9:00 a.m. and continued through at least 11:00 p.m. Highest temperature of 100.9  Achiness in joints, especially tops of legs.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Individual reported developing Hives 2 hours post vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Anaemia, Colectomy, Decreased activity, Enema administration, Haematochezia
Clinical narrative: As described by parents on September the 14th, 2020, she developed an unusual vomiting, and she had a decreased activity, so as this clinic situation progressed infant had a decreased intake and had a bilious vomit so she was taken to ER were she was evaluated  IVFS RL bolus given 10cc/kg and IVFS maintenance started, while being evaluated she produced a frankly bilious vomit a pediatrics surgery consulted who ordered an UGI Series , which was negative for Volvulus or Malrotation. Trasferred  to the floor she developed a frankly bloody stool on September the 16th, 2020 she had KUB series twice since 6 hrs apart that could not ruled out Volvulus . An US performed after demonstrated an Intussusception and so she she was brought to Radiology urgently for a barium enema reduction . Multiple attempts at reduction were unsuccessful requiring a laparoscopic converted to open resection of distal Ileum (with resection of ileocecal valve) cecum and right colon with stapled IC anastomosis .She required aggressive IVFs a central line was placed for that purpose. Pathology revealed resection of 12 cm distal Ileum and 18 cm of right Colon . Transferred to PICU where found anemic 1 u PRBC given plus IVFs TPN and antibiotic treatment accordingly , she was started on progressive feedings until no further episodes of vomiting and with a appropriate stooling and voiding and she was well appearing she was discharge on September the 24th , 2020. Note this is a record taken from the hospital discharge note on record.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Hypophagia, Ileocaecal resection, Intensive care, Intestinal anastomosis, Intussusception
Clinical narrative: As described by parents on September the 14th, 2020, she developed an unusual vomiting, and she had a decreased activity, so as this clinic situation progressed infant had a decreased intake and had a bilious vomit so she was taken to ER were she was evaluated  IVFS RL bolus given 10cc/kg and IVFS maintenance started, while being evaluated she produced a frankly bilious vomit a pediatrics surgery consulted who ordered an UGI Series , which was negative for Volvulus or Malrotation. Trasferred  to the floor she developed a frankly bloody stool on September the 16th, 2020 she had KUB series twice since 6 hrs apart that could not ruled out Volvulus . An US performed after demonstrated an Intussusception and so she she was brought to Radiology urgently for a barium enema reduction . Multiple attempts at reduction were unsuccessful requiring a laparoscopic converted to open resection of distal Ileum (with resection of ileocecal valve) cecum and right colon with stapled IC anastomosis .She required aggressive IVFs a central line was placed for that purpose. Pathology revealed resection of 12 cm distal Ileum and 18 cm of right Colon . Transferred to PICU where found anemic 1 u PRBC given plus IVFs TPN and antibiotic treatment accordingly , she was started on progressive feedings until no further episodes of vomiting and with a appropriate stooling and voiding and she was well appearing she was discharge on September the 24th , 2020. Note this is a record taken from the hospital discharge note on record.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Laparoscopic surgery, Packed red blood cell transfusion, Procedural failure, Ultrasound scan abnormal, Urinary system X-ray
Clinical narrative: As described by parents on September the 14th, 2020, she developed an unusual vomiting, and she had a decreased activity, so as this clinic situation progressed infant had a decreased intake and had a bilious vomit so she was taken to ER were she was evaluated  IVFS RL bolus given 10cc/kg and IVFS maintenance started, while being evaluated she produced a frankly bilious vomit a pediatrics surgery consulted who ordered an UGI Series , which was negative for Volvulus or Malrotation. Trasferred  to the floor she developed a frankly bloody stool on September the 16th, 2020 she had KUB series twice since 6 hrs apart that could not ruled out Volvulus . An US performed after demonstrated an Intussusception and so she she was brought to Radiology urgently for a barium enema reduction . Multiple attempts at reduction were unsuccessful requiring a laparoscopic converted to open resection of distal Ileum (with resection of ileocecal valve) cecum and right colon with stapled IC anastomosis .She required aggressive IVFs a central line was placed for that purpose. Pathology revealed resection of 12 cm distal Ileum and 18 cm of right Colon . Transferred to PICU where found anemic 1 u PRBC given plus IVFs TPN and antibiotic treatment accordingly , she was started on progressive feedings until no further episodes of vomiting and with a appropriate stooling and voiding and she was well appearing she was discharge on September the 24th , 2020. Note this is a record taken from the hospital discharge note on record.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: As described by parents on September the 14th, 2020, she developed an unusual vomiting, and she had a decreased activity, so as this clinic situation progressed infant had a decreased intake and had a bilious vomit so she was taken to ER were she was evaluated  IVFS RL bolus given 10cc/kg and IVFS maintenance started, while being evaluated she produced a frankly bilious vomit a pediatrics surgery consulted who ordered an UGI Series , which was negative for Volvulus or Malrotation. Trasferred  to the floor she developed a frankly bloody stool on September the 16th, 2020 she had KUB series twice since 6 hrs apart that could not ruled out Volvulus . An US performed after demonstrated an Intussusception and so she she was brought to Radiology urgently for a barium enema reduction . Multiple attempts at reduction were unsuccessful requiring a laparoscopic converted to open resection of distal Ileum (with resection of ileocecal valve) cecum and right colon with stapled IC anastomosis .She required aggressive IVFs a central line was placed for that purpose. Pathology revealed resection of 12 cm distal Ileum and 18 cm of right Colon . Transferred to PICU where found anemic 1 u PRBC given plus IVFs TPN and antibiotic treatment accordingly , she was started on progressive feedings until no further episodes of vomiting and with a appropriate stooling and voiding and she was well appearing she was discharge on September the 24th , 2020. Note this is a record taken from the hospital discharge note on record.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Rash
Clinical narrative: Right arm swollen and has a rash all over started yesterday.  Treated with Benadryl.  This morning rash is gone but still swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Periarthritis
Clinical narrative: Patient called and said at night she had pain and couldn?t move her hand even for 10 degrees, she searched online and believes she has frozen shoulder. Advised her to contact her doctor or emergency room ASAP to be evaluated and treated and completed the report.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Woke up approximately 11:50 PM. Severe pain in stomach area. Nausea. Used bathroom to defecate. Took Gasx.   Went back to sleep and woke again approximately 1:20 AM. Continued stomach pain, nausea. Violently vomited small amount. Went back to sleep.   Woke 5:30 AM. Mild nausea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Extremely fatigued, rash on torso day after second dose.  Patient denied any fever, chills, body aches. Rash resolved within 2 days.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Dizziness, Laboratory test normal, Loss of personal independence in daily activities, Nausea
Clinical narrative: 9/18/2020 at 11:15 am Client stated she became nauseated and dizzy. Client reported this to her supervisor. Client went on 9/18/2020 for COVID Testing which was negative. Client stated on 9/20/2020 she went to urgent care because she began  vomiting and had severe vertigo and was given a CT scan and prescribed Meclizine and Zofran. Client had little improvement and visited her doctor 9/23/2020 as she could not return to work. Her doctor prescribed more Zofran and started her on antibiotics which the client noticed she began to notice improvements. Client returned to work on 9/29/2020 still having episodes of dizziness but less than before.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative, Vertigo, Vomiting
Clinical narrative: 9/18/2020 at 11:15 am Client stated she became nauseated and dizzy. Client reported this to her supervisor. Client went on 9/18/2020 for COVID Testing which was negative. Client stated on 9/20/2020 she went to urgent care because she began  vomiting and had severe vertigo and was given a CT scan and prescribed Meclizine and Zofran. Client had little improvement and visited her doctor 9/23/2020 as she could not return to work. Her doctor prescribed more Zofran and started her on antibiotics which the client noticed she began to notice improvements. Client returned to work on 9/29/2020 still having episodes of dizziness but less than before.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Erythema, edema, pain, tactile warmth began on 9/28/20, the same day he received vaccines.  Parent treated with ice and Tylenol at home.  Parent reported reactions to PCP office on 9/30/20 and was advised to have him seen.  Parent took him to an Urgent Care where they prescribed Benadryl and triamcinolone acetonide topical cream and advised to keep clean & dry and take IBU PRN.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Burning sensation, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports that her arm is still hurting, she said it was burning before and swollen. Now it got better but still hurts sometimes when she gets dressed and picks up her arm
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Cyanosis, Foetal exposure during pregnancy
Clinical narrative: turned blue; This case was reported by a consumer via interactive digital media and described the occurrence of cyanosis in a female child exposed to Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received Influenza vaccine Quadrivalent unspecified season. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The child was exposed to  at an unknown time during the pregnancy. The child was diagnosed with cyanosis. On an unknown date, the outcome of the cyanosis was unknown.   It was unknown if the reporter considered the cyanosis to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The patient turned blue hours after the flu vaccine, head of pediatrics said oops this did happen, they would put it in her medical file to never give it to her again. The reporter consented to follow up. This case is linked with US2020AMR192700, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR192700:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Illness
Clinical narrative: trying to get my strength back; sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and strength loss of. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the strength loss of was not recovered/not resolved.   It was unknown if the reporter considered the sickness and strength loss of to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated to be careful with the flu shot. The patient was so sick for 3 days and was just trying to get the strength back. This was the first time that had ever happened to the patient.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Transient ischaemic attack
Clinical narrative: TIA in June; dose was given prior to her stroke / spent 1 night in the hospital; This case was reported by a pharmacist via call center representative and described the occurrence of transient ischemic attack in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date 19th December 2021) for prophylaxis.   On 16th June 2020, the patient received the 1st dose of Shingrix. On 27th June 2020, 11 days after receiving Shingrix, the patient experienced transient ischemic attack (serious criteria hospitalization and GSK medically significant) and stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the transient ischemic attack and stroke were unknown.   It was unknown if the reporter considered the transient ischemic attack and stroke to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had transient ischemic attack/stroke and spent one night in the hospital. The patient wanted to get her 2nd dose of Shingrix on the date of reporting. The reporter was asking if this was advisable. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic shock, Asthenia, Eye pain, Headache, Joint swelling
Clinical narrative: anaphylactic shock; Headache; Pain behind the right eye; Swollen joints; Weakness; Body rash; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic shock in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 20th September 2022) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant and life threatening), headache (serious criteria life threatening), pain behind eyes (serious criteria life threatening), swollen joints (serious criteria life threatening), weakness (serious criteria life threatening) and generalized rash (serious criteria life threatening). The patient was treated with corticosteroid nos (Corticoids). On an unknown date, the outcome of the anaphylactic shock was unknown and the outcome of the headache, pain behind eyes, swollen joints, weakness and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the anaphylactic shock, headache, pain behind eyes, swollen joints, weakness and generalized rash to be related to Shingrix.  Additional information was provided as follows: The patient suffered and adverse reaction (Headache, Pain behind the right eye, Swollen joints, Weakness, Body rash) after fist dose of Shingrix administration. The patient was still under medical treatment with corticoids after the adverse reaction. Patient's doctor informed that the reaction was  consequence of an anaphylactic shock after receiving Shingrix. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: anaphylactic shock; Headache; Pain behind the right eye; Swollen joints; Weakness; Body rash; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic shock in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 20th September 2022) for prophylaxis.   On 13th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant and life threatening), headache (serious criteria life threatening), pain behind eyes (serious criteria life threatening), swollen joints (serious criteria life threatening), weakness (serious criteria life threatening) and generalized rash (serious criteria life threatening). The patient was treated with corticosteroid nos (Corticoids). On an unknown date, the outcome of the anaphylactic shock was unknown and the outcome of the headache, pain behind eyes, swollen joints, weakness and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the anaphylactic shock, headache, pain behind eyes, swollen joints, weakness and generalized rash to be related to Shingrix.  Additional information was provided as follows: The patient suffered and adverse reaction (Headache, Pain behind the right eye, Swollen joints, Weakness, Body rash) after fist dose of Shingrix administration. The patient was still under medical treatment with corticoids after the adverse reaction. Patient's doctor informed that the reaction was  consequence of an anaphylactic shock after receiving Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program.  A female consumer of unknown age received pneumococcal 13-val conjugated vaccine (dipht crm197 protein) (PREVNAR 13) for immunization many years before the report. Medical history included celiac disease. Concomitant medications were unknown. Consumer stated that she had the original pneumonia shot many years before the report; consumer also stated that she did not want to get the shingles again so she was due to receive a shingles vaccine the day after the report. The outcome of the event was unknown. No follow-up attempts are possible. Information regarding batch/lot number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 74 year old patient who just received the Fluzone Quadrivalent instead of fluzone high dose, no AE; Initial information received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 74 years old female patient who received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on 23-Sep-2020 (PT: wrong product administered).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).it was also reported that several other patients that could have received the Fluzone High-Dose.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Rash, Rash erythematous
Clinical narrative: Mother called the clinic on Tuesday 9-29-2020 to report and seek counseling that her daughter (pt) had broken out in a rash Thursday afternoon. The rash started with a few red bumps on her face and slowly progressed down her arms/trunk/legs over the next day. States rash has stayed the same, it is not getting worse. Mother reports that rash is still present but there is no itching associated with it. States it is not hives, just generalized rash. States rash hasn't been treated. Encouraged to use Benadryl cream on rash or take Benadryl tablets and to call family doctor if rash gets worse or does not seem to be improving after taking several Benadryl for a couple of days. Supervisor also spoke with mom over phone using speaker phone. Reassured mom. We will follow up with phone call to mom on Friday.
Age: 33.0
Sex: M
Vaccine: FLUA3
Symptoms: Headache, Sleep disorder
Clinical narrative: I had an extremely severe headache beginning Tuesday mildly and escalating to severe by Thursday affecting my sleep and continuing through Saturday when it slowly abated. I don't get headaches ordinarily. It was bad enough I considered going to the hospital Sunday if it didn't improve but it was bad enough I attributed it to be more likely a brain tumor or something than related to the vaccine. I can't figure out what else it could possibly have been.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Adverse reaction started about 3 hours after injection.    Had   headache (6 to 7 on pain scale) which lasted  24 hours, accompanied with tiredness, mild arm pain, chills, muscle aches.    Adverse reactions began resolving late afternoon of September 29. Had similar adverse reaction with FIRST shingrix injection which was not reported to VAERS.   First shingrix adverse reactions lasted 1 day longer then adverse reaction from SECOND shingrix.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Generalised tonic-clonic seizure, Loss of consciousness, Postictal state
Clinical narrative: Pt presented today for a flu immunization. She is accompanied by her mother and two younger brothers. All three received the Fluzone quadrivalent vaccine (NDC 49281-0633-15; LOT: UJ457AA; EXP: 6/30/21) provided by the program. She was seated.   Four minutes after administration pt stated "I don't feel good" and became unconscious. She then began seizing w/posturing and convulsions. RN was in the rm, called for assistance, and began seizure management. MD came into the room within 30 seconds and assisted with management. EMS was called.   Pt was tonic-clonic for ~45 seconds, and post-ictal for ~10 minutes. RN and MD stayed with the pt until she left via ambulance to hospital.   EMS obtained a BP of 93/56, BG of 84. Pt was A&Ox4 when EMS arrived. She only complained of fatigue.   Pt was able to walk unassisted to the ambulance and left the clinic in good condition.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Posturing, Seizure
Clinical narrative: Pt presented today for a flu immunization. She is accompanied by her mother and two younger brothers. All three received the Fluzone quadrivalent vaccine (NDC 49281-0633-15; LOT: UJ457AA; EXP: 6/30/21) provided by the program. She was seated.   Four minutes after administration pt stated "I don't feel good" and became unconscious. She then began seizing w/posturing and convulsions. RN was in the rm, called for assistance, and began seizure management. MD came into the room within 30 seconds and assisted with management. EMS was called.   Pt was tonic-clonic for ~45 seconds, and post-ictal for ~10 minutes. RN and MD stayed with the pt until she left via ambulance to hospital.   EMS obtained a BP of 93/56, BG of 84. Pt was A&Ox4 when EMS arrived. She only complained of fatigue.   Pt was able to walk unassisted to the ambulance and left the clinic in good condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Besides the expected soreness at the injection site, I began feeling fatigued with  body aches around 3 p.m. the day of the injection. At midnight I had a 99.5 temp with chills, increased body aches, and  skin of my upper torso and arms were  sensitive to the touch. No rash though.  I took 2 Ibuprofen at that time but my temp peaked at 100.1 by 1 a.m.  I took 2 more ibuprofen at 4 a.m. and my temp started to go back to normal. I rested most of the following day because I still had the body aches and fatigue, not just tired. The skin sensitivity was gone. My temp started to increase again at 9:30 pm so I took 2 more ibuprofen. My normal body temp is usually 96.7 - 97.3.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: Besides the expected soreness at the injection site, I began feeling fatigued with  body aches around 3 p.m. the day of the injection. At midnight I had a 99.5 temp with chills, increased body aches, and  skin of my upper torso and arms were  sensitive to the touch. No rash though.  I took 2 Ibuprofen at that time but my temp peaked at 100.1 by 1 a.m.  I took 2 more ibuprofen at 4 a.m. and my temp started to go back to normal. I rested most of the following day because I still had the body aches and fatigue, not just tired. The skin sensitivity was gone. My temp started to increase again at 9:30 pm so I took 2 more ibuprofen. My normal body temp is usually 96.7 - 97.3.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: IZ area is red, swollen, and very itchy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, IPV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Two doses of IPOL  given at same office visit.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Peripheral swelling
Clinical narrative: 30 minutes after administration of Pneumovax 23 patient noticed itching, redness, and a hive at the sight of injection.  As the evening progressed, the itching became unbearably worse.  Patient had to take Benadryl and use Hydrocortisone cream to relieve itching.  When she woke up, her arm is extremely swollen and there is an erythema that extends from her shoulder to slightly past elbow and covers most of the width of the outside and some of the inside of the arm.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Swollen tongue, Throat tightness
Clinical narrative: Pt developed throat tightness, tongue swelling and numbness of lips. No  respiratory distress, no wheezing, no tachycardia. S/S started 30 seconds after injection. Alert throughout - no chest tightness.  No Hives or skin disturbance. Vital signs remained stable Given Prednisone 20 mg po at 0945 and 40 mg  at 0950 am to take 10/1/2020 am, Solumedrol 125 mg IM
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Heart rate increased, Insomnia, Lymphadenopathy
Clinical narrative: Swelling & redness of lymph node on upper left chest that lasted for 3-4 days, fever & chills 2nd night, elevated resting heart rate....normal is 60-65, 2nd night it stayed over 90 and 3rd night is was over 80. Then back to normal.  Insomnia for 3 nights.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling & redness of lymph node on upper left chest that lasted for 3-4 days, fever & chills 2nd night, elevated resting heart rate....normal is 60-65, 2nd night it stayed over 90 and 3rd night is was over 80. Then back to normal.  Insomnia for 3 nights.
Age: 8.0
Sex: M
Vaccine: FLUA3
Symptoms: Syncope
Clinical narrative: Patient with witnessed syncope following administration of vaccine. No injuries. Recovered within 20 minutes.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pt described swelling and rash in left arm injected with Shingrix on 9/25/20 at 5pm after getting vaccination in the morning that day.  Pt states that she took 2 Benadryl 25mg that night, and then continued her regular loratadine 10mg nightly.  Pt then described a rash on her back on Wednesday 9/30/20 in the AM after showering.  Recommended that the patient replace her loratodine 10mg in the evening with 2 Benadryl 25mg and monitor and follow up with primary care.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Urticaria
Clinical narrative: upset stomach - followed by hives - benadryl  taken
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 102 most of the night of 9/29/20.  Brought it down by taking ibuprofen.  (FYI - I am not sure what type of flu vaccine I received).
Age: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash, redness, and warm to the touch and injection site only.  Patient was given 10 day course of prednisone and as well as benedryl. patient's reaction was much better following day
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Right arm:  red, hot, swollen circle around injection site 2" in diameter-lasted 2 days.  Fever up to 101 for 30 hrs, nausea, fatigue, muscle aches.  Took tylenol and motrin (off/on).  Arm still sore at 40 hour point, redness going down, fever gone, aches minimal,
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Right arm:  red, hot, swollen circle around injection site 2" in diameter-lasted 2 days.  Fever up to 101 for 30 hrs, nausea, fatigue, muscle aches.  Took tylenol and motrin (off/on).  Arm still sore at 40 hour point, redness going down, fever gone, aches minimal,
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sickest I've ever been in my life; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sickest ever been in life for next 10days. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR190407:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain in extremity, Swelling face
Clinical narrative: Swelling of her lymph nodes in her neck; Swelling in face; arm was Sore; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced enlargement of lymph nodes, facial swelling and pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the enlargement of lymph nodes, facial swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, facial swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid. The age at vaccination was not reported. After receiving Shingrix, the patient experienced swelling of her lymph nodes in her neck, swelling in face and her right arm was sore. The patient took Ibuprofen and symptoms disappeared after second day.  For the tolerance of 2nd dose, refer linked case US2020189744. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189744:same patient, 2nd dose
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: very tired; mild Fever; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced tiredness, fever and influenza-like symptoms. On an unknown date, the outcome of the tiredness, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the tiredness, fever and influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The patient experienced mild fever, tiredness and flu like symptoms after receiving 1st dose of Shingrix. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2020AMR190335.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR190335:Same patient- 2nd dose
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eye pruritus, Facial pain, Headache, Herpes zoster
Clinical narrative: shingles; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; area is itchy/right eye is itchy in the corner; area is itchy, achy including the whole right side of her forehead; headache; right eye is itchy in the corner; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 8 years ago).   On 27th August 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, 18 days after receiving Shingrix, the patient experienced shingles, eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus. On an unknown date, the outcome of the shingles was unknown and the outcome of the eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported that she had the previous shingles vaccine 8 years ago and she got shingles. The patient reported that she had the first dose of Shingrix on 27th August 2020. A week before the time of reporting the patient started to get shingles symptoms including tenderness to the touch on the right side of her face, temple and eye and up into her scalp. The patient claimed that the area was itchy, achy including the whole right side of her forehead.  The patient had a headache on and off and her right eye was itchy in the corner.  The reporter claimed that the symptoms she was experiencing were not bad enough to see a physician. The reporter called back on 23rd September 2020 to provide date of birth. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain of skin, Pruritus
Clinical narrative: shingles; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; tenderness to the touch on the right side of her face, temple and eye and up into her scalp; area is itchy/right eye is itchy in the corner; area is itchy, achy including the whole right side of her forehead; headache; right eye is itchy in the corner; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 8 years ago).   On 27th August 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, 18 days after receiving Shingrix, the patient experienced shingles, eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus. On an unknown date, the outcome of the shingles was unknown and the outcome of the eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, eye tenderness, facial pain, scalp tenderness, pruritus, pain, headache and eye pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported that she had the previous shingles vaccine 8 years ago and she got shingles. The patient reported that she had the first dose of Shingrix on 27th August 2020. A week before the time of reporting the patient started to get shingles symptoms including tenderness to the touch on the right side of her face, temple and eye and up into her scalp. The patient claimed that the area was itchy, achy including the whole right side of her forehead.  The patient had a headache on and off and her right eye was itchy in the corner.  The reporter claimed that the symptoms she was experiencing were not bad enough to see a physician. The reporter called back on 23rd September 2020 to provide date of birth. The reporter consented to follow up.
Sex: F
Vaccine: FLUR4, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was to  be vaccinated with Fluzone High-Dose Quadrivalent vaccine, but was administered with the Flublok Quadrivalent vaccine instead, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 84 years old female patient who was to be vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number UJ446AA and expiration date 18-Mar-2021) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date were not reported) via intramuscular route in the left deltoid for prophylactic vaccination on 23-Sep-2020 (PT: wrong vaccine administered).  Patient vaccination history included flu vaccines in the past, including high-dose flu vaccine and she had experienced local reaction of pain or soreness or puffiness at the injection site for a few days after the flu vaccine injection.  Medical history, medical treatment(s) and family history were not provided.  Patient received no concomitant vaccines on 23-Sep-2020.   It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.