chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient lost consciousness for approximately one minute right after administration of vaccines. Pt was hypotensive and had bradycardia  during recovery time. Pt was observed for approximately 15 minutes after event. Pt was discharged home in stable condition.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, MNQ, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient lost consciousness for approximately one minute right after administration of vaccines. Pt was hypotensive and had bradycardia  during recovery time. Pt was observed for approximately 15 minutes after event. Pt was discharged home in stable condition.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Muscular weakness, Pain in extremity, Tenderness
Clinical narrative: The patient had noticed moderate arm soreness starting the day following the immunization, and she stated it worsened going into the next day. She also stated that the same arm was feeling weak. It was tender to the touch, and she had at red spot at the site of the injection as well as 3 other red spots about 3 inches from the injection site that were about 1/2 inch each in diameter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Flank pain, Herpes zoster, Neuralgia, Rash
Clinical narrative: I received the Shingrix shot on a Thursday (7/16/20) and did not have any reaction at all. Upon waking up 5 days later, Tuesday (7/21/20) I started to have intermittent pain on my right side flank. I was hoping it would go away. I woke up early the next morning (7/22/20) in excruciating pain on my right side. It felt like someone was stabbing me over and over and I was bent over in pain. I went to Urgent Care.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Altered state of consciousness, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after Menactra vaccine administration, patient felt dizzy and almost passed out and escorted to lay down. Patient reports that she has not recollection of events after vaccine being administered until when she saw herself on the floor. No seizure or seizure like activity reported. Blood pressure in the 70's during recovery.  Patient was referred to ER for further management.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Acoustic stimulation tests, Dizziness, Immediate post-injection reaction, Ophthalmological examination, Skin striae
Clinical narrative: Immediately after Menactra vaccine administration, patient felt dizzy and almost passed out and escorted to lay down. Patient reports that she has not recollection of events after vaccine being administered until when she saw herself on the floor. No seizure or seizure like activity reported. Blood pressure in the 70's during recovery.  Patient was referred to ER for further management.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Syncope, Vaccination complication, Varicocele, Visual impairment
Clinical narrative: Immediately after Menactra vaccine administration, patient felt dizzy and almost passed out and escorted to lay down. Patient reports that she has not recollection of events after vaccine being administered until when she saw herself on the floor. No seizure or seizure like activity reported. Blood pressure in the 70's during recovery.  Patient was referred to ER for further management.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after Menactra vaccine administered patient felt dizzy but did not lose consciousness, no seizure or seizure like activity. Reportedly initial systolic blood pressure was in 70 s , Patient was advised to lay down . Repeat blood pressure was normal . Orthostats were normal. Patient was referred to the ed for further management.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient noticed pain, redness and swelling at the injection site within hours of vaccination.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Moderate pain in right shoulder. More painful than any other vaccine ever received.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Contusion, Full blood count, Immune thrombocytopenia, Immunoglobulin therapy, Laboratory test
Clinical narrative: Within a few weeks of getting vaccinated patient had a lot of bruising on his legs and arms. Due to quantity of bruises I asked for a CBC to be done on him. His platelet count was 8 thousand. He was admitted to the hospital on 7/31/2020 and had a variety of tests performed. He was diagnosed with ITP and had IVIG treatment. His platelets increased to 64 thousand and he was released from the hospital on 8/2/2020.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Platelet count decreased
Clinical narrative: Within a few weeks of getting vaccinated patient had a lot of bruising on his legs and arms. Due to quantity of bruises I asked for a CBC to be done on him. His platelet count was 8 thousand. He was admitted to the hospital on 7/31/2020 and had a variety of tests performed. He was diagnosed with ITP and had IVIG treatment. His platelets increased to 64 thousand and he was released from the hospital on 8/2/2020.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Knot at injection site Irritable Redness at injection site Swollen injection site Eczema in elbow and knee creases
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainting incident
Age: 21.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Received MMR and Hepatitis B vaccines on 7/29/20 - called 7/31/20 that her arm had red swollen area from MMR vaccine - . No further increase in swelling - some pain localized reaction per description advised Tylenol, cool/ice, allergy med orally.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pain, Pruritus, Skin warm
Clinical narrative: Noticed on Saturday later in the day at around 12pm 8/1/2020 a knot and its warm to the touch and it itches and is a little sore
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Employee came in exhibiting redness, itching & swelling to injection site which was (L) back of arm measuring 70 x 70 mm No fever, vomiting or nausea noted.  2 25 mg Benadryl Tab was given per Dr.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient lost consciousness and fell from the table.  He hit his head lightly with his mom partially  catching him. After 15-30 sec he regained consciousness. 5 min later upon sitting up he passed out again for 5-10 seconds. He could not sit up for 30 min - 1 hour later without  getting dizzy and was transferred to the ER.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Vomiting
Clinical narrative: Rec'd Menveo & HPV. Seemed fine  walked out of office, felt faint &  vomited. Came back inside.  Had eaten breakfast but no fluids
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood pressure decreased, Dizziness, Pallor
Clinical narrative: Rec'd Menveo, HPV, Bexsero & after HPV became dizzy, pale, felt faint. BP dropped. Had eaten breakfast prior to visit
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electrocardiogram normal, Irritability, Pyrexia
Clinical narrative: Patient received 4 month vaccines on 7/27/20. Was fussy throughout that night and woke up at 5am with a fever of 100.4, which improved with acetaminophen. On the evening of 7/28/20 patient was sleeping deeply in her grandfathers arms when her grandmother thought she was not breathing. Grandmother took the baby and blew on her face causing the baby to startle awake. The total episode lasted approximately 30 seconds. There was no significant color change or change in tone and the baby returned to baseline immediately after waking up. Was brought to the Emergency Room for evaluation. No further episodes.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Differential white blood cell count, Full blood count, Injection site discolouration, Injection site erythema, Injection site haemorrhage
Clinical narrative: Shot given approximately 10 AM, later in day while at  park & about in car seat 4 hrs later mother  noted lower legs to look bright red + now 5 hrs  after shots (L) leg clear but (R) lower leg with purplish  macular rash with few petechiae on lower leg.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Shot given approximately 10 AM, later in day while at  park & about in car seat 4 hrs later mother  noted lower legs to look bright red + now 5 hrs  after shots (L) leg clear but (R) lower leg with purplish  macular rash with few petechiae on lower leg.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pyrexia
Clinical narrative: pain at injection site immediately, worsening for 4 hours overall body ache, 5 hours post ijection fever 100.5F 15 hours post injection
Age: 8.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 8-year-old female patient. On 29-FEB-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000082: US-009507513-2008USA000081: US-009507513-2008USA000080: US-009507513-2008USA000079:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 administered to patient after experiencing temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On 23-JUL-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, lot# reported as 163741, which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date 16-FEB-2022; route and strength were not provided) for prophylaxis. The temperature excursion included 8.83 degree Celsius for 20 hours. There was no previously temperature excursion. There was a data logger involved. No additional adverse events were reported.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Injection site pain, Injection site reaction, Muscle tightness, Musculoskeletal pain
Clinical narrative: injection site soreness; tightness/soreness in his back and shoulder blade; tightness/soreness in his back and shoulder blade; tightness/soreness in his back and shoulder blade; This spontaneous report was received from a 59 years old male patient referring to himself. The patient's concurrent condition included diabetes. The patient was allergic to penicillin (unspecified). The patient's concomitant therapy was not provided.  On 27-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) booster shot (0.5 milliliter; strength, frequency, lot # and expiration date were unknown) intramuscularly for prophylaxis.        On the same date, the patient started experiencing injection site soreness and tightness/soreness in his back and shoulder blade. The patient didn't seek medical attention. The outcome of the events was not recovered. The causality assessments between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Sex: F
Vaccine: MMR, PPV
Symptoms: Adrenal insufficiency, Autoimmune hepatitis, B-lymphocyte count, Blood smear test normal, Bronchiectasis
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR, PPV
Symptoms: Bronchoalveolar lavage abnormal, Bronchoscopy abnormal, Computerised tomogram thorax abnormal, Cough, Functional gastrointestinal disorder
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR, PPV
Symptoms: Hypoparathyroidism, Immune-mediated pneumonitis, Immunoglobulin therapy, Immunoglobulins normal, Loss of personal independence in daily activities
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR, PPV
Symptoms: Lung infiltration, Measles antibody negative, Mucocutaneous candidiasis, Pneumonia, Pneumonia staphylococcal
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR, PPV
Symptoms: Purulent discharge, Pyrexia, Sinusitis, Sjogren's syndrome, Streptococcus test positive
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR, PPV
Symptoms: Sweat test normal, Ultrasound spleen
Clinical narrative: Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 2-year-old female patient. On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 12-year-old female patient. On 29-FEB-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 14-year-old female patient. On 29-FEB-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: felt under the weather; Initial information was received on 28-Jul-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via email.  This case is linked to case 2020SA200718 (same reporter).  This case involves an unknown demographic patient who felt under the weather (malaise), while the patient received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination and family history were not provided.   The patient's concomitant medication was not provided.  On 27-Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient felt under the weather (malaise), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data were not reported.  Final diagnosis was malaise.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event (with 2 days duration).  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel reached a temperature of -10 F for 30 minutes as it was accidentally placed in freezer instead of refrigerator, no AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a female patient and the vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: u6676aa, Expiry date: 16-May-2022 ) which reached a temperature of -10 F for 30 minutes as it was accidentally placed in freezer instead of refrigerator (Product storage error).  Medical history, medical treatment(s), vaccination, concomitant medications and family history were not provided.  It was a case of an actual medication error due to Product storage error temperature too low.  At the time of 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: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ActHib powder was mixed with a Pentacel liquid component instead of HIB component of Pentacel and administered, no AE; Initial information received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a six-month-old patient who received third dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ146AAA and expiration date: 14-Feb-2021) where the liquid component (lot number U6314AB and expiration date: not reported) was reconstituted with HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ1188AB and expiration date: 07-Dec-2020) in place of HIB component (lot number UJ146AA and expiration date: not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on 29-Jul-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that physician when reconstituting Pentacel vaccine, a HCP used a stand-alone ActHIB lypolized powder vial rather than the HIB component of the Pentacel co-pack.  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 and Module VI of the 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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 1st day-Arm began feeling extremely sore, very tired; 2nd day-arm was very painful, hot and bright red (3" diameter) around injection site, chills, 99.8 degree fever, felt like I had the flu, slept most of the day; 3rd day-totally normal with the exception of my arm at injection site.  It took approximately 4 days for the redness and soreness to go away.  I took ibuprofen for the pain and fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: 1st day-Arm began feeling extremely sore, very tired; 2nd day-arm was very painful, hot and bright red (3" diameter) around injection site, chills, 99.8 degree fever, felt like I had the flu, slept most of the day; 3rd day-totally normal with the exception of my arm at injection site.  It took approximately 4 days for the redness and soreness to go away.  I took ibuprofen for the pain and fever.
Sex: M
Vaccine: MENB
Symptoms: Death, Meningitis
Clinical narrative: my 6 year old brother died of meningitis within a few days of receiving a vaccine for it; This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a 6-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included immunodeficiency.   On an unknown date, the patient received Bexsero. On an unknown date, couple of days after receiving Bexsero, the patient experienced meningitis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the meningitis was fatal. The reported cause of death was meningitis.   The reporter considered the meningitis to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient died on an unknown date. The reporter stated that, my two years old had never received a vaccine because my 6 years old brother died of meningities within a few days of receiving a vaccine.  for it that's a story it's short but its truth he should not have received it he had an immune deficiency already it was just too much this was exactly why they should not force anything, everyone reacts differently.; Reported Cause(s) of Death: Meningitis
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 4" red hot swelling at site of injection on upper arm,  pain, itchy feeling lingers  Fever x 2 days (101.4 degrees)   Nausea 1 day Headache x3 days Sniffles
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: 4" red hot swelling at site of injection on upper arm,  pain, itchy feeling lingers  Fever x 2 days (101.4 degrees)   Nausea 1 day Headache x3 days Sniffles
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type IV hypersensitivity reaction
Clinical narrative: A type IV reaction is described as redness, swelling and pain from injection site down the left arm. Lasted 2 days. No treatment.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Rash
Clinical narrative: PT DEVELOPED RASH AND SORENESS LEFT BREAST AND SIDE
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Throat tightness
Clinical narrative: patient complained of chest and throat tightness as well as lightheadedness following the injection, seen at urgent care 2 days later 7/29/2020
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient is experiencing an itching arm ever since receiving both doses of shingrix.
Age: 16.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events; 16 year old female patient who weighs 154 pounds was administered an adult dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 16-year-old female patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 27-JUL-2020, the adolescent patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) reported as vial but established as syringe upon lot validation (lot # S021729, expiration date: 20-AUG-2020) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability