chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Eyelid rash, Herpes zoster, Lip swelling, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from an elderly, 66 year old female patient, who was reporting on herself. The patient did not have any pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date about a year or two ago, the patient was vaccinated with ZOSTAVAX subcutaneous injection (exact dose, lot # and expiration date were not reported) for prophylaxis. On approximately 10-OCT-2017 (reported as "around 10-OCT-2017"), the patient developed a rash over both eyes and on her lips. She also developed swelling on her lips and pain in her mouth. The patient stated that on an unknown date in October 2017, her unidentified "vision provider" diagnosed her as having shingles. She was treated with unspecified antiviral eye drop and oral solution since an unspecified date. She was scheduled for an appointment with her primary physician on an unspecified date next week. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The causality assessment between the event and ZOSTAVAX was not provided. Upon internal review, the event of rash over both eyes treated with "unidentified antiviral eye drop" (ophthalmic herpes zoster) was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain
Clinical narrative: This spontaneous report was received from an elderly, 66 year old female patient, who was reporting on herself. The patient did not have any pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date about a year or two ago, the patient was vaccinated with ZOSTAVAX subcutaneous injection (exact dose, lot # and expiration date were not reported) for prophylaxis. On approximately 10-OCT-2017 (reported as "around 10-OCT-2017"), the patient developed a rash over both eyes and on her lips. She also developed swelling on her lips and pain in her mouth. The patient stated that on an unknown date in October 2017, her unidentified "vision provider" diagnosed her as having shingles. She was treated with unspecified antiviral eye drop and oral solution since an unspecified date. She was scheduled for an appointment with her primary physician on an unspecified date next week. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered. The causality assessment between the event and ZOSTAVAX was not provided. Upon internal review, the event of rash over both eyes treated with "unidentified antiviral eye drop" (ophthalmic herpes zoster) was considered to be medically significant.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 16-year-old male patient who received BEXSERO (batch number 169701, expiry date unknown). On 13th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). In September 2017, less than a week after receiving BEXSERO, the patient experienced cellulitis (serious criteria disability, GSK medically significant and other: as per reporter) and fever (serious criteria disability and other: as per reporter). The patient was treated with KEFLEX. On an unknown date, the outcome of the cellulitis and fever were recovered/resolved. The reporter considered the cellulitis and fever to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received 1st dose of BEXSERO on unknown deltoid and experienced a fever of 102 degree F and cellulitis. The cellulitis was in the arm that received the BEXSERO injection. It was unknown if he received any other vaccines in his other arm. On 15th September 2017, the patient returned to the office with these symptoms. The patient's parents were instructed to call the office if the symptoms did not resolve. The office had not heard back and assumed the symptoms had resolved. The reporter believed that was disabling and jeopardized the patient because he had to seek medical treatment and was prescribed KEFLEX. The patient visited emergency room. This case was 1 of the 3 cases, reporter by the same reporter.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Nausea
Clinical narrative: Burning pain in arm for 30 min post injection, very sore arm/injection site for 3 days. Severe Fatigue and weakness, nausea, sore throat and joints, fever for 4 days 101-spiking for hours at 103 for full 4 days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Burning pain in arm for 30 min post injection, very sore arm/injection site for 3 days. Severe Fatigue and weakness, nausea, sore throat and joints, fever for 4 days 101-spiking for hours at 103 for full 4 days.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Cough, Dizziness, Fatigue, Headache
Clinical narrative: A small tickle feeling started in my throat Tuesday (day after). The tickle wasn't as dramatic as initial symptoms of a normal cold. Wednesday, I had significant fatigue and nasal symptoms (congestion, runny nose). I had to keep a tissue nearby. I took diphenhydramine at night. By Thursday I was coughing and still fatigued. I also couldn't think as sharply. Friday, I woke up with a headache and dizziness. In fact, my husband had to take my son to school because I felt like I was going to pass out and vomit. I felt like maybe I didn't breathe well as I slept, so I just practiced consciously breathing all day and took some generic migraine medicine (acetaminophen, aspirin, caffeine). I went to the store later and got fatigued again, feeling I was going to pass out. I went home and rested and drank lots of water despite light yellow urine (I did not feel dehydrated). By Saturday I was better and decided to exercise (jump on trampoline) for endorphins. I tolerated it well. I have felt fine since then.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Nasal congestion, Nausea, Rhinorrhoea, Throat irritation
Clinical narrative: A small tickle feeling started in my throat Tuesday (day after). The tickle wasn't as dramatic as initial symptoms of a normal cold. Wednesday, I had significant fatigue and nasal symptoms (congestion, runny nose). I had to keep a tissue nearby. I took diphenhydramine at night. By Thursday I was coughing and still fatigued. I also couldn't think as sharply. Friday, I woke up with a headache and dizziness. In fact, my husband had to take my son to school because I felt like I was going to pass out and vomit. I felt like maybe I didn't breathe well as I slept, so I just practiced consciously breathing all day and took some generic migraine medicine (acetaminophen, aspirin, caffeine). I went to the store later and got fatigued again, feeling I was going to pass out. I went home and rested and drank lots of water despite light yellow urine (I did not feel dehydrated). By Saturday I was better and decided to exercise (jump on trampoline) for endorphins. I tolerated it well. I have felt fine since then.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Intense pain in shoulder down to elbow. Time has not alleviated the pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Right arm, very tender, swollen to the size of an orange, red and firm to touch.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Myalgia, Pain, Tenderness
Clinical narrative: Localized tenderness immediately increasing to deltoid pain with forward flexion, crossbody adduction. Increasing in severity past 1-2 weeks.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness, warmth and pain starting the following day, worsening so came into office on day 2.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 12-year-old male patient who received BEXSERO (batch number 169701, expiry date 31st January 2019). On 13th September 2017, the patient received the 1st dose of BEXSERO (intramuscular). In September 2017, less than a week after receiving BEXSERO and an unknown time after starting KEFLEX, the patient experienced cellulitis (serious criteria disability, GSK medically significant and other: as per reporter) and fever (serious criteria disability and other: as per reporter). The patient was treated with KEFLEX. On an unknown date, the outcome of the cellulitis and fever were recovered/resolved. The reporter considered the cellulitis and fever to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received 1st dose of BEXSERO on unknown deltoid and experienced a fever of 100 degree F and cellulitis. The cellulitis was in the arm that received the BEXSERO injection. It was unknown if he received any other vaccines in his other arm. On 15th September 2017, the patient returned to the office with these symptoms. The patient's parents were instructed to call the office if the symptoms did not resolve. The office had not heard back and assumed the symptoms had resolved. The reporter believed that was disabling and jeopardized the patient because he had to seek medical treatment and was prescribed KEFLEX. The patient visited emergency room. This case was 1 of the 3 cases, reporter by the same reporter.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Patient claims the injection was given very high to the shoulder into the bursa sack, and she is still experiencing pain.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Headache, Muscle spasms, Peripheral swelling, Pruritus
Clinical narrative: S&S: itching, flushing, tongue swelling, hands swelling/cramping, headache within half an hour of injection. Meds Given: ibuprofen, BENADRYL, prednisone. Patient had decrease in symptoms and was discharged home with parent at 4:45pm 10/30/2017.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Swollen tongue
Clinical narrative: S&S: itching, flushing, tongue swelling, hands swelling/cramping, headache within half an hour of injection. Meds Given: ibuprofen, BENADRYL, prednisone. Patient had decrease in symptoms and was discharged home with parent at 4:45pm 10/30/2017.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness and tenderness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Blood test, Cyanosis, Electrocardiogram, Eye pain, Head discomfort
Clinical narrative: La niña subio las escaleras de la casa y estaba observando, su boca en el espejo y poco a poco se acosto en el suelo. Al hablarle por su nombre no respondia tenia una baja respiracion, la boca morada y su cuerpo estaba flacido al cargarla, la llevamos a urgencias y tardo 30 minutos en estar consiente. La valoraron heciendole estudios de sangre, electrocardigrama, entre otros, Al Preguntarle a ella que sucedio dice o relata que sintio su cabeza y pies duros y sus ojos se cerraron porque le delian mucho que escuchaba su nombre pero no podia abrir sus ojos. The girl went up the stairs at her house and was observing her mouth in a mirror, then slowly she laid on the floor. When called by her name she didn't respond, breathing was shallow, her lips were blue, and her body was flaccid when picking her up, we took her to urgent care and it took 30min before she recovered consciousness. They did a blood work up, electrocardiogram and other lab tests. When the girl was asked what happened she says she felt her head and feet very heavy and her eyes closed because they were hurting so bad, she could hear someone calling her name but couldn't open her eyes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Hypopnoea, Hypotonia, Laboratory test, Limb discomfort, Loss of consciousness
Clinical narrative: La niña subio las escaleras de la casa y estaba observando, su boca en el espejo y poco a poco se acosto en el suelo. Al hablarle por su nombre no respondia tenia una baja respiracion, la boca morada y su cuerpo estaba flacido al cargarla, la llevamos a urgencias y tardo 30 minutos en estar consiente. La valoraron heciendole estudios de sangre, electrocardigrama, entre otros, Al Preguntarle a ella que sucedio dice o relata que sintio su cabeza y pies duros y sus ojos se cerraron porque le delian mucho que escuchaba su nombre pero no podia abrir sus ojos. The girl went up the stairs at her house and was observing her mouth in a mirror, then slowly she laid on the floor. When called by her name she didn't respond, breathing was shallow, her lips were blue, and her body was flaccid when picking her up, we took her to urgent care and it took 30min before she recovered consciousness. They did a blood work up, electrocardiogram and other lab tests. When the girl was asked what happened she says she felt her head and feet very heavy and her eyes closed because they were hurting so bad, she could hear someone calling her name but couldn't open her eyes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: La niña subio las escaleras de la casa y estaba observando, su boca en el espejo y poco a poco se acosto en el suelo. Al hablarle por su nombre no respondia tenia una baja respiracion, la boca morada y su cuerpo estaba flacido al cargarla, la llevamos a urgencias y tardo 30 minutos en estar consiente. La valoraron heciendole estudios de sangre, electrocardigrama, entre otros, Al Preguntarle a ella que sucedio dice o relata que sintio su cabeza y pies duros y sus ojos se cerraron porque le delian mucho que escuchaba su nombre pero no podia abrir sus ojos. The girl went up the stairs at her house and was observing her mouth in a mirror, then slowly she laid on the floor. When called by her name she didn't respond, breathing was shallow, her lips were blue, and her body was flaccid when picking her up, we took her to urgent care and it took 30min before she recovered consciousness. They did a blood work up, electrocardiogram and other lab tests. When the girl was asked what happened she says she felt her head and feet very heavy and her eyes closed because they were hurting so bad, she could hear someone calling her name but couldn't open her eyes.
Age: 87.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 3 inch diameter red area around injection site, warm to the touch, itchy.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history and drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route, lot# and expiry date were not reported). No concomitant medications were reported. On 06-OCT-2017, the patient developed "redness and inflammation down to her wrist" on an unspecified arm. No treatment was given. The outcome for the aforementioned events was unknown. The causality assessment between PNEUMOVAX 23 and the reported events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 17-OCT-2017, the patient was inadvertently vaccinated with PROQUAD injection, via subcutaneous route, lot # reported as M044032 with expiration date on 03-JUL-2019 (dose was not reported) and not the intended M-M-R II. No adverse effects were reported. Lot number M044032 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live.
Sex: F
Vaccine: FLUX
Symptoms: Alanine aminotransferase normal, Antinuclear antibody negative, Aspartate aminotransferase normal, Biopsy kidney abnormal, Blood albumin decreased
Clinical narrative: A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: F
Vaccine: FLUX
Symptoms: Blood cholesterol increased, Blood creatinine normal, Blood urea normal, Complement factor C3 increased, Complement factor C4
Clinical narrative: A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: F
Vaccine: FLUX
Symptoms: Complement factor normal, Face oedema, Glomerulonephritis minimal lesion, Haemoglobin normal, Hepatitis B test negative
Clinical narrative: A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: F
Vaccine: FLUX
Symptoms: Hepatitis C test negative, Oedema peripheral, Periorbital oedema, Platelet count increased, Protein urine
Clinical narrative: A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Sex: F
Vaccine: FLUX
Symptoms: Proteinuria, Treponema test negative, Urine abnormality, Urine protein/creatinine ratio increased, White blood cell count normal
Clinical narrative: A report has been received from a literature meeting abstract concerning a 45-year-old, female patient. In Dec-2014, patient was diagnosed with minimal change disease (MCD) after presenting with abrupt onset of bilateral hand, facial, and lower extremity edema, and frothy urine. She had no significant past medical or allergy history and no signs of systemic infection. She was normotensive. Urinalysis (UA) showed 3+ protein and urine protein-to-creatinine (UPCR) was 6.5 g/g. Serum albumin was 1.5g/dL, total cholesterol 465 mg/ dL, WBC 6.79K/mm3, hemoglobin (Hgb) 14.5 g/dL, platelets 417K/mm3, BUN 20 mg/ dL, creatinine 1.0 mg/dL, AST 29IU/L, ALT 20 IUL/L, C3 155mg/dL, and C4 29.3mg/dL. RPR, hepatitis B & C serologies, and ANA were negative. After approximately 2 weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone 1mg/kg daily was started in addition to torsemide 5mg/day and rosuvastatin 5mg/day. Complete remission of proteinuria was documented 2 weeks later and persisted after completing a 6-month course of prednisone. Patient remained in complete remission until Oct-2016 when, just after receiving influenza vaccine (Influenza vaccine), she developed periorbital edema and frothy urine. She denied recent infections or NSAID use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein 100 mg/dL and 24 hour proteinuria was 1.5 g. Relapse of minimal change disease (MCD) (Preferred Term: Glomerulonephritis minimal lesion) was attributed to recent influenza vaccination in the absence of other potential triggers of minimal change disease (MCD). She was treated with oral prednisone 50mg/day and proteinuria resolved within 21 days. The patient recovered from minimal change disease relapse on an unspecified date. The company physician considered minimal change disease relapse as important medical event.; Sender's Comments: Glomerulonephritis minimal lesion (reported as minimal change disease relapse) is not listed in the company core data sheet for Q/LAIV (quadrivalent live attenuated influenza vaccine). Patient's prior episode of minimal change disease could be contributory for the event reoccurrence as the event has potential for relapse even after complete remission was observed initially to steroidal treatment. Due to limited information on etiology for the previous episodes of event occurrence, details on vaccine administration, concurrent diseases, concomitant medications, autoimmune disorders, diagnostic workup such as autoantibody tests, skin test before vaccination and allergological work up, it is not possible to make a conclusive assessment of the causal relationship of event with Q/LAIV. Follow up information is being requested to make the case more complete and enable the assessment of the relationship.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Muscular weakness, Musculoskeletal pain
Clinical narrative: This is a spontaneous report from a contactable physician.   A 66-year-old Caucasian female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13) (Unclear lot number: T08483 or TO8483; Expiry Date 30Sep2019; NDC number 0000519710), intramuscular in right deltoid on 17Oct2017 at 0.5 ml, single for immunisation , and first dose of influenza vaccine (FLUZONE) (Lot UI877AB; Expiry Date 17May2018), on 17Oct2017 intramuscular in left deltoid at unknown dose for immunisation. Medical history included bariatric surgery in Nov2014, ongoing iron deficiency and due to this she probably had a B12 deficiency too, cervical cancer, ongoing gastrooesophageal reflux disease treated with ranitidine. Concomitant medication included ongoing ranitidine (unknown manufacturer) 75 mg twice daily for reflux. On 18Oct2017 the patient experienced pain to right arm from shoulder down to her elbow, and numbness and weakness to third fourth and fifth fingers of right hand. On 26Oct2017 the patient experienced pain across right upper back and shoulder blade area. The events were considered serious as medically significant. The outcome of the events was not recovered. The physician considered the events related to pneumococcal 13-val conjugate vaccine (dipht crm197 protein).; Sender's Comments: Considering the plausible time association, the vaccination with PREVENAR 13 might have played a contributory role in triggering the occurrence of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Pain in extremity, Skin warm
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 71-years-old female patient received PREVNAR 13, via an unspecified route of administration on left arm on 26Sep2017 10:00 at single dose for prevention of pneumonia at Physician Office. Medical history included breathing problems and cholesterol condition from an unknown date and unknown if ongoing. Concomitant medication included ongoing LIPITOR for probably almost 20 years, COMBIVENT started 2 months ago to help with breathing problems. The patient experienced arm was still sore, huge lump on arm, very warm to touch all on early morning 05Oct2017. On 06OCT2017, she went back to the doctor's office, in which she was told this was normal. On 25Oct2017 she went back to the doctor's office and was told the office was having problems with prolonged soreness with the injection, as they had other reports of this complaint. The outcome was not recovered.
Age: 50.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore right arm on an unspecified date. The outcome of event was unknown.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Slight swelling at the injection site, redness, and warm.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Eye pain, Headache, Migraine, Musculoskeletal stiffness
Clinical narrative: Dizziness, light sensitivity, HA/migraine, eye pain, stiff and painful neck. TYLENOL was not helpful for pain relief. Symptoms worsened on 10/28, 10/29. Symptoms began to improve on their own 10/31/17.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Photophobia
Clinical narrative: Dizziness, light sensitivity, HA/migraine, eye pain, stiff and painful neck. TYLENOL was not helpful for pain relief. Symptoms worsened on 10/28, 10/29. Symptoms began to improve on their own 10/31/17.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Lethargy, Pain, Pain in extremity
Clinical narrative: Around 4pm of the same day, patient's right arm became swollen, red, warm to touch, and painful. Patient developed chills, feverish, body aches, lethargic. Patient did not take anything for aches and fever, went to bed and slept the entire night. Patient slept the entire next day and night. Drank water throughout the day and night. On 10-19-17, patient got up around noon, took shower, and began to feel better.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Around 4pm of the same day, patient's right arm became swollen, red, warm to touch, and painful. Patient developed chills, feverish, body aches, lethargic. Patient did not take anything for aches and fever, went to bed and slept the entire night. Patient slept the entire next day and night. Drank water throughout the day and night. On 10-19-17, patient got up around noon, took shower, and began to feel better.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test negative, Culture throat negative, Hypoaesthesia, Paraesthesia, Vomiting
Clinical narrative: Approximately 5 minutes after getting flu vaccine 10/17, he developed numbness, tingling sensation lateral to nose bilaterally. No weakness, rashes, itching or pain. 10/22 he also had numbness thoracic back, now resolved. Vomited x 1 on 10/22.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture
Clinical narrative: COMPLAINT OF NUMBNESS AND TINGLING ARMS AND LEFT SIDE OF FACE, LOWER EXTREMITIES. LOWER EXTREMITY WEAKNESS. SEEN IN THE EMERGENCY ROOM AND ADMITTED UNDER NEUROLOGY SERVICE WITH TENTATIVE DIAGNOSIS OF GUILLAIN BARRE SYNDROME. HAD FLU VACCINE IN THE PAST WITH NO ISSUES.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: COMPLAINT OF NUMBNESS AND TINGLING ARMS AND LEFT SIDE OF FACE, LOWER EXTREMITIES. LOWER EXTREMITY WEAKNESS. SEEN IN THE EMERGENCY ROOM AND ADMITTED UNDER NEUROLOGY SERVICE WITH TENTATIVE DIAGNOSIS OF GUILLAIN BARRE SYNDROME. HAD FLU VACCINE IN THE PAST WITH NO ISSUES.
Age: 64.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Injection site inflammation, Injection site nodule, Injection site warmth, Pain in extremity
Clinical narrative: At site of injection I developed a 6mm round area that was warm, inflamed, with a nodule like area beneath the skin, (I also received the flu vaccine the same day in my right arm, without a reaction) that was too painful to sleep on for 3 days. I ran a low-grade temperature of 100.3 -100.6 for three days. Cool compresses, topical ointments were ineffective in decreasing the swelling and itching. One week post injection the redness and erythema is gone but appears red/purple and the nodule can still be palpated. As an infant I was hospitalized at 6 months and one year with pneumonia. On 10/30/2017 my PCP prescribed a 4 mg MEDROL dosepak.
Age: 64.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pruritus, Pyrexia, Sleep disorder, Swelling
Clinical narrative: At site of injection I developed a 6mm round area that was warm, inflamed, with a nodule like area beneath the skin, (I also received the flu vaccine the same day in my right arm, without a reaction) that was too painful to sleep on for 3 days. I ran a low-grade temperature of 100.3 -100.6 for three days. Cool compresses, topical ointments were ineffective in decreasing the swelling and itching. One week post injection the redness and erythema is gone but appears red/purple and the nodule can still be palpated. As an infant I was hospitalized at 6 months and one year with pneumonia. On 10/30/2017 my PCP prescribed a 4 mg MEDROL dosepak.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Breast swelling, C-reactive protein increased, Cellulitis, Erythema
Clinical narrative: Around 4:00 PM, left arm was swelling, ADVIL was taken, 5:30 PM swelling worse, was size of a grapefruit, hard, red and painful, ice applied which improved the pain some, temperature before going to bed was 99.9. By the next evening, the arm was swollen even into the chest and L breast area, painful. Went to the emergency room: CRP was 51, WBC 8. Was admitted and treated with 2 IV antibiotics for cellulitis. On Monday Sept 25 was discharged after being seen by her private physician. She was discharged on prednisone for inflammation, not cellulitis. Complete recovery.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Inflammation, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Around 4:00 PM, left arm was swelling, ADVIL was taken, 5:30 PM swelling worse, was size of a grapefruit, hard, red and painful, ice applied which improved the pain some, temperature before going to bed was 99.9. By the next evening, the arm was swollen even into the chest and L breast area, painful. Went to the emergency room: CRP was 51, WBC 8. Was admitted and treated with 2 IV antibiotics for cellulitis. On Monday Sept 25 was discharged after being seen by her private physician. She was discharged on prednisone for inflammation, not cellulitis. Complete recovery.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, White blood cell count normal
Clinical narrative: Around 4:00 PM, left arm was swelling, ADVIL was taken, 5:30 PM swelling worse, was size of a grapefruit, hard, red and painful, ice applied which improved the pain some, temperature before going to bed was 99.9. By the next evening, the arm was swollen even into the chest and L breast area, painful. Went to the emergency room: CRP was 51, WBC 8. Was admitted and treated with 2 IV antibiotics for cellulitis. On Monday Sept 25 was discharged after being seen by her private physician. She was discharged on prednisone for inflammation, not cellulitis. Complete recovery.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Developed shoulder joint pain in left arm and right arm. Have pain when doing everyday tasks and also when sleeping at night. Hurts to lay on left or right arm. Occasionally have pain shooting down left arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itchy, painful area of injection site that has lasted over 2 months.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, itching, warm to touch. Treated prophylactically with Bactrim.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage
Clinical narrative: PATIENT RETURNED TO THE PHARMACY 8 HOURS AFTER RECEIVING VACCINATION. INJECTION SITE AND SURROUNDING AREA WAS RED AND INJECTION SITE WAS STILL BLEEDING. PATIENT WAS TAKEN TO THE HOSPITAL SHORTLY AFTER WHERE THEY WERE ABLE TO STOP THE BLEEDING.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Fever night of vaccination, two days later diagnosed with chickenpox.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Electrocardiogram abnormal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient called after hours 10/30/17 to report an injection reaction in her right arm where PPSV23 was administered earlier that day. Patient followed up in the office with a visit on 10/31/17. According to notes the reaction area is red, warm and tender to the touch. According to the PA who saw patient 10/31/17 the reaction area starts 2 cm below the injection site and extends 13 cm towards the elbow and extends from the bicep to mid tricep. PA recommended symptomatic treatment during our discussion, however, the office visit note is not finished.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: The patient did NOT have an adverse event. He received his flu shot on a previous date at a different facility, he presented to our clinic for a Tdap vaccine and was mistakenly given another flu shot.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017, the patient was vaccinated with one dose of improperly stored M-M-R II rHA, injection, lot # M045400, expiration date: 14-NOV-2018, for prophylaxis (route of administration was not reported). Concomitant therapy included sterile diluent (MERCK) which did not undergo a temperature excursion. The vaccine underwent a temperature excursion between 47 to 77 Fahrenheit degrees for 14 hours. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a physician referring to an 11 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and the vaccination with GARDASIL 9 was not intended to be administered to this patient. The reporter also denied any adverse effects reported by the patient.
Age: 0.67
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 8 month old patient. On 17-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.