chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Customer was given her second dose of Shingrix. 2-3 minutes afterwards she felt overly dizzy, and about to loose consciousness. Her husband helped her to the ground, I rushed out for assistance. She did not loose consciousness but felt tingly and nauseous. 911 was called. kept feet elevated, monitored breathing and heart rate untill paramedics arrived and took over. Patient got better shortly after and did not leave to hospital.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired Monovalent Pfizer 0.3 ml via IM patient had NO adverse reactions or any side effects. Notified patient of medication error, stated that she felt perfectly fine.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Circumstance or information capable of leading to medication error, Medication error, No adverse event, Product administered by wrong person
Clinical narrative: This was a medication error.  The wrong student was vaccinated at the school.  School pulled this student from class and brought him to the on-site vaccine clinic with the paper consent of another student.  These two students have the same first name and same first surname, but different second surnames and DOBs, and they are in the same class.  Our vaccinator administered flu mist to this student.  The student who was vaccinated did not have a consent signed by his parent.  No adverse outcome.  The school contacted both families (the family of the child who should have been vaccinated with flu mist and was not and the family of the child was was not scheduled to be vaccinated and was vaccinated.  Our vaccine branch staff made several attempts to reach the family of the child who was mistakenly vaccinated, and has not connected with anyone to date.  Our vaccine branch staff looked the child up in Vaccine System, and this child had not yet received his flu vaccine for this season.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: 24 hours after receiving  vaccine there  was no adverse outcome, based on phone call with parent. Child was given Pfizer 5-11yr BV instead of monovalent vaccine as first dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count abnormal, Laboratory test, White blood cell count decreased
Clinical narrative: From the time i received my covid 19 vaccines and boosters; my wbc has been dropped from normal range to abnormal. On 12/12/2018 my WBC was 4.3. On 10/26/2022 I get another labs work done and my wbc dropped to 3.2. My concerns are not only based on just my reading but I also have other 3 people that I know who have experienced the same issue to the point where one of them had to be on meds to raise his WBC up. For your information, all of us are of the same race.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Blister rupture, Injection site pain, Pruritus, Tenderness
Clinical narrative: Patient reported a blister behind her left shoulder after receiving a flu vaccine in her left arm with pain leading from injection site to blister. Symptoms started the night of vaccination. The blister opened and patient was seen at an urgent care and received an antibiotic ointment to place on the open blister.  The blister has since healed but remains tender and itchy.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gastrointestinal disorder, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient reported to have itching, swelling and redness at the site of injection for couple of days. Patient also got flu like symptoms, nausea and GI issues for 5 days after vaccination. Patient is better now
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea
Clinical narrative: patient reported to have itching, swelling and redness at the site of injection for couple of days. Patient also got flu like symptoms, nausea and GI issues for 5 days after vaccination. Patient is better now
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond use date, but before the exp. date of 11/24/2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PT RECEIVED MONOVALENT PFIZER INJECTION (EVEN THOUGH PT WANTED BIVALENT PFIZER). THIS WAS DOSE  #4. PT MADE AWARE OF INCIDENT AND TO COME BACK IN 2 MONTHS TO GET THE OMNICRON BIVALENT ONE. TOLD PT TO UPDATE THEIR COVID CARD TO CORRECT LOT NUMBER.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received a Fluad vaccine on 9/28/22 and then she received a Fluad on 11/28/22.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PT RECEIVED MONOVALENT PFIZER INJECTION (EVEN THOUGH PT WANTED BIVALENT PFIZER). PT MADE AWARE OF INCIDENT AND TO COME BACK IN 2 MONTHS TO GET THE OMNICRON BIVALENT ONE. TOLD PT TO UPDATE THEIR COVID CARD TO CORRECT LOT NUMBER.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot number 052B22A expired 11/23 and was administered 11/29/22
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge, Underdose
Clinical narrative: After plunging vaccine into the patient's thigh, most of the vaccine ran out
Age: 1.08
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant gave the patient Gardasil 9 instead of Prevnar 13. No symptoms but mom has been informed.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: PT RECEIVED MONOVALENT PFIZER INJECTION (EVEN THOUGH PT WANTED BIVALENT PFIZER). PT MADE AWARE OF INCIDENT AND TO COME BACK IN 2 MONTHS TO GET THE OMNICRON BIVALENT ONE. TOLD PT TO UPDATE THEIR COVID CARD TO CORRECT LOT NUMBER.
Age: 59.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Electrocardiogram, Generalised tonic-clonic seizure
Clinical narrative: tonic clonic seizure
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Head injury, Nausea, Syncope
Clinical narrative: Pt reports feeling fine initially. But 11 to 12 hours later at night, she felt severely nauseated. Also, pt fainted in the rest room that led to her ER visit. Pt also reports of hitting her head on the floor.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given the original Pfizer grey cap as a booster instead of the Pfizer Bivalent grey cap.  The technician accidentally handed me, the pharmacist, the wrong vile and they look identical except for the description, which is in very small font.  We did not realize until afterwards when trying to batch fill the rx for the vaccine.  We were unable to reach the patient after many attempts by phone.  Recommendation would be to vaccinate with the Pfizer Bivalent 2 months from date 11/08/22.   No known adverse reactions occurred from the Vaccine administration error.
Age: 41.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: General rash, hives, itchiness.   Cetirizin Sandoz 10mg on 11/25, 11/26, 11/28, 11/29 resulted in temporary relief of symptoms.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received 0.2 mL of vaccine undiluted. Monitored for 30 mins after dosage error recognized without any side effects or adverse reactions occurring during that time. Pfizer contacted regarding administration error. Patient?s mother educated on administration error and increased possibility of localized or systemic side effects. Advised to treat symptoms with Tylenol or ibuprofen to keep child comfortable and to seek further medical care if symptoms not manageable with fever/pain reducers. Mother verbalized understanding back of instruction.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received 0.2 mL of vaccine undiluted. Monitored for 30 mins after dosage error recognized without any side effects or adverse reactions occurring during that time. Pfizer contacted regarding administration error. Patient?s mother educated on administration error and increased possibility of localized or systemic side effects. Advised to treat symptoms with Tylenol or ibuprofen to keep child comfortable and to seek further medical care if symptoms not manageable with fever/pain reducers. Mother verbalized understanding back of instruction.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Patient received vaccine and a few minutes after complained of dizziness.  She was then given water and a little piece of chocolate which did not help and eventually she had fainted. Patient regained consciousness after a few minutes when paramedics came and checked her blood pressure which was found to be low (systolic was around 80). Patient did not go to the hospital and left the pharmacy.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Chills, Headache, Pain in extremity
Clinical narrative: headaches, Right upper back pain, Left arm pain, chills.  headaches still present, but improving
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal distension, Diarrhoea, Discomfort, Fatigue
Clinical narrative: Initial fatigue of first 32 hours was followed by gaseous distension of abdomen and some minor discomfort. Hour 44 started explosive diarrhea that lasted for a total of 17 hours. Gas-X (2 chewable tablets) taken initially, some relief until diarrhea started.  Imodium (2 tablets) immediately administered. Diarrhea continued. Another Imodium tablet taken. Diarrhea returned. Another tablet taken. 4 hours later, diarrhea returned. Another Imodium tablet taken.  Diarrhea continued. Another Imodium tablet taken. 45 minutes later, diarrhea ceased.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: Enlarged, huge swollen axial arm lymph node, fever x2 days, nausea, diahreah, chills, pain in neck,
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Enlarged, huge swollen axial arm lymph node, fever x2 days, nausea, diahreah, chills, pain in neck,
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Magnetic resonance imaging, X-ray
Clinical narrative: Left shoulder pain; MRI; treatment in progress
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Approx 24 hours after 5th booster shot, (this is my 1st Pfizer Bivalent Booster),  I have a raised, very red, and painful somewhat circular spot on my arm that received the vaccine. It measures approximately 2" x 2".  I do have a photo available.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was 4 years of age.  He was given the vaccine for the 5-12s years old His father was notified of the error. No report of adverse reaction wass made to the clinic
Age: 27.0
Sex: M
Vaccine: COVID19-2
Symptoms: Head injury, Syncope
Clinical narrative: SYNCOPE, FAINTED AND HIT HEAD ON POLE, SMALL CUT ON SIDE OF FOREHEAD
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, General symptom, Nasal congestion, Product administered to patient of inappropriate age
Clinical narrative: He is 11 y/o But got the Pfizer Covid Bivalent Booster for 12 y/o and up. Please see enclosed. I believe his symptoms are a continuation and result of his allergies and nose congestion. I am reporting VAERS due to incorrect dose of vaccine being the 12 y/o dose versus 5-11 y/o dose. This report is as of 11/24/22 visits and phone calls as of 11/24/22 I will continue to monitor.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypokinesia, Pain, Swelling, X-ray limb
Clinical narrative: Redness, swelling, pain, limited movement steroid pack, warm compress, physical therapy TENS - ongoing treatment
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Lip swelling, Rash
Clinical narrative: Full body rash and lip swelling, she went to ER and was treated for an allergic reaction with the following medications, Prednisone, Cetirizine 10 mg and Benadryl. She has to go to the ER on two different visits, The day of the reaction on 9/2/2021 and then 9/4/2021 for further treatment. After she was given the same type of medications at a high amount her conditions resolved.
Age: 49.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Wrong product administered
Clinical narrative: unknown
Age: 49.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Two weeks and one day after the vaccine, I experienced numbness in three fingers in my dominant hand, the three fingers are the thumb, and the pointer and the middle finger. It's basically the first section of the finger, from the thumb down in the joint. And then there are swelling on those fingers.  I can bend the hand, there are no pain anywhere else in any joints in my hand, or the palm or the wrist. It's just 24 hours of numbness every single day. It feels like the nervous system was attacked by the virus. As a result of this, I have the inability to write, because I cant hold any writing device in my left hand. I cant form the letters. I have to print, I cant do script anymore. Unable to fully form each letter.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Vaccination site reaction
Clinical narrative: Two weeks and one day after the vaccine, I experienced numbness in three fingers in my dominant hand, the three fingers are the thumb, and the pointer and the middle finger. It's basically the first section of the finger, from the thumb down in the joint. And then there are swelling on those fingers.  I can bend the hand, there are no pain anywhere else in any joints in my hand, or the palm or the wrist. It's just 24 hours of numbness every single day. It feels like the nervous system was attacked by the virus. As a result of this, I have the inability to write, because I cant hold any writing device in my left hand. I cant form the letters. I have to print, I cant do script anymore. Unable to fully form each letter.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Dysgraphia, Hypoaesthesia, Peripheral swelling
Clinical narrative: Two weeks and one day after the vaccine, I experienced numbness in three fingers in my dominant hand, the three fingers are the thumb, and the pointer and the middle finger. It's basically the first section of the finger, from the thumb down in the joint. And then there are swelling on those fingers.  I can bend the hand, there are no pain anywhere else in any joints in my hand, or the palm or the wrist. It's just 24 hours of numbness every single day. It feels like the nervous system was attacked by the virus. As a result of this, I have the inability to write, because I cant hold any writing device in my left hand. I cant form the letters. I have to print, I cant do script anymore. Unable to fully form each letter.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient came in for Pfizer COVID Booster vaccine. Pharmacy only has monovalent Pfizer at the time and monovalent was given to patient. (Guideline bilvalent just changed 2 days ago. No adverse event happened for the monovalent Pfizer injection given to patient.
Age: 85.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint swelling, Mobility decreased, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Pt reports swelling at site and cannot lift her arm
Age: 85.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Asthenia, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Weakness-Severe, Additional Details: Pt reports swelling at site and cannot lift her arm
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Abdominal X-ray, Asthenia, Central venous catheterisation, Chest X-ray, Computerised tomogram head
Clinical narrative: Covid, Influenza and Zoster vaccines were all administered at Pharmacy on 11/5/2022. On 11/22/2022 patient came into the ER. Patient claimed she felt weak the day after the vaccines. with lost of all sensation and control over her legs.  Patient was admitted in the ER and sent to the medical floor for observation.  Numbness also spreads to her hands and the tip of her tongue.  Patient received Neurology Consult and possible Guillain Barre Syndrome.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Electrocardiogram, Endotracheal intubation, Fall, Immunoglobulin therapy, Intensive care
Clinical narrative: Covid, Influenza and Zoster vaccines were all administered at Pharmacy on 11/5/2022. On 11/22/2022 patient came into the ER. Patient claimed she felt weak the day after the vaccines. with lost of all sensation and control over her legs.  Patient was admitted in the ER and sent to the medical floor for observation.  Numbness also spreads to her hands and the tip of her tongue.  Patient received Neurology Consult and possible Guillain Barre Syndrome.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness, Wheelchair user
Clinical narrative: Covid, Influenza and Zoster vaccines were all administered at Pharmacy on 11/5/2022. On 11/22/2022 patient came into the ER. Patient claimed she felt weak the day after the vaccines. with lost of all sensation and control over her legs.  Patient was admitted in the ER and sent to the medical floor for observation.  Numbness also spreads to her hands and the tip of her tongue.  Patient received Neurology Consult and possible Guillain Barre Syndrome.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral, Mobility decreased, Sensory loss
Clinical narrative: Covid, Influenza and Zoster vaccines were all administered at Pharmacy on 11/5/2022. On 11/22/2022 patient came into the ER. Patient claimed she felt weak the day after the vaccines. with lost of all sensation and control over her legs.  Patient was admitted in the ER and sent to the medical floor for observation.  Numbness also spreads to her hands and the tip of her tongue.  Patient received Neurology Consult and possible Guillain Barre Syndrome.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient experienced no adverse event as described by caretakers. However, patient was given an undiluted dose of pediatric pfizer.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Menstrual disorder, Polymenorrhoea, Pyrexia
Clinical narrative: Changes to menstrual cycle.   I had a normally scheduled period about a week after the shot on 10/10.  I?ve had three more since then, with the most recent starting 11/28.  My cycle is normally pretty regular and about 30 days.  I had period changes last time I got the booster, but they were less dramatic.  This time my fever was higher with the booster (102.3 vs. 101.9 last year) but for a shorter duration (1 day vs. 3).
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Antiphospholipid antibodies, Biopsy kidney
Clinical narrative: crescentic & sclerosing glomerulonephritis; This is a literature report for the following literature source(s):  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "crescentic & sclerosing glomerulonephritis". The patient underwent the following laboratory tests and procedures: Antibody test: 25; cleared; Antineutrophil cytoplasmic antibody: Negative; Negative; Antinuclear antibody: Negative; Antiphospholipid antibodies: Negative; Biopsy kidney: crescentic and sclerosis glomerulonephritis; Blood pressure measurement: 175/103 mmHg, notes: On admission; Blood urea nitrogen/creatinine ratio: 16/1.5; Computerized tomogram: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Cystoscopy: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Double stranded DNA antibody: Negative; Hemoglobin: 13.3; Heart rate: 104, notes: Unit: per min. On admission; Immunology test: linear GBM staining; c3/c4 level: Negative; Several glomeruli showed segmental scars and, notes: fibrous crescents in addition to focal cellular crescents of varying ages raising the possibility of concurrent ANCA vasculitis; Negative; unremarkable; Renal function test: improved; Urine analysis: revealed dysmorphic RBCs and and proteinuria; White blood cell count: 16600. Therapeutic measures were taken as a result of glomerulonephritis rapidly progressive. Sender's Comments: Based on available information, the causal association between the event GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE and suspect drug BNT162b2 cannot be excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood urea nitrogen/creatinine ratio, Computerised tomogram, Cystoscopy, Double stranded DNA antibody
Clinical narrative: crescentic & sclerosing glomerulonephritis; This is a literature report for the following literature source(s):  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "crescentic & sclerosing glomerulonephritis". The patient underwent the following laboratory tests and procedures: Antibody test: 25; cleared; Antineutrophil cytoplasmic antibody: Negative; Negative; Antinuclear antibody: Negative; Antiphospholipid antibodies: Negative; Biopsy kidney: crescentic and sclerosis glomerulonephritis; Blood pressure measurement: 175/103 mmHg, notes: On admission; Blood urea nitrogen/creatinine ratio: 16/1.5; Computerized tomogram: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Cystoscopy: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Double stranded DNA antibody: Negative; Hemoglobin: 13.3; Heart rate: 104, notes: Unit: per min. On admission; Immunology test: linear GBM staining; c3/c4 level: Negative; Several glomeruli showed segmental scars and, notes: fibrous crescents in addition to focal cellular crescents of varying ages raising the possibility of concurrent ANCA vasculitis; Negative; unremarkable; Renal function test: improved; Urine analysis: revealed dysmorphic RBCs and and proteinuria; White blood cell count: 16600. Therapeutic measures were taken as a result of glomerulonephritis rapidly progressive. Sender's Comments: Based on available information, the causal association between the event GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE and suspect drug BNT162b2 cannot be excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis rapidly progressive, Haemoglobin, Heart rate, Immunology test, Investigation
Clinical narrative: crescentic & sclerosing glomerulonephritis; This is a literature report for the following literature source(s):  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "crescentic & sclerosing glomerulonephritis". The patient underwent the following laboratory tests and procedures: Antibody test: 25; cleared; Antineutrophil cytoplasmic antibody: Negative; Negative; Antinuclear antibody: Negative; Antiphospholipid antibodies: Negative; Biopsy kidney: crescentic and sclerosis glomerulonephritis; Blood pressure measurement: 175/103 mmHg, notes: On admission; Blood urea nitrogen/creatinine ratio: 16/1.5; Computerized tomogram: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Cystoscopy: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Double stranded DNA antibody: Negative; Hemoglobin: 13.3; Heart rate: 104, notes: Unit: per min. On admission; Immunology test: linear GBM staining; c3/c4 level: Negative; Several glomeruli showed segmental scars and, notes: fibrous crescents in addition to focal cellular crescents of varying ages raising the possibility of concurrent ANCA vasculitis; Negative; unremarkable; Renal function test: improved; Urine analysis: revealed dysmorphic RBCs and and proteinuria; White blood cell count: 16600. Therapeutic measures were taken as a result of glomerulonephritis rapidly progressive. Sender's Comments: Based on available information, the causal association between the event GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE and suspect drug BNT162b2 cannot be excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Urine analysis, White blood cell count
Clinical narrative: crescentic & sclerosing glomerulonephritis; This is a literature report for the following literature source(s):  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "crescentic & sclerosing glomerulonephritis". The patient underwent the following laboratory tests and procedures: Antibody test: 25; cleared; Antineutrophil cytoplasmic antibody: Negative; Negative; Antinuclear antibody: Negative; Antiphospholipid antibodies: Negative; Biopsy kidney: crescentic and sclerosis glomerulonephritis; Blood pressure measurement: 175/103 mmHg, notes: On admission; Blood urea nitrogen/creatinine ratio: 16/1.5; Computerized tomogram: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Cystoscopy: revealed left hydronephrosis, no nephrolithiasis, notes: or urothelial lesions; Double stranded DNA antibody: Negative; Hemoglobin: 13.3; Heart rate: 104, notes: Unit: per min. On admission; Immunology test: linear GBM staining; c3/c4 level: Negative; Several glomeruli showed segmental scars and, notes: fibrous crescents in addition to focal cellular crescents of varying ages raising the possibility of concurrent ANCA vasculitis; Negative; unremarkable; Renal function test: improved; Urine analysis: revealed dysmorphic RBCs and and proteinuria; White blood cell count: 16600. Therapeutic measures were taken as a result of glomerulonephritis rapidly progressive. Sender's Comments: Based on available information, the causal association between the event GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE and suspect drug BNT162b2 cannot be excluded. 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: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of PROQUAD that was accidently administered to a 17 year old patient; This spontaneous report was received from a nurse, referring to a 17-year-old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On 16-AUG-2022, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, vaccination squeme, anatomical site and route of administration were not reported) Lot No. U039955 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date not reported, but upon internal validation established as 14-JUN-2023 (product administered to patient of inappropriate age).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE.; HCP reporting a patient was administered MMRII intramuscularly instead of subcutaneously.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, once, lot #W023075, expiration date: 05-APR-2024, administered intramuscularly instead of subcutaneously for prophylaxis (Incorrect route of product administration). There was no adverse event reported.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Overdose, Wrong product administered
Clinical narrative: No additional AE reported; Customer reported a patient got PROQUAD and VARIVAX today (11/17/2022) instead of MMR II and VARIVAX.; Customer reported a patient got PROQUAD and VARIVAX today (11/17/2022) instead of MMR II and VARIVAX.; This spontaneous report was received from a medical assistant regarding a 12-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 17-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, product quantity 1, lot #U039958, expiration date: 14-JUN-2023 (also reported as 24-JUN-2023, conflicting information), administered as prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #U039947, expiration date: 16-DEC-2023, administered as prophylaxis (strength, and route of administration were not provided) (Overdose) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), and varicella virus vaccine live (oka/merck) (VARIVAX) (Wrong product administered).
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Arm was sore; Headache; Nausea; Tiredness; Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, headache, nausea, tiredness and muscle pain. On an unknown date, the outcome of the pain in arm, headache, nausea, tiredness and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm, headache, nausea, tiredness and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingrix and immediately after vaccination his/her arm was sore but two days later the patient had a headache, nausea, tiredness and muscle aches. The reporter asked how soon do the side effects appear after the first dose of Shingrix and asked could it be from the shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching; This case was reported by a consumer via interactive digital media and described the occurrence of itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itching. On an unknown date, the outcome of the itching was unknown.   It was unknown if the reporter considered the itching to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-NOV-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient had Itching The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: FLU3
Symptoms: Medication error, Product storage error
Clinical narrative: 3rd box opened on 09Nov had tag alert alarm read #2; This case was reported by a other health professional via other and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal TIV Dresden (Fluarix) (batch number 997A5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix. On an unknown date, unknown after receiving Fluarix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: As per management, the reporter reported this intercepted medication error.  There was an order placed for a 98 packs/980 doses of Fluarix that shipped in 3 packages via parcel service. When the order arrived on 6th October 2022, the customer only opened and checked the tag alert for 2 of the 3 boxes, and did not check/open the last box of 42 packs/420 doses.  All 3 boxes were delivered next day by parcel service.  When they finally opened the 3rd box on 9th November 2022, the tag alert alarm read 2.  The tag alert was ok when they received the other two boxes. On there end, they were handling a request from the customer to return the 3rd box of 42 packs, but wanted to report this to them as they could not confirm viability of the vaccines. Additional supportive information: The reporter could not confirm viability of the Fluarix vaccines, which led to intercepted product storage error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired Fluarix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The pharmacist called to ask for information about the administration of Fluarix season 2021-2022 to a patient instead of the current Fluarix 2022-2023.  The reporter asked if the patient had to be re-vaccinated. The reporter did not provide patient identifiers nor data about the expired dose of Fluarix. Did not consent to follow-up. Additional supportive information: The patient received an expired dose of Fluarix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over 3 years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Nov-2022 Reporter's comment: Pharmacist reported that if a patient received her first dose of Shingrix vaccine over 3 years ago and has not receive her 2nd dose. The reporter asked that we need to restart the series. Called pharmacy but health care professional was not available.  Completed adverse event with just data provided as conservative. Since it was just this message there were no patient's or vaccine's identifiers, no opportunity to request follow up. Not sure if a patient was in fact involved. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. In worst approach case was kept valid with event incomplete course of vaccination considering that patient was involved and did not receive her 2nd dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: Pain and aches all over; 1st dose March2022, 2nd never; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced general body pain and incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK receipt date: 21-Nov-2022 and 24-Nov-2022 Reporter's comment: The patient had the first shot almost a year ago and had the side effects- pain, aches etc lasted a couple of days so, the patient never got the second shot.   The vaccine was Shingrix, and the patient believed the first dose was March 2022.   When asked the location of the pain and aches, the patient stated all over.  Reporter did not had the dose lot number information. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second shot of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 22Nov2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in unknown location on 22nd November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The pharmacist asked that should restart the series. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via company representative concerned a patient of an unspecified age, sex, race and ethnicity. Initial information processed with additional information received from department on 22-NOV-2022. The patient's height, and weight were not reported. The patient was healthy. The patient had previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with dose 1 of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) as booster (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date following vaccination with booster shot of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer), the patient got so sick and was hospitalized (date unspecified) from covid which was a suspected covid-19 infection (Dose number in series 2). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. It was reported that "One of my friends healthy took the shots booster and got so sick in the hospital from covid. Other friends got it. I got it and it was not that bad I took the vitamins it said to take". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000260239 and 90000260240. The suspected product quality complaint has been confirmed to be voided (did not meet criteria, as this report states the reporter has friends with covid after vaccination. There is no product quality issue described in the information reported as there is no timeline for date of vaccination to contracting covid, no brand of vaccination mentioned, and no positive confirmatory test reported to determine vaccination failure) based on the evaluation/investigation performed. Sender's Comments: V0:20221148369-suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e. there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 47 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, and moderate to severe hidradenitis suppurativa, and other pre-existing medical conditions included: There was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 4571858 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for covid-19 prophylaxis. Duration of drug administration was 1 days. Age at time of vaccination 45 years old. No concomitant medications were reported. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number: 1165521 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for psoriatic arthritis, and moderate to severe hidradenitis suppurativa. On an unspecified date, the patient experienced suspected covid-19 (covid symptoms) (Dose number in series 1). The patient received two doses of Pfizer BioNTech COVID-19 vaccine (Dose number in series 2) (form of admin, intramuscular, batch number: 4782537 expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 and second dose on 10-SEP-2022 for covid-19 vaccination. Duration of drug administration was 1 days. It was unknown whether patient had any adverse events post two doses of Pfizer BioNTech COVID-19 vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from suspected covid-19. This report was non-serious.