chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, FLU4, PNC15, DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: WRONG MODERNA FORMULATION GIVEN.  SHOULD HAVE BEEN 0.25 MG/ug BUT GAVE 0.2 MG/ug FORMULATION.  PATIENT HAD HISTORY OF ONE DOSE MODERNA BIVALENT GIVEN ON  5/4/23  STARTED HAVING DIFFUSE RED RASH ON BACK.  MOM STATES THAT IT APPEARS TO BE LIKE "HEAT RASH" & IS NOT RAISED OR BUMPY.  MOM DENIES RASH ANYWHERE ELSE.  SHE CRIED & WAS "INCONSOLABLE" FOR THE ENTIRE NIGHT.  THIS STARTED ABOUT 4-5 HOURS POST VACCINATION.  MOM STATES THAT THEY HAD TO TAKE SHOWERS WITH THE CHILD ALL NIGHT INTERMITTENTLY.  SHE THINKS SHE WAS FEBRILE BUT DID NOT TAKE HER TEMPERATURE.  SHE STATES THAT HER FOOD INTAKE HAS BEEN "MINIMAL" FOR 24-HOURS.  SHE STATES THAT HER URINARY OUTPUT IS "THE SAME AS USUAL... SHE'S BEEN HAVING NORMAL WET DIAPERS."   MOM STATES THE CHILD'S LEFT LEG IS HARD TO THE TOUCH BUT DOES NOT APPEAR READ OR SWOLLEN.  THE CHILD IS ALLOWING HER TO RUB ON THE SITE & SHE IS "DOING SO TO TRY & HELP SOFTEN IT".  SHE &  HER HUSBAND HAVE BEEN ADMINISTERING CHILDREN'S TYLENOL Q  HOURS SINCE YESTERDAY.  MOM DENIES THE NEED TO CALL HER PEDIATRICIAN, AS SHE FEELS THE CHILD IS IMPROVING SOME TODAY. .
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Dry skin, Erythema
Clinical narrative: A 21 year old college student was given MMR vaccine on 6/6/23 on Left upper arm at Health Clinic. On 6/12/23 patient reports redness to vaccine. Patient came to Health Clinic on 6/13/23 and was evaluated by NP for possible allergic reaction. NP and supervising MD evaluated the possible vaccine reaction on LUA, isolated erythema and dryness to L upper arm in the shape of band aid applied to site. No SOB or diffuse rash or hives noted.  Student with previous allergy to adhesive. No referral to ED required. Student advised to treat lesion with OTC hydrocortisone cream and emollients to improve skin dryness.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Cough, Eosinophil count abnormal, Fatigue, Hypoaesthesia, Influenza like illness
Clinical narrative: Patient reports the day after the vaccine was administered he reported flu-like symptoms which continued for 4-5 days. Day 7 he started to develop sinus infection symptoms. Day 10 he started Doxycycline and steroids. He reports both of those helped with the sinus infection symptoms but not the overall malaise and fatigue. He also reports a cough even after continuing steroids and antibiotics. A day or 2 after completing steroids and antibiotics he started to develop numbness and tingling in toes, hands, and forearms. He reports that when washing his hands in hot water, it feels cold. Patient states that he started noticing pins-and-needles sensation. Patient states that he does not notice any weakness or rashes and is still experiencing extreme fatigue. PCP ordered CBC with Diff, CMP, Sed Rate, C-Reactive Protein, TSH, Referral for EMG, and Prednisone 20mg x7 days. NP reviewed recent labs and states that other than EOS count, his labs were within normal limits.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Laboratory test normal, Malaise, Paraesthesia, Reversed hot-cold sensation, Sinusitis
Clinical narrative: Patient reports the day after the vaccine was administered he reported flu-like symptoms which continued for 4-5 days. Day 7 he started to develop sinus infection symptoms. Day 10 he started Doxycycline and steroids. He reports both of those helped with the sinus infection symptoms but not the overall malaise and fatigue. He also reports a cough even after continuing steroids and antibiotics. A day or 2 after completing steroids and antibiotics he started to develop numbness and tingling in toes, hands, and forearms. He reports that when washing his hands in hot water, it feels cold. Patient states that he started noticing pins-and-needles sensation. Patient states that he does not notice any weakness or rashes and is still experiencing extreme fatigue. PCP ordered CBC with Diff, CMP, Sed Rate, C-Reactive Protein, TSH, Referral for EMG, and Prednisone 20mg x7 days. NP reviewed recent labs and states that other than EOS count, his labs were within normal limits.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: C-reactive protein normal, Full blood count, HIV test negative, Hepatitis C test negative, Hypoaesthesia
Clinical narrative: Patient reports the day after the vaccine was administered he reported flu-like symptoms which continued for 4-5 days. Day 7 he started to develop sinus infection symptoms. Day 10 he started Doxycycline and steroids. He reports both of those helped with the sinus infection symptoms but not the overall malaise and fatigue. He also reports a cough even after continuing steroids and antibiotics. A day or 2 after completing steroids and antibiotics he started to develop numbness and tingling in toes, hands, and forearms. He reports that when washing his hands in hot water, it feels cold. Patient states that he started noticing pins-and-needles sensation. Patient states that he does not notice any weakness or rashes and is still experiencing extreme fatigue. PCP ordered CBC with Diff, CMP, Sed Rate, C-Reactive Protein, TSH, Referral for EMG, and Prednisone 20mg x7 days. NP reviewed recent labs and states that other than EOS count, his labs were within normal limits.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Immunology test normal, Influenza like illness, Laboratory test abnormal, Metabolic function test, Paraesthesia
Clinical narrative: Patient reports the day after the vaccine was administered he reported flu-like symptoms which continued for 4-5 days. Day 7 he started to develop sinus infection symptoms. Day 10 he started Doxycycline and steroids. He reports both of those helped with the sinus infection symptoms but not the overall malaise and fatigue. He also reports a cough even after continuing steroids and antibiotics. A day or 2 after completing steroids and antibiotics he started to develop numbness and tingling in toes, hands, and forearms. He reports that when washing his hands in hot water, it feels cold. Patient states that he started noticing pins-and-needles sensation. Patient states that he does not notice any weakness or rashes and is still experiencing extreme fatigue. PCP ordered CBC with Diff, CMP, Sed Rate, C-Reactive Protein, TSH, Referral for EMG, and Prednisone 20mg x7 days. NP reviewed recent labs and states that other than EOS count, his labs were within normal limits.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Red blood cell sedimentation rate normal, Vitamin B1, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Patient reports the day after the vaccine was administered he reported flu-like symptoms which continued for 4-5 days. Day 7 he started to develop sinus infection symptoms. Day 10 he started Doxycycline and steroids. He reports both of those helped with the sinus infection symptoms but not the overall malaise and fatigue. He also reports a cough even after continuing steroids and antibiotics. A day or 2 after completing steroids and antibiotics he started to develop numbness and tingling in toes, hands, and forearms. He reports that when washing his hands in hot water, it feels cold. Patient states that he started noticing pins-and-needles sensation. Patient states that he does not notice any weakness or rashes and is still experiencing extreme fatigue. PCP ordered CBC with Diff, CMP, Sed Rate, C-Reactive Protein, TSH, Referral for EMG, and Prednisone 20mg x7 days. NP reviewed recent labs and states that other than EOS count, his labs were within normal limits.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: pt received vaccine next day pt called and said pt injection site was swollen to golf ball size pt had fever and was vomiting too pt ice area and took ibuprofen and after 2 days symptoms improved still a little swollen but much better
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: The patient reports that yesterday evening after the vaccine she experienced itching and a rash on her ankle.  Today the rash has gotten worse and is appearing on both legs and is spreading to the rest of her legs.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chemotherapy, Computerised tomogram abnormal, Constipation, Intestinal mass
Clinical narrative: Started having abdominal pain and constipation.  CT revealed rectal Mass. Dx with rectal ca with mets. Had to have major surgery. Chemo and radiation
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Radiotherapy, Rectal cancer metastatic, Surgery
Clinical narrative: Started having abdominal pain and constipation.  CT revealed rectal Mass. Dx with rectal ca with mets. Had to have major surgery. Chemo and radiation
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pulmonary pain, SARS-CoV-2 test positive
Clinical narrative: After coming in contact with a large number of people on 11/08/2022, I began experiencing respiratory difficulty (coughing and upper respiratory pain) on 11/11/2022.  So, I went to the Urgent Care Clinic on the morning of 11/12/2022.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Death, Pneumonia
Clinical narrative: vaccine was given on friday, felt weak over weekend went to Doctor on Monday and diagnosed with double pneumonia and sent straight to hospital and passed away within 4 days
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: Patient experienced sweating, was pale, vision changes and headache. immediately sat down again, apply juice and crackers were brought, MD brought into room to evaluate patient. After sitting for a few minutes and juice, patient reported feeling much better, was no longer pale or sweating. Patient was encouraged to sit an additional few minutes to ensure resolved symptoms, and instructed to move slowly upon standing. Patient confirmed upon standing, symptoms resolved and no further complaints. Patient exited clinic.
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Balance disorder, Chills, Ear pain, Fatigue
Clinical narrative: Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Grip strength decreased, Headache, Heart rate increased, Hypersomnia, Injection site pain
Clinical narrative: Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site pruritus, Insomnia, Laboratory test normal, Lymphadenopathy, Mobility decreased
Clinical narrative: Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Muscle spasms, Myalgia, Neuralgia, Pain in extremity, Pruritus
Clinical narrative: Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Pyrexia, Swelling
Clinical narrative: Tetanus (tdaP) -- none. No complaints.  Shingrix -- tired, muscle pain, chills/fever, inability to sleep, itching/pain at shoulder site in right arm. Swelling, headache, right ear pain, rapid heartbeat, lymph node swelling on right side of neck, nerve pain/itching throughout right arm, loss of balance periodically, ordinary objects difficult to hold with right hand, right shoulder/right elbow/right hand/right index finger nerve pain -- arm is useless. Difficulty opening or holding anything with right arm. Random spasms in right arm. Sleeping more.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient received Prevnar 20 on 6/7/23. Symptoms of bruising, redness, pain, and itching at site of injected started 2 days after on 6/9/23. Patient reached out to provider and provider's office recommended icing site of injection. Patient states to put a frozen water bottle for extended period of time at the site and it has worsen with icing. The icing may  have led to redness around the injection site. Advised patient she needs to wrap towel around ice pack and only apply for 10 min on with rest in between. Recommended ibuprofen for pain and benadryl for itching. If no improvement, contact provider a second time for evaluation. No swelling. No limitation with daily activities. No tingling sensation down arm or restrictions when raising arm. No fever or other systemic symptoms.
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA, HPV9, HPV9, HPV9
Symptoms: Biopsy cervix, Biopsy cervix abnormal, Cervical dysplasia, Colposcopy abnormal, Endocervical curettage
Clinical narrative: On Jan 19, 2018 my Pap Smear results came back as negative/normal. A little over a year later on June 6, 2019 I received the Gardasil 9 vaccine, 2nd dose August 19, 2019, and 3rd dose December 26, 2019. 2 years later after getting these vaccines, on June 17, 2021 I receive results back from my next Pap Smear which shows Epithelial Cell Abnormality HSIL: High Grade squamous intraepithelial lesion. These were my signs and symptoms reagrding these vaccines after only 2 years later. I also recived 1st Hep A on June 17, 2019 and 2nd Hep A on December 26, 2019. Which I have listed below
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA, HPV9, HPV9, HPV9
Symptoms: Human papilloma virus test positive, Immunohistochemistry, Loop electrosurgical excision procedure, Pathology test, Precancerous cells present
Clinical narrative: On Jan 19, 2018 my Pap Smear results came back as negative/normal. A little over a year later on June 6, 2019 I received the Gardasil 9 vaccine, 2nd dose August 19, 2019, and 3rd dose December 26, 2019. 2 years later after getting these vaccines, on June 17, 2021 I receive results back from my next Pap Smear which shows Epithelial Cell Abnormality HSIL: High Grade squamous intraepithelial lesion. These were my signs and symptoms reagrding these vaccines after only 2 years later. I also recived 1st Hep A on June 17, 2019 and 2nd Hep A on December 26, 2019. Which I have listed below
Age: 23.0
Sex: F
Vaccine: HEPA, HEPA, HPV9, HPV9, HPV9
Symptoms: Smear cervix abnormal, Surgery
Clinical narrative: On Jan 19, 2018 my Pap Smear results came back as negative/normal. A little over a year later on June 6, 2019 I received the Gardasil 9 vaccine, 2nd dose August 19, 2019, and 3rd dose December 26, 2019. 2 years later after getting these vaccines, on June 17, 2021 I receive results back from my next Pap Smear which shows Epithelial Cell Abnormality HSIL: High Grade squamous intraepithelial lesion. These were my signs and symptoms reagrding these vaccines after only 2 years later. I also recived 1st Hep A on June 17, 2019 and 2nd Hep A on December 26, 2019. Which I have listed below
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory bowel disease, Laboratory test normal, Mobility decreased, Rash, Rash erythematous
Clinical narrative: Pt received 2nd dose 1 year later from 1st dose. Pt has had difficulty raising the left arm that received the shot and has red, raised, hard, warm, patches on both lower legs. Went to vascular MD and ruled out blot clots, not other treatment options were given. Today's visit, was advised to use antihistamine and ibuprofen for at least a week to see if any improvement, and to inquire about the reaction with PRIVACY to see a physician and/or other potential treatment.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash papular, Skin warm
Clinical narrative: Pt received 2nd dose 1 year later from 1st dose. Pt has had difficulty raising the left arm that received the shot and has red, raised, hard, warm, patches on both lower legs. Went to vascular MD and ruled out blot clots, not other treatment options were given. Today's visit, was advised to use antihistamine and ibuprofen for at least a week to see if any improvement, and to inquire about the reaction with PRIVACY to see a physician and/or other potential treatment.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Inappropriate schedule of product administration, Limb discomfort, Mobility decreased, Pain
Clinical narrative: Pt received 2nd dose 1 year later from 1st dose. Pt has had difficulty raising the left arm that received the shot and has red, raised, hard, warm, patches on both lower legs. Went to vascular MD and ruled out blot clots, not other treatment options were given. Today's visit, was advised to use antihistamine and ibuprofen for at least a week to see if any improvement, and to inquire about the reaction with PRIVACY to see a physician and/or other potential treatment.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness, Thrombosis, Vaccination site pain
Clinical narrative: Pt received 2nd dose 1 year later from 1st dose. Pt has had difficulty raising the left arm that received the shot and has red, raised, hard, warm, patches on both lower legs. Went to vascular MD and ruled out blot clots, not other treatment options were given. Today's visit, was advised to use antihistamine and ibuprofen for at least a week to see if any improvement, and to inquire about the reaction with PRIVACY to see a physician and/or other potential treatment.
Age: 22.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Round and bumpy swelling around injection site for the flu vaccination. Hives growing at the nape of the neck. Right arm had no swelling. Over time swelling in left arm went down. Took 50mg of Benadryl.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Medical Assistant was aware that lyophilized gEAntigen component needed to be mixed prior th shingrix injection.
Sex: U
Vaccine: TDAP
Symptoms: Physical product label issue
Clinical narrative: Opened box of Adacel Tdap 49281-0400-10 and the last remaining vial in the box was not labeled. Since we are unable to confirm the identity of the product for safe use it was disposed.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient given a Twinrix vaccine that expired on 5/20/23
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Headache, Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Immediately after the 2nd COVID vaccine, I felt shooting pain traveling from the site of injection to my head. After that I had severe headache. Everyday x 6 months I had severe headache unresolved completely by Excedrin. I also had short term memory loss where there would be complete blank in memory. As time passed the severity of frequency of memory loss decreased but after 2 years there's still occasional short term memory loss with a complete blank in time line. I also experienced inability to organize and complete simple tasks such as Christmas gift lists and completing tax returns.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Immediately after the 2nd COVID vaccine, I felt shooting pain traveling from the site of injection to my head. After that I had severe headache. Everyday x 6 months I had severe headache unresolved completely by Excedrin. I also had short term memory loss where there would be complete blank in memory. As time passed the severity of frequency of memory loss decreased but after 2 years there's still occasional short term memory loss with a complete blank in time line. I also experienced inability to organize and complete simple tasks such as Christmas gift lists and completing tax returns.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, CSF test normal, Culture urine negative, Metabolic encephalopathy, Pyrexia
Clinical narrative: Runaway fever (105-106F) and metabolic encephalopathy 18 hours following Pfizer bivalent COVID booster. Fever did not respond to acetaminophen. Similar reaction in October to the Moderna bivalent COVID booster. Both events required hospitalization.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccine positive rechallenge
Clinical narrative: Runaway fever (105-106F) and metabolic encephalopathy 18 hours following Pfizer bivalent COVID booster. Fever did not respond to acetaminophen. Similar reaction in October to the Moderna bivalent COVID booster. Both events required hospitalization.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Intraocular pressure increased
Clinical narrative: Developed eye problem after receiving 2nd Shingles vaccine. Was treated by cornea specialist for several months with anti-viral, elevated eye pressure and anti steroid inflammation. Needed multiple eye appointments for weeks to treat symptoms.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Fibrin D dimer increased, Platelet count, Thrombocytopenia, Thrombosis with thrombocytopenia syndrome
Clinical narrative: J&J vaccine use for COVID-19 under Emergency Use Authorization (EUA): Dural venous sinus thrombosis (DVST), Thrombocytopenia, Hematology was consulted and diagnosed her with VIIT..
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Received a call from mother of patient on 06/14/2023 @ 3:00 p.m. and informed me that patient started fever last night and right upper arm injection site is red, swollen and warm to the touched. Patient mother administered tylenol every 6 hours started 06/13/2023 @ 8:00 p.m. with good relief. At the time when mother called she said that fever has subsided but swelling on the injection site continues. I advised to apply ice pack every 20 minutes and tylenol every 6 hours PRN pain and fever. Take patient to Urgent Care if office is close if fever and pain continues. Call the office the next day during office hours if symptoms continues.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Pyrexia, Seizure
Clinical narrative: On evening of vaccines given patient had a fever of 105.0 degree F rectal. He had a seizure that lasted 15 minutes. Patient was taken to ER and left ER with a temperature of 97.2. As of today 6/14/23 he is still running a fever of 102.2 rectal. Parent advised to monitor closely, treat fever with tylenol and if he has another seizure that lasts longer then 5 minutes to call EMS.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient was administered the wrong vaccine. Provider ordered a prevnar 20 & she was given a pneumovax 23. Patient had this vaccine in 2015.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3, COVID19, UNK
Symptoms: Death
Clinical narrative: Found dead in bed following morning
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: No AE reported; Product was improperly stored and administered to a patient on 5/10/2023.; This spontaneous report was received from a nurse on behalf HCPand refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W039840 was valid, expiration date established as 12-JUN-2024, albumin status established as rHA (route of administration and anatomical location not provided) for prophylaxis. Before administration, the vaccine underwent temperature excursion for 168 hours on 74 degrees fahrenheit (F) (23.3 Celsius degrees) (product storage error). There was no previously temperature excursion. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE reported; Product was improperly stored and administered to a patient on 5/10/2023.; This spontaneous report was received from a nurse on behalf HCPand refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W039840 was valid, expiration date established as 12-JUN-2024, albumin status established as rHA (route of administration and anatomical location not provided) for prophylaxis. Before administration, the vaccine underwent temperature excursion for 168 hours on 74 degrees fahrenheit (F) (23.3 Celsius degrees) (product storage error). There was no previously temperature excursion. No additional adverse event reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; GARDASIL 9 was administered following temperature excursion.; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 16-MAY-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.   The vaccine had a temperature excursion of 96 hours with a lowest recorded temperature of 52.86 Fahrenheit (F). It was confirmed that no previous temperature excursions occurred.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; HCP called to report an expired dose of GARDASIL 9 was administered to a patient. Caller confirmed the GARDASIL 9 has not had any temperature excursions. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 18-MAY-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 ml as prophylaxis (no more vaccination details provided) (lot number 1687293 and expiration date of 30-APR-2023; both have been verified to be a valid) (expired product administered). The vaccine had not had any temperature excursions. No additional adverse event (no adverse event) was reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: he got the first dose on Feb of 2021 and the second dose on April of 2021... I wanted to see if he needed to get a third dose now or if he needs to restart; No AE/PQC reported; This spontaneous report has been received from a consumer regarding to himself a 41-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On an unspecified date in February 2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (dose, strength, route of administration, anatomical location, lot number, and expiration date were not provided). On an unspecified date in April 2021, he received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  The patient would like to know if he needed a third dose or if he should restart the vaccination series.  No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; Nurse reported AE for improperly stored administered GARDASIL 9; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 25-MAY-2023, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection (lot number w013388 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); expiration date has been established as 16-DEC-2024, administered for prophylaxis (strength, and anatomical site of administration were not provided). No other adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; Nurse reported AE for improperly stored administered MMRII; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 01-JUN-2023, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (product storage error) subcutaneous injection (lot number w034592 was determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); expiration date was established as 10-MAY-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). No additional adverse events were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE/no PQC; Medical assistant reported AE related to an adult patient that received a pediatric dose of RECOMBIVAX HB.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 07-JUN-2023, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (incorrect dose administered) intramuscular injection, strength: 5/0.5 mcrg/ml (lot number W025817 was determined to be valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date has been established as 21-MAY-2025), administered for prophylaxis (route of administration was not provided). No additional adverse was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report patient received MMR II expired 4/15/2023.; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.    On 15-MAY-2023 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U011995 and expiration date 15-APR-2023 for prophylaxis (exact dose, dose number and route of administration were not provided (expired product administered and no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccines but got shingles last week / suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had vaccines but got shingles last week / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by the patient via interactive digital media. The patient had vaccines but got shingles last week  The shingles lasted for a week only with medication and no pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles two years after getting the shots/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (severe) and post herpetic neuralgia (painful than shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles two years after getting the shots/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and again experienced very very light case of shingles at the same place. The patient stated that he or she never heard of it but found out 20 percentage of people over 60 years old end up with the shingles. The patient stated that alone is worth of getting the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Vaccination failure
Clinical narrative: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; know 4 ppl myself you got shingles FROM the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: know 4 ppl myself you got shingles FROM the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-Jun-2023 The case was received from the consumer via interactive digital media. The reporter know the patient himself or herself and stated that got shingles from the shot. In the instance they lasted over a year debilitating for sure. This report is one of four linked patients, reported by same reporter. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR082851:same reporter US-GSK-US2023AMR082853:same reporter US-GSK-US2023AMR082854:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Vaccination failure
Clinical narrative: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people with himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 3 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR082854:same reporter US-GSK-US2023AMR082851:same reporter US-GSK-US2023AMR082797:same reporter
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 12-JUN-2023, the patient received Infanrix. On 12-JUN-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 12-Jun-2023 The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up via email. The patient received an expired dose of Infanrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix was not reconstituted properly; Shingrix was not reconstituted properly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number G9455), (batch number 7373X), (batch number 3FE44), (batch number 5T495), (batch number HL9AJ), (batch number 22M3K), (batch number L4459), (batch number MY2Y2) and (batch number C9Z43) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix was not reconstituted properly) and inappropriate dose of vaccine administered (Verbatim: Shingrix was not reconstituted properly). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Jun-2023 The registered nurse stated that she believed that Shingrix was not reconstituted properly and only the adjuvant portion was administered to a patients as she had one lyophilized vial left but not an adjuvant. The reporter thought that the occurrence was with one patient but cannot be certain as they had just started investigating and did not had any patient identifiers at the moment. The reporter asked that if the lot number on the box matches the lyophilized component. The reporter provided the following lot numbers but stated that she cannot narrow down which one was administered as some of the lots pull up as Shingrix and some do not. It was explained that the box and lyophilized component have the same lot number. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received only received the adjuvant portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: the dose was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-week-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 12-JUN-2023, the patient received the 2nd dose of Engerix B. On 12-JUN-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the dose was expired). 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: 12-Jun-2023 At the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Salivary gland disorder, Salivary gland enlargement, Tongue discomfort
Clinical narrative: STIFFNESS OF THE SUBLINGUAL ONE; PRESSURE IN THE TONGUE; PROGRESSIVE ENLARGEMENT OF THE SUBMANDIBULAR SALIVARY GLAND BOTH ON THE LEFT AND RIGHT/IT GROWS EVEN LARGER WHEN CONSUME FOOD AND DRINKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced progressive enlargement of the submandibular salivary gland both on the left and right/it grows even larger when consume food and drinks. On an unspecified date, the patient experienced stiffness of the sublingual one, and pressure in the tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from progressive enlargement of the submandibular salivary gland both on the left and right/it grows even larger when consume food and drinks, and stiffness of the sublingual one, and the outcome of pressure in the tongue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Nerve compression, Neuralgia, Thrombosis
Clinical narrative: Had a blood clot in my liver; pinch nerve for 3 months, pinch nerve in my neck and my shoulder; Had a pinch nerve for 3 months, I was in pain every day for 3 months; a pinch nerve in my neck and my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "recovered", described as "Had a blood clot in my liver"; NERVE COMPRESSION (non-serious), outcome "recovered", described as "pinch nerve for 3 months, pinch nerve in my neck and my shoulder"; NEURALGIA (non-serious), outcome "recovered", described as "Had a pinch nerve for 3 months, I was in pain every day for 3 months; a pinch nerve in my neck and my shoulder". The patient underwent the following laboratory tests and procedures: Blood test: Unknown Result. Therapeutic measures were taken as a result of thrombosis. Clinical course:  Patient was sick. Patient had a pinch nerve for 3 months and was in pain everyday for 3 months for something that has nothing to do with COVID. Patient had a pinch nerve in neck and shoulder so didn't want to deal with it. It was hard time just living life let alone going to work. Patient was normal for past 3 weeks. Patient had encountered blood clots after vaccine shot. Patient stated to check hospital stay and all blood tests that was done. Patient had blood clot in liver and had to take surgery and then cleaning it out and doing some anti blood clot drugs (Treatment) and dissolved it. Patient was not sure of the dates and stated that it was couple months after got the covid shot May and it was in 2019 or 20, Patient was not sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Systolic dysfunction
Clinical narrative: Systolic dysfunction; This is a spontaneous report received from contactable reporter (Other HCP).  A 65-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Oct2019 as dose number unknown (0.5 ml), single (Lot number: AG8347, Expiration Date: 31May2021) at the age of 65 years intramuscular for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTOLIC DYSFUNCTION (non-serious) with onset 27May2020, outcome "unknown".