chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Syncope, Tremor
Clinical narrative: AFTER RECEIVING THE IMMUNIZATION, THE PATIENT WAS SHOPPING IN THE STORE AND FAINTED (VASOVAGAL SYNCOPE).  SHE REAGINED CONCIOUSNESS IMMEDIATELY.  SHE CONTINUED TO FEEL LIGHTHEADED AND DIZZY.  SHE ALSO EXPERIENCED SOME SHAKINESS AND COLD SWEATS.  I ADMINISTERED DIPHENHYDRAMINE 50mg JUST IN CASE THERE WAS A MORE SERIOUS REACTION OCCURRING.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Myositis, Pain in extremity, Paraesthesia
Clinical narrative: Patient noticed this flu shot was more painful than in the past. It was more achy and it progressively got worse as time went on. She is on a second round of prednisone. Says she has pain in her arm. Numbness and Tingling as well. Dr thought there was some inflammation in the muscle.
Age: 66.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Hives, rash on face, torso, arms, groin, legs. High temperature 101 F Tool Benadryl, tyelenol. Symptoms return after 8 hrs. Symptoms lasted 4 days post vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pain in extremity, Skin warm
Clinical narrative: Patient has large red area approx 3 inch diameter with slight rash surrounding site.  Arm is warm to touch and sore.  Treatment with cool/ice pack. Instructed patient to seek medical attention if not better, worsened , or fever develops
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hyperaesthesia, Pain, Rash
Clinical narrative: Patient got 1st dose of Shingrix on 8/11/2020. According to patient about 1 week later on 8/18/2020, patient felt like there was a bruise forming on her outer left thigh. When patient looked at the site, there was nothing visible on her thigh but skin in the area was sensitive to touch, painful and felt like a "brush-burn".  About another week later on 8/29/2020, patient finally noticed a rash cluster on the same area she was feeling pain and upon further inspection, the rash seems to have spread to the crease in the groin area. The area is still sensitive to touch and has not resolved.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Shivering, vomiting, fever over 103, bp 120
Age: 41.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT PRESENTED WITH A SWOLLEN, RED, AND PAINFUL ARM TWO DAYS AFTER RECEIVING HER PNEUMOVAX 23 VACCINE AND FLUCELVAX QUAD IN HER RIGHT ARM.  SHE SAID IT SWELLED UP THE FIRST NIGHT, BUT HAD NOT IMPROVED MUCH AFTER 48 HOURS. I RECOMMENDED SHE USE SOME ICE ON IT AS WELL AS TYLENOL TO HELP WITH THE PAIN AND TO KEEP AN EYE ON IT.  I ADVISED HER TO LET US KNOW IF HER SYMPTOMS WORSENED.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Contusion, Haemorrhage
Clinical narrative: Patient experienced a bruise starting about 2 weeks ago, and then a couple of days ago small blisters that were bleeding
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Diarrhoea, Feeling cold, Malaise, Mobility decreased
Clinical narrative: Woke up the next morning and could hardly get myself out of bed.  Just dragging!  Showered and popped back into bed.  Arm was KILLING ME.  Very s?l..o?w?.  Did not feel well (stomach felt icky, body ached).  Temp was 99.8 this morning.  Went hiking after taking an Aleve.  Anything I ate the day after turned into diarrhea...  Still have fever at 3:03 p.m. ? 99.38  After I posted at 3:03 p.m., I was OK for about another 45 minutes, and then got freezing cold. Put on my heavy winter jacket over a vest socks and turn the heat up to 72. Still could not get warm, so went to bed with the vest and my robe on.  FREEZING!!!!  Slept or something for about four hours before I finally got hot enough. Once I cooled down, I felt pretty good.  10 pm and no fever!!!!!  Everything was fine after that nap. However, my arm hurts for at least a week and maybe a little diarrhea.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke up the next morning and could hardly get myself out of bed.  Just dragging!  Showered and popped back into bed.  Arm was KILLING ME.  Very s?l..o?w?.  Did not feel well (stomach felt icky, body ached).  Temp was 99.8 this morning.  Went hiking after taking an Aleve.  Anything I ate the day after turned into diarrhea...  Still have fever at 3:03 p.m. ? 99.38  After I posted at 3:03 p.m., I was OK for about another 45 minutes, and then got freezing cold. Put on my heavy winter jacket over a vest socks and turn the heat up to 72. Still could not get warm, so went to bed with the vest and my robe on.  FREEZING!!!!  Slept or something for about four hours before I finally got hot enough. Once I cooled down, I felt pretty good.  10 pm and no fever!!!!!  Everything was fine after that nap. However, my arm hurts for at least a week and maybe a little diarrhea.
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: Patient received Shingrix in right arm and Fluad in the left arm and the next day reported that she experienced chills, fever, insomnia  and nausea over night. She had pain at the Shingrix  injection site which was alleviated by taking Ibuprofen
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Lasted from 7 pm till this report posting.  Most severe from 7pm time 1 pm ( scale of pain 1-10) it was a solid 8 going on nine.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Swelling
Clinical narrative: rash on deltoid and swelling
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Dyspnoea, Musculoskeletal chest pain, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Patient called stating he received a flu vaccine yesterday in the morning and in the evening he developed rib and back pain. The next morning he developed pain in his tonsils and nasal drainage. He also reports a little difficulty breathing which he has not previously experienced.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: patient reports that arm was sore the next day. We were closed on Sunday, patient reported it was still sore after a few days after event and that it did not dissipate.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm at first. Low grade fever and chills about 12 hours after vaccine.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: patient alerted pharmacy on 9-1-20 that she had been seen by her PCP for pain, heat and redness extending down her right arm beginning and inch or two below injection site and stopping just above elbow. she had no injection site reaction. she experienced stomach upset, nausea, and vertigo for which prescriber gave her meclizine.  patient believes the illness is vaccine related although she said she has never experienced a reaction to flu vaccine in the past. she was vaccinated at same time as 2 other family members by same vaccinator and said neither of the other family members became ill. the patient's arm continued to be visibly red and warm to the touch today. she is not sure why she experienced this unusual response but we will report in hopes it may become clear.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: patient alerted pharmacy on 9-1-20 that she had been seen by her PCP for pain, heat and redness extending down her right arm beginning and inch or two below injection site and stopping just above elbow. she had no injection site reaction. she experienced stomach upset, nausea, and vertigo for which prescriber gave her meclizine.  patient believes the illness is vaccine related although she said she has never experienced a reaction to flu vaccine in the past. she was vaccinated at same time as 2 other family members by same vaccinator and said neither of the other family members became ill. the patient's arm continued to be visibly red and warm to the touch today. she is not sure why she experienced this unusual response but we will report in hopes it may become clear.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient  received the Pneumovax 23 on 08/30/20 per patient she called back to report swelling , itching, and redness.  She was seen by a prescriber 09/01/2020 .
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Vaccination site pain
Clinical narrative: Bright red rash on both upper arm area both sides of my lower back waist area. It was not itchy, blistery, or bothersome. The following morning the rash was fading. My left arm where the vaccine was given is still a little tender.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF glucose increased, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome
Clinical narrative: & GUILLAIN BARRE
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Swelling
Clinical narrative: Redness, Pain, itching and tingling and slight swelling in the arm below the injection site, along with some other mild symptoms shortly after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: redness, swelling, pain, warm
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait inability, Incoherent, Myalgia, Pyrexia
Clinical narrative: Intense Muscle pain-Full body Fatigue-Not Able to walk - Did not urinate - Fever of 99.5 - was incoherent- This took a toll on my body & Mind-I am scared to take the Booster shot, but Also Afraid Not to take it. Please AdviseME.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary retention
Clinical narrative: Intense Muscle pain-Full body Fatigue-Not Able to walk - Did not urinate - Fever of 99.5 - was incoherent- This took a toll on my body & Mind-I am scared to take the Booster shot, but Also Afraid Not to take it. Please AdviseME.
Sex: F
Vaccine: FLUA3
Symptoms: Pain
Clinical narrative: FLUAD(65+) Administered on 3/10/20 8/18/20 Patient reports she has a burning pain from shoulder to elbow that started when she got the Flu shot and is not Relenting this far out.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Balance disorder, Dizziness, Flushing, Gait inability
Clinical narrative: Immediately felt nauseated, chin fell quickly to my chest, my right arm was stiff, my eyesight was blurred my speech was affected, my head was dizzy. The back of my neck (Left side) was flushed with cerebral fluid. I lost my balance & couldn't walk to another room in the office with out help to lay down for 20 minutes. I got to drink a little water & eat crackers. For 60 days I was like commatoast. Now I sleep 24 & 7 everyday with low energy levels. I can't stop sleeping. I take a shower eat breakfast & fall immediately to sleep 10x a day My mind thinks backwards words are turned around and thoughts now I have very low energy
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersomnia, Immediate post-injection reaction, Musculoskeletal stiffness, Nausea, Speech disorder
Clinical narrative: Immediately felt nauseated, chin fell quickly to my chest, my right arm was stiff, my eyesight was blurred my speech was affected, my head was dizzy. The back of my neck (Left side) was flushed with cerebral fluid. I lost my balance & couldn't walk to another room in the office with out help to lay down for 20 minutes. I got to drink a little water & eat crackers. For 60 days I was like commatoast. Now I sleep 24 & 7 everyday with low energy levels. I can't stop sleeping. I take a shower eat breakfast & fall immediately to sleep 10x a day My mind thinks backwards words are turned around and thoughts now I have very low energy
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Thinking abnormal, Vision blurred
Clinical narrative: Immediately felt nauseated, chin fell quickly to my chest, my right arm was stiff, my eyesight was blurred my speech was affected, my head was dizzy. The back of my neck (Left side) was flushed with cerebral fluid. I lost my balance & couldn't walk to another room in the office with out help to lay down for 20 minutes. I got to drink a little water & eat crackers. For 60 days I was like commatoast. Now I sleep 24 & 7 everyday with low energy levels. I can't stop sleeping. I take a shower eat breakfast & fall immediately to sleep 10x a day My mind thinks backwards words are turned around and thoughts now I have very low energy
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Ligament pain, Myalgia
Clinical narrative: Pain in arm of injection, unable to raise arm above head, extreme muscle/ligament pain that has not gotten better after 1 month.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: swelling (R) thigh (approximately 4 cm with induration) with minimal redness)
Age: 53.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 2 hours after injections in upper left arm, patient started experiencing a 6-8" area of redness around injection site, pain, hardness & itching. She applied ice to area on 7/27/2020.  These symptoms lasted approx. one week- Today 8/5/2020 Symptoms have subsided with  slight redness remaining
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Dizziness, fever, chills, pain, body aches low grade temp, nausea starting on Friday & on Sat. felt better on Sunday lasting arm pain & swelling @ injection site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Dizziness, fever, chills, pain, body aches low grade temp, nausea starting on Friday & on Sat. felt better on Sunday lasting arm pain & swelling @ injection site.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: Patient concerned about injection site reaction. Redness, hot, itchy, painful arm. reaction still there on 9/1/20
Age: 74.0
Sex: U
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Erythema, Heart rate increased
Clinical narrative: patient developed SOB, red face, pain in chest under breasts and rapid heart beat within 1 minute of flu shots, we called 911. EMT came and patient BP was 160/90. She felt better by 5:40pm and refused further TX.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Breast enlargement, Breast pain, Dizziness, Fatigue, Hemiparesis
Clinical narrative: Rec'd vaccine on June 27, 2017 - as soon as the injection was administered - it pained and burned terribly as it went into my arm. I mentioned it to the nurse immediately. It immediately became swollen and redness after that. and was hot - gave me weakness in my right side and dizzy. Dr. sent me to Radiology for complete 3D mamogram - Following week or so Dr. sent me to emergency room - Aug 26, 2020 three years later my right bust and right arm are still large than the left. Records and photos included. Thank you for taking the time to review my report. HPI: 18:40 This 76 yrs old female presents to ED via Walk-in with complaints of right arm swelling. 18:40 Patient presents with right arm swelling which started 9 days ago after she received the pneumococcal vaccine for the first time. She states that the vaccine burned initially when it went into her arm and since then she has been having intermittent itching, dizzy episodes, fatigue. She has right arm swelling, pain which radiates into the bilateral breasts. She told her PCP about the symptoms and he sent her for a mammogram and breast ultrasound 1 week ago at radiology. The results were unremarkable. She states she continues to have persistent symptoms and cannot take Benadryl because it makes her agitated. She was taking Motrin 800 mg which did not help. She called her PCP again today and he told her to come to the emergency room. She denies fever, chills, headache, cough, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, numbness/weakness in the extremities. She had surgery on her veins in February 2017 and has had bilateral leg edema since then which is unchanged. History obtained from patient.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rec'd vaccine on June 27, 2017 - as soon as the injection was administered - it pained and burned terribly as it went into my arm. I mentioned it to the nurse immediately. It immediately became swollen and redness after that. and was hot - gave me weakness in my right side and dizzy. Dr. sent me to Radiology for complete 3D mamogram - Following week or so Dr. sent me to emergency room - Aug 26, 2020 three years later my right bust and right arm are still large than the left. Records and photos included. Thank you for taking the time to review my report. HPI: 18:40 This 76 yrs old female presents to ED via Walk-in with complaints of right arm swelling. 18:40 Patient presents with right arm swelling which started 9 days ago after she received the pneumococcal vaccine for the first time. She states that the vaccine burned initially when it went into her arm and since then she has been having intermittent itching, dizzy episodes, fatigue. She has right arm swelling, pain which radiates into the bilateral breasts. She told her PCP about the symptoms and he sent her for a mammogram and breast ultrasound 1 week ago at radiology. The results were unremarkable. She states she continues to have persistent symptoms and cannot take Benadryl because it makes her agitated. She was taking Motrin 800 mg which did not help. She called her PCP again today and he told her to come to the emergency room. She denies fever, chills, headache, cough, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, numbness/weakness in the extremities. She had surgery on her veins in February 2017 and has had bilateral leg edema since then which is unchanged. History obtained from patient.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Mammogram normal, Pain, Peripheral swelling, Pruritus
Clinical narrative: Rec'd vaccine on June 27, 2017 - as soon as the injection was administered - it pained and burned terribly as it went into my arm. I mentioned it to the nurse immediately. It immediately became swollen and redness after that. and was hot - gave me weakness in my right side and dizzy. Dr. sent me to Radiology for complete 3D mamogram - Following week or so Dr. sent me to emergency room - Aug 26, 2020 three years later my right bust and right arm are still large than the left. Records and photos included. Thank you for taking the time to review my report. HPI: 18:40 This 76 yrs old female presents to ED via Walk-in with complaints of right arm swelling. 18:40 Patient presents with right arm swelling which started 9 days ago after she received the pneumococcal vaccine for the first time. She states that the vaccine burned initially when it went into her arm and since then she has been having intermittent itching, dizzy episodes, fatigue. She has right arm swelling, pain which radiates into the bilateral breasts. She told her PCP about the symptoms and he sent her for a mammogram and breast ultrasound 1 week ago at radiology. The results were unremarkable. She states she continues to have persistent symptoms and cannot take Benadryl because it makes her agitated. She was taking Motrin 800 mg which did not help. She called her PCP again today and he told her to come to the emergency room. She denies fever, chills, headache, cough, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, numbness/weakness in the extremities. She had surgery on her veins in February 2017 and has had bilateral leg edema since then which is unchanged. History obtained from patient.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed a rash extending around her abdomen and back within 4 hours of vaccine administration, on 8/27/20.  On 8/31/20, Patient developed high fevers, reaching 103.6 degrees on 9/1/20.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: a 12 month old baby received PROQUAD and VARIVAX.; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender.      The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not provided.  On 21-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter (route of administration, lot/batch # and expiration date were not reported), and with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (route of administration, lot/batch # and expiration date were not reported). Both administered as prophylaxis.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received improperly stored VAQTA and VARIVAX on 7/23/2020.; No additional adverse effect; This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent (manufacturer unknown). The patient's medical history, historical drugs, previous drug reactions, and allergies were not reported.   On 23-JUL-2020, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023504, expiration date on 16-AUG-2020, which was reconstituted with properly stored diluent; and with hepatitis a vaccine, inactivated (VAQTA), lot No. S032055 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 09-NOV-2020 both as prophylaxis  (formulations, strengths, doses, frequencies, routes of administration, and anatomical locations were not reported). No additional adverse effect reported.  The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion of minus 14 degrees Celsius to minus 10 degrees Celsius (minus 12.61 degrees Celsius) for 12 hours and 45 minutes; and minus 9 degrees Celsius to 8 degrees Celsius (minus 7.98 degrees Celsius) for 2hours and 45 minutes.  The administered dose of hepatitis a vaccine, inactivated (VAQTA), experienced the temperature excursion above 47 degrees Fahrenheit/ 9 degrees Celsius: 9.92 degrees Celsius for 10 hours and 30 minutes; 8.56 degrees Celsius for 8 hours and 30 minutes; 8.56 degrees Celsius for 3 hours and 30 minutes; and 9.05 degrees Celsius for 1 hours and 15 minutes.  There was no previous temperature excursion reported. Data logger was involved in both vaccines. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: on 8/21/2020, the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse, referring to a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 21-AUG-2020, the patient was administered improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T002848, which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot number S008566, which has been verified to be valid, expiration date reported and validated as 16-NOV-2021).  The vaccine underwent multiple temperature excursions between minus 14 degrees Celsius (C) to -10C (-12.1C) for 3 hours and multiple temperature excursions between -9C to 8C (-7.5C) for 8 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.
Age: 31.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: consumer received MMRV and VARIVAX concomitantly; VARIVAX administered by IM route; This spontaneous report was received from a nurse referring to a 31-year-old male patient. The patient's concurrent conditions, relevant medical history and concomitant medications were not provided.    On 21-AUG-2020 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (Dosage regimen; lot and expiration date were not reported) administered intramuscularly (IM) (Incorrect route of product administration) for prophylaxis.  On 24-AUG-2020, the patient returned to clinic with no complaints; and on an unspecified date in August 2020, he was vaccinanted with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) (Dosage regimen; lot and expiration date were not reported) for prophylaxis. On 27-AUG-2020, it was identified that the patient was vaccinated concomitantly with both vaccines (inappropriate schedule of product administration).
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was administered improperly stored V ARlV AX; This spontaneous report has been received from a registered nurse  concerning a 4 years-old male patient. The patient's concomitant therapies included sterile diluent( MERCK STERILE DILUENT). The patient's concurrent conditions, historical drugs and medical history were not reported.    On 13-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, Lot # T002848 has been verified to be a valid lot number, expiration date 23-JAN-2022 for prophylaxis (dosage regimen was not provided).  It was reported that multiple excursions took place. One temperature excursion, was reported to had been in between -14°C to -10°C, more specifically at -12.1°C for 3 hours. A different temperature excursion, was reported to had been in between -9°C to 8°C, more specifically at -7.5°C for 8 hours and 30 minutes.  The sterile diluent used to reconstitute the Varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly.  There was digital data logger involved and  no previous temperature excursion was reported.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 4-years-old male patient. The patient's pertinent medical history, concurrent conditions, , previous drug allergies or reactions and concomitant medications were not reported.    On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number T002848; expiration date 23-JAN-2022, as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT) (Lot number S008566; expiration date 16-NOV-2021).    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of -14 degree Celsius (°C) to -10 °C (average temperature was -12.1 °C) degree Celsius (°C) for a period of 3 hours with multiple excursions: -9°C to 8 °C (average temperature was -7.5 °C) for 8 hours 30 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a different dosing schedule outside of the prescribing information; This spontaneous report was received from a pharmacist, referring to a 23 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date in October 2014, 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) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date in April 2015 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on an unknown date November 2017, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  The pharmacist stated that the patient received a different dosing schedule outside of the prescribing information.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patient was administered improperly stored  VARIVAX; This spontaneous report has been received from a registered nurse  concerning a 12 months old male patient. The patient's concomitant therapies included sterile diluent( MERCK STERILE DILUENT). The patient's concurrent conditions, historical drugs and medical history were not reported.    On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) formulation not reported but defaulted to subcutaneous injection, Lot # T002848 has been verified to be a valid lot number, expiration date 23-JAN-2022 for prophylaxis (dosage regimen was not provided).  It was reported that multiple excursions took place. One temperature excursion, was reported to had been in between -14°C to -10°C, more specifically at -12.1°C for 3 hours. A different temperature excursion, was reported to had been in between -9°C to 8°C, more specifically at -7.5°C for 8 hours and 30 minutes.  The sterile diluent used to reconstitute the Varicella virus vaccine live (oka/merck)(VARIVAX) was stored properly.  There was digital data logger involved and  no previous temperature excursion was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; vaccine was labeled expiration date was 8/20/2020 and it was administered to patient on 8/25/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 25-AUG-2020,post expiry date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1.0 mL, non-valid lot #S0218729 with an expired date reported on 20-AUG-2020, for prophylaxis. No additional adverse event/product quality complaint was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine in patient over the age of 45; This spontaneous report was received from a pharmacist concerning an unspecified patient over the age of 45 (unknown age and gender).    The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date were not provided) for prophylaxis.      This is a non-valid case due to lack of patient identifier.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 27-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 24-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 (also reported as TOO2843) and expiration date reported as 23-JAN-2022 ).   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was previous temperature excursion.   A digital data logger was involved.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014711:
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning, but not previously reported, involving VARIVAX; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 28-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 25-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 and expiration date reported as 23-JAN-2022.   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was no previous temperature excursion.   A digital data logger was involved.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion that was intermittent beginning, but not previously reported, involving VARIVAX; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 28-JUL-2020, varicella virus vaccine live (oka/merck)(VARIVAX) were improperly stored and had temperature excursions.   On 25-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml for prophylaxis, lot #T002843 and expiration date reported as 23-JAN-2022.   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was no previous temperature excursion.   A digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   Since 28-JUL-2020,  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) were improperly stored and had temperature excursions.   On 25-AUG-2020, the patient was vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  0.5 ml for prophylaxis, lot #T009929 and expiration date reported as 16-SEP-2021, albumin status rHA.   The temperature excursion was reported from -14°C to -10°C (max -9.5°C), during a time frame of 38 hours and 30 minutes. There was previous temperature excursion.   A digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: nursing assistant reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 05-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, which has been verified to valid, expiration date reported and validated as 23-JAN-2022) for prophylaxis,  that experienced a temperature excursion (product storage error). The administered dose of the vaccine experienced a temperature and time frame of -10.2 degrees Celsius, during 1 hour and 53 minutes, as recorded by data logger. No previous temperature excursion was reported.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2008USA014757: US-009507513-2008USA014767: US-009507513-2008USA014697: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014803: US-009507513-2008USA014820: US-009507513-2008USA014825: US-009507513-2008USA014869: US-009507513-2008USA014871: US-009507513-2008USA014937: US-009507513-2008USA015018: US-009507513-2009USA000112:
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: patient received 2nd dose of GARDASIL 9 and became dizzy, did not pass out, just got dizzy; This spontaneous report was received from a consumer, via a company representative, referring to herself, a female patient of unknown age. Patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown.      On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection once, for prophylaxis and she became dizzy, did not pass out, just got dizzy. Patient received treatment for the adverse experience, was observed in office and she left the office on her own later that day, recovering this same vaccination day, after being monitored.       The causality assessment was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX administered after temperature excursion; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 14-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number T002846 has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014705: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869: US-009507513-2008USA014951:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX administered after temperature excursion; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 13-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number T002846 has been verified to be valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature excursion of -10.2 degrees Celsius (C) for 1 hour and 53 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014705: US-009507513-2008USA014950: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: his arm is redder; his arm / swelling; his arm / is spreading warm to touch; This case was reported by a other health professional via interactive digital media and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. On 23rd August 2020, 3 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the erythema of extremities, swelling arm and skin warm were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient arm was redder and swelling was spreading warm to touch. The patient asked to put cold or warm compress on the site.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a several patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. After receiving Shingrix, some patients experienced fever or headache. This case was linked with case US2020171331, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020171331:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is killing me. How long should it hurt for?/my arm still hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine a month ago and had pain in arm. The patient asked how long it hurt and how long should wait to get the Flu vaccine after receiving the Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: shingles/ suspected vaccination failure; shingles; rash with blister; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blistery rash. On an unknown date, the outcome of the vaccination failure, shingles and blistery rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blistery rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The doctor reported that patient experienced a rash with blisters consistent with Shingles. The the patient did not experienced pain after receiving a dose of Shingrix. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had the shingles vaccine about a month ago. The patient reported that the patient's  arm was killing. The patient's asked how long should it hurt for?
Sex: F
Vaccine: HEP, IPV
Symptoms: Erythema multiforme
Clinical narrative: developed Erythem Multiform after receiving / hep-b vaccine and a polio vaccination; This case was reported by a other health professional via call center representative and described the occurrence of erythema multiform-like eruption in a female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   Concurrent medical conditions included multiple myeloma.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine and the 1st dose of POLIO VACCINE. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced erythema multiform-like eruption (serious criteria GSK medically significant). On an unknown date, the outcome of the erythema multiform-like eruption was unknown.   It was unknown if the reporter considered the erythema multiform-like eruption to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Hepatitis B vaccine and Polio vaccine, the patient experienced erythema multiform-like eruption. The patient had tested due to her medical history of Multiple myeloma not related to a vaccine. The reporter consented to follow up. This case was linked with case US2020173731, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020173731:same patient