chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Rash generalised
Clinical narrative: APPROXIMATELY 24 HOURS AFTER ADMINISTRATION, THE PATIENT NOTICED A RASH ON THE FRONT OF HER BODY FROM NECK TO TOES. THE RASH WAS NOT PAINFUL NOR DID IT ITCH. SHE DID TAKE DIPHENHYDRAMINE 25MG EVERY 4 HOURS FOR 24 HOURS AS A PRECAUTION. SHE DID NOT SEEK MEDICAL ATTENTION. THE RASH RESOLVED WITHIN 36 HOURS.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Presyncope
Clinical narrative: Immediately after injection was given pt. became light headed, faint, and nauseated. Pt. had not eaten or drank anything. Given Powerade, crackers, and laid down on exam table. Vasovagal rxn. lasted approx 15 minutes. Pt. fully recovered.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Loss of consciousness, Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of lost consciousness in a 63-year-old male patient who received SHINGRIX (batch number 4492P, expiry date unknown). On 6th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th March 2018, 3 hrs after receiving SHINGRIX, the patient experienced lost consciousness (serious criteria GSK medically significant), fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain. On an unknown date, the outcome of the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain were unknown. It was unknown if the reporter considered the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient stated that three to four hours after vaccination he started to feel light headed, when he was speaking with his wife. The patient sat down, and he felt like arms and legs went stiff. The patient then fainted, lost consciousness, duration unknown. After regaining consciousness the patient reported that less than a day after vaccination, all the muscles in his body were hurting, joints hurt and then tingling. The patient did not go to urgent care or emergency room. The patient visit was at 11:30 and received injection approximately at 12 noon, fainting happened around 3 PM and he felt the joint pain until 11 PM. Next morning patient reported that right hand was still tingling. The patient had requested not to be given the second dose. Visit was a wellness visit and the patient did not receive any other injections at physician visit.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Syncope
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of lost consciousness in a 63-year-old male patient who received SHINGRIX (batch number 4492P, expiry date unknown). On 6th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th March 2018, 3 hrs after receiving SHINGRIX, the patient experienced lost consciousness (serious criteria GSK medically significant), fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain. On an unknown date, the outcome of the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain were unknown. It was unknown if the reporter considered the lost consciousness, fainting, light headedness, limbs stiffness, muscle pain, tingling and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient stated that three to four hours after vaccination he started to feel light headed, when he was speaking with his wife. The patient sat down, and he felt like arms and legs went stiff. The patient then fainted, lost consciousness, duration unknown. After regaining consciousness the patient reported that less than a day after vaccination, all the muscles in his body were hurting, joints hurt and then tingling. The patient did not go to urgent care or emergency room. The patient visit was at 11:30 and received injection approximately at 12 noon, fainting happened around 3 PM and he felt the joint pain until 11 PM. Next morning patient reported that right hand was still tingling. The patient had requested not to be given the second dose. Visit was a wellness visit and the patient did not receive any other injections at physician visit.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 13 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2018, the patient was vaccinated with a dose of improperly stored dose GARDASIL 9 injection (strength, dose and route of administration were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. The vaccine experienced a temperature excursion of 0 degrees Celsius (C) to 1 C for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information were provided. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA005427.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Extra dose administered, Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report was received from a medical assistant via company representative regarding a 2 months old infant. Information on pertinent medical history, drug reactions/allergies and concomitant medication was reported as unknown. On 20-FEB-2018, the patient received ROTATEQ lot# N021027 with expiry date of 27-FEB-2019, orally for prophylaxis. The patient spit up. On the same day, the patient received a second dose of ROTATEQ lot# N021027 with expiry date of 27-FEB-2019. Patient also received PREVNAR 13 and PENTACEL. Outcome of the event "Infantile spitting up" was reported as recovered. Causality of the event "Infantile spitting up" was not reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer Company representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 single dose for immunisation. The medical history and concomitant medications were not reported. The patient experienced pain at the injection site for about 3-4 days after use of product. Event outcome was unknown.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Odynophagia, Pharyngeal oedema, Pruritus, Sensation of foreign body
Clinical narrative: Itching in multi areas of the body, swelling inside throat, painful swallowing, it felt as though an obstruction had swelled in the back of the throat.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Within 24 hours pain redness swelling of entire arm. -> Cellulitis.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Chills, Full blood count normal, Headache, Influenza virus test negative
Clinical narrative: Fever, chills, aches. Vomiting. Started w/in 10 hours of the vaccine and was previously well. 36 hours later, pt. largely improved with some headache persisting.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, aches. Vomiting. Started w/in 10 hours of the vaccine and was previously well. 36 hours later, pt. largely improved with some headache persisting.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Within 12 hrs pain swelling, redness and warm. Cellulitis.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Immediately felt sharp pain and could not move arm.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Broke out in a itchy rash, under arms, side of torso, inner thigh, outside thigh, and mid back.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The patient received the immunization in the early afternoon of 03-07-2018. The patient had pain in his arm that night. On Friday 03-09-2018 the patient presented back to the complaining of L arm/shoulder pain yet the RN was not available that day. The patient called on 03/13/18 in the am to report the pain. The patient states the pain is worse at night. The patient has been taking 400 mg of ibuprofen at night. The patient has been doing gentle stretching exercises which seem to help. The patient has a history of arthritis. RN advised the patient to increase the dose of ibuprofen as tolerated taking 400 mg in the morning and 400 mg at night with food to prevent stomach upset. The RN advised the patient to call back on Friday 3/16/18 so RN could check for improvement. RN advised the patient to call PMD for an appointment if the pain does not improve.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Pruritus generalised, Urticaria, Wheezing
Clinical narrative: The next morning after the shot, she started to have hives and itching all over her body, she also experienced wheezing and cough, she contacted her doctor and was advised to take diphenhydramine and not to get the second shot. It was 1 week after and still patient have the cough and some itching, although patient did not see the doctor so no steroids was prescribed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope
Clinical narrative: Patient in office to have cast applied to wrist-Fx 2 days ago. Wt 72.2, Ht 57 inches, BP 100/60. Administered 2nd HPV following cast application. Five mins after shot patient hopped off table, fainted, hit back of head.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Headache, Influenza virus test negative, Pregnancy test negative
Clinical narrative: Patient came to office for BEXSERO #2, pt waited in waiting room after shot was given for 10 minutes, checked patient she was fine and said she was and felt fine. Time was 3:25pm on 2/8/2018 patient went to PED at 12:18am 2/9/2018 for mild dizziness, weakness, lightheadedness, headache.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 60-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced rash, fever and joint pain. The patient was treated with ZYRTEC. On an unknown date, the outcome of the rash, fever and joint pain were unknown. It was unknown if the reporter considered the rash, fever and joint pain to be related to SHINGRIX. Additional information was received as follows: The patient was seen in the office on 6th March 2018, and prescribed with ZYRTEC. The patient's status was unknown at the time of reporting. No further information was reported regarding the event. The batch number reported for SHINGRIX (9XC38), did not exist and was updated to 9XC39, as per sales database.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was concerned to received the scheduled 2nd dose of the SHINGRIX vaccine because, she had a reaction (not specified) to the 1st dose of SHINGRIX. The patient also expressed concern as she would not be able to donate the blood as the vaccine was listed as live vaccine by Food and Drug Administration.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dyspnoea, Fatigue
Clinical narrative: Pain and soreness in the location of injection immediate. After 2 hours, I begun to feel tired and got soreness, muscle pain and joint pain and stiffness, nausea, fever, shortness of breath, severe headaches, stomach pain, shivering. The fever was severe within 10 hours for 10 hours and susided but continued on for 24 hours. Most symptons are gone by 7 AM on 3/14/2018. Mild muscles pain and joint aches continued.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Joint stiffness, Myalgia
Clinical narrative: Pain and soreness in the location of injection immediate. After 2 hours, I begun to feel tired and got soreness, muscle pain and joint pain and stiffness, nausea, fever, shortness of breath, severe headaches, stomach pain, shivering. The fever was severe within 10 hours for 10 hours and susided but continued on for 24 hours. Most symptons are gone by 7 AM on 3/14/2018. Mild muscles pain and joint aches continued.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Pain and soreness in the location of injection immediate. After 2 hours, I begun to feel tired and got soreness, muscle pain and joint pain and stiffness, nausea, fever, shortness of breath, severe headaches, stomach pain, shivering. The fever was severe within 10 hours for 10 hours and susided but continued on for 24 hours. Most symptons are gone by 7 AM on 3/14/2018. Mild muscles pain and joint aches continued.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Back pain, Fatigue, Impaired driving ability, Injection site pain
Clinical narrative: Within a few hours got stiff and sore but about 4pm right arm completely stopped working--I couldn't lift it up. Left arm was sore but nothing like the right. Could barely drive home with one arm. Took ALEVE at night and then ADVIL to supplement it but not enough to help. Spine, neck, shoulders started aching and cramped up. Used heating pad and sleeping pill, but in severe pain--pain at level 9 during the evening. Back, shoulders, neck hurt severely like beat with a rubber hose. Doing the same daily work but feel like have been mugged--feel so overworked. Has been taking ALEVE twice a day as per doctor's instructions with no relief. All joints hurt like if had severe arthritis. Called the doctor the next day and contacted them on several occasions since to provide update and request additional advice.  Went to doctor office on 3/13 and got some testing done.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Mobility decreased, Muscle spasms, Musculoskeletal disorder, Musculoskeletal stiffness, Neck pain
Clinical narrative: Within a few hours got stiff and sore but about 4pm right arm completely stopped working--I couldn't lift it up. Left arm was sore but nothing like the right. Could barely drive home with one arm. Took ALEVE at night and then ADVIL to supplement it but not enough to help. Spine, neck, shoulders started aching and cramped up. Used heating pad and sleeping pill, but in severe pain--pain at level 9 during the evening. Back, shoulders, neck hurt severely like beat with a rubber hose. Doing the same daily work but feel like have been mugged--feel so overworked. Has been taking ALEVE twice a day as per doctor's instructions with no relief. All joints hurt like if had severe arthritis. Called the doctor the next day and contacted them on several occasions since to provide update and request additional advice.  Went to doctor office on 3/13 and got some testing done.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain, Pain in extremity, Spinal pain
Clinical narrative: Within a few hours got stiff and sore but about 4pm right arm completely stopped working--I couldn't lift it up. Left arm was sore but nothing like the right. Could barely drive home with one arm. Took ALEVE at night and then ADVIL to supplement it but not enough to help. Spine, neck, shoulders started aching and cramped up. Used heating pad and sleeping pill, but in severe pain--pain at level 9 during the evening. Back, shoulders, neck hurt severely like beat with a rubber hose. Doing the same daily work but feel like have been mugged--feel so overworked. Has been taking ALEVE twice a day as per doctor's instructions with no relief. All joints hurt like if had severe arthritis. Called the doctor the next day and contacted them on several occasions since to provide update and request additional advice.  Went to doctor office on 3/13 and got some testing done.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Large localized redness, swelling, with lots of localized tenderness and pain over 3 days, then slowly improving by time of evaluation when seen 2 days after it started.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Bed sharing, Death, Passive smoking, Sudden infant death syndrome
Clinical narrative: On 03/13/2018 this patient expired with SIDS. This report is being generated because do not know if vaccines were a contributing factor. There was smoking around child, and child had been sleeping with mother at checkup visit.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4
Symptoms: Contusion, Platelet count decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 64-year-old male patient who received FLUARIX Quadrivalent (batch number C559A, expiry date 30th June 2018. Co-suspect products included BOOSTRIX (batch number 345B4, expiry date 19th October 2019 and PNEUMOVAX (batch number N020502, expiry date 8th February 2019). Previously administered products included Flu vaccine with an associated reaction of contusion (received in 2017, bruising occurred 4 months after vaccination, referred case US2018GSK042500). On 15th January 2018, the patient received FLUARIX Quadrivalent (intramuscular) .5 ml, BOOSTRIX (intramuscular) and PNEUMOVAX (intramuscular). In February 2018, 30 days after receiving FLUARIX Quadrivalent and 30 days after receiving BOOSTRIX, the patient experienced contusion and platelet count low. On an unknown date, the outcome of the contusion and platelet count low were not recovered/not resolved. The reporter considered the contusion and platelet count to be possibly related to FLUARIX Quadrivalent and BOOSTRIX. Additional information was received as follows: The patient received FLUARIX Quadrivalent on the left arm (top of the deltoid), BOOSTRIX on the right arm and PNEUMOVAX on the left arm (bottom of the deltoid). The patient noticed that he had severe bruising so he went to the physician who referred him to go and see a hematologist because he had low platelet counts. On 15th February 2018, the patient had low platelet count. It was unknown if the reporter considered the platelet count low and contusion to be related to PNEUMOVAX as well. The pharmacist did not aware of any concomitant medications or medical conditions that the patient had that could impact this. This case has been linked to the case US2018GSK042500, reported by the same reporter.
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4
Symptoms: Contusion, Platelet count decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of contusion in a adult male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, 122 days after receiving Influenza vaccine Quadrivalent, the patient experienced contusion and platelet count low. On an unknown date, the outcome of the contusion and platelet count low were unknown. The reporter considered the contusion and platelet count low to be possibly related to Influenza vaccine Quadrivalent. Additional information was received as follows: The age at vaccination was not reported. One year before the time of reporting, the patient received flu vaccine (unknown brand) and experienced adverse event. This case has been linked to the case US2018039393, reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient was mistakenly given dose of the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient also had quite a bit of pain and redness around the injection site but the pharmacist assured the patient that it happened because it was given subcutaneously. At the time of this report, the patient was asking if the patient needed a repeat dose of dose 1 or should just continue with dose 2 in 2-6 months.
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Product administered at inappropriate site, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO. On 5th March 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 5th March 2018, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. In March 2018, the patient experienced injection site pain (serious criteria disability), fever (serious criteria disability) and injected limb mobility decreased (serious criteria disability). The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the injection site pain, fever and injected limb mobility decreased to be probably related to BEXSERO. Additional details were provided as follows: Field representative was reporting on behalf of healthcare professional. The Patient was teenager, specific date of birth or age was unknown. The age at vaccination was not reported. Injection site reaction was described as pain. There was pain present at time of BEXSERO injection, and then the pain woke her at 3 am on the morning following injection. The patient could not use her arm due to pain. The patient also experienced a fever of 101 degree F which had now resolved. Events were managed with TYLENOL and ibuprofen. The reporter also mentioned that the injection was given high on the arm, which led to inappropriate site of administration. He felt as though it might had been above the deltoid. The healthcare professional was not treating physician, he was patient's father. Treating physician unknown by field representative. Field representative planned to forward healthcare professional questions onto MSL, so MSL may also submit adverse event details to Agency.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of welts in a 71-year-old male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced welts, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the welts, erythema, swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the welts, erythema and swelling to be related to SHINGRIX. Additional details were reported as follows: The age at the vaccination was not reported. The patient received SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced large welt, clearly demarcated redness and swelling. The reporter had denied permission to be contacted for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 29 year old patient on unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 07-FEB-2018, the patient was vaccinated with M-M-R II, and on 05-MAR-2018 (also reported as "26 days later"), the patient was vaccinated with VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 16 year old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dose, units, frequency and route not reported) (lot# N020353, expiration date: 28-APR-2020 and lot # N017686, expiration date: 02-FEB-2020) at a temperature from 47 Fahrenheit (F) to 77 F for 21 hours 45 minutes. No adverse effects were reported. No previous temperature excursion was occurred to the vaccine GARDASIL 9. Data logger was involved. No product quality complaint was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1803USA005946: US-009507513-1803USA005947: US-009507513-1803USA005945.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ vial (strength, dose and route of administration were not reported) (lot # N012762, expiry date: 04-FEB-2019) for prophylaxis. The vaccine experienced a temperature excursion of 0 degrees Celsius (C) to 1 C for 2 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No further information were provided. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA003508.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 14 year old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dose, units, frequency and route not reported) (lot# N020353, expiration date: 28-APR-2020 and lot # N017686, expiration date: 02-FEB-2020) at a temperature from 47 Fahrenheit (F) to 77 F for 21 hours 45 minutes. No adverse effects were reported. No previous temperature excursion was occurred to the vaccine GARDASIL 9. Data logger was involved. No product quality complaint was involved. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004556: US-009507513-1803USA005947: US-009507513-1803USA005946.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 17 year old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dose, units, frequency and route not reported) (lot# N020353, expiration date: 28-APR-2020 and lot # N017686, expiration date: 02-FEB-2020) at a temperature from 47 Fahrenheit (F) to 77 F for 21 hours 45 minutes. No adverse effects were reported. No previous temperature excursion was occurred to the vaccine GARDASIL 9. Data logger was involved. No product quality complaint was involved. This is one of 4 reports received from the same reporter.  Sender's Comments: US-009507513-1803USA004556: US-009507513-1803USA005945: US-009507513-1803USA005947.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ) (unknown lot and expiration date) used for the reconstitution of M-M-R II. On 08-MAR-2018, the patient was vaccinated with improperly stored M-M-R II (dose, units, frequency and route not reported) (lot# N010495 and expiration date: 31-MAR-2019) at a temperature from 47 Fahrenheit (F) to 77 F for 21 hours 45 minutes. No adverse effects were reported. No previous temperature excursion was occurred to the vaccine GARDASIL 9. Data logger was involved. No product quality complaint was involved. This is one of the 4 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004556: US-009507513-1803USA005945: US-009507513-1803USA005946.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Bedridden, Fatigue, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer Control Number 00755869). A contactable nurse reported that a patient of unspecified age, ethnicity, and gender received PREVNAR 13 (lot number: R122776) via an unspecified route of administration in the left arm on 11Jul2017 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The field representative stated that she first learned of the AE on 28Feb2018. The reporter is field representative who is reporting AE information provided by Nurse Practitioner. The nurse practitioner reported that a patient was administered PREVNAR 13 (Manufacturer Pfizer) on 11Jul2017. Immediately after the vaccination the patient became "very weak and achy, feverish and was bedridden for 3-4 days." On 20Jul2017 patient saw the nurse practitioner and had a "Significant local reaction on left arm (arm of administration of PREVNAR 13) 4 cm x 3 cm nodule and erythema from shoulder to the elbow (of left arm)." On 04Aug2017, the patient saw the nurse practitioner and the "redness was improving but was still present." The patient was seen "one week ago by nurse practitioner for a check up and still has fatigue and increased weakness ever since the administration of the PREVNAR 13 on 11Jul2017. No further clarifying information provided. The event redness was recovering while the outcome of the other events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site nodule, Local reaction, Pain, Pyrexia
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck (Manufacturer Control Number 00755869). A contactable nurse reported that a patient of unspecified age, ethnicity, and gender received PREVNAR 13 (lot number: R122776) via an unspecified route of administration in the left arm on 11Jul2017 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The field representative stated that she first learned of the AE on 28Feb2018. The reporter is field representative who is reporting AE information provided by Nurse Practitioner. The nurse practitioner reported that a patient was administered PREVNAR 13 (Manufacturer Pfizer) on 11Jul2017. Immediately after the vaccination the patient became "very weak and achy, feverish and was bedridden for 3-4 days." On 20Jul2017 patient saw the nurse practitioner and had a "Significant local reaction on left arm (arm of administration of PREVNAR 13) 4 cm x 3 cm nodule and erythema from shoulder to the elbow (of left arm)." On 04Aug2017, the patient saw the nurse practitioner and the "redness was improving but was still present." The patient was seen "one week ago by nurse practitioner for a check up and still has fatigue and increased weakness ever since the administration of the PREVNAR 13 on 11Jul2017. No further clarifying information provided. The event redness was recovering while the outcome of the other events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 65-year-old female patient received first dose of PREVNAR 13 (lot#: T52799, expiry date: 01Feb2020, NDC #: 0005-1971-01), intramuscular in the left deltoid on 01Mar2018 17:45 at 0.5 ml, single for routine vaccination. Vaccination was done in the physician's office. There were no relevant medical history and concomitant medications. On 03Mar2018, the patient experienced extremely large cellulitis just below the site and down to the elbow with redness and swelling on her left arm. The patient came back to the physician's office on 05Mar2018 and was told to call back if she had further questions or problems. The outcome of the events was unknown. It was also stated that these issues were noted on the posterior part of the patient's arm and the reporter thought that it was weird. It looked like the inner part of her left arm against the breast was affected. The reporter assessed the events serious as medically significant and related to the product.; Sender's Comments: Based on a drug event temporal association, it cannot be fully excluded that the vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of cellulitis with redness and swelling on her left arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX. On 7th March 2018, the patient received SHINGRIX (intramuscular). On 7th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received an injection of SHINGRIX by a pharmacist later that evening, the patient noticed swelling at the injection site about the size of a silver dollar. The patient had denied permission to contact their physician.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Tingling and numbness at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac disorder, Chest X-ray, Chest discomfort, Electrocardiogram
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number FJ575 ?, expiry date 30th January 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 2nd March 2018, the patient experienced heart disorder, chest discomfort, tiredness, headache, queasy and troponin increased. The patient was treated with Aspirin. On an unknown date, the outcome of the pain in arm, chest discomfort, tiredness, headache and queasy were recovered/resolved and the outcome of the heart disorder and troponin increased were unknown. The reporter considered the pain in arm, chest discomfort, tiredness, headache and queasy to be probably related to SHINGRIX. It was unknown if the reporter considered the heart disorder and troponin increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had family history of heart attack and stroke. On 1st March 2018, at 15:35, the patient received SHINGRIX on right deltoid. The patient experienced something (discomfort) she had never felt before in her chest just below the breast and at the top of rib cage. The patient was concerned about her heart. The patient went to a clinic on 2nd March 2018, (Friday) afternoon and was taken to the emergency room and was there for 3 hours. On 2nd March 2018, the patient went to a clinic and then the patient undergone electrocardiogram, blood test and a chest x-ray which were resulted unknown and troponin test resulted elevation. The patient wanted to speak with someone about this event. The reported batch number FJ575, did not exist in sales database.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number FJ575 ?, expiry date 30th January 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 2nd March 2018, the patient experienced heart disorder, chest discomfort, tiredness, headache, queasy and troponin increased. The patient was treated with Aspirin. On an unknown date, the outcome of the pain in arm, chest discomfort, tiredness, headache and queasy were recovered/resolved and the outcome of the heart disorder and troponin increased were unknown. The reporter considered the pain in arm, chest discomfort, tiredness, headache and queasy to be probably related to SHINGRIX. It was unknown if the reporter considered the heart disorder and troponin increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had family history of heart attack and stroke. On 1st March 2018, at 15:35, the patient received SHINGRIX on right deltoid. The patient experienced something (discomfort) she had never felt before in her chest just below the breast and at the top of rib cage. The patient was concerned about her heart. The patient went to a clinic on 2nd March 2018, (Friday) afternoon and was taken to the emergency room and was there for 3 hours. On 2nd March 2018, the patient went to a clinic and then the patient undergone electrocardiogram, blood test and a chest x-ray which were resulted unknown and troponin test resulted elevation. The patient wanted to speak with someone about this event. The reported batch number FJ575, did not exist in sales database.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Troponin increased
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number FJ575 ?, expiry date 30th January 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm. On 2nd March 2018, the patient experienced heart disorder, chest discomfort, tiredness, headache, queasy and troponin increased. The patient was treated with Aspirin. On an unknown date, the outcome of the pain in arm, chest discomfort, tiredness, headache and queasy were recovered/resolved and the outcome of the heart disorder and troponin increased were unknown. The reporter considered the pain in arm, chest discomfort, tiredness, headache and queasy to be probably related to SHINGRIX. It was unknown if the reporter considered the heart disorder and troponin increased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had family history of heart attack and stroke. On 1st March 2018, at 15:35, the patient received SHINGRIX on right deltoid. The patient experienced something (discomfort) she had never felt before in her chest just below the breast and at the top of rib cage. The patient was concerned about her heart. The patient went to a clinic on 2nd March 2018, (Friday) afternoon and was taken to the emergency room and was there for 3 hours. On 2nd March 2018, the patient went to a clinic and then the patient undergone electrocardiogram, blood test and a chest x-ray which were resulted unknown and troponin test resulted elevation. The patient wanted to speak with someone about this event. The reported batch number FJ575, did not exist in sales database.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Pt. was given the flu vaccine on admission to the hospital as part of their admission assessment procedure on 2/15/2018. Guillain-Barre syndrome was diagnosed on 2/27/2018, treated with IV fluids, IVIG, steroids.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Pruritus, Rash, Varicella virus test
Clinical narrative: Employee had complaints of itching, rash to thighs, left upper arm at site of vaccine, forearms and neck on 2/24/18. Reports had a Varicella vaccine on her left upper arm, and a MMR shot on right upper arm, both on 2/12/18. Stated that she was also treated by her MD with a one time dose of DIFLUCAN  on 2/19/180. No rash was ever noted to the right upper arm, MMR vaccine injection site. Used OTC AVEENO baths. Followed up in the employee health office, rash disappeared by 3/1/18.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye swelling, Swelling face
Clinical narrative: Right face and eye "very" swollen, no difficulty breathing or respiratory distress.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Blood test normal, Decreased appetite, Lethargy
Clinical narrative: After getting the first of 3 scheduled shots for HPV from her pediatrician, my daughter started to feel nauseus, lethargic, and have a severe lack of appetite. This happened gradually, and we didn't connect it to the shot at first. We followed up with the 2nd shot 2 months later as we still didn't make the connection to the shot. She went in for an unrelated doctor's visit 05/26/16 where they noted she had lost 7 pounds (from 123 to 116 lbs) since her February physical. The doctor wanted us to see some specialists and get blood work done. The blood work came back normal and the subsequent visits to Cardiology and Genetics found nothing wrong. We ended up at an Adolescent Specialist who has worked with her for the past 1 1/2 years. While waiting to get an appointment with the Specialist she had her 3rd shot of HPV vaccine, as we still had not made the connection. After many visits with the Specialist and subsequent blood, urine, feces tests and many medications, he diagnosed her with an autoimmune disorder, Dysautonomia, which he said may have been brought on by the HPV vaccination. There are no other events or diseases we could connect to the sudden start of extreme symptoms. He is the one who told us to make this report. One way he helped us connect it to the vaccine was because patient's younger sister, got the same shot and started to display slightly less severe syptoms that were the same as patient had just after her shot. We stopped after only 1 shot for her sister.  After I did a lot of research on vaccinations, and the HPV vaccine in particular, I discovered that there had been reports of over 700 girls who had recieved the HPV vaccine and then all had started to experience the same symptoms patient has. The agency had supplied the vaccine and has denied any connection, but the evidence is there. Certain genetic factors make the vaccine trigger this autoimmune response.  There are many other reports of similar findings in other places, including here. I have 2 other kids who also had 1 or 2 doses of the HPV vaccine before we made the discovery that it was the likely trigger for the problems, and they did not display any symptoms. They are very different, genetically, and are both being treated for other issues, unlike the patient and her sister, who were both very healthy prior to the vaccination.