chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; received 2 of the Shringex / still had Shingles TWICE this year; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, received dose 2 of Shingrix and still had shingles twice a year, which led to vaccination failure. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Day after vax, heart rate began to be rapid. Had tachichardia for 4 days. Went back to normal after day 4.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site mass, Injection site reaction, Skin indentation
Clinical narrative: Small knot felt at the injection site, dimple in thigh at injection site
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash down top of arm to elbow Used hydrocortizone cream Two weeks
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Cough, Headache, Hyperhidrosis, Malaise
Clinical narrative: Patient received Shingrix in her left arm on 11/8/20 at 3:06pm.  On 11/9/20 at 9:45am she called the pharmacy to report that she was not feeling well.  She stated that she started around 7pm on 11/8/20 with a headache and neck ache.  She took Tylenol which did not help.  In the night, she had sweats, coughing and dreams.  She states that she works from home and did not take her temperature.  As of 9:45am she had repeated the Tylenol dose and was no longer sweating and starting to feel a little better.  She will call back if her symptoms worsen or do not improve in the next day or so.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Patient received Shingrix in her left arm on 11/8/20 at 3:06pm.  On 11/9/20 at 9:45am she called the pharmacy to report that she was not feeling well.  She stated that she started around 7pm on 11/8/20 with a headache and neck ache.  She took Tylenol which did not help.  In the night, she had sweats, coughing and dreams.  She states that she works from home and did not take her temperature.  As of 9:45am she had repeated the Tylenol dose and was no longer sweating and starting to feel a little better.  She will call back if her symptoms worsen or do not improve in the next day or so.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Swelling
Clinical narrative: ARM PAIN, NUMBNESS, SWELLING , SORENESS TWO WEEKS AFTER SHOT
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear swelling, Headache, Myalgia, Paranasal sinus discomfort, Swelling face
Clinical narrative: Extreme Muscle soreness  Area very sore to touch Non-stop headache even with meds (Tylenol, excedrin migraine) "Sinus" type pressure and swollen feeling in ears, cheeks, under eyes
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Extreme Muscle soreness  Area very sore to touch Non-stop headache even with meds (Tylenol, excedrin migraine) "Sinus" type pressure and swollen feeling in ears, cheeks, under eyes
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Spoke with patient's mom, only has soreness around injection site.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, sore shoulder and headache
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever, chills, body aches, sore shoulder and headache
Age: 0.25
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On count, realized FluLaval was administered instead of a PCV13. Provider notified, contacted clinic administrator, provider contacted CDC per guidance and parents notified.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills once on 11/7 at night. Fever up to 100F, headache, overall body ache, tiredness for 24+ hours Took Tylenol when chills started; it helped with chills, temperature, and headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Oedema peripheral, Pyrexia
Clinical narrative: Extreme chills 6-7 hours after vaccine.  No appetite and dull, constant headache.  Fever as high as 102.  Armpit side closest to breast on right shoulder where shot given swollen for 30 hours after shot.  Majority of adverse effects lasted for 18 hours.  Two Ibuprofen taken every 6 hours.  Completely back to normal 44 hours from time of shot.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered
Clinical narrative: The patient receives 1 mL instead of 0.5 mL
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Arm began itching 24 hrs post vaccination with progressive redness, swelling, and warmth 48 hrs post vaccination
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient got a rash and bump at injection site. She also had chills but no fever. She also experienced pain at injection site from 10/29/20 when she received the vaccine and is still experiencing that pain 11/9/20
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Pruritus, Radial nerve palsy, Urticaria
Clinical narrative: After shaving my legs at about 7:30 am on 11/7/2020 I noticed some itchiness, thought it was razor burn.  Slight itchiness on legs continues throughout the day, nothing too alarming.  Around 5:00 pm the itchiness became more pronounced.  I took a Claritin and went to be about 9:00 and noticed my arms becoming itchy and started seeing small hives and then my upper legs started showing red pin prick like marks.  By the middle of the night I had hives all over my legs and arms.  On Sunday, 11/8/2020, I used Benadryl to try to relieve the itching, the hives decreased in size but redness and itchiness remained.  Hives returned equally as bad the night of 11/8/2020 to 11/9/2020z. Aside from hive and itching, no other issues such as shortness of breath.  At the site of injection there was a small bruise, but otherwise nothing notable.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site vesicles
Clinical narrative: ARM RED, AND BLISTER BUBBLE AT SIGHT OF INJECTION THAT HAS GROWN LARGER
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever, malaise, sore arm, flu-like symptoms
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient reported to medical clinic 2 hours post-vaccination to report hives on face, chest, and upper limbs. No SOB or life-threatening response. Treated with Benadryl 50mg . Symptoms resolved within 45 minutes of medication administration.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Swelling 24 hours post vaccination. Pain and itching in arm. Unable to raise arm 24 hours post vaccination but mom reported that it was improving at the visit 48 hours post vaccination. Mom treated with Benadryl and Motrin (3 doses) which seemed to improve symptoms. Doctor prescribed Bactrim and Prednisone for the symptoms.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: RED BURING SENSATION IN THE LEFT BICEP FOR 3 DAYS, AND ITCHING
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Swelling
Clinical narrative: Patient reported swelling 24 hours post vaccination with progressive swelling 48 hours post vaccination.
Age: 38.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product preparation issue
Clinical narrative: no additional AEs reported; the vial used to administer the third injection was not rolled or shaken; the vial used to administer the third injection was not rolled or shaken and concerned if the dosage was good; the vial used to administer the third injection was not rolled or shaken and concerned if the dosage was good; This spontaneous report was received from a medical assistant calling on behalf of physician and refers to a male patient There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (reported as the age of 38), the patient started the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Approximately in March 2019 (reported as around), the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose for prophylaxis (route of administration, lot # and expiration date were not reported). It was reported, that the patient received all doses at the scheduled interval times (exact dates were not provided).   It was reported, that the health care professional (HCP) that administered the third dose of vaccine did not shake the contents in the vial prior to administration. The patient expressed concerns to physician, that the vial used to administer the third injection was not rolled or shaken like the first two doses and he was worried if the dosage was good. The medical assistant reports, that the patient was unable to provide details in regards to the appearance of the contents in the vial. No additional adverse events (AEs) were reported.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion on RECOMBIVAX HB. This product was administered today.; This spontaneous report was received from a medical assistant (also reported as customer) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-NOV-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, 1 time dose, therapy type: thimerosal-free, lot # R034547 with expiration date on 09-JUN-2021 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit for 1 hour. It was also reported there was previous temperature excursion of 50 degrees Fahrenheit for 45 minutes. Digital data logger was not involved. No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; customer called in to report a temperature excursion on GARDASIL 9. Temperature above 47F. This product was administered today.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # S033308, expiration date 08-APR-2022 (route of administration and anatomical location were not reported) for prophylaxis. It was stated that it was 1 time dose. Administered dose of vaccine was stored in temperature above 47 degrees Fahrenheit (reported as above 47F) for 1 hour. There was no previous temperature excursion. Digital data logger was not involved. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; caller reports a temperature excursion with administration of GARDASIL 9 during the excursion; temperature 1.8 C; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-OCT-2020 (reported as during the excursion), the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot # S022599 , expiration date 25-FEB-2022 (route of administration was not provided). There was no adverse event reported. Administered dose of vaccine was stored in an inappropriate temperature of 1.8 degrees Celsius for 7 hours and 25 minutes.   Digital data logger was not involved. No previous temperature excursion occurred. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; Customer reports an expired dose of V AQTA was given to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 30-OCT-2020, the patient was vaccinated with an expired, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) 25 U/0.5 mL injection, 1 dose, lot # S026003, expiration date 17-OCT-2020 (dose number and anatomical location were not specified) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, SARS-CoV-2 test negative
Clinical narrative: It was sore that night; red patch that surrounded the injection site; body temperature went up to 100.7 F; cannot pick up my left arm; red patch that surrounded the injection site, went under my left arm toward my arm pit and around on the other side of my arm.; She advised me I had a severe reaction; This spontaneous report was received from a 62 year old female patient with hypertension and allergy to penicillin and amlodipine which caused her hives and edema of feet hand legs swell respectively. The patient was vaccinated with pneumococcal 13v conj vaccine in 2018. Concomitant therapies included potassium, vitamins, calcium, biotin and fish oil.  On 12-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left arm for prophylaxis. The patient reported that it was sore that night and by the next morning there was a red patch that surrounded the injection site, went under my left arm toward my arm pit and around on the other side of my arm. The red spot was 4 inches up and down my arm and 6 to 7 inches across my arm. It was very painful, and my body temperature went up to 100.7 degrees Fahrenheit. She called her doctor and went in to see her on that Thursday 15-OCT-2020. She tested her for COVID, but she was negative. She advised her she had a severe reaction. A treatment the patient apply ice and acetaminophen (TYLENOL) every 4 hours , and now acetaminophen (TYLENOL) every 6 hours. Told to rub it but was to painful, but now I can rub it.   At the reporting time, the outcome of the events was reported as recovering, but still cannot pick up my left arm, or pick up anything that weighs more than a pound or two.  Causality was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 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 chills and fever. On an unknown date, the outcome of the chills and fever were recovered/resolved.   The reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was spoken from  the payment office. No further information was reported. The reporter provided limited information. This case was linked with case US2020219731 as reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219731:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: 11 year old patient was given expired product with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other helath care professional on behalf of a consumer via Medical Information (Reference number- 00342166) and transmitted to Sanofi 02-Nov-2020.  This case involved a 11 years old patient of unknown demographics who received a suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported, expiry date: 23-Oct-2020) via unknown route in unknown administration site for prophylactic vaccination, on 26-Oct-2020 (Expired product administered).  Relevant medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to expired product administered (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Myalgia
Clinical narrative: Muscle pain and weakness continues 4 weeks after vaccination.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Muscle tightness, Myalgia
Clinical narrative: Slight spasms to both lower extremity muscles with severe tightness and soreness of the muscles of both lower extremities. The symptoms gradually decreased over a 36-48 hour time span with complete resolution of the symptoms at this time.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gaze palsy, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: severe soreness, very red, lots of swelling, inj. site very swollen and red, ran fever, muscle aches and headache. Started between 4-5 pm, got worse after that. Took acetaminophen and went to bed. Worse next morning. Couldn't move arm at all. No fever, but lots of pain on Thursday. Stayed on acetaminophen and bed rest all day Thursday. Friday: still swollen and red, no fever, lots of pain still. Saturday saw my PCP Dr. Swelling down, still red and hot to the touch. More acetaminophen and ice packs. Sunday: much better!
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: severe soreness, very red, lots of swelling, inj. site very swollen and red, ran fever, muscle aches and headache. Started between 4-5 pm, got worse after that. Took acetaminophen and went to bed. Worse next morning. Couldn't move arm at all. No fever, but lots of pain on Thursday. Stayed on acetaminophen and bed rest all day Thursday. Friday: still swollen and red, no fever, lots of pain still. Saturday saw my PCP Dr. Swelling down, still red and hot to the touch. More acetaminophen and ice packs. Sunday: much better!
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: The next morning (11/07/2020)  after receiving the vaccine, patient experience hives on her left shoulder, arm, left side of neck, and left side of face.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Loss of personal independence in daily activities, Mobility decreased, Tenderness
Clinical narrative: Severe pain in shoulder, involving tendons and possibly the joint,  Decreased range in motion.  Cannot lay on it, hard to get clothing on and off.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Swelling, Redness at injection site. tingling on arm
Age: 45.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Dry skin, Eye pruritus, Pruritus, Skin discolouration
Clinical narrative: after receiving vax, after 24 hrs, started having itching in eyes, and on face. Face became very rough, and color of skin on face is changing darker and darker. symptoms are still increasing after 3 days later. Feel weak, do not feel feverish. Face is still dark, rough and itchy.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Pain in left shoulder that has persisted since 10/10/20
Age: 45.0
Sex: F
Vaccine: FLUA3
Symptoms: Incorrect dose administered
Clinical narrative: I had a job at the time I received the vaccine from the Health Department.  I was not making a lot of money at my job, so I sot the assistance of the Health Department for a flu vaccine.  The phlebotomist was not experienced enough to administer vaccines and I received too much vaccine out of vile into the syringe.   On Friday, November 6, 2020, I received a flu vaccine from the Hospital that was pre-measured and today is Monday, November 9th 2020, and I'm not experiencing any adverse events.  Friday was the first time in 12 years that I felt comfortable enough to get the flu vaccine.  Pre-measured is the way to go!   I thought it is necessary to keep my immune system up in these times of Covid-19.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Nervousness
Clinical narrative: The patient received a flu shot at our pharmacy in November 2,2020 (Monday). She came back November 4,2020 (Wednesday) to inform us that, after reviewing her medical records at home, her primary physician had already administered a flu shot (Fluarix=lot P100251770,exp07-30-2020) in September 17,2020. She was feeling OK ( no side effects), but was very nervous. We provided counseling about the situation and told her to call us or her primary physician in case she had any concern. Apparently, she was interested in receiving the tetanus toxoid vaccine. But, when the pharmacist is ready to administer the vaccine she/he always asks the patient her/his name and tells her/him what vaccine is going to be administered and where it is going to be administered. Asks if it's OK and proceeds.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Pruritus, Rash
Clinical narrative: Patient is currently pregnant and followed up with her OB.  Symptoms started with scattered rash that "spread all over body and down to her toes" itching began on left arm then on entire body.  Physician ordered Benadryl & OTC hydrocortisone cream.  the following day after little relief she contacted her physician again and received order for steriods.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Eye swelling, Heart rate increased, Peripheral swelling, Pyrexia
Clinical narrative: Fever 101 to 102 for 4 days, swollen arm, swollen eyes, high heart rate (90 to 160 bpm)  Took benedryl and Tylenol.  Flu vaccine, Shingles vaccine and pneumonia vaccine.  I don't know which specifically, you would need to contact the provider.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Pain
Clinical narrative: Per Employee, "I got the flu shot and had burning pain immediately. My left shoulder has been achy since the shot. Now with movement I am having shooting pains down and up my arm. I have been icing, heating, and taking antipyretics at home without improvement".
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Hallucination, Insomnia, Restlessness
Clinical narrative: Shortly after taking aripiprazole dose, he was unable to fall asleep, sit still, began pacing/walking back and forth, hallucinating, fidgeting. Mother states he has never had a reaction like this before and is concerned the flu vaccine precipitated the reaction to his usual dose of aripiprazole.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Called to report a temperature excursion, reported that MMR-II was administered after a temperature excursion; This spontaneous report has been received from a health care professional concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 26-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Lot # S031482, expiration date 07-OCT-2021 for prophylaxis (dosage regimen was not reported) which experienced a temperature excursion.       The temperature was reported to had been below 36°Fahrenheit (F)/2°Celsius (C) ( 0.9°C to 1.9°C) for 10 hours, and above 47°F/9°C (9.1°C) for 30 minutes.    The total time frame was reported as 10 hours and 30 minutes.  There was no digital data logger involved and no previous temperature excursion was reported. ; Sender's Comments:  US-009507513-2010USA010872:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was administered to 4 patients on 10/26/2020 after a temperature excursion; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration were not reported; lot# T007035, expiration date reported as 01-MAY-2022, was valid) for prophylaxis.  Administered dose of vaccine underwent a temperature excursion below 36 degrees Fahrenheit/3 degrees Celsius (0.9 to 1.9 degrees Celsius) for 10 hours an above 47 degrees Fahrenheit/9 degrees Celsius (9.1 degrees Celsius) for 30 minutes. There was no previous temperature excursion. No data logger was involved.  This is one of four reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011190: US-009507513-2010USA011203: US-009507513-2010USA011367:
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: he has not had any issues since receiving the 2nd dose; a consumer had received a extra dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 21-OCT-2018, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. On 11-OCT-2019, he received an extra dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. The patient had not had any issues since receiving the second dose.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no further AE reported; administration of an expired V AQTA vaccine; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 03-NOV-2020, the patient was vaccinated with an expired, pediatric dose of hepatitis a vaccine, inactivated (VAQTA) strength: 25 U/0.5 ml, 1 injection, lot # S025993, expiration date on 17-NOV-2020, for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood pressure increased, Chills, Erythema, Fatigue
Clinical narrative: redness in her face; tiredness; headache; neck hurts; back hurts; sore arm; her heart racing; blood pressure increased; did not sleep all night; feel cold; shivering; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. please refer the case US2020AMR220019).   On 1st November 2020, the patient received the 2nd dose of Shingrix. On 1st November 2020, 5 hrs 30 min after receiving Shingrix, the patient experienced feeling cold, shivering, heart racing, increased blood pressure and insomnia. On 2nd November 2020, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. On an unknown date, the outcome of the feeling cold, shivering, heart racing and increased blood pressure were recovered/resolved and the outcome of the red face, tiredness, headache, neck pain, back pain and pain in arm were not recovered/not resolved and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the feeling cold, shivering, red face, tiredness, headache, neck pain, back pain, pain in arm, heart racing, increased blood pressure and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at 11:30 am. She started to feel cold around 5:00 pm (5 hrs 30 min after vaccination). The shivering started around 9:00 pm (9 hrs 30 min after vaccination). By 12:30 AM the shivering was uncontrollable and last until about 4:30 am.  Less than a day after vaccination, the patient experienced heart racing, blood pressure increased and insomnia. The patient did not sleep all night due to it.  One day after vaccination, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. The redness in her face presented this morning and she described it as beet red.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220019:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Insomnia, Neck pain, Pain in extremity
Clinical narrative: redness in her face; tiredness; headache; neck hurts; back hurts; sore arm; her heart racing; blood pressure increased; did not sleep all night; feel cold; shivering; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. please refer the case US2020AMR220019).   On 1st November 2020, the patient received the 2nd dose of Shingrix. On 1st November 2020, 5 hrs 30 min after receiving Shingrix, the patient experienced feeling cold, shivering, heart racing, increased blood pressure and insomnia. On 2nd November 2020, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. On an unknown date, the outcome of the feeling cold, shivering, heart racing and increased blood pressure were recovered/resolved and the outcome of the red face, tiredness, headache, neck pain, back pain and pain in arm were not recovered/not resolved and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the feeling cold, shivering, red face, tiredness, headache, neck pain, back pain, pain in arm, heart racing, increased blood pressure and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at 11:30 am. She started to feel cold around 5:00 pm (5 hrs 30 min after vaccination). The shivering started around 9:00 pm (9 hrs 30 min after vaccination). By 12:30 AM the shivering was uncontrollable and last until about 4:30 am.  Less than a day after vaccination, the patient experienced heart racing, blood pressure increased and insomnia. The patient did not sleep all night due to it.  One day after vaccination, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. The redness in her face presented this morning and she described it as beet red.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220019:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: redness in her face; tiredness; headache; neck hurts; back hurts; sore arm; her heart racing; blood pressure increased; did not sleep all night; feel cold; shivering; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date. please refer the case US2020AMR220019).   On 1st November 2020, the patient received the 2nd dose of Shingrix. On 1st November 2020, 5 hrs 30 min after receiving Shingrix, the patient experienced feeling cold, shivering, heart racing, increased blood pressure and insomnia. On 2nd November 2020, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. On an unknown date, the outcome of the feeling cold, shivering, heart racing and increased blood pressure were recovered/resolved and the outcome of the red face, tiredness, headache, neck pain, back pain and pain in arm were not recovered/not resolved and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the feeling cold, shivering, red face, tiredness, headache, neck pain, back pain, pain in arm, heart racing, increased blood pressure and insomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at 11:30 am. She started to feel cold around 5:00 pm (5 hrs 30 min after vaccination). The shivering started around 9:00 pm (9 hrs 30 min after vaccination). By 12:30 AM the shivering was uncontrollable and last until about 4:30 am.  Less than a day after vaccination, the patient experienced heart racing, blood pressure increased and insomnia. The patient did not sleep all night due to it.  One day after vaccination, the patient experienced red face, tiredness, headache, neck pain, back pain and pain in arm. The redness in her face presented this morning and she described it as beet red.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220019:same reporter
Sex: F
Vaccine: FLUX, MENB
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pain, Peripheral swelling
Clinical narrative: headache; body ache and chills; body ache and chills; This is a spontaneous report from a contactable physician received via Pfizer Sales Representative.   An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA) at single dose, and influenza vaccine (Quadravalent flu vaccine, Sanofi), both in right arm on 27Oct2020 for immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received a dose of TRUMENBA at single dose and FLU vaccine, both in right arm in 2019 for immunization and experienced neck stiffness headache and swelling in the arm. The patient experienced headache, body ache and chills on 27Oct2020. The outcome of headache, body ache and chills were recovered after one day in Oct2020. Patient was seen on the 29Oct2020 and physician confirmed to the reporter.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Muscle ache; Joint pain; Fatigue; This is a spontaneous report from a contactable Physician. A 66-years-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 02Nov2020 at 0.5 ml single to protect against pneumococcal pneumonia. There was no medical history. There were no concomitant medications. He got a dose of Prevnar 13 and experienced the typical muscle aches, joint pain and fatigue that may arise, he thinks that happens typically it is nothing major but he thought he should report it. He says the muscle aches, joint pain and fatigue better now than it was this morning and he is assuming that by tomorrow he will be back to baseline because it is better tonight than it was this morning. He says this is his first time reporting and he just experienced it today, it started today 03Nov2020. He says it was nothing from the shot itself. He received the injection yesterday (02Nov2020) and then the muscle aches, joint pain and fatigue started today. He says he has no reason to believe there was a problem with the product or anything was defective, he thinks this is just something that happens. He believes the dose 0.5 ml one time injection. It is just one time injections for adults, he believes kids have to get more frequent scheduled injections of it but for adults it is just once. Causality was not provided. He believes these are very common things that happen and aren't serious, they happen all the time. He says if for some reason it gets worse he would call back but he assumes it will be going away. Events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot obtained.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: patient contracted pneumonia a couple times already in life; patient contracted pneumonia a couple times already in life; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age (age: 50 units: unspecified) and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient contracted pneumonia a couple times already in life. The outcome of event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Myalgia
Clinical narrative: Muscle pain; The worse headache of her life; This is a spontaneous report from a contactable Pharmacist through a Pfizer Sponsored Program.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced muscle pain and the worse headache of her life on an unspecified date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Chest discomfort, Chills, Injection site pain, Nasal congestion
Clinical narrative: Soreness at injection site; Nasal and chest congestion/coughing; Nasal and chest congestion/coughing; coughing; Chills and shivering without associated fever; This is a spontaneous report from a contactable consumer.  A 50-year-old patient of an unspecified gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 03Nov2020 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced soreness at injection site, nasal and chest congestion/coughing, chills and shivering without associated fever. Soreness at injection site developed 6 hours after administration and was ongoing. Nasal and chest congestion/coughing developed 7 hours after administration and resolved 2 hours after onset. Chills and shivering without associated fever developed 7 hours after administration and resolved 12 hours after onset. The events were non-serious.  The information on the batch/lot number has been requested.
Sex: F
Vaccine: FLUX, MENB
Symptoms: Headache, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: neck stiffness; headache; swelling in the arm; This is a spontaneous report from a contactable physician via Sales Representative.  An adolescent female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA) and influenza vaccine (FLU), both in via an unspecified route of administration in right arm on 2019 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date in 2019 the patient experienced neck stiffness, headache and swelling in the arm. The events were non-serious with outcome of unknown.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever - 100.8.   Body muscle ache.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Injected limb mobility decreased, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: Lt arm pain occured several hours after flu vaccine injection. Difficulty moving arm. TX: Voltaren gel 1% QID, physical therapy, aleve once daily. reduced work shifts. Next f/u appointment is scheduled 12-4-2020.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient reports bumps and raised lesions on both sides of trunk along with down the length of the arms. The "rash" appeared about 24-48 hours after receving vaccination. The rashes began to go away after about 1 week. Patient also had swelling and redness at sight of injection.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Culture negative, Epistaxis, Herpes simplex test negative, Inflammation
Clinical narrative: Event 1: Cold sore on outside of lip, noticed 02/13/2020 (approx.).  Ran its course 7 to 10 days, no treatment. Event 2: Peeling, bleeding inside both nostrils, noticed 03/06/2020 (approx.). Ran its course about 14 days, no treatment. Event 3: Peeling, burning, base of both nostrils, noticed end of May 2020. Treated with Eucerin. Event 4: (Major Flare 1) Outside weeping, then burning blister on outside of lip 06/05/2020; 06/07/2020 multiple bleeding sores (ulcers) above left eye and on both lips and sore under tongue. Treated with Abreva OTC and 1000 MG Lysine. Started on Valacyclovir 1 GM and Sulfameth/Trimethoprim 800/160 MG; ran its course until 06/16/2020. Event 5: (Major Flare 2): Weeping, then multiple bleeding sores (ulcers) on both lips 07/11/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 07/19/2020. Event 6 (Major Flare 3): Multiple bleeding sores (ulcers) on both lips 08/23/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 08/30/2020. Event 7 (Lesser Flare 4): Multiple bleeding smaller sores (ulcers) on both lips 09/21/2020. Treated with Valacyclovir 500 MG (current dosage) and Dexamethasone 0.5 MG/5ML elixir for internal mouth ulcer; current course in progress for 3 months; experiencing some inflammation on lips and reddish scar tissue where ulcers were appearing. Also treating lips and nostrils with EUCERIN for comfort.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip blister, Lip ulceration, Mouth ulceration, Oral herpes, Scar
Clinical narrative: Event 1: Cold sore on outside of lip, noticed 02/13/2020 (approx.).  Ran its course 7 to 10 days, no treatment. Event 2: Peeling, bleeding inside both nostrils, noticed 03/06/2020 (approx.). Ran its course about 14 days, no treatment. Event 3: Peeling, burning, base of both nostrils, noticed end of May 2020. Treated with Eucerin. Event 4: (Major Flare 1) Outside weeping, then burning blister on outside of lip 06/05/2020; 06/07/2020 multiple bleeding sores (ulcers) above left eye and on both lips and sore under tongue. Treated with Abreva OTC and 1000 MG Lysine. Started on Valacyclovir 1 GM and Sulfameth/Trimethoprim 800/160 MG; ran its course until 06/16/2020. Event 5: (Major Flare 2): Weeping, then multiple bleeding sores (ulcers) on both lips 07/11/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 07/19/2020. Event 6 (Major Flare 3): Multiple bleeding sores (ulcers) on both lips 08/23/2020 and sore under tongue. Treated with Valacyclovir 1 GM and Sulfamethoxazole/Trimethoprim 800/160 MG and Mupirocin 2% ointment; ran its course until 08/30/2020. Event 7 (Lesser Flare 4): Multiple bleeding smaller sores (ulcers) on both lips 09/21/2020. Treated with Valacyclovir 500 MG (current dosage) and Dexamethasone 0.5 MG/5ML elixir for internal mouth ulcer; current course in progress for 3 months; experiencing some inflammation on lips and reddish scar tissue where ulcers were appearing. Also treating lips and nostrils with EUCERIN for comfort.