chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: felt tired; achy; She feels run down still; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix. On 31st August 2020, less than a day after receiving Shingrix, the patient experienced tiredness, pain and feeling bad. On an unknown date, the outcome of the tiredness, pain and feeling bad were recovering/resolving.   It was unknown if the reporter considered the tiredness, pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt tired and achy. The reporter feels run down still but it was lessening as time goes on. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: arm sensation / "feels like the liquid went into muscle and just sat there; This case was reported by a pharmacist via call center representative and described the occurrence of arm discomfort in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 29th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2020, less than 3 months after receiving Shingrix, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was not recovered/not resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a sensation in his arm. The pharmacist describes the arm sensation stating feels like the liquid went into muscle and just sat there.  The pharmacist also stated it was a sensation was always aware of. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to arthropod sting, Anaphylactic reaction, Blood pressure decreased, Blood pressure increased, Lip swelling
Clinical narrative: could have died; In the ER his blood pressure dropped to 80/60; anaphylaxis; face and lips swelled up; face and lips swelled up; blood pressure went through the roof/blood pressure dropped to 80/60 something; got stung by many yellow jackets; He was never allergic to bee stings before getting the shingrix vaccine.; rash presented on his back, legs, buttocks hips and under arms/ The rash was very itchy.; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced itchy rash. On 28th August 2020, the patient experienced anaphylaxis (serious criteria GSK medically significant), facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting. On an unknown date, the patient experienced near death experience (serious criteria GSK medically significant) and blood pressure decreased. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved and the outcome of the near death experience, blood pressure decreased, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting were unknown and the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the anaphylaxis, near death experience, blood pressure decreased, itchy rash, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had his first dose 3 weeks ago from reporting date in his left arm. Three to four days following the injection, a rash presented on his back, legs, buttocks hips and under arms. More on the right under arm than the left but still present in both areas. The rash was very itchy. The patient took benadryl on and off and even though it did not fully resolved, it was manageable. On 28th August 2020, the patient was working out in the yard and got stung by many yellow jackets and went into anaphylaxis. His face and lips swelled up and his blood pressure went through the roof. He was transported to the emergency room, treated and released. The patient was never allergic to bee stings before getting the shingrix vaccine. The reporter stated that the patient could have died and in the emergency room his blood pressure dropped to 80/60. The reporter consented to follow up. This case is linked with case US2020180921,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180921:same reporter US-GLAXOSMITHKLINE-US2020AMR181528:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Near death experience, Pain, Rash pruritic, Swelling face
Clinical narrative: could have died; In the ER his blood pressure dropped to 80/60; anaphylaxis; face and lips swelled up; face and lips swelled up; blood pressure went through the roof/blood pressure dropped to 80/60 something; got stung by many yellow jackets; He was never allergic to bee stings before getting the shingrix vaccine.; rash presented on his back, legs, buttocks hips and under arms/ The rash was very itchy.; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced itchy rash. On 28th August 2020, the patient experienced anaphylaxis (serious criteria GSK medically significant), facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting. On an unknown date, the patient experienced near death experience (serious criteria GSK medically significant) and blood pressure decreased. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylaxis was not recovered/not resolved and the outcome of the near death experience, blood pressure decreased, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting were unknown and the outcome of the itchy rash was recovering/resolving.   It was unknown if the reporter considered the anaphylaxis, near death experience, blood pressure decreased, itchy rash, facial swelling, lip swelling, increased blood pressure, sting and allergy to insect sting to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had his first dose 3 weeks ago from reporting date in his left arm. Three to four days following the injection, a rash presented on his back, legs, buttocks hips and under arms. More on the right under arm than the left but still present in both areas. The rash was very itchy. The patient took benadryl on and off and even though it did not fully resolved, it was manageable. On 28th August 2020, the patient was working out in the yard and got stung by many yellow jackets and went into anaphylaxis. His face and lips swelled up and his blood pressure went through the roof. He was transported to the emergency room, treated and released. The patient was never allergic to bee stings before getting the shingrix vaccine. The reporter stated that the patient could have died and in the emergency room his blood pressure dropped to 80/60. The reporter consented to follow up. This case is linked with case US2020180921,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020180921:same reporter US-GLAXOSMITHKLINE-US2020AMR181528:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received the two doses of Shingrix on 2018 and experienced Shingles on January, 2020/Suspected vaccination failure; Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female 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. In January 2020, 2 years 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 recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received the two doses of Shingrix in 2018 and experienced Shingles on January, 2020 which led to suspected vaccination failure. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Malaise
Clinical narrative: fall; had a lot of things going on with his health; This case was reported by a consumer via call center representative and described the occurrence of fall in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fall and feeling unwell. On an unknown date, the outcome of the fall was unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the fall and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's father resides in a nursing facility. The patient received Shingrix and had has had a lot of things going on with his health including a fall. The reporter was trying to determine when her father should get the 2nd dose of Shingrix. No further details were provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: her left arm is shaking.; This case was reported by a other health professional via sales rep and described the occurrence of tremor limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tremor limb. On an unknown date, the outcome of the tremor limb was not recovered/not resolved.   It was unknown if the reporter considered the tremor limb to be related to Shingrix.  This case was reported by a other health professional via sales rep and described the occurrence of tremor limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tremor limb. On an unknown date, the outcome of the tremor limb was not recovered/not resolved.   It was unknown if the reporter considered the tremor limb to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix month ago and left arm was shaking. The reporter consented to follow up. This was reported in an email to the field rep. by the physician assistant.   This was all the information she had.   The PA permitted follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Peripheral swelling
Clinical narrative: " her arm "got big; dose 1 subcutaneously instead of the indicated intramuscular route; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine subcutaneously instead of the indicated intramuscular route, which led to intramuscular formulation administered by other route. The reporter stated that her arm got big and that it took awhile to get better. The reporter did not consent to follow up. Registered nurse declined to provide any demogrpahic information for this AE, remained anonymous. She declined to provide any additional information for this adverse event.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: I got pins and needles in my injection arm within an hour.  Within 4 hours, the pins and needles  spread to my entire body.   Within 12 I was very weak and felt unsafe to walk without tripping.  After a day, pain was added.  After 2 days the pain was gone.  Now almost a week later, I only have pins and needles in my injection arm.  Still some "numbness" in my hand.  Maybe some weakness as well.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Muscle tightness
Clinical narrative: Gave pt flu shot at 11:30 am Pt came back after shot arojnd 11:45am and said Back tightened up , then said had trouble breathing , told to take mask off to help breathe better, Breathing did not improve in 5 mintues called emt. They responed in at 12:05, And took gentleman to ER .
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain
Clinical narrative: left quadricept pain post rabies vaccine x4 and IgG administration. pain with ambulation and running. No sx of local infection or site reaction
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Skin warm, Swelling
Clinical narrative: inflammation, swollen, warm to the touch
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dysstasia, Fatigue, Feeling abnormal, Syncope
Clinical narrative: Approximately 10 minutes after receiving the vaccination, while walking to his car with his mother, the patient became lightheaded, felt out of it, and needed to sit down.  Mother brought him back to office where he had a brief syncopal episode while sitting with feet elevated.  The momentary syncope lasted only a few seconds, but he continued to feel lightheaded and out of it for an additional 20 minutes and remained fatigued and lightheaded for the next 24 hours.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Barley even red at injection site. No treatment at this time.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Patient was seen in office for her 12 month Well Child Check.  She was given above vaccines around 10am.  Within 5 minutes of admin, all injection sites were bright red and child's entire body had a hive like appearance including face, belly and legs.  Patient was give dose of Benadryl, remaining in office for another 10-15 minutes.  Patient's symptoms subsided dramatically prior to dismissal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Flushing, Headache, Injection site erythema
Clinical narrative: A mild constant headache lasted almost a week.  I went to bed last night with it still throbbing but today Mon Sep 14th, it appears to be gone.  I developed a large red area around the injection site, about the diameter of a tennis ball and 4" in length, extremely tender and hot to the touch.  This morning it was finally gone.  I also developed a rash/hive-like appearance on my chest and upper back.  My cheeks were also flushed and red and when I ran my fingers around the top of my forehead and under my eyes at the top of my cheeks, it was tender to the touch.  Once again, all of these symptoms lasted through Sep 13th.  Today, the redness, soreness, and tenderness are gone, and my energy level is returning. I am wondering if it is safe for me to get the second injection, and if so, should I wait the full 6 months?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Pain, Rash, Tenderness
Clinical narrative: A mild constant headache lasted almost a week.  I went to bed last night with it still throbbing but today Mon Sep 14th, it appears to be gone.  I developed a large red area around the injection site, about the diameter of a tennis ball and 4" in length, extremely tender and hot to the touch.  This morning it was finally gone.  I also developed a rash/hive-like appearance on my chest and upper back.  My cheeks were also flushed and red and when I ran my fingers around the top of my forehead and under my eyes at the top of my cheeks, it was tender to the touch.  Once again, all of these symptoms lasted through Sep 13th.  Today, the redness, soreness, and tenderness are gone, and my energy level is returning. I am wondering if it is safe for me to get the second injection, and if so, should I wait the full 6 months?
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: A mild constant headache lasted almost a week.  I went to bed last night with it still throbbing but today Mon Sep 14th, it appears to be gone.  I developed a large red area around the injection site, about the diameter of a tennis ball and 4" in length, extremely tender and hot to the touch.  This morning it was finally gone.  I also developed a rash/hive-like appearance on my chest and upper back.  My cheeks were also flushed and red and when I ran my fingers around the top of my forehead and under my eyes at the top of my cheeks, it was tender to the touch.  Once again, all of these symptoms lasted through Sep 13th.  Today, the redness, soreness, and tenderness are gone, and my energy level is returning. I am wondering if it is safe for me to get the second injection, and if so, should I wait the full 6 months?
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness
Clinical narrative: Patient states next day when waking up he was very dizzy, lightheaded  for 15 min per day. this has been continuing till this date of submission of form
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Hypertension, Rash
Clinical narrative: Rash over chest area, High blood pressure.   Treatment-OTC benadryl
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ERYTHEMA, ITCHING, WARMTH, SWELLING, PAIN AT INJECTION SITE 80MM
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt very sick for 8 days gradually improving after 4 days. 1st dose given, was ok. Booster was one I had a lot of difficulty with. My main concern is if I should have any other vaccinations i e flu shot Covid when approved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient has developed a rash and warm to the touch since receiving the shingrix vaccination on 9/11/2020.
Age: 83.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Erythema, Insomnia, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Left arm was sore, itchy, red & warm Hard for patient to sleep. She iced it down occasionally which helped and the area is still a little red & slightly warm after 5 days
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Burning sensation, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Red rash - pimples - itching - Burning - fever Around my neck both ears hot ears - still have rash and itching
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Red rash - pimples - itching - Burning - fever Around my neck both ears hot ears - still have rash and itching
Age: 2.17
Sex: F
Vaccine: HEPA
Symptoms: Electroencephalogram, Hypotonia, Postictal state, Specialist consultation, Staring
Clinical narrative: possible seizure - limp & staring with postictal phase lasting 30 minues
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: fever of 99 degrees; rash at her injection site; nowthe rash is occurring all over her body (feet, lower legs, and arms) the size of dime and nickel.; This spontaneous report was received from a 65 year old female patient, who was reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUN-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S036495, expiration date 13-SEP-2021 (strength, dose and route of administration), as preventative vaccine. On 01-JUL-2020, the patient experienced fever of 99 degrees and a rash at her injection site. On an unknown date in 2020, the rash expanded and at the time of the report was occurring all over her body (feet, lower legs and arms) the size of dime and nickel. The patient's rash was treated with clobetasol propionate cream. She had tried contacting her doctor but the office administrator said that they do not had the information of her getting the vaccine administered and when she requested the visit summary the caller said that there was also inaccurate information. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S036495; expirationdate: 13-SEP-2021; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 19-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: S031881, expiration date: 07-APR-2021) 0.5 ml (route of administration was not provided) diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: S012467, expiration date: 20-OCT-2020) 0.5 ml (route of administration was not provided) diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; An unspecified amount of improperly stored doses of PROQUAD and VARIVAX were administered; This non-valid spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions, medical history, historical drugs,drug reactions/allergies and concomitant medications were not provided.   Since an unknown date in February 2020, an unspecified amount of patients were vaccinated with an unknown improperly stored doses of Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (dosage regimen and route of administration not provided), lot# S021622, expiration date 09-JAN-2021; and with varicella virus vaccine live (VARIVAX) (dosage regimen and route of administration not provided), lot # S021924,expiration date 15-JUL-2021, given as prophylaxis.  All the lot# involved experienced a range of temperature between 6 Fahrenheit (°F) to 14 °F (average temperature of 13 °F) for 40 minutes. The vaccines did not have any previous temperature excursion. The call was placed due to a digital data logger. No additional adverse effects reported.  This is a non-valid case due to lack of patient identifiers.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently unknown patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number, and route not specified) for long-term prevention of shingles and/or zoster-related conditions (prophylaxis). Shortly after vaccination, the patient was treated for shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring, treatment, medication and supplies; diminished capacity for the enjoyment of life, diminished quality life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages, and will continue to suffer such losses, and damages in the future. The outcome of the event was shingles was not recovered.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: spiked a fever of 104.7; throbbing at injection site; myalgias; This case was reported by a nurse via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number G4HX3, expiry date 13th May 2022) for prophylaxis.   On 8th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th September 2020, less than a day after receiving Shingrix, the patient experienced fever, injection site pain and myalgia. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the myalgia was unknown.   It was unknown if the reporter considered the fever, injection site pain and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had myalgias, throbbing at injection site and spiked a fever of 104.7 degree F last night of reporting date.  On the day of reporting, the patient was afebrile and the throbbing was less.  The reporter consented to follow up.
Age: 1.5
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 18 months old patient was administered adacel instead of Daptacel, no AE; patient was administered ADACEL instead of Daptacel, no AE; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 18 months old female patient who was administered with 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: Lot: U6511AA expiration date: 22-Oct-2021) instead of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] via intramuscular route in the right thigh as prophylactic vaccination on 03-Sep-2020 (wrong product administered and product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination and Avacta.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event symptoms reported at the time of reporting.  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: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Dizziness
Clinical narrative: she felt  dizzy and weak she felt it was the pneumovax shot. she went to urgent care and the wait was so long she left and ended up feeling better later that night
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Malaise, Mobility decreased
Clinical narrative: I was extremely sick, unable to get out of bed, chills, aches, pains, no energy.  Injection site extremely painful
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I was extremely sick, unable to get out of bed, chills, aches, pains, no energy.  Injection site extremely painful
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient got a full body rash 2 days after getting the vaccine. He took Benadryl and applied hydrocortisone cream and was instructed to call MD
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Body aches, chills night of vaccine, next day nausea, vomiting x 1. Injection site very red, swollen and sore.  Still sore 3 days later.
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Body aches, chills night of vaccine, next day nausea, vomiting x 1. Injection site very red, swollen and sore.  Still sore 3 days later.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Hyperventilation, Vomiting
Clinical narrative: Pt hyperventilated, was dizzy and fell (according to witnesses) . Pt also vomited.  Pt sat for 20 minutes then departed store.
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives. Patient was given Benadryl
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Rash
Clinical narrative: patient woke up on 9/10/2020 with a red ring around her upper arm at the site of injection and a rash on her back
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Blood test, Limb discomfort, Musculoskeletal discomfort, Streptococcus test
Clinical narrative: DISCOMFORT IN ARM AND NECK- ER VISIT
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: rash/swelling/hot/painful at site of injection,  fever of 102 for 3 days.  today (5 days later) her deltoid muscle is still red and swollen.  Her primary physician recommended Benadryl otc.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: rash/swelling/hot/painful at site of injection,  fever of 102 for 3 days.  today (5 days later) her deltoid muscle is still red and swollen.  Her primary physician recommended Benadryl otc.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: swollen arm area and red rash, low grade fever 99.5, nausea, chills,
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm, Swelling
Clinical narrative: received the vaccine , by 3 hours later the area was swollen 'like a large goose egg size' and was painful, used an ice pack and Tylenol 100 mg plus Benadryl 25 mg one dose and again the next day. 9/12 the next day the arm was still swollen and warm to the touch. The area increased in redness and size as well as very tender. Each day after has slowly resolved.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: received the vaccine , by 3 hours later the area was swollen 'like a large goose egg size' and was painful, used an ice pack and Tylenol 100 mg plus Benadryl 25 mg one dose and again the next day. 9/12 the next day the arm was still swollen and warm to the touch. The area increased in redness and size as well as very tender. Each day after has slowly resolved.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Burning sensation, Erythema, Herpes zoster
Clinical narrative: 8/26 Shingles breakout (pox, itching, redness) Severe pain at injection site for 1 1/2 weeks severe pain during blood draw at same Dr office on 8/27 9/14 woke up with aggravated breakout on my right arm, blisters, rash, itching , burning, inflamed
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Pruritus, Pustule, Rash
Clinical narrative: 8/26 Shingles breakout (pox, itching, redness) Severe pain at injection site for 1 1/2 weeks severe pain during blood draw at same Dr office on 8/27 9/14 woke up with aggravated breakout on my right arm, blisters, rash, itching , burning, inflamed
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Contusion, Rash, Skin warm, Swelling
Clinical narrative: sever swelling rash bruising hot to the touch
Age: 31.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Asthenia, Burning sensation, Chills, Discomfort, Headache
Clinical narrative: I went to the pharmacy to receive a TDAP booster vaccine (BOOSTRIX TDAP vaccine syringe, Glaxosmithkline) after an accidental cut on my leg . I asked to get the flu shot along with it (to get it out of the way for this year). I'm not sure if it was the combination of the two vaccines, but a few hours later I was totally wiped out. I had a mild fever, headache, muscle aches, weakness, and chills.  It was brief, through the night, but was extremely uncomfortable. My head was pounding and felt like it was on fire. I'm feeling better today, no fever--just weak and achy. I figured I would report the side effects, in case it helped.
Age: 31.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: I went to the pharmacy to receive a TDAP booster vaccine (BOOSTRIX TDAP vaccine syringe, Glaxosmithkline) after an accidental cut on my leg . I asked to get the flu shot along with it (to get it out of the way for this year). I'm not sure if it was the combination of the two vaccines, but a few hours later I was totally wiped out. I had a mild fever, headache, muscle aches, weakness, and chills.  It was brief, through the night, but was extremely uncomfortable. My head was pounding and felt like it was on fire. I'm feeling better today, no fever--just weak and achy. I figured I would report the side effects, in case it helped.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Sore arm, red and warm to the touch that has gotten worse since receiving the injection
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Very sore arm, persistent. After 2-3 after shot given. From shoulder to elbow.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Induration, Peripheral swelling, Transient ischaemic attack
Clinical narrative: Patient says the Pneumovax made her arm swell and become rock hard, she got a headache that lasted for 2 weeks, and subsequently had 2 mini strokes. She did not have any high blood pressure issues or pre-existing conditions before
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated that injection was painful. Stated pain grew worse over next couple days and had limited range of motion of shoulder. Took ibuprofen and used heating pad over weekend to self treat. At time patient informed us of issue (9-14-20) was only able to lift arm approximately 30%.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: Patient states that they are "feeling bad" that they are experiencing muscle aches, chills and a head ache but is afebrile. The patient was advised to take Tylenol 1000mg three times daily.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Injection site reaction, red swollen arm. Pain in left arm.
Age: 35.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Pain, Pain in extremity
Clinical narrative: Patient is currently in her 3rd trimester. She received a Fluzone vaccine on her right arm and her Boostrix on the right arm. She was complaining of intense pain in her shoulder area radiating down the arm. She has been taking tylenol around the clock to help ease the pain. It went away for a couple of days but on 9/5/20 when she came into the pharmacy she stated that the pain came back.  I counseled her to continue taking the tylenol and also try putting ice on the area. I advised her to follow up with her OB if the pain doesn't go away.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Cold sweat, Dizziness, Nausea, Pallor, Paraesthesia
Clinical narrative: As soon as Gardasil was administered tingling down legs, then cold sweats, very dizzy, very pale, nausea, whites dots
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Swollen tongue
Clinical narrative: Allergic reaction, shortly after shot, including difficulty breathing, swollen lips and tongue.  Patient received epinephrine and oral corticosteroids and has to her description, fully recovered.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Lower respiratory tract congestion, Oropharyngeal pain
Clinical narrative: Allergic reaction, shortly after shot, including difficulty breathing, swollen lips and tongue.  Patient received epinephrine and oral corticosteroids and has to her description, fully recovered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Headache, Nausea
Clinical narrative: chills, fever, swollen arm, extreme weakness, headache, dizziness, nausea, vomiting
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: chills, fever, swollen arm, extreme weakness, headache, dizziness, nausea, vomiting
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Injection site vesicles, Injection site warmth, Peripheral swelling, Purulent discharge
Clinical narrative: Patient developed serious reaction 2 days after getting pneumonia vaccine. She woke up 2 days later with swollen left arm. Her upper arm was dark brown and then turned red. The upper arm felt warm to the touch and developed blisters that started to puss. Symptoms started to resolve several days later. On 9/14, swelling and blisters were gone, but slight redness remained. Patient was seen by provider on 9/14 and is being follwed up by wound care. Patient received flu shot in right arm, but no issues with that vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Activated partial thromboplastin time normal, Blister, Blood immunoglobulin A increased, Differential white blood cell count, Full blood count
Clinical narrative: 8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Henoch-Schonlein purpura, Herpes simplex test negative, Joint swelling, Lice infestation, Mycoplasma test negative
Clinical narrative: 8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Peripheral swelling, Petechiae, Platelet count, Prothrombin time normal, Purpura
Clinical narrative: 8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Rash macular, Scrotal swelling, Skin lesion, Spinal X-ray normal
Clinical narrative: 8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Urine analysis normal, Weight bearing difficulty, X-ray limb abnormal
Clinical narrative: 8/26/2020 -pt presented to local ER due to L knee swelling and rash on shins and refusing to bear weight. Mom also presented to ER due to lice infestation at daycare. Pt given Permethrin and Xray of knee done , dc'd home. follow up appt in office , pt 's rash progressed to red blotchy lesions on buttocks,  and thigh, bumpy, also noted to have R foot swollen and L hand swelling. No fevers. No diarrhea or bloody stools. No abdominal pain. urinating fine. Presumed dx' of HSP given. Rec supportive care and to f.u after weekend- 3 days later with urine specimen.  Pt presented to Local ER again on 8/30/2020 due to rash spreading to face, and scrotal swelling noted with blister formation on lesions on leg, Derm consulted in ER, poss of EM raised,  Blood tests including Mycoplasma and HSV titers drawn.  Followed up here on 8/31/2020- swelling on both hands noted, but previous swelling and scrotal swelling had subsided. Petechial and purpuric lesions as well as bullae noted on legs. No real target lesions. For diagnosis, complement levels, IGA coats and derm referral ordered   Pt seen by Derm on 9/1/2020. agreed with  HSP diagnosis.  Last visit prior to this report was on 9/8/2020. Rash resolved from face  and buttocks, and bullae had resolved.  No swelling of extremities noted. Still with petechia on feet and purpuric lesion on LE's.  Has f/u scheduled on 9/22/2020- awaiting f/u urinalysis as well