chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Limb discomfort, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: Marked sore arm which developed parasthesias 18 days after injection Patient here complaining of numbness and weakness to left arm after receiving flu vaccine 2 weeks ago. Patient states that the numbness radiating into left hand and pain radiating into left shoulder and up into her neck. Patient states that arm feels heavy and weak. Pain to injection site when pressure is applied. Had injection in her left deltoid on Wednesday Oct 21 at Pharmacy. Felt sore the next day, "like I would expect" but pain never resolved. On Thursday October 29 she developed diarrhea and has this, along with a headache on Thursday, Friday, Sat and Sunday. Yesterday, stools were formed but pain in the arm markedly escalated with throbbing pain and radiation moving into the neck and hand on the left side. The patient is a 39 year old female who presents with a complaint of Arm pain. The onset of the arm pain had been sudden and has been occurring in a persistent pattern for 18 days (but markedly worse the last 48 hours). The course has been increasing. The arm pain is described as moderate.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Mean cell volume normal, Muscular weakness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Marked sore arm which developed parasthesias 18 days after injection Patient here complaining of numbness and weakness to left arm after receiving flu vaccine 2 weeks ago. Patient states that the numbness radiating into left hand and pain radiating into left shoulder and up into her neck. Patient states that arm feels heavy and weak. Pain to injection site when pressure is applied. Had injection in her left deltoid on Wednesday Oct 21 at Pharmacy. Felt sore the next day, "like I would expect" but pain never resolved. On Thursday October 29 she developed diarrhea and has this, along with a headache on Thursday, Friday, Sat and Sunday. Yesterday, stools were formed but pain in the arm markedly escalated with throbbing pain and radiation moving into the neck and hand on the left side. The patient is a 39 year old female who presents with a complaint of Arm pain. The onset of the arm pain had been sudden and has been occurring in a persistent pattern for 18 days (but markedly worse the last 48 hours). The course has been increasing. The arm pain is described as moderate.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Platelet count normal, Red blood cell count normal, Red cell distribution width decreased, White blood cell count normal
Clinical narrative: Marked sore arm which developed parasthesias 18 days after injection Patient here complaining of numbness and weakness to left arm after receiving flu vaccine 2 weeks ago. Patient states that the numbness radiating into left hand and pain radiating into left shoulder and up into her neck. Patient states that arm feels heavy and weak. Pain to injection site when pressure is applied. Had injection in her left deltoid on Wednesday Oct 21 at Pharmacy. Felt sore the next day, "like I would expect" but pain never resolved. On Thursday October 29 she developed diarrhea and has this, along with a headache on Thursday, Friday, Sat and Sunday. Yesterday, stools were formed but pain in the arm markedly escalated with throbbing pain and radiation moving into the neck and hand on the left side. The patient is a 39 year old female who presents with a complaint of Arm pain. The onset of the arm pain had been sudden and has been occurring in a persistent pattern for 18 days (but markedly worse the last 48 hours). The course has been increasing. The arm pain is described as moderate.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient called in 9:30 11-3-20 to report her arm was red, swollen, and sore. She stated she had a fever of 100.4 Per Dr. Patient should take Tylenol for pain and fever if redness spreads she should follow up in office. As of 4 pm 11-3-20 her temp did return to normal.
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Reports pain in left arm, unable to reach overhead or lift above shoulder level. Denies any S/S at time of vaccination or until present.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Paraesthesia
Clinical narrative: Employee had pain at time of injection and continued to have pain in left shoulder with worsening pain on 10/26/2020 and now decrease Range of motion of joint.  numbness and tingling in left 3,4,5 finger.
Age: 13.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dyskinesia, Eye movement disorder, Sensory disturbance, Unresponsive to stimuli
Clinical narrative: approximately 4:15 pm immunizations given well tolerated by student.  4:18 pm student was moved to a seated position in a chair for recheck of B/P.  4:20 pm Student noted to began starring and dropped his head backward began involuntary jerking movements eyes rolled backward mother and nurse practitioner witnessed.  Student was unresponsive less than one minute and was aroused with yelling his name.  He was able to state where he was at and drink water.   Student complained of bilateral "hands feeling funny."  B/P 120/88 HR120.  4:22 pm EMS called.  Cool cloth to forehead and neck .    4:25 pm B/P 120/90  small oscillating movements of both eyes noticed mother states student has had this in the past this was not new.  4:33 pm EMS present student is A& O x3 he is able to stand unassisted states "feel strange"  after speaking with mother rescue and mother have decided mother will drive student in POV to ER.  4:37 pm student was taken to POV via wheelchair no change in status en route to ER.  4:38 pm called ER to provide report of occurence after immunizations given.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Hypersensitivity, Pruritus
Clinical narrative: On 10/14, patient received flu shot at office at 3:20PM. Patient reports that she experienced itching all over her body, including extremities. She also felt that her "inside was itching, a lot". She used hydrocortisone on her skin, and it helped only a little bit with itching. The next day, pt experienced blisters popping up all over her skin. She went to the ER. They said it was an allergic reaction to the flu shot, and to follow up with primary if it doesn't go away. The blisters did not, and she came for follow up on 11/4/20.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headaches, muscle aches across body, tiredness
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, X-ray
Clinical narrative: Horrible Pain in the Upper Left Arm
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Illness, Influenza, Nausea, Pain
Clinical narrative: Got flu symptoms late that mon night better next couple days than severe fri, sat, sun, mon, tues ,weds which is today.  Nausea, achy, headache, severe.  I live alone and have been quarsntining..I have had issues with flu shots before but could never prove it was from the shot.  This year thanks to covid quarantine I know I've had no other exposures.  Also had a negative covid test sat...very sick I want my life back.  Last year one week after flu shot couldn't stop vomiting and ended up in hospital.  Didn't link it to shot because there were other exposures in the world.  This year I know its the shot
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got flu symptoms late that mon night better next couple days than severe fri, sat, sun, mon, tues ,weds which is today.  Nausea, achy, headache, severe.  I live alone and have been quarsntining..I have had issues with flu shots before but could never prove it was from the shot.  This year thanks to covid quarantine I know I've had no other exposures.  Also had a negative covid test sat...very sick I want my life back.  Last year one week after flu shot couldn't stop vomiting and ended up in hospital.  Didn't link it to shot because there were other exposures in the world.  This year I know its the shot
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received Pneumovax on 10/17/20.  On 10/19/20, patient reported fever of 101.6, on 10/20/20 patient reported arm was red, hard, warm, and painful to the touch.  Redness, soreness, and warmth began to spread towards elbow and back of arm the next day.  MD diagnosed as cellulitis and prescribed a 7 day course of Bactrim.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Received Pneumovax on 10/17/20.  On 10/19/20, patient reported fever of 101.6, on 10/20/20 patient reported arm was red, hard, warm, and painful to the touch.  Redness, soreness, and warmth began to spread towards elbow and back of arm the next day.  MD diagnosed as cellulitis and prescribed a 7 day course of Bactrim.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction
Clinical narrative: Injection site reaction of 3-4 inch diameter redness
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Computerised tomogram head, Cyanosis, Eye movement disorder, Fall, Injection site erythema
Clinical narrative: Pt given vaccine on Thurs l0/29  on l0/30 warm didn't want to nap in am then during diaper change on floor pt head fell back eyes  rolled back and generalized twitching of arms, legs, pale lips turned blue duration 3 min  called 9ll   no temp taken  Pt transported to ER via ambulance vomited x 4 during transport lethargic in ER  No fever  On Thurs pt also fell off bed while playing with brother, hit carpet no LOC, no vomiting or behavior chg CT scan of head ordered in ER neg  left leg at site of vaccine red and warm on Sat l0/31 self resolved on ll/1/2020
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site warmth, Lethargy, Muscle twitching, Pallor, Vomiting
Clinical narrative: Pt given vaccine on Thurs l0/29  on l0/30 warm didn't want to nap in am then during diaper change on floor pt head fell back eyes  rolled back and generalized twitching of arms, legs, pale lips turned blue duration 3 min  called 9ll   no temp taken  Pt transported to ER via ambulance vomited x 4 during transport lethargic in ER  No fever  On Thurs pt also fell off bed while playing with brother, hit carpet no LOC, no vomiting or behavior chg CT scan of head ordered in ER neg  left leg at site of vaccine red and warm on Sat l0/31 self resolved on ll/1/2020
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: skin was very warm at injection site and 2 days later site started to itch and continues to itch as of today although not as bad.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Disturbance in attention, Dizziness, Flushing, Impaired work ability
Clinical narrative: Almost immediately arm was sore and felt light headed.  Arm grew increasingly uncomfortable.  Small swelling at injection site.   Hard to sleep/lift arm/open car door, etc.  11/4 (day after vaccine) flu-like symptoms started:  flushed face, light headed, nauseas, weak, unable to work, concentrate or participate in normal activities.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site discomfort, Injection site movement impairment, Injection site swelling, Insomnia
Clinical narrative: Almost immediately arm was sore and felt light headed.  Arm grew increasingly uncomfortable.  Small swelling at injection site.   Hard to sleep/lift arm/open car door, etc.  11/4 (day after vaccine) flu-like symptoms started:  flushed face, light headed, nauseas, weak, unable to work, concentrate or participate in normal activities.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Almost immediately arm was sore and felt light headed.  Arm grew increasingly uncomfortable.  Small swelling at injection site.   Hard to sleep/lift arm/open car door, etc.  11/4 (day after vaccine) flu-like symptoms started:  flushed face, light headed, nauseas, weak, unable to work, concentrate or participate in normal activities.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: 1st dose Unknown date ( around August or September)@ 3:00. had severe chills and fever. Took Tylenol for fever. Sick for about 8 hours. 2nd Dose 10/26/20: Around 8pm started having chills. 2am started having chills and fever.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Diarrhoea, Electrocardiogram, Erythema, Feeling hot
Clinical narrative: arm redness, warmth, swelling, pain, itching. nausea, diarrhea, chest pain, headache
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pruritus, Swelling
Clinical narrative: arm redness, warmth, swelling, pain, itching. nausea, diarrhea, chest pain, headache
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pt stated that she noticed the pain and redness on the right arm close to the elbow. There was no pain or redness at the injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling and soreness at injection site, stiffness in shoulder and neck of same side as injection.
Age: 14.0
Sex: U
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Refusal of vaccination
Clinical narrative: at 14 years old, patient received MMRII; This spontaneous report was received from a pediatrician referring to a 14-year-old patient. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not provided. The patient only ever received an unspecified hepatitis B vaccine when the patient was a baby.   On 27-OCT-2020, the patient received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX), poliovirus vaccine inactivated (vero) (IPOL) and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported for any of the vaccines). The patient was due to receive a total of 9 immunizations including the previously mentioned vaccines; the patient would not agree to receive the remaining immunizations at event time.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: trying to get the third dose now off schedule; This spontaneous report was received from a pharmacist referring to a current 25 years old patient of unknown gander. The patient got the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in September 2019 and the second dose in December 2019 for prophylaxis. The patient was trying to get the third dose now off schedule (inappropriate schedule of vaccine administered).
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: full body hives / hives; This case was reported by a consumer via other manufacturer and described the occurrence of hives in a 30-year-old female patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th December 2021) for prophylaxis.   On 16th September 2020, the patient received Engerix B (intramuscular) 1 ml. On 17th September 2020, 1 days after receiving Engerix B, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   The reporter considered the hives to be related to Engerix B.  Additional details were provided as follows: The patient was vaccinated with booster dose of Engerix B. Next day after vaccination patient had full body hives. The reported that hives had appeared 1-2 times per week since vaccine administered. The patient believed hives was related to the vaccine since she cannot attribute to another source. No further information were reported. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: single vesicle in the immunized arm which subsequently scabbed over; This case was reported by a other health professional via interactive digital media and described the occurrence of scab in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scab. On an unknown date, the outcome of the scab was unknown.   It was unknown if the reporter considered the scab to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age was not reported but it was selected as an adult as per vaccine indication. The reported mentioned that the patient developed a single vesicle in the immunized arm which subsequently scabbed over. The reported asked should receive 2nd dose. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: feel sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness 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 was selected as per the vaccine indication. The patient received 2nd Shingrix shot and had all the side effects listed how much longer will  the patient feel sick.
Age: 55.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Dehydration, Dizziness, Headache, Hyperhidrosis
Clinical narrative: positive Covid-19 test yesterday; received the Shingrix vaccine underneath his arm in the tricep; dehydrated; dizzy; headache; was sweaty; stiff joints; had body aches in neck and shoulders; had body aches in the arms, neck and shoulders; had body aches in  shoulders; still has aches here and there; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 virus test positive.   On 23rd October 2020, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular) and Shingrix. On 23rd October 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix and less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and vaccine administered at inappropriate site. On 25th October 2020, the patient experienced coronavirus test positive. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dehydration, dizziness, headache, sweating and stiff joint were recovered/resolved and the outcome of the neck pain, pain in arm, shoulder pain and general body pain were not recovered/not resolved and the outcome of the coronavirus test positive and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and coronavirus test positive to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were provided as follows: The patient received dose of flu vaccine in the left. The patient received dose of Shingrix underneath his arm in the tricep instead of deltoid region of the upper arm, which led to vaccine administered at inappropriate site. The reporter staated that, on the day of vaccination in the evening, the patient experienced body aches in the arms, neck and shoulders, stiff joints, was sweaty, headache, dizziness, and dehydration. The reporter stated, the patient kept drinking water and took Tylenol for these symptoms. The reporter stated that, the events had resolved except aches here and there. On 25th October 2020, the patient had positive Covid-19 test. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212948:same reporter
Age: 55.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Joint stiffness, Neck pain, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: positive Covid-19 test yesterday; received the Shingrix vaccine underneath his arm in the tricep; dehydrated; dizzy; headache; was sweaty; stiff joints; had body aches in neck and shoulders; had body aches in the arms, neck and shoulders; had body aches in  shoulders; still has aches here and there; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 virus test positive.   On 23rd October 2020, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular) and Shingrix. On 23rd October 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix and less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and vaccine administered at inappropriate site. On 25th October 2020, the patient experienced coronavirus test positive. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dehydration, dizziness, headache, sweating and stiff joint were recovered/resolved and the outcome of the neck pain, pain in arm, shoulder pain and general body pain were not recovered/not resolved and the outcome of the coronavirus test positive and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and coronavirus test positive to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were provided as follows: The patient received dose of flu vaccine in the left. The patient received dose of Shingrix underneath his arm in the tricep instead of deltoid region of the upper arm, which led to vaccine administered at inappropriate site. The reporter staated that, on the day of vaccination in the evening, the patient experienced body aches in the arms, neck and shoulders, stiff joints, was sweaty, headache, dizziness, and dehydration. The reporter stated, the patient kept drinking water and took Tylenol for these symptoms. The reporter stated that, the events had resolved except aches here and there. On 25th October 2020, the patient had positive Covid-19 test. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212948:same reporter
Age: 55.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive Covid-19 test yesterday; received the Shingrix vaccine underneath his arm in the tricep; dehydrated; dizzy; headache; was sweaty; stiff joints; had body aches in neck and shoulders; had body aches in the arms, neck and shoulders; had body aches in  shoulders; still has aches here and there; This case was reported by a consumer via call center representative and described the occurrence of dehydration in a 55-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 virus test positive.   On 23rd October 2020, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular) and Shingrix. On 23rd October 2020, less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix and less than a day after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and vaccine administered at inappropriate site. On 25th October 2020, the patient experienced coronavirus test positive. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dehydration, dizziness, headache, sweating and stiff joint were recovered/resolved and the outcome of the neck pain, pain in arm, shoulder pain and general body pain were not recovered/not resolved and the outcome of the coronavirus test positive and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the dehydration, dizziness, headache, sweating, stiff joint, neck pain, pain in arm, shoulder pain, general body pain and coronavirus test positive to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional details were provided as follows: The patient received dose of flu vaccine in the left. The patient received dose of Shingrix underneath his arm in the tricep instead of deltoid region of the upper arm, which led to vaccine administered at inappropriate site. The reporter staated that, on the day of vaccination in the evening, the patient experienced body aches in the arms, neck and shoulders, stiff joints, was sweaty, headache, dizziness, and dehydration. The reporter stated, the patient kept drinking water and took Tylenol for these symptoms. The reporter stated that, the events had resolved except aches here and there. On 25th October 2020, the patient had positive Covid-19 test. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212948:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Stem cell transplant
Clinical narrative: Stem cell implant; This case was reported by a pharmacist via call center representative and described the occurrence of stem cell transplant in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced stem cell transplant. On an unknown date, the outcome of the stem cell transplant was unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Shingrix.  Additional details were reported as follows: The case was reported by the pharmacist on behalf of the patient. The age at vaccination was not reported. The patient received both Shingrix vaccine in 2018. The patient has since had a stem cell implant. The reporter did not consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Lip swelling, Swollen tongue
Clinical narrative: allergic reaction; swelling of the tongue; swelling of the tongue and lips; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2020, less than a day after receiving Shingrix, the patient experienced allergic reaction, swollen tongue and lip swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, swollen tongue and lip swelling were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, swollen tongue and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an allergic reaction that included swelling of the tongue and lips, after receiving the 1st dose of the Shingrix vaccine. Vaccine was given in the left deltoid on 29th December 2020 at 2pm .  The patient was instructed to take Benadryl for the swelling. As of 3pm, the swelling was going down.  When the reporter last spoken to the patient at 4pm the swelling has gone down.  Thus far, there had been no follow-up with the patient. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Pain in extremity, Pyrexia
Clinical narrative: chills; fever; pain in the right arm; first dose of Shingrix vaccine in December 2019 and has not received the second dose yet; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression and rheumatoid arthritis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, fever, pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the chills, fever and pain in arm were recovered/resolved and the outcome of the incomplete course of vaccination was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In December 2019, the patient received the 1st dose and still not received the second dose, which led to Incomplete course of vaccination. The patient reported the day after receiving the vaccine she had fever, chills, and pain in the right arm and these effects lasted 2 to 3 days and then resolved.  The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Screaming, Wrong technique in product usage process
Clinical narrative: pharmacist "ramped" it into her arm, that made her scream; having pain at the injection site; cannot play her piano or do any house work; scream.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On 12th October 2020, unknown after receiving Shingrix, the patient experienced wrong injection technique. In October 2020, the patient experienced injection site pain, activities of daily living impaired and screaming. The patient was treated with hydrocodone and paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, activities of daily living impaired, screaming and wrong injection technique were unknown.   It was unknown if the reporter considered the injection site pain, activities of daily living impaired and screaming to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and she stated the pharmacist ramped it into her arm, that made her scream. Since then the patient experienced pain at the injection site and was taking hydrocodone and acetaminiphen to control the pain.  The patient could not play her piano or not able to do any house work.  The patient would be seing the doctor on 2nd November 2020. The reporter did not consent to follow-up.
Sex: U
Vaccine: PNC13
Symptoms: Ageusia, Anosmia, Back pain, Dizziness, Headache
Clinical narrative: Inability to lift arm; Fatigue; Achy back; Headache; dizziness; Mild loss of taste and smell; Mild loss of taste and smell; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received  first dose pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration on 29Oct2020 at single dose for immunisation and influenza vaccine via an unspecified route of administration on 14Oct2020 at single dose for immunisation. The patient's medical history included  asthma. Concomitant medications were not reported. The patient experienced side effects include inability to lift arm, fatigue, achy back, headache and dizziness. Also experienced mild loss of taste and smell. Event took place after use of product on an unknown date. This is the patient first time getting Prevnar-13 vaccine. The patient also received flu vaccine on 14Oct2020. The patient has asthma and takes Dupixent injections every 2 weeks. Last dose was 20Oct2020.The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Musculoskeletal disorder
Clinical narrative: Inability to lift arm; Fatigue; Achy back; Headache; dizziness; Mild loss of taste and smell; Mild loss of taste and smell; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received  first dose pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via an unspecified route of administration on 29Oct2020 at single dose for immunisation and influenza vaccine via an unspecified route of administration on 14Oct2020 at single dose for immunisation. The patient's medical history included  asthma. Concomitant medications were not reported. The patient experienced side effects include inability to lift arm, fatigue, achy back, headache and dizziness. Also experienced mild loss of taste and smell. Event took place after use of product on an unknown date. This is the patient first time getting Prevnar-13 vaccine. The patient also received flu vaccine on 14Oct2020. The patient has asthma and takes Dupixent injections every 2 weeks. Last dose was 20Oct2020.The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was given to a 15 years old patient with no AE; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 15 years old male patient who received 0.5 mL dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ497AA, expiry date: 03-May-2021) via intramuscular route on left deltoid site for prophylactic vaccination (product administered to patient of inappropriate age) on 09-Oct-2020.   The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant therapy receive by patient.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, patient had not experienced any adverse event.  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: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; while administering vaccine, some of the vaccine liquid leaked out of the syringe and down the patient's arm, no adverse event; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 31 year old female patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, batch number and expiration date were not reported) via an intramuscular route in the deltoid on 05-Oct-2020 for prophylactic vaccination, however while administering, some of the vaccine liquid leaked out of the syringe and down the patient's arm (exposure via skin contact and underdose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not reported.  The patient did not receive any concomitant medication.  This was an actual medication error case due to vaccine underdose (latency was same day).  Also, this was a case of syringe leak (syringe issue) and vaccine exposure via skin contact.  The reporter wanted to know if another type of flu vaccine could be given and what is appropriate time to re-administer.  At the time of reporting, no adverse event reported to the patient and she did not receive any corrective treatment.  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.  There will be no information available on the batch number for this case.
Age: 6.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 year old received Flublok instead of Fluzone with no adverse event; received Flublok instead of Fluzone with no adverse event; Both vaccines do look very similar with no adverse event; Initial information regarding this unsolicited non-serious valid case from a pharmacist on 12-Oct-2020 .  This case is linked to case 2020SA284812.  This case involved a 6-years-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiration date was unknown for both) via an unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age) and (Wrong product administered) on an unknown date.  Medical history and concomitant medications were not reported.  It was a case of an actual medication due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: Same day).  The reporter also reported that both the vaccines looks very similar (Product confusion).  At the time of reporting, patient had not experienced any adverse event.  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.  There will be no information available on batch number for this case.
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8 year old patient had been given with Flublok vaccine, no adverse event; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves an 8 years old female patient who received an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown) via unknown route and site on unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (latency: on the same day)  At the time of reporting, patient did not experience any adverse event.  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.  There will be no information available on the batch number.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 or 5 year-old child received Flublok, no Adverse event; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a child patient (age reported as 4 or 5 year-old) who received an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: unknown, expiry date: unknown) via unknown route and site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (latency- on the same day).  At the time of reporting, patient had not experienced any adverse event.  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 and Module VI of the 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.  There will be no information available on the batch number for this case.
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: five year old patient received FLUBLOK QUADRIVALENT vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Health Authority (Reference number- 00322459) and transmitted to Sanofi on 19-Oct-2020.  The case was linked to cases 2020SA295722 and 2020SA295712 (same reporter).  This case involves a 5-year-old male patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (strength: standard, Lot: QFAA2051, expiry date: 30-Jun-2021) via an intramuscular route in the right arm for prophylactic vaccination (product administered to patient of inappropriate age) on 19-Oct-2020.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  No other vaccines were administered.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  Pharmacist wanted to know if any adverse events related use of Flublok in patients under the age of 18 years and about re-vaccinated with an appropriate flu vaccine.   At the time of reporting, patient had not experienced any adverse event.  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: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered FLUBLOK QUADRIVALENT to a 15 year old patient with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00326437) and transmitted to Sanofi on 21-Oct-2020.  This case involved a 15 year old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by the pharmacist (lot number: UJ487AA and expiry date: 17-Apr-2021) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, concomitant medication, vaccinations details and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced any adverse event.  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.