chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient received the vaccine Subcutaneously instaed of intramuscularly/no adverse event; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old male patient who was vaccinated with 0.5 mL (once) INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] via subcutaneously instead of intramuscularly (batch number UT7041JA and expiry date 30-Jun-2021) at an unknown site on 20-Oct-2020 for prophylactic vaccination (incorrect route of product administration).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination (latency was on same day).  At the time of report, patient had not experienced any adverse events.  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: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Arthritis, Gait disturbance, Lymph node pain, Lymphadenopathy
Clinical narrative: barely able to move; body is aching; affecting her ability to walk; lymph nodes hurt; lymph nodes are swollen; neck is hurting; spine achy; patient imagine arthritis feels; ribs are achy; joints hurts and pain in elbow; Initial information regarding an unsolicited valid serious case was received from a consumer or non-health care professional via Health Authority (Reference number- 00328232) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 53-years-old female patient who experienced barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment,  concomitant medication and family history were not provided.   no other vaccines given.  On 12-Oct-2020, the patient received a once 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength: standard, lot UJ463AA and expiry date: 19-Mar-2021) via an intramuscular route in the right arm  for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain) one day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory details were not reported.   No corrective treatment was received.  The event outcome was unknown for all events.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Mobility decreased, Musculoskeletal chest pain, Neck pain, Pain, Spinal pain
Clinical narrative: barely able to move; body is aching; affecting her ability to walk; lymph nodes hurt; lymph nodes are swollen; neck is hurting; spine achy; patient imagine arthritis feels; ribs are achy; joints hurts and pain in elbow; Initial information regarding an unsolicited valid serious case was received from a consumer or non-health care professional via Health Authority (Reference number- 00328232) and transmitted to Sanofi on 22-Oct-2020.  This case involves a 53-years-old female patient who experienced barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment,  concomitant medication and family history were not provided.   no other vaccines given.  On 12-Oct-2020, the patient received a once 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength: standard, lot UJ463AA and expiry date: 19-Mar-2021) via an intramuscular route in the right arm  for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious barely able to move (movement disorder), joints hurts and pain in elbow (arthralgia), body is aching (pain), affecting her ability to walk (gait disturbance), lymph nodes hurt (lymph node pain), lymph nodes are swollen (lymphadenopathy), neck is hurting (neck pain), spine achy (spinal pain), also patient imagine arthritis feels (arthritis) and ribs are achy (musculoskeletal chest pain) one day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Laboratory details were not reported.   No corrective treatment was received.  The event outcome was unknown for all events.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Gait disturbance
Clinical narrative: pt said she woke up at night and couldn't even walk. She had to hang on to the wall to get to the bathroom. And she was tired for 2 days. She called her dr (we don't have any dr on file except our protocol dr) the office never returned her call. She just called us 11-2-20 to report this incident.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 2 hours after receiving her flu vaccine at 0800 patient noticed redness, swelling, itching, and warmth at the site.  She was advised to complete a visit with an employee health practitioner.
Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient says she's had difficulty moving her arm since receiving her flu shot and it aches throughout the entire day.  She had not tried any interventions for pain yet. Recommended taking an NSAID for inflammation and swelling and hot pack.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: Patient telephoned pharmacy 11/4/20 to state that she had been experiencing arm pain at the injection site since the time of administration. She stated that she had notified her primary care provider but the office made no intervention or diagnosis.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Haematoma, Limb discomfort, Myalgia, Skin mass, Skin tightness
Clinical narrative: Patient said her arm is sore and tender to the touch.  Her skin is usually soft but feels tight when she extends or relax her arms.  She said her pain have moved to her right bi-ceps.  She also said it is not noticable but lumpy.  She saw a nurse from work and the nurse said she may have a hematoma and the nurse told her to take Tylenol and hydrate.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Patient said her arm is sore and tender to the touch.  Her skin is usually soft but feels tight when she extends or relax her arms.  She said her pain have moved to her right bi-ceps.  She also said it is not noticable but lumpy.  She saw a nurse from work and the nurse said she may have a hematoma and the nurse told her to take Tylenol and hydrate.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Confusional state, Dizziness, Fatigue, Impaired work ability, Meningoencephalitis viral
Clinical narrative: Patient developed temperature, does not remember exact number. had trouble with confusion, fatigue and dizziness. 2 days after vaccination was admitted to the hospital and diagnosed with viral meningoencephalitis. Continues to suffer with weakness of the extremities, mental acuity is not as sharp, not able to return to work yet.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Mental impairment, Muscular weakness
Clinical narrative: Patient developed temperature, does not remember exact number. had trouble with confusion, fatigue and dizziness. 2 days after vaccination was admitted to the hospital and diagnosed with viral meningoencephalitis. Continues to suffer with weakness of the extremities, mental acuity is not as sharp, not able to return to work yet.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Motor dysfunction, Musculoskeletal discomfort, Pain in extremity, Pyrexia
Clinical narrative: extremely sore arm, shoulder, neck pain. Unable to lift arm for 12 hours. fever
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Discomfort, Dizziness, Fatigue
Clinical narrative: High fever over 102F and chills throughout night of vaccine and next day. Misery and could not sleep. Then on next day 5/27/2020, I felt weak and was trying to drink a lot of fluids and eat a little, yet I still fainted in the late morning on my kitchen floor (from a standing position). The feeling of light-headedness before it happened while I was sitting was scary. I don?t know how long I was unconscious, but it probably wasn?t too long. I don?t remember passing out, just woke up on the floor. I had no injuries from falling. I don?t have high or low blood pressure issues. I do get fevers easily, even with colds, and have fainted previously from viruses after using the toilet, but never fainted when I didn?t just use the bathroom. I was almost feeling normal on 5/28/2020 and okay by 5/29/2020 (which was weird that I could feel that sick and then be over it fairly quickly, because it was a vaccine and not an illness). I will not get this vaccine again. The first dose caused only a very mild fever for a few hours and fatigue.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Loss of consciousness, Pyrexia, Sleep deficit, Syncope, Vaccination complication
Clinical narrative: High fever over 102F and chills throughout night of vaccine and next day. Misery and could not sleep. Then on next day 5/27/2020, I felt weak and was trying to drink a lot of fluids and eat a little, yet I still fainted in the late morning on my kitchen floor (from a standing position). The feeling of light-headedness before it happened while I was sitting was scary. I don?t know how long I was unconscious, but it probably wasn?t too long. I don?t remember passing out, just woke up on the floor. I had no injuries from falling. I don?t have high or low blood pressure issues. I do get fevers easily, even with colds, and have fainted previously from viruses after using the toilet, but never fainted when I didn?t just use the bathroom. I was almost feeling normal on 5/28/2020 and okay by 5/29/2020 (which was weird that I could feel that sick and then be over it fairly quickly, because it was a vaccine and not an illness). I will not get this vaccine again. The first dose caused only a very mild fever for a few hours and fatigue.
Age: 24.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching , redness and swelling at the injection site . Hydrocortisone cream .
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Fatigue, Hypoaesthesia
Clinical narrative: left big toe numb. progressed into right arm and wrist. Swollen tingling feeling. Spread to both legs and both arms. now spread to entire body. Spread to face. Inflammation and numbness in entire body. Experiencing fatigue and tiredness. Tightening in airway. Sore throat/scratchy. Going to neurologist
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Oropharyngeal discomfort, Oropharyngeal pain, Paraesthesia, Spirometry
Clinical narrative: left big toe numb. progressed into right arm and wrist. Swollen tingling feeling. Spread to both legs and both arms. now spread to entire body. Spread to face. Inflammation and numbness in entire body. Experiencing fatigue and tiredness. Tightening in airway. Sore throat/scratchy. Going to neurologist
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: left big toe numb. progressed into right arm and wrist. Swollen tingling feeling. Spread to both legs and both arms. now spread to entire body. Spread to face. Inflammation and numbness in entire body. Experiencing fatigue and tiredness. Tightening in airway. Sore throat/scratchy. Going to neurologist
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Induration, Injection site discomfort, Muscle spasms, Muscular weakness
Clinical narrative: I woke up to major spasms in my neck on the right side.  The spasms were so bad it would make my neck go rock hard and clench into my  jaw and lower skull, trapezius and clavicle regions.  It was like I had a kink but much different.  I was unable to lie back from a sitting position without the severe spasms so I would have to literally hold my head and turn to the side to lie down.  This lasted for about two weeks with the spasms lessening, however now, four weeks out leaving me with light spasms, neck weakness and discomfort in the same areas and now into the right deltoid.  Never did I have any arm pain at the site of injection, nor did I have fever, body aches or sickness.  I will see workmed for evaluation and abide to the recommendations there. I contacted my employee health nurse who looked up if this was a side effect, and she asked me to complete this adverse event report.  I waited at first, but when the problems persisted, it was too coincidental that I am still having issues.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort
Clinical narrative: I woke up to major spasms in my neck on the right side.  The spasms were so bad it would make my neck go rock hard and clench into my  jaw and lower skull, trapezius and clavicle regions.  It was like I had a kink but much different.  I was unable to lie back from a sitting position without the severe spasms so I would have to literally hold my head and turn to the side to lie down.  This lasted for about two weeks with the spasms lessening, however now, four weeks out leaving me with light spasms, neck weakness and discomfort in the same areas and now into the right deltoid.  Never did I have any arm pain at the site of injection, nor did I have fever, body aches or sickness.  I will see workmed for evaluation and abide to the recommendations there. I contacted my employee health nurse who looked up if this was a side effect, and she asked me to complete this adverse event report.  I waited at first, but when the problems persisted, it was too coincidental that I am still having issues.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, CSF protein increased, CSF test normal, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre. presented with acceding weakness, numbness/tingling in hands/feet and upper leg pain/low back pain
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Pain in extremity, Paraesthesia
Clinical narrative: Guillain-Barre. presented with acceding weakness, numbness/tingling in hands/feet and upper leg pain/low back pain
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Localised infection, Peripheral swelling, Pustule, Secretion discharge
Clinical narrative: Next day patient awoke to a wet arm that was swollen & oozed pus. There was a square on arm where Bandage was removed. URGent Care provided an Antibiotic cream stating infection in the arm. UrGent care told him likely due to vaccine being administered too low.
Sex: U
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: SNEEZE ATTACK; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number n/a), via nasal route, on an unknown date.     On an unknown date, the patient experienced sneeze attack (preferred term: Sneezing).     It is unknown if any action was taken with Flumist Quadrivalent (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Blood pressure abnormal, Bone pain, Chest pain, Myalgia
Clinical narrative: aching in her bones; aching in her bones and muscles in her arms; aching in her bones and muscles in her arms, shoulders; aching in her bones and muscles in her arms, shoulders and chest; blood pressure has been "up and down", ranging from 170/85-90 to 70/63; This case was reported by a consumer via other manufacturer and described the occurrence of blood pressure abnormal in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included paralysis. Concurrent medical conditions included endometrial cancer. Concomitant products included lenvatinib mesilate (Lenvima).   On 22nd October 2020, the patient received Influenza vaccine Quadrivalent unspecified season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced blood pressure abnormal. On 24th October 2020, the patient experienced bone pain, muscle pain, shoulder pain and chest pain. On an unknown date, the outcome of the blood pressure abnormal, bone pain, muscle pain, shoulder pain and chest pain were unknown.   It was unknown if the reporter considered the blood pressure abnormal, bone pain, muscle pain, shoulder pain and chest pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. It was reported that female patient dignose with the endometrial cancer and for that prescripiton was taken by the patient of Prescribed Lenvima 14mg daily,from 5th October,2020 . It was reported that paient's blood pressre was "up and down", ranging from 170/85-90 mmHg to 70/63 mmHg than the patient's usual blood pressure 80/60 mmHg. On 22nd October,2020 patient received the flu vaccine and on 24th October,2020 started feeling an aching in her bones and muscles in her arms, shoulders and chest. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102.2; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever 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 had Fever.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: have three welts besides the injection site / shingles after the shot around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had three welts besides the injection site. The reporter asked was it possible to get shingles after the shot around the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 102.2 fever considered severe reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever 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 had Fever.
Sex: U
Vaccine: HEP
Symptoms: Allergy to metals, Dermatitis contact, Type IV hypersensitivity reaction
Clinical narrative: severe allergic contact dermatitis; type iv hypersensitivity reaction; Allergy to aluminum; This case was reported by a consumer and described the occurrence of allergic contact dermatitis in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, 1 day after receiving Hepatitis B vaccine, the patient experienced allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum. On an unknown date, the outcome of the allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum were unknown.   It was unknown if the reporter considered the allergic contact dermatitis, type iv hypersensitivity reaction and allergy to aluminum to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2014 the patient had severe allergic contact dermatitis the day after the hepatitis B vaccine.  The reporter found out this was type iv hypersensitivity reaction and reporter thought it was the aluminum.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: lump at the injection site; Feels the area hot to touch; Redness at injection site; Pain at injection site/Feels the area is flamed; low grade fever; Rash on neck, chest and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash. On an unknown date, the outcome of the injection site lump, injection site warmth, low grade fever and rash were unknown and the outcome of the injection site erythema and injection site burning were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient receive the vaccinations on different facility) and felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever. The pharmacist also reports that patient experienced redness and pain at injection site.  The patient was still experiencing these symptoms, coming and going. For tolerance of 2nd dose, refer case US2020AMR214623. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214623:2nd dose, same patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia, Rash, Tracheitis
Clinical narrative: lump at the injection site; Feels the area hot to touch; Redness at injection site; Pain at injection site/Feels the area is flamed; low grade fever; Rash on neck, chest and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash. On an unknown date, the outcome of the injection site lump, injection site warmth, low grade fever and rash were unknown and the outcome of the injection site erythema and injection site burning were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient receive the vaccinations on different facility) and felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever. The pharmacist also reports that patient experienced redness and pain at injection site.  The patient was still experiencing these symptoms, coming and going. For tolerance of 2nd dose, refer case US2020AMR214623. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214623:2nd dose, same patient
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Shoulder injury related to vaccine administration
Clinical narrative: Shoulder Injury Related to Vaccine Administration (SIRVA); Pain has persisted after the second; She is not able to put on a shirt; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder injury related to vaccine administration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer linked case US2020AMR215983).   On 3rd June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shoulder injury related to vaccine administration, pain and mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shoulder injury related to vaccine administration, pain and mobility decreased were unknown.   It was unknown if the reporter considered the shoulder injury related to vaccine administration, pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had called pharmacy stating she had Shoulder Injury Related to Vaccine Administration (SIRVA) after receiving the second dose of the Shingrix vaccine. The patient also reported recently to the pharmacist that the pain had persisted after the second Shingrix vaccine (which had resolved after 1st dose) and that she was not able to put on a shirt.  Additional information were not available. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215983:Same suspect, same reporter, same patient, different dose (1st dose)
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Feeling hot
Clinical narrative: Felt like she had a fever; muscle weakness; headache; myalgia; fatigue; shivering; Skin was painful; Skin was painful and burning to the touch; gastrointestinal upset; pain around injection site; Right deltoid was swollen; Right deltoid was red; Right deltoid was warm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, muscle swelling, localized erythema and localized feeling of warmth. On 27th October 2020, the patient experienced muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset. On 28th October 2020, the patient experienced fever. On an unknown date, the outcome of the injection site pain, muscle swelling, localized erythema and localized feeling of warmth were recovered/resolved and the outcome of the muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset were not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, muscle swelling, localized erythema, localized feeling of warmth, muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin, gastrointestinal upset and fever to be related to Shingrix.   Additional details were provided as follows: The patient received Shingrix in the right arm. The patient reported on day 3 after receiving the vaccine, her right deltoid was swollen, right deltoid was red, right deltoid was warm, and pain around the injection site. The patient reported these events had resolved by day 5 after receiving the vaccine. The patient reported on day 7 after receiving the vaccine had headache, myalgia, fatigue, shivering, gastrointestinal upset, muscle weakness and skin was painful and burning to the touch and all of these were still ongoing at this time.  The patient reported last night (28th October 2020), she felt like she had a fever and she took her temperature and it was 98.6 degree F. The reporter consented to follow up and did not have lot number or expiration date information to provide.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Muscle swelling, Muscular weakness, Myalgia
Clinical narrative: Felt like she had a fever; muscle weakness; headache; myalgia; fatigue; shivering; Skin was painful; Skin was painful and burning to the touch; gastrointestinal upset; pain around injection site; Right deltoid was swollen; Right deltoid was red; Right deltoid was warm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, muscle swelling, localized erythema and localized feeling of warmth. On 27th October 2020, the patient experienced muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset. On 28th October 2020, the patient experienced fever. On an unknown date, the outcome of the injection site pain, muscle swelling, localized erythema and localized feeling of warmth were recovered/resolved and the outcome of the muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset were not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, muscle swelling, localized erythema, localized feeling of warmth, muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin, gastrointestinal upset and fever to be related to Shingrix.   Additional details were provided as follows: The patient received Shingrix in the right arm. The patient reported on day 3 after receiving the vaccine, her right deltoid was swollen, right deltoid was red, right deltoid was warm, and pain around the injection site. The patient reported these events had resolved by day 5 after receiving the vaccine. The patient reported on day 7 after receiving the vaccine had headache, myalgia, fatigue, shivering, gastrointestinal upset, muscle weakness and skin was painful and burning to the touch and all of these were still ongoing at this time.  The patient reported last night (28th October 2020), she felt like she had a fever and she took her temperature and it was 98.6 degree F. The reporter consented to follow up and did not have lot number or expiration date information to provide.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Pyrexia, Skin burning sensation
Clinical narrative: Felt like she had a fever; muscle weakness; headache; myalgia; fatigue; shivering; Skin was painful; Skin was painful and burning to the touch; gastrointestinal upset; pain around injection site; Right deltoid was swollen; Right deltoid was red; Right deltoid was warm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd October 2020, 3 days after receiving Shingrix, the patient experienced injection site pain, muscle swelling, localized erythema and localized feeling of warmth. On 27th October 2020, the patient experienced muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset. On 28th October 2020, the patient experienced fever. On an unknown date, the outcome of the injection site pain, muscle swelling, localized erythema and localized feeling of warmth were recovered/resolved and the outcome of the muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin and gastrointestinal upset were not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the injection site pain, muscle swelling, localized erythema, localized feeling of warmth, muscle weakness, headache, myalgia, fatigue, shivering, skin pain, burning skin, gastrointestinal upset and fever to be related to Shingrix.   Additional details were provided as follows: The patient received Shingrix in the right arm. The patient reported on day 3 after receiving the vaccine, her right deltoid was swollen, right deltoid was red, right deltoid was warm, and pain around the injection site. The patient reported these events had resolved by day 5 after receiving the vaccine. The patient reported on day 7 after receiving the vaccine had headache, myalgia, fatigue, shivering, gastrointestinal upset, muscle weakness and skin was painful and burning to the touch and all of these were still ongoing at this time.  The patient reported last night (28th October 2020), she felt like she had a fever and she took her temperature and it was 98.6 degree F. The reporter consented to follow up and did not have lot number or expiration date information to provide.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: shingles like local reaction after the administration of first dose; This case was reported by a physician via call center representative and described the occurrence of local reaction in a adult 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 local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The physician reported that the patient presented shingles like local reaction after the administration of first dose of Shingrix (occurred a year ago, no specific date informed). The reporter did not consent to follow up. This case has been linked with US2020216258 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216258:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Lymphadenitis, Pain in extremity
Clinical narrative: arm erythema; arm pain; axillary pain; possible lymphadenitis; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a female 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 erythema of extremities, pain in arm, axillary pain and lymphadenitis. On an unknown date, the outcome of the erythema of extremities, pain in arm, axillary pain and lymphadenitis were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm, axillary pain and lymphadenitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm erythema and pain, axillary pain and possible lymphadenitis following dose one of Shingrix. The patient's initials and date of birth were not provided. The patient received the dose at pharmacy, no details for pharmacy provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: horizontal strip on arm that was hot to the touch and swollen; horizontal strip on arm that was hot to the touch and swollen; red horizontal strip on arm; sore arm causing decreased mobility; Sore arm / soreness when arm is lifted to shoulder level; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2020, less than a day after receiving Shingrix, the patient experienced mobility decreased and pain in arm. On an unknown date, the patient experienced swelling, feeling hot and erythema of extremities. On an unknown date, the outcome of the swelling, feeling hot and erythema of extremities were recovered/resolved and the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the swelling, feeling hot, erythema of extremities, mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: On 30th August 2020, the patient received 1st dose of Shingrix in the left arm, within a day developed a sore arm causing decreased mobility.  Less than 2 months after receiving vaccination, the patient also reported a red horizontal strip on arm that was hot to the touch and swollen that all went away within a week.  The patient still experienced soreness and decreased mobility in arm although it has become better.  Now, patient reported soreness when arm was lifted to shoulder level. When arms were down, the patient reported no pain. This case has been linked to US2020AMR217273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR217273:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: she developed hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient had her last flu shot many years before reporting reportedly in the 1980s when flu vaccine was for H1N1 she developed hives and took Benadryl for relief. Consumer was the reporter and declined to provide any contact information and details for Safety report. Limited information provided.
Sex: M
Vaccine: FLUX
Symptoms: Fear, Rash
Clinical narrative: broke out in a rash that looked like poison ivy; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional.via Medical Information (Reference number- 00297310) and transmitted to Sanofi on 01-Oct-2020.  This case involves a male patient (age at the time of report was 91 years) who broke out in a rash that looked like poison ivy (dermatitis contact) after he received vaccine INFLUENZA VACCINE 30 year ago on an unknown date.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. The patient was a known allergic to egg.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient broke out in a rash that looked like poison ivy (dermatitis contact) unknown latency following the administration of INFLUENZA VACCINE.  The patient had questions about FLUBLOK QUADRIVALENT. The patient asked for any information for precautions for individuals who have an egg base allergy and receiving Flublok. Patient stated that because of the reaction that he had 30 years ago he was afraid to take a chance.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for dermatitis contact.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok quadrivalent administered to a 17 year old inadvertently with 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 17 years old female patient who inadvertently received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ446AA, expiry date: 18-Mar-2021) via intramuscular route on right arm 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- 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.
Age: 66.0
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered with Flublok Quadrivalent 2 times, 30 days apart with no AE; Initial information regarding this unsolicited valid non-serious case was received from other healthcare professional via agency (Reference number- 00321520) and transmitted to Sanofi on 19-Oct-2020.  This case involves a 66 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] 2 times, 30 days apart (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date in Sep-2020, the patient received a first dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number unknown and expiration date unknown] via unknown route at unknown administration site for prophylactic vaccination and on 16-Oct-2020 (one month later from first dose), the patient received a 0.5 ml second dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number UJ455AA and expiration date 17-Mar-2021] via intramuscular route at unknown administration site for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered (latency: same day of extra dose administered).  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 holders 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.