chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site; Pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist reported that the patient received FluLaval Quadrivalent and had redness and pain at the injection site. The reporter consented to follow up. The registered pharmacist had no further details but was agreeable to recontact. This case was linked with the cases US2019AMR165268 and US2019164595, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Significant redness; Significant swelling; This case was reported by a physician via sales rep and described the occurrence of erythema 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, less than 2 years after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   The reporter considered the erythema and swelling 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 physician stated he had about 3 patients with significant redness and swelling after receiving Shingrix and it has resolved on its own in a couple of days. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This case was reported by a consumer and described the occurrence of cold in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cold. On an unknown date, the outcome of the cold was recovering/resolving.   It was unknown if the reporter considered the cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experiencing a cold since receiving the first dose. The patient asked whether the patient could received 2nd shot if the patient recovering from a cold.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Local reaction, Urticaria
Clinical narrative: Rash looked like hives on the top half of the arm; Rash on left arm; This case was reported by a physician via sales rep and described the occurrence of hives in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced hives and injection site rash. On an unknown date, the outcome of the hives and injection site rash were unknown.   The reporter considered the hives and injection site rash to be possibly related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and 24 hours later the patient returned to office with a rash.  The patient did not have any pain but after work went home and notice the rash on her left arm. Rash looked like hives on the top half of the arm. The patient not aware of any allergies. Looked like a localized reaction from vaccine. The physician thought this could be related to the vaccine based on the time after the vaccine and the location vaccine given. The reporter agreed to follow up.
Age: 70.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Discomfort, Dizziness, Fatigue, Gait inability
Clinical narrative: Weak; Tired; Dizzy; Difficulty Sleeping; Dragging as if he could not walk to go to the bathroom; Being uncomfortable; Lethargic; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   The patient's past medical history included stroke (stroke survivor from 1997).   On 9th September 2019 09:00, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 9th September 2019 22:00, 13 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy. On an unknown date, the outcome of the weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy were not recovered/not resolved.   It was unknown if the reporter considered the weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix vaccine in his left arm as well as an unknown manufacturer of the flu vaccine in an unspecified arm.  The patient was going to the bathroom, caller reports he was very weak, tired, dizzy, and dragging as if he could not walk to go to the bathroom.  The caller reports it was difficult for her husband to sleep last night due to being uncomfortable.  The patient was currently sleeping although he usually wakes up around 7:30 AM. The caller reports he did not seem as lethargic at the time of reporting compared to day before. The reporter did not consent to follow up. The caller was wife of the patient.  The caller had limited information about vaccines since she did not go with him to the pharmacy for vaccination.  The caller currently did not consent to health care professional follow up, but might call back later and consent if symptoms did not subside within the next day or two.
Age: 70.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Insomnia, Lethargy
Clinical narrative: Weak; Tired; Dizzy; Difficulty Sleeping; Dragging as if he could not walk to go to the bathroom; Being uncomfortable; Lethargic; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   The patient's past medical history included stroke (stroke survivor from 1997).   On 9th September 2019 09:00, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 9th September 2019 22:00, 13 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy. On an unknown date, the outcome of the weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy were not recovered/not resolved.   It was unknown if the reporter considered the weakness, tiredness, dizziness, difficulty sleeping, unable to walk, discomfort and lethargy to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix vaccine in his left arm as well as an unknown manufacturer of the flu vaccine in an unspecified arm.  The patient was going to the bathroom, caller reports he was very weak, tired, dizzy, and dragging as if he could not walk to go to the bathroom.  The caller reports it was difficult for her husband to sleep last night due to being uncomfortable.  The patient was currently sleeping although he usually wakes up around 7:30 AM. The caller reports he did not seem as lethargic at the time of reporting compared to day before. The reporter did not consent to follow up. The caller was wife of the patient.  The caller had limited information about vaccines since she did not go with him to the pharmacy for vaccination.  The caller currently did not consent to health care professional follow up, but might call back later and consent if symptoms did not subside within the next day or two.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Redness at injection site; Pain at injection site; Blistering; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema, injection site pain and blister. On an unknown date, the outcome of the injection site erythema, injection site pain and blister were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and blister to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist reported that the patient received FluLaval Quadrivalent and had redness, blister and pain at the injection site. The reporter consented to follow up. The Registered Pharmacist has no further details but was agreeable to recontract. This case linked with US2019AMR165267and US2019AMR165268, reported by same reporter.
Age: 79.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Anger, Formication, Headache, Irritability
Clinical narrative: Spider web like sensation on her face; Irritation; Short temper; Headache; This case was reported by a consumer via call center representative and described the occurrence of crawling sensation of skin in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix and TETANUS VACCINE. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving TETANUS VACCINE, the patient experienced crawling sensation of skin, irritability, short tempered and headache. On an unknown date, the outcome of the crawling sensation of skin, irritability, short tempered and headache were recovering/resolving.   It was unknown if the reporter considered the crawling sensation of skin, irritability, short tempered and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and on the same day she also received tetanus vaccine on her other arm. Within a week after she experienced a spider web like sensation on her face. She also experienced irritation, short temper and headaches.  All the side effects were still present. The reporter did not consent to follow up. No further details were provided. It was unknown if the reporter considered the crawling sensation of skin, irritation skin, short tempered and headache to be related to tetanus vaccine as well.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Patient said she had noticed a red rash on her arm on 9/20/19. She also said she wasn't sure how long it had been there. She said it wasn't bothering her.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dry skin, Erythema, Injection site reaction, Skin discolouration, Skin exfoliation
Clinical narrative: Patient has dark and rough and peeling skin around injection site. Some redness extending up to 6 inches from injection site. Patient has been taking prednisone for 3 days to reduce symptoms. Appears to be resolving. Advised patient to get rechecked if no improvement or worsening of area occurs.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye swelling, Hypersensitivity, Ocular hyperaemia, Periorbital swelling
Clinical narrative: Within 2 hour, allergic reaction started: swollen, puffy  and red eyes, airway irritated, voice hoarse, tremors and fever.  Took 2 Motrin and eventually fell sleep around 1am.   Today, throat is not as irritate, eyes are still puffy and red, and voice hoarse.   Contacted the pharmacy and they confirmed that the vaccine was Thimerosol-free and that it was possible that she reacted to vaccine. Per patient she was not asked which vaccine she wanted; she would have chosen the regular as she has never had a problem with that one. It would be helpful if patients are given the choice.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract irritation, Tremor
Clinical narrative: Within 2 hour, allergic reaction started: swollen, puffy  and red eyes, airway irritated, voice hoarse, tremors and fever.  Took 2 Motrin and eventually fell sleep around 1am.   Today, throat is not as irritate, eyes are still puffy and red, and voice hoarse.   Contacted the pharmacy and they confirmed that the vaccine was Thimerosol-free and that it was possible that she reacted to vaccine. Per patient she was not asked which vaccine she wanted; she would have chosen the regular as she has never had a problem with that one. It would be helpful if patients are given the choice.
Age: 56.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Back pain, Laboratory test, Pain in extremity, Rash, Urticaria
Clinical narrative: Around 9/2/19 She started with quarter size welts on right arm and chest/breast,  central belly, inner thighs (started with right thigh now she says it's on both thighs) and excruciating pain in right arm. Internal pain in back, but but no breakouts on back. Breaking out on face. Broken out everywhere on scalp.  She saw lady about it and she said it was mosquito bites or spider bites.  Patient disagrees and thinks it's the vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient stated feels dizzy today (day after administration). Her MD sent her in a prescription for meclizine to help with dizziness.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Loss of consciousness
Clinical narrative: According to patient, 4 hrs later after receiving vaccine, patient blacked out, went to ER. Blood pressure dropped severely. Unclear the connection.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe rigors, fever, headache, starting 7 hours after dosing. Temperature to 103F. Took naproxen 2 tablets. Went to bed. Around 3 AM next day (15 hours after vaccination), woke up with heavy sweat. Still had headache. In the AM, had muscle pain from the previous day's rigors. Felt shakey and febrile. Took two more naproxen at 8 AM. Now, at 26 hours post-vaccination, no fever, rigors, or headache finally!  Also,severe pain, left arm (injection site), that became worse over 2 hours, limiting mobility. Then, after a few hours, pain subsided. It is still present now (26 hours after injection) but at lower level.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Severe rigors, fever, headache, starting 7 hours after dosing. Temperature to 103F. Took naproxen 2 tablets. Went to bed. Around 3 AM next day (15 hours after vaccination), woke up with heavy sweat. Still had headache. In the AM, had muscle pain from the previous day's rigors. Felt shakey and febrile. Took two more naproxen at 8 AM. Now, at 26 hours post-vaccination, no fever, rigors, or headache finally!  Also,severe pain, left arm (injection site), that became worse over 2 hours, limiting mobility. Then, after a few hours, pain subsided. It is still present now (26 hours after injection) but at lower level.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Erythema, Headache, Pain
Clinical narrative: Two days after receiving second dose of Shingrix, patient reports developing welts down her left arm and experiencing pain on the trunk of her body below her left armpit .  She later developed shooting pains about every 30 seconds on the right side of her head that later moved to her right jaw and ear canal which lasted approximately 12 hours.  Five days after her vaccination, a red blister-like sore developed on the middle finger of her right hand.  When a second blister developed on the same finger, she was given a prescription for Valtrex from her provider.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Urticaria
Clinical narrative: Two days after receiving second dose of Shingrix, patient reports developing welts down her left arm and experiencing pain on the trunk of her body below her left armpit .  She later developed shooting pains about every 30 seconds on the right side of her head that later moved to her right jaw and ear canal which lasted approximately 12 hours.  Five days after her vaccination, a red blister-like sore developed on the middle finger of her right hand.  When a second blister developed on the same finger, she was given a prescription for Valtrex from her provider.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Hyperhidrosis, Nausea, Palpitations, Pyrexia
Clinical narrative: At about 9pm, patient reports fever 100.6, headache minor, nausea, sweating, and racing heart.  Symptoms lasted 3 hours and disappeared--went to back to normal.  Patient did not take any other medicine than usual. Patient has received Flu vaccines with no problems for years so can only relate symptoms to vaccine.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash developed on posterior aspect of leg immunized
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red raised area developed at injection site. Size of a pancake
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Injection site swelling
Clinical narrative: Rapid Heartbeat, severe headache, swelling at injection site,
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Neuralgia, Pain in extremity, Pyrexia, Skin irritation
Clinical narrative: The vaccine was the second dose of Shingrix. The first was uneventful other than a very sort left arm. The second resulted again in a very sore left arm and a low grade fever the next day. The other symptoms came about three weeks later and now, on September 21, have not subsided: on the inner thighs and the back of the thighs. Sensitive to clothes rubbing, even skin on skin, and sensitive when sitting. Symptoms have variously been burning, irritation, and what feels like heightened nerve endings. There has never been a rash. I was first prescribed a topical steroid which I took for about a week, and then a dermatologist told me to stop it because I did not have signs of a rash. It was triamcinolone acetonide 0.1%. . After around two weeks, I saw a neurologist who prescribed gabapentin - 100 mg twice a day which I could increase to the same dosage three times I day. I started that yesterday.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: The vaccine was the second dose of Shingrix. The first was uneventful other than a very sort left arm. The second resulted again in a very sore left arm and a low grade fever the next day. The other symptoms came about three weeks later and now, on September 21, have not subsided: on the inner thighs and the back of the thighs. Sensitive to clothes rubbing, even skin on skin, and sensitive when sitting. Symptoms have variously been burning, irritation, and what feels like heightened nerve endings. There has never been a rash. I was first prescribed a topical steroid which I took for about a week, and then a dermatologist told me to stop it because I did not have signs of a rash. It was triamcinolone acetonide 0.1%. . After around two weeks, I saw a neurologist who prescribed gabapentin - 100 mg twice a day which I could increase to the same dosage three times I day. I started that yesterday.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Injection site erythema, Nasopharyngitis, Peripheral swelling, Urticaria
Clinical narrative: Expected soreness but at around 9-10pm area was red, was wheezing and coughing. Affected area spread to the top of the arm.  Took Tylenol and Benadryl to help with the the cold-like symptoms.   The medicine helped for the cold like symptoms developed swollen hives all over arm the size of tennis ball. Used some Mentholatum on area an left it alone.  Patient hast not checked in with doctor yet
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Wheezing
Clinical narrative: Expected soreness but at around 9-10pm area was red, was wheezing and coughing. Affected area spread to the top of the arm.  Took Tylenol and Benadryl to help with the the cold-like symptoms.   The medicine helped for the cold like symptoms developed swollen hives all over arm the size of tennis ball. Used some Mentholatum on area an left it alone.  Patient hast not checked in with doctor yet
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injected limb mobility decreased, Pain, Product administered at inappropriate site, Vomiting
Clinical narrative: experienced severe side effects afterwards, pain,  vomiting/ weakness.  He ended up in the emergency room and based on the Band-Aid placement and further evaluation, the doctor determined that the vaccine was administered in the shoulder joint.  Her dad is now receiving cortisone shots and is unable to move that arm.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Disorientation, Erythema, Fall, Feeling abnormal
Clinical narrative: pt received PPSV23 and Fluzone-HD on 9/17/19. That evening he noticed feeling weak in bed. The following morning he experienced weakness and instability and fell several times at home.  He also developed redness, inflammation, and pain around the injection sites on his arm.  Pt also states he was mentally foggy and had some disorientation on the morning of 9/18. His caretaker took him to the hospital 9/18 where he was admitted overnight.  Pt was monitored and released the afternoon of 9/19 after improvement in strength and mental clarity. Pt states he continues to improve but still has pain, tenderness, redness in arm
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Injection site erythema, Injection site inflammation, Injection site pain, Laboratory test
Clinical narrative: pt received PPSV23 and Fluzone-HD on 9/17/19. That evening he noticed feeling weak in bed. The following morning he experienced weakness and instability and fell several times at home.  He also developed redness, inflammation, and pain around the injection sites on his arm.  Pt also states he was mentally foggy and had some disorientation on the morning of 9/18. His caretaker took him to the hospital 9/18 where he was admitted overnight.  Pt was monitored and released the afternoon of 9/19 after improvement in strength and mental clarity. Pt states he continues to improve but still has pain, tenderness, redness in arm
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: pt received PPSV23 and Fluzone-HD on 9/17/19. That evening he noticed feeling weak in bed. The following morning he experienced weakness and instability and fell several times at home.  He also developed redness, inflammation, and pain around the injection sites on his arm.  Pt also states he was mentally foggy and had some disorientation on the morning of 9/18. His caretaker took him to the hospital 9/18 where he was admitted overnight.  Pt was monitored and released the afternoon of 9/19 after improvement in strength and mental clarity. Pt states he continues to improve but still has pain, tenderness, redness in arm
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Pain and redness below the injection site
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: erythema, warmth, swelling and tenderness of right upper extremity at the site of pneumonia vaccine. On exam today: It is around 4 inches in size and is spreading medially    was seen in the office today by provider; cellulitis  prescribed Keflex 500mg twice daily for 5 days follow up at visit in 1-1/2 week for reeval
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Rash
Clinical narrative: Raised rash that occurred 1 day after injection, rash lasted at least 2 weeks, significant arm weakness which onset the day after vaccination and is still occurring, although there has been some improvement.
Age: 9.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fatigue, Headache, Vomiting
Clinical narrative: Child became light-headed approximately 5 minutes after receiving vaccines.  She seemed to recover from this approximately 20 minutes later.  She developed a headache about 1 hour later and became very fatigued.  Tylenol was administered.  Child then proceeded to vomit multiple times.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Mass, Pain in extremity
Clinical narrative: Patient called the morning of 9/20/19 .   Patient reports that late last night she noticed that her arm was really sore and painful.  She also states that on the same side (left) she has a significant lump under her clavicle that she believes to be a swollen lymph node.  I advised patient to call her Humira doctor, to take Benadryl, and to call me with questions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal pain, Rash pruritic
Clinical narrative: Pain in left shoulder; Chills; Rash associated with itching on the right side at midsection of the body about 7 to 8 inches in size from bra area to the waistband, and towards the back; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shoulder pain, chills and itchy rash. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the shoulder pain and chills were recovered/resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the shoulder pain, chills and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in her left shoulder and chills that lasted for couple days and took motrin for it.  About 5 days after vaccination, she broke out in a rash associated with itching on the right side at midsection of the body about 7 to 8 inches in size from her bra area to the waistband, and towards the back.  She had reached out to her doctor via email portal. The reporter did not consent to follow up. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband. This report 1 of 3 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain, Pain
Clinical narrative: Injection Site Swelling; Injection Site Redness; Heat at the injection site; Feel Achy; Low grade fever; Sore Throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be between 82 or 83 years. The reporter stated that, the patient experienced swelling, redness, and heat at the injection site. The patient also felt achy, had a low grade fever, and a sore throat. The reporter stated that, the patient at the time of reporting was having these symptoms. The reporter was unable to obtain additional details because her mother was not with her at the time of reporting. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection Site Swelling; Injection Site Redness; Heat at the injection site; Feel Achy; Low grade fever; Sore Throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be between 82 or 83 years. The reporter stated that, the patient experienced swelling, redness, and heat at the injection site. The patient also felt achy, had a low grade fever, and a sore throat. The reporter stated that, the patient at the time of reporting was having these symptoms. The reporter was unable to obtain additional details because her mother was not with her at the time of reporting. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 2nd dose of Shingrix. In March 2019, 1 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in right arm. The patient received the second dose of the Shingrix vaccine 6 months ago. The patient experienced nausea the day after receiving the vaccine that lasted for one day. The reporter was unable to provide additional information. The reporter consented to follow up. This was 2 of 4 linked cases reported by the same reporter.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: headache; sore joints; arm hurts; felt like hit by a truck; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019 16:00, the patient received the 2nd dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced headache, soreness of joint, pain in arm and feeling abnormal. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, soreness of joint, pain in arm and feeling abnormal were unknown.   The reporter considered the headache, soreness of joint and pain in arm to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: On 10th September 2019 at 9:50 AM, the patient reported that, the patient felt like hit by a truck, headache, sore joints and arm hurts as expected. The patient took Tylenol. The patient asked if there was anything else to do regarding these events.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Colitis
Clinical narrative: abdominal pain; colitis; This case was reported by a other health professional via sales rep and described the occurrence of colitis in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 2nd September 2019, 6 days after receiving Shingrix, the patient experienced colitis. On an unknown date, the patient experienced abdominal pain. On an unknown date, the outcome of the colitis and abdominal pain were unknown.   The reporter considered the colitis and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient went to hospital on 2nd September 2019, because of abdominal pain and diagnosed with colitis. The reporter stated that, the patient does not want to take second dose of Shingrix when due. The reporter was agree to follow up from GlaxoSmithKline.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Reddened area; Whenever I rest left wrist on a keyboard, get an electrical-like shock that goes from elbow to end of fingers; Gave injection somewhat forward of the deltoid muscle; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced erythema of extremities, electric shock sensation and vaccine administered at inappropriate site. On an unknown date, the outcome of the erythema of extremities, electric shock sensation and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema of extremities and electric shock sensation to be related to Shingrix.  Additional details were provided as follows: The patient stated that the pharmacist gave the injection somewhat forward of the deltoid muscle, which led to inappropriate route of vaccination. The patient had a reddened area about 6x8 inches toward the inner aspect of upper arm and got an electrical like shock that goes from elbow to the end of fingers. The patient asked could it hit a nerve.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever 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, less than 2 years after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The reporter stated that, the patient had fever and chills, that lasted for 1 week. The reporter did not consent to follow up. This case has been linked with case US2019166363, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 12th September 2019, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional setails were provided as follows: The age at vaccination was not reported. The reporter reported for his wife. The reporter reported that, the patient received dose of Shingrix 5 weeks ago and on the date of reporting had flu like symptoms.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme  Tiredness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The patient received dose of Shingrix, on monday at about 3pm. The patient asked, an average how long would the fatigue continue and also ask if need to really get for the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: side effects; This case was reported by a consumer and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had side effects. The reporter asked how long could the side effects last from the Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: pain; redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of pain 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, less than 2 years after receiving Shingrix, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown.   It was unknown if the reporter considered the pain, erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose experienced extreme pain, redness, and swelling. This case has been linked with case US2019AMR167047, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever; Feel Sick; Arm hurts a lot; This case was reported by a consumer and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever, feeling unwell and pain in arm. On an unknown date, the outcome of the fever, feeling unwell and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, feeling unwell and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and had fever, feel sick and her arm hurts a lot. The patient asked when would I feel better and would I be allowed to get the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Herpes zoster, Neuralgia
Clinical narrative: Shingles; Cold sores; Fatigue; Shooting nerve pain from the corner of my eye to just below my nose; Shooting nerve pain from the corner of my eye to just below my nose/ pain; Just blow my nose I developed a Red blister/ blister; Just blow my nose I developed a Red blister/ blister; Tingling; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, cold sores, fatigue, nerve pain, shooting pain, blister, localized erythema and tingling. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, cold sores, fatigue, nerve pain, shooting pain, blister, localized erythema and tingling were unknown.   The reporter considered the shingles, cold sores, nerve pain, shooting pain, blister, localized erythema and tingling to be unrelated to Shingrix. The reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, she received her 1st dose of Shingrix in the mid August 2019. The patient had expected fatigue reaction, but in addition she developed a shooting nerve pain from the corner of eye to just below her nose and just below nose she developed a red blister. She then quickly took acyclovir which had been prescribed for a cold sore and it went away. The patient enquired hat, whether she should take acyclovir prophylactically before receiving 2nd Shingrix dose. The patient further stated, this reaction was not listed anywhere and since Shingrix was not a live vaccine, she did not understand how she could have a case of shingles, since there was no denying that she had tingling, pain or blister. To answer patient's question, the call center representative provided information that, Shingrix does not contain any live virus, so it can not cause Shingles. Also there were no known interactions between Shingrix and acyclovir. The patient then asked, could Shingrix cause an outbreak of oral herpes in a new location, might be just from whacking the immune system but the call center representative denied it by explaining her that, shingles and herpes are two different infections caused by two different viruses. Shingles is caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. Herpes is caused by the herpes simplex virus.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain, Paraesthesia
Clinical narrative: Shingles; Cold sores; Fatigue; Shooting nerve pain from the corner of my eye to just below my nose; Shooting nerve pain from the corner of my eye to just below my nose/ pain; Just blow my nose I developed a Red blister/ blister; Just blow my nose I developed a Red blister/ blister; Tingling; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, cold sores, fatigue, nerve pain, shooting pain, blister, localized erythema and tingling. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, cold sores, fatigue, nerve pain, shooting pain, blister, localized erythema and tingling were unknown.   The reporter considered the shingles, cold sores, nerve pain, shooting pain, blister, localized erythema and tingling to be unrelated to Shingrix. The reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, she received her 1st dose of Shingrix in the mid August 2019. The patient had expected fatigue reaction, but in addition she developed a shooting nerve pain from the corner of eye to just below her nose and just below nose she developed a red blister. She then quickly took acyclovir which had been prescribed for a cold sore and it went away. The patient enquired hat, whether she should take acyclovir prophylactically before receiving 2nd Shingrix dose. The patient further stated, this reaction was not listed anywhere and since Shingrix was not a live vaccine, she did not understand how she could have a case of shingles, since there was no denying that she had tingling, pain or blister. To answer patient's question, the call center representative provided information that, Shingrix does not contain any live virus, so it can not cause Shingles. Also there were no known interactions between Shingrix and acyclovir. The patient then asked, could Shingrix cause an outbreak of oral herpes in a new location, might be just from whacking the immune system but the call center representative denied it by explaining her that, shingles and herpes are two different infections caused by two different viruses. Shingles is caused by the varicella zoster virus (VZV), the same virus that causes chickenpox. Herpes is caused by the herpes simplex virus.
Sex: F
Vaccine: FLUX
Symptoms: Drug hypersensitivity, Swelling face, Urticaria
Clinical narrative: allergic; Covered in hives; Swelling in my face; This case was reported by a consumer via interactive digital media and described the occurrence of drug allergy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included cold and influenza. Previously administered products included Proair.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy, hives and facial swelling. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the drug allergy, hives and facial swelling were unknown.   It was unknown if the reporter considered the drug allergy, hives and facial swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had only pro air and nebulizer to fall back on and tried to avoid cols and flu. The patient reported that, after vaccination had very allegic to flu shot and covered in hives, and swelling on face past 2 times.