chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Shingrix for prophylaxis. On 11th October 2018, the patient received the 1st dose of Shingrix. On 11th December 2018, 61 days after receiving Shingrix, the patient experienced diarrhea and fever. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, diarrhea and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. The reporter considered the diarrhea and fever to be unrelated to Shingrix. Additional details were provided as follows: The patient reported that after the injection with Shingrix on 11th October 2018, he did have a sore arm for a day or two. The patient had an appointment to get his second shot of the series on the date of reporting but was not sure if he should post-pone because on 11th December 2018 or 12th December 2018, he had diarrhea and a fever. These events lasted for less than 24 hours and the fever was 99.7 at the highest point. The patient not attributing these events to Shingrix, both symptoms resolved within 24 hours and was feeling fine. The patient did not want to receive any mail or phone calls from GSK and had provided contact details of the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 73-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced nausea, fever and shingles. Shingrix was discontinued. On an unknown date, the outcome of the nausea, fever and shingles were unknown. It was unknown if the reporter considered the nausea, fever and shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a friend had first dose of Shingrix sometime earlier this year and experienced nausea and fever and then several days later developed shingles. The patient's doctor advised her against getting the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult patient who received 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Shingrix. Additional details were provided as follows: The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist reported that the patient had a severe local reaction to the 1st dose of Shingrix. The reaction was further described as a swollen arm. The pharmacist did not consent to follow up. The pharmacist did not have adverse event information for this event and did not want to be contacted by Safety regarding this event.
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of psoriasis flare-up in a adult female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. Concurrent medical conditions included psoriasis. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced psoriasis flare-up. On an unknown date, the outcome of the psoriasis flare-up was recovered/resolved.  It was unknown if the reporter considered the psoriasis flare-up to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient was over 50 years old. The age at vaccination was not reported. The caller reported that she received a flu vaccine and within 24 hours her psoriasis flared. The reporter had consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received Shingrix for prophylaxis. On 2nd October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, general body pain and feeling cold. On an unknown date, the outcome of the injection site pain, general body pain and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain and feeling cold to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years. The patient had received both doses of Shingrix. After each dose he had some pain at the injection site, but his whole body ached like he got beat up and he felt very cold as well. The symptoms resolved after a day and a half. The consent was provided for follow-up. For tolerability of the second dose of Shingrix, refer case US2018GSK232277.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Balance disorder, Chills, Condition aggravated, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received Shingrix for prophylaxis. Concurrent medical conditions included dribbling of urine (was previously under control with medication). On 10th December 2018, the patient received the 1st dose of Shingrix (intramuscular). On 10th December 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. On 12th December 2018, the patient experienced headache, tremor, shivering, unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the headache, tremor and shivering were recovering/resolving and the outcome of the unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated were unknown. It was unknown if the reporter considered the injection site pain, headache, tremor, shivering, unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Batch number was not provided.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Tremor, Urinary incontinence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received Shingrix for prophylaxis. Concurrent medical conditions included dribbling of urine (was previously under control with medication). On 10th December 2018, the patient received the 1st dose of Shingrix (intramuscular). On 10th December 2018, less than a day after receiving Shingrix, the patient experienced injection site pain. On 12th December 2018, the patient experienced headache, tremor, shivering, unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the headache, tremor and shivering were recovering/resolving and the outcome of the unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated were unknown. It was unknown if the reporter considered the injection site pain, headache, tremor, shivering, unsteadiness, tiredness, upset stomach, dribbling of urine and condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left deltoid. Batch number was not provided.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Eosinophilic cellulitis, Pain of skin, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 70-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Boostrix for prophylaxis. Previously administered products included Zostavax. On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Boostrix (intramuscular) 1 ml. In August 2018, 7 days after receiving Shingrix and Boostrix, the patient experienced rash, pruritus, eosinophilic dermatitis and subacute spongiotic dermatitis. On an unknown date, the patient experienced stinging skin. On an unknown date, the outcome of the rash, pruritus and stinging skin were not recovered/not resolved and the outcome of the eosinophilic dermatitis and subacute spongiotic dermatitis were unknown. It was unknown if the reporter considered the rash, pruritus, stinging skin, eosinophilic dermatitis and subacute spongiotic dermatitis to be related to Shingrix and Boostrix. Additional details were provided as follows: About a week later after receiving Shingrix and Boostrix, the patient experienced a rash on her back, along with itching in the scalp area. The itching and rash continued across lower stomach, top of the breast, legs and consistently on the back. On 14th August 2018, She visited her primary care physician, who recommended her to a dermatologist. On 21th August 2018, She visited the dermatologist. She started putting on the steroid cream on her skin. Initially she was experiencing a lot of itching, then the itching decreased and she started to experience stinging on the skin. On 30th October 2018, She had a biopsy of her skin done and results showed spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition. The rash and stinging was still present, along with some itching which was better than before. One of her primary care physician friend also suggested that the reaction she was experienced could also be from the Shingrix. The reporter did not want to consent for follow up. Emgergency room visit required. No further details were provided. Lab Comments: On 30th October 2018 biopsy was performed which showed result of spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 70-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Boostrix for prophylaxis. Previously administered products included Zostavax. On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Boostrix (intramuscular) 1 ml. In August 2018, 7 days after receiving Shingrix and Boostrix, the patient experienced rash, pruritus, eosinophilic dermatitis and subacute spongiotic dermatitis. On an unknown date, the patient experienced stinging skin. On an unknown date, the outcome of the rash, pruritus and stinging skin were not recovered/not resolved and the outcome of the eosinophilic dermatitis and subacute spongiotic dermatitis were unknown. It was unknown if the reporter considered the rash, pruritus, stinging skin, eosinophilic dermatitis and subacute spongiotic dermatitis to be related to Shingrix and Boostrix. Additional details were provided as follows: About a week later after receiving Shingrix and Boostrix, the patient experienced a rash on her back, along with itching in the scalp area. The itching and rash continued across lower stomach, top of the breast, legs and consistently on the back. On 14th August 2018, She visited her primary care physician, who recommended her to a dermatologist. On 21th August 2018, She visited the dermatologist. She started putting on the steroid cream on her skin. Initially she was experiencing a lot of itching, then the itching decreased and she started to experience stinging on the skin. On 30th October 2018, She had a biopsy of her skin done and results showed spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition. The rash and stinging was still present, along with some itching which was better than before. One of her primary care physician friend also suggested that the reaction she was experienced could also be from the Shingrix. The reporter did not want to consent for follow up. Emgergency room visit required. No further details were provided. Lab Comments: On 30th October 2018 biopsy was performed which showed result of spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Dermatitis contact, Erythema, Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 91-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included squamous blepharitis. On 7th September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the injection site erythema, injection site itching and decreased immune responsiveness were not recovered/not resolved and the outcome of the topical adhesive allergy, red face and cold were unknown. It was unknown if the reporter considered the sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold to be related to Shingrix. Additional details were provided as follows: The patient had removal of squamous cells from face before receiving Shingrix. After receiving second dose of Shingrix on the 7th of September, she had a tremendous reaction to it. She could not remember the exact symptoms but she was very sick and it took a long time to recovered. At the time of report, she still had the redness and itching at the injection site which came from time to time. She also feels like Shingrix changed her immune system. She is very susceptible to colds normally and recently she felt like coming down with the cold, she took some cold medicine and it went away and this was not normal for her. She also mentioned having some squamous cells removed from her face recently and it was fine but she experienced a terrible allergy reaction to the telfa pads on the side of her temple and she has never had that before. She experienced some redness on her face: on her eyelid, eye, upper part of cheeks and around eye socket. Her physician said that all those symptoms were a result of allergy to telfa pads. The patient consented to follow up with her physician.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 91-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included squamous blepharitis. On 7th September 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the injection site erythema, injection site itching and decreased immune responsiveness were not recovered/not resolved and the outcome of the topical adhesive allergy, red face and cold were unknown. It was unknown if the reporter considered the sickness, injection site erythema, injection site itching, decreased immune responsiveness, topical adhesive allergy, red face and cold to be related to Shingrix. Additional details were provided as follows: The patient had removal of squamous cells from face before receiving Shingrix. After receiving second dose of Shingrix on the 7th of September, she had a tremendous reaction to it. She could not remember the exact symptoms but she was very sick and it took a long time to recovered. At the time of report, she still had the redness and itching at the injection site which came from time to time. She also feels like Shingrix changed her immune system. She is very susceptible to colds normally and recently she felt like coming down with the cold, she took some cold medicine and it went away and this was not normal for her. She also mentioned having some squamous cells removed from her face recently and it was fine but she experienced a terrible allergy reaction to the telfa pads on the side of her temple and she has never had that before. She experienced some redness on her face: on her eyelid, eye, upper part of cheeks and around eye socket. Her physician said that all those symptoms were a result of allergy to telfa pads. The patient consented to follow up with her physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old male patient who received Shingrix for prophylaxis. On 16th December 2018, the patient received the 1st dose of Shingrix. On 17th December 2018, 1 days after receiving Shingrix, the patient experienced nausea, pain and fever. On an unknown date, the outcome of the nausea, pain and fever were not recovered/not resolved. It was unknown if the reporter considered the nausea, pain and fever to be related to Shingrix. Additional details were provided as follows: The patient received the first Shingrix vaccine and next morning he woke up with the slight nausea, achy all over and a little fever. The reporter did gave consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Incorrect route of product administration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 69-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea, fatigue and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea and fatigue were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea and fatigue to be related to Shingrix. Additional details were provided as follows: The patient was the reporting healthcare professional. The patient was unsure that he received the 1st dose of Shingrix in March 2018 or April 2018. The patient stated that the dose was inadvertently administered subcutaneously instead of the approved intramuscular, which led to intramuscular formulation administered by other route. The patient stated that he developed three days worth of aches, pains, chills, headache, gastrointestinal distress, nausea, fatigue, site swelling, redness and induration. All symptoms resolved after three days. The patient had not receive his 2nd dose in the recommended time frame due to product supply issue, refer case US2018227880. The healthcare professional consented for follow up, but did not provide his address. The healthcare professional did not have vaccine information for this adverse events.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Nausea, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 69-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea, fatigue and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea and fatigue were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the pain, chills, headache, injection site erythema, injection site swelling, injection site induration, distress gastrointestinal, nausea and fatigue to be related to Shingrix. Additional details were provided as follows: The patient was the reporting healthcare professional. The patient was unsure that he received the 1st dose of Shingrix in March 2018 or April 2018. The patient stated that the dose was inadvertently administered subcutaneously instead of the approved intramuscular, which led to intramuscular formulation administered by other route. The patient stated that he developed three days worth of aches, pains, chills, headache, gastrointestinal distress, nausea, fatigue, site swelling, redness and induration. All symptoms resolved after three days. The patient had not receive his 2nd dose in the recommended time frame due to product supply issue, refer case US2018227880. The healthcare professional consented for follow up, but did not provide his address. The healthcare professional did not have vaccine information for this adverse events.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Drooling, Mobility decreased, Posture abnormal
Clinical narrative: Patient received Hib, PCV, and Hep A vaccines yesterday. She woke up this morning at 0600 and was normal. 0640, she took a one hour nap. When she woke up, her right arm had no movement for 30 minutes and she was trying to use it. She had a large amount of drool under her face when she woke up. She was wobbling her head for a few minutes when she woke up. She has been on TYLENOL and MOTRIN and mother noticed that she seems "drugged" from the medication. She has been acting fine after her episode of not moving her arm.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of HAVRIX was drawn up and only 1/2 was given as RN giving vaccine noticed the dose as she was administering. She is very confident that she only gave 1/2 of a dose or 0.5ml.   Mother is aware of incorrect dose given and that we would not expect any adverse effects.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyskinesia, Tic
Clinical narrative: Mother reported patient was having jerking "ticks" and was taken to pcp in November when symptom started. PCP thinks was due to vaccines. Patient has appt with neuro in Jan 2019.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Has recurring pain around injection site not relieved by ibuprofen or naproxen.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Clinic Assistant gave both vaccines in his right deltoid. Patient reported fever, mild chills, aches, anorexia to a significant degree that started later in the day the vaccines were given and lasted greater than 72 hrs, also noted progressive pain, swelling and redness at the injection site. No history of issue with flu vaccine in the past.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Clinic Assistant gave both vaccines in his right deltoid. Patient reported fever, mild chills, aches, anorexia to a significant degree that started later in the day the vaccines were given and lasted greater than 72 hrs, also noted progressive pain, swelling and redness at the injection site. No history of issue with flu vaccine in the past.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received vaccine at pharmacy, 2-3 days later, started with a rash along trigeminal dermatome; R sided; Now about 10 days out it is resolving.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Borrelia test negative, Inflammatory marker increased, Influenza like illness
Clinical narrative: Began as typical malaise but escalated into major arthritic condition of hips and arm and shoulder arthritic pain. Malaise flu like symptoms lasted for two months but major arthritic symptoms have lasted including pain at shot site in left arm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Rheumatoid factor negative
Clinical narrative: Began as typical malaise but escalated into major arthritic condition of hips and arm and shoulder arthritic pain. Malaise flu like symptoms lasted for two months but major arthritic symptoms have lasted including pain at shot site in left arm.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Shingrix for prophylaxis. On 12th December 2018, the patient received Shingrix. In December 2018, less than a week after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown. It was unknown if the reporter considered the general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday evening last week from the date on reporting, the patient received Shingrix and experienced body ache for five days. The patient asked how long would these side effects last. The patient provided limited information. The patient did not consent to receive call back.
Sex: F
Vaccine: MEN
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received Meningococcal B vaccine for prophylaxis. In December 2018, the patient received Meningococcal B vaccine. In December 2018, less than a week after receiving Meningococcal B vaccine, the patient experienced swelling arm and pain in arm. The patient was treated with ethanol (Alcohol). On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: Age at vaccination was not reported. The patient was daughter of the reporter. 3 days ago the reporting, the patient received the Meningococcal B shot. The patient arm was swollen and want to know that what should be done. The reporter put alcohol on the patient's arm, but still the arm was swollen and hurting.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythema of extremities in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the erythema of extremities to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The patient's spouse reported told to nurse that the patent had red streaks on arm post injection. The reporter did not remember the patient who was just spouse mentioned on phone while calling into the office and the patient refused treatment in the office for the adverse event. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weight loss in a male patient who received RABAVERT for prophylaxis. Previously administered products included RABAVERT (received 1st dose in October 2017). On 28th January 2018, the patient received the 2nd dose of RABAVERT. On 28th January 2018, immediately after receiving RABAVERT, the patient experienced tingling. In February 2018, the patient experienced unable to swallow, weakness and sleep problem. On an unknown date, the patient experienced weight loss, difficulty breathing and dizziness. On an unknown date, the outcome of the weight loss was unknown and the outcome of the unable to swallow, weakness, sleep problem, difficulty breathing, dizziness and tingling were not recovered/not resolved. It was unknown if the reporter considered the weight loss, unable to swallow, weakness, sleep problem, difficulty breathing, dizziness and tingling to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not provided. In February 2018, 25 days after receiving the vaccine, the patient was not able to swallow with left side of throat, the was weak had no stamina and could only sleep for 3 hours at a time. Couple of months later, the patient was having difficulty in breathing and dizziness. Over a two and half month period after vaccination, the patient had lost 50 pounds. The patient was experiencing tingling in feet for a long time, it started shortly after receiving the vaccine. No consent to follow up. Reporter was not willing to provide any additional information. He said that he had reported this before. However, multiple reports were identified for same reporter and vaccine.
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia, Sleep disorder, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weight loss in a male patient who received RABAVERT for prophylaxis. Previously administered products included RABAVERT (received 1st dose in October 2017). On 28th January 2018, the patient received the 2nd dose of RABAVERT. On 28th January 2018, immediately after receiving RABAVERT, the patient experienced tingling. In February 2018, the patient experienced unable to swallow, weakness and sleep problem. On an unknown date, the patient experienced weight loss, difficulty breathing and dizziness. On an unknown date, the outcome of the weight loss was unknown and the outcome of the unable to swallow, weakness, sleep problem, difficulty breathing, dizziness and tingling were not recovered/not resolved. It was unknown if the reporter considered the weight loss, unable to swallow, weakness, sleep problem, difficulty breathing, dizziness and tingling to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not provided. In February 2018, 25 days after receiving the vaccine, the patient was not able to swallow with left side of throat, the was weak had no stamina and could only sleep for 3 hours at a time. Couple of months later, the patient was having difficulty in breathing and dizziness. Over a two and half month period after vaccination, the patient had lost 50 pounds. The patient was experiencing tingling in feet for a long time, it started shortly after receiving the vaccine. No consent to follow up. Reporter was not willing to provide any additional information. He said that he had reported this before. However, multiple reports were identified for same reporter and vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 68-year-old female patient who received Shingrix for prophylaxis. On 16th December 2018, the patient received the 1st dose of Shingrix (intramuscular). In December 2018, less than a week after receiving Shingrix, the patient experienced upset stomach, chills, headache and joint pain. On an unknown date, the outcome of the upset stomach, chills, headache and joint pain were not recovered/not resolved. It was unknown if the reporter considered the upset stomach, chills, headache and joint pain to be related to Shingrix. Additional information was provided as follows: The patient received Shingrix in the left arm. The caller reports that the events was improving but have not resolved yet. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On 23rd July 2018, the patient received the 1st dose of Shingrix. On 23rd July 2018, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced arm hurt for an entire week right after the 1st Shingrix dose was administered. The reporter was calling for information about finding dose so she could get the 2nd vaccination. No other information was shared or available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Rash, Rash pruritic, Skin hyperpigmentation
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 75-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced itchy rash, painful rash, neuropathic pain and skin hyperpigmentation. On an unknown date, the outcome of the itchy rash and painful rash were recovered/resolved and the outcome of the neuropathic pain and skin hyperpigmentation were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, painful rash, neuropathic pain and skin hyperpigmentation to be related to Shingrix. Additional details were provided as follows: About a month ago before reporting, the patient received the vaccine (date was unknown) on an unknown arm. The patient experienced a painful itchy rash on her back, and neuropathic pain shooting down her legs. The neuropathic pain and hyper-pigmentation on the back remained ongoing till the time of reporting. The reporter stated that there was no additional information. The vaccine was not administered by the reporting facility. The reporter did not consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, his patient had a case of shingles 3 weeks after the 1st dose of SHINGRIX vaccination. The reporter was unable to provide demographic details at the time of reporting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Shingrix for prophylaxis. In November 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The patient received the second dose of Shingrix in the left arm. In 2018, the patient experienced pain and soreness at the injection site which lasted for about 3 days. The patient did not consent to follow-up. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Shingrix for prophylaxis. On 20th October 2018, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2018, 1 days after receiving Shingrix, the patient experienced fever and shivering. On 22nd October 2018, the outcome of the fever and shivering were recovered/resolved. It was unknown if the reporter considered the fever and shivering to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm. The patient planned to continue follow up with her pharmacy on an unknown date. The patient had consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle soreness in a 63-year-old female patient who received SHINGRIX (batch number 4Y5KD, expiry date 10th April 2021) for prophylaxis. On 21st November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced muscle soreness, pain in joint involving shoulder region, joint range of motion decreased and pain in arm. On an unknown date, the outcome of the muscle soreness, pain in joint involving shoulder region, joint range of motion decreased and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the muscle soreness, pain in joint involving shoulder region, joint range of motion decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller was a medical assistant reporting an adverse event on behalf of the patient. The patient received SHINGRIX in the left deltoid. The reported stated that the patient received the dose of SHINGRIX. The patient developed soreness in her left arm that turned into left shoulder joint soreness and decrease in range of motion in the left shoulder.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint noise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 18th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th December 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and joint clicking. On an unknown date, the outcome of the pain in arm and joint clicking were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and joint clicking to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported that the patient received the first dose of SHINGRIX on 17th October 2018. The patient received the 2nd dose of SHINGRIX on left arm and experienced arm pain and shoulder joint popping. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received 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 headache and pain in arm. On an unknown date, the outcome of the headache and pain in arm were unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced mild headache and a sore arm. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. For tolerance to next dose, refer case US2018GSK232226.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site rash, Lymphadenopathy, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received 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 headache and pain in arm. On an unknown date, the outcome of the headache and pain in arm were unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced mild headache and a sore arm. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. For tolerance to next dose, refer case US2018GSK232226.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received 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 headache and pain in arm. On an unknown date, the outcome of the headache and pain in arm were unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced mild headache and a sore arm. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. For tolerance to next dose, refer case US2018GSK232226.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye pain
Clinical narrative: Patient woke up with a pain in his left eye and then a little while later he couldn't see anymore. He went to an optometrist who told him he possibly has herpes zoster in his eye and gave him some eye medications. He will follow up with an ophthalmologist.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Laboratory test normal, Ultrasound scan normal, Uterine dilation and curettage
Clinical narrative: Spontaneous abortion/Miscarriage after flu shot. I was in the first trimester in my pregnancy. I received the flu vaccine at about three weeks of gestation. I miscarried at about 6 weeks gestation. I had received the flu vaccine in the previous year. My PCP did not ask, warn, nor did the information indicate any concerns with flu vaccine and miscarried. According to the CDC, they are still doing research on miscarriage and the flu vaccine due to vaccine signaling cause of miscarriage. I had one previously 1.5yrs ago and the chances of second miscarriage is 2%. After the D&C, my OB reported she doesn't give the flu vaccine to mothers in the first or second trimester due the concerns of miscarriage after receiving the flu vaccine.
Age: 29.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blister, Pallor, Procedural site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Possible Conjunctivitis (seen on 21Dec2018 and cleared by ophthalmology at hospital in the following days), Bullae on two separate surgical wound sites (Seen at clinic on 27Dec2018)... Surgical sites were secondary to an appendicitis (was seen for appendicitis on 21Dec2018)... A erythematous rash over the left upper thigh that blanches with pressure 5cm x 3cm and is pruritic but does not weep.
Age: 29.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Appendicectomy, Blister, Incision site rash, Incision site vesicles, Laparoscopic surgery
Clinical narrative: Possible Conjunctivitis (seen on 21Dec2018 and cleared by ophthalmology at hospital in the following days), Bullae on two separate surgical wound sites (Seen at clinic on 27Dec2018)... Surgical sites were secondary to an appendicitis (was seen for appendicitis on 21Dec2018)... A erythematous rash over the left upper thigh that blanches with pressure 5cm x 3cm and is pruritic but does not weep.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Fatigue, Influenza, Influenza virus test positive, Mobility decreased
Clinical narrative: I went to the pharmacy for a flu shot on Saturday,  December 22. I felt fine that day, but by Sunday afternoon, had a mild fever and was very tired. Some online research convinced me these were normal side effects to the shot, so I wasn't overly concerned. However, by Monday (Christmas Eve), I was coughing excessively. On Christmas Day,  I had a fever in excess of 103°, and could not get out of bed all day. I went to the doctor on December 26, and was given a flu test,  and diagnosed with the flu. I realize that it is supposed to be impossible to get the flu from the vaccination, however I felt completely fine prior to the shot, and am the only one in my home that came down with the flu. It just seemed too coincidental to not report it.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: I went to the pharmacy for a flu shot on Saturday,  December 22. I felt fine that day, but by Sunday afternoon, had a mild fever and was very tired. Some online research convinced me these were normal side effects to the shot, so I wasn't overly concerned. However, by Monday (Christmas Eve), I was coughing excessively. On Christmas Day,  I had a fever in excess of 103°, and could not get out of bed all day. I went to the doctor on December 26, and was given a flu test,  and diagnosed with the flu. I realize that it is supposed to be impossible to get the flu from the vaccination, however I felt completely fine prior to the shot, and am the only one in my home that came down with the flu. It just seemed too coincidental to not report it.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: About 10 minutes post injection patient broke out in hives to bilateral arms, trunk and bilateral legs. No itching, SOB, difficulty breathing, swelling or lightheadedness. Rash began fading within 30 minutes post injection.