chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Injection site induration, Injection site mass, Lymphadenopathy, Malaise
Clinical narrative: so sick; can't move my arm after 3 days; vomiting; worst body ache; sweat / sweated; Arm is so painful; heart was racing; had diarrhea; shaking, shivering; every bone in her body aches; there's a big hard lump; lymph nodes are swollen; and slept from 12 PM until 8 AM Sunday; got 1 shot of adjuvant only then immediately; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date unknown) and (batch number 9G44C, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, the 2nd dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication. On an unknown date, the outcome of the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes and hypersomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 1st dose of shingrix on 11 September 2020 and second dose on 13th November 2020. Patient received only adjuvent of second dose which because HCP did not mixed it well and given without adjuvent which led inappropriate preparation of medication. It was reported that after that patient immediately got the second shot with adjuvent and antigen ( replacement dose). It was stated that patient experienced some event like patient was sick and after 3 days patient not able to move arm. Patient also experienced vomiting,worst body ache,sweat and very painful arm. Patient also reported that heart was racing at tha moment. On friday 13th November 2020 in night by 9 PM patient went for dinner and experienced vomiting and had diarrhea. On Saturday AM from 7 AM to 12 PM then lay down with shaking, shivering, sweated through her pajamas and slept from 12 PM until 8 AM Sunday. It was also reported that it was worse than the flu every bone in her body aches (getting slightly better now) also At injection site there was big hard lump and her lymph nodes are swollen. The reporter consented to follow up. The case was considered as medication error with harm.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity, Palpitations, Product preparation issue
Clinical narrative: so sick; can't move my arm after 3 days; vomiting; worst body ache; sweat / sweated; Arm is so painful; heart was racing; had diarrhea; shaking, shivering; every bone in her body aches; there's a big hard lump; lymph nodes are swollen; and slept from 12 PM until 8 AM Sunday; got 1 shot of adjuvant only then immediately; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date unknown) and (batch number 9G44C, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, the 2nd dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication. On an unknown date, the outcome of the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes and hypersomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 1st dose of shingrix on 11 September 2020 and second dose on 13th November 2020. Patient received only adjuvent of second dose which because HCP did not mixed it well and given without adjuvent which led inappropriate preparation of medication. It was reported that after that patient immediately got the second shot with adjuvent and antigen ( replacement dose). It was stated that patient experienced some event like patient was sick and after 3 days patient not able to move arm. Patient also experienced vomiting,worst body ache,sweat and very painful arm. Patient also reported that heart was racing at tha moment. On friday 13th November 2020 in night by 9 PM patient went for dinner and experienced vomiting and had diarrhea. On Saturday AM from 7 AM to 12 PM then lay down with shaking, shivering, sweated through her pajamas and slept from 12 PM until 8 AM Sunday. It was also reported that it was worse than the flu every bone in her body aches (getting slightly better now) also At injection site there was big hard lump and her lymph nodes are swollen. The reporter consented to follow up. The case was considered as medication error with harm.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: so sick; can't move my arm after 3 days; vomiting; worst body ache; sweat / sweated; Arm is so painful; heart was racing; had diarrhea; shaking, shivering; every bone in her body aches; there's a big hard lump; lymph nodes are swollen; and slept from 12 PM until 8 AM Sunday; got 1 shot of adjuvant only then immediately; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 50-year-old patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date unknown) and (batch number 9G44C, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 13th November 2020, the patient received the 2nd dose of Shingrix. On 13th November 2020, the 2nd dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication. On an unknown date, the outcome of the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes, hypersomnia and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the sickness, mobility decreased, vomiting, general body pain, sweating, pain in arm, heart racing, diarrhea, chills, bone pain, injection site lump, enlargement of lymph nodes and hypersomnia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 1st dose of shingrix on 11 September 2020 and second dose on 13th November 2020. Patient received only adjuvent of second dose which because HCP did not mixed it well and given without adjuvent which led inappropriate preparation of medication. It was reported that after that patient immediately got the second shot with adjuvent and antigen ( replacement dose). It was stated that patient experienced some event like patient was sick and after 3 days patient not able to move arm. Patient also experienced vomiting,worst body ache,sweat and very painful arm. Patient also reported that heart was racing at tha moment. On friday 13th November 2020 in night by 9 PM patient went for dinner and experienced vomiting and had diarrhea. On Saturday AM from 7 AM to 12 PM then lay down with shaking, shivering, sweated through her pajamas and slept from 12 PM until 8 AM Sunday. It was also reported that it was worse than the flu every bone in her body aches (getting slightly better now) also At injection site there was big hard lump and her lymph nodes are swollen. The reporter consented to follow up. The case was considered as medication error with harm.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site scar
Clinical narrative: swelling / to thee injection site; redness / to thee injection site; tenderness to thee injection site; skin burn; scar tissue; This case was reported by a consumer via media and described the occurrence of injection site swelling in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th November 2020, the patient received Boostrix. In November 2020, less than a week after receiving Boostrix, the patient experienced injection site swelling, injection site erythema, injection site tenderness, burn and scar. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site tenderness, burn and scar were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, burn and scar to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and caused swelling, redness and tenderness to the injection site in the left deltoid, followed by skin burn and scar tissue.  The reporter asked what could did for that.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Limb discomfort, Pain
Clinical narrative: Arm weighs a ton; Body is aching from top of head to bottom of feet; Felt like a car ran over me / Feels like a fully loaded dump truck rolled over me and is sitting in park; This case was reported by a consumer and described the occurrence of heaviness in arm in a 55-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th November 2020, the patient received Shingles vaccine. On 17th November 2020, less than a day after receiving Shingles vaccine, the patient experienced heaviness in arm, general body pain and feeling abnormal. On an unknown date, the outcome of the heaviness in arm, general body pain and feeling abnormal were unknown.   It was unknown if the reporter considered the heaviness in arm, general body pain and feeling abnormal to be related to Shingles vaccine.  Additional information was provided as follows: The patient got a shingles vaccine in the morning on the day of reporting. The patient felt like her arm weighed a ton and her body was aching from top of head to bottom of feet. The patient wanted to know if anyone else ever experience this side effect. The patient also mentioned that last night just felt like a car ran over her, felt like a fully loaded dump truck rolled over her and was sitting in park. The patient definitely did not want shingles,so this was the better alternative. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix and reported arm hurt.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Arthralgia, Back pain, Gait disturbance, Insomnia
Clinical narrative: hair started falling out / still ongoing; severe joint pain/ severe pain in the knees / hip pain; severe back pain; trouble getting up and down / trouble getting up and down stairs; trouble walking; she could not sleep.; This case was reported by a consumer and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 24th july 2020 in left arm, refer case US2020AMR229141).   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 24th September 2020, the patient experienced joint pain, back pain, mobility decreased and walking difficulty. On 29th September 2020, the patient experienced alopecia. On 28th September 2020, the outcome of the joint pain, back pain, mobility decreased, walking difficulty and insomnia were recovered/resolved. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the joint pain, back pain, mobility decreased, walking difficulty, insomnia and alopecia to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, the patient received 2nd dose of Shingrix in the left arm and later on that same day had severe joint pain, severe pain in the knees, severe back and hip pain, trouble getting up and down and trouble walking, and trouble getting up and down stairs and the same night the patient could not sleep. The patient reported the pain came on immediately that same day as the vaccine. On 26th September 2020, the patient went to the physician and the week before about these events. The patient stated that these events lasted 3 days and then resolved by 28th September 2020. On 29th September 2020, the patient's hair started falling out and this was still ongoing currently. The patient reported she had been in contact with a nutritionist twice to discuss these side effects. The reporter consented to follow up. This case had been linked with US2020228560, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228560:same reporter (sister´s case) US-GLAXOSMITHKLINE-US2020AMR229141:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: hair started falling out / still ongoing; severe joint pain/ severe pain in the knees / hip pain; severe back pain; trouble getting up and down / trouble getting up and down stairs; trouble walking; she could not sleep.; This case was reported by a consumer and described the occurrence of joint pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on 24th july 2020 in left arm, refer case US2020AMR229141).   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 24th September 2020, the patient experienced joint pain, back pain, mobility decreased and walking difficulty. On 29th September 2020, the patient experienced alopecia. On 28th September 2020, the outcome of the joint pain, back pain, mobility decreased, walking difficulty and insomnia were recovered/resolved. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the joint pain, back pain, mobility decreased, walking difficulty, insomnia and alopecia to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, the patient received 2nd dose of Shingrix in the left arm and later on that same day had severe joint pain, severe pain in the knees, severe back and hip pain, trouble getting up and down and trouble walking, and trouble getting up and down stairs and the same night the patient could not sleep. The patient reported the pain came on immediately that same day as the vaccine. On 26th September 2020, the patient went to the physician and the week before about these events. The patient stated that these events lasted 3 days and then resolved by 28th September 2020. On 29th September 2020, the patient's hair started falling out and this was still ongoing currently. The patient reported she had been in contact with a nutritionist twice to discuss these side effects. The reporter consented to follow up. This case had been linked with US2020228560, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228560:same reporter (sister´s case) US-GLAXOSMITHKLINE-US2020AMR229141:same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: felt like she was getting the flu; felt a little off for 2 days; This case was reported by a consumer and described the occurrence of influenza like illness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza like illness and feeling abnormal. On an unknown date, the outcome of the influenza like illness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the influenza like illness and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine in the left arm and she felt like was getting the flu and felt a little off for 2 days and then these reactions resolved. The patient did not had lot number or expiration date information to provide. For tolerance of 2nd dose of Shingrix, refer case US2020AMR229116, reported by same reporter. This case has been linked with US2020228560, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228560:same reporter (sister´s case) US-GLAXOSMITHKLINE-US2020AMR229116:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: soreness by the injection site; headache; muscle ache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. On an unknown date, the outcome of the injection site pain, headache and muscle pain were unknown.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: I am running temperature 100.4; muscle soreness; tired; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, 1 days after receiving Shingrix, the patient experienced fever, muscle soreness and tiredness. On an unknown date, the outcome of the fever, muscle soreness and tiredness were unknown.   It was unknown if the reporter considered the fever, muscle soreness and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix, fever,muscle soreness and tiredness. The patient had fever of 100.4 degree fahrenheit. The age group was not reported but taken as adult as per vaccine indication. The information regarding consent to follow up was not reported. No further information was available.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of anaphylactic reaction (had an anaphylactic reaction to Fluarix last year).   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flulaval the allergist performed skin test and had no reaction but under the skin test resulted in hives and itching. The reporter did not consent to follow up. This case linked with US2020228553, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache
Clinical narrative: headache; felt like being on a carnival ride"; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   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 feeling abnormal. On an unknown date, the outcome of the headache and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the headache and feeling abnormal to be related to Shingrix.  Additional information are as follows : The age at vaccination was not reported. The patient received the 1st dose of shingrix and experienced felt like being on a carnival ride for six hours and had a headache, which was resolved. The consumer refused to provide any demographics, declined any additional information for these adverse events case. The reporter did not consented to follow up. For further tolerance of 2nd dose refer case US2020226574 reported by same reporter. This case was linked with case US2020AMR229312; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229312:Husband's case US-GLAXOSMITHKLINE-US2020226574:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Got sick every year/ still get sick once a year; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the patient designation. The patient got flu shot every year in the military.  The patient got sick every year, stopped taking them when the patient retired, still the patient get sick once a year. The patient reported that may be the shot didn't give him or her the flu, but it sure as hell didn't keep the patient from getting sick.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity
Clinical narrative: Sore arm; Briefly "sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in August 2020 and had a sore arm and was briefly sick  The reporter did not consent to follow-up. For the tolerance of 2nd dose refer case US2020226580.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226580:same reporter
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Myalgia, Rash
Clinical narrative: Have never seen it cause shingles before; Initial local redness over his upper arm; Muscle pain in the upper arm / forearm; Rash over his forearm; This case was reported by a physician and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced shingles, erythema of extremities, myalgia upper extremities and rash. On an unknown date, the outcome of the shingles, erythema of extremities, myalgia upper extremities and rash were unknown.   It was unknown if the reporter considered the shingles, erythema of extremities, myalgia upper extremities and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had local redness over his upper arm.  Within a few days began experiencing muscle pain in the upper arm that moved into his forearm.  The patient then developed a rash over his forearm and shingles. The reporter asked was this a known side effect.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Drug ineffective, Myalgia, Nausea, Vocal cord inflammation
Clinical narrative: muscle aches; experienced nausea; vocal cords to become inflamed; Drug ineffective; developed bronchitis; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder for asthma and bronchitis and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device) inhaler for asthma and bronchitis.   On an unknown date, the patient received the 1st dose of Shingrix and Advair Diskus at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the patient started Advair Diskus Dry Powder Inhaler Device. In August 2019, less than 4 months after receiving Shingrix, not applicable after starting Advair Diskus and Advair Diskus Dry Powder Inhaler Device and an unknown time after starting Advair Diskus and Advair Diskus Dry Powder Inhaler Device, the patient experienced bronchitis. On an unknown date, the patient experienced muscle pain, nausea, vocal cord inflammation and drug ineffective. The patient was treated with fluticasone propionate, salmeterol xinafoate (Advair Diskus) and fluticasone propionate+salmeterol xinafoate diskus dry powder inhaler device (Advair Diskus Dry Powder Inhaler Device). The action taken with Advair Diskus was unknown. On an unknown date, the outcome of the muscle pain and bronchitis were recovering/resolving and the outcome of the nausea, vocal cord inflammation and drug ineffective were unknown.   It was unknown if the reporter considered the muscle pain, nausea, bronchitis and vocal cord inflammation to be related to Shingrix. The reporter considered the vocal cord inflammation to be related to Advair Diskus and Advair Diskus Dry Powder Inhaler Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received 1st dose of Shingrix in May or June 2019 and experienced muscle ache and nausea. The reporter stated that, in August 2019, the patient developed bronchitis and the 250/50 was not helping. It was increased to 500/50 for 2 weeks and that caused vocal cords to become inflamed and the patient went back to the 250/50 after the bronchitis cleared up. The reporter did not consent to follow up. This was 1 of 2 linked cases reported by same reporter for same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228558:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: mildly itchy rash on my torso; fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on unknown date. please refer the case US2020AMR230273).   On 14th November 2020, the patient received the 2nd dose of Shingrix. On 14th November 2020, less than a day after receiving Shingrix, the patient experienced fever. On 17th November 2020, the patient experienced itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and itchy rash were unknown.   It was unknown if the reporter considered the fever and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient experienced fever and a fine mildly itchy rash on torso.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230273:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had fever on Saturday as I did with first dose; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccinaation was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, had fever after 1st dose of Shingrix. For the tolerence of 2nd dose refer case US2020AMR230269.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230269:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced muscle aches 12hours after 2nd dose of Shingrix. The patient asked, if this was a Shingrix side effect or something else like flu or Covid.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic lymphocytic leukaemia, Incomplete course of vaccination, Incorrect route of product administration, Lymphocytic lymphoma
Clinical narrative: I have CLL / SLL cancer; small lymphocytic lymphoma; 1st dose of Shingrix / through a subcutaneous injection; This case was reported by a consumer and described the occurrence of chronic lymphocytic leukemia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2018, the patient received the 1st dose of Shingrix (subcutaneous). In January 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced chronic lymphocytic leukemia (serious criteria GSK medically significant) and lymphocytic lymphoma (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic lymphocytic leukemia, lymphocytic lymphoma and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the chronic lymphocytic leukemia and lymphocytic lymphoma to be related to Shingrix.  Additional information were received as follows: The age at vaccination was not reported. The patient had incorrectly administered the 1st dose of Shingrix to me through a subcutaneous injection. This led to  At the time of reporting, the physician recommended that I not have the 2nd dosage as Chronic lymphocytic leukemia cancer and a determination had not been made at that time as to what the effect would be of that incorrectly administered 1st dosage. Shingrix was now recommended for patients with CLL / SLL and almost 2 years have past since the incorrectly administered 1st dosage.
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: skin raised and a hive presented; Redness appeared at the injection site; site of the injection became very warm to the touch.; raised again and became hard to the touch/swelling; skin raised and a hive presented/raised again and became hard to the touch; This case was reported by a nurse via sales rep and described the occurrence of hives in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA418A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, less than a day after receiving Menveo, the patient experienced hives, injection site erythema, injection site warmth, swelling and skin induration. The patient was treated with benadryl (nos) (Benadryl) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the hives, injection site erythema, injection site warmth, swelling and skin induration were unknown.   It was unknown if the reporter considered the hives, injection site erythema, injection site warmth, swelling and skin induration to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in left arm and the nurse noticed his skin raised and a hive presented itself. Afterward it went down and then raised again and became hard to the touch. The redness appeared at the injection site and the site of the injection became very warm to the touch. The patient was treated with 50mg of Benedryl intramuscular and placed a cold pack on it to relive the swelling. The consent to follow-up was granted.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event (received for years).   On 2nd November 2020, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine and had got sick.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Left arm pain; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Previously administered products included chemotherapy (about 18 years ago). Concurrent medical conditions included hashimoto's disease.   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 in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shignrix vaccine in the left arm (date unknown) she had some tiredness and left arm pain which resolved. For the tolerance of 2nd dose refer case; Sender's Comments:  US-GLAXOSMITHKLINE-US2020228597:same reporter US-GLAXOSMITHKLINE-US2020228595:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the flu after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure' in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at the vaccination was not reported.  The patient reported years ago when it was a live virus he/she got the flu after the shot but now it's a dead virus and took the flu shot every year now and had not had the flu. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for flu were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Slight headache every day; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported, but it could be 66 or 67 year The patient receiced Shingles vaccination and had a slight headache every day.  The patient taking Over-the-counter medication and amp getting some relief, was this reaction common.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Developed muscle aches / getting worse; Feverish; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2020 09:30, the patient received the 2nd dose of Shingrix. On 18th November 2020 21:00, 11 hrs 30 min after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were unknown.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received second Shingrix vaccine at 9:30 am the patient was fine until about 9PM, when the patient developed muscle aches and feeling feverish (without a measurable fever).  The muscle aches were getting worse.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel miserable; This case was reported by a consumer and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received shingles shot and the patient felt miserable. For tolerance of Nucala, refer case US2020226625, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226625:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: SWELLING UNDER BOTH ARMPITS; This case was reported by a consumer via other manufacturer and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The patient experienced swelling under both armpits. The reporter did not have patient initials, age, date and time of contact or product lot number. This case has been linked with case US2020210284, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020210284:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: I spiked a fever; shivering chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 12 hrs after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, 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 had no side effects after the first dose. The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. About 12 hours spiked, the patient experienced fever and shivering chills.  The patient asked how long do the side effects usually last.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site redness; swelling / injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient asked what should do for swelling and injection site redness from Shingrix.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Laboratory test, Malaise, Pyrexia
Clinical narrative: Don't feel good; Temperature of 104; Sick; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell, fever and sickness. On an unknown date, the outcome of the feeling unwell, fever and sickness were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. Years ago in young age, the patient was received flu shot and the patient was did not feel good, had temperature of 104 degree F, went home was so sick for two weeks.  The patient get the flu shot now and don't get sick.