chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Product administered at inappropriate site
Clinical narrative: Lymph node swollen in groin area; the patient was administered with the Shingrix vaccine in glutes; This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced enlargement of lymph nodes and vaccine administered at inappropriate site. On an unknown date, the outcome of the enlargement of lymph nodes and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The reporter stated that the patient presented with swollen lymph node in the groin area after she was administered with the Shingrix vaccine in the glutes. The reporter consented to follow up. Additional Supportive Information: The patient was administered with the Shingrix vaccine in glutes, which led to vaccine administered at inappropriate site.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis atopic, Immune-mediated adverse reaction
Clinical narrative: severe atopic dermatitis; immune reaction; This case was reported by a consumer and described the occurrence of atopic dermatitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 7th September 2021, 1 year after receiving Shingrix, the patient experienced atopic dermatitis and immune-mediated adverse reaction. On an unknown date, the outcome of the atopic dermatitis and immune-mediated adverse reaction were unknown.   It was unknown if the reporter considered the atopic dermatitis and immune-mediated adverse reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: The patient self-reported this case. The patient stated that approximately 1 year after Shingrix caused immune reaction leading to severe atopic dermatitis requiring prescription of 50 thousand per year which the patient could not afford since make 30 thousand per year. The insurance did not cover. The total cost of treatment over lifetime was 1 million. The reporter consent to follow up. Additional Supportive Information: Time to onset was conservatively captured.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash on arm; Looked and felt like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and vesicular rash. On an unknown date, the outcome of the rash and vesicular rash were unknown.   It was unknown if the reporter considered the rash and vesicular rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient broke out in a rash on arm he/she received Shingles vaccine in after 1st dose. The patient reported that there was no live virus, but it was sure looked and felt like Shingles. The patient stated that the doctor said did not take the next dose, so the patient guess that he/she was only partially protected. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Condition aggravated
Clinical narrative: pain at the injection site; rash at the injection site; heat at the injection site; oral herpes simplex virus; Fever; tremors; shivers, chills; mylasis; joint pain; muscle soreness; loss of appetite; diarrhea; upset stomach; weakness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex oral. Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 28th July 2022 and also experienced nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise, refer case US2022112840).   On 21st October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022112840   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The patient stated that she had her second dose of Shingrix and had been experiencing fever, tremors, shivers, chills, malaise, joint pain, muscle soreness, loss of appetite, pain at the injection site, rash at the injection site, heat at the injection site, diarrhea, upset stomach, weakness, tiredness. The patient further stated that she had a history of oral herpes simplex virus and that she had been having outbreaks since having this second dose. The reporter consented to reach out to the pharmacy that she received this second dose.; Sender's Comments:  US-GSK-US2022112840:Same patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Injection site pain, Injection site rash
Clinical narrative: pain at the injection site; rash at the injection site; heat at the injection site; oral herpes simplex virus; Fever; tremors; shivers, chills; mylasis; joint pain; muscle soreness; loss of appetite; diarrhea; upset stomach; weakness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex oral. Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 28th July 2022 and also experienced nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise, refer case US2022112840).   On 21st October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022112840   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The patient stated that she had her second dose of Shingrix and had been experiencing fever, tremors, shivers, chills, malaise, joint pain, muscle soreness, loss of appetite, pain at the injection site, rash at the injection site, heat at the injection site, diarrhea, upset stomach, weakness, tiredness. The patient further stated that she had a history of oral herpes simplex virus and that she had been having outbreaks since having this second dose. The reporter consented to reach out to the pharmacy that she received this second dose.; Sender's Comments:  US-GSK-US2022112840:Same patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Myalgia, Oral herpes, Pyrexia
Clinical narrative: pain at the injection site; rash at the injection site; heat at the injection site; oral herpes simplex virus; Fever; tremors; shivers, chills; mylasis; joint pain; muscle soreness; loss of appetite; diarrhea; upset stomach; weakness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex oral. Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 28th July 2022 and also experienced nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise, refer case US2022112840).   On 21st October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022112840   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The patient stated that she had her second dose of Shingrix and had been experiencing fever, tremors, shivers, chills, malaise, joint pain, muscle soreness, loss of appetite, pain at the injection site, rash at the injection site, heat at the injection site, diarrhea, upset stomach, weakness, tiredness. The patient further stated that she had a history of oral herpes simplex virus and that she had been having outbreaks since having this second dose. The reporter consented to reach out to the pharmacy that she received this second dose.; Sender's Comments:  US-GSK-US2022112840:Same patient
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: pain at the injection site; rash at the injection site; heat at the injection site; oral herpes simplex virus; Fever; tremors; shivers, chills; mylasis; joint pain; muscle soreness; loss of appetite; diarrhea; upset stomach; weakness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex oral. Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 28th July 2022 and also experienced nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise, refer case US2022112840).   On 21st October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site rash, injection site warmth, herpes simplex oral, fever, tremor, shivers, malaise, joint pain, myalgia, appetite lost, diarrhea, upset stomach, weakness and tiredness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022112840   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: The patient stated that she had her second dose of Shingrix and had been experiencing fever, tremors, shivers, chills, malaise, joint pain, muscle soreness, loss of appetite, pain at the injection site, rash at the injection site, heat at the injection site, diarrhea, upset stomach, weakness, tiredness. The patient further stated that she had a history of oral herpes simplex virus and that she had been having outbreaks since having this second dose. The reporter consented to reach out to the pharmacy that she received this second dose.; Sender's Comments:  US-GSK-US2022112840:Same patient
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: administering intranasal; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 14-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qivpre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intranasal) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The health department had a flu clinic one day before the reporting date. The reporter reported that they were administering Flulaval and an intranasal flu vaccine and a nurse volunteer gave Flulaval intranasally to 3 patients. The vaccine administration facility was the same as primary reporter. The facility address was also reported above in health care professional's details. The reporter consented to follow-up by phone. This was for 1 of 3 linked cases reported by same reporter. Additional supportive information: The patient received Flulaval vaccine intranasally, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022154656:Same reporter US-GSK-US2022154657:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first shot August 2019, second on October 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on August 2019).   On 25th October 2022, the patient received the 2nd dose of Shingles vaccine. On 25th October 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked pharmacist for 3rd dose however pharmacist stated that patients do not need to restart the vaccine. Additional supportive information: As patient received 2nd dose after too long duration which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: have them, have shingles; got shot years ago, not booster; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient stated that he/she was vaccinated with Shingles vaccine a few years before reporting and did not know he/she needed a booster. The patient had shingles at the time of reporting. Additional Supportive Information: The patient missed the booster dose of shingles vaccine, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: Nurse shared her own personal experience regarding adverse events after having received the 1st dose of Shingrix. She stated that she experienced pain at the injection site for about a week. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: The worst headache ever; nausea; chills; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. On 26th October 2022, 2 days after receiving Shingles vaccine, the patient experienced headache, nausea and chills. On 26th October 2022, the outcome of the headache, nausea and chills were recovered/resolved.   The reporter considered the headache, nausea and chills to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media The patient received her 2nd dose of Shingles vaccine 2 days prior to the reporting. The patient experienced worst headache, nausea, chills. The patient reported that she received text from her friend that she had shingles, she then described how painful and uncomfortable her experience was. The patient had read articles about shingles, learned about prevention and talked with doctor. After listening to her friend described what she was going through, she took action.  Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue
Clinical narrative: Shivers; Fatigue; Blood pressure 154/127; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced shivers, fatigue and blood pressure increased. On an unknown date, the outcome of the shivers, fatigue and blood pressure increased were unknown.   It was unknown if the reporter considered the shivers, fatigue and blood pressure increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The reporter stated that after recieving shingles vaccine he/she experienced shivers, fatigue and his/her blood pressure was 154/127. The patient wanted to know was it normal. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I always get sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she already been vaccinated with Shingles vaccine. The patient stated that after receiving Shingles vaccine he/she always get sick. The patient stated that how could a vaccine do you any good. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Herpes zoster
Clinical narrative: Have had it; burning sensation; it hurts pretty bad, cant take how it feels, it's painful,; warmth sensation under right breast; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles, burning sensation, pain and feeling of warmth. On an unknown date, the outcome of the shingles, burning sensation, pain and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning sensation, pain and feeling of warmth to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingles vaccine couple of weeks ago but he/she guessed he/she had to have another one there's two shots they have to had, he/she thought it was within six months. The patient just had a burning sensation other than it was hurts, he couldn't take how it felt, it was painful other than like he/she said it was hurts pretty bad. The patient was hoping it eventually went away but like he/she said he/she was not broke out he/she just had that warm sensation and burning and it was right on the right side up under his/her right breast. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: body pain; Can hardly move comfortably; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain and mobility decreased. On an unknown date, the outcome of the general body pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the general body pain and mobility decreased to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR155404   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Patient took first dose it only lasted 1 day. By first dose his/her body had body aches and pain patient could hardly move around comfortably. Additional supportive information: For tolerance to the 2nd dose refer case US2022AMR155404.; Sender's Comments:  US-GSK-US2022AMR155404:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: severe body pain, pain; Can hardly move comfortably; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (first dose was received on an unknown date, refer case US2022AMR155372).   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and mobility decreased to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR155372   Additional Information: GSK Receipt Date: 26-Oct-2022 Reporter's Comment: Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received second dose of shingles vaccine this past Monday morning. This dose his/her body had more severe body aches and pain. The patient could hardly move around comfortably. Additional Supportive Information: The follow up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR155372:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received shingrix on 12/16/2021/did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 50 mcg of first dose on 16th December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The patient stated that for patients 50 years or older, there was a time that was preferred in the 2 to 6 month time-frame to get the second dose of Shingrix. The administration approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2 to 6 months after the first dose. Disease control had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible, patients did not need to restart the vaccine series. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The details were reported for first dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Dry skin, Paraesthesia, Pruritus
Clinical narrative: side effects /dry skin patches; prickly sensation on my back; itch; This case was reported by a consumer via interactive digital media and described the occurrence of dry skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dry skin, tingling sensation and pruritus. On an unknown date, the outcome of the dry skin, tingling sensation and pruritus were unknown.   It was unknown if the reporter considered the dry skin, tingling sensation and pruritus to be related to Shingles vaccine.     Additional Information: Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: This case was reported by consumer via interactive digital media. The patient had the 2 shots, after the second, he/she had side effects, dry skin patches, prickly sensation on his/her back and itch. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the second dose of Shingrix shot before the day of reporting. The patient experienced a bad headache after second dose. The patient was asking for any medication for headache could take.  Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Nausea, Pyrexia
Clinical narrative: pain at injection site; fever; shivering; lethargy; nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, fever, shivering, lethargy and nausea. On an unknown date, the outcome of the injection site pain, fever, shivering, lethargy and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, shivering, lethargy and nausea to be related to Shingrix.  Linked case(s) involving the same patient:US2022155554   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient had the same symptoms (fever, shivering, lethargy, pain at the injection site and nausea) but to a lesser degree.  The symptoms after her first dose had resolved. The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022155554, reported by same reporter.; Sender's Comments:  US-GSK-US2022155554:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Soreness in arms after each dose; This case was reported by a consumer and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2020 1st dose received. refer case US2022AMR156681).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. 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.     Linked case(s) involving the same patient:  US2022AMR156681   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: In 2020 (summer), the patient received Shingrix. The patient experienced soreness in her arm after injection in 2020.; Sender's Comments:  US-GSK-US2022AMR156681:Same reporter
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK receipt date :27-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received first dose of shingrix vaccine and experienced rash after 3 days of vaccination . The patient stated that he/she did not had any conditions to compromise immunity and asked for the second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Gastrointestinal disorder, Heart rate increased
Clinical narrative: Pain at injection site; redness at injection site; Shivering; gastro intestinal effects; Nausea; Stomach pain; Fever; Tiredness; Fast heart rate; Lymph gland under arm, swollen up huge; lymph gland was tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient reported that, she got her Shingrix vaccine.  The patient reported that, she had all the symptoms that were described as common side effects.  The patient reported pain at injection site, redness at injection site, shivering, gastro intestinal effects, like nausea and stomach pain, fever, tiredness and fast heart rate.  These side effects were last about 24 hours and they had resolved.  The patient reported a lymph gland under the arm swollen up huge. The patient reported that, the under the right arm where she got the vaccine the lymph gland was swollen and tender.  This last the longest and it resolved in about a week.  The lot and expiry date of the vaccine were unknown. Not all information was available. The reporter consented to follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Pain at injection site; redness at injection site; Shivering; gastro intestinal effects; Nausea; Stomach pain; Fever; Tiredness; Fast heart rate; Lymph gland under arm, swollen up huge; lymph gland was tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient reported that, she got her Shingrix vaccine.  The patient reported that, she had all the symptoms that were described as common side effects.  The patient reported pain at injection site, redness at injection site, shivering, gastro intestinal effects, like nausea and stomach pain, fever, tiredness and fast heart rate.  These side effects were last about 24 hours and they had resolved.  The patient reported a lymph gland under the arm swollen up huge. The patient reported that, the under the right arm where she got the vaccine the lymph gland was swollen and tender.  This last the longest and it resolved in about a week.  The lot and expiry date of the vaccine were unknown. Not all information was available. The reporter consented to follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at injection site; redness at injection site; Shivering; gastro intestinal effects; Nausea; Stomach pain; Fever; Tiredness; Fast heart rate; Lymph gland under arm, swollen up huge; lymph gland was tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient reported that, she got her Shingrix vaccine.  The patient reported that, she had all the symptoms that were described as common side effects.  The patient reported pain at injection site, redness at injection site, shivering, gastro intestinal effects, like nausea and stomach pain, fever, tiredness and fast heart rate.  These side effects were last about 24 hours and they had resolved.  The patient reported a lymph gland under the arm swollen up huge. The patient reported that, the under the right arm where she got the vaccine the lymph gland was swollen and tender.  This last the longest and it resolved in about a week.  The lot and expiry date of the vaccine were unknown. Not all information was available. The reporter consented to follow up with HCP.
Age: 0.42
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 months old received Flulaval; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comments: The reporter reported that one of his/her nurses accidentally administered Flulaval to a 5 months old patient. The reporter was seeking information on this. The chat dropped before user could provide any information. Additional supportive information: The patient received Flulaval Quadrivalent at 5 month old, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose May2022, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on May 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: HCP called to ask for information about the second dose of Twinrix in a patient who received the first dose in May 2022. The second dose was not administered a month later as stated in the prescribing information.  HCP asked if the patient could receive the second dose or if the vaccination had to start over.  The reporter did not provide the lot number and expiration date of the first dose of the Twinrix vaccine. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 0.67
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered on 19Oct2022; 1st Flulaval dose 15Sep2022, 2nd 26Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 8-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 19th October 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th September 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 19th October 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too short were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received second dose of Flulaval QIV earlier than the recommended interval, which led to shortening of vaccine schedule. The patient received third dose of Fluarix QIV, which led to extra dose administered.