chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and I've gotten it four more times / suspected vaccination failure; I had the shot and I've gotten it four more times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shot and I've gotten it four more times / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shot and I've gotten it four more times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-AUG-2023 This case was reported by patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: hives; itching; mild fever; was achy; This non-serious case was reported by a consumer and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On 20-JUL-2023, the patient received Shingrix. On 21-JUL-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: mild fever) and pain (Verbatim: was achy). On 23-JUL-2023, the patient experienced hives (Verbatim: hives) and pruritus (Verbatim: itching). The patient was treated with benadryl (nos) (Benadryl). The outcome of the fever and pain were not reported and the outcome of the hives and pruritus were not resolved.   It was unknown if the reporter considered the fever, pain, hives and pruritus to be related to Shingrix.     It was unknown if the company considered the fever, pain, hives and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The patient received the vaccine last Thursday and on Friday he was achy all over and had a mild fever.  The patient still felt achy on Saturday in a tiny bit on Sunday and Sunday night around 10:00, he started itching, went to get his shower took shirt off and saw all the hives.  The patient stated that they came on all of a sudden.  The patient took Benadryl per an online visit with a physician and they had subsided by morning.  The patient stated that again last night about the same time the hives reappeared and were itchy, not as numerous but still there.  The patient stated that his only assumption was it was from the vaccine he received. The patient never had hives ever in his life until then, he just wanted to report it. The reporter gave permission to contact them.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Movement disorder, Pain in extremity
Clinical narrative: redness around the injection site; swelled up around the injection site.; significant pain in arm; She had difficulty lifting the arm; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness around the injection site), injection site swelling (Verbatim: swelled up around the injection site.), pain in arm (Verbatim: significant pain in arm) and movement disorder (Verbatim: She had difficulty lifting the arm). The patient was treated with non-drug therapy (Ice Pack (No Medication)). In JUL-2023, the outcome of the injection site erythema, injection site swelling, pain in arm and movement disorder were resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and movement disorder to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, pain in arm and movement disorder to be related to Shingrix.   Additional Information: GSK Receipt date: 27-JUL-2023 The reporter reported that the patient took injection of Shingrix and had significant pain in arm with redness that swelled up around the injection site. The reporter reported that she had difficulty lifting the arm and had to put an ice pack on it, this was within the past 7 days from the reporting day, but she reported that the symptoms had gone away now. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: had redness; swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema 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, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: had redness) and swelling (Verbatim: swelling). The outcome of the erythema and swelling were not reported.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     It was unknown if the company considered the erythema and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 It was reported that patient upon receiving both her doses of Shingrix, had redness and swelling afterwards. No other information reported. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2023AMR103388, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR103388:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: a little arm pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-JUL-2023, the patient received Shingles vaccine. On 27-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: a little arm pain). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 The case was received from the patient interactive digital media. The patient thankful, as on the day of reporting he/she had an appointment at the clinic and asked for the vaccine, and could you believed that they gave it to him/her now, just a little pain in my arm. The patient hoped it helped, she did not had shingles, just for prevention. The patient saw a lot of the comments of those who went through it and it scared him/her. The patient hoped everything would be fine. The patient thanked for your comments and blessings. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue; General sickness; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and feeling unwell (Verbatim: General sickness). The outcome of the fatigue and feeling unwell were resolved (duration 24 hrs).   It was unknown if the reporter considered the fatigue and feeling unwell to be related to Shingrix.     It was unknown if the company considered the fatigue and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter's sister experienced adverse experience of fatigue and general sickness after Shingrix. The adverse events were resolved within 24 hours. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: temperature excursion of 10.6C for 15 minutes; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number T2XC9, expiry date 13-DEC-2023) for prophylaxis.   On an unknown date, the patient received Havrix (left thigh) .5 ml. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: temperature excursion of 10.6C for 15 minutes). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 1-AUG-2023 HCP reported that a patient received a dose of HAVRIX, NDC number 5816001818-11, following undergo of a temperature excursion of 10.6 degree C for 15 minutes. The HCP reported that the patient did not experience any issues, side effects, or adverse reactions from the administered and improperly stored Havrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Lot of pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Lot of pain). The outcome of the pain was resolved (duration 1 week).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 1-AUG-2023 This case was reported by a consumer via interactive digital media. The patient have had the 2 vaccinations and got it twice, but it was mild, very painful for a week.; Sender's Comments:  US-GSK-US2023AMR105058:Second dose
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Myalgia, Nasal congestion
Clinical narrative: generalized weakness; congestion; no appetite; headache; fever; achy arm; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 8 hrs after receiving Shingrix, the patient experienced weakness (Verbatim: generalized weakness), nasal congestion (Verbatim: congestion), appetite absent (Verbatim: no appetite), headache (Verbatim: headache), fever (Verbatim: fever), pain in arm (Verbatim: achy arm) and muscle soreness (Verbatim: Muscle soreness). The outcome of the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness were resolved (duration 1 week).   It was unknown if the reporter considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.     It was unknown if the company considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter calling in response to a message, where he had shared his adverse event experience following both of his Shingrix vaccinations. The patient experienced an achy arm where the shot was administered, along with fever, muscle soreness, headache, no appetite, congestion and generalized weakness necessitating him staying in bed for 3 days.  These symptoms lasted about one week. This case is linked to the case US2023101963, reported for wife's patient.; Sender's Comments:  US-GSK-US2023101963:Same reporter,female patient
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: generalized weakness; congestion; no appetite; headache; fever; achy arm; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 8 hrs after receiving Shingrix, the patient experienced weakness (Verbatim: generalized weakness), nasal congestion (Verbatim: congestion), appetite absent (Verbatim: no appetite), headache (Verbatim: headache), fever (Verbatim: fever), pain in arm (Verbatim: achy arm) and muscle soreness (Verbatim: Muscle soreness). The outcome of the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness were resolved (duration 1 week).   It was unknown if the reporter considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.     It was unknown if the company considered the weakness, nasal congestion, appetite absent, headache, fever, pain in arm and muscle soreness to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter calling in response to a message, where he had shared his adverse event experience following both of his Shingrix vaccinations. The patient experienced an achy arm where the shot was administered, along with fever, muscle soreness, headache, no appetite, congestion and generalized weakness necessitating him staying in bed for 3 days.  These symptoms lasted about one week. This case is linked to the case US2023101963, reported for wife's patient.; Sender's Comments:  US-GSK-US2023101963:Same reporter,female patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Joint swelling, Limb discomfort, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: pain (fingers); discomfort (right arm and hand); swollen joints; depression; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in fingers in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2r375, expiry date 28-MAY-2024) for prophylaxis.   On 06-JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in fingers (Verbatim: pain (fingers)), arm discomfort (Verbatim: discomfort (right arm and hand)), swollen joints (Verbatim: swollen joints) and depression (Verbatim: depression). The outcome of the pain in fingers was resolving and the outcome of the arm discomfort and depression were unknown and the outcome of the swollen joints was not resolved.   It was unknown if the reporter considered the pain in fingers, arm discomfort, swollen joints and depression to be related to Shingrix.     It was unknown if the company considered the pain in fingers, arm discomfort, swollen joints and depression to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUL-2023 The patient reported that she received first dose of Shingrix and after the vaccine she felt discomfort in her right hand which went to her whole arm. The patient also states that she had unbearable pain in her middle finger and the next day, she went to the physician with pain in her fingers.  The patient had to take an ambulance to the hospital due to the pain.  The patient had taken several medication for the pain and the pain did reduce but her joints were still swollen.  The patient also stated that she was depressed due to these side effects. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Chills, Injection site swelling, Oral herpes, Pain
Clinical narrative: right arm swelling; fever; chills; body aches; mouth broke out with canker sores; fever blisters; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 10-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: right arm swelling), fever (Verbatim: fever), chills (Verbatim: chills), general body pain (Verbatim: body aches), canker sore (Verbatim: mouth broke out with canker sores) and fever blister (Verbatim: fever blisters). On 20-MAY-2023, the outcome of the injection site swelling, fever, chills, general body pain, canker sore and fever blister were resolved (duration 10 days).   It was unknown if the reporter considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.     It was unknown if the company considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2023 The reporter was a patient. The reporter called and asked that she received dose of Shingrix and had a adverse reaction of right arm swelling (site of injection), fever, chills, body aches and mouth broke out with canker sores inside and fever blisters on the outside. The reporter stated that all the adverse events resolved by day 10 after receiving the Shingrix Vaccine dose. Reporter questioned getting the 2nd dose of Shingrix and was referred to HCP for advise, gave medical disclaimer. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: right arm swelling; fever; chills; body aches; mouth broke out with canker sores; fever blisters; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 10-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: right arm swelling), fever (Verbatim: fever), chills (Verbatim: chills), general body pain (Verbatim: body aches), canker sore (Verbatim: mouth broke out with canker sores) and fever blister (Verbatim: fever blisters). On 20-MAY-2023, the outcome of the injection site swelling, fever, chills, general body pain, canker sore and fever blister were resolved (duration 10 days).   It was unknown if the reporter considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.     It was unknown if the company considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2023 The reporter was a patient. The reporter called and asked that she received dose of Shingrix and had a adverse reaction of right arm swelling (site of injection), fever, chills, body aches and mouth broke out with canker sores inside and fever blisters on the outside. The reporter stated that all the adverse events resolved by day 10 after receiving the Shingrix Vaccine dose. Reporter questioned getting the 2nd dose of Shingrix and was referred to HCP for advise, gave medical disclaimer. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15-JUN-2023, the patient received the 2nd dose of Boostrix. On 07-JUN-2023, the patient received the 1st dose of Boostrix. On 07-JUN-2023, not applicable after receiving Boostrix and an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023). On 15-JUN-2023, the patient experienced expired vaccine used (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023) and drug dose administration interval too short (Verbatim: two doses of expired Boostrix were administered/One was given on 7-JUN-2023 and the other on 15-JUN-2023). The outcome of the expired vaccine used, drug dose administration interval too short and expired vaccine used 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: 26-JUL-2023 The Medical assistant reported that two doses of expired Boostrix were administered.  The reporter opted out of follow-up and providing additional information. The reporter did not consent to follow-up. The patient received 2 expired doses of Boostrix, which led to expired vaccine used. The patient received 2nd dose of Boostrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.; NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   On 26-JUL-2023, the patient received Kinrix. On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.) and inappropriate age at vaccine administration (Verbatim: NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 26-JUL-2023 The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The reporter stated that a 4 month old received Kinrix and was supposed to get a separate Dtap and IPV, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Stress, Vaccination failure
Clinical narrative: stabbing pain; itching along the left side under her arm were severe; mild outbreak of shingles/suspected vaccination failure; mild outbreak of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included stress.   In JAN-2023, the patient received the 2nd dose of Shingrix (injection, right arm). In JUL-2022, the patient received the 1st dose of Shingrix (injection, left arm). On 24-JUL-2023, 7 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: mild outbreak of shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: mild outbreak of shingles). On an unknown date, the patient experienced pain (Verbatim: stabbing pain) and pruritus (Verbatim: itching along the left side under her arm were severe). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were unknown and the outcome of the pain and pruritus were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter called to report a mild outbreak of shingles. She reported that she had shingles in the past before receiving Shingrix. The recent outbreak did not involve a rash or blisters/vesicles but stabbing pain and itching along the left side under her arm were severe.  She visited an urgent care and received a prescription for Valtrex which she said helped greatly. The pain and itching had calmed now and she said that she felt ok at the time of reporting but would continue the Valtrex until all doses were taken which was a 7-day supply. She said her pharmacist told her she must be in the unlucky 3 percent who still get shingles after being fully vaccinated. She said that she was under a lot of stress at the time of the outbreak. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Erythema, Fatigue, Pain in extremity
Clinical narrative: tiredness; weakness; lost of appetite; fever; arm was red; arm sore and hot; arm sore and hot; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: arm was red), skin warm (Verbatim: arm sore and hot) and pain in arm (Verbatim: arm sore and hot). On an unknown date, the patient experienced tiredness (Verbatim: tiredness), weakness (Verbatim: weakness), appetite lost (Verbatim: lost of appetite) and fever (Verbatim: fever). The outcome of the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm were resolved (duration 5 days).   It was unknown if the reporter considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023104702   Additional Information: GSK Receipt date: 27-JUL-2023 The patient self-reported this case. The same night of vaccination she noticed her arm was red, sore and hot.  She also had fever, lost of appetite, weakness and tiredness. All lasted about 5 days. For tolerance of 2nd dose, refer case US2023104702, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023104702:same patient
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: tiredness; weakness; lost of appetite; fever; arm was red; arm sore and hot; arm sore and hot; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: arm was red), skin warm (Verbatim: arm sore and hot) and pain in arm (Verbatim: arm sore and hot). On an unknown date, the patient experienced tiredness (Verbatim: tiredness), weakness (Verbatim: weakness), appetite lost (Verbatim: lost of appetite) and fever (Verbatim: fever). The outcome of the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm were resolved (duration 5 days).   It was unknown if the reporter considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.     It was unknown if the company considered the tiredness, weakness, appetite lost, fever, erythema of extremities, skin warm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023104702   Additional Information: GSK Receipt date: 27-JUL-2023 The patient self-reported this case. The same night of vaccination she noticed her arm was red, sore and hot.  She also had fever, lost of appetite, weakness and tiredness. All lasted about 5 days. For tolerance of 2nd dose, refer case US2023104702, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023104702:same patient
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Ear pain, Headache, Hypersomnia
Clinical narrative: diarrhea; she slept all day; Joint pain; left ear pain; fever; nausea; headache; joint and muscle pain.; left jaw pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of jaw pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. On 22-JUL-2023, 1 days after receiving Shingrix, the patient experienced jaw pain (Verbatim: left jaw pain), ear pain (Verbatim: left ear pain), low grade fever (Verbatim: fever), nausea (Verbatim: nausea), headache (Verbatim: headache), muscle pain (Verbatim: joint and muscle pain.) and joint pain (Verbatim: Joint pain). On 23-JUL-2023, the patient experienced sleep excessive (Verbatim: she slept all day ). On 27-JUL-2023, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the jaw pain was resolved (duration 1 day) and the outcome of the ear pain, low grade fever, nausea, headache, muscle pain, diarrhea and joint pain were not resolved and the outcome of the sleep excessive was not reported.   It was unknown if the reporter considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter was the patient and reported the next she experienced left jaw pain then resolved in one day.  The patient experienced left ear pain, low grade fever, nausea, severe headache, joint and muscle pain. None of which have resolved as of today (on the day of reporting).  Also today (on the day of reporting), she was having issues with diarrhea. Caller reported she slept all day on Sunday. The reporter gave permission to contact her HCP in this case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in jaw, Pyrexia
Clinical narrative: diarrhea; she slept all day; Joint pain; left ear pain; fever; nausea; headache; joint and muscle pain.; left jaw pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of jaw pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. On 22-JUL-2023, 1 days after receiving Shingrix, the patient experienced jaw pain (Verbatim: left jaw pain), ear pain (Verbatim: left ear pain), low grade fever (Verbatim: fever), nausea (Verbatim: nausea), headache (Verbatim: headache), muscle pain (Verbatim: joint and muscle pain.) and joint pain (Verbatim: Joint pain). On 23-JUL-2023, the patient experienced sleep excessive (Verbatim: she slept all day ). On 27-JUL-2023, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the jaw pain was resolved (duration 1 day) and the outcome of the ear pain, low grade fever, nausea, headache, muscle pain, diarrhea and joint pain were not resolved and the outcome of the sleep excessive was not reported.   It was unknown if the reporter considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the jaw pain, ear pain, low grade fever, nausea, headache, muscle pain, diarrhea, joint pain and sleep excessive to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter was the patient and reported the next she experienced left jaw pain then resolved in one day.  The patient experienced left ear pain, low grade fever, nausea, severe headache, joint and muscle pain. None of which have resolved as of today (on the day of reporting).  Also today (on the day of reporting), she was having issues with diarrhea. Caller reported she slept all day on Sunday. The reporter gave permission to contact her HCP in this case.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: an adult patient today was administered a pediatric dose of Engerix-B; an adult patient today was administered a pediatric dose of Engerix-B; an adult patient today was administered a pediatric dose of Engerix-B/first dose was administered in 2012; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 53-year-old male patient who received HBV (Engerix B pediatric) (batch number EM9E4) for prophylaxis.   Previously administered products included Engerix B (1st dose was administered in 2012).   On 27-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 27-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: an adult patient today was administered a pediatric dose of Engerix-B), adult use of a child product (Verbatim: an adult patient today was administered a pediatric dose of Engerix-B) and drug dose administration interval too long (Verbatim: an adult patient today was administered a pediatric dose of Engerix-B/first dose was administered in 2012). The outcome of the underdose, adult use of a child product and drug dose administration interval too long 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: 27-JUL-2023 The reporter was an office manager. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter. An adult patient was administered a pediatric dose of Engerix-B as 2nd dose later than the recommended schedule, which led to underdose and adult use of a child product and lengthening of vaccination schedule.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: a patient received a dose of Kinrix subcutaneously instead of intramuscularly; Inappropriate age at vaccine administration; This non-serious case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   Concomitant products included MEASLES MUMPS RUBELLA VACCINE.   On 26-JUL-2023, the patient received Kinrix (subcutaneous). On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: a patient received a dose of Kinrix subcutaneously instead of intramuscularly) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the intramuscular formulation administered by other route and inappropriate age at vaccine administration 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: 27-Jul-2023 The physician told that such dose was administered on the same leg as an MMR vaccine dose (brand was not specified). The reporter consented to follow-up. The patient received a dose of Kinrix subcutaneously instead of intramuscularly at an inappropriate age, which led intramuscular formulation administered by other route and inappropriate age at vaccine administration.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included DTaP (had 5 prior DTaP doses).   On 26-JUL-2023, the patient received Kinrix. On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead), inappropriate schedule of vaccine administered (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead) and inappropriate age at vaccine administration (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead). The outcome of the wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration 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: 27-Jul-2023 Pediatric office reported that the patient had 5 prior DTaP doses, not counting one day before the reporting day dose.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up.   The patient was supposed to be given Boostrix dose one day before the reporting day, but was administered a dose of Kinrix instead at an inappropriate age, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 5.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: inadvertently received a dose of Menveo and Bexero; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA902A) for prophylaxis.   On 28-JUL-2023, the patient received Bexsero and Menveo. On 28-JUL-2023, an unknown time after receiving Bexsero and Menveo, the patient experienced wrong vaccine administered (Verbatim: inadvertently received a dose of Menveo and Bexero). The outcome of the wrong vaccine administered 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: 28-Jul-2023 Nurse stated that neither vaccine was intended to be administered.  The Vaccine Administration Facility was the same as Primary Reporter. Caller declined safety follow-up. Did not consent to follow-up. A patient inadvertently received a dose of Menveo and Bexero on the day of reporting, which led to wrong vaccine administered.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix dose to a 14-year-old patient instead of the HPV vaccine; Shingrix dose to a 14 year old patient today on 7/28/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received Herpes zoster (Shingrix) (batch number 59C4, expiry date 04-AUG-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 28-JUL-2023, the patient received Shingrix (left deltoid). On 28-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Shingrix dose to a 14-year-old patient instead of the HPV vaccine) and inappropriate age at vaccine administration (Verbatim: Shingrix dose to a 14 year old patient today on 7/28/2023). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter was a medical assistant. The reporter called to inquire that what to look for the patient. The reporter mentioned that the patient received a Havrix dose as well at the time of reporting.  The reporter did not consent to follow-up. The reporter reported that they inadvertently administered that was intended, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric dose of Engerix-B; Adult patient received pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Engerix B pediatric .5 ml. On 28-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient received pediatric dose of Engerix-B) and adult use of a child product (Verbatim: Adult patient received pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter was a clinical coordinator. The reporter stated that the patient did not had an adverse reaction. The adult patient was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did consent to follow up.
Sex: M
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 63-year-old male patient who received HBV (Engerix B pediatric) (batch number N73FA) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number AX205) for prophylaxis.   On 01-MAR-2023, the patient received the 2nd dose of Engerix B pediatric. On 26-JAN-2023, the patient received the 1st dose of Engerix B pediatric. On 26-JAN-2023, not applicable after receiving Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult) and underdose (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult). On 01-MAR-2023, the patient experienced adult use of a child product (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult) and underdose (Verbatim: patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation they are an adult). The outcome of the adult use of a child product, underdose, adult use of a child product and underdose 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: 28-JUL-2023 A pharmacist called in to report that a patient accidentally received 2 doses of Engerix-B, having received the pediatric formulation even though they are an adult and wished to receive information about how to proceed.  Partial information was given about the event, patient and vaccine.  The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.