chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/my mother got the shingle vaccine and ended up getting the shingles; ended up getting the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: This case received from the patient's children via interactive digital media. The patient got the shingle vaccine and ended up getting the shingles, the physician made money and kick backs for administrating these drugs. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR119929, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR119929:Same case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/our neighbor got the shingle vaccine and ended up getting; ended up getting the shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: This case received from the patient's neighbor via interactive digital media. The reporter's neighbor got the shingle vaccine and ended up getting the shingles, the physician made money and kick backs for administrating these drugs. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR119927, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR119927:Same case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Hyperaesthesia, Insomnia, Nausea
Clinical narrative: Got the shots, still got Shingles/suspected vaccination failure; Shingles/ still got shingles; pain/random stabbing pain/painful/felt punch in gut/At its worst (usually at night) the lightest touch to my back or torso felt like I was being punched in the gut; keep me awake trough night; so nauseated; lost 13 pounds in one week; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain, sleeplessness, nausea and weight loss. On an unknown date, the outcome of the vaccination failure, shingles, sleeplessness, nausea and weight loss were unknown and the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, sleeplessness, nausea and weight loss to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and still got shingles. The patient have had the pain for two months now. The patient told that it could last for much longer, at its worst (usually at night) the lightest touch to his/her back or torso felt like the patient was being punched in the gut.  The patient would get random stabbing pains that would keep him/her awake through the night. The antiviral med that was prescribed to the patient made so nauseated that the patient lost 13 pounds in one week. The patient had no idea how extremely painful shingles could be. Additional supportive information: It was unknown if the reporter considered the nausea and weight loss to be related to antiviral med.   This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder, Vaccination failure, Weight decreased
Clinical narrative: Got the shots, still got Shingles/suspected vaccination failure; Shingles/ still got shingles; pain/random stabbing pain/painful/felt punch in gut/At its worst (usually at night) the lightest touch to my back or torso felt like I was being punched in the gut; keep me awake trough night; so nauseated; lost 13 pounds in one week; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain, sleeplessness, nausea and weight loss. On an unknown date, the outcome of the vaccination failure, shingles, sleeplessness, nausea and weight loss were unknown and the outcome of the back pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, sleeplessness, nausea and weight loss to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots and still got shingles. The patient have had the pain for two months now. The patient told that it could last for much longer, at its worst (usually at night) the lightest touch to his/her back or torso felt like the patient was being punched in the gut.  The patient would get random stabbing pains that would keep him/her awake through the night. The antiviral med that was prescribed to the patient made so nauseated that the patient lost 13 pounds in one week. The patient had no idea how extremely painful shingles could be. Additional supportive information: It was unknown if the reporter considered the nausea and weight loss to be related to antiviral med.   This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Headache, Incomplete course of vaccination, Peripheral swelling, Rash
Clinical narrative: first dose June 2019, never had the second; Arm was swollen; small rash; Headache; Abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of swollen arm in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swollen arm, rash, headache, abdominal pain and incomplete course of vaccination. On an unknown date, the outcome of the swollen arm, rash, headache and abdominal pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swollen arm, rash, headache and abdominal pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: The case was self reported by the patient. The patient had arm was swollen and with a small rash. Also had headache and abdominal pain. These reactions that lasted three weeks. The patient had the 1st dose of Shingrix but never had the 2nd dose.  The patient asked as he/she protected just with one dose. The patient asked there had been three years since the 1st dose of Shingrix. Could he/she get the 2nd dose now after three years. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is a little sore; This 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 an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR118362   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingles vaccine. The patient experienced sore arm. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR118362. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118362:Second dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm is a little sore; This 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.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received first dose on an unknown date and refer case US2022AMR118356.).   On 9th August 2022, the patient received the 2nd dose of Shingles vaccine. On 9th August 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR118356   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received second dose of Shingles vaccine on the reporting day. The patient had no side effects. The patient experienced just arm was a little sore but same as the first dose. Additional supportive information:  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118356:First dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Worse pain/lingering pain; lingering pain when I'm tired; This 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.   Concurrent medical conditions included migraine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the tiredness was unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, worse pain than his/her migraines and he/she still had lingering pain when tired.  Shingles shot had helped but had not taken the lingering pain totally away. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Limb discomfort
Clinical narrative: Took 2 weeks to start being comfortable sleeping on arm; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and TETANUS VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was recovered/resolved.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's comment: The patient self-reported the case via via interactive digital media. The patient stated that he/she made a mistake of taking Shingles and Tetanus shot at same time in same arm, left one.  It took him/her two weeks to start being comfortable sleeping on that arm.  The patient would get the second dose of the shingles shot in November and hoped it goes better. Additional Supportive Information: Follow-up would not possible as no contact details were available. It was unknown if the reporter considered the arm discomfort to be related to Tetanus vaccine.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Induration, Pain, Peripheral swelling
Clinical narrative: left arm 3 inches bigger than right; left arm hard; left arm hot; temperature between 99 and 101; tired; achy; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS VACCINE for prophylaxis.   The patient's past medical history included shingles and lymph node excision. Concurrent medical conditions included asthma, type ii diabetes mellitus and mastectomy bilateral.   In July 2022, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: The patient self-reported this case. The patient had a Shingles vaccine almost two weeks ago (the day before reporting) and still having side effects. The patient reported that 13 days ago (the day before reporting) he/she received the first dose of Shingrix into unknown arm, Pneumonia vaccine and Tetanus vaccine and the patient left arm was three inches bigger than toe over a wheel and hard and hot.  The patient's body temperature ranges between 99 and 101 degree F. Tylenol got it down to 99 degree F. The patient had been tired and achy. The reported that tomorrow it would be two weeks. Because of the lymph nodes removed from right arm during mastectomy everything was to be done in left arm. The patient asked was still how long before this end and would patient have the same problem with the second shot. The patient had shingles and he/she knew how awful it was. The patient received a dose of Pneumonia vaccine and Tetanus vaccine and less than 2 weeks patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, fever, tiredness and pain to be related to Pneumonia vaccine and Tetanus vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: left arm 3 inches bigger than right; left arm hard; left arm hot; temperature between 99 and 101; tired; achy; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS VACCINE for prophylaxis.   The patient's past medical history included shingles and lymph node excision. Concurrent medical conditions included asthma, type ii diabetes mellitus and mastectomy bilateral.   In July 2022, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comment: The patient self-reported this case. The patient had a Shingles vaccine almost two weeks ago (the day before reporting) and still having side effects. The patient reported that 13 days ago (the day before reporting) he/she received the first dose of Shingrix into unknown arm, Pneumonia vaccine and Tetanus vaccine and the patient left arm was three inches bigger than toe over a wheel and hard and hot.  The patient's body temperature ranges between 99 and 101 degree F. Tylenol got it down to 99 degree F. The patient had been tired and achy. The reported that tomorrow it would be two weeks. Because of the lymph nodes removed from right arm during mastectomy everything was to be done in left arm. The patient asked was still how long before this end and would patient have the same problem with the second shot. The patient had shingles and he/she knew how awful it was. The patient received a dose of Pneumonia vaccine and Tetanus vaccine and less than 2 weeks patient experienced swelling arm, induration, extremities hot feeling of, high temperature, tiredness and pain. It was unknown if the reporter considered the swelling arm, induration, extremities hot feeling of, fever, tiredness and pain to be related to Pneumonia vaccine and Tetanus vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Immune system disorder, Influenza
Clinical narrative: flu lowered resistance as shingles shot was wearing off; flu lowered resistance as shingles shot was wearing off; This case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza and immune system disorder. On an unknown date, the outcome of the influenza and immune system disorder were unknown.   It was unknown if the reporter considered the influenza and immune system disorder to be related to Shingles vaccine.     Additional Information: GSK receipt date: 09-Aug-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient stated that the flu lowered patient's resistance just as his/her shingles shot was wearing off. As it was reported that no one told patient needed another shot in 5 years, so patient felt very lucky to experience no pain. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Illness, Nausea, Pain
Clinical narrative: Sick in bed; Huge headache sore; Sore and achy; Tired; Nauseated; 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.   Previously administered products included Shingrix (first dose received on an unknown date).   On 1st August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness, headache, pain, tiredness and nausea. On an unknown date, the outcome of the sickness, headache, pain, tiredness and nausea were unknown.   It was unknown if the reporter considered the sickness, headache, pain, tiredness and nausea to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the second dose one day before reporting day. The patient experienced sick and he/she was in bed and patient was glad to get it. The patient was asking that did anyone had a huge headache, sore and achy and tried and nauseated. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: failed to get the 2nd one/I lost track of getting the 2nd Shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (1st dose received) and COVID-19 Vaccine (Patient had to got COVID shots and then the booster dose.).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine. The reporter stated that the patient did not received second dose because patient had to get the Covid vaccine and then the booster dose. The patient due to so many shots patient lost track of getting the second Shingles vaccine dose. The reporter stated that the patient definitely will get the Second dose. the patient never want to deal with shingles again. Follow-up would not possible as no contact details were available. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: second vaccine past the recommended 2-6 month window; rash on her left shoulder/ rash has now spread and dispersed all over her body and on both sides; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5ml, in left arm on November 2021).   On 13th July 2022, the patient received the 2nd dose of Shingrix .5 ml. On 13th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2022, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's comment: The patient received Shingrix vaccine in left arm. The patient stated that about a week after her second shingrix vaccine, she started with a rash on her left shoulder.  The rash had now spread and dispersed all over her body and on both sides.  It was not painful or vesicular in nature.  The patient also reported that she got her second vaccine past the recommended 2-6 month window.  The patient did not consent to follow-up. The follow-up for Healthcare professional was denied.
Age: 0.33
Sex: M
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: dose of ROTATAX 02/14/2022, On 4/22/2022 they administered Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L4NH3, expiry date 23rd July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th February 2022, the patient received ROTATEQ. On 22nd April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 10-AUG-2022 Reporter's comments: The reporter reported that, a patient was vaccinated with a dose of Rotateq on 14th February 2022.  The patient was then administered with the Rotarix and second dose was not administered yet. The reporter did not consent to follow-up. Additional Supportive Information: As patient first received Rotateq followed by Rotarix, which led to Interchange of vaccine products. Note: As the discrepancy in vaccine name Rotatax, the Rotatax was considered Rotateq conservatively.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number abxb39ab, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-AUG-2022 Reporter's Comment: The reporter was medical assistance. The reporter reported that, a patient was administered with an expired dose of Bexsero . No adverse event was reported. The reporter consented to follow up by phone. Additional Supportive Information: The reporter reported that, a patient was administered with an expired dose of Bexsero, which led to expired vaccine used. The case US2022118004 was identified as duplicate of US2022118010. The case US2022118010 would be voided, and all the future correspondence would be added in this case US2022118004 which stands as a case of record for this patient.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 month old received Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 322CM, expiry date 15th February 2024) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 8th August 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 8th August 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 11-AUG-2022 Reporter's comment: The certified Medical Assistant reported that the patient received a dose of Pediarix and Rotarix.   The reporter consented to follow up by postal. Additional Supportive Information: The one month old patient received a dose of Pediarix and Rotarix, which led to inappropriate age at vaccine administration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extra dose administered, Illness, Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms; chills; nausea; patient was "sick"; gave third dose, August of 2022 / third dose of Shingrix on 5-Aug-2022; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021) and Shingrix (2nd dose received in December 2021). Concurrent medical conditions included hypertrophic cardiomyopathy.   On 5th August 2022, the patient received the 3rd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, nausea, sickness and extra dose administered. In August 2022, the patient experienced pain in arm. On 7th August 2022, the outcome of the influenza-like symptoms, chills, nausea and sickness were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, nausea, sickness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-AUG-2022 and 12-AUG-2022 Reporter's Comments: The patient called and only gave limited demographic information.  Her pharmacy gave her a third dose two weeks ago of reporting date in August of 2022.  The patient then experienced chills, nausea, and a sore arm.  The nurse reported that the patient (reporter´s sister) who had a clinical history of hypertrophic cardiomyopathy received a third dose of Shingrix in error on Friday.  The patient was sick from Friday to Sunday and described it as flu-like symptoms. Adverse event filed. Gave medical disclaimer.  Referred to Health care professional.  Spoke per package insert and content.  Provided medical incharge phone number for health care professional reference.  Offered after call survey. Additional Supportive Information: The patient received 3rd dose of Shingrix which led to extra dose administered. The reporter consented to follow up. The case US2022118022 was identified as duplicate of US2022118577. The case US2022118577 would be voided, and all the future correspondence would be added in this case US2022118022 which stands as a case of record for this patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu-like symptoms; chills; nausea; patient was "sick"; gave third dose, August of 2022 / third dose of Shingrix on 5-Aug-2022; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021) and Shingrix (2nd dose received in December 2021). Concurrent medical conditions included hypertrophic cardiomyopathy.   On 5th August 2022, the patient received the 3rd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, nausea, sickness and extra dose administered. In August 2022, the patient experienced pain in arm. On 7th August 2022, the outcome of the influenza-like symptoms, chills, nausea and sickness were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, nausea, sickness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-AUG-2022 and 12-AUG-2022 Reporter's Comments: The patient called and only gave limited demographic information.  Her pharmacy gave her a third dose two weeks ago of reporting date in August of 2022.  The patient then experienced chills, nausea, and a sore arm.  The nurse reported that the patient (reporter´s sister) who had a clinical history of hypertrophic cardiomyopathy received a third dose of Shingrix in error on Friday.  The patient was sick from Friday to Sunday and described it as flu-like symptoms. Adverse event filed. Gave medical disclaimer.  Referred to Health care professional.  Spoke per package insert and content.  Provided medical incharge phone number for health care professional reference.  Offered after call survey. Additional Supportive Information: The patient received 3rd dose of Shingrix which led to extra dose administered. The reporter consented to follow up. The case US2022118022 was identified as duplicate of US2022118577. The case US2022118577 would be voided, and all the future correspondence would be added in this case US2022118022 which stands as a case of record for this patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the second dose of shingrix before than recommended; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 15th December 2021, the patient received the 2nd dose of Shingrix. On 15th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 11-Aug-2022 Reporter's comment: The patient received the second dose of shingrix before than recommended according to the schedule of Shingrix.  The patient did not consent to follow-up. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Infanrix on a 15 y/o; administration of Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa (Infanrix) (batch number 4L9EF, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 9th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 11-AUG-2022 Reporter's Comments: The reporter stated that the administration of Infanrix on a 15 year old patient instead of Boostrix. The reporter gave Consent to follow up. Additional supportive Information: The 15 year old Patient recived Infanrix instead of Boostrix which lead to wrong vaccine administration and Inappropriate age at vaccine administration.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patient received extra dose of Shingrix on 6/24/2022; patient received first dose of Shingrix on 1/11/2018 and the second dose on 7/10/2019; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th Jan 2018 ).   On 24th June 2022, the patient received the 3rd dose of Shingrix. On 10th July 2019, the patient received the 2nd dose of Shingrix. On 10th July 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 24th June 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.       Additional Information: GSK receipt date:12-AUG-2022 Reporters comment: The reporter was daughter in law of patient. The patient received first dose of Shingrix on 11th Jan 2018 and the second dose on 10 July 2019. The patient received 3rd dose of Shingrix on 24th June 2022, from their pharmacy.  The reporter given consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix  which led to Extra dose administered and patient received 2nd dose late which led to lengthening of vaccination schedule.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: tiredness; bad headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's comments: The reporter was the patient herself, who had received her second dose of Shingrix on Monday, 8th August 2022. She stated that she had experienced tiredness and a bad headache after her dose. The symptoms had not resolved at the time of reporting.  The reporter had consented to follow-up.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) 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.   On 12th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 12-AUG-2022 Reporter's Comments: The medical assistance reported female patient was administrated with an expired dose of Twinrix on 12th August 2022 which was expired on 7th August 2022, which led to expired vaccine used.  The patient had no adverse event reported. The reporter did not consented to follow-up. Additional supportive information: The patient received expired dose of Twinrix which led expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix in error; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The patient received a third dose of Shingrix in error. The reporter was not asked about follow-up. Additional Supportive Information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old was given Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Kinrix and Kinrix 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: 15-AUG-2022 Reporter's comment: The physician reported that the patient received a dose of Kinrix into right thigh. The patient was not experienced any side effects. The reporter did not consent to follow up. Additional Supportive Information: The two month old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a dose of that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) 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.   On 13th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 16-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received a dose of Twinrix that had expired on 7th August 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired Twinrix, which led to expiry vaccine used.