chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Vaccination failure
Clinical narrative: Series completion in September, current case of shingles/suspected vaccination failure; Mild shingles on face/Shingles from outside eye; Tingling; Pain; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, Flu vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after receiving COVID-19 VACCINE, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tingling and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, tingling and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tingling and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, tingling and pain to be related to Flu vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The reporter reported the patient getting her 2nd dose of Shingrix in the September timeframe in between got her flu and COVID shots which she spaced out. The patient had a current case of mild shingles on left side of face from outside eye to lips.  The patient woke up a few days ago with tingling, pain and called her provider immediately. The patient was seen and prescribed a course of Valtrex which she was currently taking.  The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles, tingling and pain to be related to COVID shots. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. As per reported information (mild shingles on left side of face from outside eye to lips), only shingles was coded as event as in shingles where outside the eye not inside.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic shock, Autoimmune disorder, Hypersensitivity
Clinical narrative: anaphylaxis to egg; autoimmune disease / never recovered /spiraled; allergic to all the top 8 allergens; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylactic shock due to eggs in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylactic shock due to eggs (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant) and allergy. On an unknown date, the outcome of the anaphylactic shock due to eggs was unknown and the outcome of the autoimmune disorder and allergy were not recovered/not resolved.   The reporter considered the anaphylactic shock due to eggs, autoimmune disorder and allergy to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 24-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that it did not work for everyone. The patient had received it and autoimmune disease was birth from that moment. The patient also experienced anaphylaxis to egg in the flu shot. The patient immune system never recovered and spiraled. The patient became allergic to all the top eight allergens. The people said how do you know. The patient got shot and went straight to the emergency room. The patient said could no longer get any vaccines.  The reporter think that the event might have been related to the product and device. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccine helped, it gives me very slightly/Suspected vaccination failure; Broke out inside me, a few sprouted in back; Awful, horrible pain; 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 and pain. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that it also gave him/her but it broke out inside him/her and the acyclovir took them away, just a few sprouted in his/her back but they were very awful pains. The vaccine helped the patient suddenly it gave him/her but very slightly they were horrible pains and worse inside because you could not heal them with anything. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Brain oedema
Clinical narrative: other also had similar problems, edema in brain; This case was reported by a physician and described the occurrence of brain edema in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced brain edema (serious criteria GSK medically significant). On an unknown date, the outcome of the brain edema was unknown.   It was unknown if the reporter considered the brain edema to be related to Shingrix.  Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: The reporter reported that other people (patient) also had problems similar to his (edema in brain). He accepted the contact from the pharmacovigilance sector only by postal mail. Additional Supportive Information: The case had been linked to US2023008033, reported by the same reporter.; Sender's Comments:  US-GSK-US2023008033:same reporter - reporter´s case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shot, still got Shingles/suspected vaccination failure; still got Shingles; pain; 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 and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and still got the shingles and reported never had the rash just the pain. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Achy arm, minimal side effects; Feeling under the weather; 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 (Shingrix) for prophylaxis.   On 16th January 2023, the patient received the 2nd dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had 2nd dose of Shingrix vaccine. The patient had minimal side effects. The patient had achy arm and feeling a little under the weather. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 22Nov2021, 2nd  not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 22nd November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The reporter stated that it was not a temperature excursion, that was what they put as the issue at first.  That was not the issue.  The issues was the patient did not get second shot of Shingrix. The reporter wanted to know if the patient need to restart the 2-shot series all over or they could just get a 2nd shot at the time of reporting and call. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Lymph node pain
Clinical narrative: Redness in arm around injection; Lymph nodes in arm pit sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema 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 injection site erythema and lymph node pain. On an unknown date, the outcome of the injection site erythema and lymph node pain were unknown.   It was unknown if the reporter considered the injection site erythema and lymph node pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had redness in arm around injection and asked could this vaccination cause lymph nodes in armpit to be sore, same arm as injection. Additional Supportive Information: Unknown arm was conservatively captured as anatomical location and lymph node pain was conservatively captured as event although in narrative it was stated as question. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was only given the liquid; Patient was only given the liquid; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comments:  The patient was only given the liquid before reconstituted. Additional Supportive Information: The patient was only given the liquid before reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR010183:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Haven't felt well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2023AMR011214   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had not felt well since got the shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact details were available. For tolerance of 2nd dose of shingles vaccine, refer case US2023AMR011214.; Sender's Comments:  US-GSK-US2023AMR011214:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Haven't felt well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of shingles vaccine received on an unknown date, for tolerance of 1st dose, refer case US2023AMR011206).   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 feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   Linked case(s) involving the same patient : US2023AMR011206   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had not felt well since got the shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR011206:Same patient
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: violently ill; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a female 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 illness. On an unknown date, the outcome of the illness was unknown.   The reporter considered the illness to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 25-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot of two. The patient was violently ill, it was not for everyone. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Discomfort
Clinical narrative: suffering the discomfort; sent me to bed, it is horrible; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort and bedridden. On an unknown date, the outcome of the discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the discomfort and bedridden to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR012339   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient got the shingles vaccine in October and in December the booster, both of them sent him/her to bed for three days it was horrible. The patient said it was worth suffering the discomfort for three days than to suffer the sequelae for all life, please get the vaccine. Additional supportive information: As per narrative shingles vaccine seems to have been administered in 2022, hence conservatively 2022 year was captured. This case had been linked with case US2023AMR012339, reported by the same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR012339:same reporter - 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Discomfort, Vaccine positive rechallenge
Clinical narrative: suffering the discomfort; sent me to bed, it is horrible; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of discomfort (received 1st dose in October 2022 and was also bedridden, refer link case US2023AMR012334).   In December 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort and bedridden. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the discomfort and bedridden to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR012334   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: This case was reported by patient via interactive digital media. The patient got the shingles vaccine in October and in December 2022 the booster, both of them sent him/her to bed for three days it was horrible. The patient said it was worth suffering the discomfort for three days than to suffer the sequelae for all life, please get the vaccine. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR012334:same reporter - 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: swelling at the injection point; welt at the injection point; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2023, the patient received the 1st dose of Shingrix. On 28th January 2023, 2 days after receiving Shingrix, the patient experienced injection site swelling and injection site wheal. On an unknown date, the outcome of the injection site swelling and injection site wheal were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site wheal to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingrix dose on Thursday.  On the day of reporting, the patient had swelling and a welt at the injection point.  The reporter wanted to know how long should this last. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2022, is late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd august 2022 with batch number:J477Y expiry date:20th May 2023).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 23-JAN-2023 Reporter comment: The pharmacist reported that a male patient received the 1st dose of Twinrix and was late for the 2nd dose. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 21Nov2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date : 23 Jan 2023 Reporters comment: The case was reported by the pharmacist. The pharmacist reported that the patient was not immunocompromised who received Shingrix first dose on 2019 and they want to administer a second dose. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. Reporter did not consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5 YO received Boostrix, when 3YO received Infanrix; 5 YO received Boostrix instead of DTap; when 3YO received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on 13th September 2017), pediarix (received 2nd dose on 16th November 2017), pediarix (received 3rd dose on 13th February 2018) and Kinrix (received dose on 17th Oct 2021).   On 18th January 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 13th May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th May 2021, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 18th January 2023, 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, 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: 23-JAN-2023 Reporter's Comments:  Nurse reports 5-year-old male patient was administered a dose of Boostrix on 18th January 2023 instead of DTaP.   The patient had Infanrix on 13th May 2021. The reporter consented to follow up.  The Vaccine Administration facility was the same as Primary Reporter. Additional Supportive Information: The 5 year old patient received Boostrix on 18th January 2023 instead of DTaP, which led to inappropriate age at vaccine administration, wrong vaccine administered. The patient received Infanrix vaccine at age of 3 years, which led to inappropriate age at vaccine administration. Infanrix captured as a suspect as per conservative approach an more clarification has been raised.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given less than 1 month after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 26th June 2022, the patient received the 2nd dose of Shingrix. On 26th June 2022, unknown after receiving Shingrix and an unknown time 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: 24-Jan-2023 Reporter's comment: The patient received first dose of Shingrix on 7th June 2022 and the second dose was administered on 26th June 2022.  Pharmacist informed that patient did not report adverse events. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: the patient received 2nd dose on 26th June 2022 and received 1st dose on 7th June 2022, which led to drug dose administration interval too short.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in2019, hasn´t had 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments:  The patient had first dose of Shingrix in 2019 and yet second dose was not administered. The reporter consented to follow up via email. Healthcare professional (HCP) was asked about patient information, vaccination date and batch number for the vaccine, information was declined. HCP looked in their system and couldn't find anything. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023010238:same reporter
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Bell's palsy, Exposure during pregnancy
Clinical narrative: being 33 weeks pregnant; Bells Palsy, gotten progressively worse; This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th January 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 13th March 2023. The patient received Boostrix at week 33 of the pregnancy. On 23rd January 2023, 3 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccine exposure during pregnancy. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)) and steroids nos (Steroids). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved and the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was lost to follow up.   It was unknown if the reporter considered the bell's palsy to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's comment: The caller was the patient and had reported that she had received an Boostrix dose in the right arm. She had reported of experiencing Bells Palsy on 23 January 2023 and was diagnosed by Healthcare Professional (HCP). She had reported that, the HCP had prescribed antibiotics and steroids as treatment.  She had reported that, her condition had gotten progressively worse, since the onset.  She had reported being 33 weeks pregnant and the expected due date was 13 March 2023. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 20Nov2019, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 20th November 2019, batch number PR5B2 and expiry date 15th November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's Comments:  The reporter asked if the patient could get the second dose of Shingrix or need to restart the series. The patient received the first dose of Shingrix back on 20th November 2019 and never got the second dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site nodule, Injection site pain, Myalgia
Clinical narrative: Nodule at injection site , painful when rubbed; Pain at injection site,  has lessened significantly/nodule is painful when rubbed; Arm pain, primarily at elbow; having pain in the left arm, primarily at the elbow; Myalgia in legs, feet, arm, upper left side of the back; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2023, the patient received the 2nd dose of Shingrix. On 19th January 2023, 1 days after receiving Shingrix, the patient experienced injection site nodule, injection site pain, pain in arm, pain in elbow, myalgia and fatigue. On an unknown date, the outcome of the injection site nodule, pain in arm, pain in elbow and myalgia were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the injection site nodule, injection site pain, pain in arm, pain in elbow, myalgia and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's comment: The caller was the patient. She had reported of receiving second dose of Shingrix in the left arm. She had experienced pain at the injection site, a nodule at the injection site, fatigue, myalgia, and arm pain and all the symptoms began the day after dose was received, on 19 January 2023. She had reported that, the fatigue had resolved after two days. She had reported all other symptoms were ongoing at the time of reporting.  She had experienced myalgia in the legs, feet, arm, and upper, left side of the back.  She had reported of having pain in the left arm, primarily at the elbow. She had reported that, the nodule was painful when rubbed. She had reported that, the pain at injection site had lessened significantly. She had reported that, all the other symptoms had been consistent, meaning they have gotten no better or worse since the onset.  The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Nodule at injection site , painful when rubbed; Pain at injection site,  has lessened significantly/nodule is painful when rubbed; Arm pain, primarily at elbow; having pain in the left arm, primarily at the elbow; Myalgia in legs, feet, arm, upper left side of the back; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2023, the patient received the 2nd dose of Shingrix. On 19th January 2023, 1 days after receiving Shingrix, the patient experienced injection site nodule, injection site pain, pain in arm, pain in elbow, myalgia and fatigue. On an unknown date, the outcome of the injection site nodule, pain in arm, pain in elbow and myalgia were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the injection site nodule, injection site pain, pain in arm, pain in elbow, myalgia and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JAN-2023 Reporter's comment: The caller was the patient. She had reported of receiving second dose of Shingrix in the left arm. She had experienced pain at the injection site, a nodule at the injection site, fatigue, myalgia, and arm pain and all the symptoms began the day after dose was received, on 19 January 2023. She had reported that, the fatigue had resolved after two days. She had reported all other symptoms were ongoing at the time of reporting.  She had experienced myalgia in the legs, feet, arm, and upper, left side of the back.  She had reported of having pain in the left arm, primarily at the elbow. She had reported that, the nodule was painful when rubbed. She had reported that, the pain at injection site had lessened significantly. She had reported that, all the other symptoms had been consistent, meaning they have gotten no better or worse since the onset.  The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Admiistered after temperature excursion; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2023, the patient received the 2nd dose of Shingrix. On 7th January 2023, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 25-Jan-2023 Reporter's comment: Consumer stated that the pharmacy contacted her about the second dose of Shingrix she had received.  Pharmacy reported to her that the dose she received had been stored outside of the recommended temperature range and that she needed to contact GSK.  Additional supportive information: the patient received Shingrix which was stored outside of the recommended temperature range, which led to Incorrect storage of drug.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Urticaria
Clinical narrative: small hives on the trunk of her body, under her right breast, and bilateral thighs; Metal taste in mouth; This case was reported by a consumer via call center representative and described the occurrence of taste metallic in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2022, the patient received the 1st dose of Shingrix. On 29th November 2022, immediately after receiving Shingrix, the patient experienced taste metallic. In January 2023, the patient experienced hives. On an unknown date, the outcome of the taste metallic was recovered/resolved and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the taste metallic and hives to be related to Shingrix.     Additional Information: GSK receipt date: 26-JAN-2023 Reporter comment: The reporter was the patient. The patient received her first dose of Shingrix experienced a metal taste in her mouth right after. The metal taste had resolved. The past 7 to 10 days, the patient has been experiencing small hives on the trunk of her body, under her right breast, and bilateral thighs. The reporter consented to follow up. Reporter/ patient gave consent to follow up with HCP (pharmacy).
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: an expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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 18th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th January 2023, 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: 26-JAN-2023 Reporter's Comment: The nurse called to report an expired dose of Twinrix was administered to a patient. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case had been linked with US2023011719 reported by same reporter.; Sender's Comments:  US-GSK-US2023011719:same reporter
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid portion only; administered liquid portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa902a, expiry date 28th February 2025) for prophylaxis.   On 26th January 2023, the patient received Menveo. On 26th January 2023, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 26-JAN-2023 Reporter comment: The reporter reported that, the MA (Medical assistant) administered Menveo liquid portion only. The adverse event contained all reported information. The health care practitioner gave consent for safety team follow up. The reporter consented to follow up. Additional Supportive Information: The Medical assistant administered Menveo liquid portion only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2020, has not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments:  The reporter was the patient. The patient stated she received her first dose of Shingrix in September 2020 and had not yet received her second dose. The reporter consented to follow up with HCP (pharmacy). Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023012632:SAME REPORTER
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: CARDIAC ARREST ISSUES; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cardiac arrest issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiac arrest issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230150683- Cardiac arrest issues- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no symptoms of fever, cough, congestion, chills. The patient previously received covid-19 vaccine ad26.cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 31-MAR-2021 for covid-19 prophylaxis It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received booster on covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 03-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JAN-2022, the patient tested positive for covid-19 (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. On 01-FEB-2022,COVID-19 virus test Clear (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 test positive on 01-FEB-2022. This report was non-serious. This case, from the same reporter is linked to 20230157162.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 175 pounds, and height was 72 inches. The patient's concurrent conditions included: non-alcohol user, smoker, marginal sugar, and marginal blood pressure, and other pre-existing medical conditions included: The patient had no known drug allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, Vaccinated at Arm (unspecified), 1 total administered on 29-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 61 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 18-JUN-2021, 20 days after the vaccine, the patient experienced stroke and after that on an unspecified date, the patient now had paralyzed in the left arm due to the stroke he had due to the vaccine. The patient was very upset regarding what happened and stated that he would never take another vaccine in his life. Since the stroke, patient was on so many medication. He also stated that let the upper board members know that are receiving bonuses that they have expedited his death and he would be dead shortly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000268985.; Sender's Comments: V0: 20230159993-Stroke. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.