chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot, still had shingles/Suspected vaccination failure; ShinglesStill had shingles; Pain/may be lessen the pain some; 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: 6-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the shot did not mean that you would not had the shingles. The patient had the shot and still had shingles, might be lessen the pain some. 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both vaccines, had shingles again/Suspected vaccination failure; shingles/ This summer i hafd shingles again; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had severe case of chickenpox ) and shingles (had shingles when the patient was younger ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK receipt date: 6-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the shingles was something to avoid if possible. The patient had shingles when he/she was younger due to a severe case of chicken pox.  After recovering, the patient made sure he/she received both vaccines. This summer (2022),  the patient had shingles again.  The patient stated that not fun. 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: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Got the shot, had shingles /Suspected vaccination failure; Shingles /worse than the shingles that I had; Busted out with blisters; 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.   The patient's past medical history included shingles.   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 blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had vaccine but still got shingle. The reporter reported that they were busted out with blisters and they had shingles, no more shots, never again, no shots. The shingle shot of vaccine was terrible and they busted out and blisters which were worse than the shingles that they had. Additional supportive information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was reported at the time of reporting. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Administered to patient after temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   On 1st August 2022, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 4-Aug -2022 Reporter's comment: Medical assistant called in to report a temperature excursion for Engerix B that was administered to the patient.  The reporter stated that the product had a temperature excursion with a lowest temperature of 35.9 degree Fahrenheit  for 40 minutes on 18th July 2022.  The reporter consented to follow up. Additional supportive information: Engerix B had a temperature excursion with a lowest temperature of 35.9 degree Fahrenheit  for 40 minutes, which led to Incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR115355:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash papular, Stress
Clinical narrative: Significant personal stress; Tiny bumps; This case was reported by a consumer via interactive digital media and described the occurrence of stress in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. In July 2022, between 1 and 2 years after receiving Shingrix, the patient experienced papular rash. On an unknown date, the patient experienced stress. On an unknown date, the outcome of the stress and papular rash were unknown.   It was unknown if the reporter considered the stress and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was 2 years post double Shingrix vaccine and had been under significant personal stress. The patient recently had tiny bumps in the past month. Additional Supportive Information: Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Children accidentally given Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comments; This case was reported by consumer via interactive digital media. The patients (children) accidentally administered with Shingrix. Additional supportive information: The patients were children accidentally administered with Shingrix which led inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only liquid component of Menveo; administered only liquid component of Menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 8-Aug-2022 Reporter's comment: The physician called back to report that a medical assistant inadvertently administered only the liquid component of Menveo to two unknown patients out of a group of a possible six patients. It was unknown which two of the group of six patients received only the liquid component.  Confirmed with the caller that no patients only had the powder component. The reporter declined follow-up.  Did not consent to follow-up. The case is for 1 of 6 linked patients reported by same reporter. Additional supportive information: The patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022116445:Same reporter US-GSK-US2022AMR116728:Same reporter US-GSK-US2022AMR116731:Same reporter US-GSK-US2022AMR116736:Same reporter US-GSK-US2022AMR116737:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Made my husband and I sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was sick and did not took second dose.  The follow-up could not be possible as no contact details were available Additional Supportive Information: The case had been linked with US2022AMR116798 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR116798:Same reporter (Husband case)
Sex: M
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: made my husband and I sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05-AUG-2022 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient was sick and did not took second dose.  The follow-up could not be possible as no contact details were available The case had been linked with US2022AMR116795 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR116795:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: So sick I wish I'd never had it done; 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.   The patient's past medical history included shingles (had a mild case of shingles in April (year unspecified)). Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR116806.).   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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR116806   Additional Information: GSK Receipt Date: 06-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had mild case of shingles, so they recommended after that, that the patient got the series of two shingles vaccines. The second one made patient so sick, the patient wished he/she would have never had it. Additional Supportive Information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR116806:Same reporter.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo powder with non-GSK sterile diluent; reconstituted Menveo powder with non-GSK sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA702A, expiry date 28th February 2023) for prophylaxis.   On 1st August 2022, the patient received Menveo. On 1st August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-AUG-2022. Reporter's Comments: The clinical supervisor called in to inquire that should they revaccinate and if so, how long to wait. The clinical supervisor reported that they reconstituted Menveo lyophilized powder with a non-GlaxoSmithKline sterile diluent and inadvertently administered to a patient. No other additional details were provided. The consent to follow up was not granted. Additional Supportive Information: As patient reconstituted Menveo lyophilized powder with a non- GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cluster headache, Condition aggravated, Malaise, Pain in extremity, Pancreatic disorder
Clinical narrative: Pancreatitis; pancreas issues; felt unwell; sore arm; fever; cluster headaches; This case was reported by a consumer via call center representative and described the occurrence of pancreatitis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cluster headaches.   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th March 2022, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain in arm and fever. On 13th March 2022, the patient experienced cluster headache. In May 2022, the patient experienced pancreatitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced pancreatic disorder. On an unknown date, the outcome of the pancreatitis, cluster headache, feeling unwell, pain in arm and fever were recovered/resolved and the outcome of the pancreatic disorder was not recovered/not resolved.   It was unknown if the reporter considered the pancreatitis, pancreatic disorder, cluster headache, feeling unwell, pain in arm and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 3-Aug-2022. Reporter's Comments: The caller was the patient itself stated that she received her Shingrix vaccine and the following day she started with a fever, sore arm and felt unwell in general for a few days. On 13th March 2022, 3 days after receiving Shingrix, the patient experienced cluster headache. She also had a history of getting cluster headaches and 2-3 days post vaccine, she started with a series of cluster headaches that lasted for about 8 weeks. In May 2022, less than 3 months after receiving Shingrix, the patient experienced pancreatitis. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pancreatic disorder. In addition, she developed pancreatitis in May that had subsided, but continued to have ongoing pancreas issues. The patient did not want to give any further demographics or have in more information about the vaccine itself. The consent to follow was not granted. Additional Supportive Information: This case was linked with US2022114898 reported by same reporter. Note: As per narrative the onset date for Pancreatitis was considered as May 2022. As per vaccination date and event onset the TTO for Pancreatitis was captured as less than 3 months.; Sender's Comments:  US-GSK-US2022114898:Same reporter. Patient 2
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pancreatitis, Pyrexia
Clinical narrative: Pancreatitis; pancreas issues; felt unwell; sore arm; fever; cluster headaches; This case was reported by a consumer via call center representative and described the occurrence of pancreatitis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cluster headaches.   On 10th March 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th March 2022, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain in arm and fever. On 13th March 2022, the patient experienced cluster headache. In May 2022, the patient experienced pancreatitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced pancreatic disorder. On an unknown date, the outcome of the pancreatitis, cluster headache, feeling unwell, pain in arm and fever were recovered/resolved and the outcome of the pancreatic disorder was not recovered/not resolved.   It was unknown if the reporter considered the pancreatitis, pancreatic disorder, cluster headache, feeling unwell, pain in arm and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 3-Aug-2022. Reporter's Comments: The caller was the patient itself stated that she received her Shingrix vaccine and the following day she started with a fever, sore arm and felt unwell in general for a few days. On 13th March 2022, 3 days after receiving Shingrix, the patient experienced cluster headache. She also had a history of getting cluster headaches and 2-3 days post vaccine, she started with a series of cluster headaches that lasted for about 8 weeks. In May 2022, less than 3 months after receiving Shingrix, the patient experienced pancreatitis. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pancreatic disorder. In addition, she developed pancreatitis in May that had subsided, but continued to have ongoing pancreas issues. The patient did not want to give any further demographics or have in more information about the vaccine itself. The consent to follow was not granted. Additional Supportive Information: This case was linked with US2022114898 reported by same reporter. Note: As per narrative the onset date for Pancreatitis was considered as May 2022. As per vaccination date and event onset the TTO for Pancreatitis was captured as less than 3 months.; Sender's Comments:  US-GSK-US2022114898:Same reporter. Patient 2
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Weight decreased
Clinical narrative: GI symptoms; Diarrhea; weight loss; first vaccine in June 2021, has not gotten second; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix, the patient experienced gastrointestinal disorder, diarrhea, weight loss and incomplete course of vaccination. In February 2022, the outcome of the gastrointestinal disorder, diarrhea and weight loss were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the gastrointestinal disorder, diarrhea and weight loss to be related to Shingrix.     Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The patient stated that she got 1st dose of Shingrix in left arm and 36 hours after getting the vaccine, she started with GI symptoms that included Diarrhea and weight loss.   These symptoms lasted until February 2022.   The patient has not gotten her second vaccine yet (inappropriate dosing schedule).   The patient did not had any further information about the vaccine itself. The reporter consented to follow-up. 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.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site bruising, Injection site discolouration, Injection site pain, Injection site urticaria
Clinical narrative: yellow/green bruise at injection site; yellow/green bruise at injection site; arm itches; 3 inch by 4 inch welt below the injection site; could barely chew; facial swelling near lip; herpes labialis flare up triggered by vaccine/suspected/possible herpes labialis flare up.; body aches; severe pain at the injection site; low grade fever; This case was reported by a nurse via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes labialis.   On 28th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 28th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain and fever. On 3rd August 2022, the patient experienced herpes labialis, chewing difficulty and facial swelling. On an unknown date, the patient experienced injection site discoloration, injection site bruising, itchy upper limbs and welts. On an unknown date, the outcome of the injection site discoloration, injection site bruising, injection site pain, itchy upper limbs, facial swelling and welts were not recovered/not resolved and the outcome of the herpes labialis and chewing difficulty were unknown and the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site discoloration, injection site bruising, injection site pain, general body pain, itchy upper limbs, chewing difficulty, facial swelling, welts and fever to be related to Shingrix. The reporter considered the herpes labialis to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-AUG-202 Reporter's Comment: The reporter herself was the patient and nurse also. On 28th July 2022 she had received her first Shingrix dose and had experienced severe pain at the injection site, described it was a ton of lead being pushed into her arm.  She had experienced a low grade fever and body aches after the injection. She had developed a 3 inch by 4-inch welt below the injection site. She now had a yellow/green bruise at the injection site.  Her arm itches. The day before reporting on 3rd August 2022 she had developed facial swelling near her lip and could barely chew (AE: swelling, not recovered). She believed that the facial swelling was a herpes labialis flare up triggered by the Shingrix vaccine. She had nothing else to report. The reporter consented to follow-up but does not had a consented physician at this time. Additional supportive information: The time taken to onset for injection site bruising, injection site pain, general body pain, pruritus, welts and fever was captured as Less than a day and for herpes labialis, facial swelling and chewing difficulty it was captured as 6 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mastication disorder, Oral herpes, Pain, Pruritus, Pyrexia
Clinical narrative: yellow/green bruise at injection site; yellow/green bruise at injection site; arm itches; 3 inch by 4 inch welt below the injection site; could barely chew; facial swelling near lip; herpes labialis flare up triggered by vaccine/suspected/possible herpes labialis flare up.; body aches; severe pain at the injection site; low grade fever; This case was reported by a nurse via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes labialis.   On 28th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 28th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain and fever. On 3rd August 2022, the patient experienced herpes labialis, chewing difficulty and facial swelling. On an unknown date, the patient experienced injection site discoloration, injection site bruising, itchy upper limbs and welts. On an unknown date, the outcome of the injection site discoloration, injection site bruising, injection site pain, itchy upper limbs, facial swelling and welts were not recovered/not resolved and the outcome of the herpes labialis and chewing difficulty were unknown and the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site discoloration, injection site bruising, injection site pain, general body pain, itchy upper limbs, chewing difficulty, facial swelling, welts and fever to be related to Shingrix. The reporter considered the herpes labialis to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-AUG-202 Reporter's Comment: The reporter herself was the patient and nurse also. On 28th July 2022 she had received her first Shingrix dose and had experienced severe pain at the injection site, described it was a ton of lead being pushed into her arm.  She had experienced a low grade fever and body aches after the injection. She had developed a 3 inch by 4-inch welt below the injection site. She now had a yellow/green bruise at the injection site.  Her arm itches. The day before reporting on 3rd August 2022 she had developed facial swelling near her lip and could barely chew (AE: swelling, not recovered). She believed that the facial swelling was a herpes labialis flare up triggered by the Shingrix vaccine. She had nothing else to report. The reporter consented to follow-up but does not had a consented physician at this time. Additional supportive information: The time taken to onset for injection site bruising, injection site pain, general body pain, pruritus, welts and fever was captured as Less than a day and for herpes labialis, facial swelling and chewing difficulty it was captured as 6 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Urticaria
Clinical narrative: yellow/green bruise at injection site; yellow/green bruise at injection site; arm itches; 3 inch by 4 inch welt below the injection site; could barely chew; facial swelling near lip; herpes labialis flare up triggered by vaccine/suspected/possible herpes labialis flare up.; body aches; severe pain at the injection site; low grade fever; This case was reported by a nurse via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes labialis.   On 28th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 28th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain and fever. On 3rd August 2022, the patient experienced herpes labialis, chewing difficulty and facial swelling. On an unknown date, the patient experienced injection site discoloration, injection site bruising, itchy upper limbs and welts. On an unknown date, the outcome of the injection site discoloration, injection site bruising, injection site pain, itchy upper limbs, facial swelling and welts were not recovered/not resolved and the outcome of the herpes labialis and chewing difficulty were unknown and the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site discoloration, injection site bruising, injection site pain, general body pain, itchy upper limbs, chewing difficulty, facial swelling, welts and fever to be related to Shingrix. The reporter considered the herpes labialis to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-AUG-202 Reporter's Comment: The reporter herself was the patient and nurse also. On 28th July 2022 she had received her first Shingrix dose and had experienced severe pain at the injection site, described it was a ton of lead being pushed into her arm.  She had experienced a low grade fever and body aches after the injection. She had developed a 3 inch by 4-inch welt below the injection site. She now had a yellow/green bruise at the injection site.  Her arm itches. The day before reporting on 3rd August 2022 she had developed facial swelling near her lip and could barely chew (AE: swelling, not recovered). She believed that the facial swelling was a herpes labialis flare up triggered by the Shingrix vaccine. She had nothing else to report. The reporter consented to follow-up but does not had a consented physician at this time. Additional supportive information: The time taken to onset for injection site bruising, injection site pain, general body pain, pruritus, welts and fever was captured as Less than a day and for herpes labialis, facial swelling and chewing difficulty it was captured as 6 days.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Pediarix and Infanrix instead of Dtap-IPV; Pediarix and Infanrix on the same day; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 4th August 2022, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and overdose. On an unknown date, the outcome of the wrong vaccine administered and overdose 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: 05-AUG-2022 Reporter's comments: The physician stated that yesterday (from the day of reporting), a 5 years old patient received Pediarix and Infanrix on the same day. The patient was supposed to get 1 Dtap but got 2 (patient should had received Dtap-IPV, MMR, Varivax). The reporter consented to follow-up via postal. Additional supportive information: The patient received Pediarix and Infanrix on the same day. The patient was supposed to get 1 Dtap but got 2 which led to wrong vaccine administered and overdose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fluid retention, Heart rate increased
Clinical narrative: increase in hear rate, went to ER, admitted to hospital; shortness of breath, admitted to hospital for a few days; dizziness, admitted to hospital; fluid retention, admitted to hospital; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Shingrix. In June 2022, 4 days after receiving Shingrix, the patient experienced heart rate increased (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), dizziness (serious criteria hospitalization) and fluid retention (serious criteria hospitalization). On an unknown date, the outcome of the heart rate increased, shortness of breath, dizziness and fluid retention were recovered/resolved.   It was unknown if the reporter considered the heart rate increased, shortness of breath, dizziness and fluid retention to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The patient self-reported this case The patient wanted to know if side effects could happen 3 to 4 days after receiving Shingrix vaccine. The patient stated that, 4 days after Shingrix dose 1 she experienced an increase in her hear rate, shortness of breath, dizziness and fluid retention. She had to go to emergency room and admitted to hospital for a few days. Her symptoms subsided but she asked if it was safe to get dose 2 of Shingrix vaccine. The reporter consent to follow up with HCP and herself.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5 YO patient received SHINGRIX; received SHINGRIX instead of KINRIX; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 5-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2022, the patient received Shingrix. On 4th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. In August 2022, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK receipt date:05-AUG- 2022 Reporters comment: The reporter was the patient's mother. 5 year old female patient who accidently received SHINGRIX instead of KINRIX.  The reporter also stated that the patient had soreness at the injection site.  The reporter did not consent for follow-up. Additional Supportive information: The patient accidently received SHINGRIX instead of KINRIX, which led to wrong vaccine administered and inappropriate age at vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix administrated with wrong adjuvant; antigen was reconstituted with a steroid water intended for live virus vaccines versus the adjuvant that Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 252jx, expiry date 14th September 2023) for prophylaxis.   On 10th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK receipt date: 5-AUG-2022 Reporters comment: Patient received Shingrix vaccine and that was reconstituted with the wrong adjuvant in the left arm. The reporter reported that the antigen was reconstituted with a steroid water intended for live virus vaccines versus the adjuvant that Shingrix came with.  The reporter did not consent to follow-up.  No HCP for follow up. Additional Supportive information: Patient received Shingrix vaccine and that was reconstituted with the wrong adjuvant which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 10cm area at injection site was red; 10cm area at injection site was hot; 10cm area at injection site was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA605A, expiry date 30th September 2022) for prophylaxis.   On 3rd August 2022, the patient received Menveo. In August 2022, less than a week after receiving Menveo, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site itching to be related to Menveo.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The reporter stated that a female patient was vaccinated with Menveo vaccine on the left arm, but on the day of reporting came into the office and reported a 10 cm area on her left arm (at injection site) that was red, hot and itchy. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Arm tenderness; Induration at the injection site; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2022, the patient received the 1st dose of Shingrix. On 6th May 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and injection site induration. On an unknown date, the outcome of the pain in arm and injection site induration were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-AUG-2022 Reporter's Comment: The patient received Shingrix vaccine. The patient had arm tenderness and the induration at the injection site. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR116654.; Sender's Comments:  US-GSK-US2022AMR116654:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Fear, Headache
Clinical narrative: Dizziness; Chills; Fever; Splitting headache; Nausea, unable to take medication due to fear of vomiting; Extreme fatigue; Slept for 16 hours; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced dizziness, chills, fever, headache, nausea, fatigue and sleepiness. On 7th August 2022, the outcome of the chills, fever and headache were recovered/resolved. On an unknown date, the outcome of the dizziness, nausea and fatigue were recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the dizziness, chills, fever, headache, nausea, fatigue and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine. The reporter stated he was feeling fine for several hours after received vaccine. The reporter reported that he experienced symptoms around 6 pm. The patient experienced dizziness, chills, fever, a splitting headache, nausea and extreme fatigue. The patient was so fatigued that the patient was slept for 16 hours on Friday night. The patient was feeling unable to took medication for symptoms due to the fear of vomiting because of the nausea. The patient had all symptoms throughout the Saturday. The reporter stated headache, fever and chills were resolved on Sunday evening. The reporter stated dizziness, fatigue and nausea were ongoing, but to a much lesser degree. The patient was feeling as through almost back to normal. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pyrexia, Somnolence
Clinical narrative: Dizziness; Chills; Fever; Splitting headache; Nausea, unable to take medication due to fear of vomiting; Extreme fatigue; Slept for 16 hours; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced dizziness, chills, fever, headache, nausea, fatigue and sleepiness. On 7th August 2022, the outcome of the chills, fever and headache were recovered/resolved. On an unknown date, the outcome of the dizziness, nausea and fatigue were recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the dizziness, chills, fever, headache, nausea, fatigue and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine. The reporter stated he was feeling fine for several hours after received vaccine. The reporter reported that he experienced symptoms around 6 pm. The patient experienced dizziness, chills, fever, a splitting headache, nausea and extreme fatigue. The patient was so fatigued that the patient was slept for 16 hours on Friday night. The patient was feeling unable to took medication for symptoms due to the fear of vomiting because of the nausea. The patient had all symptoms throughout the Saturday. The reporter stated headache, fever and chills were resolved on Sunday evening. The reporter stated dizziness, fatigue and nausea were ongoing, but to a much lesser degree. The patient was feeling as through almost back to normal. The reporter did not consent to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: by mistake a DTAP instead of TDAP ( Infanrix instead of Boostrix); 11YO patient received DTAP instead of TDAP ( Infanrix instead of Boostrix); This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The patient received DTAP instead of TDAP (Infanrix instead of Boostrix).  The reporter consented to follow-up. Additional Supportive Information: The 11 years old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Difficulty breathing while playing soft ball; Chest pains; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a day after receiving Shingrix, the patient experienced difficulty breathing and chest pain. On an unknown date, the outcome of the difficulty breathing and chest pain were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: On 2nd August 2022, less than 24 hours later Shingrix vaccination, the patient experienced chest pains and difficulty breathing while playing soft ball. ER (emergency room) visit required. The reporter consented to follow up. Additional Supportive Information: The partial event onset dates were captured to reflect correct time to onset.