chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter knew that this was outside the recommended age range. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix in error at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 57.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Headache, Myalgia, Pain, Pain in extremity
Clinical narrative: 101.6 degree fever; muscles from her thighs to her neck hurt; body aches; headache; arms were sore and hurt; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 8th December 2022, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On 8th December 2022, less than a day after receiving Shingles vaccine and Flu vaccine, the patient experienced pain in arm and chills. On 9th December 2022, the patient experienced fever, muscle pain, general body pain and headache. The patient was treated with paracetamol (Tylenol) and theraflu (nos) (Theraflu). On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, general body pain, headache and pain in arm were not recovered/not resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, muscle pain, general body pain, headache, pain in arm and chills to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 09 DEC 2022 Reporter's comment:  The patient reported that got Shingles vaccine in right arm and Flu vaccine in left arm . The patient reported after she went to bed in the evening on 8th December 2022 and had chills the patient said her arms started getting sore and that they hurt a few hours after getting the vaccines on 8th December 2022. The patient woke up on 9th December 2022 and had headache, body aches, a 101.6 degree fever, and the muscles from her thighs to her neck hurt.  Patient said that she then took a tylenol and her temperature came down to 100.7 degrees and took a 1 hour nap and waited. Patient said later she took more tylenol and theraflu. She said the fever is coming down a little but still present. Patient said her normal body temperature is 96.5 degrees. Patient said she can not take ibuprofen because she "can't take non steroidal non inflammatory drugs. The patient did not know if she received the Shingrix vaccine, just that that she received the shingles vaccine.  Patient did not know the lot number or expiration date of the shingles vaccine she received. Reported did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: 101.6 degree fever; muscles from her thighs to her neck hurt; body aches; headache; arms were sore and hurt; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 8th December 2022, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On 8th December 2022, less than a day after receiving Shingles vaccine and Flu vaccine, the patient experienced pain in arm and chills. On 9th December 2022, the patient experienced fever, muscle pain, general body pain and headache. The patient was treated with paracetamol (Tylenol) and theraflu (nos) (Theraflu). On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the muscle pain, general body pain, headache and pain in arm were not recovered/not resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, muscle pain, general body pain, headache, pain in arm and chills to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 09 DEC 2022 Reporter's comment:  The patient reported that got Shingles vaccine in right arm and Flu vaccine in left arm . The patient reported after she went to bed in the evening on 8th December 2022 and had chills the patient said her arms started getting sore and that they hurt a few hours after getting the vaccines on 8th December 2022. The patient woke up on 9th December 2022 and had headache, body aches, a 101.6 degree fever, and the muscles from her thighs to her neck hurt.  Patient said that she then took a tylenol and her temperature came down to 100.7 degrees and took a 1 hour nap and waited. Patient said later she took more tylenol and theraflu. She said the fever is coming down a little but still present. Patient said her normal body temperature is 96.5 degrees. Patient said she can not take ibuprofen because she "can't take non steroidal non inflammatory drugs. The patient did not know if she received the Shingrix vaccine, just that that she received the shingles vaccine.  Patient did not know the lot number or expiration date of the shingles vaccine she received. Reported did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood calcium, Blood phosphorus increased, Fatigue, Influenza
Clinical narrative: it hurt; tired; Flu symptoms; sick in the stomach; feeling sick; levels of phosphorous had increased; This case was reported by a consumer via call center representative and described the occurrence of blood phosphorus increased in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 17th August 2022 on left arm). Concurrent medical conditions included bone disorder (patient had bone issues).   On 30th November 2022, the patient received the 2nd dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced blood phosphorus increased. On an unknown date, the patient experienced pain, tiredness, flu symptoms, upset stomach and feeling unwell. On an unknown date, the outcome of the blood phosphorus increased, pain, tiredness, flu symptoms and upset stomach were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the blood phosphorus increased, pain, tiredness, flu symptoms, upset stomach and feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 09-DEC2022 Reporters comment: Patient reported feeling sick for about 1-2 days.  Patient reported Flu symptoms, sick in the stomach, tired, and it hurt. Patient reported she had a test 2-3 days ago because had bone issues. Patient did report that her bone issues was a previous condition before taking the Shingrix vaccine series (both doses). Patient reported that the increase of phosphorous from 4 to 5 was firstly detected in the test that she had 2-3 days ago. Patient mentioned the name of another shot that she had taken for years but the name was not clear.  Not all information was available. Lot and expiry date were not provided. Patient mentioned the name of another shot that she has taken for years but the name was not clear "Polie" . Patient was just concern if this increase was the vaccine or is it something else. Lab work was to check Calcium, Phosphorous and Vitamin D. Did not consent to follow-up. Customer did not provide consent for follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Malaise, Pain, Vitamin D
Clinical narrative: it hurt; tired; Flu symptoms; sick in the stomach; feeling sick; levels of phosphorous had increased; This case was reported by a consumer via call center representative and described the occurrence of blood phosphorus increased in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 17th August 2022 on left arm). Concurrent medical conditions included bone disorder (patient had bone issues).   On 30th November 2022, the patient received the 2nd dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced blood phosphorus increased. On an unknown date, the patient experienced pain, tiredness, flu symptoms, upset stomach and feeling unwell. On an unknown date, the outcome of the blood phosphorus increased, pain, tiredness, flu symptoms and upset stomach were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the blood phosphorus increased, pain, tiredness, flu symptoms, upset stomach and feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 09-DEC2022 Reporters comment: Patient reported feeling sick for about 1-2 days.  Patient reported Flu symptoms, sick in the stomach, tired, and it hurt. Patient reported she had a test 2-3 days ago because had bone issues. Patient did report that her bone issues was a previous condition before taking the Shingrix vaccine series (both doses). Patient reported that the increase of phosphorous from 4 to 5 was firstly detected in the test that she had 2-3 days ago. Patient mentioned the name of another shot that she had taken for years but the name was not clear.  Not all information was available. Lot and expiry date were not provided. Patient mentioned the name of another shot that she has taken for years but the name was not clear "Polie" . Patient was just concern if this increase was the vaccine or is it something else. Lab work was to check Calcium, Phosphorous and Vitamin D. Did not consent to follow-up. Customer did not provide consent for follow up with HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid of component  was used; Only liquid of component  was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number he4p7, expiry date 25th January 2024) 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: 12-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient only received liquid component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Vaccination failure
Clinical narrative: Shingrix series completed, get shingles/Suspected vaccination failure; Shingles; Rash; PHN; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles, rash and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and post herpetic neuralgia to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter inquired about after a series of Shingrix had been completed, the patient get shingles. The patient asked that it was possible for the actual rash could look different since the patient was vaccinated as opposed to a non-vaccinated patient. There patient also asked that there was any outcomes data that show the actual reduction of post herpetic neuralgia if vaccinated with Shingrix. Due to medical information guideline, this adverse event was reported even when another GlaxoSmithKline representative was first to hear around them. The reporter consented to follow-up. 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.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Blindness unilateral, Eye contusion, Eye swelling, Herpes zoster
Clinical narrative: permanent loss of vision in  left eye; retinal detachment; chickenpox herpes virus/shingles; Swelling; Bruising; redness (bloodshot) of  left eye; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant), retinal detachment (serious criteria GSK medically significant), shingles, eye swelling, eye contusion and bloodshot eye. On an unknown date, the outcome of the loss of vision was not recovered/not resolved and the outcome of the retinal detachment and shingles were unknown and the outcome of the eye swelling, eye contusion and bloodshot eye were recovered/resolved.   It was unknown if the reporter considered the loss of vision, retinal detachment, shingles, eye swelling, eye contusion and bloodshot eye to be related to Shingrix.  Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: The case was reported by the patient.  The reporter reported receiving Shingrix in October of 2022 at their local pharmacy, in the left arm.  The patient reported that, they did not receive the second dose and had no intentions of doing so.  The patient reported experiencing swelling, bruising, and redness (bloodshot) of the left eye approximately 3 weeks after receiving dose.  The patient reported all symptoms occurred overnight.  The patient reported it appeared as though they had been hit in the eye.  The patient reported seeing optometrist and being referred to a retina center.  The patient reported retina center diagnosed them with the chickenpox herpes virus.  The patient reported receiving weeks of eye care and having to undergo two surgeries for detached retina.  The patient reported these events had left them with permanent loss of vision in the left eye.  The reporter consented to follow up. Note: For 2nd dose as per 2 to 6 month schedule for Shingrix there is still time to received 2nd dose, so no medication error was captured.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Retinal detachment, Retinopexy, Varicella
Clinical narrative: permanent loss of vision in  left eye; retinal detachment; chickenpox herpes virus/shingles; Swelling; Bruising; redness (bloodshot) of  left eye; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant), retinal detachment (serious criteria GSK medically significant), shingles, eye swelling, eye contusion and bloodshot eye. On an unknown date, the outcome of the loss of vision was not recovered/not resolved and the outcome of the retinal detachment and shingles were unknown and the outcome of the eye swelling, eye contusion and bloodshot eye were recovered/resolved.   It was unknown if the reporter considered the loss of vision, retinal detachment, shingles, eye swelling, eye contusion and bloodshot eye to be related to Shingrix.  Additional Information: GSK Receipt Date: 13-DEC-2022 Reporter's Comment: The case was reported by the patient.  The reporter reported receiving Shingrix in October of 2022 at their local pharmacy, in the left arm.  The patient reported that, they did not receive the second dose and had no intentions of doing so.  The patient reported experiencing swelling, bruising, and redness (bloodshot) of the left eye approximately 3 weeks after receiving dose.  The patient reported all symptoms occurred overnight.  The patient reported it appeared as though they had been hit in the eye.  The patient reported seeing optometrist and being referred to a retina center.  The patient reported retina center diagnosed them with the chickenpox herpes virus.  The patient reported receiving weeks of eye care and having to undergo two surgeries for detached retina.  The patient reported these events had left them with permanent loss of vision in the left eye.  The reporter consented to follow up. Note: For 2nd dose as per 2 to 6 month schedule for Shingrix there is still time to received 2nd dose, so no medication error was captured.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 03Jun2022, 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 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 03rd June 2022).   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 :14 DEC 2022 Reporters comment: Reporter is the HCP who stated that it had been more than 6 months since a patient received his first dose of Shingrix. The patient had not yet received his second dose. Did not consent 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.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 04May2022, 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 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (a patient received their first dose of Shingrix on 4th May 2016).   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: 14-DEC-2022. Reporter's Comment:  The second dose has not been given yet. HCP declined to provide additional information. Additional Supportive Information: The patient not received 2 dose yet which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain; pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The reporter stated that most people complain of arm pain right after receiving Shingrix and that it was more (pain) than with any other vaccine they have received. HCP does not have any additional details (patient demographics, lot number, expiry date) as she stated that most of them say it in passing. The reporter gave consent to follow up via postal.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Stomatitis, Taste disorder
Clinical narrative: Oral irritation; Altered taste; This case was reported by a other health professional via call center representative and described the occurrence of mouth irritation in a 34-year-old male patient who received HAB (Twinrix adult) (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 9th September 2022, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. In September 2022, 3 days after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced mouth irritation and taste altered. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the mouth irritation and taste altered were recovered/resolved.   It was unknown if the reporter considered the mouth irritation and taste altered to be related to Twinrix adult and Twinrix 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.   Linked case(s) involving the same patient:  US2022AMR187830   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The reporter stated that the patient received his first Twinrix dose on 9th Sep 2022 and three days later he experienced oral irritation and altered taste.  The reporter state that the effects were treated with Zyrtec then Benadryl and the oral irritation and altered taste resolved.  The reporter gave consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR187830.; Sender's Comments:  US-GSK-US2022AMR187830:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the adjuvant; Administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2022, the patient received Shingrix. On 12th December 2022, 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: 14-DEC-2022. Reporter's Comment:  The reporter stated that Shingrix adjuvant was given to a patient without reconstituting with the active powder ingredient. The reporter gave consent to follow up. Additional Supportive Information: The patient received Shingrix adjuvant was given to a patient without reconstituting with the active powder ingredient which leads to inappropriate preparation of medication were unknown and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Jul2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of Shingrix on July 2021).   On an unknown date, the patient did not 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: 14-DEC-2022. Reporter's Comment:  The pharmacist reported that a patient did not received the 2nd dose of shingrix. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked to the case US2022187391 reported by the same reporter.; Sender's Comments:  US-GSK-US2022187391:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Jul2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of Shingrix on July 2021).   On an unknown date, the patient did not 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: 14-DEC-2022. Reporter's Comment:  The pharmacist reported that a patient did not received the 2nd dose of shingrix. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked to the case US2022187389 reported by the same reporter.; Sender's Comments:  US-GSK-US2022187389:Same reporter
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid component; Received only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 30th November 2023) for prophylaxis.   On 12th December 2022, the patient received the 1st dose of Menveo. On 12th December 2022, 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: 14-DEC-2022 Reporter's comment: The nurse reported that the patient received only the liquid conjugated component of Menveo (without the powder). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by fax. Additional Supportive Information: The patient received only the liquid conjugated component of Menveo (without the powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old received Flulaval; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2A3H9, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received the 1st dose of FluLaval Quadrivalent 2022-2023 season .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's comment: The medical assistant reported that the patient under the recommended age received a dose of FluLaval. Information for adverse event was given and specific information about vaccine was relayed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The four months old patient received a dose of FluLaval, which led to inappropriate age at vaccine administration.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old male patient who received HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving Havrix and Havrix 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: 14-DEC-2022 Reporter's Comment: The nurse reported that a 1st dose of Havrix vaccine that had expired on 4th December 2022 was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix dose, which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incorrect route of product administration, Injection site pain, Neuralgia
Clinical narrative: NERVE PAIN from ear to top of head; Harp pain on top of head; Intramuscular formulation administered by other route; SORENESS AT INJECTION SITE; FEVER; HEADACHE; TIRED; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2022, the patient received Shingrix (subcutaneous). On 9th December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, headache, tiredness and intramuscular formulation administered by other route. On 14th December 2022, the patient experienced nerve pain and pain. On 10th December 2022, the outcome of the injection site pain, fever, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nerve pain, pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, tiredness, nerve pain and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The consumer was the reporter and the patient.  The reporter reported that patient received the Shingrix vaccine and experienced fever , headache, soreness at injection site and was feeling tired. The reporter reported that there side effects started in the evening the day she got her injection and went away the following morning.  The consumer reported that yesterday on 14th December 2022 patient experienced nerve pain from her ear to the top of her head and had harp pain when she touched the top of her head.  The call got disconnected and agent called patient back but the call went straight to voicemail.  The reporter was unable to collect patients date of birth and HCP contact information. Additional Supportive Information: The patient received Shingrix vaccine via Subcutaneous route, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: NERVE PAIN from ear to top of head; Harp pain on top of head; Intramuscular formulation administered by other route; SORENESS AT INJECTION SITE; FEVER; HEADACHE; TIRED; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2022, the patient received Shingrix (subcutaneous). On 9th December 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, headache, tiredness and intramuscular formulation administered by other route. On 14th December 2022, the patient experienced nerve pain and pain. On 10th December 2022, the outcome of the injection site pain, fever, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nerve pain, pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, tiredness, nerve pain and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: The consumer was the reporter and the patient.  The reporter reported that patient received the Shingrix vaccine and experienced fever , headache, soreness at injection site and was feeling tired. The reporter reported that there side effects started in the evening the day she got her injection and went away the following morning.  The consumer reported that yesterday on 14th December 2022 patient experienced nerve pain from her ear to the top of her head and had harp pain when she touched the top of her head.  The call got disconnected and agent called patient back but the call went straight to voicemail.  The reporter was unable to collect patients date of birth and HCP contact information. Additional Supportive Information: The patient received Shingrix vaccine via Subcutaneous route, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Pain in extremity
Clinical narrative: BIT A SORE ARM; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via pfizer via concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 01 in total was administered, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received second and third dose of moderna vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Was unknown whether patient had any adverse events following vaccination with second and third dose of moderna vaccine (dose number in series 2.) The patient received fourth of pfizer vaccine (tozinameran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced bit a sore arm, and revaccination with different covid-19 vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The outcome of the bit a sore arm and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: EDS FLARED ENTIRE BODY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: ehlers-danlos syndrome (eds). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced eds flared entire body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eds flared entire body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: HAIR FALL; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hair fall after last booster (dose number in series 2). It was reported that, "After my last booster my hair is falling out." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair fall was not reported. This report was non-serious. This case is a duplicate of 20221241559.
Sex: U
Vaccine: COVID19
Symptoms: Muscle atrophy, Off label use, Pain
Clinical narrative: MUSCLES ARE MELTING AWAY; CHRONIC PAIN; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The drug was associated with Off label use (Off label dosing frequency) (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced muscles melting, chronic pain (Dose number in series 3) and it was reported as "On top of getting three of those shots my muscles are melting away. I'm a chronic pain all the time with no relief in sight unless I go buy drugs on the street." (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscles are melting away, and chronic pain, and the outcome of off label dosing frequency was not reported. This report was non-serious.  This case is a duplicate of 20221237009 and 20221237086.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIFFERENT KINDS OF PAIN EVERYDAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced different kinds of pain everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from different kinds of pain everyday. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious. This case, involving the same patient is linked. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ALMOST KILLED AND CAUSED LOT OF MEDICAL ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported 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 almost killed and caused lot of medical issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost killed and caused lot of medical issues was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative via social media  concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (unspecified manufacturer), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1).  The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction (Dose number in series 2). It was reported as " put your report on VAERS. I had two shots and had to report on VAERS due to the severe reaction. NEVER AGAIN". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20221237290.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: The patient was on medication for rheumatoid arthritis (RA). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sickness was not reported. This report was non-serious. This case is a duplicate of 20221238194 and 20221240998. This case, involving the same patient is linked to 20221238349.