chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia, Post herpetic neuralgia
Clinical narrative: Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (The patient also experienced nerve pain from shingles) and shingles (the patient had Shingles in November 2021). Previously administered products included Gabapentin and Tramadol.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: After the patient was pain free for about 3 weeks, the patient received her first dose of Shingrix.  Within days after receiving the Shingrix vaccine, the patient experienced nerve pain in the same area as before, although the pain was not as bad.  This nerve pain had not resolved.  The patient did not wish to provide contact information.  The patient did not wish to provide consent for follow up. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: there were 2 drops on her arm/leaked out and dropped down; there were 2 drops on her arm/leaked out and dropped down; there were 2 drops on her arm/leaked out and dropped down; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Shingrix. On 14th October 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's comment: Pharmacist called from a doctor's office and stated that upon receiving the second dose of Shingrix to the patient, two drops of vaccine leaked out and dropped down her arm. No additional details were available (lot number and expiration date). The reporter consented to follow-up via email. Additional Supportive Information: Upon receiving the second dose of Shingrix to the patient, two drops of vaccine leaked out and dropped down her arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The case US2022153065 was identified as duplicate of US2022153066. The case US2022153066 would be voided, and all the future correspondence would be added in this case US2022153065 which stands as a case of record for this patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 10/16/2021, 2nd not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient 1st dose of Shingrix on 16th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter stated that the patient never returned back over the weekend to get 2nd dose.  The reporter also stated that 2nd dose had not been administered at time of call. No additional data available. The reporter give consent to follow up. Additional Supportive Information: The patient had not received 2nd dose which led to incomplete course of vaccination. This case is linked with US2022153073, reported by the same reporter.; Sender's Comments:  US-GSK-US2022153073:Same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Scratch, Skin infection, Skin wound, Urticaria
Clinical narrative: Hives on both arms; Scratched the hives, broke the skin; Broke the skin, got it infected; Scratched the hives, broke the skin; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2022, the patient received the 1st dose of Shingrix .5 ml. In September 2022, 24 hrs after receiving Shingrix, the patient experienced hives, broken skin, skin infection and scratch. On an unknown date, the outcome of the hives, broken skin, skin infection and scratch were unknown.   It was unknown if the reporter considered the hives, broken skin, skin infection and scratch to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment:  Patient reported that received Shingrix vaccine in left arm. Patient stated 24 hours later broke out in hives on both arms. Patient also mentioned she was scratching the hives and broke the skin and it got infected. Reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Numbing sensation in face, cheecks, forehead; Numbness in lips and tongue; Slight puffiness in face; Pain at the injection site, still painful; Injection site are is raised; Injection site is red; Can only lift arm to the height of shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 24R5E, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included prednisone. Concurrent medical conditions included psoriatic plaque. Concomitant products included ustekinumab (Stelara).   On 8th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 8th September 2022, immediately after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and immediately after starting FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, injection site swelling, injection site erythema and injected limb mobility decreased. On 9th September 2022, the patient experienced numbness facial, hypoesthesia oral and facial puffiness. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injected limb mobility decreased, numbness facial, hypoesthesia oral and facial puffiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injected limb mobility decreased, numbness facial, hypoesthesia oral and facial puffiness to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: Reporter is patient. The patient stated that received Flulaval on left arm. Immediately, patient experienced pain at the injection site area is red, raised, and is still painful.  The patient could only lift her arm to the height of her shoulder without experiencing pain. One day after, patient experienced a numbing sensation in her face had numbness in her cheeks and forehead, which come and go, but the numbness in her lips and tongue endure. Patient had slight puffiness on face. The patient has been treated with 2 rounds of a prednisone taper, and patient has been applying ice to her arm. Patient was scheduled to have an MRI this week. Reporter gave consent to follow up with HCP.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Swelling face
Clinical narrative: Numbing sensation in face, cheecks, forehead; Numbness in lips and tongue; Slight puffiness in face; Pain at the injection site, still painful; Injection site are is raised; Injection site is red; Can only lift arm to the height of shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 24R5E, expiry date 29th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included prednisone. Concurrent medical conditions included psoriatic plaque. Concomitant products included ustekinumab (Stelara).   On 8th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 8th September 2022, immediately after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and immediately after starting FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, injection site swelling, injection site erythema and injected limb mobility decreased. On 9th September 2022, the patient experienced numbness facial, hypoesthesia oral and facial puffiness. The patient was treated with prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injected limb mobility decreased, numbness facial, hypoesthesia oral and facial puffiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injected limb mobility decreased, numbness facial, hypoesthesia oral and facial puffiness to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: Reporter is patient. The patient stated that received Flulaval on left arm. Immediately, patient experienced pain at the injection site area is red, raised, and is still painful.  The patient could only lift her arm to the height of her shoulder without experiencing pain. One day after, patient experienced a numbing sensation in her face had numbness in her cheeks and forehead, which come and go, but the numbness in her lips and tongue endure. Patient had slight puffiness on face. The patient has been treated with 2 rounds of a prednisone taper, and patient has been applying ice to her arm. Patient was scheduled to have an MRI this week. Reporter gave consent to follow up with HCP.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperaesthesia, Incomplete course of vaccination, Pain in extremity, Peripheral swelling
Clinical narrative: swelling to her right arm above her elbow, her right arm and it is 6 cm wider than her left arm; pain to her upper arm; Small, red, pin-point dots on her upper arm; Hurts to have anything, including light clothing, touch her skin; 1st dose more than six months ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (above right eyebrow) and pain. Concomitant products included valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and did not receive the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, pain in arm, erythema of extremities, touch sensitivity increased and incomplete course of vaccination. The patient was treated with trolamine salicylate (Aspercreme). On an unknown date, the outcome of the swelling arm, pain in arm, erythema of extremities and touch sensitivity increased were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema of extremities and touch sensitivity increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The reporter was the patient.  The patient received Shingrix dose in her right deltoid.  She could not recall when exactly the dose was given but sometime within the past year and more than six months ago. Within about one month of the vaccine she experienced swelling to her right arm above her elbow.  Her doctor measured her right arm and it was 6 cm wider than her left arm.  She also experienced pain to her upper arm.  She described this pain as being similar to when she had shingles in the past.  It hurts to have anything, including light clothing, touch her skin.  She also noticed small, red, pin-point dots on her upper arm.  She had been treating the pain with Aspercreme, which temporarily helped her.  She had a follow up appointment with her doctor on Thursday. The reporter might follow up with patient.  There was no MD information provided. The consent to follow-up was requested. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: Did not get 2nd dose because it was not available; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The consumer reported they received 1st dose of Shingrix and did not get 2nd dose because it was not available.  The consumer called GlaxoSmithKline to ask if they needed to get the second dose or restart the series. The reporter did not consent to follow up. Additional Supportive Information: The patient did not receive 2nd dose of Shingrix because it was not available, due to product supply issue.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 28-Jul-2020, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The office staff reported that a patient received 1st dose of Shingrix and had not received 2nd dose. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Bexsero last year, 70 years old.; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 70-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 25-OCT-2022 Reporter's Comment:  Reporter reported that her HCP gave her Bexsero last year and she is 70 years old (at the time of reporting). No additional demographics collected.  Did not consent to follow-up. Caller did not give permission to contact HCP. Additional supportive information: As patient received Bexsero at an inappropriate age which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses, one day apart; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date unknown) for prophylaxis.   Concurrent medical conditions included diabetes (Patient is diabetic). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 21st October 2022, the patient received the 2nd dose of Shingrix. On 21st October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter called to ask for information about the administration of two doses of Shingrix to a patient one day apart.  The reporter asked for safety information and how to proceed with patient vaccination.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to drug dose administration interval too short.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose few years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) on an unknown date, on left arm, a few years ago).   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: 25-OCT-2022 Reporter's comment:  The patient reported that she had not gotten the second vaccine yet. She did not want to provide anymore demographics and did not have any further information about the vaccine itself.  The reporter did not consent to follow up. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of 2-doses of the Shingrix adjuvant to a patient; administration of 2-doses of the Shingrix adjuvant to a patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number AB377, expiry date 29th September 2023) for prophylaxis.   On 25th October 2022, the patient received Shingrix. On 25th October 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: 25-OCT-2022 Reporter's Comments: The licensed practical nurse reported the administration of 2 doses of the Shingrix adjuvant to a patient. The nurse stated that they used 2 vials of the Shingrix adjuvant to administer 1 dose of Shingrix vaccine and they only used the adjuvant and did not use the lyophilized portion of the Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: The patient received only 2 adjuvants of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 76.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Hemodialysis patient received only 1 ml of Engerix-B on 19TH Oct 2022 instead of 2ml dosing; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 76-year-old male patient who received HBV (Engerix B) (batch number AC397, expiry date unknown) for prophylaxis.   Concurrent medical conditions included hemodialysis.   On 19th October 2022, the patient received Engerix B 1 ml. On 19th October 2022, unknown after receiving Engerix B, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 25-Oct-2022 Reporter's comment: The clinical manager reported a hemodialysis patient received only 1 ml of Engerix-B instead of 2 ml dosing. The consent to follow-up was granted. Additional Supportive Information: The patient received only 1 ml of Engerix-B instead of 2 ml dosing, which led to underdose.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient was given a pediatric dose; adult patient was given a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date:26-Oct-2022 Reporter's comment: The reporter reported that she did not had any patient information at time of call. The reporter consented to follow-up via email. Additional supportive information: The patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 7 year-old received Kinrix; This was the third Dtap on patient´s schedule.; 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 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap vaccine  (received 2 doses of Dtap series on an unknown date).   On 20th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The health care professional reported that this  kinrix shot was the third Dtap on the patient's vaccination schedule. The reporter consented to follow-up by email. Additional supportive information: The patient received Kinrix vaccine as third Dtap dose by error at inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 week old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2022 10:00, the patient received Kinrix (intramuscular). On 26th October 2022, the patient started Kinrix Pre-Filled Syringe Device. On 26th October 2022 10:00, 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: 26-Oct-2022 Reporter's comment: Nurse reported that 12 week old patient accidentally received Kinrix in right thigh on the day of reporting around 10 am. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Kinrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 0.92
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Havrix - Administration to a 11 month-old patient.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 30th November 2023) for prophylaxis.   On 26th October 2022, the patient received Havrix. On 26th October 2022, unknown after receiving Havrix, 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: 26-Oct-2022 Reporter's comment: The reporter asked about safety information and how to proceed with the patient. The reporter consented to follow-up. Additional supportive information: The patient received Havrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 26th October 2022, the patient received the 1st dose of Havrix. On 26th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter did not provide patient information. The reporter reported that, expired dose of Havrix 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 reporter reported that, expired dose of Havrix was administered to a patient, which led to expired vaccine used.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: hot arm at injection site; red arm at injection site; swelling at injection site; sore and painful at  injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 21st October 2022, 1 hr after receiving Shingrix, the patient experienced injection site pain. On 24th October 2022, the patient experienced injection site warmth, injection site erythema and injection site swelling. On 23rd October 2022, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter stated that the patient received her first Shingrix vaccine on 21st Oct 2022, in the left arm.   The reporter stated that her arm was sore and painful at the injection site when she received the vaccine and that resolved a few days later.  The reporter also mentioned about 3 days ago her arm became hot, red and swollen at the injection site area and has not resolved. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose May 2019/2nd dose yet not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in unknown arm in May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The caller only received first dose of Shingrix at the time of call. The caller did not give permission to contact her health care professional. The caller did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Pediarix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Pediarix and Pediarix 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: 27-Oct-2022 Reporter's comment: The pharmacy technician reported via chat that an expired dose of Pediarix was administered. The reporter asked that could you check the lot and saw that and was the correct expiration date. The national drug code (NDC) was 58160-0811-52. The reporter did not had that information. It was given at a remote sites of there. The reporter asked that could you email this information to him/her. No other information was known. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient given 3rd dose of SHINGRIX; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 5592T, expiry date 31st October 2023) for prophylaxis.   On 29th October 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 29th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received Shingrix vaccine. The reporter stated that this was her 3rd dose which was an extra dose. The patient did not experienced side effects. The reporter wanted to know more information on what to do next. The reporter did not consent to follow up. Additional supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number 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 died. It was reported as "Your Covid shot killed my brother". On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20221060412-DEATH. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Rash, SARS-CoV-2 test
Clinical narrative: Redness to my groin area; Skin rash; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19), ERYTHEMA (Redness to my groin area) and RASH (Skin rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01622A, 017FZ1A, 031LZOA and 039K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Fish allergy, Drug allergy, High cholesterol since 2003, Blood pressure since 2019, COPD since 2017, Allergy since 2015 and Irritable bowel syndrome since 2015. Concomitant products included SIMVASTATIN for High cholesterol, LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE), ALPRAZOLAM, HYOSCYAMINE, ATENOLOL and COLECALCIFEROL (D3) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ERYTHEMA (Redness to my groin area) and RASH (Skin rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing from 2021 at a dose of daily. At the time of the report, COVID-19 (COVID-19) outcome was unknown and ERYTHEMA (Redness to my groin area) and RASH (Skin rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA (Redness to my groin area) and RASH (Skin rash) to be related. No further causality assessment was provided for COVID-19 (COVID-19).    There was no acute illness at the time of vaccination and before one month before reported. It was reported the event caused the patient to seek medical care. No other potential causes for the event, and patient did not experienced similar event in the past. After each vaccine patient developed a severe skin rash and redness to my groin area. Patient went to the Skin doctor and medication did not help. Patient started taking Benadryl daily and did not seem to help some on the rash for awhile but not the groin area. Benadryl did not seem to work as well anymore.   This case was linked to MOD-2021-280030, MOD-2022-662372 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 038A21A and 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included METHADONE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot). On 12-Mar-2021, CHEST DISCOMFORT (Worst heaviness in the chest/heart immediately after first and 2nd primary shot/Less Severe heaviness in the chest/heart immediately after first booster shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Immediately after each shot, she had Heaviness in chest and heart, but it was worst with the first two shots. The heaviness in the chest disappeared after 1 day. She stated that she has reported the side effect to V-Safe.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: Body aches; Fatigue; Arm pain; Dose 1 : 1-FEB-2021, Dose 2: 15-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 : 1-FEB-2021, Dose 2: 15-MAR-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Allergy to Levaquin), Drug allergy (Allergy to Statins), Contrast media allergy (Allergy to contrast dye) and Tinnitus.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 : 1-FEB-2021, Dose 2: 15-MAR-2021). At the time of the report, MYALGIA (Body aches), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 : 1-FEB-2021, Dose 2: 15-MAR-2021) outcome was unknown.            No concomitant products reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient received within 2 weeks of vaccination. All previous shots were Moderna and all administered. All Moderna shots caused a day of body ache, arm pain, fatigue. The Pfizer shot taken on 28 Sep 2022 in left arm as dose 5 did too but a day or two after the shot and  noticed that the usually mild tinnitus ringing of 10 plus years increased significantly. It was ongoing and very loud loud enough to distract from all activities included tv, working outdoors, conversations, working indoors, reading, and writing the description. It decreased quality of life. Prior to vaccination the patient was not diagnosed with COVID-19.  No treatment products reported.   This case was linked to MOD-2022-666563 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            No known allergies provided. No concomitant drugs were provided. No relevant medical history were provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. For HUMIRA, the reporter causality for the event of COVID with Adalimumab Solution for Injection was Reasonable Possibility and Agency's opinion was that the causality for the event of COVID with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Capillary fragility, Epistaxis, Feeling hot, Headache
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), NASAL DISCOMFORT (She kept feeling something in her nose/The capillaries in her nose started to get very red and inflamed, like getting a nosebleed), CAPILLARY FRAGILITY (She noticed broken capillaries on the side), PAIN (Pain in all of my body/ she had minor pains in her body) and PAIN IN EXTREMITY (Pains in my legs/Pain was excruciating in my thighs/ The pain was excruciating and she couldn't walk. It was unbelievable pain) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Non-smoker. Previously administered products included for Product used for unknown indication: Flu shot (A month before the Moderna bivalent.) in September 2022. Past adverse reactions to the above products included No adverse effect with Flu shot. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for an unknown indication.             Company comment: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected  of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old female patient, with no reported medical history, who experienced the non-serious unexpected of arthritis (like inflammation, arthritis) after receiving a dose of mRNA-1273.222 vaccine. Patient states that after vaccination she experienced pain in the legs and head and all of her body, like inflammation, arthritis. She says her doctor has told her to give it time and has been using heating pads and paracetamol as treatment. No further information on diagnostic tests or clinical assessment was provided. The benefit-risk relationship of vaccine is not affected by this report.