chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Arm became sore/ sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix (injection, left arm) 50 ug. On 20-APR-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm became sore/ sore arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2023 The patient self-reported this case. On the same evening of vaccination, patient's arm became sore and was still sore to the touch in the spot where she received the on the day of reporting.  The reporter consented to follow up. This case had been linked with US2023059944, reported by same reporter.; Sender's Comments:  US-GSK-US2023059944:Same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: red spot on arm, dots above it, around injection area; warm to the touch, arm warmth; The spot is deeper red and spotty; Sore Arm; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) 50 µg. On 20-APR-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore Arm) and fever (Verbatim: Fever). On 21-APR-2023, the patient experienced injection site erythema (Verbatim: red spot on arm, dots above it, around injection area), injection site warmth (Verbatim: warm to the touch, arm warmth) and red spotty rash (Verbatim: The spot is deeper red and spotty). On 24-APR-2023, the outcome of the fever was resolved (duration 4 days). The outcome of the injection site erythema, injection site warmth, pain in arm and red spotty rash were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, pain in arm, fever and red spotty rash to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site warmth, pain in arm, fever and red spotty rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-APR-2023 Reporter was the wife calling on behalf of her husband who received his dose of Shingrix, and that same evening developed a sore arm and a fever. The morning after receiving the vaccine, the husband noticed a red spot on his arm about the size of a dollar bill, 6 inches long and 3 inches wide, with dots above it, all around the injection area. The spot was deeper red and spotty in the spot where the injection was given, and the area was warm to the touch.  The patient was still experiencing the arm warmth and large red spot on the day of reporting. The patient also developed a 105 degree F fever the evening of receiving the vaccine, that went down and came back each day until day of reporting. The reporter consented to follow up. This case is linked with US2023059936, reported by the same reporter.; Sender's Comments:  US-GSK-US2023059936:Same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 4, received Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient under 4, received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 24-APR-2023 The physician reported a patient under the age of 4 received the Kinrix vaccine. Not able to consent to follow-up due to chat disconnecting. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This case is linked with US2023059942, reported by same reporter.; Sender's Comments:  US-GSK-US2023059942:Same reporter
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: patient younger than 4yo got Kinrix; 3rd dose of dtap and polio; the patient received kinrix on thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 12-APR-2023, the patient received Kinrix (intramuscular, right thigh). On 12-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient younger than 4yo got Kinrix), inappropriate schedule of vaccine administered (Verbatim: 3rd dose of dtap and polio) and vaccine administered at inappropriate site (Verbatim: the patient received kinrix on thigh). The outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and vaccine administered at inappropriate site 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: 24-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. The reporter reported that patient received third dose of dtap and polio at 7 months old, which led to Inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered. The patient received Kinrix on thigh, which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2023059931:Same reporter
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Heart rate increased, Hypoaesthesia, Laboratory test abnormal, Neuropathy peripheral
Clinical narrative: Neuropathy; Numbness in hands and feet, increased dramatically; Tingling in hands and feet, increased dramatically; rapid heart rate, body reacting; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included small fiber neuropathy (for several years, that was diagnosed by a nerve test in February 2022).   On 20-MAR-2023 13:00, the patient received the 1st dose of Shingrix (injection, left deltoid) 50 ug. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), hypoesthesia (Verbatim: Numbness in hands and feet, increased dramatically), tingling feet/hands (Verbatim: Tingling in hands and feet, increased dramatically) and heart rate increased (Verbatim: rapid heart rate, body reacting). The outcome of the neuropathy was not reported and the outcome of the hypoesthesia and tingling feet/hands were not resolved and the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.     It was unknown if the company considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter self-reported this case. The patient reported that she received the Shingrix in her upper left arm. Tuesday, 21-MAR-2023 she went to the Doctor because of rapid heart rate, which the doctor told her was her body reacting to receiving the vaccine.  On Wednesday, 22-MAR-2023, the patient reported that the intensity of numbness and tingling in her hands and feet increased dramatically after having received the Shingrix vaccine 2 days before.  The patient was not spoken with her doctor about this increase in numbness and tingling but did go to a drive in because her doctor thought she might have varicose veins, and she was told at the clinic that she had neuropathy, not varicose veins.  The patient reported that she was still having this numbness and tingling in her hands and feet on the day of reporting. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Neuropathy; Numbness in hands and feet, increased dramatically; Tingling in hands and feet, increased dramatically; rapid heart rate, body reacting; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included small fiber neuropathy (for several years, that was diagnosed by a nerve test in February 2022).   On 20-MAR-2023 13:00, the patient received the 1st dose of Shingrix (injection, left deltoid) 50 ug. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy) (serious criteria GSK medically significant), hypoesthesia (Verbatim: Numbness in hands and feet, increased dramatically), tingling feet/hands (Verbatim: Tingling in hands and feet, increased dramatically) and heart rate increased (Verbatim: rapid heart rate, body reacting). The outcome of the neuropathy was not reported and the outcome of the hypoesthesia and tingling feet/hands were not resolved and the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.     It was unknown if the company considered the neuropathy, hypoesthesia, tingling feet/hands and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-APR-2023 The reporter self-reported this case. The patient reported that she received the Shingrix in her upper left arm. Tuesday, 21-MAR-2023 she went to the Doctor because of rapid heart rate, which the doctor told her was her body reacting to receiving the vaccine.  On Wednesday, 22-MAR-2023, the patient reported that the intensity of numbness and tingling in her hands and feet increased dramatically after having received the Shingrix vaccine 2 days before.  The patient was not spoken with her doctor about this increase in numbness and tingling but did go to a drive in because her doctor thought she might have varicose veins, and she was told at the clinic that she had neuropathy, not varicose veins.  The patient reported that she was still having this numbness and tingling in her hands and feet on the day of reporting. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 18 January 2022 the patient received 1st dose, Lot number 3AA9T, expiration date 20Apr2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist reported that a patient received the first dose of Shingrix and had not yet received 2nd dose.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: General body aches; soreness in the arm she got her vaccine in; This non-serious 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 24-APR-2023, the patient received the 2nd dose of Shingrix (unknown arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site reaction/ caller is the patient and didn't want to give any demographics or AE specifics. She states that she got her second Shingrix vaccine 4/24/2023 and she is experiencing body aches and soreness in the arm she got her vaccine in). On 24-APR-2023, the patient experienced general body pain (Verbatim: General body aches). The outcome of the injection site pain and general body pain were not resolved.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the general body pain to be related to Shingrix.     The company considered the injection site pain to be related to Shingrix. It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 25-APR-2023 The patient self-reported this case. The patient did not want to give any demographics or adverse event specifics.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: pain at injection site; redness at injection site; swelling at injection site; knees aches; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 19-APR-2023, the patient received Boostrix (intramuscular, left arm). In APR-2023, several hours after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: swelling at injection site), knee pain (Verbatim: knees aches) and general body pain (Verbatim: body aches). In APR-2023, the outcome of the knee pain and general body pain were resolved (duration 2 days). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, knee pain and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, knee pain and general body pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-APR-2023. The patient reported that she received TDAP vaccine in left arm on 19 April 2023. The patient stated that hours later she had pain, redness and swelling at injection site that had not resolved.  The patient also experienced knees and body ached for 2 days, resolved now.  The patient referred to health care professional Reporter consented to follow up.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received pediatric dose; Adult received pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 34-year-old male patient who received HAV (Havrix pediatric) for prophylaxis.   On 19-APR-2023, the patient received Havrix pediatric .5 ml. On 19-APR-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: Adult received pediatric dose) and adult use of a child product (Verbatim: Adult received pediatric dose). The outcome of the underdose and adult use of a child product 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: 25-APR-2023 The registered nurse reported that the patient received a pediatric dose of Havrix. The reporter called to inquire how to proceed with Havrix and would patient need one ml. The reporter did not consent to follow up. The adult patient received a dose of Havrix pediatric, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-APR-2023 A pharmacist called in to report that a patient received their first dose of Shingrix and had not receive the second dose yet.  They ended the call without giving information and proceeded to dismiss agent. The reporter ended the call while the medical information was given and did not provide more information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered reconstituted vaccine refrigerated more than 6 hours; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administered reconstituted vaccine refrigerated more than 6 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was a medical doctor. The reporter wanted to know about the information of if reconstituted Shingrix vaccine was refrigerated but outside the 6 hours window and then accidentally administered to the patient. The reporter confirmed that this was an attempt at the patient's first dose of Shingrix. The reporter was unable to provide any additional vaccine details at the time of reporting. The reporter did consent to follow-up. The Shingrix vaccine was reconstituted and refrigerated but outside the 6 hours window and then accidentally administered, which led to incorrect storage of drug.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Extra dose administered, Hyperinsulinaemia
Clinical narrative: Hyperinsulinemia; Extra Pediarix dose; This serious case was reported by a nurse via call center representative and described the occurrence of hyperinsulinemia in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 25L32, expiry date 28-MAR-2025) for prophylaxis.   Previously administered products included Vaxellis. Concomitant products included PEDIARIX.   On 26-APR-2023, the patient received the 4th dose of Pediarix. On 02-FEB-2023, the patient received the 2nd dose of Pediarix. On 27-MAR-2023, not applicable after receiving Pediarix and 53 days after receiving Pediarix, the patient experienced hyperinsulinemia (Verbatim: Hyperinsulinemia) (serious criteria hospitalization and clinically significant/intervention required). On 26-APR-2023, the patient experienced extra dose administered (Verbatim: Extra Pediarix dose) (serious criteria hospitalization and clinically significant/intervention required). The outcome of the hyperinsulinemia was resolved and the outcome of the extra dose administered was unknown.   The reporter considered the hyperinsulinemia to be unrelated to Pediarix and Pediarix Pre-Filled Syringe Device.   The company considered the hyperinsulinemia to be unrelated to Pediarix and Pediarix 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: 26-APR-2023 The patient was hospitalized for Hyperinsulinemia on 27th March 2023 and received the 6-month Pediarix shot there. On the day of reporting the patient went for her physical, and then received the extra Pediarix (4th dose). Although the Healthcare professional stated that the Hyperinsulinemia was unrelated to the Pediarix, it was corrected by surgery. The reporter also mentioned that the 1st dose, the patient received was Vaxelis, and the last 3 were Pediarix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received 4th dose as Pediarix which led to extra dose administered.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Condition aggravated, Injection site pain, Lethargy, Migraine
Clinical narrative: She woke up with mouth sores,mouth sores, Inflammation of mouth; Inflammation in joints; Imprints of teeth on tongue; lethargy; Increase in vascular migraines; Increase in vascular migraines; swollen tongue, jamming on the edges of teeth; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number j93gx, expiry date 25-NOV-2024) for prophylaxis.   The patient's past medical history included migraine.   On 25-JAN-2023, the patient received Boostrix (left arm). On 25-JAN-2023, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site). In FEB-2023, the patient experienced sores mouth (Verbatim: She woke up with mouth sores,mouth sores, Inflammation of mouth), joint inflammation (Verbatim: Inflammation in joints), scalloped tongue (Verbatim: Imprints of teeth on tongue), lethargy (Verbatim: lethargy), migraine (Verbatim: Increase in vascular migraines), condition aggravated (Verbatim: Increase in vascular migraines) and swollen tongue (Verbatim: swollen tongue, jamming on the edges of teeth). The outcome of the injection site pain was resolved and the outcome of the sores mouth, joint inflammation, scalloped tongue, migraine, condition aggravated and swollen tongue were not resolved and the outcome of the lethargy was unknown.   It was unknown if the reporter considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was the consumer. The reporter stated that she did experience pain at the injection site after administration of Boostrix. The reporter reported about 10 days later she woke up with mouth sores, inflammation in joints, imprints of teeth on tongue, inflammation in mouth, lethargy, increase in vascular migraines, and a swollen tongue that was jamming on the edges of her teeth. Consented to follow up.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Scalloped tongue, Stomatitis, Swollen tongue
Clinical narrative: She woke up with mouth sores,mouth sores, Inflammation of mouth; Inflammation in joints; Imprints of teeth on tongue; lethargy; Increase in vascular migraines; Increase in vascular migraines; swollen tongue, jamming on the edges of teeth; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number j93gx, expiry date 25-NOV-2024) for prophylaxis.   The patient's past medical history included migraine.   On 25-JAN-2023, the patient received Boostrix (left arm). On 25-JAN-2023, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: pain at injection site). In FEB-2023, the patient experienced sores mouth (Verbatim: She woke up with mouth sores,mouth sores, Inflammation of mouth), joint inflammation (Verbatim: Inflammation in joints), scalloped tongue (Verbatim: Imprints of teeth on tongue), lethargy (Verbatim: lethargy), migraine (Verbatim: Increase in vascular migraines), condition aggravated (Verbatim: Increase in vascular migraines) and swollen tongue (Verbatim: swollen tongue, jamming on the edges of teeth). The outcome of the injection site pain was resolved and the outcome of the sores mouth, joint inflammation, scalloped tongue, migraine, condition aggravated and swollen tongue were not resolved and the outcome of the lethargy was unknown.   It was unknown if the reporter considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, sores mouth, joint inflammation, scalloped tongue, lethargy, migraine, condition aggravated and swollen tongue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was the consumer. The reporter stated that she did experience pain at the injection site after administration of Boostrix. The reporter reported about 10 days later she woke up with mouth sores, inflammation in joints, imprints of teeth on tongue, inflammation in mouth, lethargy, increase in vascular migraines, and a swollen tongue that was jamming on the edges of her teeth. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This serious case was reported by a pharmacist via call center representative and described the occurrence of pneumonia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.     It was unknown if the company considered the pneumonia to be related to Shingrix.   Additional Information: GSK receipt date: 27-APR-2023 The pharmacist reported that a patient received first dose of Shingrix and started prednisone 40 mg sometime after for pneumonia.  The patient would stop prednisone on 28th April 2023. The caller declined to provide more information. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only received liquid portion; Accidentally received the liquid portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA911A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only received liquid portion) and inappropriate dose of vaccine administered (Verbatim: Accidentally received the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: The reporter was a clinical pharmacy manager. The reporter reported that the patient accidentally received the liquid portion of Menveo. Adverse event information was collected but reporter did not had all the details at the time of reporting. The reporter gave by error Menveo liquid portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter did consent to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 19-APR-2023, the patient received Kinrix. On 19-APR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired Kinrix administered). 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: 28-APR-2023 The reporter reported that the patient received the expired Kinrix vaccine, which lead to expired vaccine used. The reporter did consent to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix  administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-week-old male patient who received HBV (Engerix B) (batch number k329e, expiry date 24-APR-2023) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix  administered). 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: 28-APR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter reported that the patient received the expired Engerix-B vaccine, which lead to expired vaccine used. The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was given on 16-SEP-2022, 2nd dose not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th September 2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First dose was given on 16-SEP-2022, 2nd dose not administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-APR-2023 The reporter reported that the patient was late for the second dose of Shingrix vaccine which was not administered yet. The reporter stated the lot number of first dose was unknown. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Deafness unilateral, Meningitis bacterial, Seizure
Clinical narrative: Seizures; Bacterial meningitis; deaf in one ear; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a 5-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced seizure (Verbatim: Seizures) (serious criteria GSK medically significant), bacterial meningitis (Verbatim: Bacterial meningitis) (serious criteria GSK medically significant) and deafness unilateral (Verbatim: deaf in one ear) (serious criteria GSK medically significant). The outcome of the seizure and bacterial meningitis were not reported and the outcome of the deafness unilateral was not resolved.  It was unknown if the reporter considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine.  It was unknown if the company considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine.  Additional Information: GSK receipt date: 26-APR-2023 This case was reported by the patient's parent via interactive digital media.  The patient had got the flu vaccine and started having seizures then it led to bacterial meningitis, now (at the moment of reporting) she was deaf in one ear. The reporter was so overwhelmed right now (at the moment of reporting). Follow-up would not possible, as no contact details were available.
Sex: M
Vaccine: COVID19
Symptoms: Adrenal gland cancer, Hereditary non-polyposis colorectal cancer syndrome, Pancreatic carcinoma
Clinical narrative: ADRENAL CARCINOMA; PANCREATIC CARCINOMA; LYNCH SYNDROME; This spontaneous report received from a patient via other manufacturer (Moderna) concerned an adult male of an unspecified 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient was diagnosed with pancreatic and adrenal carcinoma, and has upcoming surgery scheduled on MAY 08. He has a 2-gene variance, one gene has lynch syndrome, the other was undetermined. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adrenal carcinoma, lynch syndrome and pancreatic carcinoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230464624- adrenal carcinoma, pancreatic carcinoma. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, considered indeterminate. The company causality is considered unassessable.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and codeine allergy. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, 1 in total was administered on 03-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 25-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with tozinameran (dose number in series 2). The patient received non-company suspect vaccine included Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: 065K21A, expiry: unknown) dose was not reported, administered on 01-APR-2022 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with elasomeran (dose number in series 3). The patient receive non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 4) (form of admin and route of admin were not reported, batch number: GH97206, expiry: unknown) dose was not reported, administered on 19-SEP-2022 to right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 4). On 11-APR-2023, the patient experienced covid-19 infection (suspected covid-19 infection) (dose number in series 4). The patient received treatment with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (route of administration and form of admin were not reported, batch number:GF7861, expiry: unknown) dose and frequency were not reported administered from 14-APR-2023 to 19-APR-2023 for covid-19 treatment. On 23-APR-2023, the patient again experienced cold symptoms similar to the original covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (dose number in series 2), elasomeran, and tozinameran (dose number in series 4) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose; This spontaneous case was reported by a non-health professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (we gave him a dose of Moderna bivalent (pink cap) yesterday, he should have received a Moderna bivalent blue cap 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The patient received a monovalent dose of Moderna vaccine on 27-Sep-2022 with lot number AR9237B.  The patient should have received a Moderna bivalent vaccine with blue cap of 0.25 ml dose instead of receiving the Moderna bivalent vaccine with pink cap.  Treatment information was not reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: He developed POTS (Postural Orthostatic Tachycardia Syndrome); This spontaneous case was reported by a pharmacist and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (He developed POTS (Postural Orthostatic Tachycardia Syndrome)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was not known after which shot the patient developed POTS. Patient was diagnosed by a cardiologist in the hospital. No treatment medication was provided. Company comment This spontaneous case concerns a 28-year-old male patient with no medical history reported, who experienced the non-serious, unexpected AESI of Postural orthostatic tachycardia syndrome (POTS). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received the 2 primary doses of mRNA-1273. It was not known after which shot the patient developed POTS. Patient was diagnosed by a cardiologist in the hospital. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: The expiration date they sent is also not correct, so she is not sure if it's monovalent; No adverse event; An immunization was flagged as a monovalent dose after the authorization had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (An immunization was flagged as a monovalent dose after the authorization had expired) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The expiration date they sent is also not correct, so she is not sure if it's monovalent).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated 2 patients were accidentally administered with Moderna COVID-19 Vaccine beyond use date).    Concomitant medication details not reported by the reporter. The vials were stored in the fridge since 12-MAR-2023. Patients were administered on 19-APR-2023 and 21-APR-2023. HCP did not knowthat patients experienced any AEs and did not have any patient's demographics but she knew they were both adults. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721681 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721681:2ND PATIENT CASE