chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Eye operation, Herpes zoster
Clinical narrative: Shingles/  flared up shingles; eye surgery; This non-serious case was reported by a consumer via patient support programs and described the occurrence of eye operation in a 62-year-old female patient who received mepolizumab (Nucala) for drug use for unknown indication.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient started Nucala and the 2nd dose of Shingles vaccine. On 22-MAR-2023, an unknown time after starting Nucala and an unknown time after receiving Shingles vaccine, the patient experienced eye operation (Verbatim: eye surgery). On an unknown date, the patient experienced shingles (Verbatim: Shingles/  flared up shingles). The action taken with Nucala was unknown. The outcome of the eye operation was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the eye operation and shingles to be related to Nucala and Shingles vaccine.     It was unknown if the company considered the eye operation and shingles to be related to Nucala and Shingles vaccine.   GSK Receipt Date: 05 Apr 2023. This report was submitted via the online direct entry reporting system. This report was submitted by site: GSK Program. Patient reported she took Nucala medication 3 weeks prior to eye surgery performed on 22 Mar 2023. Patient also reported she had 2 shingle shots recently, and the second shingle shot flared up her shingles and made them worse. Patient gave consent to contact her from safety department should any additional questions arise.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Feeling hot; like 4 days my arm hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling hot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced feeling hot (Verbatim: Feeling hot) and pain in arm (Verbatim: like 4 days my arm hurt). The outcome of the feeling hot was unknown and the outcome of the pain in arm was resolved (duration 4 days).  It was unknown if the reporter considered the feeling hot and pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the feeling hot and pain in arm to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-APR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that the he/she had it for the first time and he/she would not have had it again. He/She had spent the second day feeling hot and like 4 days his/her arm hurt it is another le he/she recommend it. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 days after received vaccine experienced shingles. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Immediate post-injection reaction
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patients received Flu vaccine. On an unknown date, immediately after receiving Flu vaccine, the patients experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.     It was unknown if the company considered the sickness to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she worked at place that had 750 peoples and everyone in that received Flu vaccine was the ones got sick and experienced other problems immediately after received flu vaccine. The reporter reported that the physician did not investigate the result, cause and effect they just the money kick back in there pocket. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR055091 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR055091:Same Reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of the DTap series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients 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 schedule of vaccine administered (Verbatim: 2nd dose of the DTap series). The outcome of the inappropriate schedule of vaccine administered 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: 13-MAR-2023 A healthcare professional (HCP) informed that Kinrix was administered to a patient as the 2nd dose of the DTap series instead of being the 5th dose of the series. The HCP told that such thing had also happened to a lot of other patients, but in that moment, she only had available the information of one patient. The reporter consented to follow up. This case is linked with US2023054684, reported by same reporter.  A lot of patient received Kinrix as a 2nd dose of Dtap series, which led to inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023054684:Same reporter. Identified patient.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Pain
Clinical narrative: Pain is unbearable/pain all the time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of condition aggravated in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 years ago). Previously administered products included Shingles vaccine. Concurrent medical conditions included pain.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced condition aggravated (Verbatim: Pain is unbearable/pain all the time). The outcome of the condition aggravated was not resolved.   It was unknown if the reporter considered the condition aggravated to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the condition aggravated to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 The patient was being in labor, had shingles two years ago and had it all over his/her torso and around to his/her back and still had the pain all the time. The patient stated that yes, he/she also had the shot before he/she got shingles, did not thought that the rash was shingles until a day and a half later when he/she could no longer stand the pain, went to the physician and had to have two more shots because the old shots they said were outdated. The patient said that, the pain was unbearable even now with no rash or sores two years later. The follow-up could not be possible as no contact details were available. As per narrative, condition aggravated was captured as the adverse event was exaggerated at the time of reporting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Nausea, Urinary tract infection, Vomiting
Clinical narrative: UTI after 1st dose; Dizziness; Nausea; Vomiting; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 12-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 12-JAN-2023, immediately after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). In FEB-2023, the patient experienced urinary tract infection (Verbatim: UTI after 1st dose). The patient was treated with macrobid (nos) (Macrobid). The outcome of the urinary tract infection, dizziness, nausea, vomiting and diarrhea were resolved.  It was unknown if the reporter considered the urinary tract infection, dizziness, nausea, vomiting and diarrhea to be related to Shingrix.  It was unknown if the company considered the urinary tract infection, dizziness, nausea, vomiting and diarrhea to be related to Shingrix.  Linked case(s) involving the same patient: US2023AMR052324  Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient. The patient had received the first dose of Shingrix into left arm and had immediately experienced nausea, vomiting, diarrhea and dizziness and urinary tract infection (UTI) one week to 10 days afterwards.  The reporter reported that her healthcare professional prescribed Macrobid for 5 days for both UTI's.  The patient reported that she had not experienced an UTI in over 10 years so she felt this be reported.  The reporter did not consent to follow up. 1 week after receiving Shingrix, the patient experienced urinary tract infection. For tolerance of second dose, kindly refer case US2023AMR052324 that was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR052324:Same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Interchange of vaccine products
Clinical narrative: doctor inadvertently ordered the patient to receive a dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A, expiry date 31-DEC-2023) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 09-APR-2023, the patient received Menveo. On 12-JUL-2022, the patient received MENACTRA. On 09-APR-2023, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: doctor inadvertently ordered the patient to receive a dose of Menveo). The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 The nurse reported that the 11 years old patient received a dose of Menactra on 12th July 2022.   The patient went for a check-up and the doctor inadvertently ordered the patient to receive a dose of Menveo which was administered 9th April 2023. The Menveo dose was administered from lot number AMVA765A and expiration date 31Dec2023. The reporter consented to follow up. The patient received a dose of Menactra and Menveo, which led to interchange of vaccine products.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: was supposed to be administered another vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30-APR-2023) for prophylaxis.   On 10-APR-2023, the patient received the 1st dose of Menveo. On 10-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: was supposed to be administered another vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt date: 10-APR-2023 Nurse reported that Menveo was administered to the patient unintentionally.  HCP (Health care professional) was asking about the recommended age and was unaware the patient fall within recommended age.  Patient had not received any meningococcal vaccines before and was supposed to be administered another vaccine, did not report which one. The reported consented to follow-up via email. Patient had not received any meningococcal vaccines before and was supposed to be administered another vaccine which led to wrong vaccine administered.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Underdose
Clinical narrative: Expired Havrix administered; 26 YO received pediatric dose; 26 YO received pediatric dose; 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 26-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.  On 10-APR-2023 16:00, the patient received Havrix pediatric. On 10-APR-2023 16:00, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered), adult use of a child product (Verbatim: 26 YO received pediatric dose) and underdose (Verbatim: 26 YO received pediatric dose). The outcome of the expired vaccine used, adult use of a child product and underdose 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: 10-APR-2023 The Healthcare Professional was unsure what dose number in the series this was, and no reactions were reported.  The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up via email. An adult patient received a pediatric dose that had also expired, which had led to expired vaccine used, adult use of a child product and underdose.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Bexsero; 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 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31-MAR-2023) for prophylaxis.   On 10-APR-2023, the patient received Bexsero. On 10-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Bexsero). 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: 11-APR-2023 The Vaccine Coordinator enquired for any guidance on how to proceed?  The reporter did not consent to follow-up. The patient had inadvertently administered an expired Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: Could not move arm for 2 weeks; This non-serious case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   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 mobility decreased (Verbatim: Could not move arm for 2 weeks). The outcome of the mobility decreased was resolved (duration 2 weeks 2 days).   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.     It was unknown if the company considered the mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 The reporter was the patient. The patient had her second dose of Shingrix approximately 2 years ago.. The patient could not move her right arm for 2 weeks and 2 days after vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Foot deformity, Hand deformity, Muscular weakness
Clinical narrative: Peripheral Neuropathy in both feet; Muscle weakness; Toes curl up on both feet at night; Hands are locking up; Fell forward,  had to sit down; Pain in front both legs, debilitating; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: Peripheral Neuropathy in both feet) (serious criteria GSK medically significant), muscle weakness (Verbatim: Muscle weakness), curly toe (Verbatim: Toes curl up on both feet at night), hand deformity (Verbatim: Hands are locking up), fall (Verbatim: Fell forward,  had to sit down) and leg pain (Verbatim: Pain in front both legs, debilitating). The patient was treated with medication unknown (Cream (Medication Unknown)). The outcome of the peripheral neuropathy, muscle weakness, curly toe, hand deformity and leg pain were not resolved and the outcome of the fall was not reported.   It was unknown if the reporter considered the peripheral neuropathy, muscle weakness, curly toe, hand deformity, fall and leg pain to be related to Shingrix.     It was unknown if the company considered the peripheral neuropathy, muscle weakness, curly toe, hand deformity, fall and leg pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 The patient reported that approximately 2 years ago he had his second dose of Shingrix and was now experiencing muscle weakness/pain in both legs.  The first episode the patient experienced was within a relatively short time after having had the Shingrix vaccination.  The patient reported that he was out for an evening walk when he kind of fell forward and had to sat down.  For approximately 2 years, the weakness/pain had been sporadic in nature but when it occurs it is debilitating. The muscle weakness/pain presents in the front of both legs.  The patient reported that he had to got up in the middle of the night to put cream on legs to relieve the pain.  He stated that at some point during these past two years his toes on both feet have started curling up at night and that his hands are now locking up.  The patient had also been diagnosed with peripheral neuropathy in both feet during these past 2 years.  He was under the care of a neurologist that had done many tests to try and diagnosis his condition.  The patient stated that the neurologist is unable to diagnose his condition.  The patient called GlaxoSmithKline today after seeing a commercial on TV for Shingrix and reported that one of the side effects mentioned was muscle weakness. The patient called to know if there was a correlation with the onset of his condition over the past two years and the Shingrix vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: Peripheral Neuropathy in both feet; Muscle weakness; Toes curl up on both feet at night; Hands are locking up; Fell forward,  had to sit down; Pain in front both legs, debilitating; This serious case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: Peripheral Neuropathy in both feet) (serious criteria GSK medically significant), muscle weakness (Verbatim: Muscle weakness), curly toe (Verbatim: Toes curl up on both feet at night), hand deformity (Verbatim: Hands are locking up), fall (Verbatim: Fell forward,  had to sit down) and leg pain (Verbatim: Pain in front both legs, debilitating). The patient was treated with medication unknown (Cream (Medication Unknown)). The outcome of the peripheral neuropathy, muscle weakness, curly toe, hand deformity and leg pain were not resolved and the outcome of the fall was not reported.   It was unknown if the reporter considered the peripheral neuropathy, muscle weakness, curly toe, hand deformity, fall and leg pain to be related to Shingrix.     It was unknown if the company considered the peripheral neuropathy, muscle weakness, curly toe, hand deformity, fall and leg pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2023 The patient reported that approximately 2 years ago he had his second dose of Shingrix and was now experiencing muscle weakness/pain in both legs.  The first episode the patient experienced was within a relatively short time after having had the Shingrix vaccination.  The patient reported that he was out for an evening walk when he kind of fell forward and had to sat down.  For approximately 2 years, the weakness/pain had been sporadic in nature but when it occurs it is debilitating. The muscle weakness/pain presents in the front of both legs.  The patient reported that he had to got up in the middle of the night to put cream on legs to relieve the pain.  He stated that at some point during these past two years his toes on both feet have started curling up at night and that his hands are now locking up.  The patient had also been diagnosed with peripheral neuropathy in both feet during these past 2 years.  He was under the care of a neurologist that had done many tests to try and diagnosis his condition.  The patient stated that the neurologist is unable to diagnose his condition.  The patient called GlaxoSmithKline today after seeing a commercial on TV for Shingrix and reported that one of the side effects mentioned was muscle weakness. The patient called to know if there was a correlation with the onset of his condition over the past two years and the Shingrix vaccination. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: male was administered a dose of Havrix on 11Apr2023  which had an expiration date of 16Dec2022.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 11-APR-2023, the patient received Havrix. On 11-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: male was administered a dose of Havrix on 11Apr2023  which had an expiration date of 16Dec2022.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date- 12-APR-2023 Pharmacist reported that patient administered a dose of Havrix on 11th April 2023 which had an expiration date of 16th December 2022, which led to expired vaccine used.  The pharmacist did not know which dose number in the series this was for the patient. The reporter was consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives on legs). The outcome of the hives was resolved (duration 1 hr).   The reporter considered the hives to be related to Shingrix.     The company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The patient reported this case for himself. He received Shingrix shot number one in February 2023. He was not sure but thought it was on the 18th Feb 2023. Sometime after receiving Shingrix shot the patient broke out in hives on his legs. The patient stated that there was nothing else different he did, not change laundry detergent. He stated that the hives were not terrible and the hives resolved in about an hour. The patient contacted GSK to seek adviced whether should he receive or not dose 2. The reporter did not consent to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Myalgia, Pain in extremity
Clinical narrative: Muscle Pain; Tiredness; Arm hurts; Shivering; Cold; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 11-APR-2023, less than a day after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering), coldness (Verbatim: Cold), fever (Verbatim: Fever) and pain in arm (Verbatim: Arm hurts). On 12-APR-2023, the patient experienced muscle pain (Verbatim: Muscle Pain) and tiredness (Verbatim: Tiredness). On 12-APR-2023, the outcome of the shivering was resolved (duration 1 day). The outcome of the coldness was not reported and the outcome of the fever was unknown and the outcome of the muscle pain, tiredness and pain in arm were not resolved.   It was unknown if the reporter considered the shivering, coldness, fever, muscle pain, tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the shivering, coldness, fever, muscle pain, tiredness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date:12-APR-2023 The patient reported the case for humself. The patient stated he received Shingrix yesterday(one day before reporting), at his physician's office, and started shivering  last night around 9:30PM until around 2AM this morning(reporting day).  The patient was also had cold last night, and also experienced a fever of unknown duration or temperature.  The patient was experiencing muscle pain and tiredness today and arm still hurts(reporting day). The reporter consented to follo-up with Healthcare professional. The reporter consented to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle Pain; Tiredness; Arm hurts; Shivering; Cold; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 11-APR-2023, less than a day after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering), coldness (Verbatim: Cold), fever (Verbatim: Fever) and pain in arm (Verbatim: Arm hurts). On 12-APR-2023, the patient experienced muscle pain (Verbatim: Muscle Pain) and tiredness (Verbatim: Tiredness). On 12-APR-2023, the outcome of the shivering was resolved (duration 1 day). The outcome of the coldness was not reported and the outcome of the fever was unknown and the outcome of the muscle pain, tiredness and pain in arm were not resolved.   It was unknown if the reporter considered the shivering, coldness, fever, muscle pain, tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the shivering, coldness, fever, muscle pain, tiredness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date:12-APR-2023 The patient reported the case for humself. The patient stated he received Shingrix yesterday(one day before reporting), at his physician's office, and started shivering  last night around 9:30PM until around 2AM this morning(reporting day).  The patient was also had cold last night, and also experienced a fever of unknown duration or temperature.  The patient was experiencing muscle pain and tiredness today and arm still hurts(reporting day). The reporter consented to follo-up with Healthcare professional. The reporter consented to follow-up.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Shingrix instead of HPV vaccine; 26-year-old received Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received Shingrix instead of HPV vaccine) and inappropriate age at vaccine administration (Verbatim: 26-year-old received Shingrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The reporter consented to follow up. A 26 year old patient by accident received a Shingrix vaccine when the intention was to administer an HPV vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Pediarix - Administration after expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   On 10-APR-2023, the patient received Pediarix. On 10-APR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix - Administration after expiration 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: 12-APR-2023 The nurse reported the administration of an expired Pediarix vaccine dose to a 3.5 years old patient. The reporter asked if the patient had to be re-vaccinated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. The patient received a Pediarix vaccine which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received first dose of Shingrix  in 2019 and never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose of shingrix in 2019).   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: patient received first dose of Shingrix  in 2019 and never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date- 13-APR-2023 The pharmacist reported that patient received first dose of Shingrix series in 2019 and never received the second dose.  The reporter was consented to fallow up Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, no 2nd dose 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 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th May 2018).   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: 1st dose 2018, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-APR-2023 The pharmacist informed that a patient had not received the 2nd dose yet. The vaccine administration facility was the same as primary reporter. 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. Details pertains to 1st dose of Shingrix in product tab.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 02Mar2023, 2nd dose 05Apr2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 34EC5, expiry date 02-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 05-APR-2023, the patient received the 2nd dose of Shingrix. On 05-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 02Mar2023, 2nd dose 05Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-Apr-203 The reporter gave permission for follow-up. An immunocompetent patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 0.25
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 month old inadvertently 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 3-month-old 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: 3 month old inadvertently received Kinrix). 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: 13-Apr-2023 The physician declined to provide more information. The permission for follow-up was not asked. The patient inadvertently received a dose of Kinrix within in the past few days at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) 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)) for COVID-19 prophylaxis.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Company comment: This spontaneous case concerns an adult patient of unknown gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. Event outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report   This case was linked to US-MODERNATX, INC.-MOD-2023-719403 (Linked Report).; Reporter's Comments: Company comment: This spontaneous case concerns an adult patient of unknown gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. Event outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719403:This case is for Doctor 2 out  of 2 doctors
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) 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)) for COVID-19 prophylaxis.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.  Company comment:This spontaneous case reported by a unknown age and gender, with no medical history, who experienced the unexpected serious (medically significant) AESI event of atrial fibrillation, which occurred unspecified days after a dose (dose number nor specified) of mRNA-1273 bivalent BA.4/BA.5 vaccination. At the time of reporting outcome of the event is unknown. No further information for medical history, lab data, concomitant medication, clinical course. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-719402 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719402:This case is for Doctor 1 out  of 2 doctors
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Swelling; Redness; itching; Pain at the injection site; moderate headache; mild nausea; Mild Joint pain; Low grade Fever; Chills; Mild muscle body aches; Fatigue; Pain at the injection site; Swelling at the injection site; Headache; Joint pain; Nausea; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (moderate headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced the first episode of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea), ARTHRALGIA (Mild Joint pain), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue). At the time of the report, SWELLING (Swelling), the last episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea) and ARTHRALGIA (Mild Joint pain) outcome was unknown and ERYTHEMA (Redness), PRURITUS (itching), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse events after 1st and 2nd Moderna monovalent booster dose.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, Swelling
Clinical narrative: Swelling; Redness; itching; Pain at the injection site; moderate headache; mild nausea; Mild Joint pain; Low grade Fever; Chills; Mild muscle body aches; Fatigue; Pain at the injection site; Swelling at the injection site; Headache; Joint pain; Nausea; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (moderate headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced the first episode of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea), ARTHRALGIA (Mild Joint pain), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue). At the time of the report, SWELLING (Swelling), the last episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea) and ARTHRALGIA (Mild Joint pain) outcome was unknown and ERYTHEMA (Redness), PRURITUS (itching), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse events after 1st and 2nd Moderna monovalent booster dose.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling; Redness; itching; Pain at the injection site; moderate headache; mild nausea; Mild Joint pain; Low grade Fever; Chills; Mild muscle body aches; Fatigue; Pain at the injection site; Swelling at the injection site; Headache; Joint pain; Nausea; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site) and HEADACHE (moderate headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced the first episode of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). On 02-Mar-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (Redness), PRURITUS (itching), the second episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea), ARTHRALGIA (Mild Joint pain), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue). At the time of the report, SWELLING (Swelling), the last episode of VACCINATION SITE PAIN (Pain at the injection site), HEADACHE (moderate headache), NAUSEA (mild nausea) and ARTHRALGIA (Mild Joint pain) outcome was unknown and ERYTHEMA (Redness), PRURITUS (itching), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Low grade Fever), CHILLS (Chills), MYALGIA (Mild muscle body aches) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient reported no adverse events after 1st and 2nd Moderna monovalent booster dose.  No treatment information was provided.