chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; has had Shingles for four months; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had Shingles for four months). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 4 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 24-OCT-2024 The reporter was friend of the patient.  The reporter reported that the patient had Shingles for four months and he had the original vaccine and had the newer 2 shot vaccine.  The reporter reported, there was still a risk of getting Shingles even though you had been vaccinated.  The reporter reported, the shots were around 90 percent effective. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st dose ) and Shingles vaccine.(2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-OCT-2024 The reporter reported that he/she got the Shingrix vaccine three years ago and just got shingles. The reporter asked questioned how common this was. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: UNK
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Product complaint
Clinical narrative: severe pain when getting the injection; painful; that it burns; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2008-2009 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Fluarix 2008-2009 season. On an unknown date, immediately after receiving Fluarix 2008-2009 season, the patient experienced injection site pain (Verbatim: severe pain when getting the injection), pain (Verbatim: painful), burning sensation (Verbatim: that it burns) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, pain, burning sensation and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.     It was unknown if the company considered the injection site pain, pain and burning sensation to be related to Fluarix 2008-2009 season.   Additional Information: GSK Receipt Date: 01-OCT-2024 and 02-OCT-2024 The pharmacist had been administering the Fluarix vaccine and many people were reporting that it hurts so bad during the injection, that it burns. Nursing staff and two providers did the vaccination and they all had severe pain when getting the injection.  Then they quarantined the vaccines after the medical staff had the shots, so they did not had any specific patient (non healthcare workers) who had got the Fluarix vaccine.  The age range of the vaccinated persons were 38 to under 52 years old. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR121802:same reporter, different patient
Sex: F
Vaccine: TDAP
Symptoms: Blister, Contusion, Mass, Rash pruritic, Scab
Clinical narrative: her chest is all scabs on it; itching and her chest is all scabs on it, it like gives her like a blister like thing/blister; really nasty big brown bruise in one of the lumps; really nasty big brown bruise in one of the lumps; really nasty big brown bruise in one of the lumps; she started experiencing an extreme itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27Y) for prophylaxis.   Previously administered products included tetanus, diphtheria, pertussis vaccine (received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago, but they don't have specific dates, brands, lot number or expiration dates).   On 19-AUG-2024, the patient received Boostrix. On 20-AUG-2024, 1 days after receiving Boostrix, the patient experienced itchy rash (Verbatim: she started experiencing an extreme itchy rash). On an unknown date, the patient experienced scab (Verbatim: her chest is all scabs on it), blister (Verbatim: itching and her chest is all scabs on it, it like gives her like a blister like thing/blister), contusion (Verbatim: really nasty big brown bruise in one of the lumps), mass (Verbatim: really nasty big brown bruise in one of the lumps) and skin discoloration (Verbatim: really nasty big brown bruise in one of the lumps). The patient was treated with cortisone and prednisone. The outcome of the itchy rash was not resolved and the outcome of the scab, blister, contusion, mass and skin discoloration were unknown.   It was unknown if the reporter considered the itchy rash, scab, blister, contusion, mass and skin discoloration to be related to Boostrix.     It was unknown if the company considered the itchy rash, scab, blister, contusion, mass and skin discoloration to be related to Boostrix.   Additional Information: GSK receipt date: 01-OCT-2024 The reporter reported that patient received Bexsero vaccine and started experiencing an extreme itchy rash that was not going away even after cortisone and prednisone cream treatment. The patient mentioned it was like an 8 out of 10 like itching and her chest wais all scabs on it, it like gives her like a blister like thing, on one of the lumps, she got a big brown bruise around it that was really nasty. The patient had appointments to be tested for formaldehyde and thimerosal. The reporter was concerned that maybe there was too much of an ingredient in the lot number (potential Product Quality Complaint) administered to them and they doubt they was the only ones experiencing these symptoms. This case had been link with US2024121079, reported by the same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2024121079:Wife report
Sex: F
Vaccine: TDAP
Symptoms: Skin discolouration
Clinical narrative: her chest is all scabs on it; itching and her chest is all scabs on it, it like gives her like a blister like thing/blister; really nasty big brown bruise in one of the lumps; really nasty big brown bruise in one of the lumps; really nasty big brown bruise in one of the lumps; she started experiencing an extreme itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KY27Y) for prophylaxis.   Previously administered products included tetanus, diphtheria, pertussis vaccine (received prior doses of Tetanus, Diphtheria, Pertussis vaccine 10 or 20 years ago, but they don't have specific dates, brands, lot number or expiration dates).   On 19-AUG-2024, the patient received Boostrix. On 20-AUG-2024, 1 days after receiving Boostrix, the patient experienced itchy rash (Verbatim: she started experiencing an extreme itchy rash). On an unknown date, the patient experienced scab (Verbatim: her chest is all scabs on it), blister (Verbatim: itching and her chest is all scabs on it, it like gives her like a blister like thing/blister), contusion (Verbatim: really nasty big brown bruise in one of the lumps), mass (Verbatim: really nasty big brown bruise in one of the lumps) and skin discoloration (Verbatim: really nasty big brown bruise in one of the lumps). The patient was treated with cortisone and prednisone. The outcome of the itchy rash was not resolved and the outcome of the scab, blister, contusion, mass and skin discoloration were unknown.   It was unknown if the reporter considered the itchy rash, scab, blister, contusion, mass and skin discoloration to be related to Boostrix.     It was unknown if the company considered the itchy rash, scab, blister, contusion, mass and skin discoloration to be related to Boostrix.   Additional Information: GSK receipt date: 01-OCT-2024 The reporter reported that patient received Bexsero vaccine and started experiencing an extreme itchy rash that was not going away even after cortisone and prednisone cream treatment. The patient mentioned it was like an 8 out of 10 like itching and her chest wais all scabs on it, it like gives her like a blister like thing, on one of the lumps, she got a big brown bruise around it that was really nasty. The patient had appointments to be tested for formaldehyde and thimerosal. The reporter was concerned that maybe there was too much of an ingredient in the lot number (potential Product Quality Complaint) administered to them and they doubt they was the only ones experiencing these symptoms. This case had been link with US2024121079, reported by the same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2024121079:Wife report
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Influenza like illness, Pain in extremity
Clinical narrative: flu-like symptoms; she had a sore left arm; freezing last night; woke up hot; woke up hot and sweaty; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-OCT-2024, the patient received the 2nd dose of Shingrix (left arm). In OCT-2024, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), pain in arm (Verbatim: she had a sore left arm), feeling cold (Verbatim: freezing last night), feeling hot (Verbatim: woke up hot) and sweating (Verbatim: woke up hot and sweaty). The outcome of the influenza-like symptoms and pain in arm were unknown and the outcome of the feeling cold, feeling hot and sweating were not reported.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, feeling cold, feeling hot and sweating to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, pain in arm, feeling cold, feeling hot and sweating to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-OCT-2024 The patient was the reporter. The reported that the patient who received her Shingrix the day before reporting. The patient stated that last night, she started getting flu-like symptoms (she was freezing last night and woke up hot and sweaty).  The patient also mentioned that she had a sore left arm.. The reporter did not consent to follow-up.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: vagal response; This non-serious case was reported by a nurse via call center representative and described the occurrence of vagal reaction in a 59-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2257N, expiry date 03-JUN-2025) for prophylaxis.   On 25-SEP-2024, the patient received FluLaval 2024-2025 season. On 26-SEP-2024, 1 days after receiving FluLaval 2024-2025 season, the patient experienced vagal reaction (Verbatim: vagal response). The outcome of the vagal reaction was unknown.   It was unknown if the reporter considered the vagal reaction to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the vagal reaction to be related to FluLaval 2024-2025 season and Flulaval 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: 02-OCT-2024 Registered nurse requested for data for causality of vagal responses with Flulaval. Reporter reported patient was administered Flulaval vaccine and experienced a vagal response. Also stated that patient was at an event with doctors, who immediately started CPR at the scene, called emergency medical services and sent patient to emergency room, where the patient was later discharged. Reporter stated that it was not thought to be a true cardiac event but a vagal event.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine administered; Nurse explained they accidentally administered Infanrix instead of Boostrix to an 11 year old patient back on September 13th 2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Infanrix (received a dose on 22-SEP-2017 with batch number PT2RK and expiry date 07th July 2019), Dtap vaccie (received a dose on 19th March 2015) and Dtap vaccine (received a dose on 10th June 2014).   On 13-SEP-2024, the patient received Infanrix and Boostrix. On 13-SEP-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Wrong vaccine administered) and inappropriate age at vaccine administration (Verbatim: Nurse explained they accidentally administered Infanrix instead of Boostrix to an 11 year old patient back on September 13th 2024.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2024 The nurse explained they accidentally administered Infanrix instead of Boostrix to an 11 year old patient back on 13th September 2024 which led to wrong vaccine administered. The patient received prior doses on 22nd September 2017 Infanrix with batch number PT2RK and expiration date 07th July 2019. On 10th June 2014 received vaccine Tetanus, Diphtheria, Acellular Pertussis Vaccine, Adsorbed 5 pertussis antigens with batch number 32PC3.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Maladministration of Pediatric Dose on an Adult Patient (2nd dose in the schedule); underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Maladministration of Pediatric Dose on an Adult Patient (2nd dose in the schedule)) and underdose (Verbatim: underdose). The outcome of the 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: 03-OCT-2024 Medical Assistant asks about to advise after a maladministration of a pediatric dose on an adult patient, which led adult use of a child product and underdose. The reporter did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: he was supposed to get the Menveo, but he ended up receiving the Bexsero, Meningococco B.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 02-OCT-2024, the patient received Bexsero. On an unknown date, the patient did not receive Menveo. On 02-OCT-2024, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: he was supposed to get the Menveo, but he ended up receiving the Bexsero, Meningococco B.). The outcome of the wrong 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: 03-OCT-2024 The reporter reported that they had an 11 year old come in yesterday and he was supposed to get the Menveo but he ended up receiving the Bexsero, Meningococco B, which led to wrong vaccine administered. The reporter stated that they were in the understanding the the Bexsero, the Meningococco B was not indicated for his age group, was indicated for 16 to 18, so they were calling o see if there was anything that they need to do on behalf of the patient. The Vaccine Administration Facility was the same as Primary Reporter The reporter mentioned that the patient's mom reported that the kid was fine yesterday evening. The GSK explained to the reporter that the Bexsero was indicated for patients of 11 to 25 years old.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 5 month old patient given HIBERIX & PENTACEL vaccines on same day. Patient has no known side effects; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included Pentacel (batch number 97F4B, expiry date 15-MAR-2026) and (batch number UK020AA, expiry date 30-JUN-2025) for prophylaxis.   On 03-OCT-2024, the patient received Hiberix and Pentacel (intramuscular, left thigh) .5 ml. On 03-OCT-2024, an unknown time after receiving Hiberix, the patient experienced overdose (Verbatim: 5 month old patient given HIBERIX & PENTACEL vaccines on same day. Patient has no known side effects). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The reporter reported that the 5 month old patient given Hiberix & pentacel vaccines on same day which led to overdose. The patient had no known side effects.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: a pregnant patient received an extra dose; a pregnant patient received an extra dose; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 37-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4799g, expiry date 12-OCT-2026) for an unknown indication.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 02-OCT-2024, the patient received the 2nd dose of Boostrix. On 12-SEP-2024, the patient received the 1st dose of Boostrix. On 02-OCT-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: a pregnant patient received an extra dose). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant patient received an extra dose). The outcome of the extra dose administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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: 04-OCT-2024 Reporter was the HCP (pharmacist) who stated that a pregnant patient received an extra dose of Boostrix which led to extra dose administered and vaccine exposure during pregnancy. The HCP did not know the lot and expiration date for the first dose but provided it for the second.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: got numbness in my left cheek and left side of my body; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (got numbness in my left cheek and left side of my body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (got numbness in my left cheek and left side of my body) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (got numbness in my left cheek and left side of my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had a total of five Moderna dose/booster since 28 Jan 2021. Patient was reluctant to have another. It was unknown if the patient experienced any additional symptoms/events. No treatment medication reported.   This case was linked to MOD-2024-775706 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Device difficult to use, No adverse event
Clinical narrative: No adverse effect; Tip caps on the Moderna Prefilled syringes are difficult to twist off/covid cap was hard to get off the syringe; The covid cap was hard to get off the syringe and when the staff member finally got it, the vaccine squirted up into her eye; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE DIFFICULT TO USE (Tip caps on the Moderna Prefilled syringes are difficult to twist off/covid cap was hard to get off the syringe), ACCIDENTAL EXPOSURE TO PRODUCT (The covid cap was hard to get off the syringe and when the staff member finally got it, the vaccine squirted up into her eye) and NO ADVERSE EVENT (No adverse effect) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On 21-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 21-Oct-2024, the patient experienced DEVICE DIFFICULT TO USE (Tip caps on the Moderna Prefilled syringes are difficult to twist off/covid cap was hard to get off the syringe) and ACCIDENTAL EXPOSURE TO PRODUCT (The covid cap was hard to get off the syringe and when the staff member finally got it, the vaccine squirted up into her eye). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE DIFFICULT TO USE (Tip caps on the Moderna Prefilled syringes are difficult to twist off/covid cap was hard to get off the syringe), ACCIDENTAL EXPOSURE TO PRODUCT (The covid cap was hard to get off the syringe and when the staff member finally got it, the vaccine squirted up into her eye) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that the covid cap was hard to get off the syringe and when the staff member finally got it, the vaccine squirted up into her eye.  When talked with other staff, they said they had a really hard time getting the caps off. They had to twist and twist and pull and pull and feel like they were going to break something trying to get them off. Treatment information was not reported.  The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which include Use of Device Problem.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Hives around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives around injection site) in a 9-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3043023) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 20-Oct-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced VACCINATION SITE URTICARIA (Hives around injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives around injection site) had not resolved.        For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was unknown if the patient experienced any additional symptoms or events.  Treatment medication use information was not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: got numbness in my left cheek and left side of my body; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (got numbness in my left cheek and left side of my body) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (got numbness in my left cheek and left side of my body) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (got numbness in my left cheek and left side of my body) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had a total of five Moderna dose/booster since 28 Jan 2021. Patient was reluctant to have another. It was unknown if the patient experienced any additional symptoms/events. No treatment medication reported.   This case was linked to MOD-2024-775709 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart was beating fast; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart was beating fast) in a 93-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Swelling of feet and Edema peripheral.    In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 25-Oct-2024, the patient experienced HEART RATE INCREASED (heart was beating fast). On 25-Oct-2024, HEART RATE INCREASED (heart was beating fast) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2024, Heart rate: Increased.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Patient stated she had taken the vaccine on 22-Oct-2024 or 23-Oct-2024, she couldn't recall exactly, and said everything was fine at the time. Patient's heart was beating fast, and it got back to normal after a while. Patient stated that might be her 3rd or 4th vaccination series. No treatment information was reported.
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: heavy night sweats; feeling of fever; chills; full body muscle and joint aches; occasional headaches; joint aches; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches) and HEADACHE (occasional headaches) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for an unknown indication.    No Medical History information was reported.   In October 2024, the patient received dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. On 24-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 24-Oct-2024, the patient experienced NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches), HEADACHE (occasional headaches) and ARTHRALGIA (joint aches). At the time of the report, NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches), HEADACHE (occasional headaches) and ARTHRALGIA (joint aches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2024, Body temperature: 96.0F-98.6F.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Reporter causality was not reported. It was reported that there were 2 days most symptoms then faded. patient wife received same vaccines with no adverse effects. It was unknown if the patient experienced any additional symptoms/events.    No treatment information was reported.
Age: 76.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Night sweats, Pyrexia
Clinical narrative: heavy night sweats; feeling of fever; chills; full body muscle and joint aches; occasional headaches; joint aches; This spontaneous case was reported by a patient and describes the occurrence of NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches) and HEADACHE (occasional headaches) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for an unknown indication.    No Medical History information was reported.   In October 2024, the patient received dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. On 24-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 24-Oct-2024, the patient experienced NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches), HEADACHE (occasional headaches) and ARTHRALGIA (joint aches). At the time of the report, NIGHT SWEATS (heavy night sweats), PYREXIA (feeling of fever), CHILLS (chills), MYALGIA (full body muscle and joint aches), HEADACHE (occasional headaches) and ARTHRALGIA (joint aches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2024, Body temperature: 96.0F-98.6F.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Reporter causality was not reported. It was reported that there were 2 days most symptoms then faded. patient wife received same vaccines with no adverse effects. It was unknown if the patient experienced any additional symptoms/events.    No treatment information was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash around neck, back, and armpits; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (rash around neck, back, and armpits) in a 47-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-Oct-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced RASH (rash around neck, back, and armpits). At the time of the report, RASH (rash around neck, back, and armpits) was resolving.      Concomitant product use was not provided by the reporter.  Patient developed rash around neck, back, and armpits. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Influenza like illness, Insomnia
Clinical narrative: worst acid reflux of [her] life; Pt required multiple pillows to be able to sleep; flu-like side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like side effects), GASTROOESOPHAGEAL REFLUX DISEASE (worst acid reflux of [her] life) and INSOMNIA (Pt required multiple pillows to be able to sleep) in a 43-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043335) for COVID-19 prophylaxis.     The patient's past medical history included Acid reflux (esophageal) (well controlled with diet and stress management). Previously administered products included for Product used for unknown indication: Moderna (primary series) in 2021 and Pfizer (late 2021 and tolerated well) in 2021. Past adverse reactions to the above products included No adverse effect with Moderna and Pfizer.    On 13-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 14-Oct-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced INFLUENZA LIKE ILLNESS (flu-like side effects). On 15-Oct-2024, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (worst acid reflux of [her] life) and INSOMNIA (Pt required multiple pillows to be able to sleep). On 14-Oct-2024, INFLUENZA LIKE ILLNESS (flu-like side effects) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (worst acid reflux of [her] life) and INSOMNIA (Pt required multiple pillows to be able to sleep) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. On next day of vaccination patient felt flu-like side effects which resolved by end of day. Patient had history of acid reflux which was under control with diet and stress management did not required medications. All had been kept at baseline (no dietary changes or stress triggers). It was triggered on 15-Oct-2024after vaccination. Patient was endorsed labored breathing due to reflux and would feel "fluttering" in area of upper stomach that was associated with acuity spike in symptoms and started with proton pump inhibitor (PPI) course to help symptoms resolve. Patient required multiple pillows to be able to sleep. It was unknown if the patient experienced any additional symptoms/events.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: They peel that off and then they saw the syringe was broken; Top came off; The initial case was missing the following minimum criteria: reportability determination. Upon receipt of follow-up information on 22Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Nurse from product quality group.  This report involved a pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1; 0.5 ml single (Lot number: LC1281, Expiration Date: 31Jan2026) for immunisation, Device Lot Number: LC1281. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "They peel that off and then they saw the syringe was broken; Top came off".  Causality for "they peel that off and then they saw the syringe was broken; top came off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Follow-up (22Oct2024): This is a spontaneous report received from product quality group, Updated information included: reportability determination, expiration date.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: during preparation, the syringe broke away from the vial when it was being attached; The initial case was missing the following minimum criteria: identifiable event. Upon receipt of follow-up information on 24Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HY1812, Expiration Date: 31Aug2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset 22Oct2024, outcome "unknown", described as "during preparation, the syringe broke away from the vial when it was being attached".  Causality for "during preparation, the syringe broke away from the vial when it was being attached" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: No patient administration involved and the patient is requesting replacement for product defect; the patient also gave an NDC 0069-0344-05 which the patient confirmed was from the box and it comes in a 5 pack box. Carton/box: She does not have the carton/box but the NDC number from the box is 0069-0344-05 and she has a serial number written down from the box that is 122242976045 but has no lot, expiry date or manufacturer name to provide from the carton/box and assumes it is the same manufacturer. Antigen Vial: There is a number but it does not look like the lot number and it is PAA209777 and verified the lot number is the one the transferring agent provided and it is HY1812, NDC 00069020701, manufacturer Pfizer. Diluent syringe: lot HM8389, expiry date Sep2025, NDC 00069025001 and states the NDC has a lot of zeros, manufacturer Pfizer.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Device connection issue, Exposure during pregnancy, Needle issue, Soft tissue foreign body
Clinical narrative: Needle attached for injection popped off during administration leaving needle in arm; Luer lock on diluent was damaged AKA melted; Luer lock on diluent was damaged AKA melted; This is a spontaneous report received from a Nurse.  A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Oct2024 as dose number unknown, single (Lot number: HM9849) at the age of 33 years, in left deltoid for maternal immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: POOR QUALITY DEVICE USED (non-serious), PRODUCT COMPLAINT (non-serious) all with onset 22Oct2024 at 15:45 and all described as "Luer lock on diluent was damaged AKA melted"; INJURY ASSOCIATED WITH DEVICE (non-serious) with onset 22Oct2024 at 15:45, described as "Needle attached for injection popped off during administration leaving needle in arm". Therapeutic measures were taken as a result of injury associated with device, poor quality device used, product complaint.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient was not taking any other medications within 2 weeks of the event starting. Luer lock on diluent was damaged AKA melted. Needle attached for injection popped off during administration leaving needle in arm, but the vaccine did not administer. Re-vaccinated with no problems.  Causality for "needle attached for injection popped off during administration leaving needle in arm" and "luer lock on diluent was damaged aka melted" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Back disorder, Vaccination site pain, X-ray
Clinical narrative: in PT for a back issue that was improved; having extreme pain in her arm after receiving the vaccine/this is really bad/happens to be my right arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "not recovered", described as "having extreme pain in her arm after receiving the vaccine/this is really bad/happens to be my right arm"; BACK DISORDER (non-serious) with onset Oct2024, outcome "recovered" (Oct2024), described as "in PT for a back issue that was improved". The event "having extreme pain in her arm after receiving the vaccine/this is really bad/happens to be my right arm" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the Pfizer Covid-19 vaccine and is seeking recommendations on if she should see a certain doctor, such as an orthopedist, for having extreme pain in her arm after receiving the vaccine. The patient stated that she had seen an orthopedist and is in PT for a back issue that was improved, but now her arm was experiencing pain. She asked if patients have reported experiencing the pain for this long. She stated that she has gotten many vaccines and has never had this before. This was really bad. It happened to be her right arm, which is her dominant arm. Caller stated that she got a flu shot in her left arm and the covid vaccine was administered in her right arm. The patient received Covid Shot over 3 weeks ago. For three weeks she had extreme pain in arm. She has never had any problems with any other vaccines before. She went to the doctor and the doctor could not find anything wrong. She was sent to get an X-ray, and it did not show anything. She read there could be certain things that could happen such as bursitis or problems with the shoulder. She does not know what is going on and the doctor does not see anything wrong. She wanted to know if she should go see an orthopedist, she does not know who she should go to.  Batch/lot number is not provided, and it cannot be obtained.