chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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, an unknown time after receiving Shingles vaccine, the patient 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 Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-OCT-2024 This case was reported by a patient via interactive digital media. The reporter's daughter got really sick from both of Shingles vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: had a burning came back; within a week the rash started, first on my chest; then the hives began on my right upper back, shoulder and neck area; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-OCT-2024, the patient received the 1st dose of Shingrix. In OCT-2024, less than a week after receiving Shingrix, the patient experienced generalized rash (Verbatim: within a week the rash started, first on my chest) and generalized urticaria (Verbatim: then the hives began on my right upper back, shoulder and neck area). On an unknown date, the patient experienced burning skin (Verbatim: had a burning came back). The outcome of the generalized rash and burning skin were not resolved and the outcome of the generalized urticaria was not reported.   It was unknown if the reporter considered the generalized rash, generalized urticaria and burning skin to be related to Shingrix.     It was unknown if the company considered the generalized rash, generalized urticaria and burning skin to be related to Shingrix.   Additional Information: GSK receipt date: 08-NOV-2024 The reporter reported that he/she got the Shingrix shot and within a week the rash started first on his/her chest and then the hives began on his/her right upper back, shoulder and neck area. On 2nd November 2024 he/she went to a because his/her doctor could not schedule for a visit. They prescribed him/her a course of steroids. The steroids helped him/her and then the day after he/she was finished, the rash and burning came back. The reporter mentioned that they had to return to see a medical professional for this severe reaction. The reporter reported he/she had not problems with hives and rashes before the Shingrix vaccine. He/she would like to know why once the steroids was completed the severe reaction returns.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Ocular shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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 ophthalmic herpes zoster (Verbatim: Ocular shingles) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 16-NOV-2024 The other health professional self reported this case for himself/herself. The other health professional was just wondering if the manufacturer has a place for counting vaccine failures, It seems important.  The other health professional got the vaccine at age 58, 7 years ago, as soon as it became available.  The other health professional now had developed ocular shingles. This case was considered as suspected vaccination failure as details regarding completion of primary immunization schedule, 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 and  details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingrix. Ophthalmic herpes zoster  is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had a shingles shots and still got shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had a shingles shots and still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2024 The patient self-reported this case. The patient reported that he/she had a Shingles shots and still got shingles when he/she was going through cancer treatment. The reporter had hated to think what it would have been like if he/she had not the vaccine. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 47.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: late than recommended intervals in between 2nd and 3rd dose; late than recommended intervals in between 1st and 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 50-year-old female patient who received Men B NVS (Bexsero) (batch number 25DB5, expiry date 31-JUL-2025) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose of Bexsero on 02-JAN-2018). Additional patient notes included Patient was under complement inhibitor medication..   On 01-JUN-2023, the patient received the 3rd dose of Bexsero. On 21-APR-2022, the patient received the 2nd dose of Bexsero. On 21-APR-2022, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: late than recommended intervals in between 1st and 2nd dose). On 01-JUN-2023, the patient experienced drug dose administration interval too long (Verbatim: late than recommended intervals in between 2nd and 3rd dose). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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: 28-OCT-2024 The patient received 2nd and 3rd dose of Bexsero vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: MENB
Symptoms: Inadvertent injection air bubble, Wrong technique in product usage process
Clinical narrative: large (about 0.25 mL) bubble from the Bexsero pre-filled syringes; Size was about half the volume of the solution (0.25 mL) in the 0.5 mL PFS; vaccine PFS contents were transferred to new, non-GSK syringes; Product Complaint; This non-serious case was reported by a other health professional via sales rep and described the occurrence of poor quality vaccine administered in six patients who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced poor quality vaccine administered (Verbatim: large (about 0.25 mL) bubble from the Bexsero pre-filled syringes), accidental underdose (Verbatim: Size was about half the volume of the solution (0.25 mL) in the 0.5 mL PFS), wrong technique in product usage process (Verbatim: vaccine PFS contents were transferred to new, non-GSK syringes) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the poor quality vaccine administered, accidental underdose, wrong technique in product usage process and pharmaceutical product complaint 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: 28-OCT-2024 The reporter reported that other experienced vaccinators in the office had also been unable to remove the large (about 0.25 mL) bubble from the Bexsero pre-filled syringes in this box. Confirmed that all operations were performed appropriately before defect was discovered. Seven doses, in this ten-dose box of pre-filled syringes, had a large bubble that was not able to be removed. Six of the vaccine pre-filled syringe contents were transferred to new, non-GlaxoSmithKline syringes and administered to patients, which led to wrong technique in product usage process. Three doses remain in the box with no bubble seen and seventh dose was discarded when the bubble could not be removed without wasting some of the vaccine.  The defect was discovered during preparation, one suspect syringe was not administered, due to the bubble. The contents of six additional Bexsero pre-filled syringes were transferred to other non-GlaxoSmithKline syringe and they were able to remove the large bubble in each and administer to six patients, which led to accidental underdose and poor quality vaccine administered. Size of bubble was about half the volume of the solution (0.25 ml) in the 0.5 ml pre-filled syringe. Large bubble that was unable to be removed from pre-filled syringe and there were no visible damage present on the syringe and also there were no temperature excursion was confirmed. Product was at room temperature when particle was observed.  All seven suspect syringes were excursion discarded and were not available for return to GlaxoSmithKline.  No picture was taken of the defect (bubble).
Age: 3.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: extended period of administration (greater than 3 months) between dose 1 and dose 2 of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose of  Menveo at the age of two years old).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: extended period of administration (greater than 3 months) between dose 1 and dose 2 of Menveo). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-OCT-2024  The registered nurse asked about an eleven year old patient that received two previous doses of Menveo vaccine (one at the age of two years old and one at three years old). A patient received 1st dose of Menveo and received 2nd dose, which led to extra dose administered. The reporter reported that they were trying to find out if it can be given another one at eleven (booster) or wait until sixteen. The registered nurse did not consent reactively for safety department follow-up and did not provide any further detail about vaccine detail (specific vaccination dates for the first and second dose) and patient demographics.
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance
Clinical narrative: trouble walking; This non-serious case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On 04-OCT-2024, the patient received Fluarix 2024-2025 season. In OCT-2024, less than a day after receiving Fluarix 2024-2025 season, the patient experienced walking difficulty (Verbatim: trouble walking). The outcome of the walking difficulty was not resolved.   It was unknown if the reporter considered the walking difficulty to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the walking difficulty to be related to Fluarix 2024-2025 season and Fluarix 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: 29-OCT-2024 Reporter was the patient who received a dose of Fluarix and said that within a day he had a hard time walking.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: received the first dose of Flulaval on Oct 23rd 2024 and today (Oct 29th 2024) a second dose was given; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 10-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 275NJ, expiry date 30-JUN-2025) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL).   On 29-OCT-2024, the patient received the 2nd dose of FluLaval 2024-2025 season. On 29-OCT-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: received the first dose of Flulaval on Oct 23rd 2024 and today (Oct 29th 2024) a second dose was given). The outcome of the extra dose 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: 29-OCT-2024 The reporter reported that a patient received the first dose of Flulaval on 23rd October 2024 and on the day of reporting a second dose was given to the patient, which led to extra dose administered. The reporter asked for expected side effects. The reporter mentioned that the same lot number and expiration date for both doses.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Incorrect diluent for reconstitution.; Incorrect diluent for reconstitution.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amvb03a, expiry date 30-APR-2024) for prophylaxis.   On 28-SEP-2024, the patient received Menveo. On 28-SEP-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Incorrect diluent for reconstitution.) and inappropriate dose of vaccine administered (Verbatim: Incorrect diluent for reconstitution.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-OCT-2024 A nurse mentioned that a dose of Menveo was reconstituted using sterile diluent instead of the liquid conjugate component of Menveo 2 vial presentation which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine was administered on Sep 28th 2024. The nurse asked for recommendations on this situation.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose in immunocompromised patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix two years ago). Concurrent medical conditions included immunocompromised.   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 drug dose administration interval too long (Verbatim: Late second dose in immunocompromised patient). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 29-OCT-2024 The other health professional reported that an immunocompromised patient who received the 1st dose two years ago, and then the 2nd dose just recently. The other health professional asked was there any data that supports this significantly immunocompromised patient to receive a 3rd dose (since 2 years have lapsed between the 1st and 2nd dose). The other health professional asked should this patient test their titer/antibody levels to check their level of protection. The patient received second dose of Shinrix longer than the recommended interval which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/ has yet to receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on December 7th 2020).   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: Inappropriate schedule of vaccine/ has yet to receive the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter was the patient. The patient did not want to share his phone number or street address or exact date of birth or answer any further questions pertaining  to the report. The patient did provide his current age which was 65 years old. The patient received 1st Shingrix shot but has yet to receive the second shot. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: accidentally give a Shingles shot instead of a Second dose of varicella vaccine; 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 64-year-old male patient who received Herpes zoster (Shingrix) (batch number A2F3R, expiry date 26-OCT-2026) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis.   Concomitant products included Varicella zoster vaccine (Varicella vaccine).   On 30-OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Varicella vaccine. On 30-OCT-2024, an unknown time after receiving Shingrix and not applicable after receiving Varicella vaccine, the patient experienced wrong vaccine administered (Verbatim: accidentally give a Shingles shot instead of a Second dose of varicella vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 Healthcare Professional called to report that he/she accidentally gave a Shingles shot instead of a Second dose of varicella vaccine. The reporter consented to follow up. The patient received a first shot of Varicella vaccine a month ago and he was supposed to receive a 2nd dose but instead, he got a First dose of Shingrix, which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in 2019 (no specific date provided)).   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: never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter was a male patient who reports that he received the first dose of Shingrix and never received the second dose (AE Filed - Inappropriate schedule of vaccine). The patient did not have any Lot Expiry/NDC information and, the patient asked to not have to answer the rest of the questions about route or location of administration. The patient have reported all that was provided about this adverse event. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Pain
Clinical narrative: 2 months ago do not walk good; pain when walking/she sees pain management for pain when she walks; This serious case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stroke and speech disorder (speech hard to understand due to stroke).   On 15-OCT-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced walking difficulty (Verbatim: 2 months ago do not walk good) (serious criteria hospitalization) and pain upon movement (Verbatim: pain when walking/she sees pain management for pain when she walks) (serious criteria hospitalization). The outcome of the walking difficulty and pain upon movement were not resolved.   It was unknown if the reporter considered the walking difficulty and pain upon movement to be related to Shingrix.     The company considered the walking difficulty and pain upon movement to be unrelated to Shingrix.   Additional Information: GSK receipt date: 14-NOV-2024 The reporter was the patient. The patient had received Shingrix vaccine and stated that for about a year now she had been having issues walking and it got worse two months ago she did not walk good. The patient sees pain management for pain when she walked and was hospitalized (No dates provided). The patient's speech was hard to understand due to a stroke and she had a long time ago, prior to getting Shingrix vaccines. The patient asked about GBS (Guillain-Barre syndrome).; Sender's Comments: Gait disturbance  and Pain are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy
Clinical narrative: She was very , very weak; enlarged lymph nodes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ASTHENIA (She was very , very weak) and LYMPHADENOPATHY (enlarged lymph nodes) in a 26-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (She was very , very weak) and LYMPHADENOPATHY (enlarged lymph nodes). At the time of the report, ASTHENIA (She was very , very weak) and LYMPHADENOPATHY (enlarged lymph nodes) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that post Moderna booster vaccination patient experienced   very serious reaction. She had enlarged lymph nodes and unable get out of the bathtub without assistance. She was very, very weak. It was also reported that patient had excellent health condition, and she was an athlete. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2024: Live non-significant follow-up received, and new reference number was added.
Sex: U
Vaccine: COVID19
Symptoms: Device material issue, Syringe issue
Clinical narrative: tip of syringe was displaced from the actual syringe - no patients involved; confirms glass part of syringe broken; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LN0589, Expiration Date: 10Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "tip of syringe was displaced from the actual syringe - no patients involved"; DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "confirms glass part of syringe broken".  Additional information: Quality issue is that the tip of syringe was displaced from actual syringe, so broke off at neck where it connects into vial. Confirmed one vaccine had the issue. They saw it was broken when they went to remove the film cover to get to the five vaccines on that tray so they were careful.  A sample of the product is available to be returned, if requested.  Causality for "tip of syringe was displaced from the actual syringe - no patients involved" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).
Sex: F
Vaccine: RSV
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: the nurse had a needlestick to herself; the nurse had a needlestick to herself; vaccine leaked out from around where the needle was luered; This is a spontaneous report received from a Pharmacist.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1; single (Lot number: HY1811, Expiration Date: Oct2025) for immunisation, Device Lot Number: H780; HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJURY ASSOCIATED WITH DEVICE (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown" and all described as "the nurse had a needlestick to herself"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "vaccine leaked out from around where the needle was luered". Additional information: this case refers to the nurse that was administering. Reporter stated  that when the vaccine leaked out from around where the needle was luered on to the syringe and that is where the vaccine product leaked and dripped on to patients arm at the end of administration to the patient, then the nurse  went to wipe the patients arm and the nurse had a needlestick to herself and so the nurse did not receive any dose. NDC number of Abrysvo: 0069-0344-05.   Causality for "the nurse had a needlestick to herself" and "vaccine leaked out from around where the needle was luered" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: COVID19
Symptoms: Cytokine storm, Myasthenia gravis crisis
Clinical narrative: developed a cytokine storm and MG crisis after receiving an mRNA-type vaccine; developed a cytokine storm and MG crisis after receiving an mRNA-type vaccine; This is a literature report for the following literature source(s).  A patient (age and gender not provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diagnosed with MG" (unspecified if ongoing), notes: 5 years earlier. The patient's concomitant medications were not reported. The following information was reported: CYTOKINE STORM (medically significant), MYASTHENIA GRAVIS CRISIS (medically significant), outcome "unknown" and all described as "developed a cytokine storm and MG crisis after receiving an mRNA-type vaccine".  No follow-up attempts are possible.; Sender's Comments: As there is limited information in the case provided, the causal association between the events cytokine storm, and myasthenia gravis crisis; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she received the Pfizer COVID shots prior to getting the COVID infection; she received the Pfizer COVID shots prior to getting the COVID infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she received the Pfizer COVID shots prior to getting the COVID infection". Clinical course: Reporter mentioned that she received the Pfizer COVID shot and was wondering how long does it take for the vaccine to take its effect. Reporter mentioned that her son and his wife were coming over for thanksgiving and they both got COVID this week. Reporter stated that she was quite more vulnerable. Reporter mentioned that she had COVID a couple of years ago and she confirmed that she received the Pfizer COVID shots prior to getting the COVID infection because she took the vaccines regularly when it is available.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: while attempting to administer Abrysvo vaccine the top that connects to the vial and to the syringe, it was wonky and defective, and it broke off; while attempting to administer Abrysvo vaccine the top that connects to the vial and to the syringe, it was wonky and defective, and it broke off; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: LG9827, Expiration Date: 31Oct2025) for immunisation, Device Lot Number: HN8587, Device Expiration Date: Sep2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "while attempting to administer Abrysvo vaccine the top that connects to the vial and to the syringe, it was wonky and defective, and it broke off".  Additional information: The reporter said that while attempting to administer Abrysvo vaccine the plunger, the tip, and everything broke off the syringe. The reporter mentioned that it was like the top that connects to the vial and to the syringe, it was wonky and defective, and it broke off. The piece on the syringe that connects it to the vial part of the syringe is what broke. The reporter also relayed that when they reconstituted it, she said they were doing something with it, and the tip of the plunger popped off, so they could not do anything with it.  Causality for "while attempting to administer abrysvo vaccine the top that connects to the vial and to the syringe, it was wonky and defective, and it broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain
Clinical narrative: bone pain; body aches; This is a spontaneous report received from an Other HCP, Program ID.  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), in May2023 as dose number unknown, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional information: The patient reported that after her last covid vaccine, she was sick for three days with bone pain and body aches. The patient said it was like she was sick with the flu. The patient states that she will wait until around april to get another covid vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-777477 (Moderna, Inc).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "GBS".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: Showed symptoms of the flu and got tested for it and said it came back as influenza; This spontaneous case, initially received on 18-Nov-2024, was reported by a non-health professional and concerns an adult male patient.  At the time of the event the patient had Type 1 diabetic.  Administration of company suspect drug: On an unknown date, the patient received Influenza virus vaccine for Not reported., Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: No batch number available.and will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 15-Nov-2024, the patient Showed symptoms of the flu and got tested for it and said it came back as influenza (Medically Significant, outcome: Not Reported).  Reporter's dad got his flu vaccine on the previous week before this report and as of the day previous report showed symptoms of the flu and got tested for it and said it came back as influenza.  Influenza virus vaccine action taken: Not Applicable  Reported assessment: The reported considered event influenza as non-serious and causality was not reported.; Reporter's Comments: Causality: Unassessable. The information provided is insufficient to perform a more in-depth analysis (unknown temporality/latency window, outcome, relevant history, date of vaccination).
Sex: F
Vaccine: UNK
Symptoms: Body temperature decreased, Nausea, Sepsis, Vomiting
Clinical narrative: Sepsis; Threw up constantly; Very low body temperature; Nausea; Vomiting; This spontaneous case, initially received on 18-Nov-2024, was reported by a non-health professional and concerns an elderly female patient.  Concomitant medications and medical history were unknown.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for flu immunization, Dose regimen: 0.5 ml, route of administration: not reported, site of administration: not reported. Lot number: Not reported and requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Sepsis (Medically Significant, Hospitalized, outcome: Unknown), Threw up constantly (Medically Significant, outcome: Unknown), Very low body temperature (Medically Significant, outcome: Unknown), Nausea (Medically Significant, outcome: Unknown), Vomiting (Medically Significant, outcome: Unknown).  Pharmacy had given the patient the fluad shot, it might been good just to let you knew that the patient did had an adverse reaction to it, the first three or for days she threw up constantly, she never ran fever, but a very low body temperature. And then several days later, again she would have nausea and vomiting, and then the worst thing was, 4 weeks later she had to go in the hospital with sepsis.  She had no opened sores. She put neosporin on the shot site and the band-aid, and she honestly had never had a reaction liked this. And she just, she didn't known, she was in the hospital for five days with sepsis. Treatment measures associated with event: Unknown  Fluad (TIV) action taken: Not Applicable Treatment medication: Neosporin  Reporter's assessment: The reporter considered the events as serious and did not provide the causality assessment.; Reporter's Comments: Causality: Related. Considering plausible temporal and biological relationship.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Device leakage, Underdose
Clinical narrative: When they pressed down on the plunger the medication came out from underneath where the needle connection was/the medication squirted out where the needle and syringe connect; doesn't think any of it was administered to the patient since it all came out from underneath the needle so he doesn't think the patient received anything; This is a spontaneous report received from a Pharmacist from medical information team.  A 76-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2024 as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) at the age of 76 years for immunisation, Device Lot Number: HM8389; H764, Device Expiration Date: Sep2025. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DEVICE LEAKAGE (non-serious) with onset 20Nov2024, outcome "unknown", described as "When they pressed down on the plunger the medication came out from underneath where the needle connection was/the medication squirted out where the needle and syringe connect"; UNDERDOSE (non-serious) with onset 20Nov2024, outcome "unknown", described as "doesn't think any of it was administered to the patient since it all came out from underneath the needle so he doesn't think the patient received anything".  Additional information: Caller is a PharmD pharmacist calling about the Abrysvo Vial and prefilled syringe presentation and reported that he would like to get a replacement of the product. During administration the volume of the Abrysvo went underneath the needle. He doesn't think it all came up from underneath needle and doesn't think the patient received the product. Caller clarified that the product was mixed, and the new needle and diluent syringe was used to withdraw the product. When they pressed down on the plunger the medication came out from underneath where the needle connection was. When they administered the product to the patient, the medication squirted out where the needle and syringe connect, like where the Luer lock is.  HCP doesn't think any of it was administered to the patient since it all came out from underneath the needle, so he doesn't think the patient received anything. Patient does not think he got any of the shot. HCP called in stating that they already gave over 100 of shots of Abrysvo, but this is the first time they experienced a prefilled syringe's volume went all the way down and shot out from underneath the needle when they are administering it to the patient. He is looking for a replacement or credit.  Abrysvo Antigen Vial: NDC 00069020701, Lot: KC7884, Expiry Date: Oct2025. Abrysvo Diluent: NDC 00069025001, Lot: HM8389, Expiry Date: Sep2025.  Abrysvo Adaptor: Lot: H764, Expiry Date: 01Jun2028.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feeling the worst he has ever felt; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug hypersensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling the worst he has ever felt". It was unknown if therapeutic measures were taken as a result of feeling abnormal.  Additional information: It was unknown whether patient receive any other vaccines on the same date or within 4 weeks prior to the Comirnaty (2024-2025 Formula). It was unknown whether patient taking any other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: dripped on to patients arm at the end of administration to the patient; dripped on to patients arm at the end of administration to the patient; had leakage patient did not get full dose; Abrysvo leaked out of syringe and dripped out when administration was almost complete/ vaccine leaked out from around where the needle was luered on to the syringe; This is a spontaneous report received from a Pharmacist.  A 75-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Nov2024 as dose 1, single (Lot number: HY1811, Expiration Date: Oct2025) at the age of 75 years for immunisation, Device Lot Number: HM8389; H780, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious) with onset 19Nov2024, outcome "unknown", described as "Abrysvo leaks out of syringe and drips out when administration is almost complete"; EXPOSURE VIA SKIN CONTACT (non-serious), ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) all with onset 19Nov2024, outcome "unknown" and all described as "dripped on to patients arm at the end of administration to the patient"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Nov2024, outcome "unknown", described as "had leakage patient did not get full dose". Additional information: NDC: 0069-0207-01 for Abrysvo Antigen Vial, NDC: 0069-0250-01 for Abrysvo Diluent Syringe, Expiration Date: 01Jul2028 for Abrysvo Vial Adapter.  Causality for "dripped on to patients arm at the end of administration to the patient", "had leakage patient did not get full dose" and "abrysvo leaked out of syringe and dripped out when administration was almost complete/ vaccine leaked out from around where the needle was luered on to the syringe " was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400307823 Same reporter/drug/event, different patient;US-PFIZER INC-202400307822 Same reporter/drug/event, different patient;
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: i have been sick for 2 weeks; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 90-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 89 years for immunisation. The patient's relevant medical history included: "only have 1 and 2 third lungs" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Get all the vaccines: shingles somebody else, for immunisation; Get all the vaccines: 6 covid by pfizer (Dose 1, single), for Covid-19 immunisation; Get all the vaccines: 6 covid by pfizer (Dose 2, single), for Covid-19 immunisation; Get all the vaccines: 6 covid by pfizer (Dose 3, single), for Covid-19 immunisation; Get all the vaccines: 6 covid by pfizer (Dose 4, single), for Covid-19 immunisation; Get all the vaccines: 6 covid by pfizer (Dose 5, single), for Covid-19 immunisation; Get all the vaccines: 6 covid by pfizer (Dose 6, single), for Covid-19 immunisation; Prevnar 20, for immunisation. The following information was reported: ILLNESS (non-serious) with onset Nov2024, outcome "recovering", described as "i have been sick for 2 weeks". The event "i have been sick for 2 weeks" required physician office visit. Therapeutic measures were taken as a result of illness.  Additional information: The patient had been sick for 2 weeks, it was starting to break up but she already had something called a D pack and that would finish its work on the 30th because it stays in your system but at 90 she didn't like to get sick and besides her right side she didn't have 2 whole lungs, she only have 1 and 2 third lungs, she was not going to be out with the family in the other room she was going to stay in her bedroom because RSV was (did not understand the word), she thought from all the symptoms she saw on this she phone cause she knew how to search anyway. It appeared that was what she have and what her doctor suspected ...the first thing he asked her is if she had the RSV vaccine and she couldn't find it she had to go through all her papers and she found out she had it last October (in 2023) but she was to busy to answer all the questions. She didn't know how she got it because she did not go out that much but some people visited here 2 or 3 weeks before so one of them probably brought it in because she was getting hugged so somebody who hugged she, gave it to her. The patient got all the vaccines that Pfizer offered, shingles somebody else but every other vaccine that Pfizer has she have gotten, 6 Covid by pfizer and she had the Prevnar 20 she had them all. She believe in vaccines after living this long she have seen the good they can do.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.