chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Dizziness, Echocardiogram, Electroencephalogram
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Liver function test, Magnetic resonance imaging
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Mitral valve incompetence, Muscle fatigue, Nausea, Postural orthostatic tachycardia syndrome
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary valve incompetence, Pyrexia, Rash, Stool analysis, Supraventricular extrasystoles
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tricuspid valve incompetence, Tunnel vision, Ultrasound abdomen, Visual acuity tests
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Visual field defect, Vitamin D decreased, X-ray
Clinical narrative: Lower back severe pain, hip joint severe pain, knee pain, ankle pain, headaches which are now migraines, low iron and vitamin D, peripheral vision is extremely blurry while straight on sight is 20/20, episodes of tunnel vision, episodes of spacing out which is now being tested for absent seizures, POTS, dizzy spells, extreme muscle fatigue, random rash outbreaks, unexplained random fevers, extreme fatigue, premature atrial contractions, stomach pain and nausea with eating anything, tachycardia, Trivial mitral valve regurgitation. Mild tricuspid valve regurgitation, pulmonary valve insufficiency
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Customer calling to report temperature excursion. She states that the product was administered on 11/20/2024. No additional AE, no PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) PROQUAD Y011215 12/18/20; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.   On 20-NOV-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) injection, lot #Y011215, expiration date: 18-DEC-2025, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided), that went through a temperature excursion of 18.4 F  for 360 hours (Product storage error). There were no previous temperature excursions, additional adverse events, nor product quality complaints.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP calling to report that 21 year old female received expired dose of MMR II. No adverse effects noted. No other information provided. No additional AE.  No PQC.; This spontaneous report was received from a Health Professional and refers to a 21-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-DEC-2024, the patient was vaccinated with the first dose of an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, lot #X022410, expiration date: 06-NOV-2024, administered for prophylaxis (Expired product administered) (strength, and route of administration were not provided). No adverse event was reported.
Age: 17.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP called to report that VARIVAX and PROQUAD were given to a 17-year-old patient on the same day in separate injection sites. Caller states this is their first dose of both vaccine products and that VARIVAX was administered in the left arm, and PROQ; PROQUAD were given to a 17-year-old patient; This spontaneous report was received from a physician refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 16-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y012341, expiration date: 11-JAN-2026, 0.5 milliliter in the right arm (route of administration was not provided) (product administered to patient of inappropriate age); and with varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot # Y010184, expiration date: 31-MAY-2026, 0.5 milliliter in the left arm for prophylaxis (overdose). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Caller reports product that experienced temperature excursion beginning 12/7/2024 was administered 12/9/2024.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-DEC-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (lot #X026480, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 12-JAN-2026; strength, dose and route of administration were not provided). It was reported that the vaccine underwent temperature excursion beginning (07-DEC-2024). Product had both below and above excursion. The temperature excursions were below 36 Fahrenheit degrees (F) (31.2F) for 144 hours 0 minutes and 0 seconds and above 47 Fahrenheit degrees (48.3F) for 144 hours 0 minutes and 0 seconds (product storage error). No previous temperature excursion was reported. No symptoms or side effects were reported. No additional adverse event (AE) details and no product quality complaint (PQC) were provided.
Sex: U
Vaccine: RVX
Symptoms: Tinnitus
Clinical narrative: Annoying sound; This serious case was reported by a consumer and described the occurrence of ear discomfort in a 89-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear discomfort (Verbatim: Annoying sound) (serious criteria hospitalization). The outcome of the ear discomfort was resolving.   It was unknown if the reporter considered the ear discomfort to be related to RSV vaccine.     The company considered the ear discomfort to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The case was self reported by patient. The patient received RSV vaccine and experienced annoying sound.; Sender's Comments: Ear discomfort is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itching all over body; small red spots; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced generalized pruritus (Verbatim: itching all over body) and red spotty rash (Verbatim: small red spots). The outcome of the generalized pruritus and red spotty rash were not reported.   It was unknown if the reporter considered the generalized pruritus and red spotty rash to be related to Shingrix.     It was unknown if the company considered the generalized pruritus and red spotty rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient had the Shingrix vaccine. The patient had itching all over body. There looks like very small red spots where itching.
Sex: U
Vaccine: RSV
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 patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 1 month).   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-NOV-2024 The patient wanted to find out the ingredients in vaccine and had been sick for over a month now after taking the shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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: 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 to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 This case was reported by a consumer via interactive digital media. The patient commented that they know someone who got the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix .
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a child prior to 4th birthday; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 07-NOV-2024, the patient received Kinrix. On 07-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a child prior to 4th birthday). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2024 The reporter reports administration of Kinrix to a patient prior to 4th birthday which led inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Administered Subcutaneously; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9R397, expiry date 27-OCT-2026) for prophylaxis.   On 19-NOV-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Administered Subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 20-NOV-2024 Nurse reported the maladministration of the vaccine administered subcutaneously on an adult patient, which led to intramuscular formulation administered via other route. Reporter needed safety and information related to this, and also needs guidance on this matter.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Product given; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Product given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2024 HCP called stating a child was accidently given Pediarix that was expired which led to expired vaccine used. HCP had no further information. Child not having any symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose, the patient forgot about it; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose around Covid pandemic).   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 patient forgot about it). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient self-reported this case.  The patient received the first dose of Shingrix around the time of the Covid pandemic and never received the second dose because each time he went back to the pharmacy to get it, the pharmacy did not had it due to the shortage of Shingrix at the time and subsequently, the patient also forgot about it. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix that was one day past the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5ay2j, expiry date 10-JUN-2024) for prophylaxis.   On 11-JUN-2024, the patient received Kinrix. On 11-JUN-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix that was one day past the expiration date). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-NOV-2024 Nurse reported that Kinrix that was administered one day past the expiration date was administered to a child on which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: each patient received only adjuvant component; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a specified number of patients who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: each patient received only adjuvant component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-NOV-2024 HCP stated that 10 different patients received the adjuvant suspension component (liquid) vial only for Shingrix vaccine at their facility. The reporter stated that the adjuvant suspension component was never mixed with the Lyophilized gE Antigen Component (powder). No patient information was provided. HCP reported that this was noticed 3 to 4 days ago after the last injection was administered. HCP reported that the 1st case happened on October 1st, 2024, until the last one administered on November 12th, 2024. HCP stated that each patient received only the adjuvant component of this lot: 425CR Expiry Date 10th August 2026 10 patients received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of the adjuvant without lyophilized component.; Administration of the adjuvant without lyophilized component; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number XD7Y2, expiry date 09-AUG-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of the adjuvant without lyophilized component.) and inappropriate dose of vaccine administered (Verbatim: Administration of the adjuvant without lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-NOV-2024 A health care provided called to report the administration of only the diluent portion of Shingrix to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked for recommendations on this situation.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Device connection issue, Needle issue, Soft tissue foreign body
Clinical narrative: connection and the needle felt insecure/loose; Product Complaint; needle remain stuck in their arm; This non-serious case was reported by a other health professional via sales rep and described the occurrence of needle stick/puncture in a 25-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 2XK44, expiry date 13-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On 10-OCT-2024, the patient received FluLaval 2024-2025 season. On 10-OCT-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced needle stick/puncture (Verbatim: needle remain stuck in their arm). On an unknown date, the patient experienced device connection issue (Verbatim: connection and the needle felt insecure/loose) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture and device connection issue were unknown and the outcome of the pharmaceutical product complaint was unchanged.   It was unknown if the reporter considered the needle stick/puncture and device connection issue to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the needle stick/puncture and device connection issue 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: 22-NOV-2024 and 04-DEC-2024  The other health professional reported that the connection between the Flulaval Pre-filled syringe Luer Lock Adaptor connection and the needle felt insecure/loose. The other health professional reported , after the full vaccine was administered, due to the loose connection, the syringe slipped when engaging the needle's safety feature and the health professional was stuck with the used needle. ( The defect was discovered after administration.  The other health professional confirmed that all operations were performed appropriately before defect was discovered, the Luer Lock safety needle was screwed on, not pushed on.  The connection still felt loose after re-tightening three times. It was unclear (the other health professional does not know) how many Flulaval Pre-filled syringe had loose Luer Lock adapter but it was more than a few. The other health professional stated this suspect device was not available for return.  The other health professional reported that they already had a patient had a needle remain stuck in their arm after the syringe was pulled away and a nurse get a needle stick in a separate incident.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: an adult patient got pediatric dose; Underdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 22-NOV-2024, the patient received the 2nd dose of Engerix B pediatric. On 22-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: an adult patient got pediatric dose) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 22-NOV-2024 Nurse reported that an adult patient got a first dose of Engerix-B on 24-October- 2024 and got a second dose, but it was a pediatric dose, which led adult use of a child product and underdose. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: She noticed after administration that it was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 22-NOV-2024, the patient received Infanrix. On 22-NOV-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: She noticed after administration that it was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-NOV-2024 The reporter reported she administered a dose of Infanrix. She noticed after administration that it was expired, which led expired vaccine used.  No reaction noted. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023081025:same reporter US-GLAXOSMITHKLINE-US2022049291:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Groin pain, Influenza like illness, Pain, Pain in extremity
Clinical narrative: flu-like symptoms; body aches; fever; chills; lesions; lesions appeared which oozed a clear; severe pain in thigh; severe pain in groin; This non-serious case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 23-OCT-2024, an unknown time after receiving Shingrix, the patient experienced pain in thigh (Verbatim: severe pain in thigh) and groin pain (Verbatim: severe pain in groin). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), general body pain (Verbatim: body aches), fever (Verbatim: fever), chills (Verbatim: chills), skin lesion (Verbatim: lesions) and skin oozing (Verbatim: lesions appeared which oozed a clear). The outcome of the influenza-like symptoms, general body pain, fever, chills and skin oozing were resolved and the outcome of the pain in thigh, groin pain and skin lesion were not resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills, pain in thigh, groin pain, skin lesion and skin oozing to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, general body pain, fever, chills, pain in thigh, groin pain, skin lesion and skin oozing to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter was a retired nurse. The patient received both doses of Shingrix three years ago. The 2nd dose caused chills, fever, body aches, and flu-like symptoms which resolved within only a day or two. On 23rd October 2024 patient awoke to severe pain in his right thigh and groin. Shortly thereafter, six lesions appeared which oozed a clear liquid. That oozing has since stopped. The lesions remain and the pain was intense. The patient saw three doctors who disagreed on whether it was indeed shingles. The neurologist did agree it was shingles and told him it will take a long time for the nerves to regenerate. The patient has visited the Emergency Room for relief of the intense pain he was feeling. The reporter stated that feel free to reach out to the patient if more information was desired. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2024153848:female stranger patient
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Skin lesion, Skin weeping
Clinical narrative: flu-like symptoms; body aches; fever; chills; lesions; lesions appeared which oozed a clear; severe pain in thigh; severe pain in groin; This non-serious case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On 23-OCT-2024, an unknown time after receiving Shingrix, the patient experienced pain in thigh (Verbatim: severe pain in thigh) and groin pain (Verbatim: severe pain in groin). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms), general body pain (Verbatim: body aches), fever (Verbatim: fever), chills (Verbatim: chills), skin lesion (Verbatim: lesions) and skin oozing (Verbatim: lesions appeared which oozed a clear). The outcome of the influenza-like symptoms, general body pain, fever, chills and skin oozing were resolved and the outcome of the pain in thigh, groin pain and skin lesion were not resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, chills, pain in thigh, groin pain, skin lesion and skin oozing to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, general body pain, fever, chills, pain in thigh, groin pain, skin lesion and skin oozing to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter was a retired nurse. The patient received both doses of Shingrix three years ago. The 2nd dose caused chills, fever, body aches, and flu-like symptoms which resolved within only a day or two. On 23rd October 2024 patient awoke to severe pain in his right thigh and groin. Shortly thereafter, six lesions appeared which oozed a clear liquid. That oozing has since stopped. The lesions remain and the pain was intense. The patient saw three doctors who disagreed on whether it was indeed shingles. The neurologist did agree it was shingles and told him it will take a long time for the nerves to regenerate. The patient has visited the Emergency Room for relief of the intense pain he was feeling. The reporter stated that feel free to reach out to the patient if more information was desired. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2024153848:female stranger patient
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   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: 06-DEC-2024 The retired nurse reported that a stranger patient in the pharmacy told him that she had gotten shingles after having the Shingrix vaccine. There was no further information available for this case. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with US2024AMR157695, reported by same reporter.; 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. US-GSK-US2024AMR157695:male patient
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthritis, Headache, Pain in extremity
Clinical narrative: arthritis was more painful then usual; pain in the arm; Headache; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of ARTHRITIS (arthritis was more painful then usual), PAIN IN EXTREMITY (pain in the arm) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3044203) for COVID-19 prophylaxis.     Concomitant products included Amlodipine besilate, Valsartan (Exforge) for Hypertension.   On 18-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram and dose of Influenza vaccine inact split 4v (Vaxigriptetra) (unknown route) 1 dosage form. On 19-Oct-2024, the patient experienced ARTHRITIS (arthritis was more painful then usual), PAIN IN EXTREMITY (pain in the arm) and HEADACHE (Headache). At the time of the report, ARTHRITIS (arthritis was more painful then usual), PAIN IN EXTREMITY (pain in the arm) and HEADACHE (Headache) was resolving.            Patient past medical treatment, vaccination and family history were not provided.  On 19 Oct 2024, he developed pain in arm, arthritis was more painful then usual and headache following administration of VaxigripTetra and Spikevax. He was on unspecified arthritis medication.  It was unknown if he experiences any additional symptoms/events.  It was not reported if he received a corrective treatment for the events.  Medical history of hypertension was cofounding factor for Headache. Medical history of polyarthritis was a cofounding factor for arthritis (Flare up arthritis). The company causality for the events was assessed as related due to temporal relationship. The benefit risk relationship of product is not affected by this report.; Reporter's Comments: Co-suspect product Influenza vaccine inact split 4v and patient's past medical history of COVID-19 are confounders for the events; Concurrent medical conditions Hypertension is a contributor for headache event and Polyarthritis is a contributor for arthritis event. The benefit -risk relationship of product is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This was my 4th confirmed Covid incident. I have taken exclusively Moderna vaccine and  boosters; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (This was my 4th confirmed Covid incident. I have taken exclusively Moderna vaccine and  boosters) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Influenza vaccine (Flu) for an unknown indication.    The patient's past medical history included COVID-19.   On 01-Nov-2024, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) .3 milliliter and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 25-Nov-2024 at 5:00 PM, the patient experienced COVID-19 (This was my 4th confirmed Covid incident. I have taken exclusively Moderna vaccine and  boosters). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) on 12-Dec-2024 for COVID-19, at an unspecified dose and frequency. On 28-Nov-2024, COVID-19 (This was my 4th confirmed Covid incident. I have taken exclusively Moderna vaccine and  boosters) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2024, SARS-CoV-2 test: (Positive) 2 home tests.         No concomitant medication was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; chronic pain throughout my body; This spontaneous case was reported by a patient and describes the occurrence of PAIN (chronic pain throughout my body) and HERPES ZOSTER (shingles) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (chronic pain throughout my body). On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, PAIN (chronic pain throughout my body) had not resolved and HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that within two weeks he had a bad case of shingles. Several months later he started dealing with chronic pain throughout his body and was not right since then. Patient life had been severally impacted. Getting out of bed and starting the day gets more and more painful for him. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-779511 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779511:Female patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: mentioned taking all Pfizer vaccines and their last booster was in Nov2023 and got covid since/ Covid After vaccine; mentioned taking all Pfizer vaccines and their last booster was in Nov2023 and got covid since/ Covid After vaccine; The initial case was missing the following minimum criteria: non-Pfizer drug. Upon receipt of follow-up information on 13Dec2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mentioned taking all Pfizer vaccines and their last booster was in Nov2023 and got covid since/ Covid After vaccine". Clinical Course: Patient has contracted covid after taking all vaccine and Booster shots. Patient last booster shot was in Nov2023. Patient has never taken Paxlovid previously however. Reporter mentioned taking all Pfizer vaccines and their last booster was in Nov2023 and got covid since. During call by reporter (wife) to register her husband for financial support in getting Paxlovid, reporter stated that she was still a little from this covid and she was not doing too good yet. She later reported that she had gotten all Pfizer covid shots and stated that the covid vaccine that she got was Pfizer, she should not be coming down with the virus because Pfizer was the one that was doing this medication now. They got the covid vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400022934 same reporter/same vaccine/different patient;
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary congestion
Clinical narrative: developed pulmonary congestion and expired a few days after; This spontaneous case was reported by an other health care professional and describes the occurrence of PULMONARY CONGESTION (developed pulmonary congestion and expired a few days after) in a 27-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (developed pulmonary congestion and expired a few days after) (seriousness criteria death and medically significant). The reported cause of death was developed pulmonary congestion and expired a few days after. It is unknown if an autopsy was performed.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that a patient received the first dose of the Moderna vaccine and was getting prepared to receive the second dose and developed pulmonary congestion and expired a few days after.  Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-779519 (E2B Linked Report).; Reporter's Comments: Very limited information regarding medical history, concomitant medications, onset latency, diagnostic workup and treatment was provided which limits further analysis. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779519:Invalid case for multiple patients; Reported Cause(s) of Death: developed pulmonary congestion and expired a few days after
Sex: F
Vaccine: COVID19
Symptoms: Device breakage, Exposure via skin contact, Injury associated with device, Occupational exposure to product
Clinical narrative: the barrel of the syringe near the plunger broke and caused intern to cut her finger on the glass; the barrel of the syringe near the plunger broke and caused intern to cut her finger on the glass; intern was injecting the vaccine/cut her finger on the glass/The patient only got about 25% of the original dose; intern was injecting the vaccine/cut her finger on the glass/The patient only got about 25% of the original dose; This is a spontaneous report received from a Pharmacist.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Dec2024 at 19:00 as dose 1, single (Lot number: LM2221) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 12Dec2024 at 19:00, outcome "unknown" and all described as "intern was injecting the vaccine/cut her finger on the glass/The patient only got about 25% of the original dose"; DEVICE BREAKAGE (non-serious), INJURY ASSOCIATED WITH DEVICE (non-serious) all with onset 12Dec2024 at 19:00, outcome "unknown" and all described as "the barrel of the syringe near the plunger broke and caused intern to cut her finger on the glass".  The reporter considered "the barrel of the syringe near the plunger broke and caused intern to cut her finger on the glass" not related to BNT162b2 omicron (kp.2). Causality for "the barrel of the syringe near the plunger broke and caused intern to cut her finger on the glass" and "intern was injecting the vaccine/cut her finger on the glass/the patient only got about 25% of the original dose" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  No follow-up attempts are possible.; Sender's Comments: There is no reasonable possibility that the event injury associated with device was related to COMIRNATY (2024-2025 FORMULA). This is more likely associated with the device constituent of BNT162b2 or the technique in administration.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: angioedema, swelling under the feet, breast, inner thigh, forehead; hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  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: ANGIOEDEMA (medically significant), outcome "unknown", described as "angioedema, swelling under the feet, breast, inner thigh, forehead"; URTICARIA (non-serious), outcome "unknown", described as "hives". The events "angioedema, swelling under the feet, breast, inner thigh, forehead" and "hives" required physician office visit. Therapeutic measures were taken as a result of angioedema, urticaria. The patient was up to date on Pfizer COVID vaccine but have been having unusual symptoms. Symptoms include angioedema, swelling under the feet, breast, inner thigh, forehead and hives. Am being treated by an allergist.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.