chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed this week with shingles.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed this week with shingles.). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 30-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that they got the shots a couple years ago and patient was diagnosed this week with 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Age: 56.0
Sex: F
Vaccine: COVID19, HEP, PNC20
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Pt was given two pneumonia vaccines within the last two weeks. Pt has a sore arm, but otherwise fine.
Age: 12.0
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Dtap vaccine given instead of Tdap.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Day of- arm soreness, Day 2- began to get red, Day 3- redness diameter spreading and began to itch and have warmth to the injection site
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Patients' daughter called stating patient had fever and swelling of face, hands and feet .Advised to go directly to ER.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Injection site erythema, Oral herpes, Pyrexia
Clinical narrative: Patient presented to office for visit on 6/3/25 for "allergic reaction to injection" following Capvaxive administration on 5/30/25. Vaccine was administered in Left deltoid and patient reported redness at the site which was endorsed by the provider but denied pain at the site. No warmth at the site noted by the provider. Provider stated injection site was not concerning for cellulitis. Pt reported subjective fever and chills the evening after receiving vaccination, though she never took her temperature at home to confirm fever and was afebrile during her appointment. She also presented with fever blisters around her mouth. No other symptoms of concern reported by patient. Provider treated Herpes labialis with Valacyclovir 2000 mg BID for one day. Provider recommended warm moist compress to the area, Tylenol and Ibuprofen PRN, and reviewed red flag warning signs and emergency precautions for injection site reaction per note.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient had pain in the injection site next day and still is experiencing pain and redness, some swelling and a small lump in the right deltoid where medication was administered.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Aortic valve sclerosis, Chest discomfort, Chest pain, Echocardiogram abnormal, Ejection fraction normal
Clinical narrative: Chest Pain/ pressure, palpitations (PVC) started in FEB 2023. Slight chest pains/ pressure still exists 2-3 times weekly. PVCs occur multiple times daily. Symptoms can increase in severity with ingestion of high salt/ sugar content foods.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Mitral valve incompetence, Palpitations, Pulmonary valve incompetence, Supraventricular extrasystoles
Clinical narrative: Chest Pain/ pressure, palpitations (PVC) started in FEB 2023. Slight chest pains/ pressure still exists 2-3 times weekly. PVCs occur multiple times daily. Symptoms can increase in severity with ingestion of high salt/ sugar content foods.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence, Ventricular extrasystoles
Clinical narrative: Chest Pain/ pressure, palpitations (PVC) started in FEB 2023. Slight chest pains/ pressure still exists 2-3 times weekly. PVCs occur multiple times daily. Symptoms can increase in severity with ingestion of high salt/ sugar content foods.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dyspnoea, Erythema
Clinical narrative: Before the vaccine I was speaking fine. After vaccine couldnt speak at all, face and neck was red, had some breathing difficulty. Sent right to ER.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Limb mass, Pruritus
Clinical narrative: Patient states that 2 months after receiving  Fluzone HD and Comirnaty that he developed a bump on his arm that has progressively become larger and itchy.  He stated that initially it resembled a pimple.  Patient denies treating with any medication or attempting to lance.  He affirmed that he would occasionally scratch the area.  Patient stated that he felt that someone should pay for him to see a provider to look at his arm.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Made an honest mistake and pulled Pediarix vaccine (Dtap/ HepB/IPV) instead of Kinrix vaccine (Dtap/IPV) given to patient on 05-30-25 - Patient tolerated vaccine well with no adverse reactions. No redness or swelling at injection site post discharge from clinic. Patient has had these vaccines prior to this with no adverse reactions.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypotension, Syncope
Clinical narrative: Patient came in to receive HPV vaccine today. Patient tolerated vaccine well during injection. Patient did eat breakfast this morning. Patient reports they have never had a syncopal episode or have reacted to a vaccine in the past. Patient's father was in the room for vaccination and mother came in afterwards. About 5 minutes after the vaccine was given, patient asked Dad for some water, he went to the cupboard in the room to find a cup. Patient then fainted while she was sitting in the chair. Dad opened the door for help and myself, and 2 MA's came into the room to assist. Patient was alert when we came into the room and was getting up with help from Dad to the chair. It was unclear if patient hit her head, her head was lying near the exam table. She did have a red mark, start of a bruise on the back of her right shoulder about the size of a dollar coin from where she fell. Patient looked pale/green and was feeling dizzy when she was sitting back in the chair. Patient wanted to lay down, we helped her to the table and put her feet up, with cold wash cloth on her forehead. Blood pressures were initially low at 78/50 but came up to 91/60 before she left. Dr. did come into the room to examine the patient and answered all parents questions. After 30 minutes, patient recovered well and was able to return to her other appointment . Parents did say that she is very active, in dance and track and did not get home until late last night. Parents denied further questions or concerns and thanked us for the care. Mother will stay home with patient today, making sure she stays hydrated and is eating and is instructed to call us if any questions or concerns arise.
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site of injection, treated with antibiotics doxycycline.
Age: 53.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was signed up for RSV vaccine and received it however turned out patient was not 60 years old yet and received vaccine. Pt had no symptoms or side effects.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Cyanosis, Electrocardiogram normal, Foaming at mouth, Loss of consciousness
Clinical narrative: patient was given vaccine and left clinic, went across the street to artic circle for ice cream and passed out in the car. Parents said patient turned blue and was foaming at the mouth for a short period. Parents brought patient to the ER next door to the clinic and was seen and vitals quickly became stable.
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itching at the injection site; redness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site itching (Verbatim: itching at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site itching and injection site erythema were not reported.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingles vaccine.     It was unknown if the company considered the injection site itching and injection site erythema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via (Shingrix chatbot) interactive digital media. Reporter asked whether it  was normal to experience itching and redness at the injection site.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Pt was given an ActHIB vaccine. Expiration date of vaccine was noted after administration (5/31/25). Dr. and nurse manager notified of expired vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Blood pressure decreased, Dizziness, Dysstasia, Loss of consciousness
Clinical narrative: (Rph) gave 2 vaccines to a patient today, 1 is covid booster and 1 is Twinrix (2nd dose). After giving the Twinrix vaccine, she had a reaction with it. She felt like a little dizziness, shaking her hand and lost her balance about 30 seconds, she lost her conscious for 5- 10 seconds. She did not have short of breath, no muscle weakness, no fever. She had that symptom for about a min and then talk back to me like normal. But then she still could not stand up and the symptom came back again. I checked her BP 118/88 and her oxygen was 97%. We called 911 and they checked her Bp again saying her bp is pretty low but not too low. They decided to admit her to the hospital after that for more investigation on which cause. I asked her before giving vaccines if she had any reaction to any vaccines but she said she did not. She also filled out on the paperwork too. After the ambulance arrived, I asked her friend coming with her if she experience any reaction like this before, and she said the patient did not feel well 2-3 days after the 1st Twinrix but she was doing okay after that so they think it was just a slight reaction. Pt is not taking any seizure medication and this is the first time happened to her. incident report filed. I will follow up with the patient before we close.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tremor
Clinical narrative: (Rph) gave 2 vaccines to a patient today, 1 is covid booster and 1 is Twinrix (2nd dose). After giving the Twinrix vaccine, she had a reaction with it. She felt like a little dizziness, shaking her hand and lost her balance about 30 seconds, she lost her conscious for 5- 10 seconds. She did not have short of breath, no muscle weakness, no fever. She had that symptom for about a min and then talk back to me like normal. But then she still could not stand up and the symptom came back again. I checked her BP 118/88 and her oxygen was 97%. We called 911 and they checked her Bp again saying her bp is pretty low but not too low. They decided to admit her to the hospital after that for more investigation on which cause. I asked her before giving vaccines if she had any reaction to any vaccines but she said she did not. She also filled out on the paperwork too. After the ambulance arrived, I asked her friend coming with her if she experience any reaction like this before, and she said the patient did not feel well 2-3 days after the 1st Twinrix but she was doing okay after that so they think it was just a slight reaction. Pt is not taking any seizure medication and this is the first time happened to her. incident report filed. I will follow up with the patient before we close.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Escherichia test positive, Intussusception, Rotavirus test positive, Salmonella test positive
Clinical narrative: Pt diagnosed with intussusception 6/1/25.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was given additional dose of Hepatitis A Vaccine. Patient had already completed 2 dose series in January of 2025. Patient did not react to vaccine today, tolerated well.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Duplicate dose received
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; have the shingles in my right side of head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have the shingles in my right side of head). The patient was treated with valacyclovir. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the shot but just found out that he/she had the shingles in his/her ride side of head so guess the shot didn't work, the doctor put the patient on valacyclovir for 7 days and hoped since he/she had the shot will have a mild 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.; 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 Shingles vaccine.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Therapy non-responder
Clinical narrative: no sero conversion rate on a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 33-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. This case was associated with a product complaint.   On 05-FEB-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: no sero conversion rate on a patient). The outcome of the therapy non-responder was not applicable.   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: 27-MAY-2025 The physician wanted to know what was the likely hood of no sero conversion rate on a patient. The physician was not sure if the vaccine was administer at the same zip code. No further information was obtained in this call. Suspect product was now expired. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal discomfort, Pain in extremity, Skin lesion
Clinical narrative: uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion; drug dose interval too short; fatigue; pain in injection arm; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 3AF9E) for prophylaxis.   Previously administered products included Shingrix (received first dose on 07-MAY-2018 with batch number LT533 For tolerance of first dose refer case US2025AMR068322).   On 07-JUN-2018, the patient received the 2nd dose of Shingrix. On 07-JUN-2018, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), pain in arm (Verbatim: pain in injection arm) and drug dose administration interval too short (Verbatim: drug dose interval too short). On an unknown date, the patient experienced skin lesion (Verbatim: uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and pheniramine aminosalicylate (Avil). Rechallenge with Shingrix was positive. The outcome of the fatigue and pain in arm were unknown and the outcome of the skin lesion was not reported and the outcome of the drug dose administration interval too short was not applicable.   It was unknown if the reporter considered the fatigue, pain in arm and skin lesion to be related to Shingrix.     It was unknown if the company considered the fatigue, pain in arm and skin lesion to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR068322   Additional Information: GSK Receipt Date: 30-MAY-2025 Physician called in to request data about the recommendation of booster doses of Shingrix after the initial series, then inquiring about the incidence of postherpetic neuralgia after Shingrix, how many doses are needed to reduce the incidence of postherpetic neuralgia and how many cases of shingles were present after vaccination with Shingrix.  This stemmed after the physician stated that whilst hiking, they started to feel an uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion but after this, they went to a physician's office and a PCR swab test was done (identified as Diasorin Molecular Symplexa VZ direct assay) which came back as abnormal and the patient started with valacyclovir, 1000 mg every 8 hours and Aliv.  They stated that the after the second doses, they had pain, with an accentuated fatigue.; Sender's Comments:  US-GSK-US2025AMR068322:For 1st dose shingrix
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: tested for HepB titers and the test showed she was not vaccinated; The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B115CB) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 02-NOV-2007, the patient received the 3rd dose of Pediarix. On 14-SEP-2007, the patient received the 2nd dose of Pediarix. On 12-JUL-2007, the patient received the 1st dose of Pediarix. On 02-NOV-2007, an unknown time after receiving Pediarix, not applicable after receiving Pediarix and Pediarix and not applicable after receiving Pediarix and Pediarix, the patient experienced drug dose administration interval too short (Verbatim: The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007). On an unknown date, the patient experienced therapy non-responder (Verbatim: tested for HepB titers and the test showed she was not vaccinated). The outcome of the therapy non-responder and drug dose administration interval too short were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2025 The patient received Pediarix when she was her last shot, it was given early, she was told that she was not vaccinated correctly, which led shortening of vaccination schedule. The reporter mentioned that they had tested for Hepatitis B titers, and the test showed she was not vaccinated, which led therapy non responder.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of Havrix was administered to a 33 year old female; pediatric dose of Havrix was administered to a 33 year old female; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 33-year-old female patient who received HAV (Havrix pediatric) (batch number 279C4, expiry date 20-SEP-2025) for prophylaxis.   On 08-MAY-2025, the patient received Havrix pediatric. On 08-MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix was administered to a 33 year old female) and underdose (Verbatim: pediatric dose of Havrix was administered to a 33 year old female). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2025 The Vaccine Administration Facility is the same as Primary Reporter A medical assistant called in to report that a pediatric of Havrix was administered to a 33 year old female on May 8th 2025 which led to adult use of a child product and underdose.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix Inappropriate Reconstitution Technique and administration; Priorix Inappropriate Reconstitution Technique and administration; 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 45-year-old female patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis.   On 28-MAY-2025, the patient received Priorix. On 28-MAY-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix Inappropriate Reconstitution Technique and administration) and inappropriate dose of vaccine administered (Verbatim: Priorix Inappropriate Reconstitution Technique and administration). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2025 Registered Nurse wanted to know if there were any concerns or consequences of given Priorix reconstituted with another diluent (from Merck's measles, mumps, and rubella vaccine) than the one provided in the box, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: somebody that died from taking this one; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (somebody that died from taking this one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-787032 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787032:For somebody; Reported Cause(s) of Death: Death
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: had the lightest cold symptoms with Delta; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had the lightest cold symptoms with Delta) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (had the lightest cold symptoms with Delta). At the time of the report, NASOPHARYNGITIS (had the lightest cold symptoms with Delta) outcome was unknown.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient had Moderna vaccines several times recommended by the doctor. When his dog had surgery, and brought Delta into the home, he lost his 2 cats but had the lightest cold symptoms with Delta that he especially had ever had.  There was bird flu in the tame and in wild flocks, so he was looking forward to receiving that vaccine. HCP recommended to get the mRNA Covid-19 vaccine several times. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported.    This case was linked to US-MODERNATX, INC.-MOD-2025-787067 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787067:For male patient
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Joint range of motion decreased, Muscle twitching
Clinical narrative: has limited range of motion in the abduction and he cannot go past 90 degrees abduction; severe muscle twitching in his deltoid and forearm region; Shoulder pain; This is a spontaneous report received from an Other HCP from medical information team.  A 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14May2025 as dose number unknown, 0.5 ml single (Lot number: LY8609, Expiration Date: 31Aug2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset May2025, outcome "recovering", described as "Shoulder pain"; MUSCLE TWITCHING (medically significant) with onset May2025, outcome "not recovered", described as "severe muscle twitching in his deltoid and forearm region"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "has limited range of motion in the abduction and he cannot go past 90 degrees abduction". Therapeutic measures were not taken as a result of muscle twitching, arthralgia, joint range of motion decreased. The patient that was given Prevnar 20 vaccine about to two weeks ago in his left deltoid. The patient returned having shoulder pain and having severe muscle twitching in his deltoid and forearm region. He has limited range of motion in the abduction, and he cannot go past 90 degrees abduction. The reporter is calling for advice on treatment and if this has been seen before. The reporter stated while performing passive range of motion on the patient the caller can get the patient's arm to go up to 180 degrees.; Sender's Comments: There is a reasonable possibility that the event arthralgia was related to PREVNAR 20 based on known drug safety profile. Based on the temporal relationship, the association between the event muscle twitching with PREVNAR20 can not be fully excluded.  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.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Cough
Clinical narrative: Patient indicated that she started coughing occasionally a few hours after receiving vaccine.  Coughing stopped within 24 hours.; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30May2025 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years for immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 30May2025 at 20:00, outcome "recovered" (31May2025), described as "Patient indicated that she started coughing occasionally a few hours after receiving vaccine.  Coughing stopped within 24 hours.". Therapeutic measures were not taken as a result of cough. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV, TDAP
Symptoms: Vaccination site erythema
Clinical narrative: Redness in arm following vaccination; This is a spontaneous report received from a consumer.  An adult female patient (pregnant) received RSV Vaccine Prot.Subunit Pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for maternal immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), as dose number unknown, single), in arm for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness in arm following vaccination".  Additional Information: Redness in arm following vaccination. The patient was vaccinated with both TDAP and RSV concomitantly.
Vaccine: COVID19, COVID19
Symptoms: Nervous system disorder
Clinical narrative: neurological complications; 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 and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "neurological complications".  Follow-up(30MAY2025) This is a literature report for the following literature source(s).This a follow-up report based on the receipt of the publication the case has been updated to include additional information identified in the publication.; Sender's Comments: The reasonable possibility that the event is related to BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown) administration cannot be excluded. This case will be reassessed should additional information become 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.
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: sick; a lot of pain; This is a spontaneous report received from an Other HCP, 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. Vaccination history included: COVID-19 vaccine (Primary immunisation series complete, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown", described as "a lot of pain".  Additional information: the reporter said there's a long term effect that's getting worse after getting the covid vaccine and booster shot. The reporter mentioned she needed a place to send a patient because the patient was sick and had a lot of pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Rhinorrhoea
Clinical narrative: dripping of or from nose; This spontaneous case, initially received on 11-May-2024 and 14-May-2024 (being processed together), was reported by a non health professional and concerns an elderly male patient.  The patient's medical history was not reported. The patient's concomitant medications included rosuvastatin and losartan. The patient's historical vaccines included plenty of flu vaccines (brand not specified) received on an unknown date for unknown indication, after which the patient has never had this situation.  Administration of company suspect drug(s):  On 31-Dec-2023, the patient received Fluad Quadrivalent,  Indication, Route of administration, Dose, Anatomical location, Lot number: Not reported.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, an unknown amount of time after vaccination, the patient experienced dripping of or from the nose (outcome: not recovered/not resolved). The patient reported there was no decrease in dripping of or from the nose. In a day mostly 3-to-9 time, dripping starts without any reason and sometimes the patient has to keep tissue in that nostril or sometimes both. The patient reported the dripping from the nose became more frequent, up to six times a day.   At the time of initial reporting, the patient had not recovered from the event of 'Runny nose'.   Non-drug treatment/Other action taken:   Fluad Quadrivalent action taken: Not Applicable  Reporters assessment:  The reporter did not provide a causality assessment and considered the event as non-serious.; Reporter's Comments: Due to lack of information and unclear temporal relationship, causality for the event of 'dripping of or from the nose'  is assessed as unassessable.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Bladder dysfunction, Blood lactic acid, Computerised tomogram head, Electrocardiogram
Clinical narrative: multiple episodes of altered consciousness, approximately 5 total, over 5 days 5/30-6/3; associated with sinus tachycardia to 140+, up to 170; has had an EEG that noted no changes to electrical activity concerning for active epileptic seizure but has had multiple episodes of altered consciousness to the point that she has been unresponsive to sternal rub.  Episodes of tachycardia occur at rest, simply while laying in bed, Friday night's episode was associated with a fall, and 1 episode was associated with loss of bladder function.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram normal, Fall, Full blood count, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: multiple episodes of altered consciousness, approximately 5 total, over 5 days 5/30-6/3; associated with sinus tachycardia to 140+, up to 170; has had an EEG that noted no changes to electrical activity concerning for active epileptic seizure but has had multiple episodes of altered consciousness to the point that she has been unresponsive to sternal rub.  Episodes of tachycardia occur at rest, simply while laying in bed, Friday night's episode was associated with a fall, and 1 episode was associated with loss of bladder function.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Sinus tachycardia, Tachycardia, Unresponsive to stimuli
Clinical narrative: multiple episodes of altered consciousness, approximately 5 total, over 5 days 5/30-6/3; associated with sinus tachycardia to 140+, up to 170; has had an EEG that noted no changes to electrical activity concerning for active epileptic seizure but has had multiple episodes of altered consciousness to the point that she has been unresponsive to sternal rub.  Episodes of tachycardia occur at rest, simply while laying in bed, Friday night's episode was associated with a fall, and 1 episode was associated with loss of bladder function.
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis reactive, Aspiration joint, Blood test, Colitis ulcerative
Clinical narrative: 10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms.  10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain.  10/27 Admission inpatient hospital; bloodwork, cultures, radiology.  10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L.  11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling.   11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home.  11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP.  11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist.  12/2 seen by rheumatologist.  12/7 R hand swelling, low-grade fevers;  12/9 gross swelling r hand. 12/13/2024 seen by PCP.  12/20 ER visit for 3 overlapping sites of pain/swelling.   2025:  1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms.  1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand.  1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office.  2/12 Seen by PCP with Lab work.   Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Culture negative, Echocardiogram, Immediate post-injection reaction, Incisional drainage
Clinical narrative: 10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms.  10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain.  10/27 Admission inpatient hospital; bloodwork, cultures, radiology.  10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L.  11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling.   11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home.  11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP.  11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist.  12/2 seen by rheumatologist.  12/7 R hand swelling, low-grade fevers;  12/9 gross swelling r hand. 12/13/2024 seen by PCP.  12/20 ER visit for 3 overlapping sites of pain/swelling.   2025:  1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms.  1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand.  1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office.  2/12 Seen by PCP with Lab work.   Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Loss of personal independence in daily activities, Muscular weakness, Neck pain, Oropharyngeal pain
Clinical narrative: 10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms.  10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain.  10/27 Admission inpatient hospital; bloodwork, cultures, radiology.  10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L.  11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling.   11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home.  11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP.  11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist.  12/2 seen by rheumatologist.  12/7 R hand swelling, low-grade fevers;  12/9 gross swelling r hand. 12/13/2024 seen by PCP.  12/20 ER visit for 3 overlapping sites of pain/swelling.   2025:  1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms.  1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand.  1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office.  2/12 Seen by PCP with Lab work.   Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Pharyngeal swelling, Pyrexia
Clinical narrative: 10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms.  10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain.  10/27 Admission inpatient hospital; bloodwork, cultures, radiology.  10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L.  11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling.   11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home.  11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP.  11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist.  12/2 seen by rheumatologist.  12/7 R hand swelling, low-grade fevers;  12/9 gross swelling r hand. 12/13/2024 seen by PCP.  12/20 ER visit for 3 overlapping sites of pain/swelling.   2025:  1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms.  1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand.  1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office.  2/12 Seen by PCP with Lab work.   Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tonsillar hypertrophy, X-ray
Clinical narrative: 10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms.  10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain.  10/27 Admission inpatient hospital; bloodwork, cultures, radiology.  10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L.  11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling.   11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home.  11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP.  11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist.  12/2 seen by rheumatologist.  12/7 R hand swelling, low-grade fevers;  12/9 gross swelling r hand. 12/13/2024 seen by PCP.  12/20 ER visit for 3 overlapping sites of pain/swelling.   2025:  1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms.  1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand.  1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office.  2/12 Seen by PCP with Lab work.   Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child needed 11 yo IZs in addition to Hep B, Hep A and Varicella. Mom decided to get Tdap, MCV and Hep B and bring child back for the rest. HPV was given instead of Hep B. Mom notified, she brought child in on Wednesday 7/31/24 for the rest of IZs. No Adverse Effects reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Extra dose administered
Clinical narrative: 6 month old child came for his 6-month IZs, I noticed that he only had 2 doses of the rotavirus vaccine and he was due for # 3 dose, he was within the right age range to complete the series; when looking at database it didn't show that #3 dose was due; I know that there have been glitches in database so I put in today's dose (06/03/25) as a historical vaccine administration and it didn't show that it was an error; I administered Rotateq only to notice after that he had received Rotarix and therefore he did not need a third dose for the rotavirus; it still shows on database that the Rotateq administered is a valid dose
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 nd MCV on child's record was not added in database- missed when going over needed IZs and gave dose when not needed. Mom aware. No adverse effects.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered Hep B on 2/12/2025 but not due until 2/21/2025. Client returned to clinic on 2/21/25 and Hep B was administered. No Adverse effects reported.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second tetanus vaccine after receiving a booster on 08/13/24. Patient reported no side effects
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, No reaction on previous exposure to drug
Clinical narrative: Patient had the shot on 4/8/25, but the next morning he has muscle weakness of both the left and right arms.  He says it went away after 1 day.  He never has any reaction to vaccines before.