chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had a dose of Shingrix on 10/25/2020 and a second on 10/11/203; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25-OCT-2020).   On 11-OCT-2023, the patient received the 2nd dose of Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I had a dose of Shingrix on 10/25/2020 and a second on 10/11/203). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter reported that the patient received first dose on 25th October 2020 and second dose received on 11th October 2023, which led to drug dose administration interval too long.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: breakout of red dots around her mouth/ looking like fever blisters before they blistered; This non-serious case was reported by a consumer via call center representative and described the occurrence of red spotty rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced red spotty rash (Verbatim: breakout of red dots around her mouth/ looking like fever blisters before they blistered). The outcome of the red spotty rash was unknown.   It was unknown if the reporter considered the red spotty rash to be related to Shingrix.     It was unknown if the company considered the red spotty rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025 Reporter was the patient who received her first dose of Shingrix a little over a week ago (from the date of reporting). She stated that the day after the vaccination, she experienced a breakout of red dots around her mouth. She described it as looking like fever blisters before they blistered.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Swelling face
Clinical narrative: pain at the injection site; redness on her left shoulder/ redness on her face around her cheekbones; swelling on her face around her cheekbones; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date).   In JAN-2025, the patient received the 2nd dose of Shingrix (left arm). In JAN-2025, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), redness (Verbatim: redness on her left shoulder/ redness on her face around her cheekbones) and facial swelling (Verbatim: swelling on her face around her cheekbones). The patient was treated with loratadine. The outcome of the injection site pain, redness and facial swelling were unknown.   It was unknown if the reporter considered the injection site pain, redness and facial swelling to be related to Shingrix.     It was unknown if the company considered the injection site pain, redness and facial swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025 Reporter was the patient who received her second dose of Shingrix 3 days ago (from date of reporting).  She experienced pain at the injection site (left arm) and redness on her left shoulder.  She said that the pain was to the touch and did not restrict any daily activities.  She also had redness and swelling on her face around her cheekbones.  Her pharmacist recommended to start an antihistamine for the swelling and the patient took a 10 milligram dose of loratadine.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 6-month-old female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique) and inappropriate preparation of medication (Verbatim: administered the diluent only portion of Hiberix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months.  The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made.  The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025002649:Same reporter/Different patient US-GSK-US2025002647:Same reporter/Different patient US-GSK-US2025002645:Same reporter/Different patient US-GSK-US2025002639:Same reporter/Different patient
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; administered the diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: administered the diluent only portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months.  The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made.  The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025002645:Same reporter/Different Patient US-GSK-US2025002649:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different Patient US-GSK-US2025002641:Same reporter/Different patient
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; diluent only portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a infant female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique) and inappropriate preparation of medication (Verbatim: diluent only portion of Hiberix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months.  The staff does not know for sure if this happened and did not know which patient it would have been, but they did had it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made.  The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025002645:Same reporter/Different Patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002649:Same reporter/Different patient
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered portion of Hiberix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 5-month-old female patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist states she was contacted by a clinic staff member who was concerned that they might have administered the diluent only portion of Hiberix to a patient within the past 1 to 2 months.  The staff does not know for sure if this happened and did not know which patient it would have been, but they did have it narrowed down to 5 patients, of which one of them could have received diluent only, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. It was possible that the 5 patients might all be given another dose, but at the time of reporting this decision has not been made.  The reporter consented to follow up. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002649:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different Patient
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: patient incorrectly received the Shingrix instead of the Varicella vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number TY7MZ, expiry date 29-OCT-2026) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis.   On 03-JAN-2025, the patient received Shingrix. On an unknown date, the patient did not receive Varicella vaccine. On 03-JAN-2025, an unknown time after receiving Shingrix and Varicella vaccine, the patient experienced wrong vaccine administered (Verbatim: patient incorrectly received the Shingrix instead of the Varicella vaccine.). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2025 The public health nurse reported that the patient was completing his process for which he needed to receive the Varicella vaccine but he was administered the Zoster (Shingrix) instead at 10 days ago. The reporter asked can they administer the varicella vaccine after the Shingrix and how long should they wait to administer the varicella vaccine. The reporter confirmed that the patient incorrectly received the Shingrix instead of the Varicella vaccine, which led to wrong vaccine administered.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: injection site soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included Influenza vaccine.   In SEP-2024, the patient received Arexvy (intramuscular, right deltoid). In SEP-2024, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: injection site soreness). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-JAN-2025 The patient self-reported this case. The patient received her Arexvy vaccine and her flu shot (manufacturer unknown) and her right deltoid became sore at the injection site on the day of the injection and had not yet resolved and it was still sore.  The patient denied redness, swelling or warmth at the injection site and had not yet seen her doctor since her vaccination, and didn't plan to see him until April 2025
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: bump near eye; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles near eye). Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On 18-MAR-2019, the patient received the 2nd dose of Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced swelling (Verbatim: bump near eye). The outcome of the swelling was not resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.     It was unknown if the company considered the swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2025  The patient self-reported this case for herself. The patient had a history of shingles, near her eye (did not mention a side). The patient had dose 2 of Shingrix.  The patient state a year later she had a bump near her eye in the same place where she had shingles bump. It comes and goes and healthcare professional would order valacyclovir that she takes when it comes back.  The patient's healthcare professional recommended she gets a booster of Shingrix.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis.   On 31-JAN-2025, the patient received Menveo .5 ml. On 31-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 The Healthcare Professional reported that a medical assistant administered the Menveo vaccine to a pair of twins and the dosage was 0.5 ml. But it had expired on 31st December 2024, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This case is linked with US2025013445, reported by same reporter.; Sender's Comments:  US-GSK-US2025013445:twin patients with same initials
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: child of 5 years of age was given Twinrix adult formulation; Adult product administered to child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced overdose (Verbatim: child of 5 years of age was given Twinrix adult formulation) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-FEB-2025 The healthcare professional reported a child of 5 years of age was given Twinrix adult formulation which led to overdose and adult product administered to child.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: MYOCARDITIS; This spontaneous report received from a consumer concerned a female patient of unspecified age via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 21-Dec-2021, the patient experienced myocarditis. (dose series 1) The reporter did some research and found that myocarditis was a side-effect of Pfizer vaccine. the reporter informed if myocarditis is listed, then the reporter will be going to the lawyer. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.   Reported cause of death was myocarditis.  The patient died of myocarditis on 21-Dec-2021.  The reporter considered the causality between janssen covid-19 vaccine and myocarditis as related. Company causality between janssen covid-19 vaccine and myocarditis as possible.  This report was serious (death).; Sender's Comments: V0; Myocarditis; The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: myocarditis
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GUILLAIN-BARRE SYNDROME (guillain barre syndrome) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced GUILLAIN-BARRE SYNDROME (guillain barre syndrome) (seriousness criteria disability and medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (guillain barre syndrome) outcome was unknown.            No concomitant medication was reported. He received three of Moderna COVID vaccinations back in 2021. He developed particular autoimmune disease and was disabled. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site cellulitis
Clinical narrative: Cellulitis of arm / where the vaccine was injected; This is a spontaneous report received from a Physician.  A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Nov2024 as dose 1, 0.5ml single (Lot number: KD0161) at the age of 35 years, in left deltoid for maternal immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), (Lot number: 3RE73) for immunization and IRON. It was reported the Tdap vaccine was administered about four weeks before rsv vaccine prot.subunit pref 2v (ABRYSVO), date unspecified. The following information was reported: VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis of arm / where the vaccine was injected". Therapeutic measures were taken as a result of vaccination site cellulitis. The patient took clindamycin, antibiotics.  Causality for "cellulitis of arm / where the vaccine was injected" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  No follow-up attempts are possible.; Sender's Comments: Based on the temporal relationship and location, the association between the event vaccination site cellulitis with ABRYSVO 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: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: ipol vials punctured and they were also administered post excursion to 3 patients.the temperature reached 8.1 degrees c for 6 minutes with no ae; Initial information received on 21-Nov-2024 regarding an unsolicited non-valid non-serious case received from Nurse.  This case is linked to US-SA-2024SA351869  This case involves, a 4 year old child male patient who was administered punctured vials IPV (Vero) [IPOL] post excursion and.the temperature reached 8.1 degrees c for 6 minutes with no adverse event  The unspecified patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Nov-2024, the unspecified patient received 0.5 ml dose of suspect punctured IPV (VERO) Suspension for injection post excursion (lot-W1C83IM, expiry date: 21-Nov-2025) (strength was unknown) via intramuscular route in left thigh as prophylactic vaccination and the temperature reached 8.1 degrees c for 6 minutes with no adverse event (poor quality product administered) (latency: same day).  Reportedly, There had been no adverse event at this time.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information regarding the unsolicited valid non-serious case received on 03-Feb-2025; follow up information includes gender, route, Anatomical Location, dosage, start date, expiry date, batch number, clinical course added, indication updated and narrative amended accordingly.; Sender's Comments:  US-SA-2024SA351869:linked case
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to adult
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm, Urticaria
Clinical narrative: 6-8 hives on left arm, swollen, erythematous, hot to touch, tight without normal elasticity; treatment currently is ice to arm, benadryl, ibuprofen, hydrocortisone cream 1% with return precautions if it worsens
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: patient reported injection site reaction --- large redness/tenderness--- low grade fever --- reported severe stiffness in neck, knee, arm (injection site arm) -- patient reported going to ER and was treated/discharged with medication
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: patient reported injection site reaction --- large redness/tenderness--- low grade fever --- reported severe stiffness in neck, knee, arm (injection site arm) -- patient reported going to ER and was treated/discharged with medication
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 2 month old infant in our facility was given PPSV23. What action do you recommend?"; No additional AEs were reported.; This spontaneous report was received from pharmacist and refers to a 2-month-ol patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional AEs were reported (Product administered to patient of inappropriate age).
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Mistakenly had his doctor office give him another shot of Prevnar; Pain in his upper arm at the site; This is a spontaneous report received from a consumer.  A 66-year-old male patient received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), on 29Jan2025 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased. Vaccination history included: Prevnar 20 (DOSE 1), administration date: 13Jan2024, when the patient was 65-year-old, for Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 29Jan2025, outcome "unknown", described as "Mistakenly had his doctor office give him another shot of Prevnar"; VACCINATION SITE PAIN (non-serious) with onset 2025, outcome "recovered" (2025), described as "Pain in his upper arm at the site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: No other vaccine administered on the same date of the suspect product. This is in reference to Prevnar 20. The patient wanted to know what Pfizer has in reference to somebody that has taken Prevnar 20 and what do they think would happen if that person takes another Prevnar 20 (or possibly Prevnar 13; pending clarification) just over a year later because the patient was told that Prevnar 20 is good for life. The patient mistakenly had his doctor office give him another shot (second dose) of Prevnar on 29Jan2025; he took the first dose of Prevnar 20 on 13Jan2024. The patient had no side effects except the pain in his upper arm at the site where it was injected so and it was like 4 to 5 days ago. Regarding the adverse event, that's the normal thing for an injection according to the patient. The patient only had that pain there for about a day it's gone too now. It's normal to experience that thing. The patient didn't have any problem with that. So, the patient was not having any problem. That was it and no other problems. The patient was just wondering what Pfizer says about somebody that got it, and it is just over a year later. They said it was good for five years so would that be the Prevnar 13 or that wouldn't be the Prevnar 20.  The information on the batch/lot number for Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Anxiety, Nervousness
Clinical narrative: He is wanting to know if jumpiness or a feeling of jumpiness or anxiety; He is wanting to know if jumpiness or a feeling of jumpiness or anxiety; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 84-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), NERVOUSNESS (non-serious), outcome "unknown" and all described as "He is wanting to know if jumpiness or a feeling of jumpiness or anxiety". Additional information: Caller just stated Pfizer RSV shot. He doesn't know the name of it. He is wanting to know if jumpiness or a feeling of jumpiness or anxiety, If that could be a side effect  of it or if that wears off. Caller stated "I noticed it 2 - 3 days ago. I was wondering if that could be, Is that a side effect of the RSV shot."  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Back pain, Fatigue, Lethargy, Pain
Clinical narrative: Lower back pain; body aches; lethargy; tiredness; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: NORTREL [LEVONORGESTREL]. The following information was reported: BACK PAIN (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "Lower back pain"; PAIN (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "body aches"; LETHARGY (non-serious) with onset Nov2024, outcome "recovered" (Nov2024); FATIGUE (non-serious) with onset Nov2024, outcome "recovered" (Nov2024), described as "tiredness". Therapeutic measures were not taken as a result of back pain, pain, lethargy, fatigue.  Additional information: No prolonged hospitalization for Lower back pain; tiredness and lethargy; body aches. The patient did not receive any other vaccines within 4 weeks prior to the vaccine for which they are reporting. The patient taking other medications within 2 weeks of the event starting.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Brain fog
Clinical narrative: brain fog; This is a spontaneous report received from a Nurse.  A 67-year-old patient received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 09Apr2021, when the patient was 63-year-old, for COVID-19 immunisation. The following information was reported: BRAIN FOG (non-serious), outcome "not recovered".  Additional information: Brain fog began after the second COVID vaccination.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400148524 same patient, same product, different dose and similar event;
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received DAPTACEL two days in a row with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 27 months old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] two days in a row with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine; Hepatitis a vaccine; Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Fluvacil for Immunisation.  On 30-Jan-2025, the patient received 0.5 ml (dose 2) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) ( lot 3CA25C1 and expiry date: 30-Apr-2026) via unknown route in the right thigh and on 31-Jan-2025 he again received 0.5 ml (dose 3 ) of the same vaccine, two days in a row, with an unknown batch number and expiry date (strength: standard, frequency twice) via unknown route in the left vastus lateralis for Immunization (extra dose administered) (latency: same day).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  Action taken  was not applicable.  Reportedly, Pediatric charge nurse reported that a patient received DAPTACEL two days in a row, yesterday and today. Patient only needed 1 shot of the vaccine. Nurse wanted to make sure that patient is not going to have any adverse reactions. Nurse said that patient missed a bunch of shots so the DAPTACEL dose yesterday was only the patient's second dose. Today's extra dose is the third. Nurse mentioned it was a medical assistant who administered both of the injections.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Headache, Pain, Sensitive skin
Clinical narrative: Woke up next morning with chills, body aches, headache, and the skin sensitivity you get when you are sick and have a fever. Took Tylenol . Body ache and headache diminished. The skin sensitivity (cutaneous hyperesthesia) remains to this day.  I saw the P.A. Who recommended seeing allergy dr. However I don?t believe it?s an allergy. I have an appointment with blood doctor, who I hope will check my blood. Then I will see my dermatologist. It?s very frustrating not to know where to go or who to talk to.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Amyotrophic lateral sclerosis, Blood creatine phosphokinase increased, Chills, Electromyogram abnormal, Hyperhidrosis
Clinical narrative: Fever, shivering and sweating for 3-4 days immediately after the vaccine. In 01/2023, started developing symptoms of ALS and was diagnosed with ALS in 01/2024.
Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immediate post-injection reaction, Pyrexia
Clinical narrative: Fever, shivering and sweating for 3-4 days immediately after the vaccine. In 01/2023, started developing symptoms of ALS and was diagnosed with ALS in 01/2024.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient reported a sore arm
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient reports a sore arm
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site haemorrhage, Injection site pain, Product preparation issue
Clinical narrative: WHILE PREPARING THE VACCINE I CLEANED THE TOP OF THE VACCINE VIAL WITH ALCOHOL AND ATTACHED THE ADAPTER TO THE DILUENT SYRINGE. I WAS INTERUPTED AND DID NOT PRESS THE SYRINGE TO MIX THE DILUENT WITH THE POWDER, BUT INSTEAD TOOK THE SYRINGE OFF AND PREPARED IT WITH A NEEDLE. WHEN THE IM DOSE WAS GIVEN THE PATIENT'S ARM BLED A LITTLE AND HE SAID THAT IT STUNG. I WAS CONCERNED AND LOOKED AT THE VIAL OF ABRYSVO THAT I HAD USED AND REALIZED THAT I HAD NOT MIXED IT.  I APPOLOGIZED AND HE CHOSE TO GET  A NEW DOSE OF ABRYSVO IN THE OPPOSITE ARM. I CALLED HIM AT 7:47 PM THAT NIGHT AND HE ASSURED ME THAT HE WAS FINE AND THAT "I DIDN'T HURT A THING"
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient was only administered the diluent, not the actual vaccine.  When this was discovered, management was notified by phone.
Age: 89.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A DUPLICATE VACCINE ON 07/20/2024. NO ADVERSE EVENTS WERE APPARENT TO PATIENT
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Injection site pain, Oedema peripheral
Clinical narrative: patient came into pharmacy on 2/5/25 and explained how she noticed a red area on her arm, it hurt when vaccine was being injected and she had some swelling under her arm.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Patient is experiencing ongoing pain at injection site from flu vaccination that occurred 1 month ago on 1/6/2025. The patient had proceeded to vacation and continued to experience severe pain to the point where her mobility is affected. Patient complains of muscle pain and decreased range of motion resulting in job limitations, which she has not reported. Patient has been advised to follow-up with a medical provider.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient is experiencing ongoing pain at injection site from flu vaccination that occurred 1 month ago on 1/6/2025. The patient had proceeded to vacation and continued to experience severe pain to the point where her mobility is affected. Patient complains of muscle pain and decreased range of motion resulting in job limitations, which she has not reported. Patient has been advised to follow-up with a medical provider.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizziness developed 50minutes after vaccination, blood pressure was elevated to 180/100, repeated after 10 min still elevated
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Dr ordered pt to receive .5ML RSV vaccine, I made a mistake and administered 1ML RSV vaccine. I spoke to Dr and employee, Dr advised that it was okay and the pt health was not at risk.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Brain fog, Exercise tolerance decreased, Fatigue, Fibromyalgia
Clinical narrative: After the vaccine I started experiencing a deep ache in my arms and legs and joint pain, brain fog and fatigue. I have been unable to perform daily tasks and exercise as I had in the past.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker test, Laboratory test, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: After the vaccine I started experiencing a deep ache in my arms and legs and joint pain, brain fog and fatigue. I have been unable to perform daily tasks and exercise as I had in the past.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendix disorder, Computerised tomogram normal, Dyspepsia, Endoscopy normal
Clinical narrative: pt states that she developed a terrible burning feeling in her upper stomach. She went to the ER. She was told she had terrible GERD. She was told there was a new procedure called TIF that would get rid of this instead of treating her with medicine. She had the procedure at the hospital on August 15, 2022. Her surgeon was Dr. She stayed in pain while trying to heal.  On Sept 7th and 25th 2022 because she was still in pain. He did an Endo test. She was told everything looked perfect and could not see any reason for her to be in pain. On Nov 17th , 2022. She saw her Gastro Dr. He did an US on Dec 11th. Dec 15th 2022 she was told he could not figure out what to do for her as the US was normal. On Jan 4th she saw Dr and he told her she had metaplasia. She had to get a mapping done on Feb 28th, 2023. She was told everything was ok. She went back to Dr because she was still not well and back to normal.  She was told there was nothing he could do. On June 21st, 2023 she went to another hospital she was told her appendix was enlarged so she it removed on July 27th 2023. She was still in pain after this procedure. On Jan 30th, 2024 she saw Dr. On Feb 3rd, 2024 she had an endoscopy procedure. She was given a muscle relaxer that did not help so was then given omeprazole. This did not help either. On July 1st 2024, had CT scan at hospital. CT was normal. On Aug 7th, 2024, she went to Gastro another Dr but was recommended to another doctor. On Aug 13th 2024 she saw Dr. He sent her for an  esophagram procedure on Aug 24, 2024. On Sept 11th, 2024. She was supposed to have a gastric emptying test but was not able to complete the test as she could not eat the food fast enough. She multiple test with no resolution. She recently has started seeing a new Gastro, Dr. She had an MRI 2/7/2025-results pending. She will have a Hida Scan will be done in March 2025.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric emptying study, Gastrooesophageal reflux disease, Magnetic resonance imaging, Metaplasia, Oesophagogastric fundoplasty
Clinical narrative: pt states that she developed a terrible burning feeling in her upper stomach. She went to the ER. She was told she had terrible GERD. She was told there was a new procedure called TIF that would get rid of this instead of treating her with medicine. She had the procedure at the hospital on August 15, 2022. Her surgeon was Dr. She stayed in pain while trying to heal.  On Sept 7th and 25th 2022 because she was still in pain. He did an Endo test. She was told everything looked perfect and could not see any reason for her to be in pain. On Nov 17th , 2022. She saw her Gastro Dr. He did an US on Dec 11th. Dec 15th 2022 she was told he could not figure out what to do for her as the US was normal. On Jan 4th she saw Dr and he told her she had metaplasia. She had to get a mapping done on Feb 28th, 2023. She was told everything was ok. She went back to Dr because she was still not well and back to normal.  She was told there was nothing he could do. On June 21st, 2023 she went to another hospital she was told her appendix was enlarged so she it removed on July 27th 2023. She was still in pain after this procedure. On Jan 30th, 2024 she saw Dr. On Feb 3rd, 2024 she had an endoscopy procedure. She was given a muscle relaxer that did not help so was then given omeprazole. This did not help either. On July 1st 2024, had CT scan at hospital. CT was normal. On Aug 7th, 2024, she went to Gastro another Dr but was recommended to another doctor. On Aug 13th 2024 she saw Dr. He sent her for an  esophagram procedure on Aug 24, 2024. On Sept 11th, 2024. She was supposed to have a gastric emptying test but was not able to complete the test as she could not eat the food fast enough. She multiple test with no resolution. She recently has started seeing a new Gastro, Dr. She had an MRI 2/7/2025-results pending. She will have a Hida Scan will be done in March 2025.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophagram, Pain, Ultrasound scan normal, X-ray
Clinical narrative: pt states that she developed a terrible burning feeling in her upper stomach. She went to the ER. She was told she had terrible GERD. She was told there was a new procedure called TIF that would get rid of this instead of treating her with medicine. She had the procedure at the hospital on August 15, 2022. Her surgeon was Dr. She stayed in pain while trying to heal.  On Sept 7th and 25th 2022 because she was still in pain. He did an Endo test. She was told everything looked perfect and could not see any reason for her to be in pain. On Nov 17th , 2022. She saw her Gastro Dr. He did an US on Dec 11th. Dec 15th 2022 she was told he could not figure out what to do for her as the US was normal. On Jan 4th she saw Dr and he told her she had metaplasia. She had to get a mapping done on Feb 28th, 2023. She was told everything was ok. She went back to Dr because she was still not well and back to normal.  She was told there was nothing he could do. On June 21st, 2023 she went to another hospital she was told her appendix was enlarged so she it removed on July 27th 2023. She was still in pain after this procedure. On Jan 30th, 2024 she saw Dr. On Feb 3rd, 2024 she had an endoscopy procedure. She was given a muscle relaxer that did not help so was then given omeprazole. This did not help either. On July 1st 2024, had CT scan at hospital. CT was normal. On Aug 7th, 2024, she went to Gastro another Dr but was recommended to another doctor. On Aug 13th 2024 she saw Dr. He sent her for an  esophagram procedure on Aug 24, 2024. On Sept 11th, 2024. She was supposed to have a gastric emptying test but was not able to complete the test as she could not eat the food fast enough. She multiple test with no resolution. She recently has started seeing a new Gastro, Dr. She had an MRI 2/7/2025-results pending. She will have a Hida Scan will be done in March 2025.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: First Dose Received Heplisav-B, Second Dose Received Engerix-B; Initial report received on 24-Jan-2025.    A pharmacist reported that a 19-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose.   No medical history or concomitant medications were reported.      On 13-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #945658, expiration date 31-Jan-2027, NDC #43528-003-05) was administered intramuscularly in the right deltoid.    On 12-Jan-2025, 30 days after having been vaccinated with HEPLISAV-B, the  patient was given ENGERIX-B (lot #95BJ9, expiration date 25-Jul-2026, NDC #58160082052) in the left deltoid as the second dose of hepatitis B vaccine. The vaccine was administered at another Pharmacy. No adverse events were reported.    No additional information was reported.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.