chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient are only receiving the diluent for the Hiberix no separate vials; patient are only receiving the diluent for the Hiberix no separate vials; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old patient who received Hib (Hiberix) (batch number 73FP5, expiry date 12-JUN-2027) for prophylaxis.   On 30-APR-2024, the patient received Hiberix. On 30-APR-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient are only receiving the diluent for the Hiberix no separate vials) and inappropriate dose of vaccine administered (Verbatim: patient are only receiving the diluent for the Hiberix no separate vials). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The reporter reported that the healthcare medical group received the Hiberix vaccine that had a syringe with diluent and a medication/powder vial. In the past, they received the 2-vial packaging of Hiberix that they banded together for safety purposes. Since the transition, they had multiple events reported where patients were only receiving the diluent for the Hiberix as the staff was not seeing the separate vial (various reasons, package insert laying over vial, etc.). The reporter asked was there a possibility that the packaging could be updated so the syringe and vial were joined/banded as in the 2 vial HIB packaging and a reminder inside of the package for reconstituting the medication. In the meantime, they would be re-educating, labeling all packages with a reminder to reconstitute and 1:1 education as needed. The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR063485:Same reporter / different patient US-GSK-US2024AMR063489:Same reporter / different patient US-GSK-US2024AMR063488:Same reporter / different patient US-GSK-US2024AMR063484:Same reporter / different patient US-GSK-US2024AMR063479:Same reporter / different patient US-GSK-US2024AMR063486:Same reporter / different patient
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered
Clinical narrative: Inappropriate preparation of medication; received Hiberix diluent alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 9-week-old patient who received Hib (Hiberix) (batch number 2A95F, expiry date 20-JAN-2026) for prophylaxis.   On 06-MAY-2024, the patient received Hiberix. On 06-MAY-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: received Hiberix diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The reporter reported about a patient who received Hiberix diluent alone from 2 different locations which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one out of 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024061908:Master case. US-GSK-US2024AMR063489: US-GSK-US2024AMR063487:
Sex: U
Vaccine: RVX
Symptoms: Cough, Malaise
Clinical narrative: still coughing; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In JAN-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced cough (Verbatim: still coughing) and sickness (Verbatim: Sick). The outcome of the cough was not resolved and the outcome of the sickness was not reported.   It was unknown if the reporter considered the cough and sickness to be related to RSV vaccine.     It was unknown if the company considered the cough and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-MAY-2024 This case was reported by a patient via interactive digital media. The patient had the shot in January 2024 and he/she was still coughing.  The patient was sick the first week when got the shot.
Sex: F
Vaccine: RV1
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 6-month-old female patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Previously administered products included Rotarix (received 1st dose at 16 weeks of age (4 month) on 12th March 2024  of batch number LN425 and expiry date 13th October 2025).   On an unknown date, the patient did not received the 2nd dose of Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-MAY-2024 The medical assistant was calling with a vaccine error for Rotarix vaccine. The patient started schedule of vaccine late already, she was already behind on her vaccines  The reporter was asking what was the next step. Till the time of reporting, the patient did not receive 2nd dose of Rotarix liquid formulation, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines were used in patients after April 5, 2024 excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: vaccines were used in patients after April 5, 2024 excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2024 The reporter requested stability data for Bexsero, Menveo (2-vial), Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liquid) stored at 53 degree F for 1 hrs.2 previous excursions for total time out of range 2hrs max tempt 56.8F. Vaccines quarantined with current excursion, no patient involvement with current excursion. The healthcare professional reported that vaccines were used in patients after 05-APR-2024 excursion, which led to incorrect storage of drug.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Maladministration of Infanrix over 7 years old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 73SX2) for prophylaxis.   Previously administered products included Pentacel (previously vaccinated with 2 Pentacel vaccines on an unknown date) and Pediarix (received on an unknown date).   On 17-MAY-2024, the patient received Infanrix. On 17-MAY-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration of Infanrix over 7 years old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAY-2024 The pediatric nurse practitioner reported that a patient received a dose of Infanrix vaccine above than the recommended age limit, which led to inappropriate age at vaccine administration. This case had been link with US2024063028, reported by the same reporter.; Sender's Comments:  US-GSK-US2024063028:Same reporter, Different patient
Age: 21.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose of hep B; 2/29/2024 3rd dose of hep B Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 21-year-old female patient who received HBV (Engerix B) (batch number 9LK2G, expiry date 21-FEB-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Hepatitis b vaccine (1st dose received on 02-AUG-2023) and Engerix b (2nd dose received on 06-SEP-2023).   On 17-MAY-2024, the patient received the 4th dose of Engerix B. On 29-FEB-2024, the patient received the 3rd dose of Engerix B. On 29-FEB-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2/29/2024 3rd dose of hep B Engerix-B). On 17-MAY-2024, the patient experienced extra dose administered (Verbatim: Extra dose of hep B). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The nurse reported that a patient received an extra dose of Hepatitis B instead of doing titers.  The patient received 3rd dose of Engerix B delayed than the recommended time interval, which led to lengthening of vaccination schedule. The patient received 4th dose of Engerix-B, which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: less than recommended interval/3rd dose administered to early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old female patient who received HBV (Engerix B) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b) and Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 20-MAY-2024, the patient received the 3rd dose of Engerix B. On 20-MAY-2024, an unknown time after receiving Engerix B, not applicable after receiving Engerix b and Engerix b and not applicable after receiving Engerix b and Engerix b, the patient experienced drug dose administration interval too short (Verbatim: less than recommended interval/3rd dose administered to early). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-MAY-2024 The nurse reported that the patient received 3rd dose of Engerix B vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. The reporter reported that they called in to solicit medical information but during the call they did provide data about the events, vaccine and patients. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Menveo extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received first dose at the age of 11 years).   In MAY-2024, the patient received the 2nd dose of Menveo. In MAY-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: Menveo extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-MAY-2024 The clinic supervisor registered nurse would like to inquire about a vaccine situation that happened at their workplace.  The nurse stated that last week (from the reporting date) a patient aged 13 was administered a Menveo vaccine and his dad believed he did not had the vaccine prior but upon entering into their state registry they discovered that he had it at age of 11 years, which led to extra dose administered.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: havrix which was for 19 years of age an older that was given to a 12 month old; Adult product administered to child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 20-MAY-2024, the patient received Havrix. On 20-MAY-2024, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: havrix which was for 19 years of age an older that was given to a 12 month old) 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: 21-MAY-2024 The Health Care Professional reported that they had one havrix which was for 19 years of age an older that was given to a 12 month old which led to overdose and adult product administered to child. The reporter was not sure about all the side effects.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received Menveo 2 vials presentation after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA909A, expiry date 30-APR-2024) for prophylaxis.   On 20-MAY-2024, the patient received Menveo. On 20-MAY-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Patient received Menveo 2 vials presentation after the expiration date ). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The registered nurse (RN) reported that patient received Menveo 2 vial presentation after that the expiration date, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingleson his face and moving towards his eye; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, RSVPreF3 adjuvanted (Arexvy) for prophylaxis and Influenza vaccine for prophylaxis.   In FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular). In DEC-2023, the patient received the 1st dose of Shingrix (intramuscular). In FEB-2024, the patient received Arexvy and Influenza vaccine. On 04-APR-2024, between 1 and 3 months after receiving Shingrix, between 3 and 5 months after receiving Shingrix and not applicable after receiving Arexvy, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingleson his face and moving towards his eye). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Arexvy.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-May-2024 The patient was self-reported this case. The patient reported that he received Shingrix vaccines and got diagnosed with Shingles in April 2024.  The patient stated that he got the first dose of Shingrix in December 2023 and the second dose of Shingrix in late February. The patient did not know the exact dates, nor did he had any lot numbers.  The also would not gave pharmacy information.  The patient stated that he received the Shingrix vaccine, Arexvy vaccine and the flu vaccine all in the same visit but they did use different anatomical sites to administer the vaccines.  The patient stated he had been to 2 urgent care clinics no info provided and also to eye doctor.  It was unknown if the company considered the shingles to be related to Influenza vaccine. The shingles reporter stated are located on his face and moving towards his eye. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Skin lesion, Swelling
Clinical narrative: raised; red; Suspected vaccination failure / She describes the outbreak as mild; She reports that she contracted shingles; lesions which were itchy,; itchy; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In NOV-2018, the patient received the 2nd dose of Shingrix. In AUG-2018, the patient received the 1st dose of Shingrix. In JAN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / She describes the outbreak as mild) (serious criteria GSK medically significant) and shingles (Verbatim: She reports that she contracted shingles). On an unknown date, the patient experienced skin lesion (Verbatim: lesions which were itchy,), pruritus (Verbatim: itchy), swelling (Verbatim: raised) and erythema (Verbatim: red). The outcome of the vaccination failure was unknown and the outcome of the shingles, swelling and erythema were resolved and the outcome of the skin lesion was resolved (duration 10 weeks) and the outcome of the pruritus was resolved (duration 6 weeks).   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, pruritus, swelling and erythema to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, skin lesion, pruritus, swelling and erythema to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2024 The patient was the reporter. She reported that she contracted shingles in January 2024. The patient described the outbreak as mild, with only few lesion were itchy, raised and red but never blister or opened after the vaccination. The itching lasted 6 weeks and the lesion were visible for 10 weeks. The patient had complete recovered. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: raised; red; Suspected vaccination failure / She describes the outbreak as mild; She reports that she contracted shingles; lesions which were itchy,; itchy; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In NOV-2018, the patient received the 2nd dose of Shingrix. In AUG-2018, the patient received the 1st dose of Shingrix. In JAN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / She describes the outbreak as mild) (serious criteria GSK medically significant) and shingles (Verbatim: She reports that she contracted shingles). On an unknown date, the patient experienced skin lesion (Verbatim: lesions which were itchy,), pruritus (Verbatim: itchy), swelling (Verbatim: raised) and erythema (Verbatim: red). The outcome of the vaccination failure was unknown and the outcome of the shingles, swelling and erythema were resolved and the outcome of the skin lesion was resolved (duration 10 weeks) and the outcome of the pruritus was resolved (duration 6 weeks).   It was unknown if the reporter considered the vaccination failure, shingles, skin lesion, pruritus, swelling and erythema to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, skin lesion, pruritus, swelling and erythema to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2024 The patient was the reporter. She reported that she contracted shingles in January 2024. The patient described the outbreak as mild, with only few lesion were itchy, raised and red but never blister or opened after the vaccination. The itching lasted 6 weeks and the lesion were visible for 10 weeks. The patient had complete recovered. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Near death experience, Surgery
Clinical narrative: It has caused 2 near death experiences; resulted in 2 near death experiences and 5 operations; This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (It has caused 2 near death experiences) and SURGERY (resulted in 2 near death experiences and 5 operations) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, received dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (It has caused 2 near death experiences) (seriousness criterion medically significant) and SURGERY (resulted in 2 near death experiences and 5 operations) (seriousness criterion medically significant). At the time of the report, NEAR DEATH EXPERIENCE (It has caused 2 near death experiences) and SURGERY (resulted in 2 near death experiences and 5 operations) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not provided. Patient was attached by his own vaccine, and it had caused 2 near death experiences and underwent 5 operations. Treatment information was not reported.  Company Comment: This is a Spontaneous case concerning a male patient of an unknown age with interchange of vaccine administration (COVID-19 vaccine, Tozinameran 1 dose) and no medical history reported, who experienced the serious (per medically significant) unexpected events of Near death experience and Surgery which occurred on unknown dates and onset latency with a dose of SPIKEVAX NOS for COVID-19 Vaccination. Very limited information regarding these events has been provided at this time.  No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     The patient's past medical history included Colonoscopy (Patient had a regular colonoscopy under general anesthesia, after they found a couple polyps in 2021). Concurrent medical conditions included Dust allergy (Allergy to dust mites), Allergy to molds (Allergy to certain molds), Pollen allergy (Allergy to certain pollens), Melanoma (Patient had 3 melanomas), Polyps (found a couple polyps) since 2021 and Eczema. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Dust allergy, Allergy to molds and Pollen allergy.    On 18-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had a lot of eczema-type skin rashes, was seeing a dermatologist regularly (3 to 4 times a year) starting in college. Patient went to allergist a decades ago.  Patient received 8 doses of Moderna COVID vaccines and had no issues with the first 7 doses. With the first 7 doses, patient experienced just what he thought to be a normal reaction to a vaccine, sore arm and 24 hours after, he would have a headache (for only about half the time).  No treatment information was provided.   This case was linked to MOD-2024-768311, MOD-2024-768285, MOD-2021-064473 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site swelling
Clinical narrative: Body aches; swelling at site; fatigue; headache; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25May2024 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CONTRAVE. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: PAIN (non-serious) with onset 26May2024, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 26May2024, outcome "not recovered"; HEADACHE (non-serious) with onset 26May2024, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious) with onset 26May2024, outcome "not recovered", described as "swelling at site". Therapeutic measures were not taken as a result of pain, vaccination site swelling, fatigue, headache. Additional information: adverse events started on 26May2024 at 12:00AM. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Gastric bypass" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ampicillin, reaction(s): "Known allergies"; Cipro, reaction(s): "Known allergies"; Tamiflu, reaction(s): "Known allergies"; Amlodipine, reaction(s): "Known allergies"; Topamax, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "recovered" (May2024) and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 14May2024 until 20May2024.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Head injury, Memory impairment, Muscle spasms, Seizure
Clinical narrative: Attacking my nerve system and causing me to have seizures, shakes; Symptoms of epilepsy seizures, but they are calling it non epilepsy seizures; Attacking my nerve system and causing me to have seizures, shakes; Shake even standing up. My whole body cramps up. My hands and my body cramp up really bad. I shake really bad; Hit my head; Forget what you and I would talk about; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: F96780) and as dose 2, single (Lot number: FD8448) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SEIZURE (medically significant), TREMOR (non-serious) all with onset 2021, outcome "unknown" and all described as "Attacking my nerve system and causing me to have seizures, shakes"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Forget what you and I would talk about"; HEAD INJURY (non-serious) with onset 2021, outcome "unknown", described as "Hit my head"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Shake even standing up. My whole body cramps up. My hands and my body cramp up really bad. I shake really bad"; EPILEPSY (medically significant) with onset 2021, outcome "unknown", described as "Symptoms of epilepsy seizures, but they are calling it non epilepsy seizures". Therapeutic measures were taken as a result of seizure, epilepsy, tremor, muscle spasms, head injury, memory impairment. Clinical course: Patient only had two vaccines. They refused for her to get the booster. It was attacking her nerve system causing to have symptoms of epilepsy seizures, but they were calling it non epilepsy seizures. It was attacking her nerve system. Patient shake even standing up. Patient whole body cramps up. Her hands and body cramp up really bad. She shake really bad and she have been having seizures. It could be twenty times a day, but they don't last long. She have wood floors, she had hit her head so many times and she forgot what we would talked about. 'She can lose train of thoughts in the middle of the time' and forget what the heck she was talking about. This was very scary for her. She never had any of this since, never, she was 42, never had this until 2021. She didn't work and drive. It took her life away.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Attacking my nerve system and causing me to have seizures, shakes; Symptoms of epilepsy seizures, but they are calling it non epilepsy seizures; Attacking my nerve system and causing me to have seizures, shakes; Shake even standing up. My whole body cramps up. My hands and my body cramp up really bad. I shake really bad; Hit my head; Forget what you and I would talk about; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: F96780) and as dose 2, single (Lot number: FD8448) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SEIZURE (medically significant), TREMOR (non-serious) all with onset 2021, outcome "unknown" and all described as "Attacking my nerve system and causing me to have seizures, shakes"; MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Forget what you and I would talk about"; HEAD INJURY (non-serious) with onset 2021, outcome "unknown", described as "Hit my head"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Shake even standing up. My whole body cramps up. My hands and my body cramp up really bad. I shake really bad"; EPILEPSY (medically significant) with onset 2021, outcome "unknown", described as "Symptoms of epilepsy seizures, but they are calling it non epilepsy seizures". Therapeutic measures were taken as a result of seizure, epilepsy, tremor, muscle spasms, head injury, memory impairment. Clinical course: Patient only had two vaccines. They refused for her to get the booster. It was attacking her nerve system causing to have symptoms of epilepsy seizures, but they were calling it non epilepsy seizures. It was attacking her nerve system. Patient shake even standing up. Patient whole body cramps up. Her hands and body cramp up really bad. She shake really bad and she have been having seizures. It could be twenty times a day, but they don't last long. She have wood floors, she had hit her head so many times and she forgot what we would talked about. 'She can lose train of thoughts in the middle of the time' and forget what the heck she was talking about. This was very scary for her. She never had any of this since, never, she was 42, never had this until 2021. She didn't work and drive. It took her life away.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired vaccine was given to a child with no reported adverse event; Initial information received on 23-May-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old male patient who was given expired HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-May-2024, the patient had received 0.5 ml of expired suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ856AB, strength: standard, frequency: once and expiry date: 25-Mar-2024) via unknown route in unknown administration site for Prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency-same day).  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: 76.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentaly give smaller dose instead of the adult dose of Engerix B; accidentaly give smaller dose instead of the adult dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 76-year-old male patient who received HBV (Engerix B pediatric) (batch number 9Pg49, expiry date 28-DEC-2024) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose of Engerix B adult on unknown date) and Engerix B adult (received 2nd dose of Engerix B adult on unknown date).   On 17-MAY-2023, the patient received the 3rd dose of Engerix B pediatric. On 17-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: accidentaly give smaller dose instead of the adult dose of Engerix B) and adult use of a child product (Verbatim: accidentaly give smaller dose instead of the adult dose of Engerix B). The outcome of the accidental underdose and adult use of a child product 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: 20-MAY-2024 The reporter reported they had accidentally given somebody (patient) the smaller Engerix B Pediatric 3rd dose on the series instead of the adult dose which led to an accidental underdoes and adult use of a child product. The reporter wanted to know what was recommended in that case. The vaccine administration facility was the same as primary reporter. It was reported that, since the 3rd dose would be considered invalid and has to be repeated, it would be late in time. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body pain
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product label issue
Clinical narrative: Pfizer Comirnaty 23-24 was administered on 05/20, although the vaccine vial reflected a non-expired vaccine, the date on the box did reflect an expired lot.  No adverse event.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Back pain, Injection site pain, Joint range of motion decreased
Clinical narrative: HEPLISAV-B 20 MCG/0.5 ML SYRNG (NDC: 43528-0003-05  QTY: 0.5).  Sharp pain at injection site, sharp pain in neck & back, shoulder pain with decreased range of motion, forearm pain and tingling in my finger tips and palm. Loss of strength in right arm, swelling in right hand. Pain has not gotten better.  Doctor prescribed predniSONE (Deltasone) x 5 days with no relief of symtoms.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Neck pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: HEPLISAV-B 20 MCG/0.5 ML SYRNG (NDC: 43528-0003-05  QTY: 0.5).  Sharp pain at injection site, sharp pain in neck & back, shoulder pain with decreased range of motion, forearm pain and tingling in my finger tips and palm. Loss of strength in right arm, swelling in right hand. Pain has not gotten better.  Doctor prescribed predniSONE (Deltasone) x 5 days with no relief of symtoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient states the next day after administration that she had a severe headache and the arm was red, swollen, hot to the touch, and sore.  the arm effects lasted 1 week before resolving.
Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Erythema, Papule, Pyrexia, Rash, Respiratory viral panel
Clinical narrative: Patient developed a rash on his face approximately 6 hours after vaccinations. He also had a low grade fever. The rash started as small red papules. The following morning spread to his arms and legs, had taken on the appearance of "bullseye" rash with dusky centers, consistent with erythema toxcium. Patient examined in the office on 5/30/24. Rash as stated previously. Baby otherwise in usual state of health. Viral respiratory panel was negative. Recommended treatment was supportive care. Discussed signs of worsening.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: 5/16 URGENT CARE VISIT DUE TO LOW GRADE FEVER AND RASH, PRESCRIBED TOPICAL TREATMENT FOR HIVES AND GIVEN IM INJECTION OF KENALOG 40 MG PER ML. 5/17/24 PRESCRIBED MEDROL DOSE PACK TAPER DUE TO WORSENING HIVES. 5/18 PRESCRIBED VALACYCLOVIR AND PREDNISONE, ENDED UP GOING TO THE ER THAT NIGHT AND WAS ADMITTED TO HOSPITAL FOR 2 DAYS - DURING THAT TIME RECEIVED 5 DOSES OF ACYCLOVIR IV. RELEASED MONDAY THE 20TH AND CONTINUED TWO WEEKS OF HIGH DOSE PREDNISONE TAPER AND ORAL ACYCLOVIR.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: 5/16 URGENT CARE VISIT DUE TO LOW GRADE FEVER AND RASH, PRESCRIBED TOPICAL TREATMENT FOR HIVES AND GIVEN IM INJECTION OF KENALOG 40 MG PER ML. 5/17/24 PRESCRIBED MEDROL DOSE PACK TAPER DUE TO WORSENING HIVES. 5/18 PRESCRIBED VALACYCLOVIR AND PREDNISONE, ENDED UP GOING TO THE ER THAT NIGHT AND WAS ADMITTED TO HOSPITAL FOR 2 DAYS - DURING THAT TIME RECEIVED 5 DOSES OF ACYCLOVIR IV. RELEASED MONDAY THE 20TH AND CONTINUED TWO WEEKS OF HIGH DOSE PREDNISONE TAPER AND ORAL ACYCLOVIR.
Age: 0.75
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; GARDASIL9 was inadvertently administered to a 9 month old patient; This spontaneous report was received from a physician and refers to a 9-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-MAY-2024, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #1957404, which had been verified to be a valid lot number, expiration date reported and confirmed as 05-OCT-2025, administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided) (Product administered to patient of inappropriate age). The patient was asymptomatic and no additional adverse event (AE) (no adverse event) reported. Operator of device was reported as a health professional.
Age: 0.33
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertent administration of GARDASIL 9 to a 4-month-old patient on 28-MAY-2024.; This spontaneous report was received from other health professional (medical assistant), referring a 4-month-old female patient.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 28-MAY-2024, she was inadvertent vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter, administered as prophylaxis (strength, route and anatomical location of administration, lot #, and expiration date were not provided). The reporter highlighted that it was a 4-months-old patient (product administered to patient of inappropriate age). No additional adverse event (AE) (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; HCP called to report an expired dose of MMRII was administered to one patient on 05/28/2024.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 28-MAY-2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin [rHA]) (M-M-R II) lot number: W039698 (lot number W039698 had been verified to be valid lot number for measles, mumps, and rubella [wistar RA 27-3] virus vaccine, live [rHA] [M-M-R II]), expiration date reported and confirmed as 24-MAY-2024 (expired product administered) (strength, exact dose, route of administration, and anatomical location were not provided) for prophylaxis. Operator of device was a health professional.   The patient was asymptomatic and no additional adverse events (AE) reported (no adverse event). No additional details provided.
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose of VARIVAX was inadvertently administered to a patient.; This spontaneous report has been received from a consumer, regarding to a 20-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 24-MAY-2024, the patient was vaccinated with an expired dose (Expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliters (ml), for prophylaxis, lot number w016747 which has been verified to be valid, expiration date reported and established as 23-MAY-2024 (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported).   No additional adverse events were reported in the patient.
Sex: U
Vaccine: RVX
Symptoms: Diarrhoea
Clinical narrative: had really bad diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced diarrhea (Verbatim: had really bad diarrhea). The outcome of the diarrhea was resolved (duration 1 week).   It was unknown if the reporter considered the diarrhea to be related to RSV vaccine.     It was unknown if the company considered the diarrhea to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 20-MAY-2024 This case was reported by a patient via interactive digital media. The patient had really bad diarrhea from this shot for a least a week. The patient did not realize until later it was not uncommon.