chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Sensitive skin
Clinical narrative: elbow pain/pain of her right elbow where it looks like a nodule; sensitive area; tiredness/tired; muscle aches/muscle aches, particularly her quads; injection site erythema/injection site (right arm) was erythematous/Site injection red; site was erythematous (red) with ecchymosis; elbow pain/pain of her right elbow where it looks like a nodule; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-MAY-2024, the patient received the 1st dose of Shingrix (right arm). On 09-MAY-2024, 2 days after receiving Shingrix, the patient experienced nodule on extremity (Verbatim: elbow pain/pain of her right elbow where it looks like a nodule) and sensitive skin (Verbatim: sensitive area). In MAY-2024, the patient experienced injection site erythema (Verbatim: injection site erythema/injection site (right arm) was erythematous/Site injection red), injection site ecchymosis (Verbatim: site was erythematous (red) with ecchymosis), pain in elbow (Verbatim: elbow pain/pain of her right elbow where it looks like a nodule), tiredness (Verbatim: tiredness/tired) and myalgia of lower extremities (Verbatim: muscle aches/muscle aches, particularly her quads). The outcome of the injection site erythema, pain in elbow, tiredness and myalgia of lower extremities were unknown and the outcome of the injection site ecchymosis, nodule on extremity and sensitive skin were not reported.   It was unknown if the reporter considered the injection site erythema, injection site ecchymosis, pain in elbow, nodule on extremity, tiredness, myalgia of lower extremities and sensitive skin to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site ecchymosis, pain in elbow, nodule on extremity, tiredness, myalgia of lower extremities and sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2024 The patient self reported that she received first dose of Shignrix on Tuesday (07-MAY-2024) and her injection site was erythematous (red) with ecchymosis. She was tired and her muscles particularly aches in quads. Today morning ( day of reporting) she woke up in severe pain in her right elbow where it looked like a nodule which was not erythematous, but looked like she had 2 elbows. She also mentioned two days after the administration of Shingrix vaccine had a huge protrusion on elbow and sensitive area.
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: patient with the Hiberix vaccine, the needle stayed stuck at the injection site and it detached from the syringe; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental needle stick in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: patient with the Hiberix vaccine, the needle stayed stuck at the injection site and it detached from the syringe). The outcome of the accidental needle stick was unknown.   It was unknown if the reporter considered the accidental needle stick to be related to Hiberix.     It was unknown if the company considered the accidental needle stick to be related to Hiberix.   Additional Information: GSK Receipt Date: 13-MAY-2024 The reporter reported that after injecting a patient with the Hiberix vaccine, the needle stayed stuck at the injection site and it detached from the syringe. At the moment, the healthcare professional was pulling the needle out of the patient, the needle got separated from the syringe and stayed inside the patient. There was no PQC (product quality complaint) since the healthcare professional was using a non luer lock compatible needle. The patient's initial, date of birth and gender were not available. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: gave vaccine and it is expired as on the 30th April 2024 and I gave it to the patient before knowing it was expired,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number 3YB52, expiry date 30-APR-2024) for prophylaxis.   On 13-MAY-2024, the patient received the 2nd dose of Bexsero. On 13-MAY-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: gave vaccine and it is expired as on the 30th April 2024 and I gave it to the patient before knowing it was expired,). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAY-2024 The medical assistant called and reported that she wanted to give Meningococcal B (Bexsero) vaccine and it was expired. She gave it to the patient before knowing it was expired, before noticing it was expired, which led to expired vaccine used. The reporter was just trying to figure out what to do for this situation. The reporter provided lot number and confirmed brand name Bexsero. The reporter said that she had 2 boxes of the expired vaccine with the lot number provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: A pharmacist called in to request data about the recommendations available for the administration of the second dose 6 years after the initial dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine on unknown date in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: A pharmacist called in to request data about the recommendations available for the administration of the second dose 6 years after the initial dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2024 The reporter called in to request data about the recommendations available for the administration of the second dose 6 years after the initial dose. The reporter provided whatever information they had on hand about the patient, vaccine and event. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient who was given Bexsero instead of Menquadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   In MAR-2024, the patient received Bexsero. In MAR-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient who was given Bexsero instead of Menquadfi). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-MAY-2024  A reporter reported that we had a patient who was given Bexsero instead of Menquadfi which led to Wrong vaccine administered. According to the reporter, the dose was administered on March 2024.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B peds administered to an adult; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 64-year-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 13-MAY-2024, the patient received Engerix B pediatric. On 13-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B peds administered to an adult) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date: 14-MAY-2024 The Other Health Professional reported that patient had received a pediatric dose of Engerix-B instead of an adult dose, which led to, adult use of a child product and underdose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: elevated blood pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced increased blood pressure (Verbatim: elevated blood pressure). The outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.     It was unknown if the company considered the increased blood pressure to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAY-2024 The patient self-reported this case. The patient's DOB (date of birth), initials and gender were not available. The patient developed an elevated blood pressure after receiving the Shingrix vaccine.  The reporter did not consent to follow-up.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 month old patient received Kinrix; patient came to receive diphtheria, tetanus, and pertussis, polio and Haemophilus influenzae type b vaccines, and they accidentally administered a first dose of Kinrix; patient received Kinrix (third dose of diphtheria, tetanus, pertussis and polio); 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 8-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Vaxelis (1st dose received on 03-JAN-2024). Concomitant products included HIB vaccine conj (OMPC) (PedvaxHIB) and Vaxelis.   On 14-MAY-2024, the patient received the 1st dose of Kinrix. On 14-MAY-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 month old patient received Kinrix), wrong vaccine administered (Verbatim: patient came to receive diphtheria, tetanus, and pertussis, polio and Haemophilus influenzae type b vaccines, and they accidentally administered a first dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: patient received Kinrix (third dose of diphtheria, tetanus, pertussis and polio)). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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: 14-MAY-2024 A nurse reported that a patient came to receive diphtheria, tetanus, and pertussis, polio and Haemophilus influenzae type b vaccines, and they accidentally administered a first dose of Kinrix because reporter thought when Kinrix said 4-6 it was 4-6 months not years of age which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient received today (on the day of reporting) Kinrix (third dose of diphtheria, tetanus, pertussis and polio), and Pedvax for Haemophilus influenzae type b which led to inappropriate schedule of vaccine administered.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: patient received a dose of Arexvy but it had been reconstituted with the wrong diluent; inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK5AC, expiry date 23-MAR-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received a dose of Arexvy but it had been reconstituted with the wrong diluent) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The director of operations called and requested on how to proceed after the patient received a dose of Arexvy but it had been reconstituted with the wrong diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the previous question was true what risks were present if a second dose was given and asked what would be the time frame that would be recommended in this scenario. They did clarify that there was a possibility that 1 patient out of 4 had been affected but were unsure as to whom and were also unsure about the vaccination date, stating it could have taken place between November 2023 and March 2024.  They provided data for the 4 patients and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. This was 2 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024060817:same reporter/ Different patient US-GSK-US2024060818:Same reporter / different patient US-GSK-US2024060821:Same reporter / different patient
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 02-MAY-2024, the patient received the 4th dose of Infanrix. On 02-MAY-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received expired dose of Infanrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2024  A nurse had a patient who had an expired dose of Infanrix on 02 May 2024, vaccine expired 21 April 2024 which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution of Hiberix with liquid diluent not supplied by GSK; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 5-month-old male patient who received Hib (Hiberix) (batch number F45JY, expiry date 14-MAR-2026) for prophylaxis.   In MAY-2024, the patient received Hiberix. In MAY-2024, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution of Hiberix with liquid diluent not supplied by GSK) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-MAY-2024 The nurse gave Hiberix yesterday and she did not use sterile saline diluent provided with Hiberix, she used Merck sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received Fluarix vaccine twice; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number DR4S2, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included Influenza vaccine inact split 4v (Fluarix quadrivalent).   On 16-MAY-2024, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season. On 16-MAY-2024, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: patient received Fluarix vaccine twice). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 16-MAY-2024 A reporter reported that a patient received fluarix vaccine today on 16 May 2024 but got 1st dose in 04 May 2024, she received it twice which led to Extra dose administered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose of Shingrix/Shingrix-Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine on an Unknown date).   On 20-OCT-2022, the patient received the 2nd dose of Shingrix. On 20-OCT-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the second dose of Shingrix/Shingrix-Late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The pharmacist reported that the patient received the second dose of Shingrix vaccine in 20th October 2022 which led to Drug dose administration interval too long. The HealthCare Professional asked if patient should restart the series. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The reporter states that it was more than 6 months between the first and second dose of SHINGRIX; 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received first dose of Shingrix vaccine in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The reporter states that it was more than 6 months between the first and second dose of SHINGRIX). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient is the reporter. The patient reported that it was more than 6 months between the first and second dose of Shingrix vaccine (Inappropriate schedule of vaccine) . The patient received the first dose of Shingrix vaccine in 2018, and just recently received the second dose of Shingrix vaccine, which led to drug dose administration interval too long. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Off label use, Product prescribing error, Vaccination failure
Clinical narrative: Received Shingrix in 2019, completed the series in 2019 and had shingles/ Suspected vaccination failure; Shingles; off label; Second series prescription; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received dose in 2010).   In APR-2019, the patient received the 2nd dose of Shingrix. In JAN-2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received Shingrix in 2019, completed the series in 2019 and had shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), off label use (Verbatim: off label) and drug prescribing error (Verbatim: Second series prescription). The outcome of the vaccination failure, off label use and drug prescribing error were unknown and the outcome of the shingles was 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 company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-May-2024 The reporter was a pharmacy technician. The reporter informed that the patient received Shingrix vaccine in 2019 and completed the series in 2019. The reporter just called on the phone as the physician prescribed her a shingles vaccine, which led to off label use and product prescribing error. The reporter was not aware of when the patient had shingles since 2019. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: An HCP reported that during administration of Kinrix and incomplete dose was given due to needle leakage.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 09-MAY-2024, the patient received Kinrix. On 09-MAY-2024, an unknown time after receiving Kinrix, the patient experienced accidental underdose (Verbatim: An HCP reported that during administration of Kinrix and incomplete dose was given due to needle leakage.). The outcome of the accidental underdose 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 reporter reported that during administration of Kinrix and incomplete dose was given due to needle leakage, which led to incomplete dose administered. The health care professional mentioned that half or 3 by 4 of the dose was administered to the patient. The reporter asked if patient had to be re vaccinated. The reporter consented to follow-up.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Inadvertently, the patient received another dose of HAVRIX on May 14, 2024; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received HAV (Havrix 720 Junior) (batch number 7PK53, expiry date 04-MAR-2026) for prophylaxis.   Previously administered products included Havrix 720 (On an unknown date received first dose). Concomitant products included Hepatitis a vaccine inact (Havrix 720 junior).   On 14-MAY-2024, the patient received Havrix 720 Junior (left thigh). On 14-MAY-2024, an unknown time after receiving Havrix 720 Junior, the patient experienced extra dose administered (Verbatim: Inadvertently, the patient received another dose of HAVRIX on May 14, 2024). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-MAY-2024 The reporter was a health care professional (Doctor of medicine). Reporter reported that the patient received the second dose of Havrix and inadvertently the patient received another dose of Havrix on 14th May 2024, which led to extra dose administered. Both injection were given in the left thigh, reporter report this event on VAERS it was not disclosed when the very first dose of Havrix was administered. Both doses from the 10th May 2024 and the 14th May 2024 were of the same lot number. The reporter reported that patient was doing great, sleeping, eating normally, there was no fever no swelling and no redness. The reporter consented to follow-up.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to Engerix-B; This serious case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a 40-year-old male patient who received HBV (Engerix B adult) (batch number 3744L, expiry date 07-MAY-2016) for prophylaxis.   Previously administered products included Twinrix (received Twinrix first dose on unknown date).   In MAY-2015, the patient received the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced anaphylactic reaction (Verbatim: Anaphylactic reaction to Engerix-B) (serious criteria GSK medically significant). The outcome of the anaphylactic reaction was unknown.   The reporter considered the anaphylactic reaction to be related to Engerix B adult.     The company considered the anaphylactic reaction to be related to Engerix B adult.   Additional Information: GSK Receipt Date: 17-MAY-2024 The pharmacist reported that patient received Twinrix first dose and then the Engerix- B adult dose and suffered anaphylactic reaction to Engerix-B vaccine.  They were comparing Twinrix and Engerix-B components to see to which component was patient allergic to.  Th pharmacist stated that with Twinrix there was not any problem but now, they cannot administer Engerix-b anymore to the patient and he had a potential hep b exposure.  The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: She had spiked a fever of 102.8/fever was down to 102.4F, followed by 100.8 F by 11:30am and finally returning to 98.5 by 2:30pm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (She had spiked a fever of 102.8/fever was down to 102.4F, followed by 100.8 F by 11:30am and finally returning to 98.5 by 2:30pm) in a 6-month-old female patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2024 at 11:00 AM, the patient received first dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. On 16-May-2024 at 7:00 PM,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced PYREXIA (She had spiked a fever of 102.8/fever was down to 102.4F, followed by 100.8 F by 11:30am and finally returning to 98.5 by 2:30pm). The patient was treated with PARACETAMOL (TYLENOL) on 16-May-2024 at a dose of UNK UNK, q3h and IBUPROFEN (MOTRIN [IBUPROFEN]) on 16-May-2024 at a dose of UNK UNK, q3h. On 17-May-2024 at 2:30 PM, PYREXIA (She had spiked a fever of 102.8/fever was down to 102.4F, followed by 100.8 F by 11:30am and finally returning to 98.5 by 2:30pm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2024, Body temperature: 102.8 F at 7 pm. On 17-May-2024, Body temperature: 102.4 F at 8:30 am, 100.8 F by 11:30 am and 98.5 by 2:30 pm.     The action taken with mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown) was unknown.       Concomitant medication was not provided. On 16-May-2024, patient had spiked a fever which was treated with Tylenol but lasted through the night. At 8:30am on 17-May-2024, the fever was down, followed by 100.8 F and finally returned to 98.5.  She was given alternating doses of Tylenol and Motrin every 3 hours.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: he felt flu or COVID-19; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt flu or COVID-19) and CHILLS (Chills) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he felt flu or COVID-19) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (he felt flu or COVID-19) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was unknown.  It was reported that after each of Moderna vaccine dose, patient felt flu-y or COVID-y and that the next day he'd be fine. Patient received on Dec-2023 (reported as last December) and had no reaction.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-767732 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-767732:same reporter Wife case
Age: 62.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: fever of 100; body aches; Headache; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), on 15May2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 15May2024, outcome "not recovered"; PAIN (non-serious) with onset 15May2024, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 16May2024, outcome "not recovered", described as "fever of 100". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain. Therapeutic measures were not taken as a result of headache, pyrexia. Additional information: she got Covid and RSV shot and got sick. Body aches started last night (15May2024) probably about two hours after the shot. Have gotten better. Treatment: Had Tylenol last night.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 and RSV VACCINE PROT.SUBUNIT PREF 2V will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400109357 same reporter/drug, different patients;
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Unapproved Age; Afterward it was realized that the Engerix-B had an expiration date of 31Mar2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number X9FT7, expiry date 31-MAR-2024) for prophylaxis.   On 10-MAY-2024, the patient received the 1st dose of Kinrix and Engerix B. On 10-MAY-2024, an unknown time after receiving Kinrix and not applicable after receiving Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age) and expired vaccine used (Verbatim: Afterward it was realized that the Engerix-B had an expiration date of 31Mar2024). The outcome of the inappropriate age at vaccine administration and expired vaccine used 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: 13-MAY-2024 The medical assistant reported that 4 month old infant came in to clinic on 10th May2024.  The patient's mother was skeptical about vaccines and so the patient was behind on vaccinations.  The mother of the patient did not want the patient to receive Hib vaccination.  The 4 month patient was administered a dose of Kinrix, which led to inappropriate age at vaccine administration. Afterward it was realized that the patient received expired Engerix-B , which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=spikevak/ vaccine dose number=7; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 5 (booster), single (Lot number: gj6796) and on 05Jun2023 as dose 6 (booster), single (Lot number: g43268) at the age of 77 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: fk9894) for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: er8729), on 11Apr2021 as dose 2, single (Lot number: ew0158) and on 03Oct2021 as dose 3 (booster), single (Lot number: fh8020) for covid-19 immunisation; elasomeran (SPIKEVAX), on 08Jan2024 as dose 7 (booster), single (Lot number: 3032680) for covid-19 immunisation. The patient's relevant medical history included: "non-hodgkin's follicular lymphoma in remission" (unspecified if ongoing); "immunoglobulin infusions", start date: 09Feb2024, stop date: 09Feb2024, notes: last one was 09Feb2024; "hypothyroidism" (unspecified if ongoing); "osteopenia" (unspecified if ongoing); "known allergies: sulfad's" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=spikevak/ vaccine dose number=7". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID taken from  07May2024 to 12May2024.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Weight
Clinical narrative: First time caller had COVID was Sep2022/Had COVID 3 times now, once each year.; First time caller had COVID was Sep2022/Had COVID 3 times now, once each year.; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose 5 (booster), single (Lot number: 6L0446) and on 29Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), on 19Feb2021 as dose 2, single (Lot number: EL9267), on 28Oct2021 as dose 3 (booster), single (Lot number: FF8841) and on 05Apr2022 as dose 4 (booster), single (Lot number: FF4554) for covid-19 immunisation. The patient's relevant medical history included: "Hay fever" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: FLONASE [MOMETASONE FUROATE] taken for seasonal allergy, hypersensitivity (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "First time caller had COVID was Sep2022/Had COVID 3 times now, once each year.". The patient underwent the following laboratory tests and procedures: Body height: About 5'5; Weight: About 160. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid on an unspecified date. Clinical course: She was curious to know why she had COVID 3 times. Knows it suppresses immune system, never expected to have it 3 times, after having all the boosters and shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400171513 Same patient/vaccine, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Cardiac valve disease, Pericarditis
Clinical narrative: Pericarditis; had to have open heart surgery to replace a valve; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown"; CARDIAC VALVE DISEASE (medically significant), outcome "unknown", described as "had to have open heart surgery to replace a valve". Therapeutic measures were taken as a result of cardiac valve disease. Clinical information: patient's son reported that his father had to have open heart surgery to replace a valve and now his girlfriend as well was to get the exact same surgery and she is only 26-year-old and she was having breathing problems, she can not breathe, she got fluid in the lungs and heart valve that is no longer working. His father works full time and he was out for eight months at work because he had to get open heart surgery and her girlfriend was to get the exact same surgery. She works two jobs she doesn't have great insurance to cover for the surgery she needs and is going to lose life if she doesn't get the surgery. It's from pericarditis was the disease that was been linked to the COVID-19 vaccines, it is been linked to the vaccine Pfizer vaccine and his father went through it and now his girlfriend was going through these exact same thing. It was right after his father's vaccine it was about three months he started getting symptoms after he got his vaccine which was about three months afterward will go get the exact date for when he had got his surgery. Reporter further stated, that he just talked to his dad and he doesn't want to report any issues with his vaccine so we can just do his girlfriend. He doesn't want to get involved with the, he doesn't want to, he is not doing good in health so he doesn't want to.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400172097 same reporter/drug, similar events, different patient;
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: Mar2023, stop date: May2024. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm left, At 11:00 AM), administration date: 20Sep2022, when the patient was 41-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 07May2024, outcome "recovered" (May2024); VACCINATION FAILURE (medically significant) with onset 07May2024, outcome "recovered" (May2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Negative, notes: could kinda sorta see a shadow of a line if I tilted the test just right. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 08May2024 to 13May2024. Clinical course: Started Paxlovid the day after symptoms began, completed 5 day course, tested "almost" negative.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered
Clinical narrative: Drug ineffective; COVID-19; Inappropriate dose of Vaccine administered; This is a spontaneous report received from a Consumer or other non HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Apr2024 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Dulga" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty omicron xbb.1.5 (DOSE 1, SINGLE, Anatomical location: right arm), administration date: 09Oct2023, when the patient was 79-year-old, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 01Apr2024 at 15:30, outcome "unknown", described as "Inappropriate dose of Vaccine administered"; COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 10May2024 to 14May2024.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "neuralgia" (unspecified if ongoing); "ascending aortic aneurysm" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "keratoses" (unspecified if ongoing); "Marfan syndrome" (unspecified if ongoing); "Silicone allergy" (unspecified if ongoing); "some soaps/ most deodorants" (unspecified if ongoing); "Nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "allergy: cough". Vaccination history included: moderna COVID-19 vaccine (DOSE 1, 0.5 ML SINGLE, Strength: 0.5 ml, Lot/batch number: 012M20A, Anatomical Location: Arm left), administration date: 29Jan2021, when the patient was 69-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 2, 0.5 ML SINGLE, Strength: 0.5 ml, Lot/batch number: 014M20A, Anatomical Location: Arm left), administration date: 26Feb2021, when the patient was 69-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot/batch number: 017FZ11A), administration date: 23Oct2021, when the patient was 70-year-old, for COVID-19 immunisation; moderna COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot/batch number: 065K21A), administration date: 09May2022, when the patient was 70-year-old, for COVID-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot/batch number: GH969A, Anatomical Location: Arm left), administration date: 27Sep2022, when the patient was 70-year-old, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "recovered" (09May2024); VACCINATION FAILURE (medically significant) with onset May2024, outcome "recovered" (09May2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 03May2024 to 08May2024.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug Ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing). The patient did not had any known allergies. Concomitant medication(s) included: METOPROLOL, start date: 01Jan2009; ATORVASTATIN, start date: 01Jan2009. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03May2024 to 07May2024.