chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelling; injection site redness; injection site pain; injection site warm to touch; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva759a, expiry date 30-NOV-2023) for prophylaxis.   On 25-APR-2023, the patient received Menveo (right deltoid). On 25-APR-2023, less than a day after receiving Menveo, the patient experienced injection site swelling (Verbatim: Injection site swelling), injection site erythema (Verbatim: injection site redness), injection site pain (Verbatim: injection site pain) and injection site warmth (Verbatim: injection site warm to touch). The outcome of the injection site swelling, injection site erythema, injection site pain and injection site warmth were resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain and injection site warmth to be related to Menveo.   Additional Information: GSK Receipt Date: 04-MAY-2023 The nurse reported that the patient received Menveo and on the same day evening experienced localized swelling, redness, pain and warm to touch at the injection site. The adverse event started the evening of the day the patient was vaccinated.  The adverse event had resolved. The reporter consented to follow up. The case is linked with US2023064923 case, by same reporter. Note: Clarification was requested regarding event onset date however, it was captured conservatively as per narrative start date of vaccination.; Sender's Comments:  US-GSK-US2023064923:Same reporter - Male case
Sex: M
Vaccine: MNQ
Symptoms: Intercepted product prescribing error
Clinical narrative: 77YO got Menveo prescription, Vx not given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 77-year-old male patient who did not receive Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient did not receive Menveo. On an unknown date, an unknown time after not receiving Menveo, the patient experienced intercepted drug prescribing error (Verbatim: 77YO got Menveo prescription, Vx not given). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The registered pharmacist reported that the 77 year old patient had a prescription for Menveo of 2 vial. Since it was out of the recommended age range, if any guidance the patient could get. No vaccine administered yet as of the call but patient has a prescription for Menveo. The reporter did not consent to follow up. The pharmacist intercepted the prescription error, which led to intercepted drug prescribing error.
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Failure to suspend medication, Wrong technique in product usage process
Clinical narrative: vaccine was clear, not re-suspended; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong technique in product usage process in a 43-year-old female patient who received HAB (Twinrix) for prophylaxis.   On 04-MAY-2023, the patient received the 1st dose of Twinrix (injection, left deltoid). On 04-MAY-2023, an unknown time after receiving Twinrix, the patient experienced wrong technique in product usage process (Verbatim: vaccine was clear, not re-suspended). The outcome of the wrong technique in product usage process 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: 04-MAY-2023 Reporter was the patient that received her first dose of Twinrix in her upper left arm and reported that when the pharmacist administered the vaccine, the vaccine was clear and not cloudy.  The patient went back to the pharmacy and spoke to the pharmacist and told the pharmacist that the vaccine was supposed to be shaken so it was a cloudy, white color and not clear.  The patient reported that the pharmacist read the directions in front of her, and the patient reported that the pharmacist stated that he did not know it had to be shaken up. The reporter consented to follow up with her and healthcare professional. The patient received Twinrix dose without shaking it prior to the administration as was indicated on the prescribing information, which led to wrong technique in product usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose missed; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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: 2nd dose missed). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 The reporter asked that if the second dose was missed would the patient had to start over with the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: incomplete dose was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 27-month-old male patient who received HAV (Havrix) (batch number y3me2, expiry date 23-FEB-2025) for prophylaxis.   On 02-MAY-2023, the patient received Havrix. On 02-MAY-2023, an unknown time after receiving Havrix, the patient experienced incomplete dose administered (Verbatim: incomplete dose was administered). The outcome of the incomplete 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: 04-MAY-2023 The reporter was a Medical Assistant. The reporter consented to follow up. Healthcare professional gave consent for safety team to follow up.  No additional adverse event details available at this time. An incomplete dose was administered a patient, which led to incomplete dose administered.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Boostrix. On 03-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-MAY-2023 The reporter reported that an expired dose of Boostrix was administered to a patient.  The reporter was consented to follow up. The patient received expired dose of Boostrix, which led to Expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Diabetes mellitus
Clinical narrative: Patient is diabetic; heart condition; This serious case was reported by a pharmacist via call center representative and described the occurrence of diabetes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diabetes (Verbatim: Patient is diabetic) (serious criteria GSK medically significant) and heart disorder (Verbatim: heart condition). The outcome of the diabetes and heart disorder were unknown.   It was unknown if the reporter considered the diabetes and heart disorder to be related to Shingrix.   It was unknown if the company considered the diabetes and heart disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2023 The reporter wanted to know if patient qualified as an immunocompromised patient in order to decide when to administer the second Shingrix dose.  The patient wanted to receive the second dose earlier than recommended.  The patient was diabetic and had a heart condition.  It was unknown if patient´s condition were before or after Shingrix first dose. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Sore shoulder, shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: Sore shoulder, shoulder pain). The outcome of the shoulder soreness was resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.     It was unknown if the company considered the shoulder soreness to be related to Shingrix.   Additional Information: GSK receipt date: 05-May-2023 This case was self reported by the patient. The patient stated that after his vaccine, his right shoulder was very sore.  The patient did not have any information concerning the vaccine itself.  The reporter did not consent to follow-up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 2HC42, expiry date 09-JUL-2024) for prophylaxis.   On 04-MAY-2023, the patient received the 3rd dose of Shingrix. On 04-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received a 3rd dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-May-2023 The pharmacist stated the patient received a third dose of Shingrix which led to extra dose administered.  The lot number not identifying as a GSK vaccine in the lot identifier, but it was verified with the healthcare professional.  The reporter consented to follow up via postal.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 08Oct2022, 2nd dose 05May2023; 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 62-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 08th October 2022 with lot no 2KE55 and expiry date as 22nd September 2023).   On 05-MAY-2023, the patient received the 2nd dose of Twinrix. On 05-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 08Oct2022, 2nd dose 05May2023). The outcome of the drug dose administration interval too long 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: 05-MAY-2023 The pharmacist reported that a patient did not receive the second dose until the day of reporting. The reporter consented for follow up via email. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional by an other manufacturer (Pfizer Inc.) was received on 02-MAY-2023 and concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and concurrent conditions included: coronary artery disease, and hypertension, and drug allergy (Lisinopril), and other pre-existing medical conditions included: The patient itself other health professional (nurse) and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAY-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 51 years old. Concomitant medications included amlodipine for drug used for unknown indication, atenolol for drug used for unknown indication, atorvastatin for drug used for unknown indication, hydrochlorothiazide for drug used for unknown indication, and losartan potassium for drug used for unknown indication. On 22-APR-2023, treatment medications included: nirmatrelvir/ritonavir. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1: 09/13/2021, dose 2:05/04/2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 09/13/2021, dose 2:05/04/2022) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 014F21A) for COVID-19 prophylaxis.     It was unknown if the patient was diagnosed with or tested positive for COVID-19.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 dosage form. On 04-May-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 dosage form. On 04-May-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 09/13/2021, dose 2:05/04/2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 09/13/2021, dose 2:05/04/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1: 09/13/2021, dose 2:05/04/2022).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2023-721275 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications was reported. It was reported that 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation. Doses were administered on 21-APR-2023 and 28-APR-2023. Each was administered as a second dose in the series. Patients ranged from 10m-5y old.  No treatment drug details was reported. This case contains information of 3rd out of 4 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723264:Patient 1
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Patient had some muscle pain with previous shots.; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Patient had some muscle pain with previous shots.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007C21A) for COVID-19 prophylaxis.     The patient's past medical history included Influenza (30 years ago).   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Patient had some muscle pain with previous shots.). At the time of the report, MYALGIA (Patient had some muscle pain with previous shots.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have family history of arthritis.  No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-722963 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: she caught covid the end of March 2023/symptom was diarrhea; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she caught covid the end of March 2023/symptom was diarrhea) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (LOT: 030A21A) on 07-Mar-2021, Moderna COVID-19 Vaccine (LOT: 019B21A) on 03-Apr-2021, Moderna COVID-19 Vaccine (LOT: 017F21A) on 22-Oct-2021 and Moderna COVID-19 Vaccine (LOT: 001M214) on 02-Apr-2022. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 20-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced COVID-19 (she caught covid the end of March 2023/symptom was diarrhea). At the time of the report, COVID-19 (she caught covid the end of March 2023/symptom was diarrhea) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient called in and inquired on the availability of the Bivalent vaccine for people who are 65. During the call, she was concerned as it has been more than 6 months since last dose. She caught covid . Had visited another country for 14 days and did wear a mask, but being at the airport and on the plane for 48 hrs, she removed the mask to eat which did help.She reported that her only symptom was diarrhea and had to go 4 times on the plane. Treatment information was not reported.   Reporter did not allow further contact
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Patient had no relevant medical history, allergy, concomitant diseases and risk factor. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant products included PENTACEL, ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), HEPATITIS B VACCINE (HEP B VAX) and PNEUMOCOCCAL VACCINE (PNEUMOCIN [PNEUMOCOCCAL VACCINE]) for an unknown indication.    On 01-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 01-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse reports that they inadvertently administered the pediatric bivalent (pink cap) as the initial dose to a 6 month old patient on 01-May-2023.).    No medical history was reported by reporter. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Chills; Fever; Feeling bad; Very tired; Patient was feeling very very weak/ had no strength to do anything; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 30-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Apr-2023, the patient experienced ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired). On 01-May-2023, the patient experienced CHILLS (Chills). At the time of the report, ASTHENIA (Patient was feeling very very weak/ had no strength to do anything), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient started feeling bad since 30-APR-2023 during the night and arrived home to sleep because she was very tired, and next day patient felt really bad, with chills, very tired, Patient did not have strength enough to do anything, this was still ongoing but improving.  No treatment information was provided.   This case was linked to MOD-2023-723032 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Hypertension, Vaccination site pain
Clinical narrative: Possibly high blood pressure.; she took the shot her arm was hurting; very tired after taking shots; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Possibly high blood pressure.), VACCINATION SITE PAIN (she took the shot her arm was hurting) and FATIGUE (very tired after taking shots) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Possibly high blood pressure.), VACCINATION SITE PAIN (she took the shot her arm was hurting) and FATIGUE (very tired after taking shots). At the time of the report, HYPERTENSION (Possibly high blood pressure.), VACCINATION SITE PAIN (she took the shot her arm was hurting) and FATIGUE (very tired after taking shots) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-287530 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site reaction
Clinical narrative: Covid Arm; she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away. she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE MASS (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away.) and VACCINATION SITE PAIN (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid Arm), VACCINATION SITE MASS (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away.) and VACCINATION SITE PAIN (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away). At the time of the report, VACCINATION SITE REACTION (Covid Arm) and VACCINATION SITE MASS (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away.) outcome was unknown and VACCINATION SITE PAIN (she read an article that a Doctor wrote in which the Doctor said that the Doctor suffered similar Covid-19 arm symptoms to the patients' symptoms of Covid Arm/Injection site became a hard lump, and painful took some time to go away) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error
Clinical narrative: he was calling to report an administration error, not an adverse event.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (he was calling to report an administration error, not an adverse event.).    No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Pruritus, Vertigo
Clinical narrative: Vertigo; confusion; chronic itch on arms and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 21:15 as dose 1, single (Lot number: ER8729) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "clinical depression" (unspecified if ongoing); "Known allergies: Penicillin" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OMEPRAZOLE; FLUTICASONE; ALLEGRA ALLERGY. The following information was reported: VERTIGO (disability) with onset 21Apr2021 at 12:00, outcome "recovered with sequelae"; PRURITUS (disability) with onset 21Apr2021 at 12:00, outcome "recovered with sequelae", described as "chronic itch on arms and legs"; CONFUSIONAL STATE (disability) with onset 21Apr2021 at 12:00, outcome "recovered with sequelae", described as "confusion". The events "vertigo", "confusion" and "chronic itch on arms and legs" required physician office visit. Therapeutic measures were not taken as a result of vertigo, confusional state, pruritus.  Clinical course: There was no other vaccine within 4 weeks. Adverse event resulted in doctor or other healthcare professional  office/clinic visit, disability or permanent damage. No treatment received for adverse event. No covid prior vaccination and no covid test taken post vaccination. Dose 2 with lot number ER8736 was administered on 28Apr2021 at 9:00 am on the right arm. Dose 3 with lot number 33130BA was administered on 13Dec2021 at 04:15 pm on the left arm.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 76-year-old male patient received BNT162b2, as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Sore arm", "Little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), outcome "unknown", described as "Little fever". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: The patient experienced nothing more than a sore arm and a little fever maybe, but no rash or no breathing problems. Just a local reaction. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/product/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Illness, Pain, Pyrexia
Clinical narrative: sick; fever; chills; body aches; chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Chronic lung disease" (unspecified if ongoing); "chronic obstructive pulmonary disease" (unspecified if ongoing); "cystic fibrosis" (unspecified if ongoing); "Heart disease" (unspecified if ongoing); "congenital heart disease" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "reflux" (unspecified if ongoing); "Heart failure due to mitral valve failure", start date: 07Feb2013 (unspecified if ongoing); "Heart failure due to mitral valve failure", start date: 07Feb2013 (unspecified if ongoing); "Mitral valve repair" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "Two stents placed in right coronary art." (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for thyroid disorder, start date: 2010 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 2013 (ongoing); CITIZEN oral taken for cardiac disorder, start date: 2016 (ongoing); ASPIRIN (E.C.) oral taken for cardiac disorder, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, lot # not provided), for COVID-19 Immunization, reaction(s): "chest pain", "chills", "body aches", "fever", "right arm hurt ached immediately after shot". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pains". Additional information: It was stated that the patient got sick after every COVID shot. She was staying away from the mRNA kind. Within 24 hour, the patient had fever, chills, body aches and chest pains and the exact same thing happened after dose 2 and booster. The patient did not seek medical attention the chest pains lasted 2-3 days.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202300180440 same patient/drug, different dose number/event; US-PFIZER INC-PV202300029860 same patient/drug, different dose number/event.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Illness, Pain, Pyrexia
Clinical narrative: sick; fever; chills; body aches; chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "reflux" (ongoing); "Heart disorder" (ongoing); "heart failure", start date: 07Feb2013 (unspecified if ongoing); "mitral valve failure", start date: 07Feb2013 (unspecified if ongoing); "mitral valve repair" (unspecified if ongoing); "Heart attack", start date: Feb2017 (unspecified if ongoing); "two stent placed in right coronary art" (unspecified if ongoing); "chronic obstructive pulmonary disease" (unspecified if ongoing); "cystic fibrosis" (unspecified if ongoing); "congenital heart disease" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 2010 (ongoing); OMEPRAZOLE taken for gastroesophageal reflux disease, start date: 2013 (ongoing); CARDIZEM [DILTIAZEM] taken for cardiac disorder, start date: 2016 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "chest pains", "chills", "body aches", "arm pain", "fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "chest pains", "chills", "body aches", "fever". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pains".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300180375 same patient/drug, different dose/event; US-PFIZER INC-PV202300029860 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Incorrect route of product administration, Suspected COVID-19
Clinical narrative: contracted COVID-19; contracted COVID-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "contracted COVID-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". Clinical course: A male patient with a history of asthma reported in market research that he contracted COVID-19 about two weeks after their Pfizer COVID-19 booster shots.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180836 Same reporter, different drug/patients.;US-PFIZER INC-202300180962 Same reporter/ drug different event for different patients.;US-PFIZER INC-202300180963 Same reporter/ drug different event for same patients.;US-PFIZER INC-PV202300080379 Same reporter/ drug/ event for different patients.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 5 / Moderna, Dose: 1, 2, 3, 4, 6; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 22Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 10Apr2023 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Swiss cheese" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2022 at 12:00, outcome "recovered", described as "Pfizer, Dose: 5 / Moderna, Dose: 1, 2, 3, 4, 6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After 2 days of negative tests for COVID, now testing positive again; Positive, notes: After 2 days of negative tests for COVID, now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181192 same reporter/patient, different product/AE;
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as DOSE 5 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 57 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 30Oct2021 at 12:30 as DOSE 3 (BOOSTER), SINGLE (lot number: FF2590), administered in the left arm and on 02May2022 at 13:00 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4991), administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE) as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment." It was reported that the original symptoms were muscle aches and cough. The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): (Apr2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from an unknown date in May2023 to an unknown date in May2023. Clinical course: No adverse event experienced. Patient's physicians nurse was persuading her from not taking Paxlovid due to potential of rebound. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.