chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Device leakage, Exposure via skin contact, Underdose
Clinical narrative: RPh thinks majority did not get into her arm; Some went down the patient's arm and on the floor; Some went down the patient's arm and on the floor; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of accidental underdose in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number J294K, expiry date 11-DEC-2025) for prophylaxis.   On 23-JAN-2024, the patient received the 1st dose of Shingrix. On 23-JAN-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: RPh thinks majority did not get into her arm), inadvertent exposure to vaccine (Verbatim: Some went down the patient's arm and on the floor) and exposure via skin contact (Verbatim: Some went down the patient's arm and on the floor). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 The regional pharmacist stated that she was a floater and may not be available. Reporter reported that Shingrix came out needle where needle was attached to base of syringe. Some went down the patient's arm and on the floor, which led to inadvertent exposure to vaccine and exposure via skin contact. Technician was not confident any got into patient's arm. Reporter thought majority of vaccine did not get into her arm, which led to accidental underdose. This was supposed to be patient's first dose. The were not sure how much the patient received if any. The reporter requested to consent to follow-up
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Headache, Induration, Injection site swelling, Pain
Clinical narrative: Injection site is swollen; hurt all over/Pain with movement; joints painful; headache; very hard; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 24-JAN-2024, the patient received Arexvy. In JAN-2024, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Injection site is swollen), pain (Verbatim: hurt all over/Pain with movement), joint pain (Verbatim: joints painful), headache (Verbatim: headache) and induration (Verbatim: very hard). The outcome of the injection site swelling, pain, joint pain, headache and induration were not reported.   It was unknown if the reporter considered the injection site swelling, pain, joint pain, headache and induration to be related to Arexvy.     It was unknown if the company considered the injection site swelling, pain, joint pain, headache and induration to be related to Arexvy.   Additional Information: GSK receipt date: 26-JAN-2024 This case was reported the consumer via interactive digital media. The patient was hurt all over, joints was painful. Hurts to move. The injection site was swollen almost to the elbow and very hard. The patient had grade temperature and headache. The vaccination was 2 days ago (before reporting).  The patient usually had a reaction to vaccines except a sore arm. The vaccine was causing pain with movement. The follow up not at per process.
Sex: U
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Aches and pains; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: Aches and pains). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Arexvy.     It was unknown if the company considered the pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-JAN-2024. This case was reported by a patient via interactive digital media. The patient already had aches and pains right now (at the time of reporting) from a recent assault.  It was reported as no vaccine for the patient on the day of reporting.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: they inadvertently administered a Shingrix third dose to a patient; 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 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 39595, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18-JUL-2023) and Shingrix (2nd dose received on 11-OCT-2023).   On 18-JAN-2024, the patient received the 3rd dose of Shingrix. On 18-JAN-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: they inadvertently administered a Shingrix third dose to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2024 The assistant office manager reported they inadvertently administered a Shingrix third dose to a patient, which led to an extra dose administered. The reporter asked if GlaxoSmithKline have any information on side effects or what to look for in the patient. The reporter did not consent to follow-up.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution; Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution) and inappropriate dose of vaccine administered (Verbatim: Found an extra diluent in the box and believe that one of the 3 patients from Jan 2023 until now received it/Non-approved diluent for reconstitution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2024 The pharmacist reported that when they opened the box of Menveo (2 vial) they found an extra diluent in the box. The pharmacist believed that one of the 3 patients from Jan 2023 until the time of reporting (now) received it.  The pharmacist was not sure who it was among the 3 patients.  One of the 3 patients received extra diluent from the box (non-approved diluent for reconstitution), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The reporter consented to follow up via phone.
Age: 0.75
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age (potential); This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old female patient who received Men B NVS (Bexsero) (batch number ABXC76DZ) for prophylaxis.   On 11-JUN-2023, the patient received the 1st dose of Bexsero. On 11-JUN-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age (potential)). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 26-JAN-2024 The reporter was a father concerned about patient who was his daughter. The patient did not receive second dose of Bexsero series as of yet.  The content stated that did not provide product information using (Privacy) Prescribing Information as foreign product information might be different. The reporter referred to vaccine by name, Bexsero, listed in suspect vaccine section. Also, reporter called at the time of reporting concerned that his daughter had an inappropriate vaccine schedule. This agent could not determine if inappropriate schedule had occurred due to vaccination PI (Prescribing Information) information of foreign product might be different than PI information. The reporter did not consent to follow-up. The patient received 1st dose of Bexsero earlier then the recommended schedule, which led to inappropriate age at vaccine administration.
Age: 47.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patient received the third dose of Havrix; received first dose on 21 July 2023 and the second dose one month later on 22 August 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 47-year-old male patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Co-suspect products included HAV (Havrix adult) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 25-JAN-2024, the patient received the 3rd dose of Havrix adult. On 22-AUG-2023, the patient received the 2nd dose of Havrix adult. On 22-AUG-2023, not applicable after receiving Havrix adult and an unknown time after receiving Havrix adult, the patient experienced drug dose administration interval too short (Verbatim: received first dose on 21 July 2023 and the second dose one month later on 22 August 2023). On 25-JAN-2024, the patient experienced extra dose administered (Verbatim: patient received the third dose of Havrix). The outcome of the drug dose administration interval too short and extra dose 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: 26-JAN-2024. The patient received 1st dose of Havrix on 21-JUL-2023. The registered pharmacist (RPH) inquired how to proceed and asked for the guidance on series. The pharmacist that a patient received the second dose one month later after first dose, earlier than recommended interval, which led to shortening of vaccination schedule. The patient received the third dose of Havrix adult, which led to an extra dose administered. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Paraesthesia
Clinical narrative: quick prick in her arm; quick prick in her arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-OCT-2023, the patient received the 1st dose of Shingrix. On 05-OCT-2023, immediately after receiving Shingrix, the patient experienced tingling sensation (Verbatim: quick prick in her arm) and prick pain (Verbatim: quick prick in her arm). The outcome of the tingling sensation and prick pain were not reported.   It was unknown if the reporter considered the tingling sensation and prick pain to be related to Shingrix.     It was unknown if the company considered the tingling sensation and prick pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JAN-2024 Pharmacist stated that she administered a patient's second dose of Shingrix on 25th January 2024 with batch number D5934 and expiry date 11-DEC-2025 and the patient called back this (on the day of reporting) morning questioning if she actually received her first dose because her second dose was a different experience.  The patient stated with her first dose she felt a quick prick in her arm but didn't see the vaccine vials.  With her second dose yesterday she felt the vaccine go in and she saw the vials.  The patient would like to knew if she should get another dose, just incase she didn't received any medication on the first dose.  Both doses were given in the same pharmacy.  The first dose was administered and no additional doses have yet been administered but the pharmacist believed the patient will be insistent upon receiving another dose. The reporter consented to the follow up.  The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Myalgia, Tenderness
Clinical narrative: injected arm was tender; patient experiences muscles aches; feels tired all the time; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included arthritis.   In JAN-2024, the patient received Arexvy (right arm) and Flu vaccine (right arm). In JAN-2024, less than a week after receiving Arexvy and Flu vaccine, the patient experienced pain in arm (Verbatim: injected arm was tender), muscle pain (Verbatim: patient experiences muscles aches) and tiredness (Verbatim: feels tired all the time). The outcome of the pain in arm was unknown and the outcome of the muscle pain and tiredness were not resolved.   It was unknown if the reporter considered the pain in arm, muscle pain and tiredness to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the pain in arm, muscle pain and tiredness to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 26-JAN-2024 The patient self-reported this case for himself. The patient received Arexvy and Flu vaccine (unknown manufacturer) in the same arm (right) and on the same day. The vaccines were administered 3 weeks before the day of reporting. After receiving the vaccines, the injected arm was tender. About 1 week later, the patient experienced muscles aches and felt tired all the time. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo two vial presentation was accidentally to 1 year old instead of MMR; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva960a, expiry date 31-AUG-2024) for prophylaxis.   On 26-JAN-2024, the patient received Menveo. On 26-JAN-2024, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo two vial presentation was accidentally to 1 year old instead of MMR). The outcome of the wrong vaccine administered was unknown.   Additional Information: RA Receipt Date: 26-JAN-2024 The medical assistant stated that Menveo two vial presentation was accidentally given to a patient instead of MMR, which led to wrong vaccine administered. The reporter consented to the follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 21-JAN-2024, the patient received Boostrix. On 21-JAN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Boostrix). 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: 26-JAN-2024 The pharmacist reported that, the patient received an expired dose of Boostrix, which led to expired vaccine used. The reporter denied consent to follow up and opted out of providing patient information.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: she got confused and, by mistake, she administered Infanrix to the 5-year-old girl/patient was up-to-date on the Dtap vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included Pediarix (received 3 previous doses of Pediarix at 2,4 and 6 months after birth), Daptacel (at 1 year old received 1 dose) and Kinrix (received on an unknown date, at 4 years old age).   On 26-JAN-2024, the patient received Infanrix. On 26-JAN-2024, an unknown time after receiving Infanrix, the patient experienced extra dose administered (Verbatim: she got confused and, by mistake, she administered Infanrix to the 5-year-old girl/patient was up-to-date on the Dtap vaccination). 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: 26-JAN-2024 A nurse mentioned that today (on the day of reporting) while administering different vaccines to a 3-year-old male and a 5-year-old girl (siblings), she got confused and, by mistake, she administered Infanrix to the 5-year-old girl (patient). The patient had 3 previous doses of Pediarix at 2,4 and 6 months after birth. When she was 1 year old, she received 1 dose of Daptacel and then, at 4 years, she got Kinrix. Therefore, the patient was up-to-date on the Dtap vaccination. The patient received extra dose of antigen DTPa antigen from Infanrix vaccine, which led to extra dose administered for DTPa antigen. The healthcare professional (HCP) asked for safety information regarding the extra dose administered.  The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Product availability issue
Clinical narrative: don't have Twinrix/the separate Hepatitis A and Hepatitis B vaccine had not yet been administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of product availability issue in a patient who received HAB (Twinrix) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced product availability issue (Verbatim: don't have Twinrix/the separate Hepatitis A and Hepatitis B vaccine had not yet been administered). The outcome of the product availability issue 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: 26-JAN-2024 The reporter stated that an immunocompromised patient received a dose of Twinrix and they did not have Twinrix but did had separate Hepatitis A and Hepatitis B vaccines, which led to product availability issue. At the time of the call, the separate Hepatitis A and Hepatitis B vaccine had not yet been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter declined to provide patient details. The reporter denied permission for consent to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: the administration of an expired vaccines; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 26-NOV-2023) for prophylaxis.   On 26-JAN-2024, the patient received the 5th dose of Kinrix. On 26-JAN-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: the administration of an expired vaccines). 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: 26-JAN-2024 The reporter inquired about Kinrix and what information was available about any information about the recommendations after the administration of an expired vaccines, which led to expired vaccine used. The nurse gave details about the event, vaccine and patient.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix underage administration; Technician from the pharmacist administered Shingrix to patient instead of Covid-19 vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-JAN-2024, the patient received Shingrix. On 26-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix underage administration) and wrong vaccine administered (Verbatim: Technician from the pharmacist administered Shingrix to patient instead of Covid-19 vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-Jan-2024 The reporter reported that the technician from the pharmacist administered Shingrix to a 17 years old patient instead of Covid 19 vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: COVID-19, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: few weeks and got an RSV infection/ Vaccination failure; RSV infection; got an COVID-19; got an flu; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Arexvy, Flu vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Arexvy and Flu vaccine, the patient experienced vaccination failure (Verbatim: few weeks and got an RSV infection/ Vaccination failure) (serious criteria hospitalization and GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV infection) (serious criteria hospitalization), covid-19 (Verbatim: got an COVID-19) (serious criteria hospitalization) and influenza (Verbatim: got an flu) (serious criteria hospitalization). The outcome of the vaccination failure, respiratory syncytial virus infection, covid-19 and influenza were unknown.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, covid-19 and influenza to be related to Arexvy and Flu vaccine.     It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection, covid-19 and influenza to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 29-JAN-2024  The reporter was the patient. The reporter stated that she heard of someone who received AREXVY, a COVID-19 vaccine and a flu vaccine. The patient was then hospitalized for a few weeks and got an respiratory syncytial virus infection, COVID-19 and the flu. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, covid-19 and influenza to be related to COVID-19 vaccine. No other information was available.  The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming influenza were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Only the diluent portion of the Shingrix vaccine was administered without the lyophilized antigen portion; Only the diluent portion of the Shingrix vaccine was administered without the lyophilized antigen portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 5dm77) for prophylaxis.   On 30-JAN-2024, the patient received Shingrix. On 30-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only the diluent portion of the Shingrix vaccine was administered without the lyophilized antigen portion) and inappropriate dose of vaccine administered (Verbatim: Only the diluent portion of the Shingrix vaccine was administered without the lyophilized antigen portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-Jan-2024 The reporter was a medical assistant. The reporter reported that only the diluent portion of the Shingrix vaccine was administered without the lyophilized antigen portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter mentioned that this had happened in their facility before with other patients but reported no specific number of patients or information. The reporter consented to follow up via email.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Syncope
Clinical narrative: HEART ATTACK; COLLAPSED; This solicited report received from a consumer via: Account concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart attack, and collapsed (Dose number in series 1). Yep. the middle-aged healthy guy sitting next to me collapsed right after the jab. They grabbed the heart defibrillator to use on him and never knew whether he made it or not.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and collapsed was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and heart attack, and collapsed was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0;  Myocardial infarction, Syncope. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Sex: U
Vaccine: COVID19, COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: Last vaccine 2 weeks later blood clots in lungs; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Last vaccine 2 weeks later blood clots in lungs) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fifth 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, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Last vaccine 2 weeks later blood clots in lungs) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Last vaccine 2 weeks later blood clots in lungs) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  It was reported that two weeks later of last vaccine blood clots in lungs. Patient was hospitalized a month later.  Treatment information was not reported.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (medically significant and hospitalization) AESI of Pulmonary embolism. The events occurred 2 weeks after the administration of the sixth dose of SPIKEVAX COVID-19 VACCINE NOS vaccine.  No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I have had reactions to all of them; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I have had reactions to all of them) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 044B22A, 047B21A and 069F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I have had reactions to all of them). At the time of the report, IMMUNISATION REACTION (I have had reactions to all of them) outcome was unknown.            Concurrent medical conditions included thyroid.  Concomitant medications included arthritis medication and thyroid medication.  Patient had reactions to all of the 5 doses of Moderna but the last one that lasted over very long time and patient was really sick.  The sixth dose was of Pfizer vaccine and patient was extremely sick the next day fever, vomiting, chills, severe headache. Patient was still having the headache and slight fever and was still not feeling the 100%.  Patient had taken Acetaminophen and the other medication Ibuprofen.  Patient hadn't taken any vaccine 4 week prior with the reference of Pfizer COVID-19 Vaccine  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-759340 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-759340:Same patient Monovalent
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Patient is lying on her death bed and has cancer everywhere; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Patient is lying on her death bed and has cancer everywhere) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Patient is lying on her death bed and has cancer everywhere) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Patient is lying on her death bed and has cancer everywhere) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of cancer. The event occurred unknown amount of time after a dose of SPIKEVAX NOS. As reported, patient was lying on her death bed with cancer everywhere and got Moderna vaccine before this happened. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-758915 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-758915:same reporter/different patient
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness, Pyrexia
Clinical narrative: fever; weakness in left side of leg; dizziness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in left side of leg), DIZZINESS (dizziness) and PYREXIA (fever) in a 48-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032679) for COVID-19 prophylaxis.     The patient's past medical history included Stroke and Heart attack in 2018. Concurrent medical conditions included Heart disorder and Anxiety. Concomitant products included FLUOXETINE for Anxiety, CARVEDILOL (COREG) for Heart disorder.    On 05-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 06-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PYREXIA (fever). In January 2024, the patient experienced MUSCULAR WEAKNESS (weakness in left side of leg) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 07-Jan-2024, PYREXIA (fever) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness in left side of leg) and DIZZINESS (dizziness) had not resolved.            It was reported that several days later, approximately 3 weeks from today patient reported to start having dizziness, weakness in left side of leg. Patient reported that on the day of reporting patient was feeling worst. Patient has been seen by neurologist and kidney doctor for follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Whenever the temperatures are going down a pain at the deltoid starts; just pain size of a ping pong ball and the deltoid area with tenderness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Whenever the temperatures are going down a pain at the deltoid starts) and TENDERNESS (just pain size of a ping pong ball and the deltoid area with tenderness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2024, the patient experienced PAIN IN EXTREMITY (Whenever the temperatures are going down a pain at the deltoid starts) and TENDERNESS (just pain size of a ping pong ball and the deltoid area with tenderness). At the time of the report, PAIN IN EXTREMITY (Whenever the temperatures are going down a pain at the deltoid starts) and TENDERNESS (just pain size of a ping pong ball and the deltoid area with tenderness) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Ocular discomfort, Pain, Pain in extremity
Clinical narrative: unilateral vestibular hypofunction; sore arm, body aches for a couple days after the shot; sore arm, body aches for a couple days after the shot; eyelids swollen; 2 weeks she symptoms of vertigo; felt very weak; felt pressure in her head and eyes with her eyelids swollen; felt pressure in her head and eyes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VESTIBULAR DISORDER (unilateral vestibular hypofunction), PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo) and ASTHENIA (felt very weak) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR DISORDER (unilateral vestibular hypofunction), PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo), ASTHENIA (felt very weak), HEAD DISCOMFORT (felt pressure in her head and eyes with her eyelids swollen), OCULAR DISCOMFORT (felt pressure in her head and eyes) and SWELLING OF EYELID (eyelids swollen). At the time of the report, VESTIBULAR DISORDER (unilateral vestibular hypofunction) outcome was unknown and PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo), ASTHENIA (felt very weak), HEAD DISCOMFORT (felt pressure in her head and eyes with her eyelids swollen), OCULAR DISCOMFORT (felt pressure in her head and eyes) and SWELLING OF EYELID (eyelids swollen) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient went to the ER and had no sign of COVID; performed a CT scan as well as blood tests, results were unknown. Also went to a specialist and was receiving therapy for unilateral vestibular hypofunction.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Vertigo, Vestibular disorder
Clinical narrative: unilateral vestibular hypofunction; sore arm, body aches for a couple days after the shot; sore arm, body aches for a couple days after the shot; eyelids swollen; 2 weeks she symptoms of vertigo; felt very weak; felt pressure in her head and eyes with her eyelids swollen; felt pressure in her head and eyes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VESTIBULAR DISORDER (unilateral vestibular hypofunction), PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo) and ASTHENIA (felt very weak) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030540) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VESTIBULAR DISORDER (unilateral vestibular hypofunction), PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo), ASTHENIA (felt very weak), HEAD DISCOMFORT (felt pressure in her head and eyes with her eyelids swollen), OCULAR DISCOMFORT (felt pressure in her head and eyes) and SWELLING OF EYELID (eyelids swollen). At the time of the report, VESTIBULAR DISORDER (unilateral vestibular hypofunction) outcome was unknown and PAIN IN EXTREMITY (sore arm, body aches for a couple days after the shot), PAIN (sore arm, body aches for a couple days after the shot), VERTIGO (2 weeks she symptoms of vertigo), ASTHENIA (felt very weak), HEAD DISCOMFORT (felt pressure in her head and eyes with her eyelids swollen), OCULAR DISCOMFORT (felt pressure in her head and eyes) and SWELLING OF EYELID (eyelids swollen) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient went to the ER and had no sign of COVID; performed a CT scan as well as blood tests, results were unknown. Also went to a specialist and was receiving therapy for unilateral vestibular hypofunction.
Age: 31.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Provider ordered Abrysvo vaccine, and it was administered to patient by MA. The patient was 9w6d on the date of administration- in the first trimester of pregnancy, which is not within the therapeutic range.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: patient expressed to me on 2/5/2024 that she had vaccine (prevnar 20) administered on 1/29/2024. the following day she experienced nausea, vomiting, chills and fever that lasted for three days. Site of injection is still red but not swollen
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Erythema, Inflammation, Injection site erythema
Clinical narrative: patient reports debilitating pain, redness,  rash and inflammation in left arm from deltoid to wrist that left them inoperable from 1/30/24 till 2/4/24
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Pain in extremity, Rash
Clinical narrative: patient reports debilitating pain, redness,  rash and inflammation in left arm from deltoid to wrist that left them inoperable from 1/30/24 till 2/4/24
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Feeling hot, Malaise
Clinical narrative: Patient reported for vaccination along with her husband.  Within about 10 minutes after the vaccination, the husband walked up to the consultation window to report that his wife was not feeling good and had kept looking upwards. When I walked to the patient she was seated and conscious and breathing normally as far as I could tell.  She complained of feeling hot and very tired. She wanted to lay down, so she was given another chair on which she stretched her legs. We called the emergency response team who came and attended to her and cleared her to go. She did not want to go on the stretcher, so she left the pharmacy walking.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: patients states had shortness of breath and was hospitalized
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Crying, Magnetic resonance imaging, Mobility decreased
Clinical narrative: 12:00 PM: vaccination received 1:30 PM: arm pain continues but is bearable, normal 3:30 PM: arm pain gets worse 9:30 PM: fever begins, can?t get out of bed very well 7:30 AM: wake up crying in pain,  severe pain has spread to armpit and shoulder blade on right side, call close relative to figure out if it?s normal 8:00 AM: call nurse triage line to get further advice, told to call 911 9:12 AM: 911 is called and ambulance comes Remainder of day: spent in ER and admitted to Hospital for treatment
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: 12:00 PM: vaccination received 1:30 PM: arm pain continues but is bearable, normal 3:30 PM: arm pain gets worse 9:30 PM: fever begins, can?t get out of bed very well 7:30 AM: wake up crying in pain,  severe pain has spread to armpit and shoulder blade on right side, call close relative to figure out if it?s normal 8:00 AM: call nurse triage line to get further advice, told to call 911 9:12 AM: 911 is called and ambulance comes Remainder of day: spent in ER and admitted to Hospital for treatment
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient described having body aches after receiving seasonal COVID shot.; This is a spontaneous report received from a Consumer or other non HCP.  A 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: PAIN (non-serious), outcome "unknown", described as "Patient described having body aches after receiving seasonal COVID shot.".  Additional information: it was unknown if the patient was diagnosed with COVID-19 prior to and since the vaccination. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.