chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: muscles aches; joint pain; fever; This serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 22-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-APR-2023, 1 hr after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscles aches) (serious criteria clinically significant/intervention required), joint pain (Verbatim: joint pain) (serious criteria clinically significant/intervention required) and fever (Verbatim: fever) (serious criteria clinically significant/intervention required).  On 24-APR-2023, the outcome of the muscle pain and fever were resolved. The outcome of the joint pain was not resolved.   It was unknown if the reporter considered the muscle pain, joint pain and fever to be related to Shingrix.     It was unknown if the company considered the muscle pain, joint pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-SEP-2023 The physician reported after administration of first dose of shingrix vaccine within 1 hour patient experienced fever, joint pain and muscles aches. Reporter stated she got over fever and muscle aches with first two days after vaccination. The patient was still suffering from joint pain and her physician asked her to see rheumatologist for the joint pain. The patient had appointment with rheumatologist on 4th October. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the diluent portion of Menveo; Patient received only the diluent portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   In AUG-2023, the patient received Menveo. In AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient received only the diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: Patient received only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-SEP-2022 The reporter reported that out of seven patients, 1 patient received only the diluent portion of Menveo vaccine. The reporter stated that it was unknown at the moment that which patient actually received the dose. The reporter reported that the possible administration date was from 14th August 2023 to 16th August 2023. The vaccine administration facility was the same as primary reporter. The reporter gave by error Menveo diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via postal.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Usage of Bexsero in patients after it was given instead of Menveo.; 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 13-year-old male patient who received Men B NVS (Bexsero) (batch number 8n989, expiry date 31-OCT-2024) for prophylaxis.   On 30-AUG-2023, the patient received Bexsero. On 30-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Usage of Bexsero in patients after it was given instead of Menveo.).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter was a medical assistant. The reporter wanted to know information about the usage of Bexsero in patient after it was given instead of Menveo. The vaccine administration facility was the same as primary reporter. The reporter reported that, they were intending to administered Menveo and inadvertently administered Bexsero instead of Menveo , which led to wrong vaccine administered. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent of Priorix was administered to a patient; only the diluent of Priorix was administered to a patient; 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 12-month-old male patient who received MMR (Priorix) (batch number aa25f, expiry date 01-NOV-2024) for prophylaxis.   On 08-AUG-2023, the patient received Priorix. On 08-AUG-2023, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent of Priorix was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the diluent of Priorix was administered to a patient).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter was a clinical manager. The reporter reported that only the diluent of Priorix was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 8 year old patient received Infanrix on 8/21/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 21-AUG-2023, the patient received Infanrix. On 21-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8 year old patient received Infanrix on 8/21/2023).The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter stated that an 8 year old patient received Infanrix, which led to inappropriate age at vaccine administration. The patient had not received any vaccines in the past. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not feel comfortable providing initials of the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: developed small bumps; itchiness on her left thigh; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26-AUG-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 week after receiving Shingrix, the patient experienced local swelling (Verbatim: developed small bumps) and itchy legs (Verbatim: itchiness on her left thigh).  The outcome of the local swelling and itchy legs were not resolved.   It was unknown if the reporter considered the local swelling and itchy legs to be related to Shingrix.     It was unknown if the company considered the local swelling and itchy legs to be related to Shingrix.   Additional Information: GSK receipt date: 12-Sept-2023 The patient received a dose of Shingrix and she developed small bumps with itchiness on her left thigh. The reporter currently had a call out to her physician. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about ten months ago).   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: has not received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Sept-2023 Pharmacist reported that a patient had not received the second dose. The Vaccine Administration Facility was the same as Primary Reporter. Forgot to ask about follow-up - mailing address was in health care professional details. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: the Boostrix was inadvertently administered to a pregnant patient; Boostrix, exposed to unknown temperature over weekend; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 40-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 06-SEP-2023, the patient received Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: the Boostrix was inadvertently administered to a pregnant patient) and incorrect storage of drug (Verbatim: Boostrix, exposed to unknown temperature over weekend).  The outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 27 Weeks Pregnancy Exposure (Boostrix): To mother in second trimester Last Menstrual Period Date: 25-FEB-2023 Estimated Delivery/Due date: 18-NOV-2023 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 12-Sept-2023 License practical nurse called to check stability of vaccine. From 1st September 2023 to 2nd September 2023, Boostrix was exposed to unknown temperature over weekend due to power outage. No prior. Did not consent to follow-up. Boostrix was inadvertently administered to a pregnant patient after temperature excursion, which led to vaccine exposure during pregnancy and incorrect storage of drug.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Patient had flu-like symptoms for 3-5 days; was administered 1st Shingrix on 20 SEP 2022 and 2nd dose of 26 OCT 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 05-OCT-2023) and (batch number 4B3RH, expiry date 25-SEP-2023) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 26-OCT-2022, the patient received Shingrix. On 26-OCT-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: was administered 1st Shingrix on 20 SEP 2022 and 2nd dose of 26 OCT 2022). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: Patient had flu-like symptoms for 3-5 days).The outcome of the influenza-like symptoms and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.   It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter reported that administration of Shingrix to an immunocompetent patient more than 50 years old. The patient had flu-like symptoms for 3-5 days after 2nd dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pharmacist calls to report an expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 11-SEP-2023, the patient received Engerix B. On 11-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Pharmacist calls to report an expired dose of Engerix-B was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter called to report an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. The reporter consented to follow up via email.
Age: 1.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 20 month old baby was administered Kinrix on Aug 7th 2023. It was supposed to be  the 2nd dose of DTAP and  IPV series; Kinrix was supposed to be  the 2nd dose of DTAP and  IPV series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2024) for prophylaxis.   On 07-AUG-2023, the patient received Kinrix. On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 month old baby was administered Kinrix on Aug 7th 2023. It was supposed to be  the 2nd dose of DTAP and  IPV series) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was supposed to be  the 2nd dose of DTAP and  IPV series).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Sept-2023 Nurse reported that this was supposed to be the 2nd dose of DTAP and IPV series. The reporter consented to follow-up. The patient received a dose of Kinrix as 2nd dose of DTAP and IPV series at an inappropriate age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: haven't gotten the second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got the first dose before Covid).   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: haven't gotten the second dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter wanted to know if she could complete the Shingrix series 3 years apart.  She was seeing patients who got the first dose before Covid and are now coming back in to see her and still have not gotten the second dose.  She wanted to know if she should restart the series or if she could give them the second dose.  She referred out to the pharmacy only, she did not vaccinate in office. No additional information was available. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: a patient received only the liquid component of Menveo; a patient received only the liquid component of Menveo; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA975A, expiry date 20-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received Menveo. On 11-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient received only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: a patient received only the liquid component of Menveo).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023  The reporter was a medical assistant. The reporter stated that the day before reporting a patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter declined to provide more information. The reporter did not consent to follow-up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: after accideantlly administering a dose instead of Infanrix; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 12-SEP-2023, the patient received Kinrix. On 12-SEP-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: after accideantlly administering a dose instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 12-Sept-2023 A nurse called in to request information about Kinrix after accideantlly administering a dose instead of Infanrix. They requested their information not be logged in the database and gave partial information and declined follow-up. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received a dose of Kinrix instead of Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mistakenly received his second Shingrix dose six weeks after the first dose; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: mistakenly received his second Shingrix dose six weeks after the first dose).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The vaccine administration facility was the same as primary reporter. The HCP/reported had limited details (unknown dates, lots, patient identifiers) as she was not at the pharmacy at the time of the call. The patient received 2nd of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up. Nothing else was reported.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late for their second dose of Twinrix; 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 patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on June 2023).   On 12-SEP-2023, the patient received the 2nd dose of Twinrix. On 12-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late for their second dose of Twinrix).  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: 13-SEP-2023 The reporter reported that the patient was late for their second dose of Twinrix vaccine. Patient was traveling overseas. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: possible late dose/first dose of Shingrix in 2020; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: possible late dose/first dose of Shingrix in 2020).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The patient stated that she got the second dose but there was no record of it. This was being reported as a possible late dose. The caller declined to provide more patient information. The reporter did not consent to follow-up. The patient received 2nd dose possibly later than recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient yet not received his second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose 0.5 ml received intramuscularly on an unknown arm 2 years ago prior to the reporting).   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: Patient yet not received his second Shingrix vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The patient was self-reported this case. Till the time of reporting, the patient did not receive the 2nd dose of Shigrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after Shingrix/Suspected vaccination Failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got shingles after Shingrix/Suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-SEP-2023 The reporter reported that she was unaware that she should report an event of a patient who got shingles after received Shingrix vaccine. The reporter cannot recall which physician it was but she remembered having a conversation with a physician regarding a patient got a bad case of shingles after receiving Shingrix.  The reporter believed that she asked the physician if the patient had received both doses or only one dose and that the physician did not know.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023127597:Same reporter US-GSK-US2023127594:Same reporter
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphthous ulcer, COVID-19 immunisation, Suspected COVID-19
Clinical narrative: CANKER SORE UNDER THE LEFT SIDE OF THE TONGUE; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to coating in canned food. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total first dose administered on unspecified date for covid-19 prophylaxis. Concomitant medications included lisinopril, and pantoprazole. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received 2 doses with non-company suspect vaccine moderna (elasomeran) (Dose number in series 2) second dose (form of admin, route of admin, and were not reported, batch number: 027H21B, expiry: UNKNOWN) dose was not reported, and third dose (form of admin, route of admin, and were not reported, batch number: 065H22A, expiry: UNKNOWN) dose was not reported, administered on unspecified date for covid-19 prophylaxis (dose number in series 2).  It was unknown whether the patient had any adverse events following two doses of moderna (elasomeran) (dose number in series 2). The patient received fourth dose of non-company suspect vaccine moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: CUS17394, expiry: UNKNOWN) dose was not reported, fourth dose administered on right arm on 09-APR-2021 date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 3) and received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: GD8819, expiry: UNKNOWN) from 03-SEP-2023 to 07-SEP-2023 for covid-19 treatment.  On 03-SEP-2023, the patient experienced canker sore under the left side of the tongue and inside of the lower mouth cavity, also experienced bitter mouth during the entire time (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2), and elasomeran (dose number in series 3) was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from canker sore under the left side of the tongue, and suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: UNK
Symptoms: Palpitations
Clinical narrative: When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations). At the time of the report, PALPITATIONS (When went to see the doctor and told her about it, the doctor, who is thin like said got the Moderna Covid vaccine and also was having heart palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  When reporter went to see the doctor and told her about it, the doctor, who was thin like said got the Moderna Covid vaccine and also was having heart palpitations.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-740764 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740764:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Typical sore arm after receiving the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Typical sore arm after receiving the Moderna vaccines) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 27-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE on 17-Feb-2021 and PFIZER BIONTECH COVID-19 VACCINE on 20-Sep-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Drug allergy (Codeine).    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Typical sore arm after receiving the Moderna vaccines). At the time of the report, PAIN IN EXTREMITY (Typical sore arm after receiving the Moderna vaccines) had resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-740870 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Granulomatosis with polyangiitis
Clinical narrative: Granulomatosis Polyangiitis- GPA; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) (seriousness criterion medically significant). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis Polyangiitis- GPA) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient was recently diagnosed with limited Granulomatosis Polyangiitis- GPA. He had a schedule for his first Rituxin infusion treatment on 10/3. He had received all the Moderna COVID boosters to date and would like to receive the newest Moderna booster. He was due of 19 days currently from Rituxin treatment. No prior immunosuppressive treatments were taken by him. Treatment information was not reported.  Company comment: This spontaneous case concerns a 70-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of Granulomatosis with Polyangiitis. The event occurred on an unknown date after a dose of mRNA-1273. As reported, patient was recently diagnosed with limited Granulomatosis Polyangiitis- GPA. and he had received all the Moderna COVID boosters to date and would like to receive the newest Moderna booster. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2023: Live follow-up received and had no new significant information. Reference number added.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Sep-2023, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) .5 milliliter. On 18-Sep-2023,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received 0.5 mL dose from a "child vial" Moderna COVID-19 Vaccine (2023-2024 Formula) (purple cap) instead of "adult vial" SPIKEVAX (2023-2024 Formula) for 12 yrs and older).    Information regarding previous COVID-19 vaccination doses were unknown. Patient did not receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as Unknown.  Treatment information was not provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Illness
Clinical narrative: passed away; very sick; Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (very sick) and FATIGUE (Fatigue). The patient died in October 2021. The cause of death was not reported. An autopsy was not performed. At the time of death, ILLNESS (very sick) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 90-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant and fatal) unexpected event of Death among other non-serious events. The event Death occurred on the following month after the first dose of mRNA-1273 vaccine. The cause of death, accurate date of death and circumstances leading to death were not provided. An autopsy was not performed. The patient also experienced non-serious events of lllness and Fatigue. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: UNK
Symptoms: Feeling abnormal
Clinical narrative: I feel lousy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (I feel lousy) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown whether the patient had any relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not.     On 18-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I feel lousy). At the time of the report, FEELING ABNORMAL (I feel lousy) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown. It was reported that the patient received the new Moderna vaccine 18 hours ago and was feeling lousy. This had happened before, normal reaction when the patient got a vaccine. No treatment medication was reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: she noticed that index finger in left in the area between the palm and first knuckle was kind of swollen for a few days; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (she noticed that index finger in left in the area between the palm and first knuckle was kind of swollen for a few days) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7180B and 015M20A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot- 015M20A, Dose-1) on 05-Feb-2021, Moderna COVID-19 Vaccine (Lot- 011A21A, Dose-2) on 05-Mar-2021, Moderna COVID-19 Vaccine (Lot -004F21A, Dose-3) on 02-Nov-2021, Moderna COVID-19 Vaccine (Lot- 045L21A and Dose-4) on 04-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Osteoarthritis.   On 15-Oct-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. On 05-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PERIPHERAL SWELLING (she noticed that index finger in left in the area between the palm and first knuckle was kind of swollen for a few days). At the time of the report, PERIPHERAL SWELLING (she noticed that index finger in left in the area between the palm and first knuckle was kind of swollen for a few days) had not 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 details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am testing positive too and I still fine/ I had the Pfizer shot; I am testing positive too and I still fine/ I had the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "I am testing positive too and I still fine/ I had the Pfizer shot". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2023) Negative, notes: I came back negative; (unspecified date) Postive, notes: I am testing positive too and I still fine; (unspecified date) Postive, notes: she still tested positive for Covid; (unspecified date) Negative, notes: She tested negative already. Paxlovid was taken as treatment for COVID-19  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: CaH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0173), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor", start date: 2015 (unspecified if ongoing), notes: breast cancer survivor (2015: chemo, Herceptin, surgery, and radiation); "chemo" (unspecified if ongoing); "surgery" (unspecified if ongoing); "radiation" (unspecified if ongoing).  Patient had no known allergies.The patient's concomitant medications were not reported. Past drug history included: Herceptin for breast cancer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 05Sep2023 to 09Sep2023.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amenorrhoea, Bipolar disorder, Depression, Headache
Clinical narrative: 1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023; bi-polar and mood disorder; suffers headaches/non-stop headaches; constant ears are ringing; it hurts/ pain on walking; my monthly Menstruation stopped; suffers from mental health; depression; 5'9" is fading away by weight loss; suffer hair loss; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received bnt162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FA7485) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No.: FA7484), administration date: 05Aug2021, when the patient was 48-year-old, for COVID-19 immunisation. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "5'9" is fading away by weight loss"; BIPOLAR DISORDER (medically significant) with onset 2021, outcome "unknown", described as "bi-polar and mood disorder"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "constant ears are ringing"; DEPRESSION (non-serious) with onset 2021, outcome "unknown"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "it hurts/ pain on walking"; AMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "my monthly Menstruation stopped"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "suffer hair loss"; MENTAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "suffers from mental health"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "suffers headaches/non-stop headaches"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "1st Dose Covid-19 on 05Aug2021;2nd Dose Covid-19 on 21Aug2023". The patient underwent the following laboratory tests and procedures: Weight: Loss, notes: 5'9" is fading away by weight loss; 130. Clinical course: She got sick for a whole month after she was forced to take the Pfizer vaccination on Aug2021. She was disabled.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305019 same reporter/product, diff event/patient;