chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP called to report administration of PROQUAD to a 20-year-old patient due to having "low titers." Patient was given PROQUAD on 25OCT2023. Patient's childhood vaccination history is unknown by reporter. No additional information was known by report; No adverse reaction; This spontaneous report was received from a Nurse regarding a 20-year-old female patient.    The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-OCT-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously on her left arm (Lot# verified X014621, Expiration date 18-NOV-2024) (Product administered to patient of inappropriate age), due to having low titers. It was reported that her childhood vaccination history was unknown by the reporter, and there was no adverse reaction (No adverse event). No additional information was provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product availability issue, Product dose omission issue
Clinical narrative: No additional AE/no PQC; HCP reported patient missed dose of PROQUAD on 02/09/2024 due to the facility not having STERILE DILUENT to admix the vaccine. Did not provide any further details. No additional AE/no PQC.; HCP reported patient missed dose of PROQUAD on 02/09/2024 due to the facility not having STERILE DILUENT to admix the vaccine. Did not provide any further details. No additional AE/no PQC.; This spontaneous report has been received from a health care professional (medical assistant), referring to a 4-year-old child. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis.  On 09-FEB-2024, the patient missed dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) due to facility not having sterile diluent to administer the vaccine. Did not provide any further details. No additional adverse event.
Sex: U
Vaccine: RVX
Symptoms: Injection site bruising, Injection site necrosis
Clinical narrative: where I got the looks like the skin is dying started out; I had a bad reaction to the site as a large bruise about the size of a quarter shot; This serious case was reported by a nurse via call center representative and described the occurrence of skin necrosis in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced skin necrosis (Verbatim: where I got the looks like the skin is dying started out) (serious criteria GSK medically significant) and injection site bruising (Verbatim: I had a bad reaction to the site as a large bruise about the size of a quarter shot). The outcome of the skin necrosis and injection site bruising were not reported.   It was unknown if the reporter considered the skin necrosis and injection site bruising to be related to RSV vaccine.     It was unknown if the company considered the skin necrosis and injection site bruising to be related to RSV vaccine.   Additional Information: GSK receipt date: 07-FEB-2024 The patient got the RSV vaccine and looked like where got the skin was dying started out as a large bruise about the size of a quarter shot the skin was dying. The reporter assumed that had a bad reaction it was going to my family doctor this coming Friday February 9th. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: MEN, TDAP
Symptoms: Autism spectrum disorder, Brain injury, Post-traumatic stress disorder, Seizure
Clinical narrative: Brain damage; Autism; Seizure; Ptsd; This serious case was reported by a consumer via interactive digital media and described the occurrence of brain damage in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine and Tdap Vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine and Tdap Vaccine, the patient experienced brain damage (Verbatim: Brain damage) (serious criteria GSK medically significant), autism (Verbatim: Autism) (serious criteria GSK medically significant), seizure (Verbatim: Seizure) (serious criteria GSK medically significant) and post-traumatic stress disorder (Verbatim: Ptsd). The outcome of the brain damage, autism, seizure and post-traumatic stress disorder were not reported.   The reporter considered the brain damage and post-traumatic stress disorder to be related to Meningococcal B vaccine. It was unknown if the reporter considered the autism and seizure to be related to Meningococcal B vaccine and Tdap Vaccine. It was unknown if the reporter considered the brain damage to be related to Tdap Vaccine. The reporter considered the post-traumatic stress disorder to be related to Tdap Vaccine.     The company considered the brain damage and post-traumatic stress disorder to be related to Meningococcal B vaccine. It was unknown if the company considered the autism and seizure to be related to Meningococcal B vaccine and Tdap Vaccine. It was unknown if the company considered the brain damage to be related to Tdap Vaccine. The company considered the post-traumatic stress disorder to be related to Tdap Vaccine.   Additional Information: GSK Receipt Date: 06-Feb-2024 This case was reported by a patient via interactive digital media. The patient reported that he or she spoke with one of the GSK representative that a few months ago about the brain damage that GSK meningitis shot left him or her with at 21. He or she looked like he or she had CP or severe autism and seizures.  The patient asked if you can explain why it was happened and he or she thought it was inactive. The patient had PTSD cause of GSK shot and a Tdap. Follow-up would not possible as no contact details were available.
Age: 79.0
Sex: M
Vaccine: RSV
Symptoms: Headache, Heart rate increased, Sleep disorder
Clinical narrative: headache; awakened him; rapid heartbeat; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 79-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 03-FEB-2024, the patient received Arexvy. In FEB-2024, less than a day after receiving Arexvy, the patient experienced headache (Verbatim: headache), wakefulness (Verbatim: awakened him) and heartbeats increased (Verbatim: rapid heartbeat). The outcome of the headache was not resolved and the outcome of the wakefulness and heartbeats increased were not reported.   It was unknown if the reporter considered the headache, wakefulness and heartbeats increased to be related to Arexvy.     It was unknown if the company considered the headache, wakefulness and heartbeats increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-FEB-2024. This case was reported via (Open field AE monitoring) interactive digital media. The patient was reporter's husband. The patient received the RSV vaccine yesterday (day before reporting) and he experienced rapid heartbeat and headache which awakened him about 1am. The reporter stated that, it was 6:30 am (on the day of reporting) and the headache was still present. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This non-serious case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 3 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to Arexvy.     It was unknown if the company considered the influenza-like symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-FEB-2024 The patient received Arexvy vaccine and experienced flu like symptoms for a 2-to-3-day period. The rest information was unknown. The reporter did not consent to follow up.
Sex: U
Vaccine: RV1
Symptoms: Excessive eye blinking, Infantile spitting up, Regurgitation, Somnolence, Underdose
Clinical narrative: falling asleep; spit up all the liquid; eyes were blinking frequently and more than usual after; spit up all the liquid; This non-serious case was reported by a physician via sales rep and described the occurrence of sleepiness in a 2-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced sleepiness (Verbatim: falling asleep), regurgitation of medication (Verbatim: spit up all the liquid), excessive eye blinking (Verbatim: eyes were blinking frequently and more than usual after) and accidental underdose (Verbatim: spit up all the liquid). The outcome of the sleepiness, regurgitation of medication and excessive eye blinking were not reported and the outcome of the accidental underdose was unknown.   The reporter considered the sleepiness, regurgitation of medication and excessive eye blinking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     The company considered the sleepiness, regurgitation of medication and excessive eye blinking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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:06-FEB-2024 The patient administered Rotarix and as soon as the liquid formulation touched the baby mouth, the patient spit up all the liquid and the baby was described as falling asleep.  The patient started vaccine last week (no specified date). They said the baby eyes were blinking frequently and more than usual after.  They kept the baby for an hour to monitor the situation and then advised them to visit the hospital for some testing (tests not specified).  The reporter asked if there had been any follow up in regard to the hospital visit and they said none yet.  The reporter advised them if they heard more information to let him/her know so that he/she could update this report. No second dose of Roatrix was given. The doctor advised to visit the hospital if anymore symptoms occurred. The reporter was still not aware if the baby went or not.  The doctor did believe this was related to the product administration. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Constipation, Headache, Injection site pain, Myalgia
Clinical narrative: pain at the injection site; constipation; Low grade fever; shivering; Muscle pain; Nausea; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 05-FEB-2024, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On an unknown date, the patient experienced injection site pain (Verbatim: pain at the injection site), constipation (Verbatim: constipation), low grade fever (Verbatim: Low grade fever) and shivering (Verbatim: shivering). On 09-FEB-2024, the outcome of the constipation, low grade fever and shivering were resolved. The outcome of the injection site pain, muscle pain, nausea and headache were not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, nausea, headache, constipation, low grade fever and shivering to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle pain, nausea, headache, constipation, low grade fever and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2024 and 09-FEB-2024 The reporter stated that within 24 hours of receiving dose, the patient began experiencing headache, muscle pain and nausea which were not resolved. The reporter did not consent to follow-up. The patient experienced constipation, a low-grade fever and shivering that resolved on reporting day. The reporter stated that the patient still had pain at the injection site that has not resolved. The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: pain at the injection site; constipation; Low grade fever; shivering; Muscle pain; Nausea; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-FEB-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 05-FEB-2024, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On an unknown date, the patient experienced injection site pain (Verbatim: pain at the injection site), constipation (Verbatim: constipation), low grade fever (Verbatim: Low grade fever) and shivering (Verbatim: shivering). On 09-FEB-2024, the outcome of the constipation, low grade fever and shivering were resolved. The outcome of the injection site pain, muscle pain, nausea and headache were not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, nausea, headache, constipation, low grade fever and shivering to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle pain, nausea, headache, constipation, low grade fever and shivering to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2024 and 09-FEB-2024 The reporter stated that within 24 hours of receiving dose, the patient began experiencing headache, muscle pain and nausea which were not resolved. The reporter did not consent to follow-up. The patient experienced constipation, a low-grade fever and shivering that resolved on reporting day. The reporter stated that the patient still had pain at the injection site that has not resolved. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult male patient received a pediatric 0.5 mL dose of Engerix-B; adult male patient received a pediatric 0.5 mL dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 57-year-old male patient who received HBV (Engerix B pediatric) (batch number 92A3, expiry date 03-MAY-2025) for prophylaxis.   On 05-FEB-2024, the patient received Engerix B pediatric .5 ml. On 05-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult male patient received a pediatric 0.5 mL dose of Engerix-B) and adult use of a child product (Verbatim: adult male patient received a pediatric 0.5 mL dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-FEB-2024 A medical assistant reported that an adult patient received a pediatric 0.5 mL dose of Engerix-B, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received an adult dose of engerix-b inadvertently; Adult product administered to child; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-month-old male patient who received HBV (Engerix B adult) for prophylaxis.   In FEB-2024, the patient received the 3rd dose of Engerix B adult. In FEB-2024, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: patient received an adult dose of engerix-b inadvertently) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-FEB-2024 The patient received an adult dose of Engerix-B inadvertently, which led to an accidental overdose and adult product administered to child. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Skin warm
Clinical narrative: Skin hot/ Feels like fever all over body; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 84-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L5C22, expiry date 18-AUG-2025) for prophylaxis.   On 05-FEB-2024, the patient received Arexvy. On 05-FEB-2024, less than a day after receiving Arexvy, the patient experienced skin warm (Verbatim: Skin hot/ Feels like fever all over body). The outcome of the skin warm was resolved.   It was unknown if the reporter considered the skin warm to be related to Arexvy.     It was unknown if the company considered the skin warm to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-Feb-2024 and 07-Feb-2024 The reporter reported that the patient received Arexvy vaccine about 3 and a half hours ago and called the pharmacist about 20 minutes ago stated that he felt like he had fever all over his body.  The reporter stated that the patient reported that his skin feels hot but his temperature was 96 F or 97.6 F The reporter did not know the exact temperature.  The patient did not had pain at the injection site. The reporter stated that 4 hours and 30 minutes after vaccination she spoke to the patient and he was doing ok. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Administration of vaccine diluent/adjuvant without active component; Administration of vaccine diluent/adjuvant without active component; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA985A, expiry date 25-DEC-2025) for prophylaxis.   On 05-FEB-2024, the patient received Menveo. On 05-FEB-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of vaccine diluent/adjuvant without active component) and inappropriate dose of vaccine administered (Verbatim: Administration of vaccine diluent/adjuvant without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-FEB-2024 and 08-FEB-2024 The reporter stated that a 11 year old received only one vial of the Menveo, administration of vaccine diluent/adjuvant without active component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of reporting,the dose has not been repeated. No symptomatic injury to the patient.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not receive second dose until 05Feb2024; 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 74-year-old male patient who received HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 03-AUG-2023 with batch number 2PG39 and expiry date:19-SEP-2025).   On 05-FEB-2024, the patient received the 2nd dose of Twinrix. On 05-FEB-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: did not receive second dose until 05Feb2024). 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: 06-FEB-2024 The pharmacist reported that the patient received first Twinrix dose on 03-AUG-2023 and did not receive second dose until 05-FEB-2024. The reporter declined to provide patient date of birth and initials. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.08
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine administered; Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 01-FEB-2024, the patient received Kinrix. On 01-FEB-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: wrong vaccine administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age). 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: 06-FEB-2024 The reporter reported that a 14-month old child was due to receive dTap and IPV and Kinrix was administered in error, which led to wrong vaccine administered and inappropriate age at vaccine administration. No symptoms were reported. The reporter consented to follow up via email.
Age: 83.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Innapropriate Age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 83-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 06-FEB-2024, the patient received Infanrix. On 06-FEB-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Innapropriate Age). 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: 06-FEB-2024 The patient received Infanrix above the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered in patient younger than recommended; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-week-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 12-FEB-2026) for prophylaxis.   On 05-FEB-2024, the patient received the 1st dose of Kinrix. On 05-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administered in patient younger than recommended). 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: 06-FEB-2024 The reporter inquired about Kinrix and what information was available about the administration of Kinrix in a patient under 3 months old. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Practice Manager reports facility ordered Infanrix vaccines instead of Boostrix vaccines, and one Infanrix vaccine was administered to the patient; Infanrix administered to 28 years old patient; 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 28-year-old male patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   On 06-FEB-2024, the patient received Infanrix. On 06-FEB-2024, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Practice Manager reports facility ordered Infanrix vaccines instead of Boostrix vaccines, and one Infanrix vaccine was administered to the patient) and adult use of a child product (Verbatim: Infanrix administered to 28 years old patient). The outcome of the wrong vaccine administered and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-Feb-2024 The reporter was a practice manager. The reporter reported that the facility ordered Infanrix vaccines instead of Boostrix vaccines and one Infanrix vaccine was administered to a 28 year old male patient, which led to wrong vaccine administered and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Infanrix in newborn; 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 neonate patient who received DTPa (Infanrix) for prophylaxis.   On 06-FEB-2024, the patient received the 1st dose of Infanrix. On 06-FEB-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Infanrix in newborn). 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: 07-Feb-2024 The reporter inquired about Infanrix and what information was available about the administration of Infanrix in a 1 day old newborn patient The reporter provided very partial information about vaccine, patient and event given. The vaccine administration facility was the same as primary reporter. The patient received Infanrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Batch number was not provided and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot (dose series 1). On an unspecified date, the patient died from blood clot. JnJ employee stated her department received an email where the consumer mentioned his father got the Janssen COVID vaccine and then died 4 months later due to a blood clot. Per the employee, this was all the information that the email contained regarding the situation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: This case concerns male patient of unspecified age who died due to blood clot 4 months after administration of covid-19 vaccine ad26.cov2.s for COVID 19 prophylaxis. Details on exact cause of death, final diagnosis, circumstances leading to death and medical history are not reported. Based on the information provided, a reasonable possibility to suggest a relationship between COVID 19 vaccine and the event Thrombosis cannot be established; hence, the event is assessed to have an indeterminate causal association to immunization, per the WHO causality classification for adverse events following immunization. Further details requested.; Reported Cause(s) of Death: BLOOD CLOT
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: APPENDICITIS; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 29-JAN-2024 was received on 13-FEB-2024 and concerned a female 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 received covid-19 vaccine ad26.cov2.s (Dose number in series-1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced appendicitis (Dose number in series-1), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of appendicitis was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20240186394.; Sender's Comments: V0-Appendicitis. 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 unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Had significant side effects; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (Had significant side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Had significant side effects). At the time of the report, ADVERSE EVENT (Had significant side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  This case was identified during the inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2021: Case unlocked on 12-Feb-2024 as a part of inspection 2023 to perform significant correction. No patient identifier was removed from classification and the case was processed as valid as single patient identifier was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Presented side effects after getting the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Presented side effects after getting the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Presented side effects after getting the vaccine). At the time of the report, ADVERSE EVENT (Presented side effects after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  This case was identified during the inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Case unlocked on 29-Jan-2024 as a part of inspection 2023 to perform significant correction. Case classification no patient identifier was deleted from the case and the case was made valid.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-003033:
Sex: U
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: some "viral reaction"; This spontaneous case was reported by a pharmacist and describes the occurrence of VIRAL INFECTION (some "viral reaction") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (some "viral reaction"). At the time of the report, VIRAL INFECTION (some "viral reaction") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was identified during the inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Case unlocked on 12-Feb-2024 as a part of inspection 2023 to perform significant correction. Updated report type to spontaneous and case converted to valid.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) 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.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.            No concomitant medications were reported.  It was reported that worst pain (Injection site pain), worst tenderness (Injection site tenderness), worst intensity of fatigue, worst intensity of pain (Muscle pain) and worst intensity of joint pain experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, 31-Jan-2024 and Thursday, 1-Feb-2024 was recorded.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.            The specified Subject ID was reported.  The other specified Subject ID was reported.  No concomitant and treatment medication were reported.  Patient had experienced moderate injection site pain interfering with activity, moderate injection site tenderness (tenderness with movement), mild injection site redness, swelling. Mild fatigue, malaise/feeling sick, muscle pain and joint and headache and no interference with activity anytime during the 2 days after COVID-19 vaccination, which occurred on 01-Feb-2024 and 02-Feb-2024.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.            The specified Subject ID was reported.  The other specified Subject ID was reported.  No concomitant and treatment medication were reported.  Patient had experienced moderate injection site pain interfering with activity, moderate injection site tenderness (tenderness with movement), mild injection site redness, swelling. Mild fatigue, malaise/feeling sick, muscle pain and joint and headache and no interference with activity anytime during the 2 days after COVID-19 vaccination, which occurred on 01-Feb-2024 and 02-Feb-2024.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Headache and no interference with activity; Moderate muscle pain with some interference with activity; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and VACCINATION SITE SWELLING (Mild injection site swelling) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), HEADACHE (Headache and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.            No concomitant medications were reported.  It was reported that worst pain (Injection site pain), worst tenderness (Injection site tenderness), worst swelling (Injection site swelling), worst intensity of fatigue, worst intensity of feeling unwell, worst intensity of pain (Muscle pain) and maximum headache severity experienced anytime during the 2 days after the COVID-19 vaccination, which occurred Friday, 2- Feb-2024 and Saturday, 3-Feb-2024 was recorded.  No treatment medications were reported.