chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccination was given IM instead of SubQ. No reaction.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Patient received this first dose 2/18/24 in the left arm IM with no indication of problem.  Patient returned to the pharmacy 2/19/24 @ 3:10pm to speak with the pharmacist about his reaction.  Approximately  2 am on the morning of 2/19/24 (14 hours after injection), the patient awoke to a sore and numb left arm that extended into the neck area.  He also had chills and a headache.  He took an anti-inflammatory that helped with the headache and put a heating pad on the sore arm and neck area.  This heat helped and,  at the time he came into the pharmacy,  he only had slight local soreness and no other symptoms.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac monitoring, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Heartbeat irregularity, chest pain, shortness of breath, difficult to talk, cannot do normal physical functions of life. these episodes lasted 5x  or more daily for around 30mins-2 hours in length for 1 month.... progressively lessened in duration and amount over course of 3 months... still experiencing occasional episodes at most 1-2x daily as of Feb 19, 2024
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Heart rate irregular, Influenza virus test negative, Loss of personal independence in daily activities, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Heartbeat irregularity, chest pain, shortness of breath, difficult to talk, cannot do normal physical functions of life. these episodes lasted 5x  or more daily for around 30mins-2 hours in length for 1 month.... progressively lessened in duration and amount over course of 3 months... still experiencing occasional episodes at most 1-2x daily as of Feb 19, 2024
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Speech disorder
Clinical narrative: Heartbeat irregularity, chest pain, shortness of breath, difficult to talk, cannot do normal physical functions of life. these episodes lasted 5x  or more daily for around 30mins-2 hours in length for 1 month.... progressively lessened in duration and amount over course of 3 months... still experiencing occasional episodes at most 1-2x daily as of Feb 19, 2024
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptoms
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: itchy  and hot to the touch
Age: 1.75
Sex: F
Vaccine: DTAP, FLU4, HEP
Symptoms: Wrong product administered
Clinical narrative: Vaccines given w/ out any complications. After giving vaccines noticed Hep B was given by error. Consulted w/ provider and w/ pts mom. No further action needed.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: hive on the upper right side of the head and middle back. Benadryl given.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Vaccine was given to patient when patient was not due for the vaccine. Let the doctor know about the error and was told that there should possibly be a fever but no other adverse events.
Age: 17.0
Sex: M
Vaccine: COVID19, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Flushing, Hyperhidrosis
Clinical narrative: While patient was receiving vaccinations ( Covid19 Moderna, Polio, MMR, Hepatitis B, and Meningococcal) the patient began to become flush and skin was clammy to touch. Moderna Due to client being unable to speak language his mother was able to translate questions. When asked patient denied any dizziness or nausea. After a few minutes it was visible that client began sweating. A cold pack was placed on the back of clients neck, also cool water was given. Clients vitals were BP 109/68, Pulse 78, Temperature 98.9 F, and Respirations 22. The mother stated the patient has experienced similar symptoms while getting immunizations. Patient was given about 10 minutes to cool down. He was able to receive the remaining vaccines without incident. The clint was monitored an additional 15 minutes. The patient stated he felt fine and the mother was comfortable with client leaving the clinic.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: C-reactive protein increased, Dehydration, Ear infection, Full blood count normal, Hyponatraemia
Clinical narrative: Tachycardia, dehydration, fever of 39.3C, requiring hospitalization x 2 nights. Patient also developed ear infection and sinusitis on 02/16/2024
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Influenza virus test negative, Metabolic function test abnormal, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Tachycardia, dehydration, fever of 39.3C, requiring hospitalization x 2 nights. Patient also developed ear infection and sinusitis on 02/16/2024
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Sinusitis, Tachycardia
Clinical narrative: Tachycardia, dehydration, fever of 39.3C, requiring hospitalization x 2 nights. Patient also developed ear infection and sinusitis on 02/16/2024
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Atrial fibrillation, Cardiac function test abnormal, Cardioversion, Chest pain
Clinical narrative: Afib-flecainide( heart back in rhythm). Chest pains( cardiologist tests. Still active). Breathing difficulties ( pulmonary tests, attempted meds. Still active). Depression and anxiety( from health issues)
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Dyspnoea, Pulmonary function test
Clinical narrative: Afib-flecainide( heart back in rhythm). Chest pains( cardiologist tests. Still active). Breathing difficulties ( pulmonary tests, attempted meds. Still active). Depression and anxiety( from health issues)
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Weight decreased
Clinical narrative: losing appetite, losing weight tremendously (over 10 lbs)
Sex: U
Vaccine: COVID19-2
Symptoms: Chest X-ray, Cough
Clinical narrative: Developed a nonproductive cough that has lasted several weeks up to this point.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram thorax, Deafness bilateral, Detoxification, Echocardiogram abnormal
Clinical narrative: MODERNA SHOT 1 1/7/2021 MODERNA SHOT 2 2/1/2021  IN JULY DEVELOPING BILATERAL HEARING LOSS, REQUIRING HEARING AIDS MALAISE, EFFORT INTOLERANCE, GENERALIZED WEAKNESS.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction, Electrocardiogram, Exercise tolerance decreased, Hearing aid user, Laboratory test
Clinical narrative: MODERNA SHOT 1 1/7/2021 MODERNA SHOT 2 2/1/2021  IN JULY DEVELOPING BILATERAL HEARING LOSS, REQUIRING HEARING AIDS MALAISE, EFFORT INTOLERANCE, GENERALIZED WEAKNESS.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pericardial effusion, Pericarditis, Positron emission tomogram
Clinical narrative: MODERNA SHOT 1 1/7/2021 MODERNA SHOT 2 2/1/2021  IN JULY DEVELOPING BILATERAL HEARING LOSS, REQUIRING HEARING AIDS MALAISE, EFFORT INTOLERANCE, GENERALIZED WEAKNESS.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Joint swelling, Peripheral swelling
Clinical narrative: When I received  the first injection I had gout in both of my feet, which caused me to not be able to walk.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Cardiac flutter, Catheterisation cardiac normal, Chest discomfort, Chest pain
Clinical narrative: Light-headedness (1st sign within 1-1.5 week post-vaccine), heart fluttering (began ~2 weeks post-vaccine, frequency increased over time),nausea (10/17/23), chest discomfort/pain (10/17/23). Went to ER on 10/20/23 w significant heart fluttering, chest discomfort/pressure, was admitted for further work-up. In ER: abnormal EKG, elevated tropinin and BNP. In hospital: normal echocardiogram and cardiac catherization. Subsequent cardiac MRIs indicated late gadolidium enhancement; diagnosed w myocarditis.  Current symptoms - abnormal EKG (inverted T-wave), reduced but still present heart fluttering, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram T wave inversion, Fatigue, Magnetic resonance imaging heart
Clinical narrative: Light-headedness (1st sign within 1-1.5 week post-vaccine), heart fluttering (began ~2 weeks post-vaccine, frequency increased over time),nausea (10/17/23), chest discomfort/pain (10/17/23). Went to ER on 10/20/23 w significant heart fluttering, chest discomfort/pressure, was admitted for further work-up. In ER: abnormal EKG, elevated tropinin and BNP. In hospital: normal echocardiogram and cardiac catherization. Subsequent cardiac MRIs indicated late gadolidium enhancement; diagnosed w myocarditis.  Current symptoms - abnormal EKG (inverted T-wave), reduced but still present heart fluttering, fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Nausea, Troponin increased
Clinical narrative: Light-headedness (1st sign within 1-1.5 week post-vaccine), heart fluttering (began ~2 weeks post-vaccine, frequency increased over time),nausea (10/17/23), chest discomfort/pain (10/17/23). Went to ER on 10/20/23 w significant heart fluttering, chest discomfort/pressure, was admitted for further work-up. In ER: abnormal EKG, elevated tropinin and BNP. In hospital: normal echocardiogram and cardiac catherization. Subsequent cardiac MRIs indicated late gadolidium enhancement; diagnosed w myocarditis.  Current symptoms - abnormal EKG (inverted T-wave), reduced but still present heart fluttering, fatigue
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not report any side effects from the expired dose; HCP reported an expired dose of the MMR II vaccine was administered to a patient on 29-JAN-2024. Patient did not report any side effects from the expired dose.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 29-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot number W019425, rHA, expiration date not reported but upon internal validation established as 07-JAN-2024 (dose, route and anatomical location were not reported) for prophylaxis (expired product administered). The patient did not report any side effects from the expired dose.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This spontaneous report was received from a company representative who learned from a nurse and refers to a currently 20-year-old  (confliction information, also reported as 44-year-old) female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date (when she was an adolescence around the age of 12-year-old), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  On an unspecified date (when she was an adolescence around the age of 12-year-old), the she experienced vaccination site pain. At the time of reporting, the outcome of the event was not provided.  This in a one of two reports from the same reporter.
Sex: M
Vaccine: PPV
Symptoms: Internal haemorrhage, Weight decreased
Clinical narrative: His father was in the hospital for 13 or 14 days for internal bleeding; He lost 20 pounds.; This spontaneous report as received from a consumer and refers to a 79-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided).  On an unknown date, the patient experienced internal bleeding and on unknown date was hospitalized for it His for 13 or 14 days. The patient was transported to another hospital around day 11 or 12 to get down to why and where the internal bleeding was coming from. The bleeding was from heart to lungs. He was on antibiotics for 1 month and 3 weeks. He lost 20 pounds. Caller informed the patient has made some recovery. The outcome of internal haemorrhage and weight decreased was reported as recovering. Action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) regarding the event was not applicable.  The reporter considered internal haemorrhage and weight decreased to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  Upon internal review event internal haemorrhage was considered medically significant.  The reporter considered event internal haemorrhage as life threatening.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE where products have been administered to patients; This spontaneous report was received from a certified medical assistant (CMA)  and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 05-FEB-2024, the patient was vaccinated  with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml, lot #X022923, expiration date: 12-MAR-2025, (strength, route of administration, and anatomical site of vaccination were not provided) for prophylaxis. The suspect vaccine underwent a temperature excursion of 5.8 Fahrenheit (F) degrees for 15 minutes. No previous temperature excursion was reported. No additional adverse event (AE) (no adverse event.
Sex: M
Vaccine: RSV
Symptoms: Vertigo
Clinical narrative: Head spinning; This non-serious case was reported by a consumer and described the occurrence of head spinning in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included metoprolol.   On 28-OCT-2023, the patient received Arexvy. On 03-NOV-2023, 6 days after receiving Arexvy, the patient experienced head spinning (Verbatim: Head spinning). The outcome of the head spinning was not resolved.   It was unknown if the reporter considered the head spinning to be related to Arexvy.     It was unknown if the company considered the head spinning to be related to Arexvy.   Additional Information: GSK receipt date: 06-NOV-2023 The patient submitted the report by public reporting via the online direct entry reporting system. The patient's blood pressure was normal and no other issues other than head spinning. The symptoms were not treated. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Abdominal discomfort, Cough, Diarrhoea, Gastrointestinal pain, Headache
Clinical narrative: gastrointestinal discomfort; Gastrointestinal pain; Cough; Diarrhea; Nausea; Headache; General malaise; This non-serious case was reported by a consumer and described the occurrence of nausea in a 54-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included panhypopituitarism and stroke. Previously administered products included Prednisone and Aspirin.   On 01-NOV-2023, the patient received Arexvy. On 02-NOV-2023, 1 days after receiving Arexvy, the patient experienced general malaise (Verbatim: General malaise). On 04-NOV-2023, the patient experienced nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On 06-NOV-2023, the patient experienced diarrhea (Verbatim: Diarrhea). On 08-NOV-2023, the patient experienced cough (Verbatim: Cough). On an unknown date, the patient experienced gastrointestinal discomfort (Verbatim: gastrointestinal discomfort) and gastrointestinal pain (Verbatim: Gastrointestinal pain). The outcome of the nausea, headache, diarrhea and general malaise were not resolved and the outcome of the cough, gastrointestinal discomfort and gastrointestinal pain were not reported.   It was unknown if the reporter considered the nausea, headache, diarrhea, general malaise, cough, gastrointestinal discomfort and gastrointestinal pain to be related to Arexvy.     It was unknown if the company considered the nausea, headache, diarrhea, general malaise, cough, gastrointestinal discomfort and gastrointestinal pain to be related to Arexvy.   Additional Information: GSK receipt date: 09-NOV-2023 It was reported that patient suffered from nausea, headache, diarrhea, general malaise. The patient reported that she had a cough that showed up day before reporting.  The patient also had gastrointestinal discomfort and pain and was not sure if this was related.  It was reported that nausea and headache were treated. It was reported that diarrhea and general Malaise were not treated.
Sex: F
Vaccine: RSV
Symptoms: Malaise, Nausea
Clinical narrative: gastrointestinal discomfort; Gastrointestinal pain; Cough; Diarrhea; Nausea; Headache; General malaise; This non-serious case was reported by a consumer and described the occurrence of nausea in a 54-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included panhypopituitarism and stroke. Previously administered products included Prednisone and Aspirin.   On 01-NOV-2023, the patient received Arexvy. On 02-NOV-2023, 1 days after receiving Arexvy, the patient experienced general malaise (Verbatim: General malaise). On 04-NOV-2023, the patient experienced nausea (Verbatim: Nausea) and headache (Verbatim: Headache). On 06-NOV-2023, the patient experienced diarrhea (Verbatim: Diarrhea). On 08-NOV-2023, the patient experienced cough (Verbatim: Cough). On an unknown date, the patient experienced gastrointestinal discomfort (Verbatim: gastrointestinal discomfort) and gastrointestinal pain (Verbatim: Gastrointestinal pain). The outcome of the nausea, headache, diarrhea and general malaise were not resolved and the outcome of the cough, gastrointestinal discomfort and gastrointestinal pain were not reported.   It was unknown if the reporter considered the nausea, headache, diarrhea, general malaise, cough, gastrointestinal discomfort and gastrointestinal pain to be related to Arexvy.     It was unknown if the company considered the nausea, headache, diarrhea, general malaise, cough, gastrointestinal discomfort and gastrointestinal pain to be related to Arexvy.   Additional Information: GSK receipt date: 09-NOV-2023 It was reported that patient suffered from nausea, headache, diarrhea, general malaise. The patient reported that she had a cough that showed up day before reporting.  The patient also had gastrointestinal discomfort and pain and was not sure if this was related.  It was reported that nausea and headache were treated. It was reported that diarrhea and general Malaise were not treated.
Age: 68.0
Sex: F
Vaccine: RVX
Symptoms: Sneezing
Clinical narrative: Sneezing excessive; This non-serious case was reported by a consumer and described the occurrence of sneezing excessive in a 68-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 13-FEB-2024, the patient received RSV vaccine. On 13-FEB-2024, less than a day after receiving RSV vaccine, the patient experienced sneezing excessive (Verbatim: Sneezing excessive). On 14-FEB-2024, the outcome of the sneezing excessive was resolved.   It was unknown if the reporter considered the sneezing excessive to be related to RSV vaccine.     It was unknown if the company considered the sneezing excessive to be related to RSV vaccine.   Additional Information: GSK receipt date: 14-FEB-2024 The reporter was requested for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unwell (Verbatim: Very ill). The outcome of the unwell was not reported.   The reporter considered the unwell to be possibly related to Shingrix.     The company considered the unwell to be possibly related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR021801   Additional Information: GSK Receipt Date: 07-FEB-2024 This case was reported by a patient via interactive digital media. The patient received both Shingrix vaccines couple of years back and these shots made him or her very ill. The patient saw his or her old administrator sick as hell and how his skin looked so he or she choose to receive both vaccines. After patient's close friend developed shingles, he or she saw how painful it could really be. The patient wants a full life live, and he or she did not want shingles to get in the way. The reporter further stated that here his or her story on why he or she started a conversation with his or her physician about his or her shingles risk. The reporter thought that the event might had been related to the product. For tolerance of the 2nd dose refer linked case US2024AMR021801, reported by the same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR021801:same patient, diffrent dose
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Needle issue, Underdose
Clinical narrative: Less than recommended volume; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 16-year-old female patient who received HAV (Havrix) (batch number g79c4, expiry date 20-SEP-2025) for prophylaxis.   On 02-FEB-2024, the patient received the 2nd dose of Havrix. On 02-FEB-2024, an unknown time after receiving Havrix, the patient experienced incomplete dose administered (Verbatim: Less than recommended volume). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-FEB-2024 The pharmacist contacted GlaxoSmithKline via phone to inquired about Havrix and what information was available about the administration of Havrix when there was a leakage in a needle not provided by GSK.  The partial information about vaccine, event and patient given.  The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The patient received less than recommended volume of Havrix vaccine, which led to an incomplete dose administered.
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of an adult dose to a 14 year old male; administration of an adult dose to a 14 year old male; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix 1440 adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 30-NOV-2020, the patient received the 1st dose of Havrix 1440 adult. On 30-NOV-2020, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: administration of an adult dose to a 14 year old male) and adult product administered to child (Verbatim: administration of an adult dose to a 14 year old male). The outcome of the 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: 12-FEB-2024 The reporter inquiring about Havrix and what information was available about the administration of an adult dose to a 14 -year old, which led overdose and adult product administered to child.  The Vaccine Administration Facility was the same as Primary Reporter. They provided data about the vaccine, patient, event and consented to receive follow-up.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: A nurse then administered her a Boostrix on 08Feb2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C75N, expiry date 06-DEC-2025) for prophylaxis.   Previously administered products included Boostrix (received dose of Boostrix on 17th October 2022) and Menquadfi  (received dose of Menquadfi on 17th October 2022). Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On 08-FEB-2024, the patient received Boostrix. On 08-FEB-2024, 479 days after receiving Boostrix, the patient experienced extra dose administered (Verbatim: A nurse then administered her a Boostrix on 08Feb2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 12-FEB-2024 Medical Assistant reported a 13 year old female patient received Menquadfi and Boostrix vaccines on 17th October 2022.  A nurse then administered her a dose of Menveo and Boostrix on 08th February 2024. The Vaccine Administration Facility was the same as Primary Reporter. The patient had extra Boostrix, which led to extra vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Engerix-B on Sep 26th 2023 and the second dose was given today; 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 29-year-old male patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 26th September 2023 ).   On 13-FEB-2024, the patient received the 2nd dose of Engerix B. On 13-FEB-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of Engerix-B on Sep 26th 2023 and the second dose was given today). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-FEB-2024 The reporter mentioned that a patient received the first dose of Engerix-B on Sep 26th 2023 and the second dose was given at the time of reporting. The reporter asked for the recommended interval between the second and the 3rd dose. The reporter did not provide patient initials. The reporter consented to follow up. The patient received 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Patient was accidently given Arexvy today with the antigen reconstituted with saline instead of with the provided adjuvant vial.; Patient was accidently given Arexvy today with the antigen reconstituted with saline instead of with the provided adjuvant vial.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-FEB-2024, the patient received Arexvy. On 13-FEB-2024, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: Patient was accidently given Arexvy today with the antigen reconstituted with saline instead of with the provided adjuvant vial.) and inappropriate dose of vaccine administered (Verbatim: Patient was accidently given Arexvy today with the antigen reconstituted with saline instead of with the provided adjuvant vial.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Feb-2024 The reporter reported that the patient was accidently given Arexvy vaccine today with the antigen reconstituted with saline instead of with the provided adjuvant vial, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Discomfort, Headache, Insomnia, Pain
Clinical narrative: General body discomfort and pain; General body discomfort and pain; Dehydration; Insomnia; Headache; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of discomfort bodily in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2024, the patient received the 1st dose of Shingrix. In FEB-2024, 8 hrs after receiving Shingrix, the patient experienced discomfort bodily (Verbatim: General body discomfort and pain), general body pain (Verbatim: General body discomfort and pain), dehydration (Verbatim: Dehydration), insomnia (Verbatim: Insomnia) and headache (Verbatim: Headache). The patient was treated with paracetamol (Tylenol). The outcome of the discomfort bodily, general body pain, dehydration, insomnia and headache were unknown.   It was unknown if the reporter considered the discomfort bodily, general body pain, dehydration, insomnia and headache to be related to Shingrix.     It was unknown if the company considered the discomfort bodily, general body pain, dehydration, insomnia and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-FEB-2024 This case was reported by patient itself. The reporter called to inform after receiving the first dose of Shingrix started feeling general body discomfort and pain. Then, less than a week after Shingrix, the patient experienced an extreme headache with pain described as 9 in a scale from 1 to 10 and the patient mentioned that she experienced extreme dehydration.  The reporter said that these symptoms kept her 18 hours on the couch trying to be relieved. The patient mentioned that she took Tylenol for the pain, but that it did not work as desired.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Arm was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (had from wearing dang mask).   On 09-DEC-2023, the patient received the 1st dose of Shingrix (left arm). In DEC-2023, several hours after receiving Shingrix, the patient experienced fever (Verbatim: Fever). On an unknown date, the patient experienced pain in arm (Verbatim: Arm was sore). In DEC-2023, the outcome of the fever was resolved (duration 24 hrs). The outcome of the pain in arm was resolved (duration 1 week).   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR021558   Additional Information: GSK Receipt Date: 14-Feb-2024 The patient was self-reported this case. The patient reported that he received Shingrix vaccine around noon and after few hours experienced a fever that lasted about 24 hours.  The patient arm was sore for a full week. This US2024AMR021558 case has been linked to the case reported by the same reporter for same patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR021558:Original Case : US2024019968
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, COVID-19, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: fatigue; malaise; arthralgia; shortness of breath; COVID; Burning in mouth; flu like symptoms; This non-serious case was reported by a physician via call center representative and described the occurrence of burning mouth in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-NOV-2023, the patient received Arexvy. On 20-NOV-2023, 8 days after receiving Arexvy, the patient experienced burning mouth (Verbatim: Burning in mouth). In DEC-2023, the patient experienced covid-19 (Verbatim: COVID). In JAN-2024, the patient experienced fatigue (Verbatim: fatigue), malaise (Verbatim: malaise), arthralgia (Verbatim: arthralgia) and shortness of breath (Verbatim: shortness of breath). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms). The patient was treated with zoledronic acid (Reclast), nystatin, fluconazole and prednisone. The outcome of the burning mouth, fatigue, malaise, arthralgia, covid-19 and shortness of breath were resolved and the outcome of the influenza-like symptoms was resolved (duration 1 week).   It was unknown if the reporter considered the burning mouth, fatigue, malaise, arthralgia, influenza-like symptoms, covid-19 and shortness of breath to be related to Arexvy.     It was unknown if the company considered the burning mouth, fatigue, malaise, arthralgia, influenza-like symptoms, covid-19 and shortness of breath to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-FEB-2024 A patient received Arexvy.  She then experienced flu-like symptoms that lasted a week.  The patient also reported that burning in her mouth on 20th November 2023 she had an infusion of Reclast.  She still had persistent burning in her mouth and on 5th December 2023 went to urgent care, Nystatin given with no response, she also tested positive for COVID in December 2023.  In January 2024, she saw her PCP (primary care physician) who ordered fluconazole.  She stated that the burning in her mouth still continued along with fatigue, malaise, arthralgia and shortness of breath.  On 30th January 2024, she was started on oral Prednisone (15 mg BID) and the symptoms had resolved. ER (emergency room) visit required. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Malaise, Oral discomfort, SARS-CoV-2 test positive
Clinical narrative: fatigue; malaise; arthralgia; shortness of breath; COVID; Burning in mouth; flu like symptoms; This non-serious case was reported by a physician via call center representative and described the occurrence of burning mouth in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-NOV-2023, the patient received Arexvy. On 20-NOV-2023, 8 days after receiving Arexvy, the patient experienced burning mouth (Verbatim: Burning in mouth). In DEC-2023, the patient experienced covid-19 (Verbatim: COVID). In JAN-2024, the patient experienced fatigue (Verbatim: fatigue), malaise (Verbatim: malaise), arthralgia (Verbatim: arthralgia) and shortness of breath (Verbatim: shortness of breath). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms). The patient was treated with zoledronic acid (Reclast), nystatin, fluconazole and prednisone. The outcome of the burning mouth, fatigue, malaise, arthralgia, covid-19 and shortness of breath were resolved and the outcome of the influenza-like symptoms was resolved (duration 1 week).   It was unknown if the reporter considered the burning mouth, fatigue, malaise, arthralgia, influenza-like symptoms, covid-19 and shortness of breath to be related to Arexvy.     It was unknown if the company considered the burning mouth, fatigue, malaise, arthralgia, influenza-like symptoms, covid-19 and shortness of breath to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-FEB-2024 A patient received Arexvy.  She then experienced flu-like symptoms that lasted a week.  The patient also reported that burning in her mouth on 20th November 2023 she had an infusion of Reclast.  She still had persistent burning in her mouth and on 5th December 2023 went to urgent care, Nystatin given with no response, she also tested positive for COVID in December 2023.  In January 2024, she saw her PCP (primary care physician) who ordered fluconazole.  She stated that the burning in her mouth still continued along with fatigue, malaise, arthralgia and shortness of breath.  On 30th January 2024, she was started on oral Prednisone (15 mg BID) and the symptoms had resolved. ER (emergency room) visit required. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant and treatment medications reported. It was reported that possible reaction was just noticed.  This case was identified during the RA 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 06-Feb-2021: Case unlocked on 16-Feb-2024 as a part of RA inspection 2023 to perform significant correction. Removed classification of no patient identifier, updated report type to Spontaneous and case converted to valid.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed; This spontaneous case was reported by a non-health professional and describes the occurrence of EPISTAXIS (nosebleed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (nosebleed). At the time of the report, EPISTAXIS (nosebleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This case was identified during the inspection 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Case unlocked on 15-Feb-2024 as a part of inspection to perform significant correction. Case upgraded as valid and classification of no patient identifier was removed.
Age: 53.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave a dose of Arexvy instead; 53 year old patient a dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 53-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3Y7P4, expiry date 21-MAR-2025) for prophylaxis.   On 10-NOV-2023, the patient received Arexvy. On 10-NOV-2023, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: gave a dose of Arexvy instead) and inappropriate age at vaccine administration (Verbatim: 53 year old patient a dose of Arexvy). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 10-Nov-2023 The reporter consented to follow-up. The patient received a dose of Arexvy instead of Shingrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: about the usage of Arexvy in patients whom only received the adjuvant; the usage of Arexvy in patients whom only received the adjuvant.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 54h92) for prophylaxis.   On 26-NOV-2023, the patient received the 1st dose of Arexvy. On 26-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: about the usage of Arexvy in patients whom only received the adjuvant) and inappropriate dose of vaccine administered (Verbatim: the usage of Arexvy in patients whom only received the adjuvant.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-NOV-2023  A Pharmacist contacted GSK via phone on 11/26/2023 inquiring about Arexvy and what information is available about the usage of Arexvy in patients who only received the adjuvant which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.  They only gave partial information about the vaccine, patient and event.  The declined to receive follow-up. Did not consent to follow-up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Respiratory tract infection
Clinical narrative: respiratory and ear infection; respiratory and ear infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 83-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lymphoma", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Chemotherapy, reaction(s): "lowered his immune system", notes: for 5 months; Chemotherapy, reaction(s): "affected his hemoglobin levels", notes: had to get a daily iron pill to elevate his hemoglobin levels. The following information was reported: RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", EAR INFECTION (non-serious), outcome "not recovered" and all described as "respiratory and ear infection". Therapeutic measures were taken as a result of respiratory tract infection, ear infection.  Additional information: Patient had lymphoma back in 2017 and had chemotherapy for 5 months which lowered his immune system and affected his hemoglobin levels. He knows his immune system might be affected by the cancer. He had to get a daily iron pill to elevate his hemoglobin levels. Patient had a pneumonia shot. Recently, patient had a respiratory and ear infection for which he took amoxicillin however, he refers his left ear has not cleared up completely.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Lot number: HF9275) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; AMLODIPINE; LISINOPRIL; ATORVASTATIN; PIOGLITAZONE; ASPIRIN 81; FEXOFENADINE HYDROCHLORIDE; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (booster); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Based on product quality investigation results, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer biontech covid-19 vaccine lot HF9275 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot HF9275, bulk and fill lots HG8610, and HG8025. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Nurse.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "lung disease" (unspecified if ongoing); "late lyme disease" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin"; Clindamycin, reaction(s): "Allergy: clindamycin"; Gluten, reaction(s): "Allergy: gluten"; Dilaudid, reaction(s): "Allergy: dilaudid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID19) with COMIRNATY can not be completely excluded.