chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB being administered to a patient with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient and reporter stated expired HIB (PRP/T) vaccine [ACT-HIB] being administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]).  On 28-Oct-2022, the patient received a expired 0.5 ml dose of suspect HIB (PRP/T) vaccine once ( 4th dose)(lot UJ594AA and expiry date 26-OCT-2022)(strength : standard) via intramuscular route in the left arm as Immunization, with no reported adverse event (expired product administered)(latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered a dose of ActHIB that was 8 days past its expiration when it was given with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation.  On 24-Oct-2022, the patient received 0.5 ml total of dose 4 of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot UJ585AAA and expiry date: 16-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 24-Oct-2022, (latency: same day) the patient was administered a dose of acthib that was 8 days past its expiration when it was given with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  It was reported, a patient was administered a dose of ActHIB that was 8 days past its expiration when it was given. A patient was given ActHIB in an unknown injection site on 24Oct2022. The ActHib vaccine that was administered had expired on 16Oct2022.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: acthib vaccine was administered that was later noted to have expired 4 days previously with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves 18 months old male patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administered that was later noted to have expired 4 days previously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) and Hepatitis A Vaccine (Hepatitis A) both for Immunisation.  On 28-Oct-2022, the patient received suspect HIB (PRP/T) VACCINE at a dose of 0.5 ml once(lot UJ588AA, expiry date: 24-Oct-2022, expired 4 days previously) via intramuscular route in unknown administration site for immunization.  On 28-Oct-2022 the acthib vaccine was administered that was later noted to have expired 4 days previously with no reported adverse event (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired dose of ACT-HIB with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male patient who received an expired dose of hib (prp/t) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar) for Immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; and hepatitis a vaccine (Hepatitis A) for Immunisation.  On 31-Oct-2022, the patient received a dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength: standard) 0.5mL (milliliter) total once (lot: UJ600AAB, expiry date: 29-Oct-2022) via intramuscular route in the thigh nos (not otherwise specified) for immunization.  On 31-OCT-2022 the patient received an expired dose of act-hib with no reported adverse event (expired product administered) same day following the administration of vaccine.  No lab data reported.  Action taken was not applicable.  Treatment- will be repeated.   At time of reporting, the outcome was Unknown for the event
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Chills, Electrocardiogram ST segment depression, Pain, Pyrexia
Clinical narrative: feeling achy; got the worst chills; high fever; chest pain; diagnosed with ST depression; Initial information received on 31-Oct-2022 regarding an unsolicited valid serious case received from a nurse(patient).  This case involves a 71 years old female patient who experienced diagnosed with ST depression, got the worst chills, high fever, chest pain and feeling achy while receiving vaccine influenza quadrival A-B high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. The patient had ongoing allergy to Halibut(fish allergy).   On 26-Oct-2022, the patient received suspect vaccine influenza quadrival A-B high dose hv vaccine at a unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On 26-Oct-2022 the patient developed a serious got the worst chills (chills), high fever (pyrexia), chest pain, feeling achy (pain) same day latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized for this event. In Oct-2022 the patient developed a serious diagnosed with ST depression (electrocardiogram ST segment depression) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. Product composition confirmed no fish was in the product.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.; Sender's Comments: Sanofi company comment dated 03-Nov-2022: This case involves a 71 years old female patient who experienced diagnosed with ST depression, got the worst chills, high fever, chest pain and feeling achy while receiving vaccine influenza quadrival A-B high dose hv vaccine [Fluzone High-Dose Quadrivalent]. The patient was allergic to Halibut. Additional information regarding condition at the time of vaccination, risk factor excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 55 year old patient was treated with Fluzone HD, with no adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 55 years old female patient who was treated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2022, the 55 year old patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ927AC and expiry 30-06-23) (product administered to patient of inappropriate age, latency same day) (formulation and strength: unknown) via intramuscular route in the left arm for Immunization.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of TENIVAC with no reported adverse event; Initial information received  on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 40 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 29-Oct-2022, the patient received 0.5ml, once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation was unknown, lot U6831AA and expiry date: 08-Oct-2022) via intramuscular route in Deltoid NOS for Immunization.  On 29-Oct-2022 the patient developed a non-serious event of patient received an expired dose of tenivac with no reported adverse event (expired product administered)(Latency: same day) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Product preparation error
Clinical narrative: diluting fluzone qiv t and administering,with no reported adverse event; diluting fluzone qiv t and administering,with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/ gender patient who reported diluting INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and administering,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 31-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (strength, dose, formulation, route, lot number not reported via unknown route in unknown administration site for immunizaton.  On 31-OCT-2022 the patient developed a non-serious events diluting fluzone qiv t and administering,with no reported adverse event (product preparation error) and (incorrect product formulation administered)following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: an extra dose of PENTACEL was inadvertently administered with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 months old male patient who was administered an extra dose of pentacel was inadvertently with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and HEPATITIS A VACCINE INACT (VAQTA).  On 28-Oct-2022, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation, strength not reported; lot UJ674AA and expiry date: 04-Jun-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 28-Oct-2022, (latency: same day) the patient developed a non-serious an extra dose of pentacel was inadvertently administered with no reported adverse event (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01347468:
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chills, Epididymitis, Fatigue, Headache
Clinical narrative: Back pain; Leg pain / arm pain; Muscle pain; Fever; Nausea; Chills; Fatigues; Headache; This spontaneous case was received on 17-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04598) and concerned an 80-year-old, female patient.  The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. The patient stated that she normally got the Fluzone.  On 16-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm, muscle pain, fever, nausea, chills, fatigues and headache. The patient stated that she was getting an epidural in her back. The patient's doctor was supposed to put steroids in her back. Percocet (oxycodone hydrochloride, paracetamol) was a treatment measure for the events.  On 16-Oct-2022, the patient recovered from all events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: An 80-year-old patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm and muscle pain, as well as fever, nausea, chills, fatigue and headache. The patient stated that she was getting an epidural in her back. Reportedly, the patient was administered with steroids in her back. The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: An 80-year-old patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm and muscle pain, as well as fever, nausea, chills, fatigue and headache. The patient stated that she was getting an epidural in her back. Reportedly, the patient was administered with steroids in her back. The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events, due to plausible chronology.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Back pain; Leg pain / arm pain; Muscle pain; Fever; Nausea; Chills; Fatigues; Headache; This spontaneous case was received on 17-Oct-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-04598) and concerned an 80-year-old, female patient.  The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. The patient stated that she normally got the Fluzone.  On 16-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm, muscle pain, fever, nausea, chills, fatigues and headache. The patient stated that she was getting an epidural in her back. The patient's doctor was supposed to put steroids in her back. Percocet (oxycodone hydrochloride, paracetamol) was a treatment measure for the events.  On 16-Oct-2022, the patient recovered from all events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: An 80-year-old patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm and muscle pain, as well as fever, nausea, chills, fatigue and headache. The patient stated that she was getting an epidural in her back. Reportedly, the patient was administered with steroids in her back. The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: An 80-year-old patient was vaccinated with Fluad Quadrivalent. On the same date, after receiving Fluad Quadrivalent, the patient experienced leg, back, arm and muscle pain, as well as fever, nausea, chills, fatigue and headache. The patient stated that she was getting an epidural in her back. Reportedly, the patient was administered with steroids in her back. The patient's concurrent condition included autoimmune disease. The patient's concomitant medications were not reported. Causality is assessed as possibly related for all events, due to plausible chronology.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary mass
Clinical narrative: A lump inside is arm (the arm that received the vaccine) with a size of a tenis ball; This spontaneous case was received on 21-Oct-2022 from pharmacist via Regulatory Group (reference number: SEQW22-04846) and concerned a 58-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular, dose: 0.5 ml, anatomical location: not reported) as prevention of influenza disease. The batch number reported was AS3704B.  On 20-Oct-2022, one day after receiving Afluria Quadrivalent, the patient woke up with a lump inside his arm (the arm that he received the vaccine) with a size of a tennis ball.   At the time of initial reporting, on 21-Oct-2022, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 58-year-old patient developed axillary mass one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.; Sender's Comments: A 58-year-old patient developed axillary mass one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided. Based on plausible temporal relationship, causality for the reported event is assessed as possibly related.
Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Dermatitis, Erythema, Hypersensitivity, Pruritus, Skin warm
Clinical narrative: Allergic local reaction/Something on the her skin (red, itchy, inflamed, warm to touch); This spontaneous case was received on 28-Oct-2022 from Other Health Professional (not-specified) via Regulatory Communications (reference number: SEQW22-05156) and concerned a 24-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 25-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose reported as '0.5 ml', route of administration: intramuscular (IM), anatomical location: not reported) for prevention of influenza disease. The batch number reported was 942432. Expiration date was 30-Jun-2022.  On 27-Oct-2022, two days after receiving Flucelvax Quadrivalent, the patient experienced something on her skin (red, itchy, inflamed and warm to touch).  On an unspecified date in Oct-2022, the patient went to urgent care and there it was concluded to be a local allergic reaction. The patient was prescribed Claritine (loratadine) and hydrocortisone two times a day.  The reporter assessed the event of 'allergic reaction' as related to the Flucelvax Quadrivalent. The reporter requested a list of ingredients of Flucelvax Quadrivalent to review with the patient that had an allergic reaction to this vaccine.  The case was assessed as non-serious.  Company comment: The event allergic reaction is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The reporter requested a list of ingredients of Flucelvax Quadrivalent to review with the patient that had an allergic reaction to this vaccine.; Sender's Comments: The event allergic reaction is assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: PERICARDITIS; This 37-year-old, female subject was participating in "A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older" and experienced the life-threatening serious adverse event of special interest of pericarditis.    The subject's medical history, as provided by the investigator, included polycystic ovarian syndrome, anemia, multiple cysts on ovaries, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation, mitral valve regurgitation, nummular eczema, and acne of the back. Concomitant medications reported included cetirizine hydrochloride, iron ferrous sulfate, methylprednisolone, metformin, betamethasone, tazarotene, colecalciferol, ethinylestradiol/norgestimate, paracetamol, and nirmatrelvir/ritonavir (prescribed for symptomatic covid-19 infection, from 7-Sep-2022 till 09-Oct-2022).   Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3) for SARS-CoV-2 vaccination on 26 Oct 2021, approximately 10 months and 29 days before onset of the event.   On 23 Sep 2022, the subject experienced pericarditis.    Treatment for the event included oral colchicine.   The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.    The event, pericarditis, was reported as resolving.    The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Company comment: This case concerns a 37-year-old, female subject with a medical history of polycystic ovarian syndrome, anemia, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation and mitral valve regurgitation among others, who experienced the unlisted life-threatening serious adverse event of special interest of pericarditis. The event occurred 2 years 1 month 13 days after the first dose of IP, and 10 months 29 days after the third and booster dose. The event, pericarditis, was reported as resolving. The event was considered unrelated to IP in agreement with the Investigator. The event might be explained by COVID-19 infection as suggested by indication of nirmatrelvir/ritonavir that was administered from 7-Sep-2022 till 09-Oct-2022. Additional indication was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Epistaxis
Clinical narrative: nosebleed/ reaction to the vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of epistaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced epistaxis. On an unknown date, the outcome of the epistaxis was recovered/resolved.   It was unknown if the reporter considered the epistaxis to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's Comments: The reporter stated that within 24 hours of receiving Shingrix, patient had a nosebleed that lasted three days. Patient asked if this was a reaction to the vaccine and if it was common.  The patient would be following up with their primary care and reported the incident to VARS.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: the most painful injection I have ever had; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got his/her 1st shingles shot 3 days before reporting and stated that it was the most painful injection he/she had ever had. The patient stated that he/she would get the 2nd shot because he/she does not want shingles. The patient asked if others found the shots to be painful. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Local reaction, Malaise
Clinical narrative: large local reaction with the first immunization; Not feeling good; This case was reported by a physician via sales rep and described the occurrence of local reaction in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local reaction and feeling unwell. On an unknown date, the outcome of the local reaction was unknown and the outcome of the feeling unwell was recovered/resolved.   The reporter considered the local reaction and feeling unwell to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR160058   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: Reporter was the patient. He reported not feeling good for 1 to 2 days after immunization with Shingrix. He had a large local reaction with the immunization. The patient asked if reported since he was a vaccine expert, he stated that he had not and these events were expected with Shingrix vaccine. The reporter did not consent to follow up. Additional supportive information: For the tolerance of the 2nd dose, refer linked case US2022AMR160058.; Sender's Comments:  US-GSK-US2022AMR160058:same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Small itchy spots; This case was reported by a consumer and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th October 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Nov-2022 Reporter's Comments: The patient self-reported this case. The patient received the 1st shot of Shingles and had small itchy spots on his/her torso and wanted to know how alarmed should he/she be.
Age: 35.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Exposure during pregnancy, Overdose
Clinical narrative: 28 weeks pregnant received FluLaval twice; Two doses of FluLaval given on the same day; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of overdose in a 35-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 7PN5D, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number 7PN5D, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FluLaval Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On 31st October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and not applicable after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the overdose and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   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: 02-NOV-2022 Reporter's Comment: The reporter reported that the patient was 28 weeks of pregnant and she received two doses of FluLaval Quadrivalent vaccines on the same day. The reporter asked for safety information and wanted to know how to proceed with this patient. The reporter did consent to follow up. Additional supportive information: The patient had received 2 dose of FluLaval Quadrivalent on the same day, which had led to overdose. The patient was 28 weeks pregnant at the time of receiving 2 doses of FluLaval Quadrivalent, Which led to the vaccine exposure during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was not reported if an autopsy was performed or not. Reporter reported that "The jab killed my dad. So your building has his blood on it. How do you sleep at night". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221107887-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: had a headache; tired; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (had a headache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Lymphoma in 2020. Concurrent medical conditions included Immunocompromised.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced HEADACHE (had a headache) and FATIGUE (tired). At the time of the report, HEADACHE (had a headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient's oncologist said she was "clinically cured " regarding the lymphoma. Did not mention any product or treatment that was involved in her possible lymphoma treatment. Patient had received the COVID-19 vaccine earlier today. It was Moderna's new COVID 19 vaccine.  Treatment drug was not reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia, Dysstasia, Fatigue, Illness
Clinical narrative: voice wasn't right; couldn't stand; felt wiped out/ had to lie down; positive for COVID; felt really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (positive for COVID), DYSSTASIA (couldn't stand), DYSPHONIA (voice wasn't right), ILLNESS (felt really sick) and FATIGUE (felt wiped out/ had to lie down) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (positive for COVID) and ILLNESS (felt really sick). On 22-Oct-2022, the patient experienced DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down). On 23-Oct-2022, the patient experienced DYSPHONIA (voice wasn't right). At the time of the report, COVID-19 (positive for COVID), DYSPHONIA (voice wasn't right) and ILLNESS (felt really sick) outcome was unknown and DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) took a home Covid test which was positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had received 2 primary doses and 2 booster doses of the Moderna vaccine followed by a dose of the Bivalent vaccine. The next morning she went to work where her symptoms continued, and she was encouraged by occupational health to go home. She came back to work the following day, but her voice wasn't right. She did not have a fever at that time. She saw her primary doctor on Thursday who stated her voice would start to come back.  Friday she felt really sick, and wiped out, so she went home. Saturday she had a problem and wanted to get a test. She took a home Covid test which was positive. Saturday night she took a downhill turn where she had to lie down. She woke up yesterday with nasal issues and congestion.  She took antiviral medications for 1 day, and felt a headache the day after that. She has an appointment with her doctor after this call today.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: voice wasn't right; couldn't stand; felt wiped out/ had to lie down; positive for COVID; felt really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (positive for COVID), DYSSTASIA (couldn't stand), DYSPHONIA (voice wasn't right), ILLNESS (felt really sick) and FATIGUE (felt wiped out/ had to lie down) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (positive for COVID) and ILLNESS (felt really sick). On 22-Oct-2022, the patient experienced DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down). On 23-Oct-2022, the patient experienced DYSPHONIA (voice wasn't right). At the time of the report, COVID-19 (positive for COVID), DYSPHONIA (voice wasn't right) and ILLNESS (felt really sick) outcome was unknown and DYSSTASIA (couldn't stand) and FATIGUE (felt wiped out/ had to lie down) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) took a home Covid test which was positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient had received 2 primary doses and 2 booster doses of the Moderna vaccine followed by a dose of the Bivalent vaccine. The next morning she went to work where her symptoms continued, and she was encouraged by occupational health to go home. She came back to work the following day, but her voice wasn't right. She did not have a fever at that time. She saw her primary doctor on Thursday who stated her voice would start to come back.  Friday she felt really sick, and wiped out, so she went home. Saturday she had a problem and wanted to get a test. She took a home Covid test which was positive. Saturday night she took a downhill turn where she had to lie down. She woke up yesterday with nasal issues and congestion.  She took antiviral medications for 1 day, and felt a headache the day after that. She has an appointment with her doctor after this call today.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A little bit of fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (A little bit of fever) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunosuppression NOS (arthritis). Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression NOS.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (A little bit of fever). At the time of the report, PYREXIA (A little bit of fever) outcome was unknown.            Patient stated that there were no side effects with first dose.  Treatment information was not provided.   This case was linked to MOD-2022-669886, MOD-2022-669892 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Sick for 2-3 days with headache and fever; Sick for 2-3 days with headache and fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Immunosuppression (Arthritis). Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever). At the time of the report, PYREXIA (Sick for 2-3 days with headache and fever) and HEADACHE (Sick for 2-3 days with headache and fever) had resolved.    Patient stated that there were no side effects with 1st dose. No treatment medication was provided. This case was linked to MOD-2022-669885 (Patient Link). Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: just a little bit / had some side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (just a little bit / had some side effects) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingrix (2nd shot had received recently and within 30 seconds patient knew he was sick and knocked on patient ass and was in bed for 4 days.) in 2022 and Shingrix (1st shot sore arm.). Past adverse reactions to the above products included Pain in arm with Shingrix; and Sickness with Shingrix. Concurrent medical conditions included Immunosuppression NOS (arthritis). Concomitant products included ETANERCEPT (ENBREL) for Immunosuppression.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (just a little bit / had some side effects). At the time of the report, VACCINATION COMPLICATION (just a little bit / had some side effects) outcome was unknown. Not Provided          On an unknown date, patient had received 1st shot of moderna vaccine and no side effects were observed. On an unknown date, patient had received 2nd shot moderna vaccine and experienced a little bit of fever. On an unknown date patient had received 3rd shot of moderna vaccine and experienced sick for 2 to 3 days with headache and fever.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-669885, MOD-2022-669886 (Patient Link).   Reporter did not allow further contact