chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site urticaria, Lip erythema, Lip swelling, Urticaria
Clinical narrative: About 1 hr after vaccine administration (patient already discharged from clinic), patient complained of itching & mother noted mild lip swelling No shortness of breath.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: About 1 hr after vaccine administration (patient already discharged from clinic), patient complained of itching & mother noted mild lip swelling No shortness of breath.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Lip swelling, Pruritus
Clinical narrative: About 1 hr after vaccine administration (patient already discharged from clinic), patient complained of itching & mother noted mild lip swelling No shortness of breath.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Acne, Eye disorder, Eye swelling, Lip swelling, Swelling face
Clinical narrative: Hives all over  body that itch, swelling red like mosquito bites . Had to go the emergency room on 11/25/2023 for swelling face, lips and numbness on left side of face. Had to go back the next day for same issues all of face, eye sockets 3 time the size and Lips the same. Treated with prednisone.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Hives all over  body that itch, swelling red like mosquito bites . Had to go the emergency room on 11/25/2023 for swelling face, lips and numbness on left side of face. Had to go back the next day for same issues all of face, eye sockets 3 time the size and Lips the same. Treated with prednisone.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Erythema, Hypoaesthesia, Lip swelling, Pruritus, Skin swelling
Clinical narrative: Hives all over  body that itch, swelling red like mosquito bites . Had to go the emergency room on 11/25/2023 for swelling face, lips and numbness on left side of face. Had to go back the next day for same issues all of face, eye sockets 3 time the size and Lips the same. Treated with prednisone.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives all over  body that itch, swelling red like mosquito bites . Had to go the emergency room on 11/25/2023 for swelling face, lips and numbness on left side of face. Had to go back the next day for same issues all of face, eye sockets 3 time the size and Lips the same. Treated with prednisone.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 0.25
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong vaccine was given. Child too young to receive Quadracel. No reactions to vaccine that we are aware of. No treatment needed. Child to finish childhood vaccines per the recommended schedule
Age: 0.25
Sex: M
Vaccine: DTAPIPV, HIBV, DTAPIPV, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong vaccine was given. Child too young to receive Quadracel. No reactions to vaccine that we are aware of. No treatment needed. Child to finish childhood vaccines per the recommended schedule
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not report any side effects or adverse issues from the administration of the expired dose of GARDASIL 9; an expired dose of GARDASIL 9 (Lot: U028825 Expiration: 11/02/2023 with no previous temperature excursions) that was inadvertently administered to a patient on 12/18/2023; This spontaneous report was received from a consumer referring to an 18-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 18-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5mL / once, lot#: U028825, expiration date: 02-NOV-2023; strength) by a certified medical assistance inadvertently for prophylaxis (expired product administered). The vaccine administered did not experience any temperature excursion before. The patient did not report any side effects or adverse issues from the administration of the expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (no adverse event).
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of twinrix on 11 August 2022 and second dose of 17 January 2023; 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 56-year-old female patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included twinrix (on 11th August 2022 received 1st dose.).   On 17-JAN-2023, the patient received the 2nd dose of Twinrix (left arm). On 17-JAN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of twinrix on 11 August 2022 and second dose of 17 January 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 18-DEC-2023 A pharmacist reported that a patient received the first dose of Twinrix on 11 August 2022 and second dose of 17 January 2023.  The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired Boostrix dose to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   On 19-DEC-2023, the patient received Boostrix. On 19-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Boostrix dose to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-DEC-2023 A nurse reported that the administration of an expired Boostrix dose to a patient which led to expired vaccine used. The HCP asked if the dose was considered valid or if it should be repeated.  The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: a 19 year old patient was administered a pediatric dose of Havrix; a 19 year old patient was administered a pediatric dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 19-year-old female patient who received HAV (Havrix pediatric) (batch number D7HA9, expiry date 27-OCT-2024) for prophylaxis.   On 18-DEC-2023, the patient received Havrix pediatric. On 18-DEC-2023, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: a 19 year old patient was administered a pediatric dose of Havrix) and underdose (Verbatim: a 19 year old patient was administered a pediatric dose of Havrix). The outcome of the adult use of a child product and underdose 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: 20-DEC-2023 A nurse reported that on December 18th of this year, a 19-year-old patient was administered a pediatric dose of Havrix which led to Adult use of a child product and underdose. The reporter consented to follow up by email.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Brain natriuretic peptide, C-reactive protein, Catheterisation cardiac, Chest X-ray
Clinical narrative: Pericarditis - reoccurent. Currently receiving treatment as of 12/2023. Multiple flare ups since initial diagnosis in October 2021 which required ICU hospitalization. Symptoms include severe chest pain, shortness of breath, fatigue, weakness, rapid pulse. Initial incidence lasted approx. 5 weeks from onset of symptoms to diagnosis. Many days of work missed during each flare up, resulting in loss of income during those times. Daily life has been altered significantly due to restrictions ordered by cardiologist.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Pericarditis - reoccurent. Currently receiving treatment as of 12/2023. Multiple flare ups since initial diagnosis in October 2021 which required ICU hospitalization. Symptoms include severe chest pain, shortness of breath, fatigue, weakness, rapid pulse. Initial incidence lasted approx. 5 weeks from onset of symptoms to diagnosis. Many days of work missed during each flare up, resulting in loss of income during those times. Daily life has been altered significantly due to restrictions ordered by cardiologist.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Impaired work ability, Intensive care, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Pericarditis - reoccurent. Currently receiving treatment as of 12/2023. Multiple flare ups since initial diagnosis in October 2021 which required ICU hospitalization. Symptoms include severe chest pain, shortness of breath, fatigue, weakness, rapid pulse. Initial incidence lasted approx. 5 weeks from onset of symptoms to diagnosis. Many days of work missed during each flare up, resulting in loss of income during those times. Daily life has been altered significantly due to restrictions ordered by cardiologist.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Metabolic function test, Pericarditis, Troponin
Clinical narrative: Pericarditis - reoccurent. Currently receiving treatment as of 12/2023. Multiple flare ups since initial diagnosis in October 2021 which required ICU hospitalization. Symptoms include severe chest pain, shortness of breath, fatigue, weakness, rapid pulse. Initial incidence lasted approx. 5 weeks from onset of symptoms to diagnosis. Many days of work missed during each flare up, resulting in loss of income during those times. Daily life has been altered significantly due to restrictions ordered by cardiologist.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Pain in extremity
Clinical narrative: cold; chills; The next day she felt super tired; at night her arm felt very sore.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (at night her arm felt very sore.), NASOPHARYNGITIS (cold), CHILLS (chills) and FATIGUE (The next day she felt super tired) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 19-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (at night her arm felt very sore.). On 20-Dec-2023, the patient experienced NASOPHARYNGITIS (cold), CHILLS (chills) and FATIGUE (The next day she felt super tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (at night her arm felt very sore.), NASOPHARYNGITIS (cold) and CHILLS (chills) had not resolved and FATIGUE (The next day she felt super tired) outcome was unknown.            No concomitant medication was reported.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: medication error due to administration of expired vaccine with no reported adverse event; Initial information received on 18-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 36 years old female patient who experienced medication error due to administration of expired typhoid VI polysaccharide vaccine [typhim VI] 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 HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination.  On 01-Dec-2023, the patient received a 0.5 ml dose of suspect typhoid VI polysaccharide vaccine Solution for injection (lot U2A471M, expiry date: 02-NOV-2023 with unknown strength) via intramuscular route in the left deltoid as Immunization that was medication error due to administration of expired vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported "the nurse who reported and the physician who gave the TYPHIM VI dose were not from the same hospital so nurse said that she cannot give more information in case there is a follow up. She gave the information of the physician documented in the patient's profile but she is not sure if it is the same physician who ordered for the administration."   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: 55.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received a single dose vial of Boostrix which was already unscrewed 3 days before   This was only used on her No adverse reading No muscle adverse/redness No symptoms
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP called to report that a dose of GARDASIL 9 with the Lot: U029622 and EXP: 10/26/2023, was given to a single patient on 11/28/2023. The patient has no signs, symptoms or issues to report. HCP has no additional AE information. Declined to give pati; Medication error ocurred at preparation for administration; This spontaneous report was received from a licensed practical nurse (LPN) regarding a patient.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-NOV-2023, the patient received an expired vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once (valid lot #U029622 with expiration date on 26-OCT-2023) administered for prophylaxis (strength and route of administration not reported). The patient had no signs or symptoms or presented any adverse event (No adverse event). There was no additional information reported.   Follow-up information was received from the LPN on 21-DEC-2023, referring to the 26-year-old female patient. The patient had no known allergies and had no illness at the time of vaccination.   On 28-NOV-2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at her left deltoid. It was stated that the error occurred at preparation for administration and that the vaccine was administered by a medical assistant at a private doctor's office/hospital and was purchased with private funds.  This case was previously considered as a non-valid case due to lack of patient's identifiers; however, in follow-up version the patient's identifiers were provided and for that reason the case is now considered to be a valid case.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No other AE; an expired dose of GARDASIL 9 was administered to a patient on 12/21/2023.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-DEC-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: 1775811, expiration date: 07-DEC-2023; strength, dose, and route of administration were not reported) by a health professional for prophylaxis (expired product administered). No symptoms or additional details provided.  No other adverse events (AE) were reported (no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Pain
Clinical narrative: Fatique; sore all over; diarrhea; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 83-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 14-DEC-2023, the patient received Arexvy .5 ml. On 15-DEC-2023, 1 days after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatique), general body pain (Verbatim: sore all over) and diarrhea (Verbatim: diarrhea). The outcome of the fatigue, general body pain and diarrhea were resolving.   It was unknown if the reporter considered the fatigue, general body pain and diarrhea to be related to Arexvy.     It was unknown if the company considered the fatigue, general body pain and diarrhea to be related to Arexvy.   Additional Information: GSK receipt date: 16-DEC-2023 This report was submitted via the online direct entry reporting system.  The patient self-reported this case. The patient received Arexvy (120 MCG), manufacturer unspecified with national drug code (NDC) 58160-0848-11 and experienced extreme fatique, soreness all over and diarrhea. The symptoms were not treated. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: I have all of the side effects. Not a good feeling; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced feeling bad (Verbatim: I have all of the side effects. Not a good feeling). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Arexvy.     It was unknown if the company considered the feeling bad to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-DEC-2023 The case was received from the patient via interactive digital media. The patient reported he/she had all of the side effects and it was not a good feeling. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: PAIN IN INJECTION AREA AND JOINTS; PAIN IN INJECTION AREA AND JOINTS; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: PAIN IN INJECTION AREA AND JOINTS) and joint pain (Verbatim: PAIN IN INJECTION AREA AND JOINTS). The outcome of the injection site pain and joint pain were not reported.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-DEC-2023 The patient experienced pain in injection area and joints.
Sex: U
Vaccine: VARZOS
Symptoms: Device connection issue, Occupational exposure to product
Clinical narrative: When they injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site.; When they injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of occupational exposure while preparing product for administration in a patient who received Herpes zoster (Shingrix) (batch number 22TX7, expiry date 06-DEC-2025) and (batch number 5SG54, expiry date 06-DEC-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: When they injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site.) and exposure via skin contact (Verbatim: When they injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site.). The outcome of the occupational exposure while preparing product for administration and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 The reporter was nurse. The reporter reported that two very experienced nurses had trouble preparing Shingrix vaccine. They injected the diluent into the antigen vial, it sprayed back in their face around the needle insertion site which led to occupational exposure while preparing product for administration and exposure via skin contact. The reporter consented to follow up granted. This case is linked with US2023173284, reported by second patient.; Sender's Comments:  US-GSK-US2023173284:2nd patient
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: shortness of breath the day after receiving the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of shortness of breath in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-DEC-2023, the patient received Arexvy. On 16-DEC-2023, 1 days after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath the day after receiving the vaccine). The outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Arexvy.     It was unknown if the company considered the shortness of breath to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter was a patient. The reporter reported that she developed shortness of breath the day after receiving the Arexvy vaccine.  The reporter did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: My daughter was given the Meningococcal vaccine (Bexsero) vaccine instead of Hepatitis A (Havrix) vaccine; 4 years old patient received Bexsero; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 15-DEC-2023, the patient received Bexsero. On 15-DEC-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: My daughter was given the Meningococcal vaccine (Bexsero) vaccine instead of Hepatitis A (Havrix) vaccine) and inappropriate age at vaccine administration (Verbatim: 4 years old patient received Bexsero). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Dec-2023 The reporter was the parent of the patient. The reporter reported that his or her daughter received Meningococcal vaccine Bexsero instead of Hepatitis A Havrix vaccine on Friday, which led to wrong vaccine administered. The reporter was told to call this number to see what to expect.  The patient was 4 years old and caller disconnected call at that time. The patient received Bexsero vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Pneumonia
Clinical narrative: hospitalized for a pneumonia; some point developed Guillain-Barré; This serious case was reported by a pharmacist via sales rep and described the occurrence of pneumonia in a 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, an unknown time after receiving Shingrix, the patient experienced pneumonia (Verbatim: hospitalized for a pneumonia) (serious criteria hospitalization and GSK medically significant) and guillain barre syndrome (Verbatim: some point developed Guillain-Barré) (serious criteria GSK medically significant). The outcome of the pneumonia was not reported and the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the pneumonia and guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the pneumonia and guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 19-DEC-2023 A pharmacist reported that a patient received his 1st dose of the Shingrix vaccine. He was then hospitalized for a pneumonia and discharged, after discharge from the hospital he went home and at some point developed Guillain-Barré.  The time frame from Shingrix 1st dose and Guillain-Barre development was approximately 6 months.  No further information was available at time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Decreased appetite, Fatigue, Jaundice
Clinical narrative: patient experienced jaundice; Exhaustion; Loss of appetite; This serious case was reported by a other health professional via sales rep and described the occurrence of jaundice in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced jaundice (Verbatim: patient experienced jaundice) (serious criteria hospitalization), exhaustion (Verbatim: Exhaustion) (serious criteria hospitalization) and appetite lost (Verbatim: Loss of appetite) (serious criteria hospitalization). The outcome of the jaundice, exhaustion and appetite lost were unknown.   It was unknown if the reporter considered the jaundice, exhaustion and appetite lost to be related to RSV vaccine.     It was unknown if the company considered the jaundice, exhaustion and appetite lost to be related to RSV vaccine.   Additional Information: GSK receipt date: 19-DEC-2023 The reporter was an office manager and reported via text. The reporter was not told which brand of RSV vaccine was involved in the adverse event. The reporter stated that a patient received a RSV vaccine in conjunction with a high dose influenza vaccine and the patient experienced jaundice, exhaustion, loss of appetite, and was hospitalized. Patient was in the hospital at the time of reporting. The reporter did not know if the vaccines were administered at the physician's office reporting the adverse event. It was unknown if the reporter considered the jaundice, exhaustion and appetite lost to be related to Influenza vaccine. No further information available. The reporter denied consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Magnetic resonance imaging, Optic ischaemic neuropathy, Visual impairment
Clinical narrative: Optic Ischemic Neuropathy; lost 25% of in the right eye; This serious case was reported by a consumer via call center representative and described the occurrence of ischemic optic neuropathy in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cataract extraction (cataract surgery in right eye was done on 14th February 2023).   In MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced ischemic optic neuropathy (Verbatim: Optic Ischemic Neuropathy) (serious criteria GSK medically significant) and partial visual loss (Verbatim: lost 25% of in the right eye). The outcome of the ischemic optic neuropathy was unknown and the outcome of the partial visual loss was not reported.   It was unknown if the reporter considered the ischemic optic neuropathy and partial visual loss to be related to Shingrix.     It was unknown if the company considered the ischemic optic neuropathy and partial visual loss to be related to Shingrix.   Additional Information: GSK receipt date:19-DEC-2023 The reporter was patient. The patient received 1st dose of Shingrix and ten days later he lost about 25 percent of the vision of the right eye (vision) and he was diagnosed with optic ischemic neuropathy. According to the patient he had an MRI on 18th July 2023 to made sure a vascular problem was not causing this issue. The patient has not received the second dose Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 6 months to get the Shingrix second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse drug reaction (On an unknown date, received first dose and  had some normal expected reactions after an injection but nothing weird). Additional patient notes included not immunocompromised .   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: more than 6 months to get the Shingrix second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The reporter called from her personal phone to request medical guidance on a not immunocompromised patient around 60 years that had wait more than 6 months to get the Shingrix second dose. Reporter added that after Shingrix first dose the patient had some normal expected reactions after an injection but nothing weird. At the moment of the call patient had not received any Shingrix second dose. At the moment of the call reporter did not had much information available about this case. No data about patient information, side effects, lot numbers or dates of administration. The reporter consented to follow-up. Till time of reporting patient did not receive the Shingrix second dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Laboratory test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; REVACCINATION WITH A DIFFERENCE COVID-19 VACCINE; REBOUND OF SYMPTOMS TESTED POSITIVE AFTER BEING NEGATIVE; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 08-DEC-2023 was received on 08-DEC-2023 and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscularly, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Pfizer covid-19 vaccine (Dose number in series 2), (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 22-NOV-2023 to 27-NOV-2023 for covid-19 prophylaxis. No concomitant medications were reported. On 01-DEC-2023, the patient experienced suspected clinical vaccination failure (Dose number in series 1), revaccination with a difference covid-19 vaccine (Dose number in series 1), and rebound of symptoms tested positive after being negative (Dose number in series 1). Laboratory data (dates unspecified) included: Lab test Positive. The action taken with covid-19 vaccine ad26.cov2.s and tozinameran was not applicable. The patient was recovering from suspected clinical vaccination failure, and the outcome of revaccination with a difference covid-19 vaccine and rebound of symptoms tested positive after being negative was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000307104. The suspected product quality complaint has been confirmed to be track wise number- 90000307104: category-medical adverse event / potency / lack of effect / decreased effect - undetermined. the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.  Additional information was received from Agency on 18-DEC-2023.The following information was updated and incorporated into the case narrative: Other identification number, product quality complaint number, and  product quality disposition result was updated.; Sender's Comments: V1:  The follow up information in this version updates about PQC details. It does not change the causality assessment of the previously reported events. Vaccination failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: I just got a Spikevax, uh vaccine and I did not realize that I had gotten one already about three months ago when it first came out; She received Spikevax on 22Sep2023 and Spikevax (lot number 3030701) again on 20Dec2023; She reports a little bit of achiness and sore arm; She reports a little bit of achiness and sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She reports a little bit of achiness and sore arm), PAIN (She reports a little bit of achiness and sore arm.), EXTRA DOSE ADMINISTERED (I just got a Spikevax, uh vaccine and I did not realize that I had gotten one already about three months ago when it first came out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received Spikevax on 22Sep2023 and Spikevax (lot number 3030701) again on 20Dec2023) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030701) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 20-Dec-2023, received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (She reports a little bit of achiness and sore arm) and PAIN (She reports a little bit of achiness and sore arm.). On 20-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXTRA DOSE ADMINISTERED (I just got a Spikevax, uh vaccine and I did not realize that I had gotten one already about three months ago when it first came out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received Spikevax on 22Sep2023 and Spikevax (lot number 3030701) again on 20Dec2023). At the time of the report, PAIN IN EXTREMITY (She reports a little bit of achiness and sore arm), PAIN (She reports a little bit of achiness and sore arm.), EXTRA DOSE ADMINISTERED (I just got a Spikevax, uh vaccine and I did not realize that I had gotten one already about three months ago when it first came out) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received Spikevax on 22Sep2023 and Spikevax (lot number 3030701) again on 20Dec2023) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received the second dose on her upper left arm. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2023: Live significant follow-up received: reported details updated, patient age and gender added, product coding updated, new events added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache
Clinical narrative: Elevated temperature; Chills; Headaches; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (Elevated temperature), CHILLS (Chills) and HEADACHE (Headaches) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Dec-2023, the patient experienced BODY TEMPERATURE INCREASED (Elevated temperature), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, BODY TEMPERATURE INCREASED (Elevated temperature), CHILLS (Chills) and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2023, Body temperature: Elevated.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient experienced severe chills, severe headaches and elevated temperature. Treatment information was not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) 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)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.        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.   No concomitant medication was reported.  Patient has received the bivalent spaced out in between doses in the past couple of years. He was also recovering from the COVID virus at this time. He was outside of his 10-day isolation window and was asymptomatic.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2023: Live Follow-up significant information received on 19-Dec-2023: Reference updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bronchitis, Headache, Malaise, Pyrexia
Clinical narrative: Bronchitis; Sinus drainage; Malaise; High fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 15-Dec-2023, the patient experienced BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache). At the time of the report, BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 degrees F, High.         Concomitant medication was not provided. Approximately 10 hours after injection, patient developed chills and high fever. Fever was accompanied by headache, sinus drainage, and body aches which lasted about 10 hours despite anti-pyretic. Over the next 6 days continued low grade fever and malaise. Additionally, on day 3 a sore throat and productive cough began with other symptoms of bronchitis. The productive cough and malaise continued with low grade fever which caused her to seek medical care.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus operation
Clinical narrative: Bronchitis; Sinus drainage; Malaise; High fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 15-Dec-2023, the patient experienced BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache). At the time of the report, BRONCHITIS (Bronchitis), SINUS OPERATION (Sinus drainage), MALAISE (Malaise), PYREXIA (High fever) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 degrees F, High.         Concomitant medication was not provided. Approximately 10 hours after injection, patient developed chills and high fever. Fever was accompanied by headache, sinus drainage, and body aches which lasted about 10 hours despite anti-pyretic. Over the next 6 days continued low grade fever and malaise. Additionally, on day 3 a sore throat and productive cough began with other symptoms of bronchitis. The productive cough and malaise continued with low grade fever which caused her to seek medical care.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Long term fatigue heavy legs; Long term fatigue heavy legs; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Long term fatigue heavy legs) and FATIGUE (Long term fatigue heavy legs) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 210F232A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FATIGUE (Long term fatigue heavy legs). On an unknown date, the patient experienced LIMB DISCOMFORT (Long term fatigue heavy legs). At the time of the report, LIMB DISCOMFORT (Long term fatigue heavy legs) outcome was unknown and FATIGUE (Long term fatigue heavy legs) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant medication was not provided. Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: she felt tired but not fatigued.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (she felt tired but not fatigued.) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.    On 20-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced FATIGUE (she felt tired but not fatigued.). At the time of the report, FATIGUE (she felt tired but not fatigued.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2023, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that the next day, 21-Dec-2023 and on the day of reporting 22-Dec-2023, patient stated that she was exhausted. It was also reported that patient was not sure if she had 4 or 5 shots prior to this one. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The callers son's boss complains of the same types of pain in her injection arm shoulder after receiving her Spikevax 2023 2024 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The callers son's boss complains of the same types of pain in her injection arm shoulder after receiving her Spikevax 2023 2024 vaccine) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The callers son's boss complains of the same types of pain in her injection arm shoulder after receiving her Spikevax 2023 2024 vaccine). At the time of the report, VACCINATION SITE PAIN (The callers son's boss complains of the same types of pain in her injection arm shoulder after receiving her Spikevax 2023 2024 vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-754629 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-754629:Same Reporter Different Patient