chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: they inadvertently administered an expired Fluarix (exp:6/30/23) vaccine this morning on 10/16/23 to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30-JUN-2023) for prophylaxis.   On 16-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season (right deltoid). On 16-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: they inadvertently administered an expired Fluarix (exp:6/30/23) vaccine this morning on 10/16/23 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: 16-OCT-2023 The reporter was medical assistant. The reporter called to inquire that how to proceed and would the patient need to be revaccinated. The reporter reported that they inadvertently administered an expired Fluarix vaccine this morning to a patient in the right deltoid, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix a few weeks ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose.) and Shingrix (received 2nd dose about 3 years ago.).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Shingrix a few weeks ago). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 16-OCT-2023 A pharmacist states a patient received a 3rd dose of Shingrix a few weeks ago (about 3 years after the 2nd dose) which led to extra dose administered.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: He has not received his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He has not received his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter was the patient who stated that he had not received his second dose of Shingrix. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: pt. received 2 of the liquid (adjuvant) portion of Arexvy only; pt. received 2 of the liquid (adjuvant) portion of Arexvy only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F3Z39, expiry date 25-APR-2026) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: pt. received 2 of the liquid (adjuvant) portion of Arexvy only) and inappropriate dose of vaccine administered (Verbatim: pt. received 2 of the liquid (adjuvant) portion of Arexvy only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter reported that patient received 2 of the liquid (adjuvant) portion of Arexvy only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported. The reporter consented to follow up via email.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired dose of Shingrix to a patient yesterday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 10-SEP-2023) for prophylaxis.   On 15-OCT-2023, the patient received Shingrix. On 15-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired dose of Shingrix to a patient yesterday). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Oct-2023 The registered pharmacist reported that street address provided was in adverse event form but might be the same as in health care professional's contact record. The reporter consented to follow-up. The patient received an expire dose of Shingrix, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.; Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.) and inappropriate dose of vaccine administered (Verbatim: Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Oct-2023 Registered nurse gave permission for follow-up for patient demographics, lot and expiration date of Menveo and administration dates. Menveo (2-vial) was reconstituted with sterile water and not the supplied diluent and administered to a patient, which led to wrong vaccine used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   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: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter stated that her mother received a single dose of Shingrix in 2019 and never received her second dose. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on her right knee; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in September of 2007 on right side of ribs) and shingles (had another case of shingles in May 2023 on right leg outside of knee).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on her right knee). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter was a patient. The reporter stated that after her vaccination with Shingrix, she developed shingles on her right knee. When she developed shingles after the vaccine, the shingles was on the same site as her last episode (right leg) The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product preparation error, Product preparation issue
Clinical narrative: vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product preparation error (Verbatim: vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe). The outcome of the intercepted product preparation error was unknown.   Additional Information: GSK Receipt Date: 16-OCT-2023 The pharmacist called to report one Arexvy vaccine was reconstituted and drawn into a syringe, then by mistake another diluent was drawn in the same syringe with first vaccine still there (Intend was to reconstitute a second Arexvy vaccine) which led to intercepted product preparation error. Then pharmacist realized that the first vaccine was still in the syringe so called for guidance to what to do with the syringe that contains 1 Arexvy vaccine plus another diluent mixed together. The reporter did not consent to follow-up. The vaccine administration facility is the same as primary reporter. No lot number was reported. No patients were involved, the vaccine was not administered at the moment of call.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Pain in extremity, Rash
Clinical narrative: she experienced fatigue; she experienced redness on her arm; she experienced muscle pain; she experienced aches; she experienced rash from her shoulders and across her chest; she experienced leg pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-OCT-2023, the patient received the 1st dose of Shingrix. On 13-OCT-2023, 2 days after receiving Shingrix, the patient experienced fatigue (Verbatim: she experienced fatigue), erythema of extremities (Verbatim: she experienced redness on her arm), muscle pain (Verbatim: she experienced muscle pain), pain (Verbatim: she experienced aches), rash (Verbatim: she experienced rash from her shoulders and across her chest) and leg pain (Verbatim: she experienced leg pain). The outcome of the fatigue, erythema of extremities, muscle pain, pain, rash and leg pain were not resolved.   It was unknown if the reporter considered the fatigue, erythema of extremities, muscle pain, pain, rash and leg pain to be related to Shingrix.     It was unknown if the company considered the fatigue, erythema of extremities, muscle pain, pain, rash and leg pain to be related to Shingrix.   Additional Information: GSK receipt date: 17-Oct-2023 The patient who received her first dose of Shingrix and 2 days after the dose she experienced fatigue, aches, muscle pain, redness on her arm, rash from her shoulders and across her chest, and leg pain.  Did not consent to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 4th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination 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: 17-OCT-2023 The pharmacist called to inform that a patient received the 1st dose of Havrix back on 04th October 2022 had not received the 2nd dose yet. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Overdose, Product preparation issue
Clinical narrative: Admin of 2 adjuvants only at the same time; 2 adjuvants only were administered.; 2 adjuvants only were administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ9F7, expiry date 08-JUL-2024) and (batch number EC4CN) for prophylaxis.   On 29-SEP-2023, the patient received the 1st dose of Shingrix. On 29-SEP-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: Admin of 2 adjuvants only at the same time), inappropriate preparation of medication (Verbatim: 2 adjuvants only were administered.) and inappropriate dose of vaccine administered (Verbatim: 2 adjuvants only were administered.). The outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 Pharmacist states they were administering the first dose of Shingrix to a patient and 2 adjuvants only were administered which led to overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The lot numbers are the same for both the adjuvants. EC4CN is lot number from the adjuvant vial. Expiry date pulled from batch identifier.  The reporter consented to follow up via postal.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache) and chills (Verbatim: chills). The outcome of the headache and chills were resolved.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.   It was unknown if the company considered the headache and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was the patient who received his Shingrix 6 months ago from the day of reporting.  He stated that after the dose, he had headache and chills which lasted 2-3 days. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix exposed at negative temperatures; This non-serious case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrix exposed at negative temperatures). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 It was reported that Shingrix was exposed at negative temperatures minus 0.9 degree Celsius was the minimum in several occasions and probably administered to patients (no patients information provided) which led to incorrect storage of drug. The reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: noticed that a Menveo Vaccine expired 30/SEP/2023 but was administered today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva725z, expiry date 30-SEP-2023) for prophylaxis.   On 17-OCT-2023, the patient received Menveo. On 17-OCT-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: noticed that a Menveo Vaccine expired 30/SEP/2023 but was administered today). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 The reporter was a nurse at a healthcare facility that was going thru paperwork at the time of reporting and noticed that a Menveo vaccine expired but was administered at the time of reporting, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: his first Shingrix dose (received March, 2019), as it has been more than 6 months from the first; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2019).   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: his first Shingrix dose (received March, 2019), as it has been more than 6 months from the first). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient asked if he should repeat his first Shingrix dose, as it had been more than 6 months from the first. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: patient thinks they may have received Shingrix via subcutaneous route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: patient thinks they may have received Shingrix via subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 18-Oct-2023 No further details regarding patient or product available. The reporter consented to follow-up. The patient thought he or she might had received Shingrix via subcutaneous route which led to intramuscular formulation administered by other route.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: a male patient received an expired dose of Shingrix on 16Oct2023. The vaccine expired on 06Oct2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number PH2R2, expiry date 06-OCT-2023) for prophylaxis.   On 16-OCT-2023, the patient received the 2nd dose of Shingrix. On 16-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: a male patient received an expired dose of Shingrix on 16Oct2023. The vaccine expired on 06Oct2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 A pharmacist reported that a patient received an expired dose of Shingrix on 16th October 2023. The vaccine expired on 06th October 2023, which led to Expired vaccine used. The HCP did not have the patient's DOB. The expired dose was the 2nd dose in the series. HCP consented to follow-up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fall, Immediate post-injection reaction, Tremor
Clinical narrative: Shortly thereafter he got dizzy; falling; disoriented; he has right upper extremity tremors; This serious case was reported by a physician via call center representative and described the occurrence of dizziness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, immediately after receiving Shingrix, the patient experienced dizziness (Verbatim: Shortly thereafter he got dizzy) (serious criteria hospitalization), fall (Verbatim: falling) (serious criteria hospitalization), disorientation (Verbatim: disoriented) (serious criteria hospitalization) and tremor limb (Verbatim: he has right upper extremity tremors) (serious criteria hospitalization). The outcome of the dizziness, fall, disorientation and tremor limb were unknown.   It was unknown if the reporter considered the dizziness, fall, disorientation and tremor limb to be related to Shingrix.     It was unknown if the company considered the dizziness, fall, disorientation and tremor limb to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The healthcare professional stated that he had 2 patients to report. The reporter stated that the patient got Shingrix (did not have date) and shortly thereafter he got dizzy, falling, and disoriented. The patient also mentioned he had right upper extremity tremors.  This report 1 of 2. The reporter consented to follow up. This case had been linked with US2023144346 due to same reporter.; Sender's Comments:  US-GSK-US2023144346:Patient 1 of 2
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: patient experienced weakness; This serious case was reported by a physician via call center representative and described the occurrence of weakness in a adult female 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 weakness (Verbatim: patient experienced weakness) (serious criteria hospitalization). The outcome of the weakness was unknown.   It was unknown if the reporter considered the weakness to be related to Shingrix.     It was unknown if the company considered the weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The healthcare professional stated that patient in her 50's had Shingrix (no date or site). The patient experienced weakness and was admitted to the hospital and now was still in a rehab center. The reporter consented to follow up. This case is linked with US2023144348, reported by same reporter.; Sender's Comments:  US-GSK-US2023144348:Patient 1 of 2
Sex: F
Vaccine: RSV
Symptoms: Cough, Pneumonia viral, Pyrexia, Wheezing
Clinical narrative: viral pneumonia; wheezing; coughing; fever; This serious case was reported by a nurse via sales rep and described the occurrence of viral pneumonia in a 89-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On an unknown date, the patient received Arexvy. On an unknown date, 24 hrs after receiving Arexvy, the patient experienced viral pneumonia (Verbatim: viral pneumonia) (serious criteria GSK medically significant), wheezing (Verbatim: wheezing), cough (Verbatim: coughing) and fever (Verbatim: fever). The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)) and steroids nos (Steroids). The outcome of the viral pneumonia, wheezing, cough and fever were unknown.   It was unknown if the reporter considered the viral pneumonia, wheezing, cough and fever to be related to Arexvy.     It was unknown if the company considered the viral pneumonia, wheezing, cough and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 Reporter reported that the patient received Covid vaccine and 5 days later she received the Arexvy vaccine. 24 hours after receiving Arexvy vaccine, the patient experienced fever, coughing, wheezing and viral pneumonia. The patient was treated with an antibiotic and steroid. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix B pediatric dose administered to 2 adult patients; Engerix B  pediatric dose administered to 2 adult patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 59-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 25-SEP-2023, the patient received Engerix B pediatric. On 25-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix B pediatric dose administered to 2 adult patients) and adult use of a child product (Verbatim: Engerix B  pediatric dose administered to 2 adult patients). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Engerix B pediatric dose administered to adult patient, which led to underdose and adult use of a child product. Same lot number and expiration date for both vaccines. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023145301 reported by the same reporter. ; Sender's Comments:  US-GSK-US2023145301:another adult patient./ same product and same event
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (pain at the injection site) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. EN6204 and EN6199) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor.    On 09-Mar-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE PAIN (pain at the injection site) had not resolved. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-746446.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Induration
Clinical narrative: thigh reaction; the area was hot to the touch and hard; This spontaneous case was reported by a medical assistant and describes the occurrence of CONTUSION (thigh reaction) and INDURATION (the area was hot to the touch and hard) in a child patient of an unknown gender who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (thigh reaction) and INDURATION (the area was hot to the touch and hard). At the time of the report, CONTUSION (thigh reaction) and INDURATION (the area was hot to the touch and hard) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746628 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746628:Same Reporter for other patients
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: previous Moderna doses she felt arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (previous Moderna doses she felt arm sore) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (previous Moderna doses she felt arm sore). At the time of the report, PAIN IN EXTREMITY (previous Moderna doses she felt arm sore) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patient felt arm sore for maybe a few days with previous Moderna doses, but with this new one, didn't feel anything at all, absolutely nothing and patient was also wanted to know, if it is possible that maybe the vaccination provider administered the vaccine wrong and maybe then the vaccine was not working.   This case was linked to US-MODERNATX, INC.-MOD-2023-746617 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746617:Same patient, different dose
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: fever; chill; nausea; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), CHILLS (chill) and NAUSEA (nausea) in a 91-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 17-Oct-2023, the patient experienced PYREXIA (fever), CHILLS (chill) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chill) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   Treatment medication not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Migraine, Nausea
Clinical narrative: migraine; other body aches; abdominal pain; headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Myelitis transverse (declared better 2years ago). Previously administered products included for Product used for unknown indication: Flu shot on 10-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot.   On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose once. On 11-Oct-2023, the patient experienced MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.     No concomitant medications were reported. Day of shot just a little tired. Day 2: Headache, fatigue, nausea, abdominal pain, other body aches. Day 3 same as day 2 with minor improvement. Day 4 still fatigued with abdominal pain. Day 5 more easily fatigued but mostly normal. Day 7 major migraine causing nausea plus fatigue. Day 8 return of abdominal pain with fatigue and body aches. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: migraine; other body aches; abdominal pain; headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Myelitis transverse (declared better 2years ago). Previously administered products included for Product used for unknown indication: Flu shot on 10-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot.   On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose once. On 11-Oct-2023, the patient experienced MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MIGRAINE (migraine), PAIN (other body aches), ABDOMINAL PAIN (abdominal pain), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.     No concomitant medications were reported. Day of shot just a little tired. Day 2: Headache, fatigue, nausea, abdominal pain, other body aches. Day 3 same as day 2 with minor improvement. Day 4 still fatigued with abdominal pain. Day 5 more easily fatigued but mostly normal. Day 7 major migraine causing nausea plus fatigue. Day 8 return of abdominal pain with fatigue and body aches. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue after 18 hours; Fever of 102.5°F; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue after 18 hours) and PYREXIA (Fever of 102.5°F) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 19-Oct-2023, the patient experienced FATIGUE (Fatigue after 18 hours). 19-Oct-2023, the patient experienced PYREXIA (Fever of 102.5°F). At the time of the report, FATIGUE (Fatigue after 18 hours) and PYREXIA (Fever of 102.5°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5A°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: flu like symptoms; achy and had pain shooting through her muscles; achy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy and had pain shooting through her muscles) and PAIN (achy) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor.     On 13-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 15-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). In October 2023, the patient experienced PAIN (achy and had pain shooting through her muscles) and PAIN (achy). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy and had pain shooting through her muscles) and PAIN (achy) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-746389 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746389:Husband's case
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Gingival discomfort, Lip swelling, Pain in extremity
Clinical narrative: Felt like something was caught up under their upper gum; Normal arm hurt; Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged), GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt) in a 79-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Heart disease, unspecified: Isosorbide (Isosorbide for heart); for Blood cholesterol abnormal: Baby Aspirin (A medicine for cholesterol). Past adverse reactions to the above products included No adverse effect with Baby Aspirin and Isosorbide.   On 17-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 17-Oct-2023, the patient experienced LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged). On an unknown date, the patient experienced GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt). At the time of the report, LIP SWELLING (Lips starting to get larger. one side of their upper lip has enlarged and half of upper lip is really enlarged), GINGIVAL DISCOMFORT (Felt like something was caught up under their upper gum) and LIMB INJURY (Normal arm hurt) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had received all Moderna previously: First dose on 07-Jan-2021 with batch no. 025L20A, second dose on 04-Feb-2021 with batch no. 032L20A, third dose on 31-Aug-2021 with batch no. 2C2119 and fourth dose on 04-Apr-2022 with batch no. 002M21A, fifth dose on 10-Jul-2022 with batch no. as 002M21A, sixth dose on 28-Oct-2022 with batch no. 013H22A. Caller reported that other than the normal arm hurt, patient felt like something was caught up under the upper gum, lips started to get larger. Patient woke up with one side of the upper lip enlarged and half of upper lip was really enlarged.  Treatment information was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site; She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site) and INJECTION SITE SWELLING (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site) and INJECTION SITE SWELLING (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site). At the time of the report, INJECTION SITE PAIN (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site) and INJECTION SITE SWELLING (She says that after she received the second dose, she had pain in her right arm and a golf ball sized swelling popped up at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that over the years the patient had received a mix of the Moderna COVID-19 and Pfizer COVID-19 vaccines. For the Moderna, the patient only had a reaction to the second dose.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-566932 (E2B Linked Report). This case was linked to MOD-2023-746425 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-566932:Same reporter Different patient
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Swelling, Urticaria
Clinical narrative: Allergic reaction; Rash (red raise bump urticaria); This spontaneous case was reported by a physician and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (1st dose, lot number 042L20A) on 17-Jan-2021, Moderna (2nd dose, lot number 011M20A.) on 14-Feb-2021, Moderna (3rd dose, lot number 071F21A) on 26-Oct-2021, Moderna (4th Dose, lot number 048L21A) on 20-Mar-2022, Moderna (5th dose, lot number AS7143C) on 26-Sep-2022, Moderna (6th dose and lot number AS7184B) on 10-May-2023. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Allergic reaction to food, Allergy to nuts, Seafood allergy, Iodine allergy, Nickel allergy, Drug allergy, Penicillin allergy and Blood pressure abnormal.    On 16-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and URTICARIA (Rash (red raise bump urticaria)) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The pharmacist told the patient that the patient might have an allergic reaction to the vaccine because the vaccine contains sucrose. The patient had a rash (red raise bump urticaria) that lasted 3 days.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Cold.    On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact