chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: a vaccine that was administered only half of the 0.5 (mL); This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 1-year-old female patient who received HAV (Havrix) (batch number 5JA57, expiry date 25-APR-2026) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix on an unknown date.).   On 28-AUG-2024, the patient received the 2nd dose of Havrix. On 28-AUG-2024, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: a vaccine that was administered only half of the 0.5 (mL)). The outcome of the underdose 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: 28-AUG-2024  The other health professional (medical assistant) reported that a vaccine that was administered only half of the 0.5 (milliliter) which led to underdose.  According to other health professional, such vaccine was Havrix, and was administered earlier on the day of reporting.  The other health professional mentioned that patient was still in the office at the time of reporting, and also mentioned to second line agent that such dose was the second dose of Havrix.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red arm; swollen arm; This non-serious case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-AUG-2024, the patient received Shingrix. In AUG-2024, 3 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Red arm) and swelling arm (Verbatim: swollen arm). The outcome of the erythema of extremities and swelling arm were not resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024  The reporter was physician's assistant. The patient had red and swollen arm about 6 inches 3 days after injection.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: persistent fever since the administration of second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: persistent fever since the administration of second dose). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2024 The patient self-reporter this case for herself. The patient reported high fever after the administration of second dose.  No further detail about vaccination date, vaccine or patient demographics was retrieved.
Sex: U
Vaccine: MEN
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: The MenCYW-135 Liquid was given alone/Men A Lyophiulized was accidentally not mixed with it.; The MenCYW-135 Liquid was given alone/Men A Lyophiulized was accidentally not mixed with it.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On an unknown date, an unknown time after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced inappropriate preparation of medication (Verbatim: The MenCYW-135 Liquid was given alone/Men A Lyophiulized was accidentally not mixed with it.) and inappropriate dose of vaccine administered (Verbatim: The MenCYW-135 Liquid was given alone/Men A Lyophiulized was accidentally not mixed with it.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not reported.  Additional Information: GSK Receipt Date: 28-AUG-2024 The reporter stated that, Meningococcal CYW-135 liquid was given alone. Meningococcal A lyophilized was accidentally not mixed with it, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked, could they reconstitute the Meningococcal CYW-135 with another Meningococcal A or should be mixed with something else.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction after getting the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient 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 allergic reaction (Verbatim: allergic reaction after getting the vaccine). The outcome of the allergic reaction was not resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported the patient via interactive digital media. The patient mentioned that he/she had bad allergic reaction to the vaccine and are cautioning other they might had the same experienced. The patient stated that was for him/her.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't give her the 2nd dose of Shingrix because she received the 1st 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 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in October 2022).   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: didn't give her the 2nd dose of Shingrix because she received the 1st dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2024 The patient self-reported this case for herself. The reporter reported that her pharmacist didn't gave her the 2nd dose of Shingrix because she received the 1st dose and informed her to contact GlaxoSmithKline first for further guidance.  Till the time of reporting the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who got his first Shingrix shot on 09/03/2021 Should he start the series over or just do his second shot now; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd September 2021).   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: patient who got his first Shingrix shot on 09/03/2021 Should he start the series over or just do his second shot now). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 27-AUG-2024 The pharmacist reported that they had a patient who got his first Shingrix shot and asked should he start the series over or just do his second shot now. It was unknown if the 2nd Shingrix vaccine was administered to patient at time of chat. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: its not supposed to be storage frozen and they had put it on the freezer, and then they gave it to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 50-year-old female patient who received MMR (Priorix) (batch number LY377, expiry date 20-JAN-2025) for an unknown indication.   On 27-AUG-2024, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: its not supposed to be storage frozen and they had put it on the freezer, and then they gave it to the patient). The outcome of the incorrect storage of drug 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: 28-AUG-2024 The reporter calling because they were just notify that one of our nurses gave a Priorix, an MMR vaccine, yesterday and we realize that it was not supposed to be storage frozen and they had put it on the freezer, and then they gave it to the patient, which led to incorrect storage of product. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse called and reported that the patient was administered with an expired dose of Boostrix vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The case is 1 of the 9 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with an expired dose of Boostrix vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The case is 1 of the 9 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107923:Same reporter/Different patient
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with expired Boostrix vaccine which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 9 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024107939:Same reporter,Different patient US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 12 year old female patient was inadvertently administered an adult dose of Havrix on 29Aug2024; 12 year old female patient was inadvertently administered an adult dose of Havrix on 29Aug2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 12-year-old female patient who received HAV (Havrix 1440) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 29-AUG-2024, the patient received the 2nd dose of Havrix 1440. On 29-AUG-2024, an unknown time after receiving Havrix 1440, the patient experienced adult product administered to child (Verbatim: 12 year old female patient was inadvertently administered an adult dose of Havrix on 29Aug2024) and accidental overdose (Verbatim: 12 year old female patient was inadvertently administered an adult dose of Havrix on 29Aug2024). The outcome of the adult product administered to child was not reported and the outcome of the accidental overdose 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: 29-AUG-2024 The nurse reported that the patient of an inappropriate age was inadvertently administered an adult dose of Havrix vaccine, which led to adult product administered to child and accidental overdose. This was the patient's second dose in the series. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Deafness unilateral
Clinical narrative: experiencing hearing loss in her left ear; This serious case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included hearing loss unilateral (born with hearing loss in her right ear).   On 26-AUG-2024, the patient received Menveo. On 27-AUG-2024, 1 days after receiving Menveo, the patient experienced hearing loss unilateral (Verbatim: experiencing hearing loss in her left ear) (serious criteria GSK medically significant). The outcome of the hearing loss unilateral was unknown.   It was unknown if the reporter considered the hearing loss unilateral to be related to Menveo.     The company considered the hearing loss unilateral to be unrelated to Menveo.   Additional Information: GSK receipt date: 30-AUG-2024 Reporter was the patient's father.  The patient received a dose of Menveo on Monday and Tuesday, the patient started experiencing hearing loss in her left ear. Consented to follow up.; Sender's Comments: Deafness unilateral is a listed event which, due to the following criteria (born with hearing loss in her right ear) is considered unrelated to GSK vaccine Menveo.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: accidentally received 2 Arexvy vaccines/1st dose she only said 1 year ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose one year ago). Concomitant products included COVID-19 vaccine.   On 02-SEP-2024, the patient received the 2nd dose of Arexvy. On 02-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: accidentally received 2 Arexvy vaccines/1st dose she only said 1 year ago). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 03-SEP-2024 The reporter reported that the patient accidentally received two Arexvy vaccines that had 1st dose one year ago, also said that the extra dose was given yesterday (prior to the reporting day), which led to extra dose administered. The reporter was wondering if that was dangerous. Also reporter did not provide the zip code where the patient received that and said that the patient got the vaccines in a pharmacy. The patient also received a bunch of vaccines such as neumocco, Nemonia, Covid, etc in the same clinic day.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever of 102.9; super bad headaches; experienced a lot of fatigue; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever of 102.9), HEADACHE (super bad headaches), FATIGUE (experienced a lot of fatigue) and CHILLS (chills) 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 PYREXIA (fever of 102.9), HEADACHE (super bad headaches), FATIGUE (experienced a lot of fatigue) and CHILLS (chills). At the time of the report, PYREXIA (fever of 102.9), HEADACHE (super bad headaches), FATIGUE (experienced a lot of fatigue) and CHILLS (chills) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   She received her eighth COVID dose on 30-AUG-2024. The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-773263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773263:Same patient with different product
Sex: M
Vaccine: COVID19
Symptoms: Giant cell arteritis, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Giant cell arteritis; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: CODEINE and Biaxin. Past adverse reactions to the above products included Allergy with Biaxin and CODEINE. Concurrent medical conditions included Depression, Heartburn, Blood pressure high, AFib, High cholesterol, Drug allergy (Codeine allergy), Allergy to antibiotic (Biaxin allergy) and Adhesive tape allergy (Paper tape allergy). Concomitant products included CITALOPRAM, PANTOPRAZOLE, AMLODIPINE, IRBESARTAN, HYDROCHLOROTHIAZIDE, APIXABAN (ELIQUIS), ROSUVASTATIN and PREDNISONE for an unknown indication.    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 POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) (seriousness criterion medically significant) and GIANT CELL ARTERITIS (Giant cell arteritis). At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) and GIANT CELL ARTERITIS (Giant cell arteritis) 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 treatment information was reported.  Company Comment: This is a spontaneous case, concerning an elderly male patient with medical history of Concurrent medical conditions included Blood pressure high, AFib, High cholesterol who experienced the unexpected serious (due to medically significant) event of polymyalgia rheumatica and the unexpected non-serious event of Giant cell arteritis wich occurred unknown days after receiving a dose of SPIKEVAX COVID-19 VACCINE NOS Vaccine. No further details about the clinical course, diagnostic procedures and treatments were provided. The outcome of the events was reported as unknown. The concurrent medical condition of Blood pressure high, AFib, High cholesterol and age are a contributor for the events; Having polymyalgia rheumatica increase the risk of developing giant cell arteritis. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he had Covid and was hospitalized and Rehab; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he had Covid and was hospitalized and Rehab) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Covid-19 Vaccine (Dose 1), Covid-19 Vaccine (Dose 2), Covid-19 Vaccine (Dose 5), Covid-19 Vaccine (Dose 4) and Covid-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse effect with Covid-19 Vaccine, Covid-19 Vaccine, Covid-19 Vaccine, Covid-19 Vaccine and Covid-19 Vaccine.    On an unknown date, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he had Covid and was hospitalized and Rehab) (seriousness criterion hospitalization). At the time of the report, COVID-19 (he had Covid and was hospitalized and Rehab) outcome was unknown.            The patient had Covid and was hospitalized in June and Rehab for 3 Weeks. The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious (due to hospitalization) unexpected, event of COVID-19, which occurred on an unknown date and with unknown latency after a dose of SPIKEVAX 2023-2024 vaccine, received as the sixth dose of COVID-19 vaccination schedule (unknown previous dates and brands). It was reported that patient had Covid and was hospitalized and Rehab for 3 Weeks. The outcome of the event was reported as unknown. No further information was disclosed. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2024: Live follow up received contains no new information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: His pulse was raised to 106, no its 107 and a little bit later he took it again and had gone up to 100 and he took a little later again and it was 114; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEART RATE INCREASED (His pulse was raised to 106, no its 107 and a little bit later he took it again and had gone up to 100 and he took a little later again and it was 114) in a 60-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Cerebral palsy.    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 HEART RATE INCREASED (His pulse was raised to 106, no its 107 and a little bit later he took it again and had gone up to 100 and he took a little later again and it was 114). At the time of the report, HEART RATE INCREASED (His pulse was raised to 106, no its 107 and a little bit later he took it again and had gone up to 100 and he took a little later again and it was 114) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Diastolic and systolic were normal.. On an unknown date, Heart rate: Pulse was raised to 107 and it gone up to 100 and gradually increased to 114..     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received COVID 19 shot the previous day of report. He received other COVID shots also and did not have the pulse rate problem previously. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2024: Live follow up received and added lab data, updated event verbatim and updated narrative.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: bubble under the injection site; It felt like the needle did not go into the deltoid; reddened warm puffy area under the injection site; reddened warm puffy area under the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (bubble under the injection site), VACCINATION SITE ERYTHEMA (reddened warm puffy area under the injection site), VACCINATION SITE WARMTH (reddened warm puffy area under the injection site) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It felt like the needle did not go into the deltoid) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     On 31-Aug-2024 at 4:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced VACCINATION SITE ERYTHEMA (reddened warm puffy area under the injection site) and VACCINATION SITE WARMTH (reddened warm puffy area under the injection site). On 31-Aug-2024, the patient experienced VACCINATION SITE SWELLING (bubble under the injection site) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It felt like the needle did not go into the deltoid). At the time of the report, VACCINATION SITE SWELLING (bubble under the injection site), VACCINATION SITE ERYTHEMA (reddened warm puffy area under the injection site) and VACCINATION SITE WARMTH (reddened warm puffy area under the injection site) had not resolved and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (It felt like the needle did not go into the deltoid) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       It was unknown if patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported. Suspect product dosage text was reported as unknown. Post vaccination, it felt like the needle did not go into the deltoid and after injection it felt like a bubble under the injection site. The patient massaged the area thinking it would cause the serum to be absorbed into the surrounding tissues. The patient looked at the arm and there was a reddened warm puffy area under the injection site. The small circle was the injection site, larger reddened circle, the patient assume was where the serum was slowly being absorbed. Reporter causality was not reported. No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2024: Live non-significant follow-up received: No new information received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site bruising, Vaccination site pain
Clinical narrative: soreness and bruising in arm where Spikevax was delivered; moderate fatigue; mild fever; soreness and bruising in arm where Spikevax was delivered; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (soreness and bruising in arm where Spikevax was delivered), FATIGUE (moderate fatigue), PYREXIA (mild fever) and VACCINATION SITE BRUISING (soreness and bruising in arm where Spikevax was delivered) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 01-Sep-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 02-Sep-2024, the patient experienced VACCINATION SITE PAIN (soreness and bruising in arm where Spikevax was delivered), FATIGUE (moderate fatigue), PYREXIA (mild fever) and VACCINATION SITE BRUISING (soreness and bruising in arm where Spikevax was delivered). At the time of the report, VACCINATION SITE PAIN (soreness and bruising in arm where Spikevax was delivered), FATIGUE (moderate fatigue), PYREXIA (mild fever) and VACCINATION SITE BRUISING (soreness and bruising in arm where Spikevax was delivered) was resolving.            Patient had spent 2 days with moderate fatigue (1 day in bed) and mild fever.  It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not provided.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: hives; itchy rash/The rash, it's moved, I've still got it, it moves though. It started on both my wrists and it's been on my arms, under my chin and neck in the front and under my one knee; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) and RASH PRURITIC (itchy rash/The rash, it's moved, I've still got it, it moves though. It started on both my wrists and it's been on my arms, under my chin and neck in the front and under my one knee) in an 84-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042646) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (8 Pfizer before). Past adverse reactions to the above products included No adverse effect with Pfizer.    On 28-Aug-2024, the patient received ninth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 29-Aug-2024, the patient experienced URTICARIA (hives) and RASH PRURITIC (itchy rash/The rash, it's moved, I've still got it, it moves though. It started on both my wrists and it's been on my arms, under my chin and neck in the front and under my one knee). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and RASH PRURITIC (itchy rash/The rash, it's moved, I've still got it, it moves though. It started on both my wrists and it's been on my arms, under my chin and neck in the front and under my one knee) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The reporter stated she had a reaction and still having it. Her first reaction was like, 17 hours after she got the shot. It was in the middle of the night. she got the shot early in the morning (28Aug2024), seventeen hours later (29Aug2024) when she was sleeping and she had hives before, she broke out. It was not bad. Only about with five hives and she went and took Benadryl and that always helps her. Three days after she got an itchy rash, but she never saw the rash. It's must be there but it's not a rash that can see, but it's real, real, real itchy. The rash, it's moved, she still got it, it moves though. It started on both her wrists and it's been on her arms, under her chin and neck in the front and under her one knee. She only weigh 105.
Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue
Clinical narrative: small particles that are floating in inside each vial/no patient involvement.; The initial case was missing the following minimum  criteria: no adverse event, product complaint only. Upon receipt of follow-up information on 26Aug2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose nuber unknown, single (Lot number: HN2630, Expiration Date: 31Aug2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "small particles that are floating in inside each vial/no patient involvement.". Additional information: reporter stated that their facility received 4 doses from Pfizer and found some small particles that are floating in inside each vial, all with the same lot no. and not administered to any patient.   The reporter considered "small particles that are floating in inside each vial/no patient involvement." not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "small particles that are floating in inside each vial/no patient involvement." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, itchiness, and some swelling at the injection site; redness, itchiness, and some swelling at the injection site; redness, itchiness, and some swelling at the injection site; headache; outside of injection site is very swollen; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 36-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Aug2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Aug2024, outcome "unknown"; SWELLING (non-serious) with onset Aug2024, outcome "unknown", described as "outside of injection site is very swollen"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 20Aug2024, outcome "not recovered" and all described as "redness, itchiness, and some swelling at the injection site".  Additional information: Caller is a patient and she experienced some adverse reaction with the Prevnar 20. She experienced some redness, itchiness and swelling on her left arm or the injection site and she is experiencing some headache but outside of injection site is very swollen. It has been 9 days since she has got the vaccine. She is still experiencing redness, itchiness, and some swelling at the injection site on her left arm. The patient just called to see if, because she was on day 9th of this, she was just wondering if day nine is normal for the duration of these symptoms.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". Clinical course: An 82-year-old male patient has previously received 4 Pfizer Covid-19 vaccinations however he has not had any vaccinations for a year now. The patient provided that he has covid right now. The patient was asking if it is advisable to receive the new 2024/2025 Pfizer Covid-19 vaccine or if he needs to wait until his covid has resolved.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 infection; COVID-19 infection; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "recovering" and all described as "COVID-19 infection". Clinical Course: Caller inquired as to whether he would still have to "mask up" around his wife, considering that her COVID-19 infection had recently started and he has been feeling better and considers that he may have immunity against the virus. Caller reported that she tested positive for COVID-19 infection last Wednesday. Caller added that he was vaccinated with the first and second vaccines, as well as the third COVID-19 vaccine (around Nov2021); nonetheless, caller stated that COVID-19 infection "hit him pretty hard", but stated that he has been "starting to feel better". Caller also mentioned that his wife tested positive on second day of his infection Caller also reported that he was no longer experiencing fever and that the infection "never went into his chest", so there was no cough. Caller also mentioned that he did not acquire the most recent version of the Pfizer COVID-19 vaccine, nor the formula before that. Caller stated that he had "fever and chills" on Wednesday. Caller further inquired as to whether Pfizer COVID-19 vaccine received on Nov2021 was still effective in protecting against COVID-19.  Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Poor quality product administered, Product distribution issue
Clinical narrative: flublok was non-viable because it arrived later than the expected date, and was administered to patient before the issue was identified with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 54-year-old female patient and reporter reported influenza trivalent recombinant vaccine [Flublok TIV] was non-viable because it arrived later than the expected date and was administered to patient before the issue was identified with no reported adverse event.  The patient's past medical history, medical treatment(s) vaccination(s) and family history were not provided. No concomitant medication.  On 26-Aug-2024, standard dose of 0.5 ml suspect influenza vaccine trivalent solution for injection with (lot U8447AA and expiry date 31-May-2024) frequency: once via intramuscular route in Left Deltoid for influenza was non-viable because it arrived later than the expected date, administered to three patients before the issue was identified with no reported adverse event (poor quality product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA252820: US-SA-2024SA252968:
Age: 53.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Poor quality product administered, Product distribution issue
Clinical narrative: flublok was non-viable because it arrived later than the expected date, and was administered to patient before the issue was identified with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to other case 2024SA252820, 2024SA253646.  This case involves a 53 years old male patient and reporter reported influenza vaccine trivalent [Flublok TIV] was non-viable because it arrived later than the expected date, and was administered to patient before the issue was identified with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or no other vaccines: None   On 26-Aug-2024, the patient received a standard dose of 0.5 ml total of suspect influenza vaccine trivalent solution for injection which was non-viable because it arrived later than the expected date, and was administered before the issue was identified with (lot U8447AA and expiry date 31-May-2024) via intramuscular route in Left Deltoid for influenza with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, No ER (emergency room) visit and no treatment was received.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA252820:02197377 US-SA-2024SA253646:02197348
Age: 62.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Poor quality product administered, Product distribution issue
Clinical narrative: flublok was non-viable because it arrived later than the expected date, and was administered to patient before the issue was identified with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to other cases 2024SA253646, 2024SA252968  This case involves a 62-year-old female patient and reporter reported influenza vaccine trivalent [Flublok TIV] was non-viable because it arrived later than the expected date, and was administered to patient before the issue was identified with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided. List concomitant or no other vaccines: None  On 26-Aug-2024, the patient received a standard dose of 0.5 ml total of suspect influenza vaccine trivalent solution for injection which was non-viable because it arrived later than the expected date, and was administered before the issue was identified with (lot U8447AA and expiry date 31-May-2025) via intramuscular route in Left Deltoid for influenza with no reported adverse event (poor quality product administered) (latency same day).  Reportedly, No ER (emergency room) visit and no treatment was received.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA253646:02197348 US-SA-2024SA252968:02197377
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: menquadfi was inadvertently given to a healthy 17 yr old female later discovered to be pregnant with no reported adverse event; Initial information received on 27-Aug-2024 regarding an unsolicited valid non-serious case received from a physician.  This case involves  17-year-old female patient and is reported that meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was inadvertently given and later discovered patient to be pregnant with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported menquadfi was inadvertently given to a healthy 17 yr old female later discovered to be pregnant with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date is 15-Mar-2025.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine (Polio vaccine) and Hepatitis a vaccine (Hepatitis a vaccine) for prophylactic vaccination (Immunisation).  On 27-Aug-2024, a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection lot U8370AA and expiry date: 30-Apr-2028 via intramuscular route in the right deltoid frequency: once, strength: standard for immunization and reported that it was inadvertently given to a healthy 17 year old female later discovered to be pregnant with no reported adverse event (exposure during pregnancy) (latency: on same day).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.