chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Computerised tomogram normal, Diarrhoea, Dizziness, Headache, Injection site erythema
Clinical narrative: dizziness; diarrhea; rash on arm of injection/rash on the injected arm; headache; muscle pain; achy legs; redness at injection site; Warm injection site; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis.   On 20-SEP-2024, the patient received Arexvy (intramuscular, left deltoid) and Fluzone high dose (intramuscular, left deltoid). On 20-SEP-2024, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site warmth (Verbatim: Warm injection site) and fever (Verbatim: fever). On 21-SEP-2024, the patient experienced headache (Verbatim: headache), muscle pain (Verbatim: muscle pain), leg pain (Verbatim: achy legs), diarrhea (Verbatim: diarrhea) and rash (Verbatim: rash on arm of injection/rash on the injected arm). On 24-SEP-2024, the patient experienced dizziness (Verbatim: dizziness). The outcome of the injection site erythema, injection site warmth, fever and rash were resolved and the outcome of the headache, muscle pain, leg pain, dizziness and diarrhea were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-SEP-2024 This case was self-reported by patient. The patient reported that she received the Arexvy vaccine and Fluzone high dose vaccine in the same arm. After receiving vaccine that same day she had redness and warmth at the injection site. The following day she began experiencing headache, muscle/leg achiness, fever of 101 degree Fahrenheit, diarrhea and a rash on the injected arm. The rash was now gone, as was the redness and warmth, but the other symptoms persist. The patient went to an emergency room for the symptoms. The laboratory investigations, a covid test and computed tomography scan, all of which were negative. The reporter said that she would call again if her condition worsened. It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Fluzone high dose.
Age: 70.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pyrexia, Rash
Clinical narrative: dizziness; diarrhea; rash on arm of injection/rash on the injected arm; headache; muscle pain; achy legs; redness at injection site; Warm injection site; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis.   On 20-SEP-2024, the patient received Arexvy (intramuscular, left deltoid) and Fluzone high dose (intramuscular, left deltoid). On 20-SEP-2024, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site warmth (Verbatim: Warm injection site) and fever (Verbatim: fever). On 21-SEP-2024, the patient experienced headache (Verbatim: headache), muscle pain (Verbatim: muscle pain), leg pain (Verbatim: achy legs), diarrhea (Verbatim: diarrhea) and rash (Verbatim: rash on arm of injection/rash on the injected arm). On 24-SEP-2024, the patient experienced dizziness (Verbatim: dizziness). The outcome of the injection site erythema, injection site warmth, fever and rash were resolved and the outcome of the headache, muscle pain, leg pain, dizziness and diarrhea were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-SEP-2024 This case was self-reported by patient. The patient reported that she received the Arexvy vaccine and Fluzone high dose vaccine in the same arm. After receiving vaccine that same day she had redness and warmth at the injection site. The following day she began experiencing headache, muscle/leg achiness, fever of 101 degree Fahrenheit, diarrhea and a rash on the injected arm. The rash was now gone, as was the redness and warmth, but the other symptoms persist. The patient went to an emergency room for the symptoms. The laboratory investigations, a covid test and computed tomography scan, all of which were negative. The reporter said that she would call again if her condition worsened. It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Fluzone high dose.
Age: 70.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: SARS-CoV-2 test negative
Clinical narrative: dizziness; diarrhea; rash on arm of injection/rash on the injected arm; headache; muscle pain; achy legs; redness at injection site; Warm injection site; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) for prophylaxis.   On 20-SEP-2024, the patient received Arexvy (intramuscular, left deltoid) and Fluzone high dose (intramuscular, left deltoid). On 20-SEP-2024, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site warmth (Verbatim: Warm injection site) and fever (Verbatim: fever). On 21-SEP-2024, the patient experienced headache (Verbatim: headache), muscle pain (Verbatim: muscle pain), leg pain (Verbatim: achy legs), diarrhea (Verbatim: diarrhea) and rash (Verbatim: rash on arm of injection/rash on the injected arm). On 24-SEP-2024, the patient experienced dizziness (Verbatim: dizziness). The outcome of the injection site erythema, injection site warmth, fever and rash were resolved and the outcome of the headache, muscle pain, leg pain, dizziness and diarrhea were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-SEP-2024 This case was self-reported by patient. The patient reported that she received the Arexvy vaccine and Fluzone high dose vaccine in the same arm. After receiving vaccine that same day she had redness and warmth at the injection site. The following day she began experiencing headache, muscle/leg achiness, fever of 101 degree Fahrenheit, diarrhea and a rash on the injected arm. The rash was now gone, as was the redness and warmth, but the other symptoms persist. The patient went to an emergency room for the symptoms. The laboratory investigations, a covid test and computed tomography scan, all of which were negative. The reporter said that she would call again if her condition worsened. It was unknown if the reporter considered the injection site erythema, injection site warmth, headache, muscle pain, leg pain, dizziness, fever, diarrhea and rash to be related to Fluzone high dose.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Acne, Asthenia, Dizziness, Influenza like illness, Malaise
Clinical narrative: Breaking out with "pimples"; patient did not feel good,; felt dizzy,; felt weak,; felt like she was coming down with the flu; The patient is experiencing hives that are itchy.; The patient is experiencing hives that are itchy.; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis.   Concurrent medical conditions included alcohol allergy.   On 11-SEP-2024, the patient received the 2nd dose of Shingrix (right arm) and Influenza vaccin (left arm). On 11-SEP-2024, less than a day after receiving Shingrix and an unknown time after receiving Influenza vaccin, the patient experienced feeling unwell (Verbatim: patient did not feel good,), dizziness (Verbatim: felt dizzy,), feelings of weakness (Verbatim: felt weak,) and influenza like illness (Verbatim: felt like she was coming down with the flu). On 13-SEP-2024, the patient experienced pimples (Verbatim: Breaking out with "pimples"). In SEP-2024, the patient experienced pruritus (Verbatim: The patient is experiencing hives that are itchy.) and hives (Verbatim: The patient is experiencing hives that are itchy.). The patient was treated with calamine. The outcome of the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives were unknown.   It was unknown if the reporter considered the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives to be related to Shingrix.     It was unknown if the company considered the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives to be related to Shingrix.   Additional Information: GSK receipt date: 25-SEP-2024 The reporter was a patient.   The patient received the second dose of Shingrix in the right arm  and also received a Flu vaccine at the same time but in the left arm.   The patient did not know which Flu vaccine she had or the manufacturer.   The patient was experiencing hives that were itchy. The same night the patient received the vaccines, the patient did not feel good, felt dizzy, felt weak, and felt like she was coming down with the flu.   About 2 days after receiving the vaccines, the patient started breaking out with pimples on her arms and stomach, subsequently, the pimples became bigger and began to itch.   The pimples were described as flat-itchy, and the size of a fingertip. The patient has been applying Calamine Lotion to the areas and were beginning to dry up.   The patient reported that it was more pronounced on her left side than on the right side. The patient stated she had not changed anything in her diet and had not changed laundry detergent Consented to follow up.
Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Breaking out with "pimples"; patient did not feel good,; felt dizzy,; felt weak,; felt like she was coming down with the flu; The patient is experiencing hives that are itchy.; The patient is experiencing hives that are itchy.; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Influenza vaccine (Influenza vaccin) for prophylaxis.   Concurrent medical conditions included alcohol allergy.   On 11-SEP-2024, the patient received the 2nd dose of Shingrix (right arm) and Influenza vaccin (left arm). On 11-SEP-2024, less than a day after receiving Shingrix and an unknown time after receiving Influenza vaccin, the patient experienced feeling unwell (Verbatim: patient did not feel good,), dizziness (Verbatim: felt dizzy,), feelings of weakness (Verbatim: felt weak,) and influenza like illness (Verbatim: felt like she was coming down with the flu). On 13-SEP-2024, the patient experienced pimples (Verbatim: Breaking out with "pimples"). In SEP-2024, the patient experienced pruritus (Verbatim: The patient is experiencing hives that are itchy.) and hives (Verbatim: The patient is experiencing hives that are itchy.). The patient was treated with calamine. The outcome of the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives were unknown.   It was unknown if the reporter considered the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives to be related to Shingrix.     It was unknown if the company considered the feeling unwell, dizziness, feelings of weakness, influenza like illness, pimples, pruritus and hives to be related to Shingrix.   Additional Information: GSK receipt date: 25-SEP-2024 The reporter was a patient.   The patient received the second dose of Shingrix in the right arm  and also received a Flu vaccine at the same time but in the left arm.   The patient did not know which Flu vaccine she had or the manufacturer.   The patient was experiencing hives that were itchy. The same night the patient received the vaccines, the patient did not feel good, felt dizzy, felt weak, and felt like she was coming down with the flu.   About 2 days after receiving the vaccines, the patient started breaking out with pimples on her arms and stomach, subsequently, the pimples became bigger and began to itch.   The pimples were described as flat-itchy, and the size of a fingertip. The patient has been applying Calamine Lotion to the areas and were beginning to dry up.   The patient reported that it was more pronounced on her left side than on the right side. The patient stated she had not changed anything in her diet and had not changed laundry detergent Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient hadn't yet received 2nd dose at the time of call; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 year prior to the reporting 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 incomplete course of vaccination (Verbatim: patient hadn't yet received 2nd dose at the time of call). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-SEP-2024 The pharmacist wants to know if the patient should go for 2nd shot or restart. The patient had not yet receive 2nd dose at the time of reporting. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: received 1/2 dose of Arexvy vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of underdose in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2024, the patient received Arexvy (intramuscular, unknown arm). On 28-SEP-2024, an unknown time after receiving Arexvy, the patient experienced underdose (Verbatim: received 1/2 dose of Arexvy vaccine). The outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2024 The patient self-reported this case. The reporter reported that she received 1/2 dose of Arexvy vaccine, which led to underdose. Patient refused to provide additional details, stated that it happened to be an unusual situation. No additional information was provided. It was unknown in which arm the vaccine was administered or the Lot and expiration date of the vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On an unknown date, the patients received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patients experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patients). 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: 30-SEP-2024 The registered nurse called to report that the reporter had a clinic that had some flu vaccines, the flulaval, and it was at 29 degrees celsius for 18 hours. On the website, it said that not to use but the reporter guessed they already gave it to, those vaccines before they knew they got out of temperature, so, they just wanted to know if they need to call the patients and have them come back. The reporter asked that what was the recommendation. While asking lot number, HCP said that she did not have the information but that they can get it if safety requests it since she consented the follow-up. The healthcare professional said that for information about patient date of birth, gender and initials, she cannot provide it by phone. Multiple patients were administered with this outside the normal storage conditions vaccines which led to incorrect storage of drug.
Sex: F
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: patient received Arexvy by mistake, the patient was supposed to receive Abrysvo; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: patient received Arexvy by mistake, the patient was supposed to receive Abrysvo). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 01-OCT-2024 The HCP (Healthcare professional) reported that a patient had received Arexvy by mistake, the patient was supposed to receive Abrysvo which led to, wrong vaccine administered. The reporter stated that the patient initials and DOB (Date of birth) was not available. The reporter consented to the follow up
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Illness, Pyrexia
Clinical narrative: I am chronically sick; Now sweat also causes severe itching; Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching; I have had chronic chills and fatigue; I have had chronic chills and fatigue; I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue) and FATIGUE (I have had chronic chills and fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2022, the patient experienced PYREXIA (I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.). On 16-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue) and FATIGUE (I have had chronic chills and fatigue). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK, qd (daily). At the time of the report, ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue), FATIGUE (I have had chronic chills and fatigue) and PYREXIA (I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient had full body hives on top of hives with new pants purchased to accommodate significant change in waist along with leg circumference.  Patient's immune system has been very noticeably hyper reactive since the booster, patient's skin condition had made changes in her lifestyle as she was very active.  It was unknown if the patient experienced any additional symptoms/events.  The patient had no concomitant disease or risk factor.  There were no lab data/results available.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I am chronically sick; Now sweat also causes severe itching; Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching; I have had chronic chills and fatigue; I have had chronic chills and fatigue; I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue) and FATIGUE (I have had chronic chills and fatigue) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2022, the patient experienced PYREXIA (I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.). On 16-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue) and FATIGUE (I have had chronic chills and fatigue). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK, qd (daily). At the time of the report, ILLNESS (I am chronically sick), HYPERHIDROSIS (Now sweat also causes severe itching), URTICARIA (Full body hives on top of hives/now sweat also causes severe itching/still itch every hour of every day since the booster/severe itching), CHILLS (I have had chronic chills and fatigue), FATIGUE (I have had chronic chills and fatigue) and PYREXIA (I get chills and fever weekly to every other week since exactly ten days after the booster and have always eaten whole clean foods.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient had full body hives on top of hives with new pants purchased to accommodate significant change in waist along with leg circumference.  Patient's immune system has been very noticeably hyper reactive since the booster, patient's skin condition had made changes in her lifestyle as she was very active.  It was unknown if the patient experienced any additional symptoms/events.  The patient had no concomitant disease or risk factor.  There were no lab data/results available.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Headache, Pyrexia, Tinnitus, Vertigo
Clinical narrative: arthritis in the right and left thumbs; vertigo; ringing in his ears; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis in the right and left thumbs), VERTIGO (vertigo), TINNITUS (ringing in his ears), PYREXIA (fever) and HEADACHE (headache) in an 80-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Hearing impaired and Ringing in ears. Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE]. Past adverse reactions to the above products included No adverse effect with FLU [INFLUENZA VACCINE].    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 26-Sep-2024, the patient experienced ARTHRITIS (arthritis in the right and left thumbs), VERTIGO (vertigo), TINNITUS (ringing in his ears), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ARTHRITIS (arthritis in the right and left thumbs), VERTIGO (vertigo), TINNITUS (ringing in his ears), PYREXIA (fever) and HEADACHE (headache) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient did receive other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  The reporter stated that patient had 3 or 4 Moderna boosters with no issues. No other details were provided. Suspect product dosage text was reported as unknown. No treatment information was reported. Company Comments: This spontaneous case concerns an 80-year-old male patient, with medical history of Hearing impaired and Ringing in ears who experienced non serious events Arthritis (considered as AESI), Vertigo, Tinnitus, Pyrexia, Headache that occurred 3 days after dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS). As reported the patient had already had 3 or 4 Moderna boosters with no issues and previously the patient was vaccinated against flu with no adverse events noted.  At the time of the report the events were not resolved. No more information reported. Considering close temporal relation the events are assessed as related to vaccination. The benefit-risk relationship of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS)is not affected by this report.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Headache; Joint aches; Rash on trunk, spreading to arms; Redness on injection site; Swelling on injection site; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), ARTHRALGIA (Joint aches), RASH (Rash on trunk, spreading to arms), VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION SITE SWELLING (Swelling on injection site) in a 49-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 1737690 00) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 02-Oct-2024, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint aches), RASH (Rash on trunk, spreading to arms), VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION SITE SWELLING (Swelling on injection site). At the time of the report, HEADACHE (Headache), ARTHRALGIA (Joint aches), RASH (Rash on trunk, spreading to arms), VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION SITE SWELLING (Swelling on injection site) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (urticaria) in a 40-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 microgram. On 27-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced URTICARIA (urticaria). At the time of the report, URTICARIA (urticaria) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or not. There were no lab data or results available. No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rash pruritic
Clinical narrative: Rash on her chest, part of her back and her thighs. Patient stated that it was itchy, but it was not severe; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Rash on her chest, part of her back and her thighs. Patient stated that it was itchy, but it was not severe) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032262) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 13-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 13-Oct-2023, the patient experienced RASH PRURITIC (Rash on her chest, part of her back and her thighs. Patient stated that it was itchy, but it was not severe). On 13-Oct-2023, RASH PRURITIC (Rash on her chest, part of her back and her thighs. Patient stated that it was itchy, but it was not severe) had resolved.            Patient stated that she had many vaccines. Unsure which one the current vaccine in her vaccination series. No known allergies or relevant medical conditions was reported. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. Patient stated that it was light and that might not even necessarily fully see it through a camera. Those symptoms lasted a few hours, and she did not take any medications. No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Dyspnoea
Clinical narrative: shaking; dry heaves; weak; sleepy; burping; difficulty breathing; light headed; chills; fever (101F); vomiting; nauseous; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy) and ERUCTATION (burping) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2023 and COVID-19 in May 2024. Concurrent medical conditions included Hypercholesterolaemia and Allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 30-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 30-Sep-2024, the patient experienced TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous). At the time of the report, TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No known drug allergies were reported. Patient was having a probiotic. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774857 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774857:Same patient diffrent moderna product
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Nausea, Pyrexia, Retching, Somnolence
Clinical narrative: shaking; dry heaves; weak; sleepy; burping; difficulty breathing; light headed; chills; fever (101F); vomiting; nauseous; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy) and ERUCTATION (burping) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2023 and COVID-19 in May 2024. Concurrent medical conditions included Hypercholesterolaemia and Allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 30-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 30-Sep-2024, the patient experienced TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous). At the time of the report, TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No known drug allergies were reported. Patient was having a probiotic. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774857 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774857:Same patient diffrent moderna product
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: shaking; dry heaves; weak; sleepy; burping; difficulty breathing; light headed; chills; fever (101F); vomiting; nauseous; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy) and ERUCTATION (burping) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2023 and COVID-19 in May 2024. Concurrent medical conditions included Hypercholesterolaemia and Allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 30-Sep-2024, the patient received eighth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 30-Sep-2024, the patient experienced TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous). At the time of the report, TREMOR (shaking), RETCHING (dry heaves), ASTHENIA (weak), SOMNOLENCE (sleepy), ERUCTATION (burping), DYSPNOEA (difficulty breathing), DIZZINESS (light headed), CHILLS (chills), PYREXIA (fever (101F)), VOMITING (vomiting) and NAUSEA (nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F.         Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No known drug allergies were reported. Patient was having a probiotic. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-774857 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774857:Same patient diffrent moderna product
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills began 6 hours after shot.; severe nausea; fever that lasted for four hours; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills began 6 hours after shot.), NAUSEA (severe nausea), PYREXIA (fever that lasted for four hours) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 03-Oct-2024, the patient experienced CHILLS (Chills began 6 hours after shot.), NAUSEA (severe nausea), PYREXIA (fever that lasted for four hours) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at a dose of 250 milligram at hour 12 and NAPROXEN at a dose of 220 milligram at hour 18. On 05-Oct-2024, CHILLS (Chills began 6 hours after shot.), NAUSEA (severe nausea), PYREXIA (fever that lasted for four hours) and HEADACHE (headache) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Chills began 6 hours after shot. 10 hours after severe nausea, chills, fever that lasted for four hours, and then intermittent for another 24 with headache. It was unknown if the patient experienced any additional symptoms/events. Patient had no concomitant disease or risk factor
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Bedridden, Fatigue, Gait inability, Hypoaesthesia
Clinical narrative: bedridden; not able to walk; my right leg feels a bit numb; tired the first day; I started feeling a sharp pain in my joints especially my knees; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (bedridden), GAIT INABILITY (not able to walk), HYPOAESTHESIA (my right leg feels a bit numb), FATIGUE (tired the first day) and ARTHRALGIA (I started feeling a sharp pain in my joints especially my knees) in a 37-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 02-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 03-Oct-2024, the patient experienced BEDRIDDEN (bedridden), GAIT INABILITY (not able to walk), HYPOAESTHESIA (my right leg feels a bit numb), FATIGUE (tired the first day) and ARTHRALGIA (I started feeling a sharp pain in my joints especially my knees). At the time of the report, BEDRIDDEN (bedridden), GAIT INABILITY (not able to walk), HYPOAESTHESIA (my right leg feels a bit numb), FATIGUE (tired the first day) and ARTHRALGIA (I started feeling a sharp pain in my joints especially my knees) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It was reported that patient received covid and flu shot together. Patient was tired in the first day. On 03-Oct-2024, the patient   felt a sharp pain in her joints especially in the knees. The patient was unable to drive due to sharp pain in her joints. Patient felt bed bedridden, and patient was not able to walk, and her right leg felt a bit numb. No treatment medications provided by the reporter.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Syringe is pretty brittle and it broke through the top cap so, the water spread out around/Syringe broke; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on [26Sep2024], this case now contains all required information to be valid.  This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: 30Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Syringe is pretty brittle and it broke through the top cap so, the water spread out around/Syringe broke". Additional information: A pharmacist calling in about a damaged Abrysvo vaccine as he tried to mix it, but this syringe is pretty brittle and it broke through the top cap so, the water spread out around and they couldn't use the vaccine. He mentioned that it never happened before. The vial is intact the syringe broke. "No missed dose, we use another. We had enough in stock we use another Abrysvo and give it to the patient." Device Sample Availability Unknown.  Causality for "syringe is pretty brittle and it broke through the top cap so, the water spread out around/syringe broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: PNC20
Symptoms: No adverse event, Syringe issue
Clinical narrative: 3 of the Prevnar 20 glass prefill syringes break at the top of the syringe; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 27Sep2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Sep2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset Sep2024, outcome "unknown", described as "3 of the Prevnar 20 glass prefill syringes break at the top of the syringe".  Causality for "3 of the prevnar 20 glass prefill syringes break at the top of the syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: Below where the needle screws on, that part has broken at one of their offices and it was the 3rd time that it happened this week (Sep2024). The reporter did verify that it is not the same LOT number but it did occur at the same office each time. The sample of the products were available to be returned, if requested, and they had already sent one (this case) back to PRIVACY, not sure about the other two. When probed if the defective Prevnar 20 was administered to any patient, it was reported that not aware that it was given to a patient.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400272234 same reporter/PC, different lot number;US-PFIZER INC-202400272233 same reporter/PC, different lot number;
Sex: F
Vaccine: RSV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Physician went to draw it up and the actual vial broke in her hand; Physician went to draw it up and the actual vial broke in her hand; This is a spontaneous report received from a Physician.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LN5460, Expiration Date: Jun2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), DEVICE BREAKAGE (non-serious) and all described as "Physician went to draw it up and the actual vial broke in her hand".  Additional information: It was reported, "So, this customer reported this to me today she has two separate issues, okay. One is she was using the active vial reconstitution formulation and one of the stoppers would not come out where she could mix the solution with the powder. So, it was a faulty (Lot: LN5466, exp: Oct2025), she can never get it to work, okay. The other one after they mixed it whenever the Physician went to draw it up and the actual vial broke in her hand (Lot: LN5460, exp: Jun2025)".  The one that broke, she ended up discarding it.  Causality for "physician went to draw it up and the actual vial broke in her hand" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).