chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: little bit of sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little bit of sore arm) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concomitant products included Celecoxib (Celexal) and Pantoprazole sodium sesquihydrate (Pantoprazole) for an unknown indication.    On 07-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of sore arm). The patient was treated with Ibuprofen (Advil) at a dose of when needed. At the time of the report, PAIN IN EXTREMITY (little bit of sore arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient stated that the first four or five that she had, she just whizzed through that with no problem at all, just a little bit of a sore arm. which didn't bother her. The patient insisted that for these vaccines, she didn't have any problems except the sore arm.   This case was linked to MOD-2024-774810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2024: Live non- significant follow-up added: narrative was updated. On 08-Oct-2024: Live significant follow-up accepted. references added. On 08-Oct-2024: Live Follow up contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Patient had a hard time hearing; This spontaneous case was reported by a patient and describes the occurrence of HYPOACUSIS (Patient had a hard time hearing) 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 first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Patient had a hard time hearing). At the time of the report, HYPOACUSIS (Patient had a hard time hearing) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Consumer stated that she already had 6 Moderna shots. Consumer had a hard time hearing and stated she don't understand anything the agent was saying and she needs a hearing aid, and the doctor was not giving it. Reporter causality was not reported. Treatment information was not provided.   This case was linked to MOD-2024-774962 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Myalgia
Clinical narrative: atrial fibrillation/muscle pain/shortness of breath; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation/muscle pain/shortness of breath) and MYALGIA (muscle pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2UA) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation/muscle pain/shortness of breath) (seriousness criteria hospitalization and medically significant) and MYALGIA (muscle pain) (seriousness criterion hospitalization). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 milligram twice a day; SACUBITRIL, VALSARTAN (ENTRESTO) at a dose of 49-51 mg (twice a day); CARVEDILOL at a dose of 3.125 milligram twice a day; FUROSEMIDE at a dose of 20 milligram once a day and Surgery (heart surgery) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation/muscle pain/shortness of breath) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no concomitant disease or risk factor.  The patient had heart surgery as well as multiple doctor visits. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: vaccine killed his grandma/Moderna vaccine has killed two of his family members; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (vaccine killed his grandma/Moderna vaccine has killed two of his family members) in an elderly female patient 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. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered DEATH (vaccine killed his grandma/Moderna vaccine has killed two of his family members) to be related.    No relevant concomitant medications were reported. No treatment medication reported.  Company Comment: This is a spontaneous case concerning an elderly female patient with no reported medical history, who experienced the serious (due to medically significant and fatal ) unexpected event of Death unexplained. The event occurred on an unknown date, after a dose of SPIKEVAX COVID-19 VACCINE NOS (dose number and date for vaccination was not provided). Death occurred on an unknown date. The cause of death was not reported. An autopsy was not performed. Circumstances leading to death, supportive diagnosis, and treatment were not provided. The outcome of the event was reported as fatal. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-774811 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2024: Live non-significant follow up added. References added. On 07-Oct-2024: Live non-significant follow up added. References added. On 07-Oct-2024: Live non-significant follow up added. References added. On 07-Oct-2024: Live non-significant follow up added. References added. On 07-Oct-2024: Live non-significant follow up added. References added. On 07-Oct-2024: Live non-significant follow up added. References added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774811:Master(Grandfather case); Reported Cause(s) of Death: unknown cause of death
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: her arm was very sore after receiving a Moderna Covid-19 shot on 07OCT2024; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her arm was very sore after receiving a Moderna Covid-19 shot on 07OCT2024) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine. Concurrent medical conditions included Asthma, Blood pressure high and Glaucoma.   On 07-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 08-Oct-2024,  after starting , the patient experienced PAIN IN EXTREMITY (her arm was very sore after receiving a Moderna Covid-19 shot on 07OCT2024). At the time of the report, PAIN IN EXTREMITY (her arm was very sore after receiving a Moderna Covid-19 shot on 07OCT2024) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       Patient did receive other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. Patient wanted to know if she can take Tylenol. No treatment information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: acute diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (acute diarrhea) in a 68-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043334) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 29-Sep-2024,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DIARRHOEA (acute diarrhea). On 30-Sep-2024, DIARRHOEA (acute diarrhea) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The duration of the event was approximately 24 to 36 hours. It was unknown if the patient experienced any additional symptoms/events.
Age: 43.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Injection site pain; Fever; chills; fatigue; muscle and joint pain; muscle and joint pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (muscle and joint pain) in a 43-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.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   On 08-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 09-Oct-2024, the patient experienced VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (muscle and joint pain) and MYALGIA (muscle and joint pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (muscle and joint pain) and MYALGIA (muscle and joint pain) was resolving.        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. No treatment medications provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Fever; chills; fatigue; muscle and joint pain; muscle and joint pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (muscle and joint pain) in a 43-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.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    No Medical History information was reported.   On 08-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On 09-Oct-2024, the patient experienced VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (muscle and joint pain) and MYALGIA (muscle and joint pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain), PYREXIA (Fever), CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (muscle and joint pain) and MYALGIA (muscle and joint pain) was resolving.        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. No treatment medications provided by the reporter.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Immunisation reaction, Pruritus, Rash erythematous
Clinical narrative: pt has red spot on lower arm, covid toes, swelling around the eyes, itchey everywhere, red rash on various parts of body.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pulmonary pain, Pyrexia, Respiratory disorder, Tremor
Clinical narrative: Patient called pharmacy to inform that she was in the hospital (10/14/24) and that she believed that receiving the shot had caused to have breathing problems, her lungs hurt, and she had also had severe chills (shakes) and a fever. Patient stated that symptoms started 10/13/24  but stated hoped to be out of the hospital tomorrow. Said no more covid vaccine for her.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Expired product administered
Clinical narrative: pt. injected on 10/14/24 intramuscularly with Pneumovax that had expired on 10/07/24. pt. tolerated and left without incident.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm x 1-2 days after injection
Age: 0.42
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt did not present with an adverse reaction at time of administration. Abrysvo was administered instead of Beyfortus by the nurse. As of 10/14/24 no adverse reactions reported by patient's parents.  REPORTING DUE TO INCORRECT VACCINE ADMINISTERED.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: GAVE PATIENT FLUZONE HIGH DOSE BEFORE REALIZING PATIENT HAD A REGULAR FLU SHOT FLU (Flulaval) ACCORDING TO DATABASE. PATIENT HAD REQUESTED THE FOR THE VACCINATION AT POINT OF TREATMENT. CALLED THE PATIENT AFTERWARD AND HER DAUGHTER WAS NOT AWARE OF THE FIRST FLU SHOT BUT SAID IT COULD HAVE HAPPENED.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had had stomach cramps during the positive phase of covid; I had had stomach cramps during the positive phase of covid; This is a spontaneous report received from an Other HCP.  An 80-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: dairy" (unspecified if ongoing); "Known allergies: wheat, coconut, peanuts" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "mild coronary and post nonhodgkins lymphoma" (unspecified if ongoing); "mild coronary and post nonhodgkins lymphoma" (unspecified if ongoing). The patient's 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Oct2024, outcome "unknown" and all described as "I had had stomach cramps during the positive phase of covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Oct2024) negative, notes: I tested negative for Covid on 06Oct2024; (07Oct2024) positive, notes: tested positive for covid. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2024-2025 FORMULA) can not be fully excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue, Underdose, Vaccination site pain
Clinical narrative: less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration; less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration; what was in the vial spilled on myself and on my arm; what was in the vial spilled on myself and on my arm; It's really painful where the syringe broke; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 52-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Oct2024 as dose 1, single (Lot number: LM2215, Expiration Date: 24Mar2025) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, on 05Oct2024 as dose 1, single. The patient also took other concomitant therapy. The following information was reported: SYRINGE ISSUE (non-serious), UNDERDOSE (non-serious) all with onset 05Oct2024, outcome "unknown" and all described as "less than the recommended dose of Comirnaty 12 plus because the syringe broke during the administration"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 05Oct2024, outcome "unknown" and all described as "what was in the vial spilled on myself and on my arm"; VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "not recovered", described as "It's really painful where the syringe broke". Therapeutic measures were not taken as a result of vaccination site pain, syringe issue, underdose, accidental exposure to product, exposure via skin contact.  Additional information: The pharmacist said that she didn't want to give the patient another shot - she didn't know how much went into her arm. Vitamins (unspecified) were reported as other concomitant medication. The patient did not receive other vaccines within four weeks prior to the vaccination with Comirnaty.  Causality for "it's really painful where the syringe broke", "less than the recommended dose of comirnaty 12 plus because the syringe broke during the administration" and "what was in the vial spilled on myself and on my arm" was determined associated to device constituent of BNT162b2 omicron (kp.2).
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dysstasia, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: sore throat; headache; allergy-related symptoms; fatigue; hasn't been able to stand up for a long period of time before she needs to lay down; gastrointestinal symptoms; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy-related symptoms"; FATIGUE (non-serious), outcome "unknown"; DYSSTASIA (non-serious), outcome "unknown", described as "hasn't been able to stand up for a long period of time before she needs to lay down"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal symptoms".  Additional information: That day she starting experiencing sore throat, headache, allergy-related symptoms and a fatigue that has lasted all this time. She hasn't been able to stand up for a long period of time before she needs to lay down. On Sunday she started experiencing gastrointestinal symptoms until this morning. She wanted to know how long these side effects may last. She still has not received assistance from her doctor.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; headache; allergy-related symptoms; fatigue; hasn't been able to stand up for a long period of time before she needs to lay down; gastrointestinal symptoms; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HEADACHE (non-serious), outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy-related symptoms"; FATIGUE (non-serious), outcome "unknown"; DYSSTASIA (non-serious), outcome "unknown", described as "hasn't been able to stand up for a long period of time before she needs to lay down"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gastrointestinal symptoms".  Additional information: That day she starting experiencing sore throat, headache, allergy-related symptoms and a fatigue that has lasted all this time. She hasn't been able to stand up for a long period of time before she needs to lay down. On Sunday she started experiencing gastrointestinal symptoms until this morning. She wanted to know how long these side effects may last. She still has not received assistance from her doctor.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He started feeling unwell late afternoon on Tuesday, tested positive using Binax yesterday; He started feeling unwell late afternoon on Tuesday, tested positive using Binax yesterday; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 62-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mechanical mitral heart valve" (unspecified if ongoing), notes: he has a mechanical mitral heart valve. Concomitant medication(s) included: ATORVASTATIN; NEBIVOLOL; WARFARIN taken for anticoagulant therapy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: unknown), administration date: 25Apr2021, when the patient was 59-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot: unknown), administration date: 02Dec2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, (BOOSTER), Lot: unknown), administration date: 13Sep2022, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, (BOOSTER), Lot: unknown), administration date: 25Apr2021, when the patient was 61-year-old, for COVID-19 immunization. The patient reported that he was administered with Comirnaty 12 plus on early Sep 11Sep2024. He started feeling unwell late afternoon on Tuesday, tested positive using Binax yesterday (09Oct2024). The patient wanted to know if he is eligible to receive Paxlovid and is asking if he can take the Paxlovid together with his other medications. He also would like to know if there are drug-drug interactions with his medications such as Atorvastatin and Nebivolol. He already checked (web link) but did not see information. No information found on Beta blockers. His primary concern is his medication, Warfarin because he has a mechanical mitral heart valve, it's a blood thinner. Caller already checked (web link) and did not see information. He was not prescribed with Paxlovid just yet.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400275087 same patient, different dose/event;US-PFIZER INC-202400275086 same patient, different dose/event;US-PFIZER INC-202400274768 same patient, dose/ different products/ event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID he got was very mild; COVID he got was very mild; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 71-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Jun2024 as dose 1, single (Lot number: LC4370, Expiration Date: 31Aug2024) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's 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 NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID he got was very mild". Clinical course: COVID was very mild.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Duodenogastric reflux
Clinical narrative: gastrointestinal distress and reflux; gastrointestinal distress and reflux; This is a spontaneous report received from a Nurse from a sales representative.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: DUODENOGASTRIC REFLUX (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "recovered" and all described as "gastrointestinal distress and reflux". It was unknown if therapeutic measures were taken as a result of duodenogastric reflux, abdominal discomfort.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site on their left arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 (BNT162B2 NOS), in Apr2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Unspecified number of doses (reported as "a bunch"), Anatomical location: Left arm, Lot #: Unknown), for COVID-19 immunisation, reaction(s): "Vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection site on their left arm".  Additional information: The pain lasted longer with the latest administration - it usually goes away within a few days to a week at most but last time for her it lasted weeks before going away (also reported as a month).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400275629 Different patients, Same reporter, drug, event.;US-PFIZER INC-202400275676 Same patient, event, Different drug dose number.;US-PFIZER INC-202400275677 Same event, Different patient, drug dose number.;
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Ride service driver mentioned that he received the Comirnaty vaccine 2 days ago and still has some soreness in that shoulder.; This is a spontaneous report and received from Consumer or other non HCPs.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 11Oct2024, outcome "unknown", described as "Ride service driver mentioned that he received the Comirnaty vaccine 2 days ago and still has some soreness in that shoulder.". It was unknown if therapeutic measures were taken as a result of arthralgia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2024 at 05:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset Oct2024, outcome "unknown"; HEADACHE (non-serious) with onset Oct2024, outcome "unknown".  Additional information: Reporter read on paper about the side effects. The patient (husband) and the reporter, both took the Pfizer COVID-19 vaccine/shot yesterday (10Oct2024) and the reporter have had diarrhea ever since she took it yesterday. The patient is having chills and headache.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Got another form of cancer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Got another form of cancer". The customer claimed different side effects that her acquaintances experienced after receiving the Pfizer vaccinations.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400131855 same product, reporter, different events and patient.;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Neoplasm malignant, Nervous system disorder
Clinical narrative: Developed cancer; heart condition; neurological problems; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Developed cancer"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological problems". Clinical course: The customer claimed that her sister developed cancer, a heart condition, and neurological problems because of getting the Pfizer vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400131855 same product, reporter, different events and patient.;
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: heart was twice it's normal size; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 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. The following information was reported: CARDIOMEGALY (non-serious) with onset 2024, outcome "unknown", described as "heart was twice it's normal size".  Additional information: The customer claimed different side effects that her acquaintances experienced after receiving the Pfizer vaccinations. After getting the Pfizer vaccinations, the customer's neighbor's heart was twice it's normal size. The reporter consider event as caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400131855 same product, reporter, different events and patient.;
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient was adminstered fluzone while being pregnant with no reported adverse event; Initial information received on 12-Sep-2024 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 28-year-old female patient who was exposed to Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in context of patient was adminstered Fluzone while being pregnant with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Patient was administered Fluzone while being pregnant with no reported adverse event occurred at 33 weeks of pregnancy and the patient was exposed To Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] at 33 weeks of pregnancy, during third pregnancy trimester.  The date of last menstrual period was reported as 31-Jan-2024. The estimated due date is 06-Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Sep-2024, the patient received (dose 1) of suspect Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot-UT8423JA) (unknown expiry date and strength) via intramuscular route in unknown administration site for Prophylactic vaccination was reported  ''Fluzone was administered while being pregnant with no reported adverse event'' (exposure during pregnancy) (latency-same day).  The outcome of pregnancy was unknown.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Decreased appetite, Dehydration, Diarrhoea, Fatigue
Clinical narrative: dehydration; decreased appetite; fatique; headache; chills; fever; nausea; substantial diarrhea; Initial information received on 24-Sep-2024 regarding an unsolicited valid  serious case received from Pizer via consumer/Non-Healthcare Professional as courtesy case.   This case involves a 43 years old female patient who had dehydration, decreased appetite, fatique, headache, chills, fever, nausea and substantial diarrhea after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy, Allergy to arthropod sting, Drug hypersensitivity, Contrast media allergy and Asthma.   On 08-Sep-2024, the patient received unknown dose of suspect Comirnaty not produced by Sanofi Pasteur (lot number, formulation, strength and expiry date not reported) via unknown route in the left arm and same patient also received unknown dose of suspect Influenza quadrivalent recombinant vaccine (lot number formulation, strength and expiry date not reported) via unknown route in the right arm both for Prophylactic vaccination.  On 11-Sep-2024 the patient developed dehydration, decreased appetite, fatique (fatigue), headache, chills , fever (pyrexia), nausea and substantial diarrhea (diarrhoea) (latency: 3 days).  The patient was hospitalized for these events.  Patient reported his primary care physician didn't have any available appointments, so he went to urgent care. They felt it was more likely viral or bacterial and run a bunch of tests. Three days later feeling worse, he was in the emergency room and treated for dehydration. His symptoms lasted 11 days all the testing produced negative results, hence why he and leading towards believing it was the vaccine or combination of the two together  Action taken: Not applicable.  An unknown corrective treatment was received for all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.; Sender's Comments: Sanofi Company Comment dated 12-OCT-2024: This case involves a 43 years old female patient who had dehydration, decreased appetite, fatique, headache, chills, fever, nausea and substantial diarrhea after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok]. Further information regarding concurrent condition during vaccination, tolerance ,laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: dehydration; decreased appetite; fatique; headache; chills; fever; nausea; substantial diarrhea; Initial information received on 24-Sep-2024 regarding an unsolicited valid  serious case received from Pizer via consumer/Non-Healthcare Professional as courtesy case.   This case involves a 43 years old female patient who had dehydration, decreased appetite, fatique, headache, chills, fever, nausea and substantial diarrhea after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy, Allergy to arthropod sting, Drug hypersensitivity, Contrast media allergy and Asthma.   On 08-Sep-2024, the patient received unknown dose of suspect Comirnaty not produced by Sanofi Pasteur (lot number, formulation, strength and expiry date not reported) via unknown route in the left arm and same patient also received unknown dose of suspect Influenza quadrivalent recombinant vaccine (lot number formulation, strength and expiry date not reported) via unknown route in the right arm both for Prophylactic vaccination.  On 11-Sep-2024 the patient developed dehydration, decreased appetite, fatique (fatigue), headache, chills , fever (pyrexia), nausea and substantial diarrhea (diarrhoea) (latency: 3 days).  The patient was hospitalized for these events.  Patient reported his primary care physician didn't have any available appointments, so he went to urgent care. They felt it was more likely viral or bacterial and run a bunch of tests. Three days later feeling worse, he was in the emergency room and treated for dehydration. His symptoms lasted 11 days all the testing produced negative results, hence why he and leading towards believing it was the vaccine or combination of the two together  Action taken: Not applicable.  An unknown corrective treatment was received for all the events.  At time of reporting, the outcome was Recovering / Resolving for all the events.; Sender's Comments: Sanofi Company Comment dated 12-OCT-2024: This case involves a 43 years old female patient who had dehydration, decreased appetite, fatique, headache, chills, fever, nausea and substantial diarrhea after receiving Tozinameran (Comirnaty) and Influenza quadrivalent recombinant vaccine [Flublok]. Further information regarding concurrent condition during vaccination, tolerance ,laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: flublok was inadvertently administered to 8 year old patient with no reported adverse event; Initial information received on 27-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to US-SA-2024SA291948.  This case involves a 8 years old male patient to whom Influenza trivalent recombinant vaccine [Flublok TIV] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2024, the 0.5 ml dose of suspect Influenza trivalent recombinant vaccine, Solution for injection (lot TFAA2421; Expiration Date : 31-May-2025) via intramuscular route in the right deltoid for Immunization was inadvertently administered to 8 year old patient with no reported adverse event (product administered to patient of inappropriate age) (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-2024SA291948:02241593
Age: 1.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient who was inadvertently administered with adacel yesterday, 26Sep2024, for her supposed 4th dose in the DTaP series with no reported adverse event; Initial information received on 27-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-year-old female patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] that was inadvertently administered yesterday, 26-Sep-2024, for her supposed 4th dose in the Diphtheria, Tetanus and Acellular Pertussis Vaccine series with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine (HIB); and Hepatitis a vaccine (Hepatitis A) for prophylactic vaccination.  On 26-Sep-2024 the patient was inadvertently administered with of Standard Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot-3CA22C1, expiry date: 28-Feb-2028) via intramuscular route in Right Deltoid for prophylactic vaccination as for her supposed 4th dose in the DTAP (Diphtheria, Tetanus and Acellular Pertussis Vaccine) series with no reported adverse event (wrong 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.
Age: 64.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red itchy rash covering arm
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Circumstance or information capable of leading to device use error, Extra dose administered, No adverse event, Underdose
Clinical narrative: The current season's influenza vaccine was ordered and administered to the patient for the second time by mistake, but due to the characteristics of her underlying behavioral disease, only less than half of the vaccine was administered to the patient, because the rest was spilled due to the struggle the patient was having, despite being held by both parents. The patient has not had any reported adverse effects to date.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Pt states she has had shoulder pain since getting the vaccine
Age: 89.0
Sex: F
Vaccine: COVID19, FLU3, RSV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Patient experienced redness, hives, swelling, on legs up to the knee caps and swelling, redness and hives on both arms. All red areas were hot to touch. The hives were small  and red but, covered a  big surface area of the body. Symptoms began on 10/11/24. She has been taking Zyrtec and hydrocortisone over the counter until her doctors visit. Her symptoms have not yet resolved since the symptoms began.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: patient was given FLU vaccine when she already got the flu vaccine this season on 09/11/2024. no immediate reaction after vaccine given. Patient was instructed to monitor.,
Age: 0.25
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Syringe issue, Wrong product administered
Clinical narrative: Started to administer Influenza vaccine (Fluzone) rather than RSV antibody injection (nirsevimab) to 3 month old infant. Infant was in clinic with older sibling who was to receive the influenza vaccine. Medical assistant reported that full dose of the Fluzone was not given and that most of the volume leaked out rather than being injected. Patients mother was notified immediately of the error. Will monitor for side effects at home. This office will contact family within 24 hours to assess for any side effects.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE EVENT, PT GIVEN HIGH DOSE INFLUEZA VACCINE INSTEAD OF FLUBLOCK QUAD VACCINE FOR HER AGE.
Age: 27.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given an MMRV instead of MMR. No known adverse effects. Pharmacy and provider consulted and contact with patient was made.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient's mother signed the patient up for the Covid-19 vaccine and the flu vaccine. Patient said she was only getting one vaccine and I asked if she was getting the flu vaccine and she said yes.   After administering the vaccine, her mother informed me that patient had already received the 2024 flu vaccine in September.  I inquired as to why it was one of the vaccines selected on the vaccine consent form and I informed mother that patient told me that is what she needed. Patient did not have any reaction to the vaccine-it was her second dose.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Eye oedema, Face oedema, Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever after 24 hours, then a diffuse red rash that was itchy, and mild facial/eye edema. Lasted about 72 hours.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash pruritic
Clinical narrative: Fever after 24 hours, then a diffuse red rash that was itchy, and mild facial/eye edema. Lasted about 72 hours.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient received two doses of this year's flu shot. They got one dose on 7/24/24 and the second accidental dose on 10/13/24