chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: intermittent chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (intermittent chills) in a 79-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043835) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine on 04-Oct-2024. Past adverse reactions to the above products included No adverse effect with Influenza vaccine.    On 21-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In November 2024, the patient experienced CHILLS (intermittent chills). At the time of the report, CHILLS (intermittent chills) 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.  Patient still had the reaction/side effect and also wanted to know if it's normal to have a patient for so many days this reaction. It was unknown if the patient experienced any additional symptoms/events. HCP checked the patient's immunization registry record and did not see any vaccines administered 4 weeks prior to Spikevax. After the vaccination last night, patient still experiencing intermittent chills. They do lots of vaccines, usually patients do not experience intermittent chills after 10 days.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Dec-2024: Live Significant follow up received: Additional reporter, patient DOB, historical vaccine, suspect product dose details, event onset and outcome, narrative and reference number were added.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: rash; high fever; swollen; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash), PYREXIA (high fever) and SWELLING (swollen) in a 46-year-old male 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RASH (rash), PYREXIA (high fever) and SWELLING (swollen). At the time of the report, RASH (rash), PYREXIA (high fever) and SWELLING (swollen) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Thrombosis
Clinical narrative: blood clots all up in his chest; heart issues/ had to get his heart shocked, and had a large heart filled up with fluid; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clots all up in his chest) and CARDIAC DISORDER (heart issues/ had to get his heart shocked, and had a large heart filled up with fluid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: allergy pill. Past adverse reactions to the above products included Asthma with allergy pill. Concurrent medical conditions included Asthma.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots all up in his chest) (seriousness criteria hospitalization and medically significant) and CARDIAC DISORDER (heart issues/ had to get his heart shocked, and had a large heart filled up with fluid) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (blood clots all up in his chest) and CARDIAC DISORDER (heart issues/ had to get his heart shocked, and had a large heart filled up with fluid) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported. Patient went to the heart doctor and was in the hospital four times. He was in ICU for a week with blood clots in all his chest. Patient had a large heart filled up with fluid in the hospital for two weeks. It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2024: Live follow-up received contains non-significant information. Added reference numbers. On 07-Dec-2024: Live follow-up received contains no new information.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Diarrhoea, Erythema, Influenza like illness, Pain
Clinical narrative: severe diarrhea; pain in my arm and redness; aches; It was like having the bad flu; fever; arm soreness/I had my usual pain, and very, very bad pain in my arm; chills; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), INFLUENZA LIKE ILLNESS (It was like having the bad flu) and PYREXIA (fever) in a 70-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 an unknown date, 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 an unknown date, the patient experienced DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), INFLUENZA LIKE ILLNESS (It was like having the bad flu), PYREXIA (fever), PAIN IN EXTREMITY (arm soreness/I had my usual pain, and very, very bad pain in my arm) and CHILLS (chills). At the time of the report, DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), PYREXIA (fever), PAIN IN EXTREMITY (arm soreness/I had my usual pain, and very, very bad pain in my arm) and CHILLS (chills) had not resolved and INFLUENZA LIKE ILLNESS (It was like having the bad flu) outcome 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. Patient had diarrhea for almost 2 weeks then and thought it would go away. It went away for a week, but  had returned and it's very watery, and very concerning. It was reported that it was going under all the way under her axillary area and that was the worst that she had experienced. Patient started to have almost normal bowel movements but on the day of reporting she had two abnormal one so she was back where she started, all water, watery and non-formed. Patient wanted to get a colonoscopy and go see my doctor.  The patient did not experience any additional symptoms/events. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-779126, US-MODERNATX, INC.-MOD-2024-779129 (E2B Linked Report). This case was linked to MOD-2021-089482, MOD-2024-779032 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779129:small percentage of people US-MODERNATX, INC.-MOD-2024-779126:Women case
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: severe diarrhea; pain in my arm and redness; aches; It was like having the bad flu; fever; arm soreness/I had my usual pain, and very, very bad pain in my arm; chills; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), INFLUENZA LIKE ILLNESS (It was like having the bad flu) and PYREXIA (fever) in a 70-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 an unknown date, 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 an unknown date, the patient experienced DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), INFLUENZA LIKE ILLNESS (It was like having the bad flu), PYREXIA (fever), PAIN IN EXTREMITY (arm soreness/I had my usual pain, and very, very bad pain in my arm) and CHILLS (chills). At the time of the report, DIARRHOEA (severe diarrhea), ERYTHEMA (pain in my arm and redness), PAIN (aches), PYREXIA (fever), PAIN IN EXTREMITY (arm soreness/I had my usual pain, and very, very bad pain in my arm) and CHILLS (chills) had not resolved and INFLUENZA LIKE ILLNESS (It was like having the bad flu) outcome 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. Patient had diarrhea for almost 2 weeks then and thought it would go away. It went away for a week, but  had returned and it's very watery, and very concerning. It was reported that it was going under all the way under her axillary area and that was the worst that she had experienced. Patient started to have almost normal bowel movements but on the day of reporting she had two abnormal one so she was back where she started, all water, watery and non-formed. Patient wanted to get a colonoscopy and go see my doctor.  The patient did not experience any additional symptoms/events. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-779126, US-MODERNATX, INC.-MOD-2024-779129 (E2B Linked Report). This case was linked to MOD-2021-089482, MOD-2024-779032 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779129:small percentage of people US-MODERNATX, INC.-MOD-2024-779126:Women case
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling, itchiness, and redness at the injection site; swelling, itchiness, and redness at the injection site; swelling, itchiness, and redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (swelling, itchiness, and redness at the injection site), VACCINATION SITE SWELLING (swelling, itchiness, and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling, itchiness, and redness at the injection site) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1st dose) on 16-Jan-2021, Moderna COVID-19 vaccine (2nd dose) on 14-Feb-2021 and Moderna COVID-19 vaccine (3rd dose) on 17-Dec-2021. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.   On 07-Dec-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (swelling, itchiness, and redness at the injection site), VACCINATION SITE SWELLING (swelling, itchiness, and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling, itchiness, and redness at the injection site). The patient was treated with Cortisone acetate at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (swelling, itchiness, and redness at the injection site), VACCINATION SITE SWELLING (swelling, itchiness, and redness at the injection site) and VACCINATION SITE ERYTHEMA (swelling, itchiness, and redness at the injection site) had not resolved.      No concomitant medications were reported. Patient took the fourth dose of Spikevax NOS on 16-Sep-2022. The patient did not experience any additional symptoms or events.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Secretion discharge
Clinical narrative: a lot of mucus and snot; bad runny nose; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 48-year-old 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: SECRETION DISCHARGE (non-serious), outcome "unknown", described as "a lot of mucus and snot"; RHINORRHOEA (non-serious), outcome "unknown", described as "bad runny nose". Additional information: Caller (patient 48 years old) got Pfizer covid vaccine on Wednesday afternoon, felt fine yesterday until last night I started having a lot of mucus and snot today I have really bad runny nose, and my wife told me to test for covid and flu with your lucira test, could he test false positive with Lucira by Pfizer COVID-19 & Flu Home Test?  and he could be just having cold, Did not test it yet asking question. Is it more likely to give me a positive result if I just had a vaccine? Is it testing for antibodies or testing for virus?  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: Coughing; Cannot stop; Asthma; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 18May2021 as dose 1, single (Lot number: EWO171) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHMA (non-serious) with onset 2021, outcome "unknown"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "Coughing; Cannot stop". Therapeutic measures were not taken as a result of cough, asthma. Additional information: Reporter reported for son, since the COVID shot, he had an adverse reaction of coughing but he cannot stop and they have given him inhaler (Suspect captured as Unspecified Medication) but it is nothing there wrong and he wants to know if there is a remedy for this cough that he acquired. He has incarcerate to jail, prison. They are not treating him. He has supposed to get, like he has got an asthma ever since. He never had asthma. Patient only had Pfizer vaccine and second dose of covid-19 vaccine was vaccination on 10Jun2021.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Lymphoedema, Myalgia, Non-pitting oedema, Ultrasound scan
Clinical narrative: Severe swelling in hands, legs & feet/no definitive diagnosis other than non pitting edema, lymphedema, myalgia; Severe swelling in hands, legs & feet/no definitive diagnosis other than non pitting edema, lymphedema, myalgia; Severe swelling in hands, legs & feet/no definitive diagnosis other than non pitting edema, lymphedema, myalgia; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Oct2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "beef heart valve" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 immunisation (dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 immunisation (dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 immunisation (dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 immunisation (dose 4, manufacturer unknown), for COVID-19 immunisation; Covid-19 immunisation (dose 5, manufacturer unknown), for COVID-19 immunisation. The following information was reported: NON-PITTING OEDEMA (non-serious), LYMPHOEDEMA (non-serious), MYALGIA (non-serious) all with onset 27Oct2024 at 14:00, outcome "unknown" and all described as "Severe swelling in hands, legs & feet/no definitive diagnosis other than non pitting edema, lymphedema, myalgia". The event "severe swelling in hands, legs & feet/no definitive diagnosis other than non pitting edema, lymphedema, myalgia" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of non-pitting oedema, lymphoedema, myalgia. Additional information: The patient have no known drug allergy. The patient did not receive any other vaccines on the same date as the suspected vaccine nor receive any other vaccines within 4 weeks PRIOR to the suspected vaccine. Infectious disease rheumatology and PCP showed no definitive diagnosis other than non pitting edema, lymphedema, myalgia. The treatment received for the adverse events include ibuprofen, lymphedema massage.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vaccination site pain
Clinical narrative: soreness at the site of injection; This is a spontaneous report received from a Pharmacist.  A 57-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 at 15:00 as dose 1, single (Lot number: LM2211) at the age of 57 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 06Dec2024 as dose number unknown, single (Lot number: 946606), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Hypersensitivity". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Dec2024 at 19:30, outcome "recovering", described as "soreness at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306660 Same patient/event, different dose;US-PFIZER INC-PV202200076464 Same patient, partial same event, different dose;US-PFIZER INC-202101781436 Same patient, partial same event, different dose;US-PFIZER INC-2021314714 Same patient, different event/dose;US-PFIZER INC-2021233657 Same patient/event, different dose;
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headaches; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 21 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Environmental allergy (unspecified)" (unspecified if ongoing); "Autism" (ongoing); "ADHD" (ongoing); "Anxiety" (unspecified if ongoing); "Dry Eye Disease" (unspecified if ongoing); "Central Auditory Processing Disorder" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Migraine Disorder" (unspecified if ongoing). Concomitant medication(s) included: AIMOVIG, start date: Mar2022, stop date: 02Dec2024; DULOXETINE DR, start date: Sep2021; METHYLPHENIDATE, start date: Aug2017; RESTASIS MULTIDOSE, start date: Sep2020; UBRELVY, start date: Mar2022, stop date: Dec2023. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin"; Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot/batch number: EL8982, Administration time: 10:45 AM , Anatomical location: Left Deltoid), administration date: 15Jan2021, when the patient was 20-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot/batch number: EN5318, Administration time: 11:30 AM , Anatomical location: Left Deltoid), administration date: 04Feb2021, when the patient was 21-year-old, for Covid-19 immunization. The following information was reported: MIGRAINE (disability) with onset Nov2022, outcome "unknown", described as "migraine headaches". The event "migraine headaches" required physician office visit. Therapeutic measures were taken as a result of migraine. Clinical course: After the 3rd dose patient developed migraine headaches for which subspecialist consult, PT, medication was given as treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300104837 Same patient/product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Have covid; Have covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 76-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Have covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400318585 same reporter/product/events; different patient;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: not feeling well; aches all over; headache; This is a spontaneous report received from an Other HCP, Program ID:  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Nov2023 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "not feeling well"; PAIN (non-serious), outcome "recovered", described as "aches all over"; HEADACHE (non-serious), outcome "recovered".  Additional information: A couple of weeks post-vaccination the patient was feeling unwell for 5 days. The patient mentioned did not have Covid but had Covid-like symptoms such as headache and aches all over.   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: Polymenorrhoea
Clinical narrative: Covid shot has decreased the menstrual cycle/it went from 30 days to 20 days; 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: POLYMENORRHOEA (non-serious), outcome "unknown", described as "Covid shot has decreased the menstrual cycle/it went from 30 days to 20 days".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL was administered post excursion with no adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to US-SA-2024SA362437 (master case)  This case involves a 10 years old male patient who received IPV (VERO) [IPOL] post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX); HEPATITIS B VACCINE (HEP B VAX); and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 12-Nov-2024, the patient received 0.5 ml dose of IPV (VERO) Suspension for injection 1x(once) lot W1C741M expiry-17-Nov-2025 via subcutaneous route in the right arm for Prophylactic vaccination (Immunisation) (strength-standard) post excursion with no reported adverse event (poor quality product administered) (latency same day).  Nurse called to report temperature excursion that lasted 24 minutes. Nurse states the vial was warm but could not provide a specific temperature. Medication was administered.   THERMOMETER WAS NOT RECORDING DURING TRANSPORT Human Error: NO   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-2024SA364281: US-SA-2024SA362335:02333379 US-SA-2024SA362437:Master case
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Punctured ipol was administered after excursion with no reported adverse event; Initial information received on 06-Dec-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case was linked to other case US-SA-2024SA364281 (Master case).  This case involves a 12 years old female patient who received punctured IPV (VERO) [IPOL] administered after excursion 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 diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Immunization, hepatitis B vaccine (hepatitis B vaccine) for immunization, measles vaccine, mumps vaccine, rubella vaccine (MMR vaccin) for Immunization.  On 12-Nov-2024, the patient received punctured 0.5 ml of suspect IPV (VERO) of standard strength with lot W1C741M and expiry date 17-Nov-2025 once via subcutaneous route in the left arm for immunization was administered after excursion with no reported adverse event (poor quality product administered) (Latency same day).  Reportedly, Nurse called to report temperature excursion that lasted 24 minutes. Reason: thermometer was not recording during transport. human Error: No. Maximum/Low Temperature reached: unknown, but MDV (multidose vial) was warm.  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-2024SA362335:02333381 US-SA-2024SA364281:02333312 (Master case)
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin mass
Clinical narrative: redness; lump under his skin; itching uncontrollably all over his body; Initial information regarding this unsolicited valid non-serious case downloaded from the Regulatory Authority database without narrative (level 2A), was received on 06-Dec-2024 from Non health care professional via Health Authorities. The following narrative is based on the information retrieved from all other accessible data.  This case involves, a 72 years old male patient who had redness, itching uncontrollably all over his body and lump under his skin after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant- no other vaccines.  On 02-Nov-2024, the patient received High Dose (once) INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (lot-U85278A, expiry date:28-Jun-2026) via intramuscular route in the left arm for Influenza.  On 04-Nov-2024, the patient developed itching uncontrollably all over his body (pruritus) (latency-2 days), on 06-Nov-2024, the patient developed redness (erythema) and lump under his skin (swelling) (latency-4 days) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Reportedly,patient received the shot the afternoon of 02-Nov-2024. He woke up the morning of 04-Nov-2024 with massive itching all over his body. He also said on 06-Nov-2024, he had a lump under his skin as well and redness. The redness swell the next day and it was like the size of 3 walnuts under his skin. On the 10-Nov-2024, he went to the emergency room and they gave him some itch cream, some itch pills and a steroid pack. He said it was a 5-day steroid treatment. On the 4th day of treatment, the itching dissipate. But 3 days after he completed the steroid treatment, the itching came back. He has been dealing with the itching for 1 month now and on 04-Dec-2024, he went to his regular doctor and they put him on another steroid pack. He started that yesterday and he has had a significant relief from the itching and stated it is almost gone right now. He is nowon the 2nd day of a 6-day treatment of steroids.   Action taken was not applicable.  It was reported the patient was given cream and pill for itching as well as steroid as corrective treatment for (pruritus).  At time of reporting, the outcome was Recovering / Resolving for the event itching uncontrollably all over his body and was Unknown for the events (redness, lump under his skin).
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriate use due to a patient being given a punctured IPOL post temperature excursion with no reported adverse event; Initial information received on 09-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age / gender patient who received punctured IPV (VERO) [IPOL] post temperature excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of punctured IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization post temperature excursion with no reported adverse event (poor quality product administered) (same day latency).   Reportedly, there were 13 excursions for one opened IPOL and believed it was administered to a patient at that time.   Information on the batch number was requested corresponding to the one at time of event occurrence.   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.
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Pyrexia, Rash, Urticaria
Clinical narrative: developed hives; flu like systems; rash; developed high grade fever; Initial information received on 09-Dec-2024 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional.  This case involves an unknown age female patient who developed hives, flu like systems, rash and high grade fever after receiving RABIES (HDC) Vaccine [Imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) Vaccine Powder and solvent for suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Prophylactic vaccination.  On an unknown date the patient developed high grade fever (pyrexia), flu like systems (influenza like illness) (latency- 48 hours), rash and hives (urticaria) (latency- 5 days).  Action taken- not applicable.  Patient was given steroids as an corrective treatment for the events (developed high grade fever, flu like systems).  It was not reported if the patient received a corrective treatment for the events (developed hives, rash).  At time of reporting, the outcome was Unknown for all the events.
Sex: F
Vaccine: FLU3
Symptoms: Anxiety
Clinical narrative: A little more Anxiety; This spontaneous case, initially received on 11-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  Medical History and concomitant medication unknown.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for influenza immunization, Dose regimen: 0.5 ml, Route of administration: Intramuscular in anatomical location Not reported, Lot number: No batch number available and will be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced A little more Anxiety (outcome: Unknown).   Fluad (TIV) action taken: Not Applicable  Reporter´s assessment: The reporter considered event as non-serious and causality was not provided.; Reporter's Comments: Event is not related
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Two product were exposed to freezing temperatures at 32 degrees for 10 hours; Product did not Freeze, but became Slushy to the touch; This spontaneous case (out of a cluster of 2 cases), initially received on 27-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Concomitant medication and medical history were unknown.  Administration of company suspect drug(s): On an unknown date, the patient received Fluad (TIV) for Indication not reported, Dose regimen: 0.5 ml, route of administration: Not reported, Lot number: 388470 and expiry date: May-2025.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, two product were exposed to freezing temperatures at 32 degrees for 10 hours (outcome: Unknown), the product did not Freeze, but became Slushy to the touch (outcome: Unknown).  There was excursion event where two of the products were exposed to freezing temperature at 32 degrees for 10 hours. The product did not freeze, but became slushy to the touch.    Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: All events were considered as not related.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Product did not Freeze, but became Slushy to the touch; Two product were exposed to freezing temperatures at 32 degrees for 10 hours; This spontaneous case (out of a cluster of 2 cases), initially received on 27-Nov-2024, was reported by a health professional and concerns a patient of unknown age/gender.  Concomitant medication and medical history were unknown.  Administration of company suspect drug(s): On an unknown date, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Not reported, Lot number: 946613 and expiry date: Jun-2025.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, two product were exposed to freezing temperatures at 32 degrees for 10 hours (outcome: Unknown), the product did not Freeze, but became Slushy to the touch (outcome: Unknown).  There was excursion event where two of the products were exposed to freezing temperature at 32 degrees for 10 hours. The product did not freeze, but became slushy to the touch  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: All events considered as not related.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: vaccine given on 12/09 and still sore and tender til today. injection site seem to be on the bicep instead of deltoid
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given pfizer vaccina for age 12+.Patient was only 11 at the time
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Paralysis
Clinical narrative: Paralysis
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Vaccine was administered at 2:43, patient tolerated well and did not experience any adverse reactions.  Reported to DON and Provider, received recommendation for patient to return to clinic in 4 weeks to receive heplasiv-B as recommended by CDC guidelines. Patient was made aware and verbalized understanding.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Flublok but should have received Fluzone based on patient's age. There was no immediate reaction. Mom was in the room when the incident occurred. Pharmacist-on-duty was notified and spoke to patient's mom about the incident. Pharmacist informed mom about filing a VAERs report and addressed concerns from mom that included signs and symptoms of reactions. Pharmacist informed mom to let doctors office know of incident in case follow-up is needed.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT HAS 2 FLUAD SHOTS ONE ON 07/31/2024 AND ANOTHER ON 12/11/2024. PHARMACIST DID NOT REALIZED AT THE TIME OF FILLING THE PRESCRIPTION.  WE SPOKE WITH THE PATIENT AND THE PRIMARY DOCTOR THE NEXT DAY OF THE INCIDENT. PATIENT HAS NO REACTION ADVERSE REACTION SO FAR.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect covid vaccine given. Moderna only for 11yrs and under. pt is 12 yrs old
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Acupuncture, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discolouration, Pain
Clinical narrative: Vaccine was given very high up in the shoulder.  Needle felt like it went directly into the bone.  Immediately hurt, area turned black and blue.  Since I have difficulty lifting my arm forward and to the side.  Cannot lay or sleep on that side, am unable to pull blankets up due to extreme pain.  I have seen the ortho doctor twice, I've been in physical therapy since November 5th, last week I tried acupuncture.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site, Sleep disorder, X-ray
Clinical narrative: Vaccine was given very high up in the shoulder.  Needle felt like it went directly into the bone.  Immediately hurt, area turned black and blue.  Since I have difficulty lifting my arm forward and to the side.  Cannot lay or sleep on that side, am unable to pull blankets up due to extreme pain.  I have seen the ortho doctor twice, I've been in physical therapy since November 5th, last week I tried acupuncture.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient reports that she did not remember receiving a dose of Flucelvax 2024-2025 on 07/29/2024 and Healthcare portal says she is due for Flucelvax 2024-2025 dose. Patient reports with minor soreness/redness on the site of injection (LA) on 12/11/2024, with no fever or other symptoms.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: given 6m-11yr dose in error
Age: 96.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Contusion, Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Tuesday night patients right arm swelled up, turned red and had a large black and blue bruise appear. It was itchy and warm to the touch.  It caused her a lot of pain and she was unable to sleep on that side due to the pain.  She used some Benadryl cream on her arm and took Tylenol for the pain. Today when it was reported it is starting to resolve but still not completely back to normal.
Age: 96.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Skin warm, Sleep disorder
Clinical narrative: Tuesday night patients right arm swelled up, turned red and had a large black and blue bruise appear. It was itchy and warm to the touch.  It caused her a lot of pain and she was unable to sleep on that side due to the pain.  She used some Benadryl cream on her arm and took Tylenol for the pain. Today when it was reported it is starting to resolve but still not completely back to normal.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: no s/s
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Day 1:  low grade fever, arm soreness, restless sleep .  Day 2:  arm soreness, then noted erythema at injection site tender to touch
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Blood pressure increased, Chest pain, Dyspnoea, Influenza virus test negative
Clinical narrative: The Associate states that about two hours after the vaccination and while at work she developed chest pain and shortness of breath and she could feel her heartbeat in her ear. When she went home she was up all night and found it hard to breath whenever she lay down. The next day she went to the emergency room with same symptoms and says they also found her to be tachycardic and had an elevated blood pressure. Says the medical provider prescribed Benadryl IV but she was driving and was instructed to take 100mg Benadryl PO at home. She reports no local injection reaction to her left arm adn states that she had even forgotten that she had been vaccinated. Says she has been alternating Tylenol and Motrin for  her achey joints and is still having some shortness of breath at this time. Also states that she took an at home test for COVID and FLU and the test was negative.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Pulse abnormal, SARS-CoV-2 test negative, Sleep disorder, Tachycardia
Clinical narrative: The Associate states that about two hours after the vaccination and while at work she developed chest pain and shortness of breath and she could feel her heartbeat in her ear. When she went home she was up all night and found it hard to breath whenever she lay down. The next day she went to the emergency room with same symptoms and says they also found her to be tachycardic and had an elevated blood pressure. Says the medical provider prescribed Benadryl IV but she was driving and was instructed to take 100mg Benadryl PO at home. She reports no local injection reaction to her left arm adn states that she had even forgotten that she had been vaccinated. Says she has been alternating Tylenol and Motrin for  her achey joints and is still having some shortness of breath at this time. Also states that she took an at home test for COVID and FLU and the test was negative.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The patient got the Prevnar 20 on 12/08/2024. The patient also received the prevnar 20 in 04/19/22
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Patient claimed that she has lost complete hearing in her right ear.  She went to an ENT doctor who has confirmed it. It initially was mis-diagnosed as an ear infection.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Burning sensation, Chills, Headache, Hyperhidrosis
Clinical narrative: Approximately 4hr after vaccine, lower back ache full body aches into the night, Chills that night with painful body aches, with sweating.  this continued for 3 days after the vaccine then Monday went to doctor and was told this should start to go away so take tylenol and plenty of fluids.  But, symptoms continued and changed to bad cramping in legs (burning feeling) to burning and tightness in arms and legs (burning) feet hurt very bad.  Day 7 bad headache.  Messaged doctor and prescribed low dose steriods and Patient had a doctor's appointment on 12/13 at 12:20pm with Dr at the same Virtua office.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Muscle tightness, Pain, Pain in extremity
Clinical narrative: Approximately 4hr after vaccine, lower back ache full body aches into the night, Chills that night with painful body aches, with sweating.  this continued for 3 days after the vaccine then Monday went to doctor and was told this should start to go away so take tylenol and plenty of fluids.  But, symptoms continued and changed to bad cramping in legs (burning feeling) to burning and tightness in arms and legs (burning) feet hurt very bad.  Day 7 bad headache.  Messaged doctor and prescribed low dose steriods and Patient had a doctor's appointment on 12/13 at 12:20pm with Dr at the same Virtua office.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Small fibre neuropathy
Clinical narrative: Small nerve neuropathy (undiagnosed for over a year) developed slowly after the vaccination. The disease is known to progress from the feet. By the time I started realizing that something was really wrong with me, it was about a year later.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 59 years old and given HD Flu for age 65+.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Pt received vaccine on friday afternoon on saturday night she experienced fever, rash, itching and swelling which continued for about a week and the rash still there although it has gotten better initially the rash was huge area 10 inches. loss of appetite for the past 5 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Nausea, pounding headache, fever (101.2), chills, arm redness, swelling, pain and itching at the injection site and all the way from my neck, down and around my arm, joint and muscle pain, rapid heartbeat, fatigue
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Nausea, pounding headache, fever (101.2), chills, arm redness, swelling, pain and itching at the injection site and all the way from my neck, down and around my arm, joint and muscle pain, rapid heartbeat, fatigue
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Nausea, pounding headache, fever (101.2), chills, arm redness, swelling, pain and itching at the injection site and all the way from my neck, down and around my arm, joint and muscle pain, rapid heartbeat, fatigue