chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness
Clinical narrative: pt reports lightheadedness/dizziness. states similar to ade received by pfizer covid vaccinations.  Discussed ade with primary care.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: none
Age: 69.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt came to pharmacy on 11/7/24 and states she was itching and had a rash on arm where she got vaccine  prevnar 20 and Spikevax, she stated she has had moderna covid before and was ok so thinks it may be prevnar.  Told her to get antihistamine(benadryl)and use cold compresses for 15 min at a time.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: The vaccine was possibly not mixed correctly so not fully vaccinated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine given out of "Best By Date." Patient notified. No reaction stated.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Pharmacist called within minutes to report this patient had received an expired (6/2024) flu shot (FLUAD) on Sunday Oct. 6, 2024.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given outside of "Best By Date." Patient notified. No reaction stated
Age: 53.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Sept 24: AM: Received flu shot in right arm.  About 1:00 PM: Moderate soreness began, expected to subside Sept 24 - Oct 1: Pain worsened instead of improving, still moderate, like deep bruising Oct 1 PM: Pain sharply increased, requiring ice and pain medication to sleep Oct 2: Day: Functioned pretty well; Evening: Much increased pain, difficult sleep Oct 3: Severe pain, unable to lift arm, dress, eat; Extreme pain even at rest, sleepless night.  Could not find relief. Oct 4: Appointment, examined, suspected frozen shoulder due to SIRVA; Referred for X-ray and Urgent Care Healthcare clinic findings:" Calcific tendinitis of right shoulder and Shoulder injury related to vaccine administration (SIRVA)"; Treatment: Corticosteroid injection; Prescribed: prednisone, tramadol, acetaminophen By Oct 5 evening: Some pain relief, especially at rest; Movement still completely limited by extreme pain Oct 7 (Today): Some/Limited mobility returning, pain is tolerable as long as I don't lift arm far (I'm not pushing it) Follow-up appointment on Oct 10 with healthcare clinic.
Age: 53.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Shoulder injury related to vaccine administration, Sleep disorder, X-ray limb abnormal
Clinical narrative: Sept 24: AM: Received flu shot in right arm.  About 1:00 PM: Moderate soreness began, expected to subside Sept 24 - Oct 1: Pain worsened instead of improving, still moderate, like deep bruising Oct 1 PM: Pain sharply increased, requiring ice and pain medication to sleep Oct 2: Day: Functioned pretty well; Evening: Much increased pain, difficult sleep Oct 3: Severe pain, unable to lift arm, dress, eat; Extreme pain even at rest, sleepless night.  Could not find relief. Oct 4: Appointment, examined, suspected frozen shoulder due to SIRVA; Referred for X-ray and Urgent Care Healthcare clinic findings:" Calcific tendinitis of right shoulder and Shoulder injury related to vaccine administration (SIRVA)"; Treatment: Corticosteroid injection; Prescribed: prednisone, tramadol, acetaminophen By Oct 5 evening: Some pain relief, especially at rest; Movement still completely limited by extreme pain Oct 7 (Today): Some/Limited mobility returning, pain is tolerable as long as I don't lift arm far (I'm not pushing it) Follow-up appointment on Oct 10 with healthcare clinic.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine for 65+ but is only 58 years old.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccination given outside of "Best By" date. Patient notified. No reaction stated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient mistakenly given Pediatric Moderna Covid 19 dosage of  0.25ml on 10/1/24 at 3:30 am in the  right deltoid in error. Patient was ordered Moderna/Spikevak 0.5ml. Patient will be contacted and scheduled to return to clinic to received the correct therapeutic dosage. Incident was discussed and reviewed with Provider, RNs,
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient requested a flu vaccine but received a covid vaccine instead
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Provider ordered one dose of the covid vaccine 6m-4y and the patient was administered 3x the amount without it being diluted.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient came in to receive RSV vaccination. Patient filled out RSV Immunization standing order. Patient was brought into counseling room and  verified Date of Birth and Vaccination before administration. After giving vaccination they asked that I feel out their vaccination card. At this time I realized that the patient has been previously vaccinated with Abrysvo 120mcg in February of 2024.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: multidose vial of baby COVID vaccine was diluted with Saline solution that was expired by 1 day, (expiration 10/01/2024). No adverse outcome occurred. Pt family was notified.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Provider ordered one dose of the covid vaccine 6m-4y and the patient was administered 3x the amount without it being diluted.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: mild fever, red rash on abdomen and back and pre pubic area and chest, very itchy
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: multidose vial of baby COVID vaccine was diluted with Saline solution that was expired by 1 day, (expiration 10/01/2024). No adverse outcome occurred. Pt family was notified.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received two covid vaccine doses in the same day
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: She had the flu shot the day before and came into the mass clinic and intended to get the RSV but asked for the flu.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: patient states arm is still stiff and sore upon moving, not to the touch.  Has been over two weeks and while it is getting better, it is still stiff and sore to move.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By: date".  Patient notified.  No reaction stated.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Pallor, Syncope
Clinical narrative: Client fainted about 5 seconds after last vaccine was administered. Presented with loss of consciousness, sweating, paleness. LOC lasted about 20 seconds after laying patient flat with feet elevated and using ammonia salts. VSS stable throughout event
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient experienced a rash after vaccination on her arm and lower body.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 7.0
Sex: F
Vaccine: FLU3, HEPA, IPV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: cpx given less than 28 days after mmr vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Skin exfoliation, Skin fissures
Clinical narrative: Soreness, swelling, hot to touch, redness, itching, skin cracking and peeling slightly
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Soreness, swelling, hot to touch, redness, itching, skin cracking and peeling slightly
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives about 3 hours after administration of vaccine
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dysstasia
Clinical narrative: 10/3  from 11:30pm chills, aches and pains throughout the night. On 10/4 at 10 AM went to bathroom, passed out, on the floor,  could not get off floor because of extreme weakness. Stayed on floor for a few minutes, was able to get up, went back to bed for half an hour, felt better, but sore hip and lower back on left side of body .
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain
Clinical narrative: 10/3  from 11:30pm chills, aches and pains throughout the night. On 10/4 at 10 AM went to bathroom, passed out, on the floor,  could not get off floor because of extreme weakness. Stayed on floor for a few minutes, was able to get up, went back to bed for half an hour, felt better, but sore hip and lower back on left side of body .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By: date".  Patient notified.  No reaction stated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: WAS GIVEN EXTRA DOSE OF ROTATEQ AND VAXELIS BY MISTAKE. NO ADVERSE EFFECTS.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. no reaction stated
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Client was given a 0.5 ml dose instead of the pediatric dose. (adult vaccine was incorrectly stored with pediatric and inadvertently given)
Age: 21.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Asthenia, Cold sweat, Feeling cold, Pallor
Clinical narrative: pt was feeling weak,  pale and cold and clammy. was asked to rest for about 15 minutes. provided with water and juice. pt felt better after.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Air embolism, Angiocardiogram, COVID-19, Cardiac arrest
Clinical narrative: PFIZER #1 2/25/2021 PFIZER #2 3/18/2021 PFIZER #3 12/10/2021  SUFFERED VACCINE INDUCED ACUTE NSTEMI REQUIRING EMERGENCY PCI STENTING LCX AND RCA.  AIR EMBOLISM AND CARDIAC ARREST IN CATHETERIZATION LABORATORY.  MILD LV DYSFUNCTION.  POST-EXERTIONAL MALAISE.   TREATED WITH ASPIRIN, EFFIENT,  ROSUVASTATIN, EZETIMIBE, REPATHA, COLCHICINE, RAMIPRIL AND PROTCOL BASE SPIKE DETOXIFICATION.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Left ventricular dysfunction, Malaise
Clinical narrative: PFIZER #1 2/25/2021 PFIZER #2 3/18/2021 PFIZER #3 12/10/2021  SUFFERED VACCINE INDUCED ACUTE NSTEMI REQUIRING EMERGENCY PCI STENTING LCX AND RCA.  AIR EMBOLISM AND CARDIAC ARREST IN CATHETERIZATION LABORATORY.  MILD LV DYSFUNCTION.  POST-EXERTIONAL MALAISE.   TREATED WITH ASPIRIN, EFFIENT,  ROSUVASTATIN, EZETIMIBE, REPATHA, COLCHICINE, RAMIPRIL AND PROTCOL BASE SPIKE DETOXIFICATION.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Percutaneous coronary intervention
Clinical narrative: PFIZER #1 2/25/2021 PFIZER #2 3/18/2021 PFIZER #3 12/10/2021  SUFFERED VACCINE INDUCED ACUTE NSTEMI REQUIRING EMERGENCY PCI STENTING LCX AND RCA.  AIR EMBOLISM AND CARDIAC ARREST IN CATHETERIZATION LABORATORY.  MILD LV DYSFUNCTION.  POST-EXERTIONAL MALAISE.   TREATED WITH ASPIRIN, EFFIENT,  ROSUVASTATIN, EZETIMIBE, REPATHA, COLCHICINE, RAMIPRIL AND PROTCOL BASE SPIKE DETOXIFICATION.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Autoscopy, Brain fog, Confusional state
Clinical narrative: patient describes it as out of body experience. patient had brain fog and confusion about her whereabouts. it lasted throughout the day and was resolved by the next day.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reactions stated.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Echocardiogram, Electrocardiogram, Laboratory test, Malaise
Clinical narrative: PFIZER #1 4/24/2021 PFIZER #2 5/15/2021 MODERNA #1 12/2/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS WITH LOSS OF MENTAL CLARITY AND POST-EXERTIONAL MALAISE.  TREATED WITH COLCHICINE, NICOTINE, MARIVIROC, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental impairment, Myopericarditis
Clinical narrative: PFIZER #1 4/24/2021 PFIZER #2 5/15/2021 MODERNA #1 12/2/2021 DEVELOPED COVID VACCINE SUBCLINICAL MYOPERICARDITIS WITH LOSS OF MENTAL CLARITY AND POST-EXERTIONAL MALAISE.  TREATED WITH COLCHICINE, NICOTINE, MARIVIROC, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By: date".  Patient notified.  No reaction stated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called for TE for VAXNEUVANCE and VAQTA see TE case 02679745. One dose of VAXNEUVANCE and VAQTA were administered, see other AE case 02679795. Consent to contact is yes. No adverse side effects were reported. No additional information available a; This spontaneous report was received from a health care professional referring to 1-year-old patient, gender was not reported. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 27-SEP-2024, the patient was vaccinated with an improperly stored dose pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, for prophylaxis. Lot number X027947 which has been verified to be valid, expiration date reported and validated as 12-JAN-2026 (strength, dose, route of administration, scheme and anatomical location not reported).  The administered dose of the vaccine was stored below 36 degree Fahrenheit (°F) (35.4 °F) for 40 minutes (improper storage of product in use). There were no symptoms reported. ; Sender's Comments:  US-009507513-2409USA010199:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; a patient received an expired PROQUAD; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 25-SEP-2024, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 1 dosage form, lot# reported as W029542, which was determined to be invalid, expiry date reported as 15-SEP-2024, for prophylaxis (therapy type, route of administration and anatomical location were not reported) (expired product administered). No additional adverse events were reported (no adverse event).   Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: was administered expired VAQTA on 10/2/2024; No symptoms reported; This spontaneous report was received from a practice manager on behalf of a patient of unspecified age and gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 02-OCT-2024, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X006702 (expiration date: 01-OCT-2024), 1ml/dose, administered for prophylaxis (strength, anatomical location, and route of administration were not provided), by a health care professional. However, no symptoms were reported, and the vaccine had not gone trough a temperature excursion (TE) (Expired product administered).    On 02-OCT-2024, the patient experienced was administered expired VAQTA on 10/2/2024, the patient experienced No symptoms reported. At the time of reporting, the outcome of the event was administered expired VAQTA on 10/2/2024 was not known, the outcome of the event No symptoms reported was not known. The action taken with VAQTA SYRINGE (DEVICE) regarding was administered expired VAQTA on 10/2/2024 was reported as Not Applicable. The action taken with VAQTA regarding was administered expired VAQTA on 10/2/2024 was reported as Not Applicable. The action taken with VAQTA regarding No symptoms reported was reported as Not Applicable. The action taken with VAQTA SYRINGE (DEVICE) regarding No symptoms reported was reported as Not Applicable.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Power outage resulting in stored temperature more than 8 degree Celsius for 10 hours; No additional reactions reported; This spontaneous report was received from a licensed practical nurse regarding to a 2-year-old female patient. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 19-SEP-2024, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) subcutaneous injection, administered via subcutaneous at right thigh, lot number X020654 (lot number X020654 had been verified to be valid lot number for measles, mumps, and rubella [Wistar RA 27-3] virus vaccine, live), expiration date 21-OCT-2024, administered for prophylaxis (strength, dose and frequency were not provided) and with diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), administered via intramuscular at left thigh, lot number UK622AA, expiration date 30-APR-2025 (formulation, strength, dose, frequency and indication were not provided); after power outage resulting in stored temperature more than 8 degree Celsius for 10 hours; without previous temperature excursion (product storage error).  No additional reactions reported. No additional adverse event (AE)/product quality complaint (PQC) reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Customer called to report an AE for VAQTA. The caller said they administered an expired dose of VAQTA. Confirmed no other AE occurred. AE letter sent to caller. No other AE. No PQC.; Confirmed no other AE occurred/No other AE. No PQC.; This spontaneous report was received from a medical assistant regarding to a patient of unknown age or gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 04-OCT-2024, the patient was vaccinated with 1 dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, lot number X006702 (lot number X006702 had been verified to be valid lot number for hepatitis A vaccine, inactivated), expiration date 01-OCT-2024 (expired product administered), administered for prophylaxis (strength, dose, frequency, route of administration and anatomical injection site were not provided).  Confirmed no other adverse event (AE) occurred. No other AE. No product quality complaint (PQC).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: They shot me in the arm had a little bit of pain for one day and that was the end of it; This spontaneous case was reported by a patient and describes the occurrence of PAIN (They shot me in the arm had a little bit of pain for one day and that was the end of it) in a 69-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (They shot me in the arm had a little bit of pain for one day and that was the end of it). At the time of the report, PAIN (They shot me in the arm had a little bit of pain for one day and that was the end of it) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. Patient stated that everything else about his health after receiving vaccine was perfect.
Sex: F
Vaccine: COVID19, RVX
Symptoms: Myalgia
Clinical narrative: Polymyalgia flared up; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Polymyalgia flared up) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Concurrent medical conditions included Polymyalgia (taking prednisone). Concomitant products included PREDNISONE for Polymyalgia.   In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On an unknown date,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced MYALGIA (Polymyalgia flared up). At the time of the report, MYALGIA (Polymyalgia flared up) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The reporter states that last year, when the patient received her Moderna COVID vaccine and the RSV vaccine two weeks later, her polymyalgia flared up afterwards.   This case was linked to MOD-2024-774721 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: malaise; severe pain at injection site; swollen lymph nodes; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), VACCINATION SITE PAIN (severe pain at injection site), LYMPHADENOPATHY (swollen lymph nodes) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 26-Sep-2024, the patient experienced MALAISE (malaise), VACCINATION SITE PAIN (severe pain at injection site), LYMPHADENOPATHY (swollen lymph nodes) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of 600 milligram three times a day. At the time of the report, MALAISE (malaise), VACCINATION SITE PAIN (severe pain at injection site), LYMPHADENOPATHY (swollen lymph nodes) and PYREXIA (fever) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had no medical history, concomitant disease or risk factor.  There were no lab data/results available.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Felt "terrible"; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt "terrible") and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 03-Aug-2024.    On 30-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 30-Sep-2024, the patient experienced FEELING ABNORMAL (Felt "terrible") and NAUSEA (Nausea). On 02-Oct-2024, FEELING ABNORMAL (Felt "terrible") and NAUSEA (Nausea) had resolved.            Concomitant medication use information was not provided by reporter.  An hours after vaccination patient felt terrible and the day after vaccination patient had nausea.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication use information was not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over). At the time of the report, RASH (rash all over) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient had unknown relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-774721 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774721:Same reporter different patient
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: sore throat; pain in the neck; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (pain in the neck) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (pain in the neck). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (pain in the neck) was resolving.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Patient had encounter sore throat and pain in the neck.  Treatment information was not provided.  Reporter causality was not reported.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the top of the diluent syringe broke off; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the top of the diluent syringe broke off".  Additional information: reporting the adapter to Abrysvo is defective stating it either snapped off or something. Clarifies she has two defective Abrysvo vaccines with different issues. One Abrysvo is defective stating the top of the diluent syringe broke off. The other Abrysvo is the one she was referring to that did not reconstitute properly and further describing when pressed the plunger to put in the diluent, the diluent came out and must have had a defective piece.   Causality for "the top of the diluent syringe broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: the product came apart when they tried to reconstitute the vaccine.; This is a spontaneous report received from an Other HCP from product quality group, Program ID:.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), outcome "unknown", described as "the product came apart when they tried to reconstitute the vaccine.".  Additional information: reported that the product came apart when they tried to reconstitute the vaccine. She said that it detached from the threaded part, clarified the threaded part that is attached to the syringe of the diluent.  Causality for "the product came apart when they tried to reconstitute the vaccine." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID-19 even though he was vaccinated; got COVID-19 even though he was vaccinated; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID-19 even though he was vaccinated". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diplopia, Eyelid ptosis, Myasthenia gravis
Clinical narrative: Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis; Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis; Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis; Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis; This is a spontaneous report received from a Nurse.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "pelvic prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergies"; Bactrim, reaction(s): "Allergies"; Morphine, reaction(s): "Allergies"; Ultram, reaction(s): "Allergies"; Percocet, reaction(s): "Allergies"; Chloraprep, reaction(s): "Allergies". The following information was reported: DIPLOPIA (caused and prolonged hospitalization), EYELID PTOSIS (caused and prolonged hospitalization), CEREBROVASCULAR ACCIDENT (caused and prolonged hospitalization), MYASTHENIA GRAVIS (caused and prolonged hospitalization), outcome "not recovered" and all described as "Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis". The patient was hospitalized and prolonged hospitalization for diplopia, eyelid ptosis, cerebrovascular accident, myasthenia gravis (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of diplopia, eyelid ptosis, cerebrovascular accident, myasthenia gravis.  Clinical course: It was reported that the patient received the vaccine on 10Mar2020 (as reported) and event onset for all events were 10May2020(as reported). Adverse event: Develop double vision and ptosis 2 weeks after shot, had stroke and developed myasthenia gravis.Patient did not take other vaccine on the same date or on four weeks. It was unknown if any medications were taken in 2 weeks; Sender's Comments: Based from suspected vaccines safety profile, the reported events are assessed as intercurrent medical conditions and not related to suspected vaccine BNT162b2. Case will be reassess pending new information.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had 3 shots in past, ended up with Covid; Had 3 shots in past, ended up with Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Had 3 shots in past, ended up with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient called regarding the current COVID shot, the 24-25 one. The patient had 3 of these shots in past, ended up with Covid. The thing he had early on with these shots, is the ingredients, has fish allergy. The patient had no prior vaccinations within 4 weeks. The patient contacted doctor when he did get Covid, never went to his office. The doctor prescribed cough medicine, that was his worst symptom, that and his chest muscles hurt and were sore.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Nausea, Pruritus, Urticaria
Clinical narrative: Nausea; Headache; Fatigue; hives; itching; This is a spontaneous report received from a Physician and a Nurse.  A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Sep2024 as dose number unknown, single (Batch/Lot number: unknown), in arm for maternal immunisation. The patient's relevant medical history included: "Allergy to sulfa" (unspecified if ongoing). The patient was 36 weeks pregnant at the event onset. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "allergy". The following information was reported: FATIGUE (non-serious) with onset 18Sep2024, outcome "recovered"; HEADACHE (non-serious) with onset 18Sep2024, outcome "recovered"; NAUSEA (non-serious) with onset 18Sep2024, outcome "recovered"; URTICARIA (non-serious) with onset 18Sep2024, outcome "recovered", described as "hives"; PRURITUS (non-serious) with onset 18Sep2024, outcome "recovered", described as "itching". Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information: The patient received the vaccine in the office, and  after the patient received this vaccine, she immediately had nausea, headache, and fatigue. The patient no longer has these events, they are gone. The patient took a 4 hour nap and she felt better. It was also reported that the patient noticed hives and itching, this was starting in the arm she received the vaccine. Then two days later, 20Sep2024 she noticed the hives and itching had spread through to her back and down to her body. The hives and itching have resolved with diphenhydramine hydrochloride (BENADRYL).
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had Covid in 2023; Patient had Covid in 2023; This is a spontaneous report received from a Nurse.  An 18-month-old female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), on 28Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 7 months, in left thigh for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "Patient had Covid in 2023".; Sender's Comments: A lack of efficacy with BNT162b2 omi xbb.1.5 cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine. ,Linked Report(s) : US-PFIZER INC-202400268863 same reporter/product/ patient, different dose/event;US-PFIZER INC-202400269371 same reporter/product/ patient, different dose/event;
Age: 44.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Headache
Clinical narrative: headache; dizzy symptoms which continued on and off through the day; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 at 02:15 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 01Oct2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "History of Migraine" (unspecified if ongoing). Concomitant medication(s) included: AZELAS; FLUTICASONE; AIMOVIG. Past drug history included: Prevnar 20, start date: 26Mar2024, stop date: 26Mar2024, for Immunization, reaction(s): "itchy lump", notes: DOSE 1, SINGLE, administration time: 13:00, administration site: left arm; Peanut, reaction(s): "Allergy".  The following information was reported: DIZZINESS (non-serious) with onset 02Oct2024 at 05:00, outcome "recovered" (02Oct2024), described as "dizzy symptoms which continued on and off through the day"; HEADACHE (non-serious) with onset 02Oct2024 at 05:00, outcome "recovered" (02Oct2024). Therapeutic measures were not taken as a result of headache, dizziness.  Additional information: Vaccine was administered at Pfizer Clinic. Patient did not received any other vaccines within 4 weeks prior to the vaccine. Patient was taking other medications within 2 weeks of the event starting. Received both covid and flu shot at the site clinic. Unsure if the flu shot was Pfizer or not. One in each arm. The following morning patient woke up with headache and dizzy symptoms which continued on and off through the day.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the diluent syringe breaks where the needles twist onto the syringe; This is a spontaneous report received from an Other HCP.  An office manager reporting on behalf of the hospital pharmacy reported about rsv vaccine prot.subunit pref 2v (ABRYSVO), (Lot number: 1973242, Expiration Date: 17Feb2026, NDC number of Abrysvo: 0006-4175-88). The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the diluent syringe breaks where the needles twist onto the syringe". The reporter confirmed the presentation is the carton/box, vial adaptor, diluent syringe and antigen vial presentation but he does not know from which component of the vaccine this information is from. The reporter does not believe that patients were administered the product, and he is pretty sure the vaccines were not administered, and he verified he has no patient specific information to provide.  Causality for "the diluent syringe breaks where the needles twist onto the syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I've never had heart issues. Now I'm on multiple meds, diet, restrictions, multiple tests etc, ever since I got the vaccine makes me question a lot; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 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: CARDIAC DISORDER (non-serious) with onset 2024, outcome "unknown", described as "I've never had heart issues. Now I'm on multiple meds, diet, restrictions, multiple tests etc, ever since I got the vaccine makes me question a lot". Therapeutic measures were taken as a result of cardiac disorder.  Additional information: Patient stated that she never had heart issues. Now she was on multiple meds, diet, restrictions, multiple tests etc, ever since she got the vaccine makes her question a lot. She never had heart issues prior.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered the fluzone high-dose vaccine to a patient that was under the age with no reported adverse event; Initial information received on 19-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 50 years old male patient who was inadvertently administered the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] vaccine that was under the age with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2024, the patient received 0.7 ml 1X total dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot U8489AA) (strength and expiry: unknown) (product administered to patient of inappropriate age) (latency same day) via intramuscular route in the right deltoid for prophylactic vaccination.  FLUZONE HIGH-DOSE vaccine to a patient that was under the age required per the package insert.    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: 77.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE HD were administered to patient post excursion with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to 2024SA287723 and 2024SA287739.  This case involves a 77 years old female patient where Influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] were administered to patient post 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 a dose of suspect Influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot- K9XL5 and expiration date- 30-JUN-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation and fluzone hd were administered to patient post excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Human Error: No Does extended stability data cover the excursion? No-  it was administered to 3 patients post excursion.  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.