chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received 0.5 mL but should be 0.7 mL, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA426941(CLUSTER).  This case involves a 67 years old female patient who received 0.5 ml but should be 0.7 ml, with no reported adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.5 ml but should be 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE with no reported adverse event (incorrect dose administered) (lot UJ900AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Prophylactic vaccination.  Action taken: not applicable.  Outcome: Unknown   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.   Based on information previously received, the following information has been amended by upgraded the case from non-case to valid Agency with no AE with addition of event "wrong dose administered".
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old patient was given expired quadracel with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 4 years old female patient who was given expired quadracel (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.)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 influenza vaccine for Immunisation.  On 02-Dec-2022, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.(formulation, strength:unknown) lot C5778BA , expiration date: 07-Oct-2022, via intramuscular route in the left deltoid for Immunization.  On 02-Dec-2022 the 4 year old patient was given expired quadracel with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (4 year old patient was given expired quadracel with no reported adverse event).  At time of reporting, the outcome was Unknown for the event
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 year old patient was administered quadracel with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 2-year-old male patient who was administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] 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 Hepatitis B Vaccine and influenza vaccine (Influenza) for prophylactic vaccination (Immunisation).  On 28-Nov-2022, the patient received dose 1 of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine at a dose of 0.5 ml once (lot C5970AA, expiry date: 02-Feb-2024) via intramuscular route in the left thigh for immunization.  On 28-Nov-2022, 2-year-old patient was administered quadracel with no reported adverse event (product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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 guidelines. 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: 0.17
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 2 months old patient vaccinated with expired dose of pentacel with no reported adverse event; Initial information  was received on 20-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who was vaccinated with expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTA for Immunisation.  On 20-Dec-2022, the patient received 0.5 mil of expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot 7419 and expiry:05-DEC-22) (expired product administered) (latency same day) via intramuscular route in the left thigh for Immunisation.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event 2 months old patient vaccinated with expired dose of pentacel with no reported adverse event.  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: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: used 0.7ml of sterile water to mix the acthib instead of the diluent provided in the carton with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 15-month-old and unknown gender patient who experienced used 0.7ml of sterile water to mix the ACT-HIB instead of the diluent provided in the carton with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for Immunization.  On 09-Dec-2022 the patient had a non-serious used 0.7ml of sterile water to mix the ACTHIB instead of the diluent provided in the carton with no reported adverse event (product preparation error) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.    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 guidelines. 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: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, Medication error, No adverse event
Clinical narrative: pregnant female patient received another FLUZONE QIV NP in error with no reported adverse event; pregnant female patient received FLUZONE QIV NP with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old female patient who is pregnant and received Influenza Quadrival A-B Vaccine [FLUZONE QIV] and another Influenza Quadrival A-B Vaccine in error with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The pregnant female patient received Influenza Quadrival A-B Vaccine [FLUZONE QIV] with no reported adverse event occurred at 10 weeks of pregnancy and another Influenza Quadrival A-B Vaccine in error with no reported adverse event occurred at 13 weeks of pregnancy and the patient was exposed to Influenza Quadrival A-B Vaccine at 10 weeks of pregnancy, during first pregnancy trimester for Influenza Quadrival A-B Vaccine.  The date of last menstrual period was reported as 03-Aug-2022. The estimated due date is 10-May-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 25-Oct-2022, the patient received second dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection at a dose of 0.5 ml total (lot number: UT76781MA, expiry date: 30-Jun-2023, Strength: Standard) via intramuscular route in the left deltoid for immunisation. On 29-Sep-2022, she also received a dose 1 of the same vaccine (lot number: UT76781MA, Expiry date: 30-Jun-2023) (Drug Treatment Duration: Once) via intramuscular route in the left deltoid for immunisation  On 29-Sep-2022, the pregnant female patient received Influenza Quadrival A-B Vaccine with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Influenza Quadrival A-B Vaccine.  On 25-Oct-2022, the pregnant female patient received another Influenza Quadrival A-B Vaccine in error with no reported adverse event (extra dose administered) latency: 27 days following the administration of Influenza Quadrival A-B Vaccine.  Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.  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: 0.33
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: received the vaccine post excursion with no reported adverse event; received the vaccine post excursion with no reported adverse event; Initial information received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received the IPV (VERO) [IPOL] vaccine post 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, TETANUS VACCINE TOXOID (DTAP), HIB VACCINE (HIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for Prophylactic vaccination.  On 20-Sep-2022, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number: V1A024M) (Frequency: once) (Suspension for injection) (Strength: standard) (formulation, Expiry date was not reported) via intramuscular route in the right thigh for Immunization.  On 20-SEP-2022 the patient received IPV (VERO) vaccine post excursion with no reported adverse event (product storage error) (poor quality product administered) (Latency: Same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, Poor quality product administered
Clinical narrative: patient received the vaccine post excursion with no adverse event; Initial information received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA519157.  This case involves a 13 years old male patient who received the IPV (VERO) [IPOL] Poliomyelitis Vaccine (Inactivated) 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 Varicella Zoster Vaccine (Varicella Vaccine) for Immunisation.  On 21-Sep-2022, the patient received 0.5 ml Total (1 X) (Dose 2) of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: V1A024M, expiry date: 17-Feb-2024, Strength: Standard, Frequency: once) via intramuscular route in the left deltoid for immunization.  On 21-Sep-2022, the patient received the Poliomyelitis Vaccine (Inactivated) post excursion with no adverse event (poor quality product administered) (Latency: same day)  Action taken: not applicable.  Outcome: Unknown   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Fluzone HD at  64 YOA  and 10 months.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: syncope, remained seated, sipped water, resolved after 15 minutes
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dry skin, Erythema, Immune system disorder, Skin exfoliation
Clinical narrative: I am already in a sustained allergic state, according to lab tests, so the "robust immune response" of the vaccine just compounded it.  I had a delayed hyperimmune response in that I became severely allergic to an OTC for acne called Salacylic Acid after vaccination that I never had after numerous applications before vaccination.  It was extremely dry, very red & excessively scaly. It wrapped around the left side of my neck, lower left side of my face, & across to both shoulders.
Age: 73.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cerebrovascular accident
Clinical narrative: Caregiver called and stated that patient had a stroke on 12/19/22 and was concerned it could be related to the vaccines.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Amnesia, Computerised tomogram normal, Magnetic resonance imaging normal
Clinical narrative: Patient complained of a 1 day loss of memory returned the next day
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Acute haemorrhagic oedema of infancy, Ecchymosis, Erythema multiforme, Full blood count abnormal
Clinical narrative: One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Joint swelling, Laboratory test, Metabolic function test normal, Microcytic anaemia
Clinical narrative: One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Normocytic anaemia, Occult blood positive, Oedema, Peripheral swelling, Postictal state
Clinical narrative: One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Rash papular, Skin lesion
Clinical narrative: One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal
Clinical narrative: One hour after vaccine, patient had a generalized tonic clonic seizure. Forehead temperature prior to seizure was 100.3F. Patient had received acetaminophen 15 mins prior to seizure and has a history of one previous febrile seizure. Post-ictal for 15 mins and returned to baseline. Patient given ibuprofen and acetaminophen around the clock for 24 hours and was on amoxicillin for otitis media. On 12/8/2022, PCP re-evaluated and said otitis improving, no other source of infection. That evening, patient developed nonspecific rash. On 12/9/2022, patient had developed diffuse papular and macular erythematous rash and evaluated in ED. Given steroids and started Zytrec. Amoxicillin discontinued. Rash progressed to edema and swelling of legs/knees, worsening rash and lesions. Saturday 12/10/2022 rash progressed to ecchymotic abdominal lesions and abdominal distention. Returned to ED and admitted 12/10/2022. Diagnosed with erythema multiforme minor. Given hydroxyzine and topical steroids. Discharged 12/11. Swelling progressed to hands on 12/12/2022. Dermatology follow up on 12/13/2022 concern for acute hemorrhagic edema of infancy. Labs and UA performed; occult stool ordered 12/14/2022 due to anemia. Rash improving and resolving, returning to baseline. Occult stool positive 12/16/2022. Dermatology follow up 12/16/2022 with tentative final diagnosis of acute hemorrhagic edema of infancy.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes ophthalmic, Herpes zoster
Clinical narrative: Developed Shingles symptoms one week after the booster vaccine.  Shingles outbreak was to the left side of the face and eye.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complained of left arm pain. Father reported that the patient spoke to the administering pharmacist and discussed the location of the vaccination and potentially given to high on the arm and possibly hitting the bone during administration. By 12/26/22 patients father reported that she was having difficulty moving her harm. They were unable to make contact with the family physician due to the holiday. Informed them if necessary to go to the emergency room for the increasing discomfort she was having with loss of range of motion.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site scab, Skin weeping
Clinical narrative: 2 years later second shot area still oozes and scabs Very sore
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia, SARS-CoV-2 test positive
Clinical narrative: He was diagnosed with Guillen Barre syndrome at hospital. Wife reports that his symptoms started on the morning of 12/23/2022 with tingling and no feeling on his right extremities and by the evening spread  to left side. He was taken to hospital and he is still there today.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensory loss
Clinical narrative: He was diagnosed with Guillen Barre syndrome at hospital. Wife reports that his symptoms started on the morning of 12/23/2022 with tingling and no feeling on his right extremities and by the evening spread  to left side. He was taken to hospital and he is still there today.
Age: 58.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: Patient called the pharmacy and spoke to me as the pharmacist on duty. He was reporting shoulder pain with limitation of movement along with range after he got his shot on 12-07-2022.  I asked him to show up to the pharmacy so I can look at the injection site. I noticed no swelling no bruising but he was complaining of pain. He told me he was using Voltaren Gel and Tylenol and that he is going to do MRI on that shoulder. I told him that we are going to follow up with him about the update of the pain level.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site injury, Mobility decreased, Nerve injury, Pain, Pain in extremity
Clinical narrative: Patient claims that she has not been able to move her arm above parallel and has been in a lot of pain since the day after her vaccine. She waited until today to obtain treatment (12/26/22) Patient doesn't have a primary doctor.   She saw the urgent care doctor because she doesn't have full use of her arm without pain and does not have full movement. She claims no redness at the injection site, however her arm is a little swollen. Doctor at the urgent care told patient that there is not sign of cellulitis but his thought is that a nerve was hit when she received the injection. Will follow up with the patient to see if improves with steroids.
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Peripheral swelling
Clinical narrative: Patient claims that she has not been able to move her arm above parallel and has been in a lot of pain since the day after her vaccine. She waited until today to obtain treatment (12/26/22) Patient doesn't have a primary doctor.   She saw the urgent care doctor because she doesn't have full use of her arm without pain and does not have full movement. She claims no redness at the injection site, however her arm is a little swollen. Doctor at the urgent care told patient that there is not sign of cellulitis but his thought is that a nerve was hit when she received the injection. Will follow up with the patient to see if improves with steroids.
Age: 45.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthritis, Condition aggravated, Enthesopathy, Psoriatic arthropathy, Tendon disorder
Clinical narrative: Flare up / Loss of remission of psoriatic arthitis lasting approximately 2 monnths. Inflammation moved to shoulder joints around vaccination site (left shoulder) glenohumeral and acromioclavicular joints.  Then to right acromioclavicular joint.  Then each Achilles tendon was affected unilaterally separately.  Then enthesis of quadriceps and patellar tendon and illiotibial band enthesis at right knee.  Medical burden included sports medicine evaluation + physical therapy appointments for multiple points of enthesitis at right knee. Loss of remission / flare of psoriatic arthritis lasted at least 2 months. Product: Flublok Quadrivalent PF, Lot # UJ931AA, NDC: 49281-0722-10.
Age: 81.0
Sex: U
Vaccine: COVID19-2
Symptoms: Asthenia, Cold sweat, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Patient states feeling achy the next day. Patient cannot confirm if patient has a fever. In addition, patient states having diarrhea and cold sweat since one day post vaccination until today/now (12/22/22 to 12/26/22). Patient states feeling very tired/weak and unable to eat or drink normal amount of fluids (today patient had a cup of Jello and 1/2 bottle of water). Patient took 1 dose of OTC pepto bismol. Due to patient's age, duration of diarrhea and decreased fluid/food intake, pharmacist advised for patient to seek urgent care. Patient states waiting for advice nurse to call back.
Age: 81.0
Sex: U
Vaccine: COVID19-2
Symptoms: Fluid intake reduced, Pain
Clinical narrative: Patient states feeling achy the next day. Patient cannot confirm if patient has a fever. In addition, patient states having diarrhea and cold sweat since one day post vaccination until today/now (12/22/22 to 12/26/22). Patient states feeling very tired/weak and unable to eat or drink normal amount of fluids (today patient had a cup of Jello and 1/2 bottle of water). Patient took 1 dose of OTC pepto bismol. Due to patient's age, duration of diarrhea and decreased fluid/food intake, pharmacist advised for patient to seek urgent care. Patient states waiting for advice nurse to call back.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Bivalent vaccine was administered as Primary series dose 1.  No adverse event reported, but wrong vaccine for primary series
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/2/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.   This case contains information for the 22nd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions. This case contains information for the 28th of 43 adult patients described by the reporter. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions. No treatment medication was provided. This case contains information for the 26th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions. This case contains information for the 27th of 43 adult patients described by the reporter. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 13th of 43 adult patients described by the reporter.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 12th of 43 adult patients described by the reporter.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 11th of 43 adult patients described by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19