chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head normal, Decubitus ulcer, Fall, Glycosylated haemoglobin increased, Imaging procedure
Clinical narrative: Patient is a 86 y.o. female patient of a MD with history of recently diagnosed with COVID-pneumonia, diabetes mellitus type 2 requiring insulin, anemia, hypertension presented to a local Hospital with mechanical fall hence the admission..   Mechanical fall No loss of consciousness or head injury. CT head shows no acute intracranial abnormality No history of syncope/near syncope Imaging showed no acute fracture/subluxation Evaluated by PT/OT, DC to SNF   Diabetes mellitus type 2. Continue home regimen after discharge   Lab Results Component Value Date   HGBA1C 7.3 (H) 03/29/2023    COVID-19 positive test (COVID-19)  Community-acquired pneumonia Patient recently started on Paxlovid And requiring 2 L of nasal cannula oxygen Started on dexamethasone and Levaquin Elevated procalcitonin We will continue dexamethasone x10 days,  Levaquin 750 mg every 48 hour Mucinex, as needed bronchodilators She is currently requiring on and off 2 L nasal cannula oxygen No evidence of respiratory distress, no accessory muscle We will DC to SNF with follow-up with PCP Data positive test 3/26//2023 Treatment: Was on Paxlovid, currently on steroids and Levaquin Estimated discontinuation of isolation 4/05/2023 AKI Baseline likely stage III CKD, with SCR~1.0 Was admitted with SCR 1.39, improved with IV fluids  Lactic acidosis?resolved Reported to be 2.2>1.3   Decubitus ulcer POA Wound care consulted
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lactic acidosis, Pneumonia, Procalcitonin increased, SARS-CoV-2 test positive
Clinical narrative: Patient is a 86 y.o. female patient of a MD with history of recently diagnosed with COVID-pneumonia, diabetes mellitus type 2 requiring insulin, anemia, hypertension presented to a local Hospital with mechanical fall hence the admission..   Mechanical fall No loss of consciousness or head injury. CT head shows no acute intracranial abnormality No history of syncope/near syncope Imaging showed no acute fracture/subluxation Evaluated by PT/OT, DC to SNF   Diabetes mellitus type 2. Continue home regimen after discharge   Lab Results Component Value Date   HGBA1C 7.3 (H) 03/29/2023    COVID-19 positive test (COVID-19)  Community-acquired pneumonia Patient recently started on Paxlovid And requiring 2 L of nasal cannula oxygen Started on dexamethasone and Levaquin Elevated procalcitonin We will continue dexamethasone x10 days,  Levaquin 750 mg every 48 hour Mucinex, as needed bronchodilators She is currently requiring on and off 2 L nasal cannula oxygen No evidence of respiratory distress, no accessory muscle We will DC to SNF with follow-up with PCP Data positive test 3/26//2023 Treatment: Was on Paxlovid, currently on steroids and Levaquin Estimated discontinuation of isolation 4/05/2023 AKI Baseline likely stage III CKD, with SCR~1.0 Was admitted with SCR 1.39, improved with IV fluids  Lactic acidosis?resolved Reported to be 2.2>1.3   Decubitus ulcer POA Wound care consulted
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Staphylococcal infection
Clinical narrative: Pt called in complaining of swelling and redness in one arm and stated that the dr diagnosed her with staph. infection when she visited the urgent care 3 days after receiving the vaccine on 6/10 and was given antibiotic for it and did pick up the antibiotic but did not mention about the reaction to me but called in a day later about it
Age: 25.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Tendonitis
Clinical narrative: Left shoulder pain, possible tendonitis. Symptoms started 4 days after immunization, has been worsening. No loss of range of motion or strength, but exam suspicious for rotator cuff tendonitis, no history of injury or prior tendonitis.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 65.0
Sex: U
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: monovalent given instead of bivalent pfizer
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dysuria, Pollakiuria, Urine analysis normal
Clinical narrative: Severe back and hip pain on left side; frequent urination; burning and irritation during and after urinating
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dilatation ventricular, Dyspnoea, Echocardiogram, Ejection fraction decreased, Gene mutation identification test
Clinical narrative: Shortness of Breath, Palpitations, Decreased Ejection Fraction of 45 %, Severe biventricular dilation, Hikar lymphadenopathy
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hilar lymphadenopathy, Magnetic resonance imaging heart, Palpitations
Clinical narrative: Shortness of Breath, Palpitations, Decreased Ejection Fraction of 45 %, Severe biventricular dilation, Hikar lymphadenopathy
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Joint range of motion decreased, Joint stiffness, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Constant shoulder pain up near shoulder joint. Limited  range of motion, can?t hold arm up as high. Nerve pain down arm. Stiff shoulder joint at times.
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Site: Swelling at Injection Site-Mild
Age: 66.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Mild
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: She was at her baseline of health until approximately 5/3 when she fell and injured her right ribs on a table.  She suffered a rib fracture and a tension pneumothorax.  She was taken to the local emergency room where she required urgent intubation and chest tube placement.  She was then transferred to the trauma unit at Hospital where she remained ventilator dependent.  She had a large amount of subcutaneous emphysema and received a "Gill slit" with wound VAC placement.  She could not be weaned from mechanical ventilation and underwent tracheostomy on 05/10. On the morning of 6/7, she aspirated tube feeding.  Her oxygen saturation plummeted into the 60s.  She required bag ventilation.  She had a brief period of unresponsiveness with seizure.  Follow-up chest x-ray showed a recurrent right pneumothorax.  Our nurse practitioner placed a right-sided chest tube with copious air leak.  During this time, I held lengthy discussions with both sons and both daughter-in-law's about current challenges and directions of care.  They request that we continue current efforts but that we not perform CPR in the event of cardiopulmonary arrest.  They are okay with her receiving a chest tube, drugs, etc..  Patient expired.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Aspiration, Chest X-ray abnormal, Chest injury, Chest tube insertion, Chest wall operation
Clinical narrative: She was at her baseline of health until approximately 5/3 when she fell and injured her right ribs on a table.  She suffered a rib fracture and a tension pneumothorax.  She was taken to the local emergency room where she required urgent intubation and chest tube placement.  She was then transferred to the trauma unit at Hospital where she remained ventilator dependent.  She had a large amount of subcutaneous emphysema and received a "Gill slit" with wound VAC placement.  She could not be weaned from mechanical ventilation and underwent tracheostomy on 05/10. On the morning of 6/7, she aspirated tube feeding.  Her oxygen saturation plummeted into the 60s.  She required bag ventilation.  She had a brief period of unresponsiveness with seizure.  Follow-up chest x-ray showed a recurrent right pneumothorax.  Our nurse practitioner placed a right-sided chest tube with copious air leak.  During this time, I held lengthy discussions with both sons and both daughter-in-law's about current challenges and directions of care.  They request that we continue current efforts but that we not perform CPR in the event of cardiopulmonary arrest.  They are okay with her receiving a chest tube, drugs, etc..  Patient expired.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Death, Dependence on respirator, Device leakage, Endotracheal intubation, Fall
Clinical narrative: She was at her baseline of health until approximately 5/3 when she fell and injured her right ribs on a table.  She suffered a rib fracture and a tension pneumothorax.  She was taken to the local emergency room where she required urgent intubation and chest tube placement.  She was then transferred to the trauma unit at Hospital where she remained ventilator dependent.  She had a large amount of subcutaneous emphysema and received a "Gill slit" with wound VAC placement.  She could not be weaned from mechanical ventilation and underwent tracheostomy on 05/10. On the morning of 6/7, she aspirated tube feeding.  Her oxygen saturation plummeted into the 60s.  She required bag ventilation.  She had a brief period of unresponsiveness with seizure.  Follow-up chest x-ray showed a recurrent right pneumothorax.  Our nurse practitioner placed a right-sided chest tube with copious air leak.  During this time, I held lengthy discussions with both sons and both daughter-in-law's about current challenges and directions of care.  They request that we continue current efforts but that we not perform CPR in the event of cardiopulmonary arrest.  They are okay with her receiving a chest tube, drugs, etc..  Patient expired.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Mechanical ventilation, Oxygen saturation decreased, Pneumothorax, Rib fracture, Seizure
Clinical narrative: She was at her baseline of health until approximately 5/3 when she fell and injured her right ribs on a table.  She suffered a rib fracture and a tension pneumothorax.  She was taken to the local emergency room where she required urgent intubation and chest tube placement.  She was then transferred to the trauma unit at Hospital where she remained ventilator dependent.  She had a large amount of subcutaneous emphysema and received a "Gill slit" with wound VAC placement.  She could not be weaned from mechanical ventilation and underwent tracheostomy on 05/10. On the morning of 6/7, she aspirated tube feeding.  Her oxygen saturation plummeted into the 60s.  She required bag ventilation.  She had a brief period of unresponsiveness with seizure.  Follow-up chest x-ray showed a recurrent right pneumothorax.  Our nurse practitioner placed a right-sided chest tube with copious air leak.  During this time, I held lengthy discussions with both sons and both daughter-in-law's about current challenges and directions of care.  They request that we continue current efforts but that we not perform CPR in the event of cardiopulmonary arrest.  They are okay with her receiving a chest tube, drugs, etc..  Patient expired.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Subcutaneous emphysema, Tracheostomy, Unresponsive to stimuli, Weaning failure, Wound closure
Clinical narrative: She was at her baseline of health until approximately 5/3 when she fell and injured her right ribs on a table.  She suffered a rib fracture and a tension pneumothorax.  She was taken to the local emergency room where she required urgent intubation and chest tube placement.  She was then transferred to the trauma unit at Hospital where she remained ventilator dependent.  She had a large amount of subcutaneous emphysema and received a "Gill slit" with wound VAC placement.  She could not be weaned from mechanical ventilation and underwent tracheostomy on 05/10. On the morning of 6/7, she aspirated tube feeding.  Her oxygen saturation plummeted into the 60s.  She required bag ventilation.  She had a brief period of unresponsiveness with seizure.  Follow-up chest x-ray showed a recurrent right pneumothorax.  Our nurse practitioner placed a right-sided chest tube with copious air leak.  During this time, I held lengthy discussions with both sons and both daughter-in-law's about current challenges and directions of care.  They request that we continue current efforts but that we not perform CPR in the event of cardiopulmonary arrest.  They are okay with her receiving a chest tube, drugs, etc..  Patient expired.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Unevaluable event
Clinical narrative: no adverse event; The customer said an expired dose was administered; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T039466, expiration date was not reported, but upon internal validation established as 20-MAY-2023, for prophylaxis (strength, and route of administration were not provided) (expired product administered). There was no other adverse event occurred (no adverse event) and the product did not have any temperature excursions prior to administration.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; The customer said an expired dose was administered; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-MAY-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #T039466, expiration date was not reported, but upon internal validation established as 20-MAY-2023, for prophylaxis (strength, and route of administration were not provided) (expired product administered). There was no other adverse event occurred (no adverse event) and the product did not have any temperature excursions prior to administration.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Pharmacist reports possible off label use of GARDASIL 9 to a 57 year old patient. No additional AE reported. No PQC reported.  AE follow up letter not sent as consent to contact provider was not provided.; No adverse event; This spontaneous report was received from a pharmacist and referred to a 57-year-old patient of unknown gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with 1 dose (reported as frequency) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (possible off label use). There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; HCP reported PROQUAD was administered after a temperature excursion; This spontaneous report was received from a health professional referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medication were not reported.      On 22-MAY-2023, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD)(lot number W012742, expiration date 16-OCT-2023, 0.5 ml, route was not reported) was administered to the patient after a temperature excursion (under temperature 19.2 Fahrenheit for 8 hours 20 minutes) (product storage error).  No additional adverse event or product quality compliant(PQC) reported(No adverse event).
Sex: F
Vaccine: MMR, UNK
Symptoms: Dizziness, Feeling hot, Flushing, Paraesthesia oral
Clinical narrative: flushing reaction; feeling hot; her tongue felt weird; little dizzy; This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, administered intramuscularly for immunization (lot #W034714, expiration date: 18-OCT-2023; strength was not provided) with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, administered intramuscularly (lot #W011298, expiration date: 27-NOV-2024; strength was not provided).  On 24-MAY-2023, the patient began having a flushing reaction (flushing), feeling hot, her tongue felt weird (paraesthesia oral), and she was a little dizzy after receiving vaccination. She had sought medical attention. Treatment with diphenhydramine hydrochloride (BENADRYL) and rest was given for the events. At the time of reporting, the patient was recovering from the events.  The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT) was not reported.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Allergies: PNEUMOCOCCAL 23-VAL PS VACCINE (reactions not documented); This spontaneous report was received from a physician assistant (PA) via Pfizer referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reactions not documented). At the time of reporting, the outcome of the event was not known. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion.; No additional AE.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W032370, expiration date: 10-OCT-2024 (strength, route of administration, and indication were not provided). The vaccine had been improperly stored in the temperature of 24.4 Fahrenheit degrees (F) for 5 hours 51 minutes 0 seconds with no previous temperature excursion (product storage error). The patient was asymptomatic. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC.  Names of vaccines involved (including lot/exp) VARIVAX W0; No additional AE; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The concomitant therapy, concurrent condition, drug reactions/allergies, and medical history were not provided.  On an unknown date, the patient received vaccine with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose (valid lot #W032370 with expiration date: 10-OCT-2024), administered for prophylaxis (strength, and route of administration were not provided), while this vaccine had a temperature excursion with temperature 24.4 Fahrenheit and time frame 5 hours 51 minutes 0 seconds (Product storage error). There was no previous temperature excursion. The patient was asymptomatic and no additional adverse event (No adverse event).
Age: 0.5
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported; Nurse calling to report that PROQUAD was inadvertently administered to a 6 month old. No side effects reported. No additional AE / no PQC.; This spontaneous report was received from a nurse and referred to a 6-month-old female patient. The concomitant therapy, concurrent condition, drug reactions/allergies, and medical history were not provided.  On 01-JUN-2023, the patient inadvertently received the first dose of vaccine with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter for prophylaxis (strength, lot#, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). There were no side effects reported and no additional adverse event (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion; Patient is asymptomatic. No additional AE.; This spontaneous report was received from a Registered Nurse (R.N.) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dose; lot # W025274, expiration date 10-AUG-2024; strength and route were not reported) for prophylaxis while the vaccine had a temperature excursion (product storage error).   The excursion temperature was 24.4 Fahrenheit (F) with time frame of 5 hours 51 minutes 0 seconds. There was no previous temperature excursion. The patient was asymptomatic. No additional AE (no adverse event).
Age: 0.08
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported; HCP reporting administration of PNEUMVAX 23 to a 6 week and 3 day old patient. No side effects reported. See request cases 02400107 and 02400128. No additional AE/PQC.; This spontaneous report has been received from an other health professional referring to a 6 weeks and 3 day old male patient. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided.      On 02-JUN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U034712, expiration date 30-JUL-2023 for prophylaxis (strength, dose and anatomical location were not provided) (product administered to patient of inappropriate age). No side effects reported. No additional AE/PQC.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic adverse events were reported; administration of expired MMR-II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported.   On 09-MAY-2023, the patient was administrated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (therapy type: recombinant Human albumin (rHA), 0.5 ml/once, lot #U011995, expiration date: 15-APR-2023; route of administration was not provided) for prophylaxis. Sterile diluent (MERCK STERILE DILUENT) (lot # U024490, expiration date: 02-NOV-2023) was used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).  The reporter confirmed that no symptomatic adverse events were reported and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not have any temperature excursions in its lifetime.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Inappropriate dose of vaccine administered; This spontaneous report was received from a pharmacist and referred to a 23-year-old male patient. The concomitant therapy, concurrent condition, drug reactions/allergies, and medical history were not provided.  On 04-JUN-2023, the patient received 1 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) Syringe as prophylaxis (valid lot# U024832 with reported expiration date 09-DEC-2023, strength and route of administration were not provided) (Extra dose administered). The patient told the pharmacist that he had not received the vaccine previously. However, patient's mother later reported that the patient had received the full 3-dose series starting in July 2016 and ending in June 2017. There was no additional adverse event (No adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Musculoskeletal pain, Pain in extremity
Clinical narrative: Raised skin sore arm redness; reforming four times bottom part of shoulder blade is itchy pain; Sore arm; blister; Heat; raised skin; Shoulder blade pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) (expiry date 05-JUN-2023) for prophylaxis.   The patient's past medical history included chemotherapy.   On 19-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 02-MAY-2023, 13 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Raised skin sore arm redness), pruritus (Verbatim: reforming four times bottom part of shoulder blade is itchy pain), pain in arm (Verbatim: Sore arm), blister (Verbatim: blister), feeling hot (Verbatim: Heat), skin disorder (Verbatim: raised skin) and shoulder blade pain (Verbatim: Shoulder blade pain). On 05-JUN-2023, the outcome of the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain were resolved (duration 1 month 3 days).   It was unknown if the reporter considered the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-June-2023 The patient had chemotherapy. The patient experienced skin sore arm redness, heat, blister on injection 2 weeks after blister breaking, reforming four times bottom part of shoulder blade is itchy pain inside. The customer unwilling to provide personal details but called to report.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin disorder
Clinical narrative: Raised skin sore arm redness; reforming four times bottom part of shoulder blade is itchy pain; Sore arm; blister; Heat; raised skin; Shoulder blade pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) (expiry date 05-JUN-2023) for prophylaxis.   The patient's past medical history included chemotherapy.   On 19-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 02-MAY-2023, 13 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Raised skin sore arm redness), pruritus (Verbatim: reforming four times bottom part of shoulder blade is itchy pain), pain in arm (Verbatim: Sore arm), blister (Verbatim: blister), feeling hot (Verbatim: Heat), skin disorder (Verbatim: raised skin) and shoulder blade pain (Verbatim: Shoulder blade pain). On 05-JUN-2023, the outcome of the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain were resolved (duration 1 month 3 days).   It was unknown if the reporter considered the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, pruritus, pain in arm, blister, feeling hot, skin disorder and shoulder blade pain to be related to Shingrix.   Additional Information: GSK receipt date: 05-June-2023 The patient had chemotherapy. The patient experienced skin sore arm redness, heat, blister on injection 2 weeks after blister breaking, reforming four times bottom part of shoulder blade is itchy pain inside. The customer unwilling to provide personal details but called to report.  The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse 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. 014H22A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    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-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023; No adverse event; a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023), PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023), PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (a 67-year-old patient received an expired 1st Booster (4th dose) Bivalent Moderna COVID-19 vaccine 05-JUN-2023) and PRODUCT STORAGE ERROR (The vaccine was expired on 01-Jun-2023 and was administered on 05-Jun-2023).    No concomitant information was reported. The 2.5 ml vial was initially stored in the refrigerator on 01-JUN-2023 and was administered on 05-Jun-2023 and did not underwent temperature excursion. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: showing expire May 30, 2023 Administered expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth 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 EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine) and NO ADVERSE EVENT (no adverse 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 adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (showing expire May 30, 2023 Administered expired vaccine).    Concomitant medication not reported.  Treatment medication not reported.
Age: 0.83
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border) and NO ADVERSE EVENT (No adverse event) in a 10-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     Patient had no relevant medical history,allergy, concomitant diseases and risk factor. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 04-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent presentation with pink cap and yellow border).    No concomitant information was reported. It was stated that no adverse events were reported. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Disturbance in attention, Headache, Nausea, Pain
Clinical narrative: Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital; trouble concentrating; nausea; Severe headaches have been increasing in frequency since the application of the vaccine; Initial information received on 07-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 25 years old female patient who had sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital, trouble concentrating, severe headaches have been increasing in frequency since the application of the vaccine and nausea after receiving vaccine yellow fever vaccine [YF-VAX].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On 14-Apr-2023, the patient received an unknown dose of suspect yellow fever vaccine, solution for injection (batch number: 4928109157920; expiry date: unknown) via subcutaneous route in unknown administration site for precaution (Yellow fever immunization).  On 14-Apr-2023 the patient had non-serious severe headaches that have been increasing in frequency since the application of the vaccine (headache) (same day latency) following the administration of yellow fever vaccine.  On 18-Apr-2023 the patient had non-serious sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital (pain), trouble concentrating (disturbance in attention) and nausea (latency: 4 days) following the administration of yellow fever vaccine.  It was reported, Severe headaches have been increasing in frequency since the application of the vaccine on 14 Apr 2023. Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital. Nausea and trouble concentrating are added side effects. I am traveling abroad for an extended period of time; so as a precaution, I got the yellow fever vaccine.  Patient did not experience any additional symptoms/events.  Action taken: not applicable.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events (Severe headaches have been increasing in frequency since the application of the vaccine, nausea, Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital, trouble concentrating).  At time of reporting, the outcome was Not Recovered / Not Resolved for the events severe headaches have been increasing in frequency since the application of the vaccine, nausea, sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital and trouble concentrating.
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received three doses of product on the following schedule: when she was 6 weeks old, when she was 18 weeks old, when she was 14 months old with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant female patient who received three doses of product Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] on the following schedule: when she was 6 weeks old, when she was 18 weeks old, when she was 14 months old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received three doses of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] of dose 0.5 ml suspension for injection with unknown strength, route, batch number & expiry date for Immunization, on the following schedule: on 13-Jun-2018 when she was 6 weeks old, on 05-Sep-2018 and when she was 18 weeks old, and on 01-Jul-2019 when she was 14 months old, with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Information on the batch number was requested.  It was reported that: Also, the patient is now 5 years old, but at the time she was receiving the DTaP injections, she was under 2 years old.  Action taken: not applicable.  At time of reporting, the outcome was 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: MNQ
Symptoms: Dizziness, Erythema, Headache, Injection site pain, Myalgia
Clinical narrative: 6/9/2023: headache, dizzy, fever, muscle soreness, redness 6/10/2023: redness, itchy, and feel burnt at the injection site 6/11/2023: redness expand larger than previous day, more frequently inchy and burnt
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Pyrexia
Clinical narrative: 6/9/2023: headache, dizzy, fever, muscle soreness, redness 6/10/2023: redness, itchy, and feel burnt at the injection site 6/11/2023: redness expand larger than previous day, more frequently inchy and burnt
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Feeding disorder, General physical condition abnormal, Haematochezia, Hypotonia
Clinical narrative: morning of 5/8/23 our child appeared very ill. He was lethargic, limp, was unable to eat, vomited, and appeared almost lifeless. We went to the ER immediately (Approximately 7:15am). Later in the day, a jelly like blood was observed in his diaper. Hospital attempted two rounds of enemas to repair the intussusception which were unsuccessful. Early morning of 5/9/23 surgery was completed.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Lethargy, Pallor, Procedural failure, Surgery
Clinical narrative: morning of 5/8/23 our child appeared very ill. He was lethargic, limp, was unable to eat, vomited, and appeared almost lifeless. We went to the ER immediately (Approximately 7:15am). Later in the day, a jelly like blood was observed in his diaper. Hospital attempted two rounds of enemas to repair the intussusception which were unsuccessful. Early morning of 5/9/23 surgery was completed.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: morning of 5/8/23 our child appeared very ill. He was lethargic, limp, was unable to eat, vomited, and appeared almost lifeless. We went to the ER immediately (Approximately 7:15am). Later in the day, a jelly like blood was observed in his diaper. Hospital attempted two rounds of enemas to repair the intussusception which were unsuccessful. Early morning of 5/9/23 surgery was completed.
Age: 45.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: Patient who was administered 2 Corresponding, Separate GARDASIL 9 Doses when Corresponding Patient was 45 Years Old; no adverse event; This spontaneous report was received from Pharmacist and refers to a 45-year-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was administered with 2 Corresponding Separate hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Doses (strength, route, dosage schedule, lot number and expiration date were not reported) when the patient was 45 Years Old (unapproved population). No adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; no adverse event; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W031813, expiration date was not reported, but upon internal validation established as 05-OCT-2024, as prophylaxis (strength, and route of administration were not provided), while it had a temperature excursion (temperature 24.4 Fahrenheit (F) for time frame as 5 hours 51 minutes 0 seconds) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event). The patient was asymptomatic.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improper storage of product in use; no adverse event; This spontaneous report was received from a nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #W025274, expiration date was not reported, but upon internal validation established as 10-AUG-2024, for prophylaxis (strength, and route of administration were not provided), while it had a temperature excursion (temperature 24.4 Fahrenheit (F) for time frame as 5 hours 51 minutes 0 seconds) (product storage error). There was no previous temperature excursion. No additional adverse event was reported (no adverse event). The patient was asymptomatic.