chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Addison's disease, Angiogram pulmonary abnormal, Anticoagulant therapy, Blood creatine phosphokinase increased
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood creatinine, Blood lactic acid, Blood potassium normal, Blood sodium normal, COVID-19
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen abnormal, Confusional state, Culture urine, Dehydration, Diarrhoea
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Encephalopathy, Gallbladder disorder, Gallbladder polyp, Hyporesponsive to stimuli, Hypotension
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypothyroidism, Hypovolaemia, Hypoxia, Illness, Imaging procedure artifact
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immobile, Lactic acidosis, Mental status changes, Pulmonary embolism, Rhabdomyolysis
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Ultrasound Doppler normal, Ultrasound abdomen abnormal, Urinary retention, Urine analysis
Clinical narrative: Patient is a 82 y.o. female who presented from home on 8/29/2023 with CC found down by family, AMS, diarrhea. Found to be hypoxic, hypotensive, and encephalopathic. Workup revealed COVID-19 and possible PE. She had a relatively quick recovery after initiation of supportive care /IVF which makes me suspect her mental status/dehydration was the main driver of her hypoxia. Steroids and remdesivir discontinued . Discharged home on RA. Started on AC for her possible PE. COVID-19  - Presented with: confusion, hypoxia, diarrhea (found nearly unresponsive with diarrhea noted around the house) - Symptom onset: unclear  - Positive COVID-19: 8/29 at Facility - Vaccination status: vaccinated X 5, last was moderna 5/2022  - CTPE on admission showed small RUL PE but o/w no acute process  - Oxygen status: 2L -- >1L NC -- >RA - Decadron: Yes. Stopped early - Remdesivir: Yes. Stopped early  - DVT prophylaxis: Currently on full anticoagulation   Acute PE - possible small acute RUL PE seen on CTPA vs artifact - given RF covid plan to treat as provoked pe - no prior pe - no CT e/o RHS - venous duplex negative for DVT  - eliquis 10 bid x 7 then 5 bid , plan 3 mo , probably can stop after    Rhabdomyolysis - due to being down for unknown period of time  - CPK 1823 on admission, continues to trend down - stop IVF   AKI - Cr 1.34 on admission, baseline < 1 , resolved with IVF - AM RFP   Lactic acidosis  - lactic acid 2.3 related to hypovolemia  - resolved with IVF   Urinary retention - related to acute illness/immobility - resolved - of note ua/culture checked and in process, hold on treatment with abx given her sx resolved and she has no dysuria, fevers, etc Abnormal CT abd/pelvis and RUQ US - GB distention noted on both CT abd/pelvis and RUQ US without gallstones. Polyps were noted on RUQ US - GS evaluated, monitor for sx, if remains asymptomatic OP follow up   Addison's disease - BP stable and Na 136, K 4.6 - hold prednisone while on decadron, transition back to pred 5 q am and pred 2.5 q pm   - cont fludrocortisone 0.1 daily   Hypothyroidism - cont levothyroxine 112 mcg daily
Age: 87.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient has dementia and she was not sure what vaccine she needs, she asked me to check with her husband since he is more aware of the situation and knows better. The husband wanted me to give the patient the Covid vaccine and the flu vaccine at the same time. I did not check the system (Immunization Information system) due to the busy workflow in the flu clinic event. After that, I was checking the patient's system and found out that her last dose of the Covid vaccine was on 09-05-2023 which is less than 8 weeks based on the CDC recommendations.  We tried to call the patient's husband and educate them about the stronger side effects that might happen, but the husband did not respond. We will continue on trying to call them and see if any adverse reactions has happened.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse event; HCP called to report inadvertent administration of VAQTA to a patient on 08/30/2023 after experiencing a temperature excursion.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 28-AUG-2023, vaccines has temperature excursion for 3 hours 31 minutes with a high of 10.7C, the on 29-AUG-2023, for 32 minutes for a low of 0.5 C.  On 30-AUG-2023, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (0.5ml/once, lot#: X010374 was verified to be valid for syringe formulation with an expiration date of 13-NOV-2024; anatomical location, route of administration and strength were not provided) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion at -0.4C for 6 hours 5 minutes (product storage error). The vaccine also experienced previous temperature excursion at 0.5C for 32 minutes and 1 C for 2 hours 1 minutes. It was reported that on 31-AUG-2023, vaccines temperature excursion was for 3 hours and 32 minutes with low of -0.4C. It was confirmed no symptomatic adverse events. No additional adverse events (AE) were reported (no adverse event).   This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered an expired dose of GARDASIL 9 with no prior TEs (POTENCY SUPPORTED). No symptoms reported. Obtained consent to contact HCP. Agency Filed (Case #02468279). No additional AE/PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patients' medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 07-SEP-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection 0.5 milliliter (lot#: U008900 with expiration date of 12-AUG-2023; formulation was confirmed as syringe; strength, route of administration and indication were not provided) (PT: Expired product administered). There was no prior "TEs" (potency supported). No symptoms reported. No additional adverse event (AE)/ Product Quality Complaints (PQC) was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: HBP reported pregnant patient received GARDSIL 9.; No additional AE; This spontaneous report was received from office manager (also reported as healthcare business partner (HBP)), referring to a 9 weeks pregnant female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the pregnant patient was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #W011266, expiration date: 05-SEP-2024, strength and route were unknown) for prophylaxis (Exposure during pregnancy). The last menstrual period (LMP) was estimated to be 25-JUL-2023 and the estimated date of delivery (EDD) was estimated to be 30-APR-2024 The pregnancy outcome was pending. The fetal outcome was unknown. The operator of the device was a nurse/healthcare professional. No additional adverse event (AE) or product quality Complaints (PQC).
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: No further AE. No PQC; RN calls to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC; This spontaneous report was received from Other Health Professional 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. Concomitant therapies were not reported.  On 08-AUG-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, lot #u013035, expiration date: 23-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, RN called to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC.  Lot Number u013035 is valid for V205c with albumin status rHa.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called with a question regarding GARDASIL 9.  HCP asked if a patient currently in her 30's that received 2 prior doses of GARDASIL 9 in her 20s, needs to restart the series, or just be administered the 3rd dose in the regimen? Request case 02483; No additional AE/No PQC.; This spontaneous report was received from Other Health Professional and refers to an adult 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 started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP called with a question regarding GARDASIL 9.  HCP asked if a patient currently in her 30's that received 2 prior doses of GARDASIL 9 in her 20s, needs to restart the series, or just be administered the 3rd dose in the regimen? Request case 02483557.  No adverse effects were reported. Consent to contact is no.  HCP refused providing patient information, and did not know exact dates of administration for the first 2 doses of GARDASIL 9.  No additional AE/No PQC.
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient involved has not reported any symptoms or medical concerns due to the administration of the dose of VAQTA; 2 month old patient that was inadvertently administered a dose of VAQTA; This spontaneous report was received from nurse and refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-OCT-2023, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided) due to an error in processing of the HCP involved during a routine vaccination appointment (Inappropriate age at vaccine administration). It was stated that the patient involved has not reported any symptoms or medical concerns due to the administration of the vaccine.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; MMRII was administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) underwent temperature excursions of 8.9 degrees Celsius for 12 hours 20 minutes on 14-AUG-2023 and 9.4 degrees Celsius for 8 hours 20 minutes on 28-AUG-2023. There were no previous temperature excursions and both reported at time of temperature excursion call. On 25-SEP-2023, the patient was vaccinated with one dose improper stored vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # W021191, expiration date: 29-MAR-2024; strength and route were not reported) for prophylaxis (product storage error). Healthcare professional (HCP) provided multiple lot numbers that did not appear to be similar to other Merck vaccine lot numbers; confirmed with HCP multiple times that these were the correct lot numbers and the products were Merck branded vaccines. No additional adverse event (AE) reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; ROTATEQ  was administered after temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 14-AUG-2023 and 28-AUG-2023, a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1968393, expiration date: 24-MAY-2024) underwent temperature excursions of 8.9 degree Celsius for a time frame of 12 hours 20 minutes and 9.4 degree Celsius for a time frame of 8 hours 20 minutes, respectively. There was no previous temperature excursion. On 20-SEP-2023, the patient was administered the improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (1 dose; strength was not provided) orally for prophylaxis (product storage error). No additional adverse event (AE) or product quality complaint (PQC).
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: AE for Supported TE for VARIVAX; This spontaneous report was received from a nurse referring to 15-month-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On unknown day, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot #X007373, expiration date 12-MAR-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown dates, the suspect vaccine experienced temperature excursion of -14 degrees Celsius (C) to -10 C (-13C) for 18 minutes. Previous temperature excursion of -14 C to -10 C (-13.8C) for 26 minutes was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-SEP-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968393, expiration date: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent a temperature excursion in 8.9 degree Celsius for 12 hours 20 minutes and in 9.4 degree Celsius for 8 hours 20 minutes (Product storage error). No additional adverse event was reported.  .
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a unknown patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968393, expiration date: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 8.9 degree Celsius for 12 hours 20 minutes (Product storgae error) and in 9.4 degree Celsius fo 8 hours 20 minutes (confilicting information due to administration on 14-AUG-2023 and temperature excursion on 28-AUG-2023). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for Supported TE for VARIVA.  Unknown Administered Date LOT# X007373  Exp 3/12/2025  Previous: -14°C to -10°C (-13.8 C) for 0 hours 26 minutes  Current: -14°C to -10°C (-13.0 C) for 0 hours 18  minutes Associated AE Case; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X007373 and expiration date 12-MAR-2025, for prophylaxis (dose number, route and site of administration were not provided) (product storage error). Previous temperature excursion lasted for 26 minutes in temperature -14°C to -10 degrees Celsius (°C) (-13.8 C). Current temperature excursion lasted for 18 minutes in temperature 14°C to -10°C (-13.0 C) degrees Celsius (°C).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-SEP-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968393 and expiration date 24-MAY-2024, for prophylaxis (dose number, route and site of administration were not provided) (product storage error). On 14-AUG-2023, temperature excursion lasted for 12 hours 20 minutes 0 seconds in temperature 8.9 degrees Celsius (°C). On 28-AUG-2023, temperature excursion lasted for 8 hours 20 minutes 0 seconds in temperature 9.4 degrees Celsius (°C).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 11-SEP-2023 the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968393 and expiration date 24-MAY-2024, for prophylaxis (exact dose, dose number and route of administration were not provided) (experienced product storage error and no adverse event). On 14-AUG-2023, the temperature excursion lasted 12 hours 20 minutes 0 second in temperature 8.9 Celsius degrees (°C). On 28-AUG-2023, the temperature excursion lasted 8 hours 20 minutes 0 seconds in temperature 9.4 Celsius degrees (°C).
Sex: F
Vaccine: FLUX, RVX, TTOX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Weakness due to pain at injection site arm; restricted usage of my right arm; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 73-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   The patient's past medical history included thyroidectomy. Previously administered products included flu vaccine with an associated reaction of no adverse event (the patient never had an issue with a flu shot). Concurrent medical conditions included clot blood. Concomitant products included TETANUS VACCINE, levothyroxine and warfarin.   On 12-AUG-2023, the patient received RSV vaccine (right arm) and FLU VACCINE (NAME UNKNOWN) (right arm). On 13-AUG-2023, 1 days after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: Weakness due to pain at injection site arm). In AUG-2023, the patient experienced injected limb mobility decreased (Verbatim: restricted usage of my right arm).  The patient was treated with ibuprofen. The outcome of the injection site pain and injected limb mobility decreased were not resolved.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to RSV vaccine.     It was unknown if the company considered the injection site pain and injected limb mobility decreased to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 The patient reported after taking the RSV vaccine she had weakness due to pain at injection site. She received her injection in Pharmacy. She received bot vaccines flu shot and RSV vaccine in right arm. She never had issues with flu shot. She was having a pain which might require ibuprofen and had resulted into weakness. She was concerned about how long the pain would continue. She stated that it was a month she had restricted usage of her right arm. The symptoms were not treated. The reporter consented to followup.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: most of the dose was not administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of underdose in a 12-month-old male patient who received HAV (Havrix) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Havrix (unknown thigh). On 26-SEP-2023, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: most of the dose was not administered).  The outcome of the underdose was unknown.   Additional Information: GSK receipt date: 26-SEP-2023 The nurse manager reached out to ask about redose for 12-month-old male patient after Havrix vaccine error.  The needle broke (no other information given), and most of the dose was not administered. The most dose was not administered which led to underdose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Genital herpes, Herpes virus infection, Neuralgia, Paraesthesia
Clinical narrative: genital herpes; Nerve pain/Nerve pain inside of my head/Nerve pain in my feet; Lip tingling with no outbreaks; awakening of the herpes virus; Tingling in affected area of outbreaks; Burning of my right hand; This non-serious case was reported by a other health professional and described the occurrence of genital herpes in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 07-JUN-2022, the patient received Shingrix .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced genital herpes (Verbatim: genital herpes), nerve pain (Verbatim: Nerve pain/Nerve pain inside of my head/Nerve pain in my feet), tingling lips (Verbatim: Lip tingling with no outbreaks), herpes virus infection (Verbatim: awakening of the herpes virus), tingling (Verbatim: Tingling in affected area of outbreaks) and extremities burning sensation of (Verbatim: Burning of my right hand).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of were not resolved.   It was unknown if the reporter considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.     It was unknown if the company considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient's description was that she was misdiagnosed by her dermatologist who said she had shingles and not the actual Herpes Simplex, her Primary care physician agreed, he suggested that she get the Shingles vaccine, which she did. The vaccine caused her symptoms to flare up and it's been 16 months with constant outbreaks and nerve pain.  The patient only received one shot and one week after vaccine shot, awakening of the herpes virus. Symptoms are still current.  Non-stop nerve pain outbreaks every 3 to 7 days and nerve pain inside of her head.  Tingling in affected area of outbreaks and lip tingling with no outbreaks.  Burning of her right hand, outbreaks on her right hand and nerve pain in her feet, antivirals did not stop the outbreaks. The symptoms were treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: genital herpes; Nerve pain/Nerve pain inside of my head/Nerve pain in my feet; Lip tingling with no outbreaks; awakening of the herpes virus; Tingling in affected area of outbreaks; Burning of my right hand; This non-serious case was reported by a other health professional and described the occurrence of genital herpes in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes virus infection.   On 07-JUN-2022, the patient received Shingrix .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced genital herpes (Verbatim: genital herpes), nerve pain (Verbatim: Nerve pain/Nerve pain inside of my head/Nerve pain in my feet), tingling lips (Verbatim: Lip tingling with no outbreaks), herpes virus infection (Verbatim: awakening of the herpes virus), tingling (Verbatim: Tingling in affected area of outbreaks) and extremities burning sensation of (Verbatim: Burning of my right hand).  The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of were not resolved.   It was unknown if the reporter considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.     It was unknown if the company considered the genital herpes, nerve pain, tingling lips, herpes virus infection, tingling and extremities burning sensation of to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient's description was that she was misdiagnosed by her dermatologist who said she had shingles and not the actual Herpes Simplex, her Primary care physician agreed, he suggested that she get the Shingles vaccine, which she did. The vaccine caused her symptoms to flare up and it's been 16 months with constant outbreaks and nerve pain.  The patient only received one shot and one week after vaccine shot, awakening of the herpes virus. Symptoms are still current.  Non-stop nerve pain outbreaks every 3 to 7 days and nerve pain inside of her head.  Tingling in affected area of outbreaks and lip tingling with no outbreaks.  Burning of her right hand, outbreaks on her right hand and nerve pain in her feet, antivirals did not stop the outbreaks. The symptoms were treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Sore throat; aches/pains; Fatigue; Congestion; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-SEP-2023, the patient received Shingles vaccine. On 26-SEP-2023, 2 days after receiving Shingles vaccine, the patient experienced sore throat (Verbatim: Sore throat), pain (Verbatim: aches/pains), fatigue (Verbatim: Fatigue) and respiratory tract congestion (Verbatim: Congestion).  The outcome of the sore throat, pain, fatigue and respiratory tract congestion were not resolved.   It was unknown if the reporter considered the sore throat, pain, fatigue and respiratory tract congestion to be related to Shingles vaccine.     It was unknown if the company considered the sore throat, pain, fatigue and respiratory tract congestion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-SEP-2023 The patient self-reported this case. The patient had sore throat, aches, pains, fatigue and congestion. The symptoms were not treated.
Sex: F
Vaccine: FLUX
Symptoms: Aphonia
Clinical narrative: lost my voice; This non-serious case was reported by a consumer via sales rep and described the occurrence of loss of voice in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concomitant products included ethinyloestradiol, ferrous fumarate, norethisterone acetate (Lo Loestrin Fe) and omega-3-acid ethyl esters (Lovaza).   On 26-SEP-2023 09:00, the patient received Flu vaccine (right deltoid). On 26-SEP-2023 18:00, 9 hrs after receiving Flu vaccine, the patient experienced loss of voice (Verbatim: lost my voice).  The outcome of the loss of voice was resolving.   The reporter considered the loss of voice to be related to Flu vaccine.     The company considered the loss of voice to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 27-SEP-2023 The patient received the flu vaccine via on site vaccination at site on Tuesday, 26 Sep around 9am. By about 6pm, the patient lost her voice and had to speak at a whisper. The patient did not know if she received the GlaxoSmithKline flu vaccine or not. The patient simply assumed that it was the GlaxoSmithKline product. The patient stated that her voice was coming back a little on the day of reporting.
Sex: U
Vaccine: RVX
Symptoms: Illness
Clinical narrative: incredibly sick for 2 days.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: incredibly sick for 2 days.).  In SEP-2023, the outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 26-SEP-2023 This case was reported the patient via interactive digital media. The patient had the vaccine last weekend and was so incredibly sick for 2 days.  The patient reported that they should warn people of the side effects. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: RVX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Hurt a little bit when I got the shot, and my arm was sore later on that day; Hurt a little bit when I got the shot and my arm was sore later on that day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, less than a day after receiving RSV vaccine, the patient experienced pain (Verbatim: Hurt a little bit when I got the shot, and my arm was sore later on that day) and pain in arm (Verbatim: Hurt a little bit when I got the shot and my arm was sore later on that day).The outcome of the pain and pain in arm were not reported.   It was unknown if the reporter considered the pain and pain in arm to be related to RSV vaccine.   It was unknown if the company considered the pain and pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that his/her doctor recommended it because he/she was 75 years old.  The patient got the RSV shot and insurance paid for it.  It hurt a little bit when he/she was got the shot and his/her arm was sore later on that day but other than that he/she had no reaction. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; An expired dose of VAQTA was inadvertently administered to the patient today 10/04/2023.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot number u036184, expiration date 02-MAR-2023) (strength, route of administration and anatomical location were not provided).    No adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Medical assistant reported VAQTA was administered after temperature excursion.; This spontaneous report has been received from other health professional concerning to a patient of an unknown age and gender.   The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.   On 16-AUG-2023, the patient was vaccinated with the first dose of improperly stored of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, anatomical location vaccination scheme frequency and route of administration were not provided; lot number reported as "Y3ME2", with expiration date reported as 23-FEB-2025, however, upon internal validation, lot number "Y3ME2" does not match any company product as confirmed by lot verification team) for prophylaxis (product storage error).   The administered dose of the vaccine was stored at a temperature of 8.9 degrees Celsius (C) on 14-AUG-2023, with a time frame of 12 hours 20 minutes 0 seconds; and 9.4 degrees Celsius (C) on 28-AUG-2023, during a time frame of 8 hours 20 minutes 0 seconds. There was no previous temperature excursion reported for "both" at the time of the called.   Additionally, it was reported that the operator of the device was a healthcare provider. The "HCP" provided lot number that did not appear to be similar to other Merck vaccine lot numbers; confirmed with HCP multiple times that this was the correct lot number, and the product was a Merck branded vaccine.  No additional adverse events (AE) were reported.