chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Wheezing
Clinical narrative: Narrative:  Patient was seen in ER for a severe allergic reaction after had received a dipteria/Tetnus vaccine same day earlier in the day. Prior to arrival pt c/o throat swelling and soa. EMS had given 1 shot of epi with slight relief. She was visibly anxious, and tachycardic. Scattered bilateral wheezing. Pt's vitals: hr 118 bp 113/59 sat ra 100% rr 22 PE mild wheezes bilateral given: benadryl 25mg iv x 2 duonebulizer epinephrine 0.3mg im ns bolus if 1L solu medrol 125mg iv push sent home with Rxs for: pepcid 40mg bid for 5days benadryl 25mg 1 po tid for 5 days prednisone 20 mg tab; 60mg for 3 days primary care provider posted allergy on her chard and decided from this point on no vaccines. Pt highly reactive with long list if allergies in pt's chart.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Palpitations, Rash, Skin warm
Clinical narrative: Narrative:  Pt was administered 2nd dose of Shingrix vaccine and complained of dizziness, SOB, throat tightness, lightheadedness, rash, and palpitations. Pt was administered EpiPen, solumedrol, Benadryl, famotidine, and fluids and symptoms resolved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Narrative:  Pt was administered 2nd dose of Shingrix vaccine and complained of dizziness, SOB, throat tightness, lightheadedness, rash, and palpitations. Pt was administered EpiPen, solumedrol, Benadryl, famotidine, and fluids and symptoms resolved.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation abnormal
Clinical narrative: Narrative: Pt was monitored closely. Oxygen saturation and activity level returned to baseline after 2 days.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Cough, Dyspnoea, Dyspnoea exertional
Clinical narrative: Headache, CoughWheeze,SOB, chest pain, dry cough, fast-fluttering heartbeat Narrative: Only had site pain for first several days following 4/8/2022 Pfizer 3rd dose. On 4/17/22, began having SOB/chest pain/fast fluttering heartbeat when walking up stairs. Symptoms also occur when employee is fast-walking and during gym workout. These symptoms have been persistent and happening daily. Chest pain is constantly present. Headaches did dissipate. Employee reports constant symptoms as SOB and fast-fluttering heart when doing little physical movement or walking up stairs with dry cough/chest pain.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Injection site pain, Wheezing
Clinical narrative: Headache, CoughWheeze,SOB, chest pain, dry cough, fast-fluttering heartbeat Narrative: Only had site pain for first several days following 4/8/2022 Pfizer 3rd dose. On 4/17/22, began having SOB/chest pain/fast fluttering heartbeat when walking up stairs. Symptoms also occur when employee is fast-walking and during gym workout. These symptoms have been persistent and happening daily. Chest pain is constantly present. Headaches did dissipate. Employee reports constant symptoms as SOB and fast-fluttering heart when doing little physical movement or walking up stairs with dry cough/chest pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, fatigue Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, fatigue Narrative:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acquired immunodeficiency syndrome, Acute respiratory failure, Death, HIV infection, Intensive care
Clinical narrative: Narrative:  Patient was inpatient MICU and died inpatient. Death was caused by: Pneumocystis Pneumonia in setting of HIV/AIDS, along with Mycobacterium TB complex Pneumonia, Psuedomonas Pneumonia with resultant acute hypoxic respiratory failure. Patient had received J&J covid vaccine on 04/12/2021 assumed at clinic although not properly recorded in patient chart. This death is not related to the COVID vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumocystis jirovecii pneumonia, Pneumonia pseudomonal, Pulmonary tuberculosis
Clinical narrative: Narrative:  Patient was inpatient MICU and died inpatient. Death was caused by: Pneumocystis Pneumonia in setting of HIV/AIDS, along with Mycobacterium TB complex Pneumonia, Psuedomonas Pneumonia with resultant acute hypoxic respiratory failure. Patient had received J&J covid vaccine on 04/12/2021 assumed at clinic although not properly recorded in patient chart. This death is not related to the COVID vaccine.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Patient received COVID J&J vaccination on 08/26/2021 at clinic. Patient was outpatient with no remarkable comorbidities, but given the length of time, it is unlikely the event is related to vaccination unless undiagnosed upon death (04/14/2022)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Narrative: Administering nurse reports pt received a vaccine today after receiving a vaccine on 4/15/22 at another location that was not reflected in record. Administering nurse reports checking the registry prior with no documentation noted of a prior vaccine. Pt also did not recall to administering nurse ever having a COVID vaccine. Radiology department later spoke with daughter and radiology notified vaccine clinic that pt had received a covid vaccine at Pharmacy on 4/15/22. Administering nurse rechecked registry and noted documentation of a Pfizer COVID vaccine on 04/15. Administering nurse reports pt left in stable condition with transportation and notified that daughter reported pt is currently stable at home. Administering nurse instructed daughter of signs and adverse reaction monitor for and when to seek medical attention. Administering nurse instructs of plans to consult with subject matter expert on further COVID vaccination due to interval and plans to notify daughter upon follow up of recommendation.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given .5ml of Moderna vaccine instead of .25ml for 2nd covid booster.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given .5ml of Moderna vaccine instead of .25ml for 2nd covid booster.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given .5ml of Moderna vaccine instead of .25 ml for 2nd covid booster. No adverse reactions reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE information; Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported.  On 15-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, lot #u019904, expiration date: 24-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA - recombinant human albumin) (M-M-R II) subcutaneous injection, 0.5 ml/once, lot #t027937, expiration date: 18-AUG-2022, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion (Product storage error).The reporter stated that the vaccines underwent  2 temperature excursions, the first one happened on 03-MAR-2022 with a temperature ranges of 14F up to 46F (40.02F) for 18 hours and 15 minutes and the second excursion happened on 08-MAR-2022 with a temperature of 56.21F for 50 minutes. No additional information about an adverse event was reported.; Sender's Comments:  US-009507513-2204USA007163:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Computerised tomogram abnormal, Deafness unilateral, Ear discomfort, Influenza like illness
Clinical narrative: So I got the shot and had normal pain in the arm, several hours later my arm hurt more, and had a fever and flu like symptoms, and then the next day I could not hear out of my left ear. It felt like my ear had been plugged and my hearing was reduced and I could not hear anymore from that ear. All the other symptoms subsided, nothing was prolonged except I could not hear for awhile. For at least a month or so, I finally contacted my dr. and he prescribed a steroid, however it did not work, it was a strict prescription however it did not work. I finally went to an ENT Dr. and told him about the steroid and by that time it was about over two months that I could not hear. The doctor took a CAT Scan and saw some things and he prescribed some drops for my ear and the drops finally worked. The hearing loss did clear up mostly but I do still have some hearing loss from time to time.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: So I got the shot and had normal pain in the arm, several hours later my arm hurt more, and had a fever and flu like symptoms, and then the next day I could not hear out of my left ear. It felt like my ear had been plugged and my hearing was reduced and I could not hear anymore from that ear. All the other symptoms subsided, nothing was prolonged except I could not hear for awhile. For at least a month or so, I finally contacted my dr. and he prescribed a steroid, however it did not work, it was a strict prescription however it did not work. I finally went to an ENT Dr. and told him about the steroid and by that time it was about over two months that I could not hear. The doctor took a CAT Scan and saw some things and he prescribed some drops for my ear and the drops finally worked. The hearing loss did clear up mostly but I do still have some hearing loss from time to time.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, COVID-19 pneumonia, Cough, Death
Clinical narrative: 9/20/21 pt transferred to Health and Rehab after hospitalization after a fall; pt had a positive COVID test on 10/12/21; cough and sneezing; took monoclonal antibodies; COVID pneumonia; 10/19/21 pt transferred to hospital again for increasing SOB and anxiety; bilateral PE; treated and sent back to Health and Rehab; 11/6/21 pt had an increase in anxiety and general decline; family requested he not go back to the hospital; pt passed away in the rehab center; death certificate and med records sent to info@vaers.org per VAERS request
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, General physical health deterioration, SARS-CoV-2 test positive, Sneezing
Clinical narrative: 9/20/21 pt transferred to Health and Rehab after hospitalization after a fall; pt had a positive COVID test on 10/12/21; cough and sneezing; took monoclonal antibodies; COVID pneumonia; 10/19/21 pt transferred to hospital again for increasing SOB and anxiety; bilateral PE; treated and sent back to Health and Rehab; 11/6/21 pt had an increase in anxiety and general decline; family requested he not go back to the hospital; pt passed away in the rehab center; death certificate and med records sent to info@vaers.org per VAERS request
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Dyspnoea, Fatigue, Headache
Clinical narrative: Eight hours after vaccine, experienced body aches.  From November 3rd to present (as of 5/9/22), long term effects:  non stop head ache, shortness of breath, trouble swallowing, chest pain, fatigue
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Eight hours after vaccine, experienced body aches.  From November 3rd to present (as of 5/9/22), long term effects:  non stop head ache, shortness of breath, trouble swallowing, chest pain, fatigue
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Delivery, Exposure during pregnancy, SARS-CoV-2 test positive
Clinical narrative: 12/09/21 presents to Triage for "SVD (spontaneous vaginal delivery)" PMHx "chicken pox".
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Delivery, SARS-CoV-2 test positive
Clinical narrative: 12/09/21 presents to Triage for "SVD (spontaneous vaginal delivery)" PMHx "chicken pox".
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Swelling
Clinical narrative: Tested Positive for COVID-19 by Rapid Test; Tested Positive for COVID-19 by Rapid Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 15Mar2021 as dose 2, single (Lot number: EL3247), in right arm, on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; ADVIL 12 HOUR; VOLTAREN ACTI. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 17:00, outcome "not recovered" and all described as "Tested Positive for COVID-19 by Rapid Test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Tested Positive for COVID-19 by Rapid Test. Prior to vaccination, was the patient diagnosed with COVID-19 reported as no. Since the vaccination, has the patient been tested for COVID-19 reported as yes.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for COVID-19 by Rapid Test; Tested Positive for COVID-19 by Rapid Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 15Mar2021 as dose 2, single (Lot number: EL3247), in right arm, on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CYCLOBENZAPRINE; ADVIL 12 HOUR; VOLTAREN ACTI. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07May2022 at 17:00, outcome "not recovered" and all described as "Tested Positive for COVID-19 by Rapid Test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Tested Positive for COVID-19 by Rapid Test. Prior to vaccination, was the patient diagnosed with COVID-19 reported as no. Since the vaccination, has the patient been tested for COVID-19 reported as yes.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Somnolence
Clinical narrative: Sleepiness; Nausea; 10 years old patient who was administered the Pfizer COVID-19 Vaccine Gray Cap/ administered the adult dose the grey cap to a 10-year-old; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Physician) from medical information team.  A 10-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 at 16:00 as dose number unknown 0.3 ml, single (Lot number: FJ4991, Expiration Date: 30May2022) at the age of 10 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 18Apr2022 at 16:00, outcome "unknown", described as "10 years old patient who was administered the Pfizer COVID-19 Vaccine Gray Cap/ administered the adult dose the grey cap to a 10-year-old"; SOMNOLENCE (non-serious), outcome "recovered", described as "Sleepiness"; NAUSEA (non-serious), outcome "recovered".  Additional information: The reporter had an error, administered the adult dose the grey cap to a 10-year-old. Expiration date said Sep2021, this one got pushed back so it should be extended to 30May2022. The patient provided information to you regarding the reported adverse event(s) with the use of the product. This occurred outside facility, patient complained if sleepiness, nausea one week later called to say improved. Unsure if causal, patient did not come into office.  Follow-up (18Apr2022): This is a spontaneous follow-up report received from the contactable Pharmacist. This Pharmacist reported for a 10-Year-old female patient that: Reporter information. Patient details (demographics). Product coding updated, Product details.  Follow up (20Apr2022): New information received in response to the mail trail sent regarding the confirmation of below mentioned query which included reporter details.  Follow-Up (02May2022): Follow-up attempts are completed. No further information is expected.  Follow-up (10May2022): This is a spontaneous follow-up report received from a contactable Physician. This Physician reported for a patient in response to HCP letter sent via follow-up letter which included that: Updated information included: New event "sleepiness, nausea". At risk was removed.  Additional information:  Did the patient provide information to you regarding the reported adverse event(s) with the use of the product: Yes,  This occurred outside facility, patient complained if sleepiness, nausea one week later called to say improved. Unsure if causal, patient did not come into office.
Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: Sleepiness; Nausea; 10 years old patient who was administered the Pfizer COVID-19 Vaccine Gray Cap/ administered the adult dose the grey cap to a 10-year-old; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Physician) from medical information team.  A 10-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 at 16:00 as dose number unknown 0.3 ml, single (Lot number: FJ4991, Expiration Date: 30May2022) at the age of 10 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 18Apr2022 at 16:00, outcome "unknown", described as "10 years old patient who was administered the Pfizer COVID-19 Vaccine Gray Cap/ administered the adult dose the grey cap to a 10-year-old"; SOMNOLENCE (non-serious), outcome "recovered", described as "Sleepiness"; NAUSEA (non-serious), outcome "recovered".  Additional information: The reporter had an error, administered the adult dose the grey cap to a 10-year-old. Expiration date said Sep2021, this one got pushed back so it should be extended to 30May2022. The patient provided information to you regarding the reported adverse event(s) with the use of the product. This occurred outside facility, patient complained if sleepiness, nausea one week later called to say improved. Unsure if causal, patient did not come into office.  Follow-up (18Apr2022): This is a spontaneous follow-up report received from the contactable Pharmacist. This Pharmacist reported for a 10-Year-old female patient that: Reporter information. Patient details (demographics). Product coding updated, Product details.  Follow up (20Apr2022): New information received in response to the mail trail sent regarding the confirmation of below mentioned query which included reporter details.  Follow-Up (02May2022): Follow-up attempts are completed. No further information is expected.  Follow-up (10May2022): This is a spontaneous follow-up report received from a contactable Physician. This Physician reported for a patient in response to HCP letter sent via follow-up letter which included that: Updated information included: New event "sleepiness, nausea". At risk was removed.  Additional information:  Did the patient provide information to you regarding the reported adverse event(s) with the use of the product: Yes,  This occurred outside facility, patient complained if sleepiness, nausea one week later called to say improved. Unsure if causal, patient did not come into office.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: tested herself came out positive; tested herself came out positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3246), on 18Feb2021 as dose 2, single (Lot number: EL9267) and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Immune deficiency diagnosed 10-15 years ago, states her body does not make antibodies" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "not recovered" and all described as "tested herself came out positive". The patient underwent the following laboratory tests and procedures: vaccine challenge test: (unspecified date) Unknown result, notes: the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first,; SARS-CoV-2 test: (unspecified date) positive, notes: she initially tested herself came out positive; (05May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Caller states she finished taking the 5 day course and was feeling better, but now she is on Day 12 from when she was first feeling symptoms and about a day or two ago she started feeling worse. States she initially tested herself came out positive and she thought she should go somewhere to get tested so there is a record and she could get some medication to alleviate her symptoms so she went to Pharmacy and a Nurse Practitioner saw her and prescribed the Paxlovid, she started 26Apr2022 and ended it on 30Apr2022, just tested last night again 05May2022, and she is still positive. States when she went back after she finished the course of Paxlovid she went to be tested again and they said she was still positive and the NP there said it can show up that she is positive for three months after the treatment, caller wants to know if this is true. Caller mentions she did receive three doses of the Pfizer COVID vaccines and the monoclonal antibodies twice and got Covid a month after. Caller states to diagnose her with the immune deficiency disorder, the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first, then they give you the Pneumovax and wait 6 weeks and then check the labs again to see if any of the numbers have changed and if they do not thats what they use to diagnose. States she was diagnosed 10-15 years ago she is not sure.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: tested herself came out positive; tested herself came out positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3246), on 18Feb2021 as dose 2, single (Lot number: EL9267) and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Immune deficiency diagnosed 10-15 years ago, states her body does not make antibodies" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "not recovered" and all described as "tested herself came out positive". The patient underwent the following laboratory tests and procedures: vaccine challenge test: (unspecified date) Unknown result, notes: the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first,; SARS-CoV-2 test: (unspecified date) positive, notes: she initially tested herself came out positive; (05May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Caller states she finished taking the 5 day course and was feeling better, but now she is on Day 12 from when she was first feeling symptoms and about a day or two ago she started feeling worse. States she initially tested herself came out positive and she thought she should go somewhere to get tested so there is a record and she could get some medication to alleviate her symptoms so she went to Pharmacy and a Nurse Practitioner saw her and prescribed the Paxlovid, she started 26Apr2022 and ended it on 30Apr2022, just tested last night again 05May2022, and she is still positive. States when she went back after she finished the course of Paxlovid she went to be tested again and they said she was still positive and the NP there said it can show up that she is positive for three months after the treatment, caller wants to know if this is true. Caller mentions she did receive three doses of the Pfizer COVID vaccines and the monoclonal antibodies twice and got Covid a month after. Caller states to diagnose her with the immune deficiency disorder, the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first, then they give you the Pneumovax and wait 6 weeks and then check the labs again to see if any of the numbers have changed and if they do not thats what they use to diagnose. States she was diagnosed 10-15 years ago she is not sure.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Investigation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested herself came out positive; tested herself came out positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3246), on 18Feb2021 as dose 2, single (Lot number: EL9267) and on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Immune deficiency diagnosed 10-15 years ago, states her body does not make antibodies" (ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01May2022, outcome "not recovered" and all described as "tested herself came out positive". The patient underwent the following laboratory tests and procedures: vaccine challenge test: (unspecified date) Unknown result, notes: the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first,; SARS-CoV-2 test: (unspecified date) positive, notes: she initially tested herself came out positive; (05May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Caller states she finished taking the 5 day course and was feeling better, but now she is on Day 12 from when she was first feeling symptoms and about a day or two ago she started feeling worse. States she initially tested herself came out positive and she thought she should go somewhere to get tested so there is a record and she could get some medication to alleviate her symptoms so she went to Pharmacy and a Nurse Practitioner saw her and prescribed the Paxlovid, she started 26Apr2022 and ended it on 30Apr2022, just tested last night again 05May2022, and she is still positive. States when she went back after she finished the course of Paxlovid she went to be tested again and they said she was still positive and the NP there said it can show up that she is positive for three months after the treatment, caller wants to know if this is true. Caller mentions she did receive three doses of the Pfizer COVID vaccines and the monoclonal antibodies twice and got Covid a month after. Caller states to diagnose her with the immune deficiency disorder, the test was they gave her a vaccine challenge test with she thinks a Pneumovax vaccine and they check your labs first, then they give you the Pneumovax and wait 6 weeks and then check the labs again to see if any of the numbers have changed and if they do not thats what they use to diagnose. States she was diagnosed 10-15 years ago she is not sure.
Age: 66.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK, COVID19
Symptoms: Chills, Diarrhoea, Head injury, Loss of consciousness, Vomiting
Clinical narrative: walking in house, found self on floor, passed out, hit head, some dizziness
Age: 66.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK, COVID19
Symptoms: Dizziness, Head injury, Loss of consciousness
Clinical narrative: walking in house, found self on floor, passed out, hit head, some dizziness
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pain
Clinical narrative: pain; cold; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement and Artificial cardiac pacemaker user. Concurrent medical conditions included Cardiac disorder (No change in condition) since 2008. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, FUROSEMIDE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills) and HEADACHE (headache) had resolved.            It was reported that the patient was very sensitive to vaccines, always had adverse reactions.  No treatment medication were reported   This case was linked to MOD-2022-563513, MOD-2022-563517, MOD-2022-563534 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol decreased, Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144 / Dropping of the cholesterol level), THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up), SOMNOLENCE (drowsiness) and PAIN IN EXTREMITY (sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065f21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Allergy and High cholesterol.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144 / Dropping of the cholesterol level), THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up), SOMNOLENCE (drowsiness) and PAIN IN EXTREMITY (sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144 / Dropping of the cholesterol level), SOMNOLENCE (drowsiness) and PAIN IN EXTREMITY (sore arm) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Low density lipoprotein: 176 (High) 176 and 144 (normal) 10 days after the 2nd booster it dropped to 144.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564750 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pressure urticaria after injection of buffered lidocaine with epinephrine.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No adverse event; Nurse reports a 6 year old male patient was administered an expired dose of PROQUAD. Caller confirmed vaccine was involved in a temperature excursion, but did not have excursion details. Caller was informed that when excursion details are available t; Nurse reports a 6 year old male patient was administered an expired dose of PROQUAD. Caller confirmed vaccine was involved in a temperature excursion, but did not have excursion details. Caller was informed that when excursion details are available t; This spontaneous report was received from a licensed practical nurse and refers to a 6-year-old male. The patient's medical history was not reported. The patient's concurrent conditions included strabismus. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and vitamins nos (MULTIVITAMINUM).   On 12-APR-2022, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #T034827, administered for prophylaxis (strength, and route of administration were not provided).  The dose of the vaccine expired 11-APR-2022. Additionally, the dose underwent a temperature excursion on an unspecified date.   By the time of reporting no adverse events were described.
Sex: U
Vaccine: HPV9, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported PROQUAD administered after a temperature excursion. No other information provided. No additional AEs or PQC reported. ? Names of vaccines involved (including lot/exp) PROQUAD W002781 7/24/2023 ? Temperature 8.4F; This spontaneous report was received from a nurse referring to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-APR-2022, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter (ml), administered subcutaneously, in left deltoid, as prophylaxis (lot # W002781 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 24-JUL-2023; strength was not reported). In addition, on the same date, the patient received  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, in right deltoid, as prophylaxis (lot number U032681 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 26-OCT-2023; strength, vaccination scheme and route of administration were not reported).   The temperature was reported as 5.36 Fahrenheit (F). Additionally, it was reported that temperature and time frame of the excursion were as 8.4 F for 30 minutes respectively. Data logger was used and showed high temperature (product storage error). There was no previous temperature excursion. No additional adverse events were reported.        It was stated that no experience a previous temperature excursion.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Overdose
Clinical narrative: a dose of PROQUAD was administered with VARIVAX for 8 different patients; This spontaneous report has been received from a pharmacy technician by a nurse at one of their facility's clinic, referring to a patient of unknown age and gender. The patient's concomitant medication, historical condition and current condition were not reported.   On 04-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (1 dose, lot# U028179 with expiration date: 08-MAR-2023, route and strength were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, lot# U024221 with expiration date: 04-AUG-2023, strength and route were unknown), both for prophylaxis (overdose). It is unknown to caller if any product confusion occurred. No further information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004906: US-009507513-2204USA004990: US-009507513-2204USA005095: US-009507513-2204USA005731: US-009507513-2204USA005733: US-009507513-2204USA005079: US-009507513-2204USA005255:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered an expired dose of VAQTA; This spontaneous report was received from an other health professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, dose reported as once, lot #T040581, expiration date: 28-MAR-2022 (exact dose, site and route of administration were not provided) for prophylaxis (Expired product administered). No further information was provided (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; PROQUAD that underwent a temperature excursion was administered at 1:00pm today; This spontaneous report was received from a registered nurse and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022 at 13:00, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human Albumin (rHA)) subcutaneous injection, lot # U031564, expiration date: 06-APR-2023, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided). Prior to the vaccination, the vaccine underwent a temperature excursion of -9 degrees Celsius for 1 hour 45 minutes and 0 seconds (product storage error). There were no previous temperature excursions. No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine not administered via SC route.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not provided.    On 21-APR-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX), both intramuscular in the deltoid area (incorrect route of product administration) for prophylaxis (strength, exact dose, frequency, lot number and expiration date for two vaccines were not reported).   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007790:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: pt did not have any symptoms or adverse effects of receiving vaccine; administration of vaccine following temperature excursion; This spontaneous report was received from a medical assistant and refers to a specified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 08-APR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter/once, lot # U024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided). Prior to being administered, the vaccine underwent a temperature excursion of -13 degrees Celsius for 1 hour (product storage error). Patient did not have any symptoms or adverse effects of receiving the vaccine (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller stated an expired vaccine was given.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliter (valid lot #T034827, expiration date: 11-APR-2022) (expired product administered) (strength, route of administration, and anatomical location were not provided) as prophylaxis. No adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; Nurse called to report that an expired dose of PROQUAD was administered to a patient.; This spontaneous report was received from a registered nurse referring to a 4-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022, the patient was vaccinated with first dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (valid lot #T034827, expiration date: 11-APR-2022) (expired vaccine used) (strength, dose, and route of administration were not provided) administered as prophylaxis. It was stated that the product had never experienced temperature excursion and had supported outcome. No adverse event was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PEDVAX HIB was administered after temperature excursion/Temperature 32.79F for 15 minutes; 34.22F for 15 min; This spontaneous report was received from a licensed visiting nurse (L.V.N), concerning a patient of unspecified age, gender and race. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 0.5 mL (lot # U024089 has been verified to be a valid lot # for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date: 27-OCT-2023) (strength, route of administration, and anatomical location were not provided) as prophylaxis. It was reported that the vaccine underwent a temperature excursion of 32.79 F degrees and 34.22 F degrees, each for a duration of 15 minutes (Product storage error). It was also reported that no previous excursions had presented. There were no further adverse events or additional information available.
Age: 0.42
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A medical assistant called and reported a AE. The caller reported that a 5 month old was administered a "double dose of HIB". The HCP reported that the 5 month old patient received a dose of Pentacel and a dose of PEDVAX HIB at the same office visit.; No adverse event; This spontaneous report has been received from a medical assistance concerning a 5-months-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On an unspecified day, the patient was administered a '' double dose of haemophilus influenza type B (HIB) ''. The patient received a dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not provided) and a dose of vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number T026962, expiration date: 06-APR-2023 (dose, strength, frequency, route of  administration, and anatomical location  were not provided) administered for prophylaxis, at the same office visit (Extra dose administered). The reporter stated the doctor ordered diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) but the diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) was inadvertently administered at the same time of the vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), instead of the diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX). However, no adverse effects were noted. No additional information was provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored ROTATEQ vaccine was administered to a patient from temperature excursion; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for the vaccine.  On 26-APR-2022, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally for use as directed to prevent rotavirus infection (lot # 1742415, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and validated as 12-OCT-2022) (product storage error).