chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Foot fracture, Inappropriate schedule of product administration, Loss of consciousness, Pain, SARS-CoV-2 test
Clinical narrative: She got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She got COVID) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (She got COVID). At the time of the report, COVID-19 (She got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. The weight of patient was reported as 165 (unit not reported). It was reported that patient had tested positive for covid potentially from 27-Sept-2021 to 01-Oct-2021. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 34-year-old female patient with no reported medical history, who experienced the unexpected non-serious of COVID-19 which occurred 11 days after receiving the first dose of mRNA-1273 Vaccine. On an unspecified date, COVID-19 test was positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-587032 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 34-year-old female patient with no reported medical history, who experienced the unexpected non-serious of COVID-19 which occurred 11 days after receiving the first dose of mRNA-1273 Vaccine. On an unspecified date, COVID-19 test was positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She got COVID) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (She got COVID). At the time of the report, COVID-19 (She got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication reported. The weight of patient was reported as 165 (unit not reported). It was reported that patient had tested positive for covid potentially from 27-Sept-2021 to 01-Oct-2021. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 34-year-old female patient with no reported medical history, who experienced the unexpected non-serious of COVID-19 which occurred 11 days after receiving the first dose of mRNA-1273 Vaccine. On an unspecified date, COVID-19 test was positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-587032 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 34-year-old female patient with no reported medical history, who experienced the unexpected non-serious of COVID-19 which occurred 11 days after receiving the first dose of mRNA-1273 Vaccine. On an unspecified date, COVID-19 test was positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; 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 male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022 at 15:00, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical Course: Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Pfizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. . None of him have had any issues with they necks or arms up to this year from Previous issue. Seems like to much of a coincidence that its' not either a side effect of the vaccine or a side effect of Covid. Each of him had a Covid infection with light to no symptoms.  The symptoms are ongoing with health care being administered with PT.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200824355 same product/event, different patient;US-PFIZER INC-202200828047 same reporter/patient, different dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; 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 male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022 at 15:00, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical Course: Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Pfizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. . None of him have had any issues with they necks or arms up to this year from Previous issue. Seems like to much of a coincidence that its' not either a side effect of the vaccine or a side effect of Covid. Each of him had a Covid infection with light to no symptoms.  The symptoms are ongoing with health care being administered with PT.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200824355 same product/event, different patient;US-PFIZER INC-202200828047 same reporter/patient, different dose/event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Each of us had a Covid infection with light to no symptoms; Each of us had a Covid infection with light to no symptoms; 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 male patient received BNT162b2 (BNT162B2), on 13Mar2021 at 15:00 as dose 1, single (Lot number: En6199), in left arm, on 03Apr2021 at 14:00 as dose 2, single (Lot number: Er8734), in left arm and on 07Jan2022 at 16:00 as dose 3 (booster), single (Lot number: Fl3209), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NASONEX; SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022 at 15:00, outcome "unknown" and all described as "Each of us had a Covid infection with light to no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2022) Positive, notes: Nasal Swab.  Clinical Course: Severe Pain in left neck and left arm. 3 male employees at a office of 24 are experiencing the same symptoms. The only thing we all have in common is the Pfizer shots. We are of different ethnicity's and age. We each have a past neck diagnosis issue from over 10 years ago. . None of him have had any issues with they necks or arms up to this year from Previous issue. Seems like to much of a coincidence that its' not either a side effect of the vaccine or a side effect of Covid. Each of him had a Covid infection with light to no symptoms.  The symptoms are ongoing with health care being administered with PT.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200824355 same product/event, different patient;US-PFIZER INC-202200828047 same reporter/patient, different dose/event;
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diffuse B cell lymphoma diagnosed Jan 2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "amoxicillin: Drug allergy"; Azithroymycn, reaction(s): "azithromycin: Drug allergy", notes: azithroymycn. Vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: EW0150), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2 , Batch/Lot No: ER8735), administration date: 23Apr2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: DIFFUSE LARGE B-CELL LYMPHOMA (medically significant) with onset Jan2022, outcome "unknown", described as "Diffuse B cell lymphoma diagnosed Jan 2022". Therapeutic measures were taken as a result of diffuse large b-cell lymphoma. Clinical course: Patient was on R-CHOP therapy every 3 weeks. Final chemo 03Jun2022   Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diffuse large B-cell lymphoma
Clinical narrative: Diffuse B cell lymphoma diagnosed Jan 2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "amoxicillin: Drug allergy"; Azithroymycn, reaction(s): "azithromycin: Drug allergy", notes: azithroymycn. Vaccination history included: BNT162b2 (Dose Number: 1 , Batch/Lot No: EW0150), administration date: 02Apr2021, when the patient was 52-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2 , Batch/Lot No: ER8735), administration date: 23Apr2021, when the patient was 52-year-old, for Covid-19 immunization. The following information was reported: DIFFUSE LARGE B-CELL LYMPHOMA (medically significant) with onset Jan2022, outcome "unknown", described as "Diffuse B cell lymphoma diagnosed Jan 2022". Therapeutic measures were taken as a result of diffuse large b-cell lymphoma. Clinical course: Patient was on R-CHOP therapy every 3 weeks. Final chemo 03Jun2022   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Prostatic specific antigen
Clinical narrative: he experienced flu-like symptoms including fever and headache.; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (he experienced flu-like symptoms including fever and headache.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he experienced flu-like symptoms including fever and headache.). At the time of the report, INFLUENZA LIKE ILLNESS (he experienced flu-like symptoms including fever and headache.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Prostatic specific antigen: 3.73 Result 3.73.         Concomitant medications details were not reported by the reporter.  It was reported that the symptoms occurred on the same day as the injection, but much later in the day around 8-9 PM. It was stated that those symptoms that patient experienced were typical to what patient had read on all the websites.   It was also reported that patient had been going to receive PSA tests for prostate for the past 10 years and over the past 2-3 years patient had been taking these tests more often and was scheduled to had test at the beginning of MAY-2022.  Patient was not taking any medications or treatments for any of symptoms.   This case was linked to MOD-2022-588193, MOD-2022-588201, MOD-2022-588204 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that on 24May2022, 1 vial was placed in the refrigerator from which 1 dose (0.25mL booster dose) was given. No temperature excursions were reported. No concomitant medication information were given. No treatment information were given.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Severe  Shingles that started 2 days after Adminstration of the vaccine including severe chest/breast pain and vesicular rash 4 days after the vaccine.  Shingles required antiviral treatment.  I have severe pain since then.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Nausea, Pain
Clinical narrative: serious chills, nausea, shivering, temperature, aching,
Age: 31.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Gait disturbance, Gait inability, Impaired driving ability, Intervertebral disc degeneration
Clinical narrative: After receiving the vaccines, I awoke on the morning of the 19th unable to walk. I seemed paralyzed from the waist down, except that I could feel everything -- the base of my spine was excruciatingly painful when I tried to roll out of bed. It took me 45 minutes to fall out of bed and push myself (using my arms) to the phone. An ambulance took me to Medical Center. An ER diagnosis was lumbosacral strain (a muscle injury due to inflammation, tearing or bruising within the muscle) and spasms It looks like I was given Motrin, Robaxin and Percocet. Subsequent testing was performed the following year(s) and found lumbar neuritis, a herniated disc (L4-L5), degenerative disc disease and osteoarthritis. Here is further information on the vaccines:  Meningococcal A,C,Y,W-135 Diphtheria Conj  VIS Version(s): 1/28/08 Tdap  VIS Version(s): 07/12/06    My symptoms were similar to Guillan-Barre Syndrome. I couldn't drive for a long time, and it was difficult to walk. I didn't report this sooner because medical providers said my symptoms weren't related to the vaccines. And I only heard of VAERS/Guillan-Barre during the Covid pandemic. Since I finally found the lot numbers, I'm reporting a potential adverse event... in case it's of significance.
Age: 31.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Intervertebral disc protrusion, Magnetic resonance imaging spinal abnormal, Muscle spasms, Muscle strain, Osteoarthritis
Clinical narrative: After receiving the vaccines, I awoke on the morning of the 19th unable to walk. I seemed paralyzed from the waist down, except that I could feel everything -- the base of my spine was excruciatingly painful when I tried to roll out of bed. It took me 45 minutes to fall out of bed and push myself (using my arms) to the phone. An ambulance took me to Medical Center. An ER diagnosis was lumbosacral strain (a muscle injury due to inflammation, tearing or bruising within the muscle) and spasms It looks like I was given Motrin, Robaxin and Percocet. Subsequent testing was performed the following year(s) and found lumbar neuritis, a herniated disc (L4-L5), degenerative disc disease and osteoarthritis. Here is further information on the vaccines:  Meningococcal A,C,Y,W-135 Diphtheria Conj  VIS Version(s): 1/28/08 Tdap  VIS Version(s): 07/12/06    My symptoms were similar to Guillan-Barre Syndrome. I couldn't drive for a long time, and it was difficult to walk. I didn't report this sooner because medical providers said my symptoms weren't related to the vaccines. And I only heard of VAERS/Guillan-Barre during the Covid pandemic. Since I finally found the lot numbers, I'm reporting a potential adverse event... in case it's of significance.
Age: 31.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Radiculopathy, Spinal pain
Clinical narrative: After receiving the vaccines, I awoke on the morning of the 19th unable to walk. I seemed paralyzed from the waist down, except that I could feel everything -- the base of my spine was excruciatingly painful when I tried to roll out of bed. It took me 45 minutes to fall out of bed and push myself (using my arms) to the phone. An ambulance took me to Medical Center. An ER diagnosis was lumbosacral strain (a muscle injury due to inflammation, tearing or bruising within the muscle) and spasms It looks like I was given Motrin, Robaxin and Percocet. Subsequent testing was performed the following year(s) and found lumbar neuritis, a herniated disc (L4-L5), degenerative disc disease and osteoarthritis. Here is further information on the vaccines:  Meningococcal A,C,Y,W-135 Diphtheria Conj  VIS Version(s): 1/28/08 Tdap  VIS Version(s): 07/12/06    My symptoms were similar to Guillan-Barre Syndrome. I couldn't drive for a long time, and it was difficult to walk. I didn't report this sooner because medical providers said my symptoms weren't related to the vaccines. And I only heard of VAERS/Guillan-Barre during the Covid pandemic. Since I finally found the lot numbers, I'm reporting a potential adverse event... in case it's of significance.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: FD7534), in right arm, on 07Apr2021 as dose 2, single (Lot number: CW0151), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: LISINOPRIL HCTZ; METOPROLOL [METOPROLOL SUCCINATE]; ASPIRIN 81. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive, notes: On day 1 (onset of mild symptoms), I tested positive for the 1st time; (10Jun2022) Positive, notes: tested positive on day 10 (home test). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: On day 1 (onset of mild symptoms),  tested positive for the 1st time and began taking Paxlovid. By day 5, ended treatment and only had a very mild cough once or twice a day. On days 6-8 patient felt almost perfectly (mild nasal congestion during sleep hours). But since day 9 patient had been sick again with new symptoms (sneezing, runny nose), like having a cold. And tested positive on day 10 (home test). Patient treated with Paxlovid, Treatment start date: 02Jun2022 and Treatment stop date: 06Jun2022 for  Indication of COVID-19
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Epistaxis, Lymphadenitis
Clinical narrative: epistaxis; lymph nodes inflammation in neck, underarm, groin and hands joint inflammation; lymph nodes inflammation in neck, underarm, groin and hands joint inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Hashimoto disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 24May2022, outcome "unknown"; LYMPHADENITIS (non-serious), ARTHRITIS (non-serious) all with onset 2022, outcome "not recovered" and all described as "lymph nodes inflammation in neck, underarm, groin and hands joint inflammation". Additional information- It was reported that patient had experienced EPISTAXIS after the  4 day administration of vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; Medical Assistant reports the administration of expired dose of VAQTA.; This non-valid spontaneous report was received from a medical assistant referring to an unknown patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies was not provided.   On 12-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a Vaccine, inactivated (VAQTA) pre-filled syringe, dose of 0.5 mL, lot number: S021094, expiration date: 18-MAY-2020 (dose number, route of administration and anatomical location was not provided) for prophylaxis (expired product administered). No additional information and no further details were provided. No additional adverse events reported (no adverse event).  This report is non-valid due to lack of patient's identifiers.  Follow up information was received on 07-JUN-2022 from a family medicine provider. The patient is a 5-year-old female.  On 12-JUN-2020, the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS) lot number: S021094, expiration date: 18-MAY-2020, administered in the right thigh (dose and route of administration were not provided) for prophylaxis.  On 12-JUL-2020, the hepatitis a Vaccine, inactivated (VAQTA) was administered in the right thigh. It was reported that on 21-APR-2022, the patient was vaccinated again with a dose of hepatitis a Vaccine, inactivated (VAQTA) (dose, lot#, expiration date, route and site of administration were not provided) for prophylaxis. No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant reported a dose of MMRII with a labeled expiry of 5/11/2022 was administered to a patient on 5/17/2022. Caller reports no temperature excursion involved. No additional information was provided. No additional AE/PQC was reported.; This spontaneous report was received from a medical assistant, concerning a 12-month-old patient of unknow gender. The patient's historical conditions, concurrent conditions and concomitant therapies were not reported.   On 17-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA)  (M-M-R II) 0.5 milliliter, product quantity 1, lot #T016198 with expiration date: 11-MAY-2022 (strength, route of administration and anatomical location were not reported) for prophylaxis (Expired product administered). No additional adverse event was reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: No additional AE details available; A 15-year-old female patient received only 1 dose of GARDASIL 9 in 2018. It is unknown why the series wasn't completed however, reporter mentioned the family may have "forgotten about" completing the series.; Information has been received from a medical assistant referring to a 15-year-old female patient. The patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided.  On an unknown date in 2018, the patient received only 1 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, route, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). It is unknown why the series wasn't completed, however, reporter mentioned the family might have "forgotten about" completing the series. The reporter would like to know if HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series could be restarted. No additional adverse event details available (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; Caller reports vaccine administered after temperature excursion; This spontaneous report has been received from a nurse referring to a patient of unknown gender and age. The patient's medical history, concurrent condition, drug reactions/allergies, and concomitant therapy were not provided.  On 10-MAY-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) after temperature excursion 0.5 ml, subcutaneous (SQ) (strength not provided, lot number U024220 has been verified to be a valid lot number, expiration date reported as 03-AUG-2023, but upon internal validation was established as 04-AUG-2023) for prophylaxis (product storage error). The temperature was 10 Fahrenheit with a time frame of 14 minutes. There was no previous temperature excursion. No additional adverse events (no adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered vaccine; This spontaneous report has been received from an office manager referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapy, and drug allergy or reaction were not provided.  On 16-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) one injection with oral default route (lot# U037809 with reported expiration date 26-MAR-2023) for prophylaxis (Product storage error). The vaccine was improperly stored with temperature (28.0 Fahrenheit (F)) below 36 F, the time frame was 96 hours. There was no previous temperature excursion occurred.  As of 31-MAY-2022 telephone call, which received from a healthcare worker, the office manager was no longer working at the office, and additional information has been requested.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA005621: US-009507513- 2205USA005673: US-009507513-2205USA005815: US-009507513-2205USA005882: US-009507513-2205USA005914:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: He had no adverse effects or symptoms after receiving the dose; Caller is a nurse manager who reports that a 4 month old patient received his first dose of ROTATEQ today. He had no adverse effects or symptoms after receiving the dose. Caller reported dose as "dose one/first dose" when asked for dose and frequency; This spontaneous report has been received from a nurse manager, referring to a 4-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date, , the patient received a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, dose one/first dose, lot number 1821811 which was verified to be a valid lot number with an expiry date of 27-JUL-2022 for prophylaxis (dose and vaccination scheme were not reported).  On 24-MAY-2022, the patient received his first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product administered to patient of inappropriate age). Therefore, the patient had no adverse effects or symptoms after receiving the dose of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addiitional AE were reported; Office manager reported that a patient received an improperly stored VARIVAX that was reconstituted with properly stored sterile diluent.; This spontaneous report has been received from office manager, regarding to a patient of unknown gender and age. The patient's concomitant therapies, historical conditions and concurrent conditions.  On 15-APR-2022, the patient was vaccinated with first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U025791 has been verified to be valid, expiration date 19-AUG-2023) (dose regimen, route of administration and anatomical location were not reported) with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date were not provided) for prophylaxis. Not adverse events (AE) were reported, and no further information was provided.  Additionally, it was reported that the varicella virus vaccine live (oka/merck) (VARIVAX)underwent a temperature excursion of 6 Fahrenheit (°F) up to 14 °F for 15 minutes and 14 °F up to 46 °F (average temperature 34.93 °F) for 1 hours and 15 minutes (product storage error). There was no previous temperature excursion.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to a 14-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 14-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA007821: US-009507513-2205USA007852:
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to an 11-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used.  On 25-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007821: US-009507513-2205USA007852:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse event; TE evaluation states vaccines have been administered; This spontaneous report was received from a medical assistant regarding a 5-year-old male patient.    There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 23-MAR-2022, a temperature excursion occurred. On 25-APR-2022, the patient was vaccinated with second dose at private doctor's office/hospital; vaccine as purchased by public funds by a health care professional (1 previous administrated dose) of varicella virus vaccine live (oka/merck) (VARIVAX) administrated subcutaneously (SQ) (formulation, strength, dose, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U025790 or U029496, which had been verified to be valid, expiration dates reported and validated as 19-AUG-2023 and 21-SEP-2023 respectively), as prophylaxis (Improper storage of product in use). The vaccine administered was stored at temperatures that went, from -14 degrees Celsius (C) up to -10 C for a time frame of 3 hours, and from -10 C up to 8 C for 1 hours 30 minutes, as recorded by a data logger. There was no previous temperature excursion. No additional AE details were reported. No PQC. Additionally, the vaccine was not available for evaluation because it was given to the patient; usage for device was initial use.    This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Age: 20.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: No additional AE information available; VARIVAX was administered to a pregnant patient; This spontaneous report was received from a medical assistant and refers to a 20-year-old, 13-weeks-pregnant female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included unspecified prenatal vitamins.  On 31-MAY-2022, the patient was administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T027299, expiration date: 12-AUG-2022, administered subcutaneously for prophylaxis (strength, exact dose, and anatomical location were not provided); and sterile diluent, solution for injection/infusion (dose, strength, lot #, expiry date, route of administration, and indication were not provided) (exposure during pregnancy). The patient received the vaccination because she needed it for school. The reporter stated that she referred the patient to her obstetrician and gynecologist (OBGYN) who ordered laboratory tests for antibodies. The patient did not have any adverse symptoms from vaccination at the time of the report (no adverse event)
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; swollen arm. Some symtomps went down all the way to the elbow; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; This spontaneous report was received from a female consumer of unknown age referring to herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date (reported as in the past), she received a dose of pneumococcal vaccine conj 7V (CRM197) (PREVNAR) without experienced any symptom; and 2 doses of tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (also reported as Pfizer's COVID-19 vaccine) that cause a little soreness but no other issue.  On 26-MAY-2022, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (valid lot #U034712, expiration date: 30-JUL-2023) in an arm (unspecified) (also reported as ''too shallow'' administration) (strength and route of administration were not provided) as routine vaccination.  Then, on the same date, after 4 hours of the administration of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the subject experienced a reaction to the vaccine which included redness (vaccination site erythema), itching (vaccination site pruritus) and swollen arm (vaccination site swelling). Some symptoms traveled down to the elbow and she "could not move her arm". Furthermore, it was reported that her body temperature was "fine" at 97.7 Fahrenheit (F) but experienced fever (pyrexia) and chills. Consequently, the patient's nurse advised her to took paracetamol (TYLENOL), diphenhydramine (BENADRYL) and use ice packs to help to alleviate or improve some symptoms related to itching, however not all the symptoms went away. At the reporting time, the subject was recovering from all the events.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events vaccination site erythema, vaccination site pruritus and vaccination site swelling, was considered as related, and regarding the events pyrexia and chills the causality was not provided.
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling, Wrong technique in product usage process
Clinical narrative: Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; swollen arm. Some symtomps went down all the way to the elbow; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; This spontaneous report was received from a female consumer of unknown age referring to herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date (reported as in the past), she received a dose of pneumococcal vaccine conj 7V (CRM197) (PREVNAR) without experienced any symptom; and 2 doses of tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (also reported as Pfizer's COVID-19 vaccine) that cause a little soreness but no other issue.  On 26-MAY-2022, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (valid lot #U034712, expiration date: 30-JUL-2023) in an arm (unspecified) (also reported as ''too shallow'' administration) (strength and route of administration were not provided) as routine vaccination.  Then, on the same date, after 4 hours of the administration of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the subject experienced a reaction to the vaccine which included redness (vaccination site erythema), itching (vaccination site pruritus) and swollen arm (vaccination site swelling). Some symptoms traveled down to the elbow and she "could not move her arm". Furthermore, it was reported that her body temperature was "fine" at 97.7 Fahrenheit (F) but experienced fever (pyrexia) and chills. Consequently, the patient's nurse advised her to took paracetamol (TYLENOL), diphenhydramine (BENADRYL) and use ice packs to help to alleviate or improve some symptoms related to itching, however not all the symptoms went away. At the reporting time, the subject was recovering from all the events.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events vaccination site erythema, vaccination site pruritus and vaccination site swelling, was considered as related, and regarding the events pyrexia and chills the causality was not provided.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  Excursion on 03-MAY-2022.  The vaccine had been administered since the excursion occurred.; This spontaneous report was received from a nurse referring to a 13 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The reporter reported two temperature excursions on multiple refrigerated vaccines.She said it was very likely all vaccines had been administered since the excursions occurred.  As she was looking through her data, she estimated there would be around 40 patients who have been administered vaccines alone and many others who had received the other vaccine types.   After all, it was confirmed that on 03-MAY-2022, the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # U014656 with expiration date on 07-MAY-2023, had a temperature excursion at 47.3F for 5 minutes. and on 09-MAY-2022, the patient was vaccinated with tat vaccine for prophylaxis (dose and route were not reported).  No additional adverse event was reported and no product quality complaint was identified.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001594: US-009507513-2206USA001600: US-009507513-2206USA001585: US-009507513-2206USA001584: US-009507513-2206USA001583: US-009507513-2206USA001589: US-009507513-2204USA002052: US-009507513-2204USA001998: US-009507513-2204USA001952: US-009507513-2204USA001865: US-009507513-2206USA001582: US-009507513-2206USA001593: 2US-009507513-206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: 2US-009507513-206USA001600:
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; Customer called and reported that a consumer received 2 doses of Hepatitis B vaccine. The consumer received one dose of PEDIARIX combo vaccine and one dose of RECOMBIVAX HB.; This spontaneous report has been received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 02-JUN-2022, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) 0,5 milliliters (ml) (lot number: U019135, which was determined to be valid, with an expiration date on 22-NOV-2022) (scheme, route and anatomical location of administration were not reported) and a dose of diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) (dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) both as prophylaxis for Hepatitis B (extra dose administered). It was reported that the vaccines mentioned were administered in different areas of the body. No additional adverse event was reported.
Age: 7.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Caller reports GARDASIL 9 administered to a 7 year old.  AE onset date was verified as 4/27/2021.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report as received from a physician referring to a 7 year old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 27-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1691180 and expiration date 15-NOV-2022, 0.5 milliliter, intramuscular for prophylaxis (product administered to patient of inappropriate age). No additional adverse event were reported.