chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Chest discomfort, Chest pain, Headache, Hyperhidrosis, Pericarditis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 19:30 as dose 3 (booster), single (Lot number: GH9694) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 1), for COVID-19 Immunization. The following information was reported: CHEST PAIN (hospitalization) with onset 13Sep2022 at 22:00, outcome "recovering"; PERICARDITIS (hospitalization, medically significant) with onset 13Sep2022 at 22:00, outcome "recovering", described as "Peri-Carditis"; HEADACHE (hospitalization) with onset 13Sep2022 at 22:00, outcome "recovering"; HYPERHIDROSIS (hospitalization) with onset 13Sep2022 at 22:00, outcome "recovering", described as "sweating"; CHEST DISCOMFORT (hospitalization) with onset 13Sep2022 at 22:00, outcome "recovering", described as "tightness in chest". The patient was hospitalized for pericarditis, chest discomfort, chest pain, headache, hyperhidrosis (hospitalization duration: 3 day(s)). The events "peri-carditis", "tightness in chest", "chest pain", "headache" and "sweating" required emergency room visit. Therapeutic measures were taken as a result of pericarditis, chest discomfort, chest pain, headache, hyperhidrosis and the treatment included NSAID and Antacid.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Renal pain
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2021 as dose 1, single (Lot number: ew0178), in left arm, on 23Aug2021 as dose 2, single (Lot number: fd8448), in left arm, on 24Jan2022 as dose 3 (booster), single (Lot number: 331308a), in left arm and on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170783 same patient/vaccine, diff dose/event;US-PFIZER INC-202201170040 same patient/vaccine, diff dose/event;
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2021 as dose 1, single (Lot number: ew0178), in left arm, on 23Aug2021 as dose 2, single (Lot number: fd8448), in left arm, on 24Jan2022 as dose 3 (booster), single (Lot number: 331308a), in left arm and on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170783 same patient/vaccine, diff dose/event;US-PFIZER INC-202201170040 same patient/vaccine, diff dose/event;
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Pollakiuria, Renal pain
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2021 as dose 1, single (Lot number: ew0178), in left arm, on 23Aug2021 as dose 2, single (Lot number: fd8448), in left arm, on 24Jan2022 as dose 3 (booster), single (Lot number: 331308a), in left arm and on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170783 same patient/vaccine, diff dose/event;US-PFIZER INC-202201170040 same patient/vaccine, diff dose/event;
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Cellulitis, Chills, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: That night my arm was burning all the way down to my elbow and had a lump and was red. Location of the bump was down low. When the vaccine was administered it was bleeding a lot and they just put a band aid one. The DR diagnosed it as cellulitis and gave me an antibiotic that made me really sick the medication was doxycycline. The arm was red for 6 days with no rash and is currently very tiny.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: That night my arm was burning all the way down to my elbow and had a lump and was red. Location of the bump was down low. When the vaccine was administered it was bleeding a lot and they just put a band aid one. The DR diagnosed it as cellulitis and gave me an antibiotic that made me really sick the medication was doxycycline. The arm was red for 6 days with no rash and is currently very tiny.
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site haemorrhage, Mass
Clinical narrative: That night my arm was burning all the way down to my elbow and had a lump and was red. Location of the bump was down low. When the vaccine was administered it was bleeding a lot and they just put a band aid one. The DR diagnosed it as cellulitis and gave me an antibiotic that made me really sick the medication was doxycycline. The arm was red for 6 days with no rash and is currently very tiny.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Bedridden, Feeding disorder, Pain in extremity
Clinical narrative: usual soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (usual soreness in the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient never had COVID-19 positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu shot in 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (general anesthesia (nausea and vomiting)), Drug allergy (Cortisone shot), Allergy to antibiotic (doxycycline (severe diarrhea)), Allergy to antibiotic (vibramycin), Drug allergy (markain (difficult of breathing)), Adhesive tape allergy (surgical tape), Childhood asthma and Bronchitis (continuing bouts of bronchitis but the last time got sick was fall of Feb-2019 before the pandemic).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (usual soreness in the arm). At the time of the report, PAIN IN EXTREMITY (usual soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported.  It was reported that patient did not seek any medical care and did not had a similar event in past. It was also reported that the symptoms were ongoing.  Treatment medications were not provided.   This case was linked to MOD-2022-647568, MOD-2022-647566 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: usual soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (usual soreness in the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient never had COVID-19 positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu shot in 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy (general anesthesia (nausea and vomiting)), Drug allergy (Cortisone shot), Allergy to antibiotic (doxycycline (severe diarrhea)), Allergy to antibiotic (vibramycin), Drug allergy (markain (difficult of breathing)), Adhesive tape allergy (surgical tape), Childhood asthma and Bronchitis (continuing bouts of bronchitis but the last time got sick was fall of Feb-2019 before the pandemic).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (usual soreness in the arm). At the time of the report, PAIN IN EXTREMITY (usual soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported.  It was reported that patient did not seek any medical care and did not had a similar event in past. It was also reported that the symptoms were ongoing.  Treatment medications were not provided.   This case was linked to MOD-2022-647568, MOD-2022-647566 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Headache, Menstruation irregular
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 2, single (Lot number: 32030BD) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO, start date: 07Mar2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medication in 2weeks was Yes. Anti-viral details: Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 17Sep2022. Stop date: 17Sep2022. Lot number: 2692144. Indication: Treatment of COVID- 19. Other medication in 2weeks product was Aubagio on 07Mar2015. Adverse event: within 45 minutes of taking her first dose, she had an awful metallic taste in her mouth and left ear started ringing. It was about 24 hours later and she still have a very loud ringing in her left ear. Her oxygen level also decreased her heart rate went up and she actually felt worse after taking just one dose of Paxlovid. No Known allergies. Other medical history was Multiple sclerosis.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, 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) (Nurse) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 2, single (Lot number: 32030BD) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO, start date: 07Mar2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medication in 2weeks was Yes. Anti-viral details: Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 17Sep2022. Stop date: 17Sep2022. Lot number: 2692144. Indication: Treatment of COVID- 19. Other medication in 2weeks product was Aubagio on 07Mar2015. Adverse event: within 45 minutes of taking her first dose, she had an awful metallic taste in her mouth and left ear started ringing. It was about 24 hours later and she still have a very loud ringing in her left ear. Her oxygen level also decreased her heart rate went up and she actually felt worse after taking just one dose of Paxlovid. No Known allergies. Other medical history was Multiple sclerosis.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Electrocardiogram, Feeling jittery, Malaise, Pain in extremity
Clinical narrative: 1.Malaise and left arm pain after the vaccination from the day of administration till 2 months later 2.Palpitations and jitteriness from 2 months after the vaccine lasting for more than 4 months. Had to have tests carried out by cardiologist and was started on a beta blocker medication.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: 1.Malaise and left arm pain after the vaccination from the day of administration till 2 months later 2.Palpitations and jitteriness from 2 months after the vaccine lasting for more than 4 months. Had to have tests carried out by cardiologist and was started on a beta blocker medication.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Electrocardiogram, Epistaxis
Clinical narrative: Significant increase in blood pressure (over 50%) from  average 100-110/ 55-65 now up to 160-170/85-95 Also a major nosebleed that took over 1 hour to stop bleeding Result: Visit primary care physician for exam & get an EKG Started taking high blood pressure medication "Lisinopril" 5mg 1X daily
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Computerised tomogram normal, Fatigue, Malaise
Clinical narrative: Started feeling achy and feverish, took a home COVID-19 test and it was positive. Was sick for about 3 days with fever, chills, fatigue, body aches. After 10 day I retested for COVID-19 and it was negative. Since then I've started to have severe headaches daily,  Dr. ordered a CT Scan without contrast. Results were clear. I was prescribed Amitriptyline and it has helped with my headaches, but now they're starting to come back.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: New daily persistent headache, Pain, Pyrexia, SARS-CoV-2 test positive, Scan with contrast normal
Clinical narrative: Started feeling achy and feverish, took a home COVID-19 test and it was positive. Was sick for about 3 days with fever, chills, fatigue, body aches. After 10 day I retested for COVID-19 and it was negative. Since then I've started to have severe headaches daily,  Dr. ordered a CT Scan without contrast. Results were clear. I was prescribed Amitriptyline and it has helped with my headaches, but now they're starting to come back.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: not inserted into the mid portion of the deltoid muscle; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information provided No treatment information provided
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no addtional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a physician and refers to a 2-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 23-AUG-2022, the patient was vaccinated with an improperly store (product storage error) hepatitis a vaccine, inactivated(VAQTA), lot number W003118 with expiration date 13-JUL-2023 or lot number W015191 with expiration date 27-OCT-2023 (the reporter did not specify  which actual lot the patient received), (dose, and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 11.3 degrees Celsius for 34 minutes. No previous temperature excursion were reported. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1879864 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number 1879864 confirmed to be valid, expiration date reported and stablished as 19-OCT-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002779: US-009507513-2209USA002722:02242101 US-009507513-2209USA002532:02242101 US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002510: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# W011278 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number W011278, expiration date 01-NOV-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002779: US-009507513-2209USA002722:02242135 US-009507513-2209USA002532: US-009507513-2209USA002469: US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002510: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after a temperature excursion; This spontaneous report was received from a healthcare business professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  On 19-AUG-2022, administered dose of vaccine experienced the temperature excursion of 5.7 degrees Fahrenheit for 30 minutes; it was also reported that on 18-JUL-2022, there was previous temperature excursion of 6 up to 14 (10F) degrees Fahrenheit for 1 hour and 8 minutes.  No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; a dose of PROQUAD was administered after a temperature excursion; This spontaneous report was received from an "healthcare professional" and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) lot #W017570, expiration date: 29-NOV-2023 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine dose underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 0 hours, 30 minutes and 0 seconds, with previous excursion of 6 F up to 14 F (9.1F) for 1 hour 6 minutes and 0 seconds.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report has been received from a healthcare business professional (HBP) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-SEP-2022, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided) after temperature excursion of 5.7 Fahrenheit (F) for 30 minutes (product storage error). There was a previous temperature excursion of 6 F to 14 F (9.1 F) for 1 hour 6 minutes. There was no additional adverse event (AE) reported, and no additional information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003637:
Age: 0.17
Sex: U
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs; Caller reported 2 month old child inadvertently received MMR II and VARIVAX.; It was also reported that VARIVAX and MMR II were administered IM instead of the recommended SQ route.; MMR II, VARIVAX and HAVRIX were inadvertently administered.; This spontaneous report was received from a nurse referring to a 2-months-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 13-SEP-2022, the patient was inadvertently vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), dose of 0.5 mL, administered intramuscularly, lot number: U006486, expiration date: 26-FEB-2023 (dose number and anatomical location were not reported), varicella virus vaccine live (oka/merck) (VARIVAX), dose of 0.5 mL, administered intramuscularly, lot number: U032852, expiration date: 20-OCT-2023 (dose number and anatomical location were not reported) (product administered to patient of inappropriate age, incorrect route of product administration) and hepatitis a vaccine inact (HAVRIX) for prophylaxis (wrong product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event). On the same date, the patient was vaccinated with dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), ROTATRIX, hib vaccine conj (tet tox) (ACT HIB) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), which were scheduled vaccines.
Age: 0.17
Sex: U
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; Caller reported 2 month old child inadvertently received MMR II and VARIVAX.; It was also reported that VARIVAX and MMR II were administered IM instead of the recommended SQ route.; MMR II, VARIVAX and HAVRIX were inadvertently administered.; This spontaneous report was received from a nurse referring to a 2-months-old patient of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 13-SEP-2022, the patient was inadvertently vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), dose of 0.5 mL, administered intramuscularly, lot number: U006486, expiration date: 26-FEB-2023 (dose number and anatomical location were not reported), varicella virus vaccine live (oka/merck) (VARIVAX), dose of 0.5 mL, administered intramuscularly, lot number: U032852, expiration date: 20-OCT-2023 (dose number and anatomical location were not reported) (product administered to patient of inappropriate age, incorrect route of product administration) and hepatitis a vaccine inact (HAVRIX) for prophylaxis (wrong product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event). On the same date, the patient was vaccinated with dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), ROTATRIX, hib vaccine conj (tet tox) (ACT HIB) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), which were scheduled vaccines.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs/no PQCs; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 12-SEP-2022, the patient was vaccinated with a improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection (lot number W019624 was verified to be a valid number, expiration date reported and established as 19-DEC-2023) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of -10 Celsius degrees up to 8 Celsius degrees (-4 Celsius) for 2 hours and 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: No other adverse event; Caller is a nurse who reports inadvertent concomitant administration of PROQUAD and VARIVAX to a 12-month-old female patient. Patient did not have any symptoms or adverse effects from administration. No further information provided; no other AE/no PQ; This spontaneous report was received from a licensed practical nurse concerning a 12-month-old female patient.  The patient's medical history, historical drugs and concurrent conditions were not reported.    On 13-SEP-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U017140, expiration date: 28-NOV-2022 (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023 (strength, and route of administration were not provided), both administered concomitantly as prophylaxis (accidental overdose), in combination with 0.7 ml of sterile diluent, lot #T001632, expiration date 01-SEP-2023. The patient did no have any symptoms or adverse effects from administration.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired PNEUMOVAX 23 via corresponding PNEUMOVAX 23 Prefilled Syringe on 09/13/2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 13-SEP-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T039322, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), expiration date reported and upon internal validation established as 09-SEP-2022) (dose, anatomical location and route of administration were not reported) for prophylaxis (Expired product administered).  No adverse event was reported. No temperature excursion was reported.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; Physician reports that a patient was inadvertently administered both VARIVAX and PROQUAD; This spontaneous report has been received from a physician, regarding a 4-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 13-SEP-2022, the patient was inadvertently administered both varicella virus vaccine live (Oka/Merck) (VARIVAX) frequency reported as once (lot number: W011622, which was determined to be valid, with an expiration date of 06-APR-2024) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) once (lot number: W017573, which was determined to be valid, with an expiration date on 29-NOV-2023), both as prophylaxis (doses, route and anatomical location of administration were not provided) (accidental overdose) (accidental exposure to product). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report has been received from a vaccine coordinator, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 24-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX 9) subcutaneous injection, 0,5 milliliters (ml) as prophylaxis (lot number: U015678, which was determined to be valid, with an expiration date on 18-MAY-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). The administered dose was placed on a refrigerator since 15-NOV-2021, where it underwent a temperature excursion with a maximum temperature of 51 degrees Fahrenheit (F) for an unspecified amount of time. It was unknown if any previous temperature excursion took place. No additional adverse event was reported.   This is one of four cases from the same reporter.; Sender's Comments:  US-009507513-2209USA006085:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a vaccine coordinator calling to report a temperautre excursion for VARIVAX. Caller reports that the VARIVAX was stored in the refrigerator since 15NOV2021. Caller reports that the refrigerator had an excursion with maximum temperautre of 5; This spontaneous report has been received from a vaccine coordinator, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 21-APR-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX 9) subcutaneous injection, 0,5 milliliters (ml) as prophylaxis (lot number: U015678, which was determined to be valid, with an expiration date on 18-MAY-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). The administered dose was placed on a refrigerator since 15-NOV-2021, where it underwent a temperature excursion with a maximum temperature of 51 degrees Fahrenheit (F) for an unspecified amount of time. It was unknown if any previous temperature excursion took place. No additional adverse event was reported.   This is one of four cases from the same reporter.; Sender's Comments:  US-009507513-2209USA006073:
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Customer calling states a dose of PROQUAD was administered to a 13 year old patient by one of the nurses at her facility.; No additional adverse event reported; This spontaneous report was received from a consumer regarding a 13-year-old patient of an unknown gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis by one of the nurses at her facility (Product administered to patient of inappropriate age). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE.; Caller is a nurse who reports a dose of VARIVAX which expired on 12Aug2022 was given to a patient on 17Sep2022.; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 17-SEP-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous injection, at a dose of 0.5 milliliters (ml) as prophylaxis(lot number T027300, which has been verified to be valid, expiration date reported and established as 12-AUG-2022)(strength, route of administration, and anatomical site of injection were not reported) plus a sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (expired product administered).  No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 13 year old patient had interruption in dosing schedule pertaining to MMR II / Patient received first dose of MMR II at 1 years old; No additional adverse events reported; This spontaneous report was received from a Medical Assistant and refers to a currently 13-year-old patient (gender not informed).  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, at the age of 1 year old, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, route of administration, lot number, and expiration date not reported) administered for prophylaxis.  It was reported that the patient had interruption in dosing schedule pertaining to this vaccine (Inappropriate schedule of product administration). No additional adverse events were reported (No adverse event). No further details were provided.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 7 Months Pregnant; Initial Report Received on 04-Aug2022  A registered nurse  reported that a 39 year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 7-months pregnant.  No medical history was reported. Concomitant medications and allergies were unknown.  The patient's last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    On 05-Jul-2022, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-01; route not reported) in the left arm. The patient had no adverse reactions.   No other information provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Received First Dose and Currently Breastfeeding; Initial Report Received on 05-Aug2022  A patient reported that she, a 32 year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while breastfeeding.  Relevant medical history and concomitant medications were not reported at the time of report.   On 04-Aug-2022, the patient, who was currently breastfeeding, received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site not reported) intramuscularly. The patient did not wish to share any further information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Dose of Heplisav-B to 17 Y.O.; Initial Report Received on 10-Aug-2022  A pharmacist in the reported that a 17-year-old patient (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 10-Aug-2022, the 17-year-old patient received a dose of HEPLISAV-B (NDC # 43528-0003-05; Lot #, expiration date, route, and injection site were unknown).  No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered a Dose of Heplisav-B to 14 Year Old; Initial Report Received on 15-Aug-2022  A registered pharmacist  reported that a 14-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no reported allergies.  On 03-Jun-2022, the 14-year-old patient received a dose of HEPLISAV-B (Lot # 937230, expiration date 11-Sep-2023, NDC # 43528-0003-05; route not reported) in the left deltoid by another pharmacist.  No other information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Patient Received 1 Dose of Heplisav-B, Then Given 1 Dose of Engerix; Initial Report Received on 18-Aug-2022 and 22-Aug-2022  A representative at a health department reported to a sales representative that a 40-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then one dose of Engerix Hepatitis B vaccine.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  In 2005, the patient received one dose of Engerix Hepatitis B vaccine (no details provided).  On 19-Jul-2022, the patient received one dose of HEPLISAV-B (Lot # 937233; expiration date 11-Mar-2023, NDC # 43528-003-05) intramuscularly in the deltoid (left or right side not specified).  On 16-Aug -2022, 29 days after having been vaccinated with HEPLISAV-B, the patient received one dose of Engerix Hepatitis B vaccine (details not provided).  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Dose One Week After First Dose; Initial Report Received on 23-Aug-2022  A pharmacist in the reported that a patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one week after the first dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date in Jul-2022, the patient received the "first dose" of HEPLISAV-B (Lot #, expiration date and NDC # not specified).   On 25-Jul-2022, the patient received the second dose of HEPLISAV-B (Lot # 937780, expiration date 13-Sep-2023 and NDC # 43528000305) in the left arm, route not provided which was "one week after the first dose".  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 24-Aug-2022  A pharmacist in the reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received and expired dose of HEPLISAV-B.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (expiration date 13-Aug-2022; lot # and NDC # not reported) in an unspecified site, route not provided.  On an unspecified date, the patient received an expired dose of HEPLISAV-B.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: Received Heplisav-B 5 months Ago and Currently Has Shingles; Initial Report Received on 24-Aug-2022.  A pharmacist reported that a female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed shingles.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site, route not reported.   On an unspecified date, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unspecified site, route not reported.   On an unspecified date, 5 months after having received the second HEPLISAV-B vaccination, the patient reported having shingles. The status of shingles is not resolved.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.