chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was only given the Dtap/IPV portion of the Pentacel vaccine/ No AE; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional (office staff).  This case is linked to case 2020SA121926 (duplicate case) and 2020SA121436 (same reporter).  This case involves a three months old male patient who received only the Dtap/IPV portion of 0.5 ml dose one of the suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6615AA and expiry date 02-Mar-2021 via intramuscular route in the right thigh for prophylactic vaccination (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Inappropriate reconstitution technique.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: hives on her side, back and arms; Initial information was received on 11-May-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 63-year-old female patient who experienced hives on her side, back and arms (urticaria), while she received RABIES (HDC) VACCINE [IMOVAX RABIES].  In 2003, a patient had received the Imovax 3 series vaccine. Medical history, medical treatment and family history were not provided.  On 29-Apr-2020, the patient received a first dose of RABIES (HDC) VACCINE [lot R1C71, expiry date: 30-Apr-2020] via unknown route at the right deltoid and on 06-may-2020, the patient received a second dose of same vaccine [lot R1713M, expiry date: 30-Apr-2020] via unknown route at the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious hives on her side, back and arms (urticaria) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Details of laboratory data not reported.  Final diagnosis was urticaria.   The patient was treated with PREDNISONE.  The event outcome was unknown for urticaria.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Contusion, Nodule
Clinical narrative: BRUISED KNOT
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: vasovagal syncope episode. Occurred only once. About 10-15mins after giving immunizations. Patient improved with sitting and water intake. Patient was feeling better within 5-10 mins.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient reports redness and swelling from shoulder to elbow starting the day after vaccination and continuing for 10 days, followed by rash and itching
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: red and erythematous skin at injection site
Age: 0.33
Sex: M
Vaccine: PPV, PPV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms at this time
Age: 0.33
Sex: M
Vaccine: PPV, PPV, UNK
Symptoms: Wrong product administered
Clinical narrative: no symptoms at this time
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient states that she started a rash about a week after receiving 2nd shingrix vaccine.  She stated that this is now a full body rash and will not relent.  Her dermatologist will not state that the rash is caused by the vaccine, according to the patient.  She stated that she had some itching after the first Shingrix vaccine received on 9-30-2019.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Rash
Clinical narrative: RASH ALL OVER THE BODY WITH REDNESS NUT NO ITCHING , WAS DESCRIBED BY DAD OVER THE PHONE
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Eye movement disorder, Headache, Muscle contractions involuntary, Musculoskeletal stiffness
Clinical narrative: Patient said she felt a little dizzy while walking down the hallway in the hospital. She had to have blood work drawn and during this she felt nauseous. At this time she became very pale and blotchy, her eyes rolled back in her head, body stiffened, hands and feet contracted. This seizure like activity lasted about 3-5 seconds per mom. Phlebotomist called ambulance. Paramedics checked blood pressure which was 151/80, they said she was alright. Per mom paramedic did not recommend going to Emergency Dept. Patient and mother left lab, was nauseated on the way home. Today 5/13/2020 patient has complaints of headache.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Pallor, Rash macular, Seizure like phenomena
Clinical narrative: Patient said she felt a little dizzy while walking down the hallway in the hospital. She had to have blood work drawn and during this she felt nauseous. At this time she became very pale and blotchy, her eyes rolled back in her head, body stiffened, hands and feet contracted. This seizure like activity lasted about 3-5 seconds per mom. Phlebotomist called ambulance. Paramedics checked blood pressure which was 151/80, they said she was alright. Per mom paramedic did not recommend going to Emergency Dept. Patient and mother left lab, was nauseated on the way home. Today 5/13/2020 patient has complaints of headache.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Pallor, Unresponsive to stimuli
Clinical narrative: Following administration of vaccines, nursing noted that patient's face appeared red.  She looked like she was going to pass out.  Mother picked her up.  She appeared pale and was not responding.  Mother stated this lasted about 15 seconds.  She returned back to her baseline.  She was monitored in clinic, and appeared well.   She was sent home.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Chills, Discomfort, Dyskinesia
Clinical narrative: sl less than 24 hours had 100.4 temperature and jerking shivering type action  wher he was uncomfortabe and hit himself in the face   he is able to  drink formula and has no vomiting or diarrhea He continues these jerky not seizure like movemts through today 5//14 but they are decreasung
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: C-reactive protein increased, Echocardiogram normal, Immunoglobulin therapy, Intensive care, Kawasaki's disease
Clinical narrative: Patient was admitted  3/19 with 3 days of fever and determined to have atypical Kawasaki disease and received one dose of IVIG on 3/21. He developed SVT on 3/20 that did not break with adenosine. He was then transferred to the CICU for esmolol therapy.  His SVT broke and he was transitioned to propanolol without recurrence of SVT. He had 2 normal echocardiograms, no evidence of coronary dilation. He has tolerated high dose aspirin initiation with GI prophylaxis without event. He has returned to normal activity
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Supraventricular tachycardia, White blood cell count increased
Clinical narrative: Patient was admitted  3/19 with 3 days of fever and determined to have atypical Kawasaki disease and received one dose of IVIG on 3/21. He developed SVT on 3/20 that did not break with adenosine. He was then transferred to the CICU for esmolol therapy.  His SVT broke and he was transitioned to propanolol without recurrence of SVT. He had 2 normal echocardiograms, no evidence of coronary dilation. He has tolerated high dose aspirin initiation with GI prophylaxis without event. He has returned to normal activity
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea chills headache
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt had requested shingrix vaccine in which came with 2 vials to be combined. Pt was given on diluent not the medication together. Pt was contacted and regiven vaccine correctly.  Advised pt to return for 2nd dose of vaccine.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Joint range of motion decreased, Pain
Clinical narrative: Patient reported being sweaty, chills, extreme pain "throbbing" pain. She stated she just wanted to lay down, had limited range of motion and went to ER for treatment.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was administered his 2nd dose of shingrix vaccine in the left arm. Within about 1 minute he began to feel light headed. I advised patient to stay in the chair and I got patient some water to see if that would help him. Before he could open the water he stopped talking and began to lean forward. I held patient to prevent him from falling to the ground. I shouted for my technician to call a code white to pharmacy. Patient fainted and was unconscious for about 30 seconds. When patient regained consciousness we had him eat some grapes to get his sugar up and had him drink more water. He then ate a little  peanut butter and jelly cracker. I stayed with patient for 1 hour until he started feeling better. Patient left pharmacy on his on will at about 2 pm on 5/14/2020. The whole incident lasted a little over 1 hour. Patient left pharmacy and went straight home. He reported being fine and said he was going to eat some food. I informed him I would follow up with him later on 5/14/2020. I contacted patient again at 6:15pm on 5/14/2020 and he said he was completely fine and thanked me for checking in with him.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Injection site pain
Clinical narrative: Patient's left arm started hurting on ~12/22/2019.  Constant sharp pain traveling back and forth from injection site down to elbow.  Pain lasted about 6 weeks.  About 4-6 weeks after the injection, patient noticed she was losing grip strength in left hand.  Patient visited an acupuncturist 4 times in February 2020, with no improvement in grip strength.  Patient contacted primary care physician, on or about 03/18/2020, whose office referred patient back to the Pharmacy where vaccine was administered.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acupuncture, Arthralgia, Grip strength decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient's left arm started hurting on ~12/22/2019.  Constant sharp pain traveling back and forth from injection site down to elbow.  Pain lasted about 6 weeks.  About 4-6 weeks after the injection, patient noticed she was losing grip strength in left hand.  Patient visited an acupuncturist 4 times in February 2020, with no improvement in grip strength.  Patient contacted primary care physician, on or about 03/18/2020, whose office referred patient back to the Pharmacy where vaccine was administered.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient's left arm started hurting on ~12/22/2019.  Constant sharp pain traveling back and forth from injection site down to elbow.  Pain lasted about 6 weeks.  About 4-6 weeks after the injection, patient noticed she was losing grip strength in left hand.  Patient visited an acupuncturist 4 times in February 2020, with no improvement in grip strength.  Patient contacted primary care physician, on or about 03/18/2020, whose office referred patient back to the Pharmacy where vaccine was administered.
Sex: F
Vaccine: MMR, MMR, UNK
Symptoms: Antibody test negative, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: an unspecified physician "drew titers" and the results came back "negative and she did not have any titers"; injection site reaction; bruising; itching; erythema; injection site hurts when I rub up against it; This spontaneous report was received from a 56-year-old female patient who was also a pharmacist, referring to herself. The patient's concurrent condition included 30-40 pounds overweight. She did not have any drug reactions/allergies (reported as none). Concomitant medications included a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, route, lot # and expiration date were not provided), as prophylaxis on the opposite arm (on 27-APR-2020).  On an unspecified date in 2007 (reported as "13 years ago"), she was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (manufacturer unknown) (reported as unspecified MMR vaccine). Then, on an unknown date, an unspecified physician "drew titers" and the results came back "negative and she did not have any titers" (antibody test negative).  On 27-APR-2020, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) rHA (M-M-R II) (dosage regimen was not provided), administered subcutaneously (SC) as prophylaxis (reported as "vaccine"), lot # S020161 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live and expiration date as 30-JUN-2021; Other suspect therapies included: sterile diluent (MERCK STERILE DILUENT) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient had injection site reaction which was 5 inches length and more than 2 inches width with erythema (injection site erythema), bruising (injection site bruising) and inching (injection site pruritus) in the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) site arm vaccination; also, her injection site hurts when she rub up against it (injection site pain). However, she did not have any injection site reaction on the opposite arm. No treatment was given for the events, and the patient did no sought medical attention. The outcome of antibody test negative was unknown. The outcome of the events of injection site reaction, injection site pain, injection site erythema, injection site pruritus and injection site bruising was reported as not recovered.  The causal relationship between all reported events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for antibody test negative was not related and for the reaming events was unknown. The causal relationship between measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live  (manufacturer unknown) for antibody test negative was unknown and for the remaining events was not related.
Sex: F
Vaccine: MMR, MMR, UNK
Symptoms: Injection site reaction
Clinical narrative: an unspecified physician "drew titers" and the results came back "negative and she did not have any titers"; injection site reaction; bruising; itching; erythema; injection site hurts when I rub up against it; This spontaneous report was received from a 56-year-old female patient who was also a pharmacist, referring to herself. The patient's concurrent condition included 30-40 pounds overweight. She did not have any drug reactions/allergies (reported as none). Concomitant medications included a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, route, lot # and expiration date were not provided), as prophylaxis on the opposite arm (on 27-APR-2020).  On an unspecified date in 2007 (reported as "13 years ago"), she was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (manufacturer unknown) (reported as unspecified MMR vaccine). Then, on an unknown date, an unspecified physician "drew titers" and the results came back "negative and she did not have any titers" (antibody test negative).  On 27-APR-2020, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) rHA (M-M-R II) (dosage regimen was not provided), administered subcutaneously (SC) as prophylaxis (reported as "vaccine"), lot # S020161 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live and expiration date as 30-JUN-2021; Other suspect therapies included: sterile diluent (MERCK STERILE DILUENT) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient had injection site reaction which was 5 inches length and more than 2 inches width with erythema (injection site erythema), bruising (injection site bruising) and inching (injection site pruritus) in the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) site arm vaccination; also, her injection site hurts when she rub up against it (injection site pain). However, she did not have any injection site reaction on the opposite arm. No treatment was given for the events, and the patient did no sought medical attention. The outcome of antibody test negative was unknown. The outcome of the events of injection site reaction, injection site pain, injection site erythema, injection site pruritus and injection site bruising was reported as not recovered.  The causal relationship between all reported events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for antibody test negative was not related and for the reaming events was unknown. The causal relationship between measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live  (manufacturer unknown) for antibody test negative was unknown and for the remaining events was not related.
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to patient's inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 10-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 14-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 13-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 15-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 20-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536: US-009507513-2005USA003382:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 2-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536: