chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lip swelling, Oral pruritus
Clinical narrative: Patient reports 2 hours after the vaccine was administered experiencing redness in her face which lasted about 2 hours. She also experiences swelling of her lips and itchy sensation in the roof of her mouth, both of these symptoms lasted about 2 days. All symptoms eventually resolved without long term damage.
Age: 76.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: fever, nausea
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: "Quadrivalent" flu vaccine administered in office on Thursday at 10 am, no details given of manufacturer or trade name.  Fairly severe muscular ache on left flank started in early evening of the day of the vaccination (Thursday).  Continued into Friday, Saturday and Sunday. On Monday morning (today) it was more of a sharp pain than an ache in the left flank.  Took two advil and the pain vanished.  Don't know how I will be tomorrow morning, so I said 'Unknown' to question about recovery below
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS, FLU4, PPV, TDAP, VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Patient stated that between 7-730pm (about 5 hours after injection)  his right arm became very painful with a severe muscle pain that he described as a "torn rotator cuff" pain and a numbness in his two middle fingers that came off and on afterwards. He took his Tylenol and morphine as prescribed for pre-existing conditions and the pain did not subside. He still had pain existing pain on 9/7/20 in the AM.
Age: 75.0
Sex: M
Vaccine: TDAP, VARZOS, FLU4, PPV, TDAP, VARZOS
Symptoms: Arthralgia
Clinical narrative: Patient stated that between 7-730pm (about 5 hours after injection)  his right arm became very painful with a severe muscle pain that he described as a "torn rotator cuff" pain and a numbness in his two middle fingers that came off and on afterwards. He took his Tylenol and morphine as prescribed for pre-existing conditions and the pain did not subside. He still had pain existing pain on 9/7/20 in the AM.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: fever of 104, chest congestion, sore throat started 1 day after getting flu shot
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness postural, Gait disturbance, Myalgia
Clinical narrative: Approximately 5 hours after receiving the shot I became extremely dizzy when I tried to stand.  The was able to stand, but could not maintain my balance or walk in a straight line.  The dizziness subsided persisted throughout the night.  By morning (16 hours after the shot) the dizziness had resolved.  Over the next two days I had mild muscle pain, continuing to the present (48 hours after the shot).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Pain
Clinical narrative: Chills, body aches, lethargy, ache at injection site
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Injection site induration, Injection site swelling, Pain
Clinical narrative: The patient had joint pain ,body ache ,headache,swelling at the injection site and around it and it felt like a rock at the injection site. he said that he never had these adverse events before and that was the first time he is experiencing these side effects. he forgot to tell the pharmacist that he got a flu shot back in January 2020
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dyspnoea, Headache, Pyrexia
Clinical narrative: 3 or 4 hour after get the Vaccine, i couldn't breath. and continue with light fever and headache. i took acetaminophen 500mg to reduce the fever and got sleep. the next morning i woke up with diarrhea... i eat plan yogurt to make it stop.  diarrhea stop, but during this 2 days got so much bad headache. i take Tylenol, but it just cover for few hour and the pain comeback.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Muscle discomfort
Clinical narrative: Headache, muscle aches, joint aches, chills/shivering, fever.  I took acetaminophen at midnight, woke up an hour or so later and the chills/shivering were gone but the rest of it stayed for 24hrs.  After that it was mostly soreness at the injection site and some muscle/joint discomfort.  The headache was gone thankfully as was the chills/fever.  The pharmacist fully prepared me for the possibility of the side effects so I was prepared.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal discomfort, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, joint aches, chills/shivering, fever.  I took acetaminophen at midnight, woke up an hour or so later and the chills/shivering were gone but the rest of it stayed for 24hrs.  After that it was mostly soreness at the injection site and some muscle/joint discomfort.  The headache was gone thankfully as was the chills/fever.  The pharmacist fully prepared me for the possibility of the side effects so I was prepared.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AT INJECTION SITE, FEEL WARM AND RAISED AT LEFT UPPER ARM. IT GOT BETTER ON 09/07/2020. DR PRESCRIBED DOXYCYCLINE FOR THE PATIENT BUT PATIENT DIDN'T WANT TO TAKE IT.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site irritation, Injection site pain, Injection site vesicles, Pain in extremity
Clinical narrative: The patient received a Shingrix vaccination in the morning of 9/6/20. The reaction started the evening of 9/6/20. The patient had irritation and pain at the injection site.  The patient applied at warm compress to the area. The pain continued through the night and the patient woke up with blisters at the injection site and pain in his arm.  The patient went to an urgent care and received antibiotics just in case he developed an infection.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site pain, Pain, Pain in extremity
Clinical narrative: PATIENT ARM IS BRUISED ALL AROUND HIS BICEP. HE HAS STABBING PAIN AT THE INJECTION SITE. ACHING PAIN ALL THE WAY DOWN HIS ARM. CANNOT RAISE HIS ARM ABOVE HIS SHOULDER WITHOUT BEING IN SEVERE PAIN.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Paraesthesia
Clinical narrative: Patient called with tingling of the left side of face and left ear.
Age: 1.5
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: On 9/2/20, 1 week after receiving his immunizations, patient developed a vesicle at the site of immunization on his right thigh and over the next 24 hours developed several more vesicles adjacent to the immunization site.  On 9/3/20,   He also developed fever to 102.8 on 9/3/20.  His fever was 101 at home on 9/4/20.   Patient seen in the office on 9/4/2020 and vesicles had "dried up."
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Constipation, Crying, Grunting, Moaning, Pain
Clinical narrative: 30 hours post vaccine: excessive crying for over 3 hours, refusal to nurse or be calmed in any way. In the months following the vaccine appointment, patient experienced constipation issues which had never occurred before. During nursing sessions, he would grunt and groan and pull his knees to his chest. He would not nurse well. There were times when he would not have a bowel movement for 5 days. He was clearly in pain. Before the vaccinations, he had multiple bowel movements each day.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Poor feeding infant, Posture abnormal
Clinical narrative: 30 hours post vaccine: excessive crying for over 3 hours, refusal to nurse or be calmed in any way. In the months following the vaccine appointment, patient experienced constipation issues which had never occurred before. During nursing sessions, he would grunt and groan and pull his knees to his chest. He would not nurse well. There were times when he would not have a bowel movement for 5 days. He was clearly in pain. Before the vaccinations, he had multiple bowel movements each day.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Constipation, Crying, Poor feeding infant
Clinical narrative: 5 hours post vaccination: excessive crying for an 1 1/2. No way to soothe him. More constipation issues and refusal to nurse. This would continue for another month until we had to give up on breastfeeding altogether. The mother changed her diet and tried a variety of things to fix the issue, but was unsuccessful. The constipation was better about a month after the vaccination.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Irritability, Sleep disorder, Urticaria
Clinical narrative: Red welt on back of arm about the size of a nickel for 3 days, fussy, difficulty sleeping.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Balance disorder, Crying, Decreased appetite, Decreased eye contact, Fatigue
Clinical narrative: 1 day post vaccinations: Fever started and lasted for 4 days intermittently. Patient was overly tired, loss of appetite, fussy, clingy, drowsy (eyes glazed throughout the day) and off balance.  Approximately 10 days post nap: Patient woke up crying from his nap. When I went to get him out of his crib, he was not moving and just stared into space and would not move or make eye contact with me. It took about 5 mins to get him to move and respond. This had never occurred before and was extremely concerning.
Age: 1.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Movement disorder, Pyrexia, Somnolence, Staring
Clinical narrative: 1 day post vaccinations: Fever started and lasted for 4 days intermittently. Patient was overly tired, loss of appetite, fussy, clingy, drowsy (eyes glazed throughout the day) and off balance.  Approximately 10 days post nap: Patient woke up crying from his nap. When I went to get him out of his crib, he was not moving and just stared into space and would not move or make eye contact with me. It took about 5 mins to get him to move and respond. This had never occurred before and was extremely concerning.
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Blood test normal, Computerised tomogram normal, Cyanosis, Electroencephalogram normal, Gaze palsy
Clinical narrative: My baby woke up having a seizure at 7:20 AM. She was sweating, she was blue and shaking with her hands by her face. Her eyes were rolling and I had to turn her on her side to calm her down. I then drove her to the ER. Spent two the first two days in the ICU. My baby had two more seizures when we arrived in the ER.
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Hyperhidrosis, Intensive care, Lumbar puncture normal, Magnetic resonance imaging normal, Seizure
Clinical narrative: My baby woke up having a seizure at 7:20 AM. She was sweating, she was blue and shaking with her hands by her face. Her eyes were rolling and I had to turn her on her side to calm her down. I then drove her to the ER. Spent two the first two days in the ICU. My baby had two more seizures when we arrived in the ER.
Age: 0.42
Sex: F
Vaccine: IPV, PNC13
Symptoms: Tremor
Clinical narrative: My baby woke up having a seizure at 7:20 AM. She was sweating, she was blue and shaking with her hands by her face. Her eyes were rolling and I had to turn her on her side to calm her down. I then drove her to the ER. Spent two the first two days in the ICU. My baby had two more seizures when we arrived in the ER.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left Deltoid swollen, warm to touch and appears red below injection site. Patient unable to move affected arm
Age: 67.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Vaccine administered 9/4/20 - the following day patient had low grade fever 99.9 & Red, sore arm, body aches for 2 days.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes in left arm per patient
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash Hives patient prescribed Hydrocortisone 2.5% cream Prednisone 10mg, Hydroxyzine 25g and Famotidine 20g on 9/7/2020
Age: 18.0
Sex: M
Vaccine: HPV4, HPV9, MMR, MNQ, TDAP
Symptoms: Body temperature abnormal, Rash erythematous
Clinical narrative: Temp 99.6-100.6 for approx. 24 hrs; Flat red rash to upper arms/shoulders for 48hrs; This spontaneous report as received from a health care professional via the agency under the freedom of information act and refers to a male patient of unknown age.    On 29-JUN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 3, intramuscular in the right arm for prophylaxis.  Other suspect therapies included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid(ADACEL), meningococcal acyw conj vaccine (crm197) (MENVEO), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). Concomitant therapies included fluoxetine (FLUOXETINE), clonidine (CLONIDINE), lamotrigine (LAMICTAL), levomefolate calcium (DEPLIN) and melatonin (MELATONIN).   On 10-JUL-2019, 12 days after onset of therapy the patient experienced body temperature abnormal and rash erythematous.    The outcome of body temperature abnormal and rash erythematous was reported as recovered/resolved.   The Agency did not assess the relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned events.   Reporter reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) with lot # N026814 which was not valid for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). However, lot# N026814 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Follow-up information has been received health care professional on 03-SEP-2020. The nurse stated she would mail the completed form. No additional information was obtained during this call.
Age: 68.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Bad headache; Stomach pain; Nausea; This case was reported by a consumer and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 2nd dose of Shingrix. On 19th August 2020, 1 days after receiving Shingrix, the patient experienced fever, stomach pain, nausea, chills and headache. On an unknown date, the outcome of the fever, chills and headache were not recovered/not resolved and the outcome of the stomach pain and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, stomach pain, nausea, chills and headache to be related to Shingrix.  Additional details were reported as follows: The patient received second dose of Shingrix and following day experienced fever, stomach pain, nausea, chills and bad headache and lasted 36 hours. Last night from the day of reporting the patient experienced exact same thing after a week of felt fine. The patient asked was this normal. At the time of reporting the patient had chilled, headache and fever.
Age: 68.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Bad headache; Stomach pain; Nausea; This case was reported by a consumer and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 2nd dose of Shingrix. On 19th August 2020, 1 days after receiving Shingrix, the patient experienced fever, stomach pain, nausea, chills and headache. On an unknown date, the outcome of the fever, chills and headache were not recovered/not resolved and the outcome of the stomach pain and nausea were recovered/resolved.   It was unknown if the reporter considered the fever, stomach pain, nausea, chills and headache to be related to Shingrix.  Additional details were reported as follows: The patient received second dose of Shingrix and following day experienced fever, stomach pain, nausea, chills and bad headache and lasted 36 hours. Last night from the day of reporting the patient experienced exact same thing after a week of felt fine. The patient asked was this normal. At the time of reporting the patient had chilled, headache and fever.
Age: 8.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: off label use of GARDASIL; patient was administered GARDASIL (4 valent) for 3 doses prior to the age of 9; This spontaneous report was received from a physician who was reporting on 8-year-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 23-SEP-2013, 03-DEC-2013 and 07-APR-2014, the patient was vaccinated with three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route of administration, anatomical location, strength lot number and expiration date were not provided), prior to the age of 9 years, for prophylaxis. On 24-JUL-2019, she was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, strength lot number and expiration date were not provided) also for prophylaxis. It was reported that the use of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) on 29-SEP-2013, was off-label.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination site pain
Clinical narrative: the vaccine burned and hurt; This spontaneous report has received from a physician's assistant via a company employee, referring to herself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On unknown dates in approximately August 2011 (reported as 9 years ago), the patient was vaccinated her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) boosters (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date in approximately August 2011 (reported upon each administration as well as for a few days afterwards), the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine burned and hurt. The reaction would resolve within a few days without treatment.      The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was considered as related.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 8 weeks patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 29-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1660704, expiration date 20-MAR-2021, dose and route of administration were not reported) for prophylaxis. On 13-AUG-2020, the patient was also administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine (lot # 1660946) was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine (lot # 1660946) was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2009USA002369: US-009507513-2009USA002370:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: Caller reported an improperly stored and administered GARDASIL 9.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, route, frequency, and anatomical location were unknown) with   lot # 1637642, and expiration date on 28-MAY-2022 for prophylaxis.  The administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced the temperature excursion of 2°C to 8°C (8.4°C)  Celsius degrees for 34 hours and 41 minutes, above 9°C (10.5°C) Celsius degrees for 6 hours. There was a digital data logger invloved, but there was no previous temperature excursion.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; the patient was administered improperly stored Varivax; This spontaneous report was received from a nurse and refers to a 17-month-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2020, the patient was subcutaneously vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032352, expiration date: 14-OCT-2021 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 2 hours and 30 minutes in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit (10.9 F) on an unknown date prior to administration. There was no previous temperature excursion. Digital Data Logger was involved.  No additional adverse effect was reported.  The outcome of medication error was unknown.
Sex: F
Vaccine: HPV4
Symptoms: Polymenorrhoea
Clinical narrative: had a decrease of her menstrual cycle from 7 days to 2 days; This spontaneous report was received from a physician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 24-FEB-2011, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot # reported as 15602 was evaluated and changed to the valid lot # 1560Z, expiration date not reported, upon internal validation established as 28-APR-2013, route reported as injection; strength and dose were not reported) for prophylaxis.    On 08-MAR-2019, the patient had a decrease of her menstrual cycle from 7 days to 2 days. The outcome of the event was not recovered. The causality assessment was not reported. combinationproductreport: Yes; brandname: GARDASIL SYRINGE (DEVICE); commondevicename: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1560Z; expirationdate: 28-APR-2013; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 01-JUL-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011564: US-009507513-2008USA013131: US-009507513-2009USA002369: US-009507513-2009USA002370:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 22-JUL-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(dose 2 ml, lot # 1660946, expiration date 10-APR-2021; exact dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to temperature excursions of 9.6 degree Celsius (C) for 2 hours and 1 minute. It was reported the vaccine was previously exposed to temperature excursions of 10.5 C for 40 hours and 5 minutes on 04-JUN-2020. A "data logger" was involved. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011564: US-009507513-2008USA013130: US-009507513-2009USA002369: US-009507513-2009USA002370:
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Antibody test negative, Measles antibody negative, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PROQUAD given to patient that is 18 years old in error; PROQUAD given to patient that is 18 years old in error; Customer reports titers done on patient resulted immune to rubella and mumps and not immune to varicella and measles.; Customer reports titers done on patient resulted immune to rubella and mumps and not immune to varicella and measles.; This spontaneous report was received from a nurse, and refers to a 18 years old patient of unknown gender.  The patient's concurrent conditions, medical history, and drug reaction or allergies were not reported.   On 26-AUG-2020, the patient was vaccinated in error (product administered to patient of inappropriate age) with Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (lot # T010288 and expiration date 20-SEP-2021) with its sterile diluent (lot # S038151 and expiration date 02-AUG-2022), (dose and route of administration not provided) as prophylaxis. It was reported that the titers done on the patient resulted immune to rubella and mumps, but not immune to varicella and measles. The nurse wanted to know if the patient needed to be revaccinated with age appropriate vaccines. The outcome of Varicella virus test negative and Measles antibody negative was not provided.   The causal relationship of Varicella virus test negative and Measles antibody negative to Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) was not reported.
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Polymerase chain reaction positive, Product administered to patient of inappropriate age, Pyrexia, Rash
Clinical narrative: Vaccine induced rash; One infant younger than 12 months;  Information has been received from author concerning to one infant younger than 12 months that had been exposed to measles in authors pediatric emergency department (ED), resulting in his receipt of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, lot number and expiration date not reported) in accordance with protocol 3 days after exposure. He returned to the pediatric ED on 2 occasions thereafter for fever and febrile seizure, and during his second visit developed a rash. This was 12 days after his original exposure, a timeline that would be consistent with contracting measles. This initiated a full postexposure investigation of 80 children who were considered at risk of measles exposure during either of his 2 visits. Ultimately, through polymerase chain reaction sequencing, he was determined to have vaccine-induced rash, a reaction that occurs in approximately 5% of individuals immunized. The sequencing results were not available until after the exposure investigation was completed. The time for sequencing in the vaccine-associated rash was 8 days, and in this time frame, critical decisions on prophylaxis needed to be made regarding suspected measles exposure. The patient's outcome was not reported.  This report is linked to case US-009507513-2009USA001403 from the same literature article.
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Vaccine induced rash; One infant younger than 12 months;  Information has been received from author concerning to one infant younger than 12 months that had been exposed to measles in authors pediatric emergency department (ED), resulting in his receipt of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, lot number and expiration date not reported) in accordance with protocol 3 days after exposure. He returned to the pediatric ED on 2 occasions thereafter for fever and febrile seizure, and during his second visit developed a rash. This was 12 days after his original exposure, a timeline that would be consistent with contracting measles. This initiated a full postexposure investigation of 80 children who were considered at risk of measles exposure during either of his 2 visits. Ultimately, through polymerase chain reaction sequencing, he was determined to have vaccine-induced rash, a reaction that occurs in approximately 5% of individuals immunized. The sequencing results were not available until after the exposure investigation was completed. The time for sequencing in the vaccine-associated rash was 8 days, and in this time frame, critical decisions on prophylaxis needed to be made regarding suspected measles exposure. The patient's outcome was not reported.  This report is linked to case US-009507513-2009USA001403 from the same literature article.
Sex: U
Vaccine: HIBV, HPV9, HPV9, PPV, RV5
Symptoms: Product storage error
Clinical narrative: unaware if any of the products with temperature excursion were administered; unaware if any of the products with temperature excursion were administered; This non-valid spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  Since 19-JUN-2020, patients might be vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R032768 (expiring on 31-AUG-2021) and lot # R024272 (expiring on 28-MAY-2021), or, pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T009743 (expiring on 27-JAN-2022), or, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660693 (expiring on 19-MAR-2021), or, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S008730 (expiring on 23-JAN-2022).  For all the vaccines, indication was prophylaxis, dose, route and site of administration were not reported.  The administered doses of the vaccines experienced a temperature excursion above 47°F for 23 hours and 45 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  The medical assistant was unaware if any of the products involved were administered.  This case was considered non-valid due to lack of individual patients' identifiers.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion for vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nurse assistant referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown day in August 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038698, expiration date 01-DEC-2021, 1 dose for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported). It was reported that on 11-AUG-2020 temperature excursion occurred for vaccines that were administered to patients after the excursion occurred (product storage error). The temperature was -10.2 degrees Celsius (C) with a time frame of 1 hour and 53 minutes; there was no previous temperature excursion, and a digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014798: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A nursing assistant reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, which has been verified to valid, expiration date reported and validated as 23-JAN-2022) as prophylaxis, that experienced a temperature excursion (product storage error). The administered dose of the vaccine was stored temperature of -10.2 degrees Celsius, for 1 hour and 53 minutes, as recorded by a data logger. No previous temperature excursion was reported.  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014951: US-009507513-2008USA014950: US-009507513-2008USA014803:AE case # 01697210 US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014888: US-009507513-2008USA014936: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion that was intermittent invoving VARIVAX states that there have been administered doses; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number S032357, expiration date 14-OCT-2021, and lot number T002843, expiration date 23-JAN-2022, 0.5 milliliter for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion that was intermittent beginning on 28-JUL-2020 (onset date also reported as 12-AUG-20202) of -14 degrees Celsius to -10 degrees Celsius (max -9.5 C) for a total of 38 hours and 30 minutes, as recorded by a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014701: US-009507513-2008USA014711: US-009507513-2008USA014788:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion that was intermittent beginning 28-JUL-2020 / there have been administered doses; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 20-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) human recombinant albumin (rHA) (route of administration not reported), lot # T009929 and expiration date 16-SEP-2021, administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion from -14 to -10 degree Celsius (°C) maximum -9.5°C for a total of 38 hours and 30 minutes beginning on 28-JUL-2020; no previous temperature excursion were reported.  The call was made due to a digital data logger.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014689: US-009507513-2008USA014694: US-009507513-2008USA014701: US-009507513-2008USA014711: US-009507513-2008USA014749: US-009507513-2008USA014777: US-009507513-2008USA014788: US-009507513-2008USA014790: US-009507513-2008USA014792: US-009507513-2008USA014795: US-009507513-2008USA014797: US-009507513-2008USA014811: US-009507513-2008USA014817: US-009507513-2008USA014843: US-009507513-2008USA014853: US-009507513-2008USA014856: US-009507513-2008USA014858: US-009507513-2008USA014861: US-009507513-2008USA014867: US-009507513-2008USA014877: US-009507513-2008USA014881: US-009507513-2008USA014883: US-009507513-2008USA014886: US-009507513-2008USA014889: US-009507513-2008USA014898: US-009507513-2008USA014914: US-009507513-2008USA014934: US-009507513-2008USA014947: US-009507513-2009USA000057:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: inappropriately stored vaccine administered; This spontaneous report was received from a register nurse and refers to patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   Since 28-JUL-2020, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen, route of administration, lot# and expiration date were not provided); and varicella virus vaccine live (oka/merck)(VARIVAX) (dosage regimen and route of administration were not reported) lot # T002843, expiration date 23-JAN-2022; and lot # S032357, expiration date 14-OCT-2021, experienced intermittent temperature excursion, but was not previously reported.  Then, on 14-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (dosage regimen and route of administration were not reported) lot # T002843, expiration date 23-JAN-2022, as prophylaxis (product storage error). Nonetheless, it was not reported if the improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S032357, expiration date 14-OCT-2021) were administered.  The improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T002843, expiration date 23-JAN-2022; and lot # S032357, expiration date 14-OCT-2021) experienced a temperature of -14 degrees Celsius (°C) to -10°C (average maximus temperature was -9.5°C) for 38 hours and 30 minutes. No previous temperature excursion was reported. The call was made due to a digital data logger.; Sender's Comments:  US-009507513-2008USA014711: US-009507513-2008USA014701:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Reported temperature excursion under case #01697141 for vaccines that were administered to patients after excursion ocurred; This spontaneous report was received from a nursing assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, drug reactions/allergies, medical history and historical drugs was not provided.  On 21-AUG-2020, the patient was vaccinated with 1 improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S038698 and expiration date 01-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.2 degree Celsius (°C) for 1 hour and 53 minutes on an unknown date; no previous temperature excursion were reported.  The excursion was called by a digital data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014798:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving V ARIV AX states that there have been administered doses.; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843, expiration date on 23-JAN-2022 or lot # S032357, expiration date on 14-OCT-2021 (anatomical location was not reported) for prophylaxis.  It was reported that the temperature excursion that was intermittent beginning 28-JUL-2020, but not previously reported. The vaccine had a temperature excursions of -14 Celsius (C) to -10 C (max. -9.5 C) without previous temperature excursions. Time frame: total 38 hours and 30 minutes. It was confirmed that a digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A nursing assistant reported temperature excursion for vaccines that were administered to patients after excursion occurred.; This spontaneous report was received from a nursing assistant and refers to a patient of unknown age and gender.    On 21-AUG-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002846 with expiration date of 23-JAN-2022, for prophylaxis (route of administration was not reported), the vaccine was under temperature excursion, temperature -10.2C, time frame 1 hour and 53 minutes, with no previous temperature excursion. The call was because of a "data logger".         This is one of several reports received from the same source. ; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.    It was reported that temperature excursion that was intermittent beginning 28-JUL-2020, but not previously reported, involving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  On 20-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T009929 with expiration date of 16-SEP-2021, for prophylaxis (route of administration was not reported).        It was stated that the vaccines underwent a temperature excursion of -14°C (degrees Celsius) to 10°C (max -9.5C), total 38 hours and 30 minutes. No previous temperature excursion was done. The call was because of a "data logger".
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion involving Varivax, states there have been administered doses; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.       On 28-JUL-2020, the varicella virus vaccine live VARIVAX began experiencing intermittent temperature excursion.  On 17-AUG-2020, the patient was vaccinated with varicella virus vaccine live VARIVAX 0.5 ml, Lot # T002843, expiration date 23-JAN-2022, For prophylaxis (Frequency and patient route of administration were not reported). The storage temperature reported was between -14°C to -10°C, being the maximum temperature at -9..5 °C for a period of 38 hours and 30 minutes.     There was digital data logger involved and  no previous temperature excursion was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccine administered after excursion ocurred; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX) lot # S038698, expiration date 01-DEC-2021 for prophylaxis  (strength, dose, frequency, and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -10.2 degree Celsius (°C) for 1 hour and 53 minutes with no previous temperature excursion.  The call was made due to a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014806: US-009507513-2008USA014825: US-009507513-2008USA015018: US-009507513-2008USA015035: US-009507513-2009USA000117: