chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Minor shivering; Muscle pain; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020 10:00, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced shivering and muscle pain. On an unknown date, the outcome of the shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced shivering and muscle pain. Till the time of reporting (8PM) small traces of the side effects.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site vesicles, Local reaction
Clinical narrative: spoke  to MD 2 d ago re: local reaction at site of varivax: quarter sized minimally tender/ minimally red: assumed "local reaction"; today mom called e "one" teenyvesical at site: allow "nontransmissible"..will attempt to confirm and respond accordingly.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site reaction
Clinical narrative: progressive weakness in her left shoulder without improvement.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain in extremity, Visual impairment
Clinical narrative: Patient stated that approximately 1.5 hours after the Shingrix injection, she had severe right arm pain, she felt dizzy, broke out in a sweat, and couldn't see clearly "everything went pale". Vitals were stable, She was shivering in clinic.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash, Swelling
Clinical narrative: Swelling/redness around injection site occurred same day of vaccine. Patient was seen at an urgent care later that day and was diagnosed with possible allergic reaction/cellulitis and was prescribed an antibiotic. Was seen at our clinic by me 3 days later and rash/swelling had mostly resolved/just faint rash remained/no swelling or tenderness remained.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reported that the day after the injection ,(3/26) the injection site was sore and a little red. 3/27 the injection site was profusely red when pt reported to the pharmacy said that it was painful and it felt warm to the touch.  I observed a medium to large size red area on the lower part of the bicep of the left arm.  Pt said that the injection site was there on lower part of the bicep almost below the tricep.  I asked again if this is where the injection was place and she confirmed this.  Speculate that this is an old tb testing site and undetermined if the site of injection was not into the upper deltoid, have not confirmed with the immunizing pharmacist.
Age: 23.0
Sex: M
Vaccine: UNK, UNK, YF
Symptoms: Apnoea, Blood test normal, Generalised tonic-clonic seizure, Incontinence, Magnetic resonance imaging
Clinical narrative: Suffered a grand mal seizure, that lasted roughly 2 minutes. Quit breathing for a length of time and became incontinent.  Then I fell into a deep sleep for 10-15 minutes and was awoken by paramedics. As a result of the seizure my vision in my right eye became blurry.
Age: 23.0
Sex: M
Vaccine: UNK, UNK, YF
Symptoms: Ophthalmological examination normal, Vision blurred
Clinical narrative: Suffered a grand mal seizure, that lasted roughly 2 minutes. Quit breathing for a length of time and became incontinent.  Then I fell into a deep sleep for 10-15 minutes and was awoken by paramedics. As a result of the seizure my vision in my right eye became blurry.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Cardiac function test normal, Computerised tomogram head normal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: employee reports hives left upper arm started on 3/25/20 at 09:00 and numbness to fingertips next day numbness progress to whole arm including upper shoulder blade.  Employee went to her PCP and was prescribed prednisone 10mg.  In the evening of 3/25/20, employee reports left leg numbness and left neck area numb as well.  Employee reports that her husband notice change in behavior and speech.  This resolved in 45 minutes and refused to go to ED.  On 3/26/20 numbness presented to left check, jaw, left eye, and left side of tongue.  At this time, Employee decided to ED.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Speech disorder, Urticaria
Clinical narrative: employee reports hives left upper arm started on 3/25/20 at 09:00 and numbness to fingertips next day numbness progress to whole arm including upper shoulder blade.  Employee went to her PCP and was prescribed prednisone 10mg.  In the evening of 3/25/20, employee reports left leg numbness and left neck area numb as well.  Employee reports that her husband notice change in behavior and speech.  This resolved in 45 minutes and refused to go to ED.  On 3/26/20 numbness presented to left check, jaw, left eye, and left side of tongue.  At this time, Employee decided to ED.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash papular
Clinical narrative: The patient called me on the phone and wanted to report a rash that had recently developed on her arm around the area where she received a Shingrix vaccine a couple weeks prior. The patient  reported a non-painful, non-irritable rash that went from the area of injection down to her elbow and slightly wrapped around her arm. She stated that the first night it appeared that the rash was slightly raised but it has since gone down and is no longer raised. She stated that she has not recently changed any of her at-home routines including lotions or other topical products. I counseled her that the rash may be going away on its own, but if it were to grow in size, become worse, or start becoming painful/irritable that she should seek medical aid from her doctor.
Sex: F
Vaccine: HEP, HEP
Symptoms: Apgar score normal, Aphasia, Apnoea, Autism spectrum disorder, Cyanosis
Clinical narrative: Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life
Sex: F
Vaccine: HEP, HEP
Symptoms: Delayed myelination, Disability, Epilepsy, Feeding tube user, Gastric disorder
Clinical narrative: Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life
Sex: F
Vaccine: HEP, HEP
Symptoms: Intensive care, Intraventricular haemorrhage, Musculoskeletal stiffness, Nervous system disorder, Respiratory arrest
Clinical narrative: Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life
Sex: F
Vaccine: HEP, HEP
Symptoms: Seizure, Selective eating disorder, Speech disorder developmental, Tremor, Vomiting
Clinical narrative: Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life
Sex: F
Vaccine: HEP, HEP
Symptoms: Wheelchair user
Clinical narrative: Patient had 9 apgar score,  after first weight check away from mom and bandaids on legs, she stopped eating well.  turned purple, shook with convulsions, stopped breathing a couple minutes at a time, vomit, acquired a stiff muscle tone.  episodes worsened april 6, discovered she was administered a second hep b according to digital medical records.  She was put into NICU on this day.  Nurse warned to keep a suction bulb nearby to help her breathe to "prevent a bad outcome".  Patient remains in a stiff posture for the rest of her life until this day.  Left ventricle hemorrhage was discovered at 3 mths old, the side of her brain that seizures where begin.  Her convulsions were eventually diagnosed as epilepsy ,   she had multiple apnea events the first 3 months of life requiring 911 serivices and emergency room visits.   She failed to develop myelin  at a proper rate, and suffered a global loss of white matter at 4 years old.  Speech was delayed , and eventually lost after a severe seizure at 20 months old..  Autism level 3, wheelchair dependent, nonverbal, feeding tube dependent .  Feeding difficulties never improved, stomach is paralyzed,   she is disabled for life
Age: 56.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Epstein-Barr virus antibody positive, Epstein-Barr virus test negative, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: markedly enlarged supraclavicular and cervical and posterior cervical lymph nodes
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Insomnia, Irritability, Pyrexia, Rash morbilliform, Rash pruritic
Clinical narrative: Patient experienced  measles-like, pruritic rash on head, chest, and back with fever (TMAX 100.5F) lasting for several days, this started 9 days following vaccination.  Other symptoms included coryza, difficulty sleeping, fussiness.  Pt had phone consult during COVID19 with provider.  At that time we took a watch and wait approach with conservative, comfort management: hydration, rest, antipyretics prn.  Pt used oatmeal baths, castor oil, and essential oils to help soothe rash.  Pt made full recovery with in a week.  Duration of symptoms was about 5-7 days from onset to resolution.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rhinitis
Clinical narrative: Patient experienced  measles-like, pruritic rash on head, chest, and back with fever (TMAX 100.5F) lasting for several days, this started 9 days following vaccination.  Other symptoms included coryza, difficulty sleeping, fussiness.  Pt had phone consult during COVID19 with provider.  At that time we took a watch and wait approach with conservative, comfort management: hydration, rest, antipyretics prn.  Pt used oatmeal baths, castor oil, and essential oils to help soothe rash.  Pt made full recovery with in a week.  Duration of symptoms was about 5-7 days from onset to resolution.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: On 3/3/20 woke up with pounding Headache, Nausea, Chills, took doxycycline hyclate as prescribed. 3/4/2020 A fever of 100 - 101.3 started and ran for 5 days was prescribed by PCP sulfameth/Trimethoprim 800/160mg. 3/6/20 muscle aches, arms & legs, Headache and other symptoms present. PCP said I was not have a reaction. He has given vaccine for years. Still have Headache, and Nausea, Chills. Did not authorize Tdap vaccine/only Tetanus Booster!
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Laboratory test abnormal, Liver disorder, Liver function test abnormal
Clinical narrative: Fever, cills, fatigue, body aches and drenching night sweets x 10 days
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Pyrexia, Renal impairment
Clinical narrative: Fever, cills, fatigue, body aches and drenching night sweets x 10 days
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Gait inability
Clinical narrative: On 03-30-2020 patients spouse spoke with PCP stating patient after Leaving the office on 12-11-19 she made it home but was unable to walk. She has improved but is still weak and feeling very tired.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 64-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 03-OCT-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. On 07-OCT-2012, the patient suffered bell's palsy (facial paralysis). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress. As consequence, the patient had suffered and would continue to suffer diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting condition, activation of latent condition and other losses and damages.  At the time of the report, the outcome of facial paralysis was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the event facial paralysis was considered as medically significant.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Diarrhoea haemorrhagic, Dyspepsia, Fatigue
Clinical narrative: BAD HEARTBURN; STOMACH PAIN; BOUTS OF DIARRHEA, SOMETIMES WITH STREAKS OF BLOOD; FEVERISH; BOUTS OF DIARRHEA, SOMETIMES WITH STREAKS OF BLOOD; FATIGUED; FELT UNWELL; This spontaneous case report (805330-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 24-year-old male consumer who had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif for an unknown indication.  Case report: The consumer was taking doses of Vivotif for about a week. On 08-Mar-2019, he had bouts of diarrhea, sometimes with streaks of blood. On 08-Mar-2019 and 09-Mar-2019 evenings, he felt unwell, feverish, and fatigued. Especially on 09-Mar-2019, he had stomach pain and bad heartburn. Since he finished vaccine, the diarrhea and worse side effects have subsided but persist. He still had tired and having loose stools.  The consumer had no medical history and no current illness.  The consumer was not taking any concomitant medication.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a male consumer had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, fever, fatigue and abdominal pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a  male consumer had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, fever, fatigue and abdominal pain are labelled as per CCDS . Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Malaise, Pyrexia
Clinical narrative: BAD HEARTBURN; STOMACH PAIN; BOUTS OF DIARRHEA, SOMETIMES WITH STREAKS OF BLOOD; FEVERISH; BOUTS OF DIARRHEA, SOMETIMES WITH STREAKS OF BLOOD; FATIGUED; FELT UNWELL; This spontaneous case report (805330-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 24-year-old male consumer who had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif for an unknown indication.  Case report: The consumer was taking doses of Vivotif for about a week. On 08-Mar-2019, he had bouts of diarrhea, sometimes with streaks of blood. On 08-Mar-2019 and 09-Mar-2019 evenings, he felt unwell, feverish, and fatigued. Especially on 09-Mar-2019, he had stomach pain and bad heartburn. Since he finished vaccine, the diarrhea and worse side effects have subsided but persist. He still had tired and having loose stools.  The consumer had no medical history and no current illness.  The consumer was not taking any concomitant medication.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a male consumer had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, fever, fatigue and abdominal pain are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a  male consumer had bouts of diarrhea, sometimes with streaks of blood, felt unwell, feverish, fatigued, stomach pain, and bad heartburn, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhea, fever, fatigue and abdominal pain are labelled as per CCDS . Hence, the causality of the events with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITING; DIARRHOEA; This spontaneous case report (807269-1) was extracted from VAERS on 21-Jun-2019. It was reported by a healthcare professional. It describes a 45-year-old male consumer who had nausea, diarrhea, and vomiting, after the administration of oral Vivotif (lot number: 3003215) for an unknown indication.  Case report: The consumer had nausea and diarrhea after taking the first and the second dose of Vivotif. Then, the events became severe after taking the third dose. He also experienced vomiting after the third dose.  The consumer's medical history included hypertension.  The consumer had not taken concomitant medication.  Action taken with Vivotif was dosage discontinued.  The consumer had not recovered from the events.  Company's Comment: In this case, it was reported that a male consumer had nausea, diarrhea, and vomiting, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer had nausea, diarrhea, and vomiting, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, diarrhea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: NAUSEA; STOMACH PAIN; VOMITING; This spontaneous case report (807526-1) was extracted through VAERS database on 21-Jun-2019. The case was reported by a consumer. It describes a 50-year-old female consumer who had stomach pain, nausea, and vomiting, after the administration of oral Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 27-Mar-2019 and on the same day, she experienced stomach pain, nausea, and vomiting.  Action taken with Vivotif was unknown.  The consumer had recovered from the events.  Company's Comment: In this case, it was reported that a female consumer who had stomach pain, nausea, and vomiting, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain, nausea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer who had stomach pain, nausea, and vomiting, after the administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach pain, nausea, and vomiting are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 13-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 5-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 18-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 19-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 19-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 19-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 23-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 30-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 01-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 5-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 03-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 03-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 04-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 15-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 14-months-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 16-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 17-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 27-SEP-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R018931, expiration date: 02-JUL-2020, expiration date (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 17-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 2-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 25-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 25-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 25-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding a 12-months-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 28-OCT-2019, the patient was inadvertently vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccine underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  This is one of the several reports received from the same reporter.