chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Skin warm, Somnolence
Clinical narrative: Patient came home and slept all day. The following day she complained of headache and the arm injected was very swollen. She had no "knot" in the arm, but it was hot, had a red appearance around the injection site, much larger than the site, and when I measured her arm, it was almost 2" larger than her other arm (the arm injected was her L arm; the left side of her body is smaller and has more atrophy than the R, as it is). By the evening, her headache was severe and all she wanted to do was sleep. Patient continued to have severe headaches, almost daily, for 3 months and was very exhausted and intolerant (this was not her typical disposition or pattern).
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Computerised tomogram normal, Dizziness, Feeling hot
Clinical narrative: Severe pain down right arm from injection site.  Profuse sweating. Body heated up, dizzy, nauseous,  vomiting,  chills, blurry vision. Passed out hitting head on floor. Went to hospital on 5/6 due to dizziness and headache, swollen cheekbone, hip pain. CT Scan and xray showed nothing broken. Rest was prescribed.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Headache, Hyperhidrosis, Injection site pain, Loss of consciousness
Clinical narrative: Severe pain down right arm from injection site.  Profuse sweating. Body heated up, dizzy, nauseous,  vomiting,  chills, blurry vision. Passed out hitting head on floor. Went to hospital on 5/6 due to dizziness and headache, swollen cheekbone, hip pain. CT Scan and xray showed nothing broken. Rest was prescribed.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Swelling face, Vision blurred, Vomiting
Clinical narrative: Severe pain down right arm from injection site.  Profuse sweating. Body heated up, dizzy, nauseous,  vomiting,  chills, blurry vision. Passed out hitting head on floor. Went to hospital on 5/6 due to dizziness and headache, swollen cheekbone, hip pain. CT Scan and xray showed nothing broken. Rest was prescribed.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: X-ray normal
Clinical narrative: Severe pain down right arm from injection site.  Profuse sweating. Body heated up, dizzy, nauseous,  vomiting,  chills, blurry vision. Passed out hitting head on floor. Went to hospital on 5/6 due to dizziness and headache, swollen cheekbone, hip pain. CT Scan and xray showed nothing broken. Rest was prescribed.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Vaccination site pain
Clinical narrative: Symptoms: severe headache, muscle ache, fatigue, pain at site of vaccination Signs: redness at site of vaccination Time: 48+ hours Treatment: Advil Outcome:  Symptoms declined
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Symptoms: headache, fatigue, muscle ache, dizziness, slight nausea, diminished appetite, injection site redness, under arm pain Treatment: rest Time: 48+ hours Outcome: Symptoms declined
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Nausea
Clinical narrative: Symptoms: headache, fatigue, muscle ache, dizziness, slight nausea, diminished appetite, injection site redness, under arm pain Treatment: rest Time: 48+ hours Outcome: Symptoms declined
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Discomfort, Gait disturbance, Lethargy, Pallor, Pyrexia
Clinical narrative: Infant's face was very pale, (torso also noticeably so when changing). He was lethargic and limp, had 100.7 fever, and lower body was very heavy to lift when needed diaper change. Lasted about half hr and subsided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Somnolence, Tremor
Clinical narrative: feeling chilled within several hours, then woozy, then marked chills, made better with acetaminophen.  Awoke at 2 am with physical shaking of hands, chills.  Sleepy most of next day.  Appetite remained okay.  Symptoms subsided by next evening (about 36 hours after vaccine was given).
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Skin around the shot got inflamed, 2 days post administration. As per pt, almost like sunburn, sore, warmer than the rest of pt's skin.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: swelling and redness.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: C-reactive protein, Fatigue, Headache, Magnetic resonance imaging brain normal, Memory impairment
Clinical narrative: POTS (Postural orthostatic tachycardia syndrome); memory difficulty; Headaches; fatigue; This report was identified from a line listing obtained on request by the Company from the FDA (HA#813633) under the Freedom of Information Act, concerning a 15-year-old male patient. The patient's medical history included mild intermittent asthma, recurrent otitis media, sinusitis. The patient's historical drugs, and previous drug reactions were not reported. His concurrent conditions included autism spectrum disorder and allergy to cats and dogs reported as sneezing. Concomitant therapies were not reported.   On 02-OCT-2017, at approximately 16:41, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular injection in right arm, lot number N009801, expiration date was not provided, but upon internal validation established as 20-NOV-2019, for prophylaxis (strength and exact dose were not provided).  On 15-OCT-2017, the patient experienced headache, postural orthostatic tachycardia syndrome (POST), memory difficulty and fatigue. The patient's adverse events were evaluated at a doctor's office or other healthcare professional's office or clinic. On unknown date, the patient had magnetic resonance imaging (MRI) performed with result described as normal brain. Additional test included erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and an unspecified toxicology test but results of these tests were not provided.  At the reporting time, the outcome of the events was unknown. . The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The events were considered to be causing the patient's disability.  As of 30-APR-2020, all telephone attempts trying to obtain additional information had been unsuccessful.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Red blood cell sedimentation rate, Toxicologic test
Clinical narrative: POTS (Postural orthostatic tachycardia syndrome); memory difficulty; Headaches; fatigue; This report was identified from a line listing obtained on request by the Company from the FDA (HA#813633) under the Freedom of Information Act, concerning a 15-year-old male patient. The patient's medical history included mild intermittent asthma, recurrent otitis media, sinusitis. The patient's historical drugs, and previous drug reactions were not reported. His concurrent conditions included autism spectrum disorder and allergy to cats and dogs reported as sneezing. Concomitant therapies were not reported.   On 02-OCT-2017, at approximately 16:41, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular injection in right arm, lot number N009801, expiration date was not provided, but upon internal validation established as 20-NOV-2019, for prophylaxis (strength and exact dose were not provided).  On 15-OCT-2017, the patient experienced headache, postural orthostatic tachycardia syndrome (POST), memory difficulty and fatigue. The patient's adverse events were evaluated at a doctor's office or other healthcare professional's office or clinic. On unknown date, the patient had magnetic resonance imaging (MRI) performed with result described as normal brain. Additional test included erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and an unspecified toxicology test but results of these tests were not provided.  At the reporting time, the outcome of the events was unknown. . The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  The events were considered to be causing the patient's disability.  As of 30-APR-2020, all telephone attempts trying to obtain additional information had been unsuccessful.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Demyelinating polyneuropathy, Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Acute inflammatory demyelinating polyneuropathy; Lumbar radiculopathy; Guiilain Barre; motor neuron weakness/progressive ascending motor weakness; Numbness and tingling of right leg/Numbness of both legs; tingling of right leg; radicular pain; muscle weakness; This case was reported by a lawyer and described the occurrence of demyelinating polyneuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information was received on 29 April 2020 via medical record (Case is now medically confirmed). Patient visited to clinic on 23 July 2019 with the chief complaint follow up of Guiilain Barre episode. The patient had problem of Numbness and tingling of right leg. Patient diagnosed with Numbness of both legs, imaging shows lumbar stenosis. On 23 July 2019, patient assessed and he had acute inflammatory demyelinating polyneuropathy in March 2019, for which he was hospitalized with continuing progressive ascending motor weakness with increased oxygen requirement and subsequent intubation. Patient had acute weakening of his legs. At that that time, there was a high suspicion that he had acute inflammatory demyelinating polyneuropathy, and he was treated with plasma exchange. The patient had L3-S1 laminectomy with micro discectomy on November 10, 2019. The patient admitted on 09 November 2018 and discharged by 12 November 2018 for Lumbar radiculopathy. Patient visited to clinic on 08 November 2018, the patient had history of back pain and radicular pain. Patient complains of lumbar pain. On 14 march 2019, The patient visited to clinic for arm and leg weakness and finding shows Mild multilevel spondylosis. On 16 march 2019, patient consulted to clinic for progressive motor neuron weakness with suspect of Guillain-Barr Syndrome and muscle weakness.
Sex: M
Vaccine: VARZOS
Symptoms: Imaging procedure abnormal, Intervertebral disc operation, Lumbar radiculopathy, Lumbar spinal stenosis, Muscular weakness
Clinical narrative: Acute inflammatory demyelinating polyneuropathy; Lumbar radiculopathy; Guiilain Barre; motor neuron weakness/progressive ascending motor weakness; Numbness and tingling of right leg/Numbness of both legs; tingling of right leg; radicular pain; muscle weakness; This case was reported by a lawyer and described the occurrence of demyelinating polyneuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information was received on 29 April 2020 via medical record (Case is now medically confirmed). Patient visited to clinic on 23 July 2019 with the chief complaint follow up of Guiilain Barre episode. The patient had problem of Numbness and tingling of right leg. Patient diagnosed with Numbness of both legs, imaging shows lumbar stenosis. On 23 July 2019, patient assessed and he had acute inflammatory demyelinating polyneuropathy in March 2019, for which he was hospitalized with continuing progressive ascending motor weakness with increased oxygen requirement and subsequent intubation. Patient had acute weakening of his legs. At that that time, there was a high suspicion that he had acute inflammatory demyelinating polyneuropathy, and he was treated with plasma exchange. The patient had L3-S1 laminectomy with micro discectomy on November 10, 2019. The patient admitted on 09 November 2018 and discharged by 12 November 2018 for Lumbar radiculopathy. Patient visited to clinic on 08 November 2018, the patient had history of back pain and radicular pain. Patient complains of lumbar pain. On 14 march 2019, The patient visited to clinic for arm and leg weakness and finding shows Mild multilevel spondylosis. On 16 march 2019, patient consulted to clinic for progressive motor neuron weakness with suspect of Guillain-Barr Syndrome and muscle weakness.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Plasmapheresis, Radicular pain, Spinal laminectomy, Spinal osteoarthritis
Clinical narrative: Acute inflammatory demyelinating polyneuropathy; Lumbar radiculopathy; Guiilain Barre; motor neuron weakness/progressive ascending motor weakness; Numbness and tingling of right leg/Numbness of both legs; tingling of right leg; radicular pain; muscle weakness; This case was reported by a lawyer and described the occurrence of demyelinating polyneuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  The initial information was received on 29 April 2020 via medical record (Case is now medically confirmed). Patient visited to clinic on 23 July 2019 with the chief complaint follow up of Guiilain Barre episode. The patient had problem of Numbness and tingling of right leg. Patient diagnosed with Numbness of both legs, imaging shows lumbar stenosis. On 23 July 2019, patient assessed and he had acute inflammatory demyelinating polyneuropathy in March 2019, for which he was hospitalized with continuing progressive ascending motor weakness with increased oxygen requirement and subsequent intubation. Patient had acute weakening of his legs. At that that time, there was a high suspicion that he had acute inflammatory demyelinating polyneuropathy, and he was treated with plasma exchange. The patient had L3-S1 laminectomy with micro discectomy on November 10, 2019. The patient admitted on 09 November 2018 and discharged by 12 November 2018 for Lumbar radiculopathy. Patient visited to clinic on 08 November 2018, the patient had history of back pain and radicular pain. Patient complains of lumbar pain. On 14 march 2019, The patient visited to clinic for arm and leg weakness and finding shows Mild multilevel spondylosis. On 16 march 2019, patient consulted to clinic for progressive motor neuron weakness with suspect of Guillain-Barr Syndrome and muscle weakness.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Malaise, Pain
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; My husband vomited several times; turned white; sweated profusely; He has stayed in bed all day; He couldnt eat dinner; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite. On an unknown date, the outcome of the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite were unknown.   It was unknown if the reporter considered the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches, vomited several times, turned white, sweated profusely. He has stayed in bed all day. He couldnt eat. This is 1 of the 4 linked cases reported by the same reporter. For tolerance after 1st dose refer case US2020AMR044283.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Bedridden, Chills, Decreased appetite, Hyperhidrosis
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; My husband vomited several times; turned white; sweated profusely; He has stayed in bed all day; He couldnt eat dinner; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite. On an unknown date, the outcome of the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite were unknown.   It was unknown if the reporter considered the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches, vomited several times, turned white, sweated profusely. He has stayed in bed all day. He couldnt eat. This is 1 of the 4 linked cases reported by the same reporter. For tolerance after 1st dose refer case US2020AMR044283.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain, Skin discolouration, Vomiting
Clinical narrative: made us both sick; we had weakness; we had chills; we had body aches; My husband vomited several times; turned white; sweated profusely; He has stayed in bed all day; He couldnt eat dinner; This case was reported by a consumer and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite. On an unknown date, the outcome of the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite were unknown.   It was unknown if the reporter considered the sickness, weakness, chills, general body pain, vomiting, skin discoloration, sweating, bedridden and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and had weakness, chills, body aches, vomited several times, turned white, sweated profusely. He has stayed in bed all day. He couldnt eat. This is 1 of the 4 linked cases reported by the same reporter. For tolerance after 1st dose refer case US2020AMR044283.
Age: 9.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patients were administered improperly stored PROQUAD; This spontaneous report was received from a vaccine coordinator, referring to two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, or medical history was provided. The concomitant therapy included sterile diluent.  Since 24-APR-2019, the patients were vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD), lot # R030801 and expiration date 22-APR-2020, for prophylaxis (dose and route of administration were not reported) which was reconstituted with properly stored sterile diluent.  The administered doses of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius (C) for 1 hour and 12 minutes and of -9 degree C to 8 degree C (-0.04 degree C) for 6 hours and 50 minutes, as recorded by a data logger. The vaccine had had previous temperature excursions of -14 degree C to -10 degree C (-11.6 degree C) for 28 minutes and of -14 degree C to -10 degree C (-13.12 degree C) for 25 minutes. There was no adverse effect reported. No product quality complaint was involved.  This case is non-valid due to lack of patient identifiers.  Follow-up information was received from the vaccine coordinator on 20-APR-2020. The reporter was ready to provide the requested information like administration dates and patient identifiers but, would have to search for the information. The reporter would call back to provide the information.  Follow-up information was received from the vaccine coordinator on  30-APR-2020. The individual patient identifiers and details were reported and the case has become valid. This case was regarding a 9 year old female patient who was vaccinated  with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rha)) (PROQUAD) on 19-AUG-2019 (previously reported as since 24-APR-2019).  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000215:
Sex: U
Vaccine: HEP, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 or RECOMBIVAX on multiple unspecified dates.; No adverse effects reported.; This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB) lot numbers R013540 and R007212 with expiration dates on 21-MAR-2021 and 04-NOV-2020 respectively or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot numbers N032284, R032766, and 1602284 with expiration dates on 22-SEP-2020, 31-AUG-2021, and 26-SEP-2021 respectively (dose, frequency, strength and route of administration were not reported) and all were given for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit / 2 degrees Celsius (27.7degrees Fahrenheit) for 408 hours. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.   As of 30-APR-2020, all telephone attempts trying to obtain additional information has been unsuccessful
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; incorrect product storage; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-DEC-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot# R028529, expiration date 09-JUN-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis.  The administered doses of the vaccines were stored with the lowest temperature of 34.3 Fahrenheit during 4 hours. There was a digital data logger involved, but there was no previous temperature excursion.  No additional adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patients were administered an improperly stored dose of VARIVAX; No additional adverse event; This non-valid, spontaneous report was received from a nurse and refers to five unspecified patients of unknown age and gender. No information was provided regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies.    On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number: R026715, expiration date: 18-SEP-2020 (strength, exact dose, frequency and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the suspect vaccine was properly stored. No additional adverse event information was provided. The vaccine underwent temperature excursion at 6.5 degree Fahrenheit for a duration of 17 minutes. There was no previous temperature excursion. Data logger was involved.  This is a non-valid case due to lack of patients' identifiers.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose ofMMR II that was expired; This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-APR-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(recombinant human albumin rHA)lot # R010474, expiration date: 10-APR-2020 for prophylaxis (dose number, dosing schedule and route of administration were not provided), reconstituted in a sterile diluent. No additional adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Androgen deficiency, Injection site reaction
Clinical narrative: I have developed testosterone deficiency; I developed an injection site reaction from that, much like the one with PNEUMOVAX 23; Severe injection site reaction; This spontaneous report was received from a physician who refers to himself, an adult male patient of an unknown age. His concurrent condition included mantle cell lymphoma. The patient's medical history included orchidectomy and pelvic radiotherapy (RT). There was no information about the patient's concomitant medication provided.  On an unknown date in 2019 (reported as last year), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) and experienced severe injection site reaction which resolved after one week.  On an unknown date, the patient developed testosterone deficiency and required intramuscular (IM) testosterone ciprionate injections every week. He developed an injection site reaction from that injections much like the one he experienced with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The outcome of severe injection site reaction was recovered on an unknown date in 2019. The outcome of androgen deficiency and injection site reaction was unknown. The causality assessment was not provided for androgen deficiency and injection site reaction. The causality assessment between severe injection site reaction and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was reported as related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms were reported.; Nurse called and reported that the patient was administered a dose of improperly stored VARIVAX (S024366, exp: 08/06/2021) on 11-MAR-2020.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and previous drug reactions/allergies were not reported.  On 11-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S024366 was verified to be a valid lot number, expiration date reported and established as 06-AGU-2021), as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported). As concomitant medication sterile diluent (MERCK STERILE DILUENT) (lot number R019504 was verified to be a valid lot number, expiration date reported and established as 04-NOV-2021), was properly stored and used to reconstituted the suspect product. The administered dose of the vaccine experienced a temperature excursion -14 degrees Celsius to -10 degrees Celsius (-12 degrees Celsius) for 4 days 11 hours 40 minutes (product storage error), as recorded by a data logger. There was no previous temperature excursion and no adverse symptoms reported.
Age: 1.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 28-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No known adverse effects.; an administered dose of ROTATEQ underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report was received from an office manager 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 23-APR-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660943, expiration date 05-NOV-2020, strength and route were not reported) for prophylaxis.    Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 21 degree Celsius for 19 hours. There was no previous temperature excursion reported. The digital data logger was involved. No known adverse effects.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; patient was administered an expired dose of MMR II on 4/22/2020; This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications was provided.  On 22-APR-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: recombinant human albumin (rHA)), lot # R011219, expiration date 17-APR-2020 (dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (STERILE DILUENT). No additional adverse effect was reported.
Age: 2.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 2-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 20-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.5
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to an 18-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity: ; manufacturerstate: ; manufacturercountry:  devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.17
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 14-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 05-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 4.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 4-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 15.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring a 15 year-old-female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 19-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate:  manufacturercountry: ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 1.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 14-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Age: 14.0
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 14-year-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749: