chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 2 year old male patient. It was reported that the child has never had any problems and was not immunocompromised. No information regarding concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date and exact dose were not reported), subcutaneously. On an unknown date, the patient developed a rash on his left side. The patient sought medical attention, was seen by a physician and a culture of rash was taken. The result came back positive for varicella zoster (date of test was not reported). The patient was treated with acyclovir (unspecified dosage). The physician assistant stated that they did not see any reason for other concerns. The outcome od the event was reported as recovering. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Lymphadenitis, Mass, Nausea
Clinical narrative: Lump left neck-sore to touch; headache; diarrhea; body aches; nausea; Arthus reaction. Dx: lymphadenitis, acute d/t Arthus reaction (serum sickness) diarrhea- reaction to Arthus.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Serum sickness, Tenderness, Type III immune complex mediated reaction
Clinical narrative: Lump left neck-sore to touch; headache; diarrhea; body aches; nausea; Arthus reaction. Dx: lymphadenitis, acute d/t Arthus reaction (serum sickness) diarrhea- reaction to Arthus.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. Information regarding relevant medical history and concurrent condition were not reported. In April 2013 the patient was vaccinated with GARDASIL (dose 1, 0.5 ml, route and lot # not reported). In September 2013 the patient was vaccinated with GARDASIL (dose 2, 0.5 ml, route and lot # not reported). The patient had not received a third dose, which should be administered by April 2014 (inappropriate schedule of vaccine administered). No adverse event reported. Additional information is not expected because there is no contact information provided.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 10 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of VAQTA injection (lot # L023232 with expiry date: 25-FEB-2017 and lot # L023936 with expiry date: 15-MAY-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated orally with improperly stored doses of ROTATEQ injection (lot # L047185 with expiry date: 17-SEP-2017 and lot # L013204 with expiry date: 28-JAN-2017; strength, dose and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 5 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.47
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 5 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.61
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 7 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 13-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse to an unspecified number of patients of unknown demographics. NO concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored MMR II injection (lot # reported as M001200 (HSA) with expiry date: 28-AUG-2016; lot# L041455 (rHA) with expiry date: 22-OCT-2017; L024265 with expiry date: 01-JUL-2017 and lot# L030162 (rHA) with expiry date: 11-AUG-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "date logger". No concomitant medications were reported. NO adverse effect reported. This is one of several reports from the same source.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported). The dose of PNEUMOVAX23 was administered after being transported on dry ice for 15 minutes on an unspecified date. The reported was unable to provided a specific temperature that the PNEUMOVAX23 was stored at during the transport. There was no adverse event reported. Additional information is not expected as the physician did not wish to be contacted.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 10 week old patient of unknown gender. The patients; concurrent conditions and medical histories were not provided. On 22-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of GARDASIL 9 lot # L043213 with expiration date 28-AUG-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients; concurrent conditions and medical histories were not provided. On 22-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016. Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of (Merck) VARIVAX injection (lot # L048468 with expiry date: 02-FEB-2017 and lot # L043622 with expiry date: 03-NOV-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # L048236 with expiry date: 31-MAR-2018; lot# L033343 with expiry date: 13-SEP-2017 and lot# L040458 with expiry date: 04-FEB-2018; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # L038503 with expiry date: 18-DEC-2017; lot# L007560 with expiry date: 15-JUN-2017 and lot# L043213 with expiry date: 28-AUG-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis, 6 in x 5 in area of redness, tenderness to touch, warmth on thigh around injection sites. Antibiotics.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Clonus, Dyskinesia, Seizure like phenomena
Clinical narrative: Daughter calls to report severe seizure like reaction after tdap.  Reports was seen by PCP, Dr. today and diagnosed as mild klonic jerking. Reports this may have also happened with regular TD when previous vaccinated after cat bite, but was diagnosed with cat scratch fever. Reports had seizure like activity then also.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersomnia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in arm at site of injection. The pain became worse the following day and persisted for over one week. Patient was unable to move arm in any direction without severe pain. Patient slept most of the day following the vaccine.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Injection site pain, Pain
Clinical narrative: Severe pain in arm at site of injection. The pain became worse the following day and persisted for over one week. Patient was unable to move arm in any direction without severe pain. Patient slept most of the day following the vaccine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Pain left shoulder following injection of flu vaccine, became progressively worse.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Autoimmune disorder, Central nervous system infection, Laboratory test, Psychiatric symptom, Streptococcal infection
Clinical narrative: A spontaneous consumer report had been received concerning a female patient. Lack of relevant history. No concomitant medications reported. The patient received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown on 31-Oct-2015. Mother of patient stated that according to the physician the vaccine triggered an autoimmune response and a development of a streptococcal infection that attacked her brain. She had developed several neurological tics and psychiatric issues. Patient was currently being tested for PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). At the time of reporting, the event of streptococcal infection that went into her brain, streptococcal infection, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues was ongoing. The company physician assessed the events of streptococcal infection that went into her brain, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues to be serious with the seriousness criteria of important medical event. The company physician identified the event of streptococcal infection from the source document and assessed it to be serious with the seriousness criteria of important medical event.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Tic
Clinical narrative: A spontaneous consumer report had been received concerning a female patient. Lack of relevant history. No concomitant medications reported. The patient received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown on 31-Oct-2015. Mother of patient stated that according to the physician the vaccine triggered an autoimmune response and a development of a streptococcal infection that attacked her brain. She had developed several neurological tics and psychiatric issues. Patient was currently being tested for PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). At the time of reporting, the event of streptococcal infection that went into her brain, streptococcal infection, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues was ongoing. The company physician assessed the events of streptococcal infection that went into her brain, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues to be serious with the seriousness criteria of important medical event. The company physician identified the event of streptococcal infection from the source document and assessed it to be serious with the seriousness criteria of important medical event.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Tic
Clinical narrative: The next day, patient began to exhibit a motor tic-head jerk down to the right.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at right deltoid.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Injection site induration, Lymphadenopathy, Throat tightness
Clinical narrative: The pt developed a localized area of induration at the shot site approximately 10 cm and mild lymphadenopathy at her axilla. She was seen in f/u on 4/7/16 and prescribed OMNICEF. On 4/9/16 she went to the ER for tightness in her throat. The ER diagnosed an allergic reaction to immunization. No respiratory distress.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report was received from a physician concerning a 19 year old female patient. The patient did not have medical history, concomitant medications or drug reactions or allergies. On 13-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly, lot number reported as L026602 with expiration date 19-OCT-2017 (dose, strength and anatomical location were not provided). On 22-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly, lot number reported as L026602 with expiration date 19-OCT-2017 (dose, strength and anatomical location were not provided). On the same date, following the second vaccination, the patient experienced syncope and "jerking seizure like movements" that lasted for 10 seconds. The patient recovered from the reported events on the same date (also reported as "the patient's present condition is fine"). The patient sought medical attention with the reporting physician and laboratory diagnostic studies were not performed. The causal relationship between syncope and "jerking seizure like movements" with vaccination with GARDASIL 9 was unknown. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dermatitis allergic, Erythema multiforme
Clinical narrative: Allergic skin rash Erythema multiforme minor
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness at injection site, hot to the touch, hard.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Noted hives on bilateral legs below knees. Patient took CLARITIN this morning and BENADRYL PO last afternoon and evening.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Dysphonia, Headache, Throat irritation
Clinical narrative: Scratchy throat, hoarseness, and headache.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Culture urine, Intussusception, Ultrasound scan, Urine analysis
Clinical narrative: VOMITING, CRYING SPELLS, INTUSSUSCEPTION.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: VOMITING, CRYING SPELLS, INTUSSUSCEPTION.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Anxiety, Dysphagia, Pharyngeal oedema, Throat tightness
Clinical narrative: Client complained solely of difficulty swallowing, throat feeling tight and swollen. Still able to speak and breathe normally. Gave total of 45mg BENADRYL. Declined epinephrine. For about 50 mins. continued with same feeling-no improvement or worsening of symptoms. Still breathing and speaking normal. Became increasingly anxious. Left in a gurney with paramedics.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Eczema
Clinical narrative: Eczema.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Fatigue, Irritability, Pyrexia, Rash erythematous
Clinical narrative: Friday 4/22 @ 2:30 patient was unusable fussy, irritable, and felt warm. She had a fever of 102.7 taken by ear thermometer, no medicine was given. Went to bed at 6:30pm with a fever of 101.6. Saturday 4/23- patient was fussy but seemed not herself all day. Tempature was around 101-102.2 all day. She went to bed  at 6:30 pm with a temp of 101.4. At 10:50pm she woke up screaming and had a temp of 103.6, was given infant MOTRIN for the 1st time in her life. Called the on all Pediatricinan, 40ish minutes later patient vomited the MOTRIN up and we promptly put her in a cool bath to clean her up. At 12:14am her temp was 102.5, she fell asleep around 12:50am. Sunday 4/24- patient had a constant temp of 101 all day. Seemed to be acting more playful but was very tired. Monday 4/25- On patient's forehead a rash started to appear around 3:00pm. By 6:30pm she had red spots on her whole face and some on her upper chest. Tuesday 4/26- 6:00am patient has the red spots all over her face and chest. As the day professed the spots have moved down her body to include her back, top of hands, legs, top of feet. Wednesday 4/27- 6:00am The red spots have somewhat faded on her face, they have turned purple, the red spots have become more red on her chest and she has more that have appeared all over her body. She now has them in her diaper area and on the back of her neck.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Screaming, Skin warm, Vomiting
Clinical narrative: Friday 4/22 @ 2:30 patient was unusable fussy, irritable, and felt warm. She had a fever of 102.7 taken by ear thermometer, no medicine was given. Went to bed at 6:30pm with a fever of 101.6. Saturday 4/23- patient was fussy but seemed not herself all day. Tempature was around 101-102.2 all day. She went to bed  at 6:30 pm with a temp of 101.4. At 10:50pm she woke up screaming and had a temp of 103.6, was given infant MOTRIN for the 1st time in her life. Called the on all Pediatricinan, 40ish minutes later patient vomited the MOTRIN up and we promptly put her in a cool bath to clean her up. At 12:14am her temp was 102.5, she fell asleep around 12:50am. Sunday 4/24- patient had a constant temp of 101 all day. Seemed to be acting more playful but was very tired. Monday 4/25- On patient's forehead a rash started to appear around 3:00pm. By 6:30pm she had red spots on her whole face and some on her upper chest. Tuesday 4/26- 6:00am patient has the red spots all over her face and chest. As the day professed the spots have moved down her body to include her back, top of hands, legs, top of feet. Wednesday 4/27- 6:00am The red spots have somewhat faded on her face, they have turned purple, the red spots have become more red on her chest and she has more that have appeared all over her body. She now has them in her diaper area and on the back of her neck.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Myalgia, Skin warm, Swelling, Tenderness
Clinical narrative: Localized redness, swelling, tenderness, muscle soreness, very hot to touch. No systemic symptoms. No other signs of infection. Better today (less red/tender/warm) per patient.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Child started crying inconsolably for 4 hours post vaccination. Mom then gave TYLENOL and child stopped crying and went to sleep. He was ok the next morning. She did not call the MD.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash, fussiness, fevers.
Age: 1.04
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abnormal behaviour, Feeling abnormal, Insomnia, Pyrexia
Clinical narrative: Patient was clingy with the parents, not sleeping (in a daze) and had fever of 103.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Rash, Rash pruritic
Clinical narrative: Mom states that sometime that night she developed a really itchy rash over both arms, trunk and back. She did not give any medication. May have felt SOB. Rash gone within 24 hours.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Ear pain, Erythema, Fatigue
Clinical narrative: Hot burning pain to injection site, radiating down forearm, across scapula, up right side of neck. Redness in blotchy pattern to upper arm down to elbow. Swelling to entire upper arm. Tender to touch. Unable to raise arm to shoulder level. Achy pain to all joints, febrile (102F, oral temp), chills, headache involving entire top of head, sore throat, ear ache. Fatigue, muscle weakness. Continue for three days, decreasing in intensity by 04/23.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Hot burning pain to injection site, radiating down forearm, across scapula, up right side of neck. Redness in blotchy pattern to upper arm down to elbow. Swelling to entire upper arm. Tender to touch. Unable to raise arm to shoulder level. Achy pain to all joints, febrile (102F, oral temp), chills, headache involving entire top of head, sore throat, ear ache. Fatigue, muscle weakness. Continue for three days, decreasing in intensity by 04/23.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Oropharyngeal pain, Pyrexia, Rash macular
Clinical narrative: Hot burning pain to injection site, radiating down forearm, across scapula, up right side of neck. Redness in blotchy pattern to upper arm down to elbow. Swelling to entire upper arm. Tender to touch. Unable to raise arm to shoulder level. Achy pain to all joints, febrile (102F, oral temp), chills, headache involving entire top of head, sore throat, ear ache. Fatigue, muscle weakness. Continue for three days, decreasing in intensity by 04/23.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tenderness
Clinical narrative: Hot burning pain to injection site, radiating down forearm, across scapula, up right side of neck. Redness in blotchy pattern to upper arm down to elbow. Swelling to entire upper arm. Tender to touch. Unable to raise arm to shoulder level. Achy pain to all joints, febrile (102F, oral temp), chills, headache involving entire top of head, sore throat, ear ache. Fatigue, muscle weakness. Continue for three days, decreasing in intensity by 04/23.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Headache, Hyperacusis, Migraine, Nausea
Clinical narrative: Migraine developed the next day. Complete with head pain, sensitivity to light and sounds, nausea and vomiting. Previous symptoms with last Tdap vaccination 6+ years prior.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia, Vomiting
Clinical narrative: Migraine developed the next day. Complete with head pain, sensitivity to light and sounds, nausea and vomiting. Previous symptoms with last Tdap vaccination 6+ years prior.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Absent bowel movement, Lethargy, Pyrexia
Clinical narrative: Fever for three days. Highest temp 101.9. Lethargic for three-four days. No bowel movements during this time.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dehydration, Dyspnoea, Erythema, Injection site erythema
Clinical narrative: Day #1 Right arm site bright red rash Day #2-4 Entire right arm red and fever Day #5 Became short of breath and weak all over and fever.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site rash, Pyrexia, Rash erythematous, Weight decreased
Clinical narrative: Day #1 Right arm site bright red rash Day #2-4 Entire right arm red and fever Day #5 Became short of breath and weak all over and fever.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: The symptoms started a couple of days later. Back stiffness, pain, limited range and movement. Stiffness in the joints. Left hip, left foot or big toe joint was swollen. Right knee cap has extremely swollen. Different symptoms over the course of 3 weeks. Including night sweats.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Night sweats, Pain, Peripheral swelling, Polyarthritis
Clinical narrative: The symptoms started a couple of days later. Back stiffness, pain, limited range and movement. Stiffness in the joints. Left hip, left foot or big toe joint was swollen. Right knee cap has extremely swollen. Different symptoms over the course of 3 weeks. Including night sweats.
Age: 0.77
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Drug screen negative, Hypotonia, Infantile spitting up, Mobility decreased
Clinical narrative: Baby was acting altered and not moving body. His arms, legs and head were limp. His eyes were half closed and looked like he was very sleepy even though he just woke up. He would vomit/spit up but couldn't cough well so he was choking on if. I set him in a bouncer to get my daughter and he was totally limp with his head leaned back on a toy. He was very altered and not responsive. We went to the emergency room. He was monitored then ultimately discharged later that morning.
Age: 0.77
Sex: M
Vaccine: FLUX
Symptoms: Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: Baby was acting altered and not moving body. His arms, legs and head were limp. His eyes were half closed and looked like he was very sleepy even though he just woke up. He would vomit/spit up but couldn't cough well so he was choking on if. I set him in a bouncer to get my daughter and he was totally limp with his head leaned back on a toy. He was very altered and not responsive. We went to the emergency room. He was monitored then ultimately discharged later that morning.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: 12 hours after vacc. fever, headache, myalgia and temp 102 degrees F 24 hr after vaccine.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral
Clinical narrative: Pt vaccinated with Tdap to Lt deltoid - no erythema - c/o numbness to partial lower lip. Denies SOB. Voices under a lot of stress. Monitored x 20 min. Numbness resolved after 20 min.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red with swelling, itchy, stinging and tender to the touch around the injection site (right upper arm) it's about 2-3 inches in diameter.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Raised erythema, firmness surrounding injection site.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patient's concurrent conditions and medical histories were not provided. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Diarrhoea, Dizziness, Headache, Tremor
Clinical narrative: Shaky, dizzy, clammy, vomiting, diarrhea, and headache 30 min after administration duration of symptoms: 3-4 hrs.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Vomiting
Clinical narrative: Shaky, dizzy, clammy, vomiting, diarrhea, and headache 30 min after administration duration of symptoms: 3-4 hrs.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Rectal temp 101. Rash.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 8 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dyspnoea, Headache, Throat tightness
Clinical narrative: About 1.5 hrs after injection, patient reports she developed headache, felt her throat was closing up, and felt like she could not breathe. Used albuterol inhaler 4 times and got relief. Symptoms were subjective. EMS not called. Stable when seen by mom. Has hx of severe shot phobia.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient went to pharmacy and got PREVNAR 13 then came to another pharmacy to get flu shot high dose. Patient got both shots in same arm, 1" apart. The following day, patient's arm was swollen and very painful. She went to ER.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 26-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 8 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 20-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional infotmation has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Redness, swelling, hives local to injection site left upper arm. Tx: BENADRYL as needed; Steroids, cold compresses as tolerated.
Age: 0.54
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 16-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored VAQTA (Lot # L043209 with expiration date of 17-SEP-2017), (dose and route were not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a 38 year old female patient. The patient had allergies to the following drugs; amoxicillin, cephalexin, corticosteroids, loratadine (manufacturer unknown) and potassium clavulanate. On approximately 16-MAR-2016, the patent was vaccinated with PNEUMOVAX 23 (lot # L018503; expiry date: 16-MAR-2017), at a dose of 0.5 ml in her right arm. The day after (on 17-MAR-2016) the patient developed cellulitis and went to the ER (emergency room). The patient was given IV antibiotics at the ER. On an unknown date in approximately 2016 the patient developed swelling. The reporter mentioned that this was the only patient, that she was aware of, that had developed cellulitis. As of 29-MAR-2016, the patient was doing fine and was still taking oral antibiotics. Hence, the outcome of cellulitis was considered recovering, while outcome of swelling was not known. The causality of the events was not reported. The case is linked to 1604USA017274 (same patient link). Additional information has been requested.