chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL injection (strength, route and site of administration, dose, lot number and expiration date were not reported), which was administered late. No adverse effect was reported. Product quality complaint was not involved. Additional information is not expected as no consent for contact was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to 3 unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown dates, the patients' were vaccinated with improperly stored doses of ZOSTAVAX (lot # L034736 with expiration date of 09-DEC-2016) (anatomical route of vaccination and dose number were not provided). There was no adverse event reported due to vaccination with ZOSTAVAX and no product quality issue involved. The pharmacist stated that ZOSTAVAX was exposed to 31 F temperature excursion for 15 hours and 30 minutes. No previous excursion was reported. 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 healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 07-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. 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 healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 01-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional regarding to 2 patients who were under the age of 19 years and of unknown gender. Information on their concurrent condition, medical history and drug allergies were not reported. On an unknown date in February 2016, the patients were vaccinated with VAQTA (lot, expiry date, route and anatomical location were not specified) strength 50/1.0 U per ml (inappropriate schedule of drug administration). Concomitant medication were not reported. No adverse events reported. There was no Product Quality Complaint (PQC) involved. 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 healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 19-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. 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 healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 18-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. 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 healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-APR-2016, the patient was vaccinated with a 0.5 ml dose of improperly stored (Oka/Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Oka/Merck) VARIVAX (which had a lot # L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Blood culture negative, Bradycardia, C-reactive protein increased, Mechanical ventilation
Clinical narrative: Apneic and bradycardia events with severe desaturation requiring vigorous stimulation. Appx 8 hrs after immunization ventilatory support added (to high flow O2/2L - 100%) Septic workup completed, antibiotics started. Viral URI PCR (-).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation decreased, Polymerase chain reaction, Viral test negative
Clinical narrative: Apneic and bradycardia events with severe desaturation requiring vigorous stimulation. Appx 8 hrs after immunization ventilatory support added (to high flow O2/2L - 100%) Septic workup completed, antibiotics started. Viral URI PCR (-).
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives on hands and face. Gave BENADRYL 12.5/5 6ml PO x one in office. No progression of hives or concerns of distress.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site infection
Clinical narrative: Skin infection at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Warmth, redness, and moderate induration measuring 6.5 cm in width by 7 cm in longitude from injection site at top of left deltoid down the left upper arm with smaller round area of slightly darker redness measuring 2.25 cm in diameter posterior to this (at varivax injection site). Advised ibuprofen, cool compresses PRN.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Local swelling, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swelling in upper left arm and armpit 48 hours after administration of Menveo and Tdap in that location. Patient is able to use arm but is painful. The patient is afebrile. There is a 1 inch tender left axillary lymph node with two pea sized mobile nodes adjacent.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Rash on body that looks like chicken pox.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Back pain, Chest pain, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Developed acute thoracic back pain and subsequently bilateral lower extremity evaluation. Patient was hospitalized and discharged to home with a diagnosis of possible transverse myelitis.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, swelling, warmth developed at site of injection and around arm.  Cellulitis developed and was treated by PCP.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Decreased appetite, Fatigue
Clinical narrative: Patient came in to pharmacy concerned about symptoms of fatigue, lack of appetite, and joint pain (back pain). She received a Prevnar 13 vaccine on 4/6/2016.  She stated the symptoms began last week (today is 4/21/16), and the symptoms have gotten progressively worse.  She believes the symptoms could possibly be due to the vaccine.  I recommended she consult with her primary care physician to rule out other possible causes.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date reported as several years ago, the patient received first dose of VAQTA dosage regimen and route unknown. Physician reports that this information was unknown to physician's staff at the time the patient transferred to physician's office and the patient then received a second dose of VAQTA on 25-NOV-2014 (Inappropriate schedule of vaccine administered). On 30-MAR-2016, the patient received third dose of VAQTA (Extra dose administered). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two multiple patient reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 13 year old male patient. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 10-APR-2015, the patient was vaccinated with the first dose of GARDASIL (which had a lot # of K006960; however, dose, route of administration and expiration date were not reported). Subsequently, on 10-APR-2015, the patient was vaccinated with the second dose of GARDASIL (which had a lot # of K006960; however, dose, route of administration and expiration date were not reported). No concomitant therapies were reported. Thirty minutes after getting vaccinated with the second dose, the patient developed hives on an unspecified area of the body. Therefore, he sought medical attention by visiting the physician and was given BENADRYL for the treatment of the adverse event. It was to be noted that no product quality complaint was involved. The hives reportedly lasted a few weeks, following which they resolved on an unspecified date in 2015. The reporter provided no causal relationship between the event and the vaccination with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017; lot # L040459, expiration date 06-APR-2017. The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients was vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiration date 31-MAR-2018 (dose and route of administration were not reported). The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. 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 healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L004014, expiration date 04-MAR-2017; lot # L045711, expiration date 08-MAY-2017; lot # L016428, expiration date 30-JUL-2017 (dose and route of administration were not reported). The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Periarthritis
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 25 year old female patient. The patient did not have any pertinent medical history, drug allergies or concomitant medications. On 03-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L028082, expiry date- 18-SEP-2017, dose 1, 0.5 ml, intramuscular in the left arm. On 03-MAR-2016, the patient experienced pain in the left shoulder and a "cold, frozen shoulder". She was not treated for the same. The patient had come back on 07-APR-2016 for the second dose in series although the physician did not givenher the second dose, instead deferred the vaccination by "one month". No laboratory tests were conducted. No product quality complaint (PQC) was involved. The outcome of events was unknown. The causality assessment was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt has swelling, redness, pain and itching to right arm (upper).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 10 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with VAQTA (lot # L015460, expiration date 20-JUL-2017, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-APR-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (lot # L022261, expiry date 01-APR-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. A year and a half ago, in approximately October 2014, the patient received the first dose of vaccinated with GARDASIL (strength, dose, route, lot # and expiration date not reported) and she received the second dose of GARDASIL (strength, dose, route, lot # and expiration date not reported) on an unspecified date in December 2015 (inappropriate schedule of drug administration). No adverse effect was reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # K021950 with expiration date: 10-NOV-2016 and albumin status of recombinant human albumin (rHA); exact dose and route of administered were not reported)., The administered doses experienced temperature excursion of 10 degrees Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. 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 medical assistant and refers to 23 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 1 degree Celsius for 1 hour and 15 minutes and of 10 degrees Celsius for 30 minutes. No previous excursion were reported. The temperature excursion was detected by a data logger. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. It was reported that from 14-MAR-2016 to 16-MAR-2016, PROQUAD (Merck) (lot # reported as L034736, expiration date 09-DEC-2016; lot # L050909, expiration date 30-DEC-2016, lot # L046508, expiration date 17-MAY-2017) were improperly exposed to -12.97 Centigrade degree for 9.5 hours and -12.59 Centigrade degree for 9.75 hours and -10.79 Centigrade degree for 14 hours. Then, on unspecified dates after 16-MAR-2016 (in 2016), the patients were vaccinated with the improperly stored vaccine (dose and route not reported). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 69 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # L035878, expiration date 11-AUG-2018 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 1 degree Celsius for 1 hour and 15 minutes and of 10 degrees Celsius for 30 minutes. No previous excursion were reported. The temperature excursions were detected by a data logger. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Childhood disintegrative disorder, Decreased appetite, Decreased eye contact, Insomnia, Malaise
Clinical narrative: Within a week of receiving vaccine, patient fell very ill. She had fevers, rash over her body, and stopped eating and sleeping  for several days. She screamed shrill painful screams all day and night for weeks (unlike anything I've heard before it was as if she was in terror). She stopped making eye contact. She had been walking and talking, and stopped both. The doctors began talking about how autism doesn't show up until the year point, and we knew that it wasn't the case. It was a nightmare period. After 2 months, she slowly began regaining her functions, starting to walk again, and making eye contact. We were relieved and today she is a normal child. We can't help but feel exceptionally lucky that she came back to us. The body is a great healer. I was too troubled at the time to submit the report, and am submitting it now since we are coming up on her fourth birthday and will positively not be giving her a second dose of MMRV, and neither will my newborn be receiving an initial or second dose after seeing what my daughter went through. It was as if she had regressed to a vegetable when she was advanced before that appointment, having started saying mama and dada at 7 months, and met every milestone early. I am not anti-vacc, and have since administered other vaccines to my newborn, but am convinced that particular LIVe vaccine harmed her and will not put her in jeapordy again or my newborn with MMRV. This is the only vaccine I am filing an exception for.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Screaming
Clinical narrative: Within a week of receiving vaccine, patient fell very ill. She had fevers, rash over her body, and stopped eating and sleeping  for several days. She screamed shrill painful screams all day and night for weeks (unlike anything I've heard before it was as if she was in terror). She stopped making eye contact. She had been walking and talking, and stopped both. The doctors began talking about how autism doesn't show up until the year point, and we knew that it wasn't the case. It was a nightmare period. After 2 months, she slowly began regaining her functions, starting to walk again, and making eye contact. We were relieved and today she is a normal child. We can't help but feel exceptionally lucky that she came back to us. The body is a great healer. I was too troubled at the time to submit the report, and am submitting it now since we are coming up on her fourth birthday and will positively not be giving her a second dose of MMRV, and neither will my newborn be receiving an initial or second dose after seeing what my daughter went through. It was as if she had regressed to a vegetable when she was advanced before that appointment, having started saying mama and dada at 7 months, and met every milestone early. I am not anti-vacc, and have since administered other vaccines to my newborn, but am convinced that particular LIVe vaccine harmed her and will not put her in jeapordy again or my newborn with MMRV. This is the only vaccine I am filing an exception for.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 20-JUN-2012, the patient was vaccinated with a first dose of GARDASIL. Then on 21-AUG-2012, the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not provided). Subsequently, on 20-APR-2016, the patient went to the office to get the first dose of GARDASIL 9 (dose, route, lot # and expiration date were not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 17-MAR-2016 the patient was inadvertently vaccinated with an expired dose of (Merck) VARIVAX (with lot # and expiration date K002920 and 26-FEB-2016, respectively) (dose and route of administration were not provided). Concomitant medications were not provided. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Paraesthesia, Pruritus, Swelling
Clinical narrative: PATIENT TOLD ME HAVE THE AREA RED, SWELLING, VERY PAINFUL, ITCHY AND TINGLING.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Central nervous system lesion, Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Paralyzed from the waist down. Treated with steroids (4/22/13). Diagnosed with Transverse Myelitis. Three plasmapheresis events, week of 4/22/13.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Paralysis, Plasmapheresis
Clinical narrative: Paralyzed from the waist down. Treated with steroids (4/22/13). Diagnosed with Transverse Myelitis. Three plasmapheresis events, week of 4/22/13.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route anatomical location, lot number and expiration date not reported). There was no concomitant medication reported. It was reported that the diluent (lot number and expiration date were not reported) used to reconstitute the vaccine was expired. NO adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Patient stated feeling numbness on L-cheek followed by tingleness on L side of jaw and numbness on L side of tongue. VS @ 02:55 pm BP 108/66, P 83, Temp 98.4 degree Fahrenheit. VS @ 03:25 pm BP 98/65, P 80 Temp 98.3 degrees Fahrenheit. VS @ 03:55 pm BP 101/65, P 80, Temp 98.2 degrees Fahrenheit.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Laboratory test, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: PT REPORTS THAT SHE BEGAN HAVING PAIN AND RANGE OF MOTION CHANGES IN HER ARM A DAY WITHIN GETTING HER INJECTION.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Asterixis, Autism, Cognitive disorder, Dyskinesia, Head banging
Clinical narrative: Not looking when name called, flapping, spinning, head banging, sensitive to noise.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Hyperacusis, Unresponsive to stimuli
Clinical narrative: Not looking when name called, flapping, spinning, head banging, sensitive to noise.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Aphasia, Autism, Developmental delay, Dyskinesia, Head banging
Clinical narrative: Spinning, head banging, lost language, not responding to his name, appearing to be death.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Unresponsive to stimuli, Vertigo
Clinical narrative: Spinning, head banging, lost language, not responding to his name, appearing to be death.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Soreness and itching at the injection site which went away with cold compress and BENADRYL.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: First my arm became sore and hurt to move or use, the next day it was swollen and the paint continued; them about 2 days later the pain subsided but the swelling remained and a day later the area became red with a rash and itching. Today is Friday 4/22/2016 and the area still has some swelling, is warm to the touch and the rash and itching continues. I guess it will clear up, but it has been 5 days already.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: First my arm became sore and hurt to move or use, the next day it was swollen and the paint continued; them about 2 days later the pain subsided but the swelling remained and a day later the area became red with a rash and itching. Today is Friday 4/22/2016 and the area still has some swelling, is warm to the touch and the rash and itching continues. I guess it will clear up, but it has been 5 days already.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PER, UNK, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Very high tempeatures 103 & 104, shaking at some times. Been giving Tylenol & Motrin for fever but not helping. Almost 48hrs later & still has these temps.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eye swelling, Eye swelling, Hypersensitivity, Infantile spitting up, Ocular hyperaemia
Clinical narrative: Raised rash all over body, face, both legs, both arms, both sides of head, all the way down chest to the middle, both eyes really swollen right one almost shut and really red.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Raised rash all over body, face, both legs, both arms, both sides of head, all the way down chest to the middle, both eyes really swollen right one almost shut and really red.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-MAR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 through intramuscular route (lot # K010465, expiration date 23-MAR-2016). There were no known adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored GARDASIL (lot # K011325 with expire date 08-APR-2017, dosage and route not provided). The conditions storage was 32 F for 240 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant via company representative, referring to a patient of unknown age and gender. The patient's pertinent medial history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II (anatomical route of vaccination, dose number, lot number, and expiration date were not provided). It was reported that the diluent (lot number and expiration date were not provided)  used to reconstitute the vaccine was expired. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. 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 registered nurse refers to unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. It was reported that from 14-MAR-2016 to 16-MAR-2016, (Merck) VARIVAX (lot # reported as L041205, expiration date 30-OCT-2017; lot # reported as L045956, expiration date 17-OCT-2017; lot # L025208, expiration date 07-JUL-2017; lot # reported as L041205, expiration date 02-OCT-2017) were improperly exposed to -12.97 centigrade degree for 9.5 hours and -12.59 centigrade degree for 9.75 hours and -10.79 centigrade degree for 14 hours. Then, on unspecified dates after 16-MAR-2016 (in 2016), the patients were vaccinated with the improperly stored vaccine (dose and route not reported). There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Facial paralysis
Clinical narrative: Ear pain within first week Bells Palsy about week after pain treatment anti viral meds prednisone.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Tdap administred 4/18/16, IM L deltoid. She called on 4/21/16 at 11:32 am to report 2x2 circle redness at site, warm to touch, slight swelling and achy.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Expired product administered
Clinical narrative: Pharmacist gave expired vaccine of PNEUMOVAZX 23 to me.  Vaccine expired 3/19/2016, vaccine given 04/20/2016.
Sex: U
Vaccine: HPV4
Symptoms: Death, Premature menopause
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. The reporter read in an article online that, on unspecified dates, an unspecified number of patients were vaccinated with GARDASIL (lot number, expiry date, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. The article reported that an unspecified number of patients developed premature ovarian failure an unspecified time after receiving GARDASIL. Additionally, the article mentioned that an unspecified number of patients passed away on unknown dates, on an unspecified time after receiving GARDASIL. It was unspecified if the patients that passed away were the same patients that developed premature ovarian failure. It was unknown if an autopsy was performed. At the time of reporting, the outcome of premature ovarian failure was unknown. The reporter did not provide a causality assessment between the reported events and the GARDASIL. The cause of death was not mentioned. Additional information is not expected, as the reporting physician did not allow further contact for follow-up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the unspecified patients were vaccinated with an improperly stored doses ROTATEQ, orally (which had a lot # of K022992 and an expiration date of 30-JUN-2016; however, dose and dosage number were not reported). However, no symptoms were reported. The vaccines experienced the following temperature excursion: not less than 32 F for 107 hours. This is one of several reports received from the same reporter. 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 certified medical assistant, and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL 9 (which had a lot # of L007560 and an expiration date of 15-JUN-2017: however, dose, dosage number, route of administration and anatomical location were not reported). However, no symptoms were reported. The vaccines experienced the following temperature excursion: not less than 32F for 107 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: Right hand swollen - multiple joints swollen & painful left ankle, left elbow, right wrist.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Febrile convulsion, Full blood count, White blood cell count increased
Clinical narrative: Set of iz given on 4/1916 (PCV13, PENTACEL. HBV). Pt transported via ambulance to the ER on 4/2016. Dx: Febrile seizure.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Rash, Skin disorder, Urine analysis
Clinical narrative: This spontaneous report was received from a 65 year old female patient reporting on herself. The patient did not have medical history, drug reactions included sulfonamide allergy. In approximately 2012, (reported as: "4 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, anatomical location, lot number and expiration date were not provided). Concomitant therapies included ZYRTEC. The patient stated that in December 2015, she developed a rash on her left side below her collar bone with migrated. In approximately 08-APR-2016 (reported as "a week ago"), she noticed 3 dots in a row in same area as in December 2015 (skin disorder). The patient received treatment for the adverse events. It was reported that a blood test an urine test was performed in August 2015 (results not provided). The outcome of rash was reported as recovered and the outcome of skin disorder was not reported. The reporter did not assess the relatedness between the event and suspect therapy. Additional information is not expected, since no consent to contact the reporter was provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions and concurrent conditions were unknown. On 02-APR-2016, the patient inadvertently was vaccinated with 2 vials of PNEUMOVAX23 (dose, frequency and indication were unknown) lot # L02936 and expiration date on 26-MAR-2017. Concomitant therapies were unknown. Product quality was not involved. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incisional drainage, Injection site infection, Injection site swelling
Clinical narrative: Swollen and infected injection site. 3 courses of antibiotics. Incision and drain by surgeon.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant via Pfizer (other company number: 2016190045) referring to a 16 year old female patient with upper respiratory allergies and food allergies. The patient's medical history included conjunctivitis and eczema which were both associated with allergies. The patient had 3 prior doses of CERVARIX years. There was no any vaccinations within four weeks prior to the vaccination of GARDASIL. The patient was sick with one week of wheezing for the first three days but better on 14-MAR-2016. On 14-MAR-2016 12:45 in the afternoon, the reporter vaccinated the patient in a physician's office with GARDASIL (lot # L045711, expiration date: 08-MAY-2017) dose 1, and TRUMENBA (lot# M13066, expiration date September 2016). Both were 0.5 ml and vaccinated intramuscularly in the right arm. Concomitant therapies included FLUZONE and MENACTRA. On 15-MAR-2016, the patient experienced redness, itchiness, and swelling in the right arm. She went to see the physician because of the redness and swelling of the right arm on 16-MAR-2016 and was told to come back if needed to. Outcome of the events and the causality were not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ, FLU3, HPV9, MENB, MNQ, FLU3, HPV4, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a medical assistant via Pfizer (other company number: 2016190045) referring to a 16 year old female patient with upper respiratory allergies and food allergies. The patient's medical history included conjunctivitis and eczema which were both associated with allergies. The patient had 3 prior doses of CERVARIX years. There was no any vaccinations within four weeks prior to the vaccination of GARDASIL. The patient was sick with one week of wheezing for the first three days but better on 14-MAR-2016. On 14-MAR-2016 12:45 in the afternoon, the reporter vaccinated the patient in a physician's office with GARDASIL (lot # L045711, expiration date: 08-MAY-2017) dose 1, and TRUMENBA (lot# M13066, expiration date September 2016). Both were 0.5 ml and vaccinated intramuscularly in the right arm. Concomitant therapies included FLUZONE and MENACTRA. On 15-MAR-2016, the patient experienced redness, itchiness, and swelling in the right arm. She went to see the physician because of the redness and swelling of the right arm on 16-MAR-2016 and was told to come back if needed to. Outcome of the events and the causality were not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Dizziness, Fatigue
Clinical narrative: Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Malaise, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting, X-ray, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Vomting, joints hurt, frequent headaches, general feeling of unwell, feeling dizzy, painful hands, feet, arms, legs, nausea, muscle weakness, tiredness, missing more school from not feeling good.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Lethargy, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: 6X8 inch swelling of arm tender fever chills nausea lethargy.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: 6X8 inch swelling of arm tender fever chills nausea lethargy.
Age: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: Pain and Redness/pink area about 4 inches around injection site.  Tightness/small knot at injection site. No fever or warm to touch at injection site.
Age: 39.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, tenderness at injection site and slight fever.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray, Pneumonia
Clinical narrative: RML, RLL Pneumonia, treated with antibiotics.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: STARTED OUT AS SMALL RED MARK, BY 4/23/2016 GREW TO ABOUT 2 INCH OVAL, HAD PT TAKE ORAL BENADRYL AND OBSERVE, IF NOT BETTER IN 2 HOURS SEEK MED ADVICE.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle and joint pain, headache, continuing at this time, 04/23/2016. 5:38 PM.  Tylenol.