chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Viral infection, Vomiting
Clinical narrative: Mom reports that child became nauseated and would not eat. Started throwing up that night and continued to the next day. Child complained of body aches and also ran a fever of 102. Went to doctor on 7/27/16 and was told that he probably got a virus and the immunizations weakened his immune system. Gave anti nausea meds.
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for her son via a company representative. A male patient of an unspecified age and ethnicity received the first dose of TRUMENBA via an unspecified route of administration, in the arm, on an unspecified date, at 0.5 ml single. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after vaccination the patient arm got swollen and he was diagnosed with cellulitis. The patient received an antibiotic. The outcome was unknown at the time of report. The physician recommended to go to an ID (Infectious Disease Doctor), and he evaluated to see if the patient could get the second shot. The reporting nurse believed that cellulitis was because of the vaccination.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Malaise, Pallor, Periorbital cellulitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician and from a contactable healthcare professional (HCP) based on the information received by Pfizer from Sanofi Pasteur, Inc. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) intramuscularly on the left upper arm on 10May2016 at 16:00 at 0.5 ml single. The patient did not receive the second dose of the vaccine. The patient had none medical history. Concomitant vaccine administered on 10May2016 included the second dose of MENACTRA (Sanofi Pasteur, lot number 05187AA) intramuscularly on the right arm. The patient previously received the first dose of MENACTRA (Sanofi Pasteur, lot number 05187AA), intramuscularly on the right arm on unknown date at 1DF and no adverse event occurred. The reporting HCP confirmed that the patient did not receive any Sanofi Pasteur product while the physician reported that the patient received two doses of MENACTRA (Sanofi Pasteur). On an unspecified date in May2016, after the vaccination, the patient had an immediate reaction fever of 102 F and she was sick. The patient also experienced pallor and tonic clonic movement arms 2-3 sec time of administration on 10May2016 and 48 hours later, in May2016, she experienced the preseptal cellulitis. No specific treatment was required for the events and no emergency room or physician visit. The outcome of the events was unknown. The physician confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccine. Follow-up (31May2016): New information from a contactable healthcare professional includes: confirmation that the patient did not receive any Sanofi Pasteur product. Follow-up (16Jul2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Jul2016): New information reported from a contactable physician includes: reporter's and patient's information, details of vaccination, concomitant vaccine and past vaccine history, new events, no emergency room or physician visit or treatment required for the events. Confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccine.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Tonic clonic movements
Clinical narrative: This is a spontaneous report from a contactable physician and from a contactable healthcare professional (HCP) based on the information received by Pfizer from Sanofi Pasteur, Inc. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) intramuscularly on the left upper arm on 10May2016 at 16:00 at 0.5 ml single. The patient did not receive the second dose of the vaccine. The patient had none medical history. Concomitant vaccine administered on 10May2016 included the second dose of MENACTRA (Sanofi Pasteur, lot number 05187AA) intramuscularly on the right arm. The patient previously received the first dose of MENACTRA (Sanofi Pasteur, lot number 05187AA), intramuscularly on the right arm on unknown date at 1DF and no adverse event occurred. The reporting HCP confirmed that the patient did not receive any Sanofi Pasteur product while the physician reported that the patient received two doses of MENACTRA (Sanofi Pasteur). On an unspecified date in May2016, after the vaccination, the patient had an immediate reaction fever of 102 F and she was sick. The patient also experienced pallor and tonic clonic movement arms 2-3 sec time of administration on 10May2016 and 48 hours later, in May2016, she experienced the preseptal cellulitis. No specific treatment was required for the events and no emergency room or physician visit. The outcome of the events was unknown. The physician confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccine. Follow-up (31May2016): New information from a contactable healthcare professional includes: confirmation that the patient did not receive any Sanofi Pasteur product. Follow-up (16Jul2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Jul2016): New information reported from a contactable physician includes: reporter's and patient's information, details of vaccination, concomitant vaccine and past vaccine history, new events, no emergency room or physician visit or treatment required for the events. Confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot Number: M67951; Expiration Date: Aug2017), via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date after vaccination, the patient experienced cellulitis and pain in her arm after injection/right arm hurting. The clinical course was as follows: The patient experienced right arm hurting and seven days after vaccination was diagnosed with cellulitis at the emergency room. Therapeutic measures may have been taken as a result of the cellulitis and pain in her arm after injection/right arm hurting as the patient was prescribed KEFLEX. It was reported that it was unknown whether the patient actually took the cephalexin, as it was reported not filled. It was reported that the patient was asked to go back to the emergency room to rule out sepsis. The clinical outcome for the events of cellulitis and pain in her arm after injection/right arm hurting was unknown. No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a child of an unspecified age, gender and ethnicity received, on an unknown date, TRUMENBA single dose. Relevant medical history and concomitant medications were not reported. The patient had an immediate seizure when given TRUMENBA. Clinical outcome was unknown at time of this report.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with improperly stored M-M-R II, lot # 1039613, expiry date 08-OCT-2017. No adverse reactions were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 102.4 with Hives covering whole back and chest, and face.
Age: 1.06
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 1 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 19-JUL-2016, the patient was vaccinated with VARIVAX (strength, dose, route of administration, lot number and expiration date were not reported) or M-M-R II (strength, dose, route of administration, lot number and expiration date were not reported). The nurse could not confirm which vaccine was given to the patient and stated that "the vaccines may have been labeled wrong prior to administration". Additionally, a healthcare worker called asking if Merck could test the syringe, filled with the vaccine, to see what product was administered. On 19-JUL-2016 (the same day of vaccination), the patient experienced a reddened area that localized at the injection site (injection site erythema) and resolved within five minutes. The patient sought unknown type of medical attention and was unknown if a treatment was given for the event. No product quality complaint was involved. The outcome of injection site erythema was reported as recovered on 19-JUL-2016. The causal relationship between the event and VARIVAX and M-M-R II was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions, historical conditions or concomitant medications were provided. In approximately 1991 (reported as 20 or 25 years ago) the patient was vaccinated with unknown hepatitis B vaccine (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). It was reported that on an unknown date (reported as recently), an unknown blood test did not show that the patient had the immunity to Hepatitis B. The outcome of the event and causality were not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified nursing assistant refers to multiple patients of unknown age and gender. the patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and site of administration, lot # and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Cytogenetic analysis, Exposure during pregnancy, Rubella antibody negative, Ultrasound scan normal
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a 25 year old female patient. Information on the patient's concurrent conditions or medical history was not reported. the patient became pregnant with last menstrual period (LMP) of 07-MAR-2016 and estimated delivery date (EDD) of 12-DEC-2016. On 18-JUL-2016, the patient (19 weeks of gestation on that day) was inadvertently vaccinated with a dose of M-M-R II (lot # L037356, expiration date: 28-SEP-2017, dose and route were not reported). Concomitant therapy included prenatal vitamins (unspecified). No treatment was given to the patient. the nurse practitioner stated that the patient was doing fine but at the time of the visit on 18-JUL-2016, the patient had prenatal labs drawn as "patient entered care late" along with an ultrasound. Per nurse practitioner, according to prenatal labs, the patient was immune to rubella and "so for all labs and ultrasound were within normal limits." the patient also received genetic test "quad screen" at time of visit on 18-JUL-2016. Per nurse practitioner, she and physician were "sending the patient to unspecified maternal/fetal medicine group for high risk ob/gyn." the pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 02-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot # M003659, expiry date: 20-SEP-2017) on 02-JUN-2016. When patient was visiting unspecified department of health for unspecified reasons, patient received second dose of GARDASIL 9 (lot information was not provided) in series on 06-JUN-2016, slightly earlier than PI schedule (inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: At 1040A patient received 7 vaccines then started to feel dizzy. PHN had patient lie flat on exam table, VS checked frequently and water given. Patient did not eat breakfast.
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased
Clinical narrative: Initial unsolicited report received from a non-health care professional on 14 October 2015. This case involves a (age unknown) female patient who was vaccinated with a [route and dose series not reported] 0.5 ml syringe dose of FLUZONE QIV (batch number, expiry date and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had increased blood pressure. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow-up information received from a non-healthcare professional  on 11 January 2016. On an unspecified date the patient got recovered. It was reported that reaction was not due to the vaccine, Patient had several other stressors at the time.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Atypical pain at injection site.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Submaxillary gland enlargement
Clinical narrative: Submandibular swelling and fever (101). AUGMENTIN prescribed. Follow up in 2 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Blister, Decreased appetite, Malaise, Papule, Pyrexia
Clinical narrative: Fever for 3 days, malaise, poor appetite developed fluid filled vesicles and smaller papules.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Headache, Lethargy, Myalgia, Nausea
Clinical narrative: 1 day after vaccine pt had headaches, fever, muscle pain, nausea, abd pain, lethargy.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: 1 day after vaccine pt had headaches, fever, muscle pain, nausea, abd pain, lethargy.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of VAQTA (lot# M003011, expiration date 15-NOV-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Approximately 30 minutes after receiving HPV 9 vaccine c/o lightheadedness followed by syncopal episode w/LOC approximately 10 sec associated w/diaphoresis. Rapid recovery over the course of supine position for approximately 15 min. Monitored for 40 minutes before discharging home.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary mass
Clinical narrative: Found lump in left axilla. Came to our office on 8/2/16 and was treated with Bactrim DS one tab twice a day for 10 days.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient experienced syncope following immunizations: Dizzy, light-headed, sweating.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Numbness, pain, tingling, loss of feeling at injection site, plus entire arm, write, hand, and shoulder. As of today, still no relief.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site reaction, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Numbness, pain, tingling, loss of feeling at injection site, plus entire arm, write, hand, and shoulder. As of today, still no relief.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site reaction
Clinical narrative: Numbness, pain, tingling, loss of feeling at injection site, plus entire arm, write, hand, and shoulder. As of today, still no relief.
Age: 37.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Numbness, pain, tingling, loss of feeling at injection site, plus entire arm, write, hand, and shoulder. As of today, still no relief.
Age: 13.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Tremor
Clinical narrative: CLIENTS FATHER CALLED AND STATED THAT ON 7/29/2016 IN THE EVENING WHILE CLIENT WAS STAYING WITH HIS MOTHER, THE CLIENTS MOTHER STATED THE CLIENT COMPLAINED OF WEAKNESS AND SHAKING. THAT THE CLIENT HAD RECEIVED A RABIES VACCINE EARLIER IN THE DAY.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Injection site pain
Clinical narrative: Dizzy, shortness of breath, injection site very sore.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Patient's mother reports that patient broke out in hives and a red rash from neck to toes after receiving DTaP, Hep B, IPV, HIB, and Prevnar.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site reaction, Pruritus, Rash generalised, Rash papular
Clinical narrative: Red raised papules started to left arm on 7/14/16 and progressively spread over entire body causing itching. Child visited primary care provider on 7/25/16 and was started on Prednisone and Zyrtec by mouth and triamcinolone 5% topically. Rash continued to spread after being on medications for 6 days. Another doctor visit on 8/1/16 and was continued on Prednisone, Zyrtec and started on zantac by mouth for 9 days. Triamcinolone topically continued. Child has followup with doctor 8/11/16.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Muscle spasms, Opisthotonus, Seizure like phenomena, Urinary incontinence
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 26-Oct-2015. This case involves a 16 years old female patient who was vaccinated with a dose of FLUZONE QIV (manufacturer: Sanofi Pasteur, batch number: UI492AA, expiry date: 30-Jun-2016, dose details, route and site of administration was not reported) on 24-Oct-2015. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies included seasonal allergies, there were no medical conditions, birth defects were not reported. The patient had several flu vaccines for past 10-11 years. On 24-Oct-2015, few seconds after vaccination, the patient passed out, had   "seizure like" arching of her back, muscle spasms and was incontinent of urine. Ambulance was called and she was transported to the hospital on an unspecified date. The patient received unspecified corrective treatment in the emergency room and was released. Laboratory investigations were not reported. The outcome of the events was reported as unknown. Upon internal review, the case was considered to be serious due to important medical events seizure like arching of her back and muscle spasms, passed out and incontinent of urine. List of documents held by sender: none. Follow up report received from a consumer (patient's parent) on 16-Nov-2015. It was reported that the patient was taken to emergency room by EMT (Emergency Medical Technician) after the incident, completed assessment was perform in ER and no abnormality found. The patient was referred to neurology for follow up.; Sender's Comments: Seizure may occur after the administration of INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is compatible with the role of the vaccine. However, a detailed laboratory work up including but not limited to EEG, blood tests etc., concomitant medication is required to assess this case. Based on the provided information the role of the vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Diplopia, Dry eye, Eye disorder, Eye pain
Clinical narrative: Initial unsolicited report received from a consumer  on 26-Oct-2015. This case involves a 67-year-old female patient who was vaccinated with intramuscular dose of FLUZONE HD (batch number and route of administration were not reported) on 14-Aug-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 25-Aug-2015, 11 days after vaccination, the patient experienced dry and sore eyes. patient experinced pain in eye and wokeup at night. After few days on an unspecified the patient developed diplopia. On 4-Sep-2015, patient was seen by her PCP who referred her an opthamologist. On 11-Sep-2015 an eye specialist stated that the patients left eye was not in focus with the right eye. Patient experinced ER/doctor visit. Laboratory investigations included MRI and blood work which was reported as WNL (within normal limits.) On 31-Aug-2015, an optometrist prescribed eye drops to moisten eyes before sleeping. On an unspecified day the patient was prescribed an eye ointment by ophthalmologist. After the MRI was performed, the neurologist prescribed mestinon to rule out Myasthenia Gravis. It was reported that the patient had a follow up with the neurologist who prescribed prednisone as Mestinon did not help. Patient was seen by the neurologist on 14-Oct-2015 and all symptoms were cleared. Patient was recovered from all the events. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial unsolicited report received from a consumer  on 26-Oct-2015. This case involves a 67-year-old female patient who was vaccinated with intramuscular dose of FLUZONE HD (batch number and route of administration were not reported) on 14-Aug-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 25-Aug-2015, 11 days after vaccination, the patient experienced dry and sore eyes. patient experinced pain in eye and wokeup at night. After few days on an unspecified the patient developed diplopia. On 4-Sep-2015, patient was seen by her PCP who referred her an opthamologist. On 11-Sep-2015 an eye specialist stated that the patients left eye was not in focus with the right eye. Patient experinced ER/doctor visit. Laboratory investigations included MRI and blood work which was reported as WNL (within normal limits.) On 31-Aug-2015, an optometrist prescribed eye drops to moisten eyes before sleeping. On an unspecified day the patient was prescribed an eye ointment by ophthalmologist. After the MRI was performed, the neurologist prescribed mestinon to rule out Myasthenia Gravis. It was reported that the patient had a follow up with the neurologist who prescribed prednisone as Mestinon did not help. Patient was seen by the neurologist on 14-Oct-2015 and all symptoms were cleared. Patient was recovered from all the events. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Headache, Pain
Clinical narrative: Initial unsolicited report received from a consumer on 26-Oct-2015. This case involves a 76 years old male patient who was vaccinated with a dose of FLUZONE HD via intramuscular route in the right arm (manufacturer: Sanofi Pasteur, batch number, expiry date and dose details were not reported) and a dose of PNUEMOVAX via intramuscular route in the right arm (manufacturer: other, batch number, expiry date, dose details were not reported), both on 26-Oct-2015. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, medical conditions, birth defects were not reported. It was unknown if the patient was previously vaccinated. On 26-Oct-2015, same day after vaccination, the patient experienced general aches, his hair was hurting, headaches and backaches. Laboratory investigations and corrective treatment was not reported. The patient required ER/doctor visit. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Sneezing, Upper-airway cough syndrome
Clinical narrative: Initial unsolicited report received from a pharmacist on 26 October 2015. This case involves a 69-year-old male patient who was vaccinated with a intramuscular [series not reported] dose of FLUZONE HD (batch number UI434AA, expiry date 04 April 2016) in left arm on 18 October 2015. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 18 October 2015, few hour following the vaccination patient had started sneezing for hours, had asthma like s/s and a nasal drip. Patient laboratory investigation and corrective treatment were not reported. On an unspecified date, patient had recovered. Upon medical review, the case was considered as serious due to important medical event asthma like s/s. List of documents held by sender: none.; Sender's Comments: Asthmatic attack is listed following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. Time to onset is compatible with a role of the vaccination; however it is not known whether asthma was well controlled in this patient with medical history of asthma. Complementary information regarding the frequency, severity and triggering factors of previous asthmatic attacks, as well as history of any previous allergies and information on any treatment adjustment following this episode would be helpful to further assess the case.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 26 October 2015. This case involves a three-year-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number-UI463AA, expiry date-30 June 2016) intramuscularly on left thigh on 23 October 2015. The patient's medical history of illness at time of vaccination, birth defects, medical conditions were not reported and the patient had none known allergies. The patient's concomitant medications were not reported. On 24 October 2015, one day following the vaccination, the patient's thigh and upper leg became very swollen , " about 3 times normal size". The patient required ER/doctor visit on 26 October 2015. Laboratory data and corrective treatment were not reported. As of 26 October 2015, it was reported that the swelling was decreased but the patient was not recovered from the events. List of documents held by sender: none.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: CLIENT DEVELOPED ERYTHEMA (10 CM IN DIAMETER) TO INJECTION SITE TO RIGHT ANTERIOR THIGH.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient faints 15 minutes after vaccinations.  Recovers quickly with no troubles noted.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test, Facial paralysis, Headache, Hypoaesthesia, Laboratory test
Clinical narrative: Bell's Palsy, Paralysis of right side of face.  Had bad headache night before and numbness of face early AM (4 AM or so),  awoke to right side of face paralyzed.  He was at camp, where he was working in the kitchens.  He was taken to the Hospital that morning (6-19-2016)  They did a tick panel, blood work, diagnosed him with Bell's Palsy, prescribed Doxycycline, prednisone, and an anti-viral that I do not have the name of with me at the moment.  Sent him home to be evaluated by his primary care physician -seen 6-22-16, saw an eye doctor on 6-23-16, recheck with Dr on 7-6-16--no improvement so sent to a Neurologist Dr (7-11-16)--he ordered an MRI (7-13-16)and physical therapy (2x a week for 6 weeks) (Dr may have ordered the therapy).  On 8-3-16, I was talking to a friend who has had Bell's Palsy and she said that she was told that hers was caused by the chickenpox/shingles virus.  I said that he was vaccinated, that he had never had chicken pox, then I remembered that we had a vaccine boosted at the physical.  When I checked my records and discovered that it was the chicken pox vaccine that we boosted, I felt that it was significant enough to report it.  I plan to call the doctor to report it as well.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Bell's Palsy, Paralysis of right side of face.  Had bad headache night before and numbness of face early AM (4 AM or so),  awoke to right side of face paralyzed.  He was at camp, where he was working in the kitchens.  He was taken to the Hospital that morning (6-19-2016)  They did a tick panel, blood work, diagnosed him with Bell's Palsy, prescribed Doxycycline, prednisone, and an anti-viral that I do not have the name of with me at the moment.  Sent him home to be evaluated by his primary care physician -seen 6-22-16, saw an eye doctor on 6-23-16, recheck with Dr on 7-6-16--no improvement so sent to a Neurologist Dr (7-11-16)--he ordered an MRI (7-13-16)and physical therapy (2x a week for 6 weeks) (Dr may have ordered the therapy).  On 8-3-16, I was talking to a friend who has had Bell's Palsy and she said that she was told that hers was caused by the chickenpox/shingles virus.  I said that he was vaccinated, that he had never had chicken pox, then I remembered that we had a vaccine boosted at the physical.  When I checked my records and discovered that it was the chicken pox vaccine that we boosted, I felt that it was significant enough to report it.  I plan to call the doctor to report it as well.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Soft tissue infection
Clinical narrative: Chills, soft tissue infection.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient arm is red, hot and swollen. Patient went to the doctor and was given an antibiotic and a pain medication.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Muscle swelling, Myalgia
Clinical narrative: Patient experienced muscle swelling, pain. Had a bump in the area of the arm where the vaccination was given. Checked with the patient today. Pt is doing ok. Mentioned her pain is gone, still has the bump but much smaller in size. her husband mentioned it is becoming smaller and smaller day by day.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, CSF white blood cell count increased, Encephalitis, Headache, Nausea
Clinical narrative: Meningoencephalitis with ADEM and optic neuritis. Headaches, nausea, vomiting. Tx: Methylprednisone.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Vomiting
Clinical narrative: Meningoencephalitis with ADEM and optic neuritis. Headaches, nausea, vomiting. Tx: Methylprednisone.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Peripheral swelling
Clinical narrative: Information has been received from a female patient of unknown age, who was also a pharmacist, concerning to herself. The patient's pertinent medical history and concurred conditions were not provided. The patient reported that on 31-JUL-2016 she was vaccinated with ZOSTAVAX (lot #, dose, route and expiration date were not provided). Concomitant therapies were not provided. It was also reported that on 01-AUG-2016, 2 days after onset date of therapy with ZOSTAVAX, her arm became swollen 5 inches around, red and she was in pain. The patient said that she "generally did not feel well". The patient stated that she needed to order brochures. The outcomes of arm swollen 5 inches around, red, pain, and generally did not feel well were unknown at the time of the report. There was no product quality complaint (PQC) involved. 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 registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were not reported. On 27-JUL-2016, the patients were vaccinated with an unspecified number of improperly stored doses of RECOMBIVAX HB lots # K021444 and M008551, expiry dates 17-SEP-2017, 27-NOV-2017 and 02-JUN-2018 respectively. The doses and routes of administration were not reported. At the same date no adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to six patients of unknown age and gender. None of their pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (which had a lot # M004116 with an expiration date of 12-OCT-2017; however, the dose, dosage number, anatomical location and route of administration were unknown). No concomitant medications were reported. The aforementioned vaccine experienced a temperature excursion of 32 F for a time frame of 30 minutes, which was called out due to a data logger. Reportedly, the vaccine had not undergone any previous temperature excursions. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from office manager refers to a 74 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were unknown. On 27-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L027732 and expiration date 23-FEB-2017) intramuscular or subcutaneous. On an unknown date in July 2016 after vaccination, he developed "pain and redness at insertion site, area of 13cm x 20cm, with a sunburn resemblance, and warm to the touch". He was treated with Ibuprofen for pain, and 25 mg of BENADRYL. At the time of reporting the outcome of the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were no reported. On 27-JUL-2016, the patient were vaccinated with an unspecified number of improperly stored doses of VAQTA lots # M021124 and M002268, expiry date 02-FEB-2018 and 20-SEP-2017 respectively. The doses and route of administration were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were no reported. On 27-JUL-2016, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ orally lots # M004890, M014544 and M007125, expiry date 10-NOV-2017, 27-NOV-2017 and 06-OCT-2017 respectively. The doses and routes of administration were not reported. At the same date no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy was not provided. On 20-JUL-2016, the patient was received an unknown dose of improperly stored ZOSTAVAX (lot # M013377, expiration date 25-MAY-2017, subcutaneous; dose was unknown). The vaccine was stored under 32F for 16 days. There was no previous temperature excursion. Data logger was not involved. No adverse effects was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to multiple patients of unknown age and gender. the patient's concurrent condition, medical history or concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot# M006729, expiration date 08-FEB-2018, dose ad route unknown). the vaccine had been stored under the temperature of 21.7 Fahrenheit. There was no previous temperature excursion and no date logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L039141 with expiration date 16-AUG-2017 and lot # M004883 with expiration date 02-OCT-2017; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical histories and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with multiple improperly stored (Oka-Merck) PROQUAD (dose and route were unknown, lot # L051098, expiration date 17-JUN-2017; lot # M002053, expiration date 11-JUL-2017; lot # L046506, expiration date 17-MAY-2017 and lot # M006102, expiration date 01-AUG-2017 (therapy type is rHA). The nurse provided the details of excursion: temperature mas of -7.2 degree centigrade for a cumulative time frame of 9 hours and 17 minutes and a max of -12.6 degree centigrade for cumulative time frame of 6 hours and 10 minutes. The current temperature was -14.1 degree centigrade, which was still out of range at the time of the report. The vaccines were also exposed to a previous excursion of -4 degree centigrade for 3 hours. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a retired pharmacist, referring to a 70 year old male patient. Prostate cancer was reported as pertinent medical history. The patient with no reactions or allergies. On approximately 2006, when the patient was 60 years old, he was vaccinated with ZOSTAVAX (lot #, expiry date, concentration, dose and route of administration were not reported). There was no concomitant medication reported. On an unknown date in 2016, when patient was 70 years old, he developed a case of shingles. The patient sought medical attention through the office visit. Labs diagnostics studies not ask if were performed. The reporter stated patient was treated with valacyclovir and unspecified anti-inflammatory medication "for pain" and patient was "getting better with time" (recovering). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to 10 patients (demographics unknown). Patient's pertinent medical history, drugs reactions and allergies were no reported. On multiple unknown dates the patients were vaccinated with improperly stored (Temperature: 8.4 degrees F, time fame 108 minutes) doses of VARIVAX (lot # M007287, expiry date 12-FEB-2018). Doses and routes of administration were no reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via a company representative refers to a female patient of unknown age. Information on patient's concurrent condition and pertinent medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number not provided). The physician reported that the unspecified patient became pregnant at unspecified time after receiving the unspecified dose of GARDASIL (maternal exposure before pregnancy). The Last Menstrual Period (LMP) date and Estimated Date of Delivery (EDD) were not reported). The outcome of pregnancy was not reported. No further details were noted. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Myalgia, Swelling
Clinical narrative: Myalgia and swollen, red, sore at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt did not look at injection site unless it was tender the next day. Noted and marked red area at 2pm. (Noon was when she felt the soreness) Initially red area measured 6x6.5cm Red area enlarged in size, now noted to be 11cm. in length, no induration, no heat.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, HPV4, MNQ
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Pt did not look at injection site unless it was tender the next day. Noted and marked red area at 2pm. (Noon was when she felt the soreness) Initially red area measured 6x6.5cm Red area enlarged in size, now noted to be 11cm. in length, no induration, no heat.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache, Musculoskeletal chest pain, Vomiting
Clinical narrative: Vomiting X2, dizziness, headache, left chest wall ache.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Lymphadenopathy, Pyrexia, Tenderness
Clinical narrative: Chills, fever, deep (R) upper arm pain. Tender and enlarged lymph nodes. Approx. 7.6 cm x 8 cm.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blister, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Vaccine given 8/1/16. Parent reported 8/3/16 that on 8/2/16 child c/o arm hurting. Parent observed redness, warmth, swelling shoulder to elbow and 4 thin, watery blisters on shoulder.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Redness and warmth x 2 days. No pain, no fluctuance, no induration. Warm compress, loratadine, ibuprofen prn. F/U in 2 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site cellulitis, Rash
Clinical narrative: 08/03/2016 Moderate rash < 14 days. Cellulitis to injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Multiple maculo-papules along entire length of arms - forearms spared. Rash was itchy and BENADRYL given.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: (L) upper arm cellulitis.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Movement disorder, Peripheral swelling, Pruritus generalised, Vaccination site induration, Vaccination site pain
Clinical narrative: Swollen and hard at vaccination site with soreness; rash and itching opposite thumb (large knuckle) was swollen and unmovable - as swelling in arm goes down this is going down.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site swelling
Clinical narrative: Swollen and hard at vaccination site with soreness; rash and itching opposite thumb (large knuckle) was swollen and unmovable - as swelling in arm goes down this is going down.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Minor swelling and complain of pain upper (L) deltoid injection site and numbness and tingling left hand.
Age: 21.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Local edema and erythema to (R) thigh - mostly in the upper part where KINRIX was administered. Pt was given 7.5 mL Children's BENADRYL (12.5 mg/5mL).
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Arthralgia, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: BEXSERO vaccine given on 7/26/16. Child c/o extreme fatigue and started with fever that evening. C/o hot/cold spells, feeling clammy, severe headache, body aches, and joint pain. Woke next day with facial swelling, severe sore throat, nausea, diarrhea and change in behavior. She kept asking what did she need to do next.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Feeling of body temperature change, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: BEXSERO vaccine given on 7/26/16. Child c/o extreme fatigue and started with fever that evening. C/o hot/cold spells, feeling clammy, severe headache, body aches, and joint pain. Woke next day with facial swelling, severe sore throat, nausea, diarrhea and change in behavior. She kept asking what did she need to do next.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Swelling face
Clinical narrative: BEXSERO vaccine given on 7/26/16. Child c/o extreme fatigue and started with fever that evening. C/o hot/cold spells, feeling clammy, severe headache, body aches, and joint pain. Woke next day with facial swelling, severe sore throat, nausea, diarrhea and change in behavior. She kept asking what did she need to do next.