chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2016US181840, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 658019) on 21 Dec 2016. This report refers to a 30 years old female patient. Past medical history and current condition were not reported. Concomitant medications included SINGULAIR, cyproheptadine and NUVARING. She was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) and PNEUMOVAX (other manufacturer, batch number: M033086); both vaccines intramuscularly into the right arm on 05 Oct 2016. After vaccination, on the same day, she experienced muscle pain, diarrhea, chills, body aches, fever and post injection inflammatory reaction. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness and causality of the events were not reported.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Flushing, Lacrimation increased, Pruritus generalised, Scleral disorder, Throat irritation
Clinical narrative: Case number PHHY2016US179652, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 658131) website on 21 Dec 2016. This report refers to a 07 years old male patient. Past medical history included as eczema, ulcerative colitis, Wolff-Parkinson-White syndrome, osteopenia and anxiety disorder due to general medical condition. Current condition Included as asthma, autism spectrum disorder, anaphylaxis, food reaction, chronic motor vocal tic disorder and obsessive compulsive disorder. Concomitant medications included as ZANTAC, OS-CAL, sertraline, epinephrine, Asacol, methotrexate, FLOVENT, CULTURELLE capsule, REMICADE and XOPENEX. The patient was vaccinated with second dose of FLUCELVAX Quadrivalent (batch number: 185886) into left arm, Intramuscularly on 06 Oct 2016. On the same day 18 to 20 minutes after vaccination, the patient experienced full body itching, facial flushing, increased throat clearing, injected sclera and water eyes. Patient given 10 ml of CLARITIN. It was reported that, symptoms resolved after 90 minutes. The patient visited the emergency room. The outcome of the events was reported as complete recovery on 06 Oct 2016. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Case number PHHY2016US180150, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 658193) website on 21 Dec 2016. This report refers to a 04-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618901) intramuscularly in left leg on 28 Sep 2016. The patient was also vaccinated with KINRIX (batch number: G352K) intramuscularly in right leg and MMR II (batch number M006544) subcutaneously in right leg and VARIVAX (batch number: M024680) subcutaneously in left leg on 28 Sep 2016. On 30 Sep 2016 after vaccination, the patient experienced right anterior thigh with a 6-7 cm area of erythema, slight warmth to touch, and slightly indurated. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Case number PHHY2016US179508, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 658306) on 21 Dec 2016. This report refers to a 43 years old male patient. Medical history was not reported. Current condition included red dye allergy. Concomitant medication was reported as unknown. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscularly into left arm on 10 Oct 2016. On same day after vaccination, the patient experienced mild tingling and itching in the throat. It was reported that, these events persisted until approximately 12:00 pm when the patient reported reaction to pharmacist and the patient was told to take oral diphenhydramine and the symptoms resolved with diphenhydramine. The outcome of the events was reported as complete recovery on 10 Oct 2016. The seriousness of the events was reported as non serious and causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHHY2016US179577 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 658322) on 21 Dec 2016. This report refers to 49 year old female patient. Historical drug included penicillin. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscular into left arm and BOOSTRIX (other manufacturer, batch number: 324Z7) intramuscular into left arm on 30 Sep 2016. On 10 Oct 2016, the patient developed swollen lymph nodes over her shoulder near her neck. The patient started on the left, and few days later the right side started too. The outcome of the event was reported as unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: Case number PHHY2016US181456, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 658534) on 21 Dec 2016. This report refers to a 15 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185886) intramuscularly into left arm on 19 Sep 2016. It was reported that, at a school on 19 Sep 2016, the teacher called for a girl to get vaccinated. A wrong girl (student) with same first name was vaccinated with FLUCELVAX QUADRIVALENT without parent consent due to mix up. It was reported that nurses were all spoken to about confirming the child's identity prior to vaccination. No adverse event was reported following this medication error.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Lethargy, Limb discomfort
Clinical narrative: Case number PHHY2016US181246, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 658871) on 21 Dec 2016. This report refers to a 34 year old female patient. Medical history was not reported. Current condition included allergy to HALDOL. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) administered intramuscularly into left arm on 05 Oct 2016. On the same day after vaccination, the patient experienced numbness in lower lip, dizziness, lethargy, numbness, tingling in left arm to 4th and 5th fingers and her arm felt heavy. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2016US181246, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 658871) on 21 Dec 2016. This report refers to a 34 year old female patient. Medical history was not reported. Current condition included allergy to HALDOL. Concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185325A) administered intramuscularly into left arm on 05 Oct 2016. On the same day after vaccination, the patient experienced numbness in lower lip, dizziness, lethargy, numbness, tingling in left arm to 4th and 5th fingers and her arm felt heavy. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 51.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Peripheral swelling, Vomiting
Clinical narrative: Case number PHHY2016US181064 is initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 658934) website on 21 Dec 2016. This report refers to a 51 year old female patient. Medical history included asthma, current condition included diabetes. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186685) intramuscular into left arm and PNEUMOVAX (other manufacturer, batch number: M033086) intramuscular into left arm on 10 Oct 2016. On 11 Oct 2016, patient arm swollen and red. Patient had vomiting. Patient received steroid shot. The patient visited emergency room/doctor (date not reported) The outcome of the events was completely resolved. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dizziness, Muscle spasms
Clinical narrative: Case number PHHY2016US179102, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number 659230) website on 21 Dec 2016. This report refers to a 40-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 1618901) intramuscularly in left arm on 07 Oct 2016. On the same day after vaccination, the patient experienced cough, chest spasm and lightheaded, dizzy. The patient received 25 mg BENADRYL and monitored for 20 more minutes. The laboratory data reported as respiratory rate (RR) was 18, blood pressure was 120/78 and AP was 75. The outcome of events was reported as complete recovery on an unspecified date. The seriousness was not reported. The causality of the events was not reported.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Case number PHHY2016US181027, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 659385) on 21 Dec 2016. This report refers to a 64 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 168605) intramuscularly on 10 Oct 2016. After vaccination, on 11 Oct 2016, the patient experienced stomach ache, nausea and vomiting a few hours after administration. The outcome of the events were reported as complete recovery on an unknown date. The seriousness of the events was reported as non-serious and causality was not reported.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immunisation, Product preparation error
Clinical narrative: PENTACEL, a two component vaccine, was administered to patient using only the diluent by an RN on 10/13/17. I received a call from RN directly on 11/6/17 stating that my daughter would need to come back in to be re-vaccinated. RN asked if we would like to just have the vaccine given again and be on our way, but we requested to speak to Dr. I was told by Dr. that the diluent was saline which I have since found to be incorrect. She recommended that we discuss this situation with our new provider at her 6 month check-up and refrain from giving a vaccine on the day we were there (11/6). I asked how they knew that she had missed the vaccine, to which they explained that every day they check the charts and at the end of the week there was one extra dose of the PENTACEL powder, but not the diluent. After investigation they found my daughter was believed to be the only one that week who received this vaccine, and they found that RN was the nurse who administered it. However, I am still not confident that after two weeks elapsed, we can be sure it was her who was improperly vaccinated. We asked what would be done to prevent this from happening again, and we were told this nurse would not be working in Peds anymore and there would be further education of nurses. I sent an email. These are the medical officer and the quality control specialist. They informed me that they had called the manufacturer of PENTACEL to ask how to proceed. They told me that she should receive a HIB only vaccine at her next check-up. This is what we did at her next medical facility.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received KINRIX (batch number unknown, expiry date 2nd December 2017). On 4th December 2017, the patient received KINRIX. On an unknown date, unknown after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: On 4th December 2017, the patient received a dose of KINRIX which was already expired on 2nd December 2017. The address, lot number and initials of the patient were not available. Follow up information received from a nurse on 16th January 2018: The patient's demographic details were updated. On 5th December 2017, the parents of the patient were notified that KINRIX was expired 2 days earlier to vaccination. Dossier Drug company information, Center for Disease Control and AICP information was available. No problems reported at this time but patient's arm was achy. On 7th December 2017, the patient's mother called and reported that right deltoid had red area about 2 inch in diameter. No fever and breathing difficulties had occurred. No other complaints from the patient were reported. Less than a week after receiving KINRIX, the patient experienced injection site hardness and redness. On 8th December 2017, patient's mother reported that the redness was decreasing. This time parent of the patient planned not to repeat the KINRIX even though that would be the recommendations.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Diarrhoea, Fatigue, Full blood count normal, Headache, Insomnia
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. The patient's current condition included obesity, hypersensitivity, blood cholesterol increased and blood triglycerides increased. On 03-JAN-2018 the patient was vaccinated with GARDASIL 9 (lot # and expiry date were not reported) for immunisation. On 04-JAN-2018, 2 days after onset of therapy the patient experienced severe headache that comes and goes,nausea, diarrhea, low grade fever(pyrexia), insomnia but sleeping throughout the day. On 10-JAN-2018, the patient came to the office reporting these adverse events. The Physician did a CBC on 20-JAN-2017. The outcome of headache, somnolence, insomnia, pyrexia, diarrhoea and nausea was reported as not recovered. Causality assessment was not provided by reporter.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Malaise, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. The patient's current condition included obesity, hypersensitivity, blood cholesterol increased and blood triglycerides increased. On 03-JAN-2018 the patient was vaccinated with GARDASIL 9 (lot # and expiry date were not reported) for immunisation. On 04-JAN-2018, 2 days after onset of therapy the patient experienced severe headache that comes and goes,nausea, diarrhea, low grade fever(pyrexia), insomnia but sleeping throughout the day. On 10-JAN-2018, the patient came to the office reporting these adverse events. The Physician did a CBC on 20-JAN-2017. The outcome of headache, somnolence, insomnia, pyrexia, diarrhoea and nausea was reported as not recovered. Causality assessment was not provided by reporter.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Diarrhoea, Full blood count, Headache, Insomnia, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. The patient's current condition included obesity, hypersensitivity, blood cholesterol increased and blood triglycerides increased. On 03-JAN-2018 the patient was vaccinated with GARDASIL 9 (lot # and expiry date were not reported) for immunisation. On 04-JAN-2018, 2 days after onset of therapy the patient experienced severe headache that comes and goes,nausea, diarrhea, low grade fever(pyrexia), insomnia but sleeping throughout the day. On 10-JAN-2018, the patient came to the office reporting these adverse events. The Physician did a CBC on 20-JAN-2017. The outcome of headache, somnolence, insomnia, pyrexia, diarrhoea and nausea was reported as not recovered. Causality assessment was not provided by reporter.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pyrexia, Somnolence
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient. The patient's current condition included obesity, hypersensitivity, blood cholesterol increased and blood triglycerides increased. On 03-JAN-2018 the patient was vaccinated with GARDASIL 9 (lot # and expiry date were not reported) for immunisation. On 04-JAN-2018, 2 days after onset of therapy the patient experienced severe headache that comes and goes,nausea, diarrhea, low grade fever(pyrexia), insomnia but sleeping throughout the day. On 10-JAN-2018, the patient came to the office reporting these adverse events. The Physician did a CBC on 20-JAN-2017. The outcome of headache, somnolence, insomnia, pyrexia, diarrhoea and nausea was reported as not recovered. Causality assessment was not provided by reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On 26-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX Injection, lot # M035696, expiration date 07-NOV-2017, for prophylaxis (strength, route and anatomical location not reported). Later, on 18-DEC-2017, the patient received an extra dose of ZOSTAVAX Injection, lot # N025703, expiration date 16-DEC-2018 (strength, route and anatomical location not reported). Both doses were reconstituted with sterile diluent for which lot numbers and expiration dates were not reported. The registered nurse confirmed that this occurred due to a human error and was not related to product confusion. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In January 2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # M000998, expiration date 07-JAN-2018 (route, dose and frequency were unknown) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-JAN-2018, the patient was administered with an expired dose of ZOSTAVAX (19400 PFU) (lot: N037656, expiry date: 29-NOV-2017) (expired product administered) subcutaneously. Concomitant medication included a sterile diluent. No adverse effects reported. Lot number N037656 is verified to be not valid for ZOSTAVAX.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JAN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose and route of administration were unknown) with lot # N020620 and expiration date of 22-JAN-2019 and sterile diluent (manufacturer unknown) (strength, dose, frequency, route of administration, lot number and expiration date were unknown) both for prophylaxis; which was reported as "49 days early". No adverse effects reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse via company representative, referring to a 11 year old female patient. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 08-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and administration route were not reported) lot number N020352, expiration date 10-APR-2020, for immunization. On 08-JAN-2018, the patient experienced dizziness post vaccination. The patient's blood pressure was checked; however, the result was not provided. She was given some water in the office, then she felt better and was able to go home without any further adverse effects. Treatment was not given for the adverse event. The outcome of dizziness was unknown. The causality assessment between GARDASIL 9 and the aforementioned event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse prescriber, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 24-JAN-2018, the patient may have received an improperly stored dose of VARIVAX lot # N023961, expiration date 01-SEP-2019 or PROQUAD lot # N024564, expiration date 06-Mar-2019 or lot # N020008, expiration date 13-JAN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The temperature range was from -14 degrees Celsius (°C) to -10 °C for a time frame of 5 minutes, with a previous temperature excursion, in the recommended frozen range from -50 °C to -15 °C for 7 minutes. The temperature excursion was called because a data logger. There was not adverse effect or product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 24-JAN-2018, the patient was vaccinated with an expired dose of ROTATEQ, orally, (lot # M025572 with an expiration date in 20-JAN-2018), for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A male patient of an unspecified age (62 unit unknown) and ethnicity received PREVNAR 13 on an unspecified date at single dose for immunisation. Medical history included heart disease, atrial fibrillation (Afib). Concomitant medication included apixaban (ELIQUIS), amisodarone (AMIODARONE). The patient experienced diffuse maculopapular pruritic rash upper and lower extremities and anterior/posterior thorax on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. An elderly male patient of an unspecified ethnicity received PREVNAR 13 (batch/lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date at 0.5 ml, single for vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at injection site and swollen arms after receiving the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) vaccine. The events recovered on their own without treatment or medications. The information on the batch/lot number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018036735 same reporter/drug/event, different patient.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Computerised tomogram normal, Headache, Influenza like illness, Lumbar puncture normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of memory loss in a 56-year-old male patient who received SHINGRIX (batch number P539L, expiry date 31st January 2020). Concomitant products included PRILOSEC and lisinopril. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, 6 days after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization). On 19th January 2018, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 20th January 2018, the patient experienced memory loss (serious criteria hospitalization, disability and other: As per reporter) and mental status changes (serious criteria hospitalization). On 21st January 2018, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. In January 2018, the outcome of the memory loss, mental status changes, headache and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the positron emission tomogram, computerized tomogram and lumbar puncture were unknown. The reporter considered the memory loss, mental status changes, headache and influenza-like symptoms to be possibly related to SHINGRIX. It was unknown if the reporter considered the positron emission tomogram, computerized tomogram and lumbar puncture to be related to SHINGRIX.  Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX vaccine in the left deltoid. On 19th January 2018, 7 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, 8 days after receiving SHINGRIX, the patient experienced memory loss and mental status changes. The patient's memory issues involved not being able to recall names and not recognizing his wife or children. On 21st January 2018, 9 days after receiving SHINGRIX, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. The patient was taken to the hospital and positron emission tomography, computerized tomography and lumbar tap were done and those were all negative. No evidence of stroke, transient ischemic attack or bacterial infection was present. The symptoms resolved after lumbar tap. The patient remained in the hospital, at the time of reporting.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Mental status changes, Positron emission tomogram normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of memory loss in a 56-year-old male patient who received SHINGRIX (batch number P539L, expiry date 31st January 2020). Concomitant products included PRILOSEC and lisinopril. On 12th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, 6 days after receiving SHINGRIX, the patient experienced headache (serious criteria hospitalization). On 19th January 2018, the patient experienced influenza-like symptoms (serious criteria hospitalization). On 20th January 2018, the patient experienced memory loss (serious criteria hospitalization, disability and other: As per reporter) and mental status changes (serious criteria hospitalization). On 21st January 2018, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. In January 2018, the outcome of the memory loss, mental status changes, headache and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the positron emission tomogram, computerized tomogram and lumbar puncture were unknown. The reporter considered the memory loss, mental status changes, headache and influenza-like symptoms to be possibly related to SHINGRIX. It was unknown if the reporter considered the positron emission tomogram, computerized tomogram and lumbar puncture to be related to SHINGRIX.  Additional details were provided as follows: This case was reported by a pharmacy intern. The patient received SHINGRIX vaccine in the left deltoid. On 19th January 2018, 7 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 20th January 2018, 8 days after receiving SHINGRIX, the patient experienced memory loss and mental status changes. The patient's memory issues involved not being able to recall names and not recognizing his wife or children. On 21st January 2018, 9 days after receiving SHINGRIX, the patient experienced positron emission tomogram, computerized tomogram and lumbar puncture. The patient was taken to the hospital and positron emission tomography, computerized tomography and lumbar tap were done and those were all negative. No evidence of stroke, transient ischemic attack or bacterial infection was present. The symptoms resolved after lumbar tap. The patient remained in the hospital, at the time of reporting.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Patient started getting a rash on the left arm, which developed on the right arm and lower back too. She took diphenhydramine with no improvement. She was prescribed Methylprednisone 4 mg dose pack for 6 days on 12/27/2017 and Hydrocortisone 0.2% cream on 1/9/2018.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Flu vaccine was injected IM too high into my left shoulder. Site pain became intense and woke me from my sleep at approx 1am on 10/7/17. After approximately 10 days, I noted no improvement in pain, radiation, numbness, tingling fingers, and limited painful range of motion. I saw an orthopedic MD specializing in shoulder pain on 10/19/17.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Rotator cuff syndrome, Sleep disorder, X-ray limb normal
Clinical narrative: Flu vaccine was injected IM too high into my left shoulder. Site pain became intense and woke me from my sleep at approx 1am on 10/7/17. After approximately 10 days, I noted no improvement in pain, radiation, numbness, tingling fingers, and limited painful range of motion. I saw an orthopedic MD specializing in shoulder pain on 10/19/17.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Sore arm at time of injection..sore shoulder blade for one week after. Severe right arm bicep pain eight days after followed by slight weakness to bilateral hands and inability to raise right arm. Affecting ability to drive, bathe etc. Went to walk in clinic, orthopedic, and two emergency rooms with no answers. 10/27/17 saw neurosurgeon and took a round of steroids and acyclovir. Primary care doctor started NEURONTIN for the nerve pain 10/20/17. Unable to raise arm for approximately one month and then able to do so with severe weakness. Began physical therapy after diagnosis of brachial neuritis on 11/03/17. Continue to do physical therapy and continued weakness to right arm with reaching and slight weakness to both hands. Currently on no medication and have no other health problems other than this event.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Neuralgia, Pain in extremity, Radiculitis brachial
Clinical narrative: Sore arm at time of injection..sore shoulder blade for one week after. Severe right arm bicep pain eight days after followed by slight weakness to bilateral hands and inability to raise right arm. Affecting ability to drive, bathe etc. Went to walk in clinic, orthopedic, and two emergency rooms with no answers. 10/27/17 saw neurosurgeon and took a round of steroids and acyclovir. Primary care doctor started NEURONTIN for the nerve pain 10/20/17. Unable to raise arm for approximately one month and then able to do so with severe weakness. Began physical therapy after diagnosis of brachial neuritis on 11/03/17. Continue to do physical therapy and continued weakness to right arm with reaching and slight weakness to both hands. Currently on no medication and have no other health problems other than this event.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Eyelid ptosis, Facial paralysis, Hypoaesthesia, Swelling face
Clinical narrative: 1/10/18 9:00 PM PT TOLD MOTHER HER FACE FELT FAT. 1/11/18 PT WOKE UP WITH DROOPY LEFT EYE 1/12/18 WOKE UP WITH LEFT SIDE OF MOUTH DROOPY- ALL THREE DAYS PT FELT LIKE HER LEFT SIDE OF FACE WAS NUMB PER MOTHER.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Fibromyalgia, Loss of personal independence in daily activities, Neuralgia, Orthostatic intolerance
Clinical narrative: I applied to graduate school for a Nurse Practitioner program which required up to date vaccinations or titers for various diseases. I received 2 Hep B, Tdap, 3 Tb and an Influenza vaccine between 7/17/17 & 10/2/2017. Around 9/15/2017 I experienced an acute panic attack that lasted for around 30 days despite multiple medication treatment attempts by a psychiatric nurse practitioner, family medicine doctor and a psychiatrist. Around early October 2017 I was diagnosed by a doctor who recognized and treats vaccine reactions regularly with acute anxiety secondary to vaccine exposure. I started chelation treatments at his office to remove the various neurotoxins in the vaccines. Once the acute anxiety declined I continued to experience severe neuralgia, Parkinson disease like symptoms i.e involuntary shaking, orthostatic intolerance, extreme exhaustion and fibromyalgia. I still suffer from most of these symptoms to date. I had to withdraw from graduate school and have been on disability from work since this began.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Panic attack, Tremor
Clinical narrative: I applied to graduate school for a Nurse Practitioner program which required up to date vaccinations or titers for various diseases. I received 2 Hep B, Tdap, 3 Tb and an Influenza vaccine between 7/17/17 & 10/2/2017. Around 9/15/2017 I experienced an acute panic attack that lasted for around 30 days despite multiple medication treatment attempts by a psychiatric nurse practitioner, family medicine doctor and a psychiatrist. Around early October 2017 I was diagnosed by a doctor who recognized and treats vaccine reactions regularly with acute anxiety secondary to vaccine exposure. I started chelation treatments at his office to remove the various neurotoxins in the vaccines. Once the acute anxiety declined I continued to experience severe neuralgia, Parkinson disease like symptoms i.e involuntary shaking, orthostatic intolerance, extreme exhaustion and fibromyalgia. I still suffer from most of these symptoms to date. I had to withdraw from graduate school and have been on disability from work since this began.
Age: 33.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth, Peripheral coldness
Clinical narrative: Left arm swollen and hot at injection site, fingers ice cold left hand.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left upper arm pain and swelling went to ER for evaluation of symptoms, followed up in office day after vaccines administered no further treatment necessary.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Full blood count abnormal, Influenza virus test negative, Lymphadenopathy, Myalgia
Clinical narrative: MMR vaccination 2 weeks prior to gradual onset of diffuse muscle and joint aches unexplained by lifestyle changes or illness as well as development of diffuse enlargement of posterior cervical lymph nodes without significant tenderness to palpation.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Neutropenia
Clinical narrative: MMR vaccination 2 weeks prior to gradual onset of diffuse muscle and joint aches unexplained by lifestyle changes or illness as well as development of diffuse enlargement of posterior cervical lymph nodes without significant tenderness to palpation.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 11-JAN-2018 the patient was vaccinated with dose one of VARIVAX from lot N022978 expiration date 23-AUG-2019 (Inappropriate age at vaccine administration) and dose one of M-M-R II from lot N020925 expiration date 01-AUG-2019; both for prophylaxis. No adverse effects reported. No further information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 62 year old male patient who was referring to himself. The patient's concurrent conditions were elevated white cell count, high blood pressure and high cholesterol. The patient's concomitant medications included unspecified high blood pressure medication and unspecified high cholesterol medication. The patient had no drug reactions and known allergies. On 03-APR-2015, the patient was vaccinated with ZOSTAVAX for prevention of shingles (dose, route of administration, lot number and expiration date were not reported). On approximately May 2015 (reported as about a month after vaccination), the patient experienced hives. The patient stated that they showed up on his body and were itchy and then were gone in a couple of hours (dates not provided). The patient also reported that the hives were worse in the winter than in the summer months. The patient was prescribed with triamcinolone cream as a treatment. There was no laboratory diagnostic studies performed. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies was provided. On 07-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 13-DEC-2017, the patient received the second dose of ZOSTAVAX (exact dose, route of administration, lot# and expiration date were not reported). No adverse symptoms were reported.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer sales representative reported similar events for two patients. This is the second of two reports for a female patient. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain injection site and swollen arm on an unspecified date with outcome of recovered. Pain and swelling went away on their own without treatment or medications. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018036967 same reporter/drug/event, different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort. The patient was treated with hydrocortisone and medication unknown (ice pack (NOS)). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain, injection site rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm. The patient's arm swelled and was very red to the extent that 4 days later she still had a 3 inch by 2.5 inch diameter circle in her arm where the injection was placed. The pharmacist told her to use ice packs and hydrocortisone ointment. The patient felt that she should be compensated for this soreness, rash, burning, and inconvenience to her and wanted to be called back.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Left thigh swelling, warmth, pain and reluctance to walk developed in the afternoon after the vaccinations. Fussiness and low grade fever (100.4 farenheit) on 1/25/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Otitis media acute, Pyrexia
Clinical narrative: Left thigh swelling, warmth, pain and reluctance to walk developed in the afternoon after the vaccinations. Fussiness and low grade fever (100.4 farenheit) on 1/25/18.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site paraesthesia, Rash vesicular, Vaccination site pain
Clinical narrative: Developed herpes zoster at vaccine site immediately after injection -- rash with vesicles, pain, tingling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site reaction
Clinical narrative: Developed herpes zoster at vaccine site immediately after injection -- rash with vesicles, pain, tingling.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash erythematous, Rash papular, Skin oedema, Swelling
Clinical narrative: Rash on left flank onset abruptly on 1/21/17. Rash was papulovesicular, red, swollen, and exquisitely tender. Pt was also febrile.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Tenderness, Ultrasound abdomen abnormal
Clinical narrative: Rash on left flank onset abruptly on 1/21/17. Rash was papulovesicular, red, swollen, and exquisitely tender. Pt was also febrile.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Inflammation, Injection site pain, Pain in extremity, Vaccination complication
Clinical narrative: Pain in right shoulder and right forearm. Also an hematoma in right forearm with inflammation.  The same day that she got the flu shot, she automedicated herself with Acetaminophen and Lidocaine cream from store. Next day she went to an Emergency Room and the physician that attended her said that this was a vaccine adverse reaction.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Full blood count normal, Irritability, Petechiae, Purpura
Clinical narrative: 10 days after her vaccines she developed fussiness and petechia and very small purpura all over her body the following day it all went away and then more purpura developed on her L hand and remained for several days. No other symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Left upper arm redness and warmth post vaccination. Received MCV, Tdap, annual flu, and HPV 1/17/18 during WCC. Unsure which vaccines he received in his left upper arm. Denies fever or itching. C/o pain with raising left arm overhead. No h/o previous vaccine reactions.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Ultrasound Doppler normal
Clinical narrative: Numbness and tingling in lower arm after injection. Resolved within 24 hours.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: When giving PENTACEL, the diluent used was sterile diluent instead of the HIB diluent included with the vaccine.
Age: 23.0
Sex: M
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Blister, Erythema, Rash
Clinical narrative: LOCAL RASH, REDNESS AND BLISTERING. NO TREATMENT OTHER THEN KEEP CLEAN, REPORT WORSENING OF SYMPTOMS
Age: 23.0
Sex: M
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Injection site rash, Injection site vesicles
Clinical narrative: LOCAL RASH, REDNESS AND BLISTERING. NO TREATMENT OTHER THEN KEEP CLEAN, REPORT WORSENING OF SYMPTOMS
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Concussion, Head injury, Loss of consciousness, Post concussion syndrome, Tooth fracture
Clinical narrative: Patient passed out and hit head on floor approx. 10 minutes after receiving vaccines resulting in a chipped tooth and a concussion. She was transported to hospital from the office by ambulance. She has been treated by Ortho and Neurology and diagnosed with a concussion and post concussion syndrome.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Myasthenia gravis
Clinical narrative: I had an exacerbation of my myasthenia gravis about 1 week later. This is the second consecutive year in a row that I received the influenza vaccine and had a myasthenia exacerbation about 1-2 weeks later.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Delirium, Lethargy, Urticaria
Clinical narrative: Patient states she had delirium, lethargy, hives so she went to the closest ER. Give IV fluids with BENADRYL 50mg and symptoms resolved, the proceeded to take BENADRYL orally 25mg every 4 hours as needed for symptoms.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 16 year old male patient. There were no concurrent conditions or medical history. Concomitant and historical drugs or vaccines were not reported. On 29-DEC-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 dose 1, in the left deltoid, lot # L040054, expiration date 26-DEC-2017, for prophylaxis (strength, dose and route of administration were not reported). The medical assistant stated that the date marked on the box of GARDASIL 9 was incorrect, as it was marked as December 2017 (reported as "12/17"). No prescription drug treatment was required. No adverse effects were reported.