chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently give 3rd Dose of MENACTRA. Prior doses were given on 12-23-11 and 2-1-17.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 0.25 FLUZONE influenza vaccine given before 6 months of age.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Severe headache that started one day after vaccine was given, and have been persistent for the past 6 weeks.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Differential white blood cell count normal, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Severe headache that started one day after vaccine was given, and have been persistent for the past 6 weeks.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Urine analysis normal
Clinical narrative: Severe headache that started one day after vaccine was given, and have been persistent for the past 6 weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a nurse regarding 4 year old male patient. The patient's medical history included Austism spectrum disorder ( reported as "autism"); no concomitant medications were mentioned. On 27-OCT-2017, the patient was administered a dose of PROQUAD (lot number N015624, expiration date 27-OCT-2017), subcutaneously as a prophylactic treatment. The vaccine was reconstituted with QUADRACEL DTAP instead of intended sterile diluent (product preparation error). The patient's physician was notified of the procedure by the nurse (vaccine provider), as well as both vaccine companies and the patient's mother. The reporter stated that there was no adverse reaction noticed in the patient; therefore, no adverse effects were reported. She also said there was "no bad outcome from this" and considered the report to be non-serious. No PQC was mentioned in the report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 72-year-old non-pregnant female patient. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX, injection (dose, route of administration, lot # and expiration date were not reported) for prevent shingles. Concomitant therapies included sterile diluent. On an unspecified date in October 2017 (reported as diagnosed on 30-OCT-2017), the patient experienced severe shingles rash that was on the trunk of her body and spread around her belly. The patient sought a medical attention. The patient was treated with unspecified antivirals and pain medication. The varicella zoster virus (VZV) was offered but the patient declined. The outcome of herpes zoster was reported as not recovered. The reporter did not assess relatedness between the event and ZOSTAVAX.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent. No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012: US-009507513-1711USA004383: US-009507513-1711USA004384: US-009507513-1711USA004385: US-009507513-1711USA004386: US-009507513-1711USA004387: US-009507513-1711USA004388: US-009507513-1711USA004389: US-009507513-1711USA004390: US-009507513-1711USA004391: US-009507513-1711USA004392: US-009507513-1711USA004393: US-009507513-1711USA004394: US-009507513-1711USA004395: US-009507513-1711USA004396: US-009507513-1711USA004397: US-009507513-1711USA004398: US-009507513-1711USA004399: US-009507513-1711USA004400: US-009507513-1711USA004401: US-009507513-1711USA004402: US-009507513-1711USA004403: US-009507513-1711USA003982: US-009507513-1711USA003981: US-009507513-1711USA003979: US-009507513-1711USA003980.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 80-year-old female patient. No information regarding the patient's concurrent conditions and pertinent medical history was reported. The patient had no allergies. On 31-OCT-2017, the patient was vaccinated with previously diluted with sterile diluent, ZOSTAVAX subcutaneously (19400 PFU; lot# N014942 with expiration date 02-FEB-2018) for prophylaxis. The patient had no concomitant medications. On 31-OCT-2017, the patient experienced local reaction at the injection site, 4 inch rash, which was red and itchy. On 03-NOV-2017, the patient sought for medical attention and returned to the pharmacy. No treatment was given for the adverse events. Laboratory test were not performed. The patient did not recover by the time of this report. Causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not provided) lot# M045392 and expiration date: 14-NOV-2018. The M-M-R II was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 47 to 77 degrees Fahrenheit for 80 hour and 30 minutes. There was no previous temperatures excursions. The digital data logger was involved in recording the temperature excursion. This was one of two reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician, via a company representative, and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In November 2010, reported as "7 years ago", the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included sterile diluent (MRK) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). On approximately 24-OCT-2017, reported as "2 weeks ago", the patient developed shingles in an unspecified area. The outcome of herpes zoster was unknown. The causality between herpes zoster and ZOSTAVAX was not reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site mass, Pruritus
Clinical narrative: Information has been received from a physician and a healthcare professional referring to a 17 year old female patient. It was reported that there was no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient had no concomitant therapies and pertinent medical history.  On 29-SEP-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection (dosage unknown, lot # N009173, expiration date 20-NOV-2019) intramuscularly for human papilloma virus (HPV) prevention. Approximately on 30-SEP-2017 (reported as at the end of September 2017), patient developed a lump on unspecified arm at injection site, random itchy and red spots on unspecified arm in an unspecified location (reported as not at injection site). On 06-NOV-2017, the patient was seen by an unspecified dermatologist and was prescribed an unspecified steroid cream to apply for the next couple of weeks and was advised not to get the third dose of GARDASIL 9. No lab was performed. There was no temperature excursion occurred before. Outcome of the events was reported as recovering. No product quality complain (PQC) was involved. Causality between the events and GARDASIL 9 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided ) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports form the same reporter.; Sender's Comments: US-009507513-1711USA002012:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports form the same reporter. Sender's Comments: US-009507513-1711USA002012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided ) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1711USA002012:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1711USA002012: Original Case : 1711USA002012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. Sender's Comments: US-009507513-1711USA002012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1711USA002012:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion. No causality assessment was provided by the reporter. Sender's Comments: US-009507513-1711USA002012.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments:  US-009507513-1711USA002012.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, approximately in 2017 (reported as "within the "last two months"), the patient was vaccinated with ZOSTAVAX one injection (route of administration, lot# and expiration dose were not reported) for prophylaxis and influenza virus vaccine (unspecified) at the same time. On an unknown date, approximately in 2017 (reported as "after getting both vaccinations at the same time"), the patient experienced feeling run-down, tired and very sick. The outcome of the events and causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-NOV-2017, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX lot number L043624 and expiration date of 03-NOV-2017 for prophylaxis, reconstituted with water sterile diluent. No adverse effects were reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Flushing, Malaise
Clinical narrative: This spontaneous report was received from a physician who refers to a 66-year-old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies.  On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection intramuscularly (lot # N024384, expiration date: 18-MAY-2019, dose was not reported)) for prophylaxis (indication was reported as "vaccination"). On 20-NOV-2017, the patient experienced generalized facial flushing, lower back pain, and malaise. The patient sought a medical attention and the intervention to prevent serious criteria was administration of epinephrine. No lab diagnostics or studies were performed. The reporter believed that the events were a reaction to the administered PNEUMOVAX 23. the physician reported that the patient continued to have malaise. The outcome of the events was reported as not recovered. The reporter considered the events to be related to PNEUMOVAX 23. The physician considered the events of generalized facial flushing, lower back pain, and malaise to be medically significant, as intervention to prevent serious criteria was performed.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not provided) lot# M045392 and expiration date: 14-NOV-2018. The M-M-R II was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 47 to 77 degrees Fahrenheit for 80 hour and 30 minutes. There was no previous temperatures excursions. The digital data logger was involved in recording the temperature excursion. This is one of two reports received from the same reporter.
Age: 9.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever occurred within 12 hours of first dose. Fever reached 101 degrees. Last dose was 11/8/2017.   Stomach ache, vomiting and nausea started 11/10/2017 and are consistent through present (11/29/2017).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Discomfort, Loss of personal independence in daily activities, Paralysis
Clinical narrative: Patient called into our office on 11/27/2017 to report that she began having symptoms on 11/22/2017, approx. 4 hrs after receiving the vaccine. Patient reported "feeling the pressure of the medication going all through her body at time of injection", however pt did not mention this during visit. She stated that approx. 4 hrs after receiving vaccination that she experienced paralysis in her shoulders and neck that required her to have her granddaughter open the door for her and to help her turn in bed that night. Pt states that these symptoms, along with chills and elevated temp although she denies taking temp with thermometer, lasted for about 36 hrs. She denies any other symptoms past the 36 hrs.
Age: 80.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 11/17/17 6pm face burning and red. 11/18/17 morning arm hurting, swollen.  11/17/17 by evening: BP 164/104 pulse over 100. 11/17/17 evening went to hospital ER--given "big dose" of Benadryl, then went home, improving. 11/19/17 saw PCP, arm still red and swollen to elbow, no further treatment.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, Wrong drug administered
Clinical narrative: Patient was given FLULAVAL 11/02/2017 and 11/24/2017 on mistake. Patient was supposed to be given TDAP at this point in her pregnancy (28 weeks) but was given FLULAVAL, again, instead. Patient will receive TDAP at next appt.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Chest X-ray normal, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Information has been received from a physician assistant and other source referring to a 75 years old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was not provided. On 25-OCT-2017 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N013541, expiration date 23-JAN-2019, 0.5 ml) intramuscularly in the left deltoid for prevention from pneumococcal disease. On 25-OCT-2017, hours after immunization, the patient developed fever with a temperature of 101.1 F and associated mild general fatigue. The patient complained on 27-OCT-2017 and came back in to the office. The patient was experiencing fever and the area around the injection site was warm to the touch. The physician assistant reported that the patient "was out of it". The physician assistant ordered unspecified bloodwork, urine test and a chest xray. All test results were negative. The patient returned to the office on 30-OCT-2017 and was feeling a little bit better. The fever and fatigue was resolved over the next couple days. No prescription drug treatment for the experience was required. The causality was not provided.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Urine analysis normal
Clinical narrative: Information has been received from a physician assistant and other source referring to a 75 years old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was not provided. On 25-OCT-2017 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N013541, expiration date 23-JAN-2019, 0.5 ml) intramuscularly in the left deltoid for prevention from pneumococcal disease. On 25-OCT-2017, hours after immunization, the patient developed fever with a temperature of 101.1 F and associated mild general fatigue. The patient complained on 27-OCT-2017 and came back in to the office. The patient was experiencing fever and the area around the injection site was warm to the touch. The physician assistant reported that the patient "was out of it". The physician assistant ordered unspecified bloodwork, urine test and a chest xray. All test results were negative. The patient returned to the office on 30-OCT-2017 and was feeling a little bit better. The fever and fatigue was resolved over the next couple days. No prescription drug treatment for the experience was required. The causality was not provided.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Mobility decreased
Clinical narrative: This spontaneous report as received from the patient's mother referring to a not pregnant 18 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-SEP-2017 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis (lot number and expiration date were not reported). On an unspecified date in September 2017, reported as almost immediately after receiving the 2nd dose of GARDASIL 9 the patient experienced extreme fatigue and difficulty getting out of bed. It was reported that the patient did not seek medical attention neither received treatment to the aformentioned events. On 14-NOV-2017, the patient symptoms fatigue and difficulty getting out of bed were still not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Fatigue, Immediate post-injection reaction, Thyroid disorder, Vitamin D deficiency
Clinical narrative: This spontaneous report as received from the patient's mother referring to a not pregnant 18 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 21-SEP-2017 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis (lot number and expiration date were not reported). On an unspecified date in September 2017, reported as almost immediately after receiving the 2nd dose of GARDASIL 9 the patient experienced extreme fatigue and difficulty getting out of bed. It was reported that the patient did not seek medical attention neither received treatment to the aformentioned events. On 14-NOV-2017, the patient symptoms fatigue and difficulty getting out of bed were still not resolved. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for an 81-year-old male patient. The patient received PREVNAR 13, (Lot Number: 108483, NDC number: 00005-1971-02, Expiry Date: Sep2019), intramuscular to left arm on 17Nov2017 12:00 at 0.5mL, single for immunisation at Pharmacy/Drug Store. The patient medical history was none. Concomitant medications were not reported. The patient experienced painful, raised, swollen, red and itchy on 18Nov2017 with outcome of unknown. The events occurred at injection site. The event painful was considered as medically significant. The pharmacist advised the patient to ice and use TYLENOL for pain. The events did not require visit to emergency room nor physician office. Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug PREVNAR 13 cannot be excluded for the reported event.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received TRUMENBA on an unspecified date, at single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date after vaccination the patient experienced pain, swollen at the injection site. Events outcome was unknown. No follow-up attempts possible. No further information expected. Information about batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Since having the vaccination in my left arm on Oct 30, 2017, I have had chronic muscle ache mid-deltoid, moderate weakness, and reduced range of motion of my upper arm unlike anything I have ever experienced before. Never before has the flu shot caused this prolonged pain in my arm. I cannot raise my arm and it is very difficult to remove my clothing over my head. The pain at night keeps me awake and it is very hard to find a comfortable way to sleep. I've been using ibuprofen and naproxen sodium and that does help, but if I do not take those throughout the day the pain is debilitating. I have had a follow-up with my doctor and he prescribed Tramadol and MOBIC. I have taken those for one month with little relief.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain
Clinical narrative: Since having the vaccination in my left arm on Oct 30, 2017, I have had chronic muscle ache mid-deltoid, moderate weakness, and reduced range of motion of my upper arm unlike anything I have ever experienced before. Never before has the flu shot caused this prolonged pain in my arm. I cannot raise my arm and it is very difficult to remove my clothing over my head. The pain at night keeps me awake and it is very hard to find a comfortable way to sleep. I've been using ibuprofen and naproxen sodium and that does help, but if I do not take those throughout the day the pain is debilitating. I have had a follow-up with my doctor and he prescribed Tramadol and MOBIC. I have taken those for one month with little relief.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Atonic seizures, Electroencephalogram, Epilepsy, Petit mal epilepsy, Seizure
Clinical narrative: Atonic and absence seizures.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Vomiting
Clinical narrative: Atonic and absence seizures.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 20 minutes post injection employee experienced numbness in entire left arm. Redness, swelling, heat and pain occurred at the injection site after the numbness subsided 24 hours later. The redness and swelling (bump the size of a golf ball) lasted x 3 weeks post injection. To date, employee is asymptomatic.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt was having rash like symptoms on her left arm around the injection site. The area was warm to the touch, red, and swelling. Dr., who was available at the time, recommended the pt ice the area and to take BENADRYL.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: SEVERE Left shoulder arm pain for over the last 3 weeks.
Age: 64.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MNQ, TDAP, YF
Symptoms: Headache, Sinus headache
Clinical narrative: Pt. reported severe headache in the morning upon awakening x 30-40 min. Reports headache was mid-forehead and felt similar to a sinus headache. Took VIVOTIF at night, before sleep and reported H/A each morning after.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Musculoskeletal pain, Pain, Pyrexia, X-ray normal
Clinical narrative: The shot was given extremely high on the arm almost on the shoulder. Have had severe shoulder pain ever since, was put on predisone for 5 days, did not help. Went back to clinic and they pretty much told me they were not responsible. Started having high fever, aches and chills the same night I received the shot. that was October 10th and I am still in a lot of pain. Went to another Dr. and he put me on a z-pack for 6 days, still in pain severe, that was about 2 1/2 weeks ago.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Apparent life threatening event
Clinical narrative: PT SHOWED SIGNS OF LIFE THREATENING EFFECTS FROM SHOT.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient's arm began swelling and itching and was painful and red. Arm was also hot to the touch. Mom called on call provider and was advised to draw a line around the swollen area and if it continued to swell to go to the ER. Arm continued to swell so mom took patient to the ER and was given DECADRON.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Abdominal Pain started 11/28/17 evening and resolved w/in a couple of hours. 11/29/17 pt reporting fatigue, overall body aches, headache, multiple joint pains. Pt is afebrile. Home treatment recommended.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Febrile convulsion, Feeling abnormal, Irritability, Lethargy
Clinical narrative: My 15 month old was administered three shots. Two were given in one thigh and one in the other. We went home and he was seemingly fine other than being a little grumpy. The next day he had very heavy breathing. I went to put him to sleep and in his sleep he was jumping and it seemed like a tic that he had never ever had before. I went on to find out that was this was is called a febrile seizure. About an hour after him being asleep, he woke up around 10pm puking out of nowhere. He puked almost nonstop for two hours. During the puking episodes he was very lethargic and totally out of it. He was also having more febrile seizures. He went back to sleep around 12 am and slept the rest of the night and had nothing else happen.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Muscle twitching, Tic, Vomiting
Clinical narrative: My 15 month old was administered three shots. Two were given in one thigh and one in the other. We went home and he was seemingly fine other than being a little grumpy. The next day he had very heavy breathing. I went to put him to sleep and in his sleep he was jumping and it seemed like a tic that he had never ever had before. I went on to find out that was this was is called a febrile seizure. About an hour after him being asleep, he woke up around 10pm puking out of nowhere. He puked almost nonstop for two hours. During the puking episodes he was very lethargic and totally out of it. He was also having more febrile seizures. He went back to sleep around 12 am and slept the rest of the night and had nothing else happen.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Blepharospasm
Clinical narrative: Pt experienced blepharospasm.
Age: 54.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Diarrhoea, Injection site reaction, Injection site swelling, Pain in extremity, Rash erythematous
Clinical narrative: Received vaccines Monday evening. Egg free flu vaccine given due to history of egg allergy/pt request. Late that night and next AM developed arm pain, red rash on arm where she received vaccine, diarrhea. Began ~12 hours post administration. Pertinent negatives include no coughing, difficulty breathing, drooling, eye itching, eye redness, eye watering, hyperventilation, itching, trouble swallowing, vomiting or wheezing. Swelling location: At injection site, none in face/mouth.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N017700 and expiration date: 09-JUN-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 15 degrees Fahrenheit (F) to 46 F for 1 hour and 9 minutes. Previous temperatures excursions were in between 6 F 14 F for 76 minutes and in between 15 F to 46 F for 1 hour and 23 minutes. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1711USA002012:
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a registered pharmacist reporting on a male patient of unknown age. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On an unknown dates, the patient received the first and second dose of M-M-R II that were reconstituted with sterile diluent (STERILE DILUENT) for prophylaxis (doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported). On an unknown date, the patient had negative titers (measles antibody negative, rubella antibody negative and mumps antibody test negative). It was unknown by the reporter if the patient sought medical attention or if received treatment for the aforementioned events. The outcome of the events measles antibody negative, rubella antibody negative and mumps antibody test negative and their causal relationship with M-M-R II or sterile diluent (STERILE DILUENT) were not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 15-NOV-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # M022947 with an expiration date 12-NOV-2017 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from nurse on 17-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a dose of FLUZONE INTRADERMAL (Batch number, expiration date, form, dose, dose in series and site of vaccination were not reported) via intradermal route on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date last year, following the vaccination, the patient developed baseball sized swollen reaction to the intramuscular, bright red swollen reaction, but then also down the arm above the elbow and up to the shoulder was swollen. The red area was also warm to touch. Laboratory data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Initial unsolicited report received from consumer (patient himself) on 16-Oct-2017. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml two doses of FLUZONE HIGH-DOSE (Batch numbers, expiry date, dose in series were not reported) intramuscularly in right arm on an 01-Oct-2015 and on an unknown date for the past two years. The patient's medical history and concomitant medications were not reported. On unknown date, after the vaccination with two doses of FLUZONE HIGH-DOSE, patient developed muscle weakness, aches, started in right shoulder both times and eventually extended to legs, patient reported that it got to the point he was almost unable to care for himself and any movement caused severe pain. It was reported as the patient did not received flu shot this year, because his right arm was still pretty painful. Laboratory investigations were not reported. It was reported as a corrective treatment patient received treatment from physician with some sort of shot in to his right arm and pills, that he had to take for 5 days. On an unknown date, patient recovered from all the events. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from consumer (patient himself) on 16-Oct-2017. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml two doses of FLUZONE HIGH-DOSE (Batch numbers, expiry date, dose in series were not reported) intramuscularly in right arm on an 01-Oct-2015 and on an unknown date for the past two years. The patient's medical history and concomitant medications were not reported. On unknown date, after the vaccination with two doses of FLUZONE HIGH-DOSE, patient developed muscle weakness, aches, started in right shoulder both times and eventually extended to legs, patient reported that it got to the point he was almost unable to care for himself and any movement caused severe pain. It was reported as the patient did not received flu shot this year, because his right arm was still pretty painful. Laboratory investigations were not reported. It was reported as a corrective treatment patient received treatment from physician with some sort of shot in to his right arm and pills, that he had to take for 5 days. On an unknown date, patient recovered from all the events. List of documents held by sender: none.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 16-Oct-2017. This case involves 62-year-old male patient was vaccinated with 0.5ml dose of FLUZONE QIV once via intramuscular route in left deltoid, batch number: UI839AA (expiry date, dose in series were not reported) on 09-Sep-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced pain in his left shoulder with shooting pains with movement. The patient was demanding compensation. Lab data and corrective treatment were not reported. Event outcome was not recovered at the time of reporting. List of documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 17-Oct-2017. This case involves 82-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE, (batch number: UI824AA, expiry date: 13-Mar-2018) via intramuscular route on 11-Sep-2017. It was reported that no other vaccines or treatment were involved. Patient's medical history and concomitant medications were not reported. On an unknown date, since the day of vaccination, patient experienced cough and runny nose. Lab data and Corrective treatment were not reported. The patient had not recovered from both the events. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site inflammation, Pain, Rotator cuff syndrome
Clinical narrative: Initial unsolicited report received from nurse on 17-Oct-2017. This case involves 72-year-old female patient, who was vaccinated with a 0.5ml once dose of FLUZONE HIGH-DOSE via intramuscular route in left arm (batch number, expiry date and dose in series were not reported) on 17-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient diagnosed her with Left rotator cuff tendonitis, she did have extensive bruising to her Left deltoid by the end of the day, entire shoulder feels inflamed and bruised, had pain with use of the arm, pain with arm use and gripping and may have administered the vaccine too high she was unable to push the plunger. The entire shoulder feels inflamed and bruised. It was an actual medication error case due to wrong injection technique. Lab data and Corrective treatment were not reported. Event's outcome were not resolved at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Multiple allergies, Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2017. This case is linked to case 2017SA207218 and 2017SA207221 (same reporter, same vaccine, different patient). This case involves a female patient (age at time of the reaction was not reported) who was vaccinated with a 0.5 ml single dose of FLUZONE QIV (batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 04-Oct-2017 at flu clinic. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patients developed hives, shortness of breath and multiple allergies. Laboratory tests were not reported. As corrective treatment, the patient required EPINEPHRINE (EPI PEN). On an unknown date, the patient recovered from all the events. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: Vaccine MMR received on 11-16-2017. Fever started 11.26/2017, Rash started 11/27/17 got worse 11/28/2017-covering body erythema multiforme.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Diagnosed with Guillain-Barre syndrome on 11/29/2017-Bilateral lower extremity numbness below knee and bilateral upper extremity numbness below elbow. Home Health Care with OCC. therapy and Physical Therapy ordered.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised, redness on upper inside of left arm about 4-5 inches in diameter.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient describes injection site as swollen, red and warm and about the size of a softball. He reports feeling fine with no fever.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Received 11/15/17. Patient called.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Scan
Clinical narrative: Patient received vaccine in the morning and started having severe pain in the injection site that afternoon. It never went away, and patient had to go to the doctor to get scans done, and receive pain medication. (over a week later).