chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2016US057315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623117) on 27 Apr 2016. This report refers to an 88 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157802) intramuscularly into left arm 07 Feb 2016. On 10 Feb 2016, three days after vaccination, the patient developed a rash on her knees and legs. The case was assessed as non-serious. Seriousness and causality of the event was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site urticaria, Pyrexia
Clinical narrative: Case number PHHY2016US056554, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623122) on 18 Apr 2016. This report refers to a 24 years old female patient. Medical history was not reported. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) at the age of 22 years old and experienced itching (see case: PHHY2016US056569). Current condition included irritable bowel syndrome. Concomitant medications included Trazodone, hyoscyamine, omeprazole and "metagenics ultra flora". The patient was vaccinated with FLUVIRIN (batch number: 1517701) intramuscularly into left arm on 17 Feb 2016. On 18 Feb 2016 the patient developed red welt at sight of injection, low grade fever and chills. Outcome of the events was recovered. Seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dizziness
Clinical narrative: Case number PHHY2016US058070, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623222) on 27 Apr 2016. This report refers to a 39 years old female patient. Medical history was not reported. Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly into left arm and HAVRIX (batch number: D232P, other manufacturer) intramuscularly into right arm on 15 Feb 2016. On Feb 2016 the patient experienced dizziness. The patient was sent to urgent care/primary care physician for evaluation. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the event was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US058078, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623299) on 27 Apr 2016. This report refers to a 47 years old female patient. Medical history and concurrent conditions were none. Concomitant medications included lisinopril, naproxen and omeprazole. The patient was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly into left arm on 17 Feb 2016. On 22 Feb 2016 the patient called the pharmacy stating that the injection site was swollen, had a bump and warm to the touch. The patient went to her primary care doctor. The case was assessed as non-serious. The outcome and causality of the events was not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2016US058327, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623678) website on 27 Apr 2016. This report refers to a 69 years old female patient. Current condition included allergic to allergy to penicillin and cephalosporins. Past historical condition and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 158104), intramuscularly on right arm and PNEUMOVAX (batch number: L022795) intramuscularly on left arm, both on 22 Feb 2016. On 24 Feb 2016, her injection site became hot and red, similar to the look of an infection. The final outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 35.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Erythema, Rash
Clinical narrative: Case number PHHY2016US058088, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 623883) on 27 Apr 2016. This report refers to a 35 years old patient of an unknown gender. Medical history was not reported. Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) and ADACEL (batch number: U5235AA) on 23 Nov 2015. On 24 Nov 2015 the patient developed rash on back of neck and legs. Further the patient developed redness of ears and little on face. The patient took BENADRYL and its reducing rash. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Skin warm
Clinical narrative: Case number PHHY2016US058845 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 624313) on 27 Apr 2016. This report refers to a 20 year old male patient. His medical history was not reported. He had no current conditions. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1515101) in the left arm on 09 Oct 2015. On 10 Oct 2015, the patient experienced red blotches all over on trunk. He had no itching, but it was warm to the touch. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Case number PHHY2016US057309, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 626233) on 27 Apr 2016. This report refers to a 23 years old female patient. Medical history was not reported. Concurrent condition included urinary tract infection (UTI). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15755P) intramuscularly into left arm on 07 Mar 2016. On the same day after vaccination the patient experienced nausea, vomiting, body aches and headaches. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Case number PHHY2016US059712, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 624752) website on 27 Apr 2016. This report refers to a 71 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516001) into left arm on 27 Jan 2016. On 28 Jan 2016 the patient experienced pain and had hard time moving arm. Outcome of the events was unknown. The case assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US068931 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 627817) on 17 May 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown start date. On an unknown date, the patient experienced numbness and pain. The outcome of the events was not reported. Seriousness and causality of the events was not reported. Further, on 13 Nov 2015, the patient received FLUVIRIN (batch number: 157604) and experienced pain, numbness and heaviness (see case number: PHHY2016US068911).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Case number PHHY2016US068931 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 627817) on 17 May 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown start date. On an unknown date, the patient experienced numbness and pain. The outcome of the events was not reported. Seriousness and causality of the events was not reported. Further, on 13 Nov 2015, the patient received FLUVIRIN (batch number: 157604) and experienced pain, numbness and heaviness (see case number: PHHY2016US068911).
Age: 61.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Case number PHHY2016US069689, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 628467) website on 17 May 2016. This report refers to a 61 years old female patient. Past medical history was not reported. Concomitant medications included as ramipril (manufacturer unknown), pantoprazole (manufacturer unknown), atorvastatin (manufacturer unknown), fenofibrate (manufacturer unknown) and sertraline (manufacturer unknown). The patient was vaccinated with FLUVIRIN (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. The patient also vaccinated with PREVNAR 13 vaccine (other manufacture, batch number: M56442) subcutaneously on an unknown date. On 29 Oct 2015, the patient experienced large red area where PREVNAR injection was given. The area had edema and slight pain to touch. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2016US070745, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 629891) on 17 May 2016. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157901) into left arm and PREVNAR 13 (batch number: L99275) into right arm on 24 Mar 2016. On 25 Mar 2016 the patient's deltoid was between red and pink. Further it was swollen. The patient said that there was little swelling on 27 Mar 2016. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2016US093576, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 630114) website on 06 Jul 2016. This report refers to a 65 years old female patient. Past medical history was not reported. Past medication included sulfa antibiotic. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1518101) into the left arm and PREVENAR 13 (other manufacturer, batch number: M35763); into the right arm; both intramuscularly on 18 Mar 2016. After vaccination, on 19 Mar 2016, she experienced soreness and there was a red spot swollen at the site which continued to get bigger the next couple days. She visited physician. She was treated with KEFLEX for the events. 3 days after starting KEFLEX therapy, the redness and swelling started to improve. Final outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Feeling abnormal, Lethargy, Migraine, Visual impairment
Clinical narrative: Case number PHHY2016US069610, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS, reference number: 630228) website on 17 May 2016. This report refers to a 58 years old male patient. Past medical history was not reported. Concomitant medication included as finasteride (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 15731P) into left arm, intramuscularly on 29 Mar 2016. On the same day after vaccination, the patient experienced migraine after 10 min, could not see, abdominal cramps, then felt crappy and lethargic. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2016US070060, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 631387) on 17 May 2016. This report refers to a 38 years old female patient. The patient had no medical history and concurrent conditions. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly into left arm on 26 Sep 2015. Immediately after administration patient had extreme pain in upper arm at the site of the injection. The pain was immediate and has lasted for months. An MRI was performed to determine the extent of damage/scar tissue done from the administration (results not reported). Final outcome of the event was recovered. The case was assessed as non-serious. Causality of the event was not reported.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: A 44 year old man received an intramuscular injection in the left deltoid of MassBiologics' Td vaccine (lot A084A) on May 13, 2016 as a booster dose. He did not receive any other immunizations that day and was not taking any other medications. Same day post-injection, the patient experienced fever, chills, generalized body aches, and severe arm pain at the injection site. The patient required a doctor's visit and was prescribed KEFLEX. Sender's Comments: All adverse events reported in this case by the primary source were assessed as both non-serious and labeled reactions (expected events). Injection site pain, generalized body aching (myalgia), and fever/chill symptoms (pyrexia) are all listed in the package insert for Td. The patient was prescribed KEFLEX by the physician seen for the reaction. No additional follow up was performed as the patient had recovered at the time of the report. Please note that report 'US-MassBiologics-AE1603' has been linked to this report as it was a similar report from the same primary source (reporter) for the same Td lot.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: A 56 year old woman was immunized with MassBiologics Td (Lot #A084A) intramuscularly in the right deltoid on May 2, 2016. On that same day, she experienced severe arm pain, generalized body aches, fever and chills. The symptoms resolved after 3-4 days. The patient did not require treatment. The patient was reported to have a history of allergy to niacin, depakote, and morphine. Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled, as injection site pain (such as the reported arm pain), myalgia (generalized body aches), and pyrexia (fever/chills) are reported in the Td package insert. No additional follow up was performed as the patient had recovered at the time of the report. Please note that report 'US-MassBiologics-AE1604' has been linked to this report as it was a similar report from the same primary source (reporter) for the same Td lot.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Tenderness
Clinical narrative: Case number PHHY2016U115256 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 639573) website on 23 Aug 2016. This report refers to a 46 year old female patient. The patient current condition included Codeine and Penicillin allergies. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into left arm on 20 Oct 2015. On the same day post flu shot patient arm was tender as it had been previous flu shots. However, pain began to increase steadily and did not subside. The patient had severe and throbbing pain in left arm with diminished range of motion. The patient was treated with heated, iced and he took ibuprofen. The patient was treated with physical therapy and shoulder injection. The outcome of events was reported as condition unchanged. The seriousness was reported as non serious. The causality of events was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3, HEP, HEPA, HPV4, MNQ, TDAP, FLU3, HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2016US134509, is an initial spontaneous report received from Vaccine Adverse Event Reporting (VAERS ID: 640081) website on 29 Sep 2016. This report refers to a 23-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516601) into left arm and Hepatitis A vaccine, hepatitis b vaccine, GARDASIL, lot number: L016428) into right arm, MENACTRA (batch number: U5185BA) into left arm and ADACEL on 09 May 2016. Initially the patient was screened and usual denied being pregnant. The patient again came to primary health care center and revealed that she was pregnant. Outcome of the event was unknown. Seriousness of the event was reported as non-serious and causality was not reported.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Patient started to not feel well, was feeling a fever of 100.8 degrees, lightheaded, nausea and chills. He felt his sinuses were plugged.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chills, Dizziness, Malaise, Nausea, Pyrexia
Clinical narrative: Patient started to not feel well, was feeling a fever of 100.8 degrees, lightheaded, nausea and chills. He felt his sinuses were plugged.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Sinus congestion
Clinical narrative: Patient started to not feel well, was feeling a fever of 100.8 degrees, lightheaded, nausea and chills. He felt his sinuses were plugged.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal death
Clinical narrative: Fetal demise 35 weeks gestation.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecific date, the patients were vaccinated with improperly stored VARIVAX. Concentration, dose and route of administration were not reported (lots # M034586, expiration date 27-JUL-2018; M025871, expiration date 24-MAY-2018 and M014916, expiration date 25-MAR-2018) for prophylaxis. It was reported that the temperature excursion was for 1 hour and 42 minutes at 17.4 degrees F, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report has been received from the patient's mother referring to a 12 years old female patient. The patient had no pertinent medical history, drug allergies/reactions, or concomitant therapies.  On 30-DEC-2016, the patient was vaccinated with the third dose of GARDASIL 9 regimen (previous vaccination information was not provided) for the prevention of human papillomavirus (lot #, expiration date, dose, and anatomical location were not reported). It was reported by the patient's mother that on the same day the patient fainted briefly after receiving the vaccination with GARDASIL 9 (syncope) and fell. She reported also that the patient recovered immediately after the event, and had no lasting effects from the fall. The patient was feeling well enough afterward to receive a "flu-shot" (manufacturer or strength not reported). In addition, the patient's mother reported that the nurse practitioner stated that the event could have occurred as a result of the patient's blood pressure dropping rapidly post injection  (Blood pressure decreased) and that they have had similar occurrences of fainting with other unspecified patients. The patient did not receive treatment, had lab diagnosis studies performed or sought medical attention for these events. No product quality complaint was involved. The causality assessment between the events and the suspect product was not reported. This is one of several reports received from the same reporter Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX (lot numbers M003658, expiration date 02-JUN-2018; M033334, expiration date 11-AUG-2018; M034894, expiration date 11-NOV-2018; L014419, expiration date 15-MAR-2017; L030609, expiration date 26-JUN-2017; M013639, expiration date 15-SEP-2017, dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008041:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008608:Original Case : 1701USA008041; US-009507513-1701USA008609:Original Case : 1701USA008041.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JUL-2013, the patient was vaccinated with GARDASIL injection, as a first dose of human papillomavirus (HPV) series (strength, dose, route of administration, lot # and expiration date were not reported). On 04-JAN-2017, the patient was vaccinated with GARDASIL 9 injection, lot # L040054, expiration date 26-DEC-2017, as a second dose. No adverse effect was reported. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) via social media and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported). It was unknown if the patient received a GARDASIL, an GARDASIL 9 or another hpv vaccine (manufacturer unknown). On an unknown date, the patient experienced "having a rash constantly itchy but have no rash and messed up recycles and her hormones" and unspecified "other side effects". Action taken with the therapy, the outcome of the events and the relatedness between the events and the unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) were not reported. Additional information is not expected as no contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Induration, Mobility decreased, Nodule, Rash
Clinical narrative: This spontaneous report was received from a 55-year-old female patient, who was reporting on herself. The patient's pertinent medical history included chickenpox. Her concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection, in an unspecified arm (dose, route of administration, lot # and expiry date were not reported) for prevention of Shingles. On an unknown date (reported as "a few days after she took her vaccine"), the patient experienced Shingles. Her arm broke into a painful rash and the patient was in so much pain that she "wanted to cut her arm off". Additionally, the patient experienced a hard knot on her arm and she was no longer able to use her arm (onset dates were not reported). The patient went to the doctor, but claimed that no doctor would touch it. She did not receive any treatment for the events and stated she could not receive another shot it that unspecified arm ever again. The outcome of the events was reported as not recovered. The patient considered Shingles to be related to ZOSTAVAX. The causality of a hard knot on her arm and not being able to use her arm was not reported. Additional information is not expected as there was no consent to contact the physician.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 65 year old female patient. There was no information about the patient's concurrent conditions or medical history provided. On 13-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M000592, expiration date 12-OCT-2017 (dose and route of administration were not reported). Concomitant therapies included an unspecified flu shot, administered on the same day in her left arm. On 14-DEC-2016, 24 hours later, the patient experienced arm cellulitis, swelling and redness in her right medial arm. The deltoid area was also tender to the touch and the area affected was approximately 3 cm by 6 cm. The patient did not receive any treatment. There were no lab diagnostic studies performed. She did not seek medical attention. The outcome of the events was reported as recovered/resolved on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of arm cellulitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant refers to unspecified number of patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, intramuscularly from a lot# M024261 with expiry date: 30-JUL-2018 (dose and anatomical location not reported), for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature excursion of 32 degree Fahrenheit and 36 degree Fahrenheit for 135 hours. The vaccine did not have previous temperature excursion. The temperature excursion was determined by digital data logger. No product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011553: US-009507513-1701USA011552.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of PEDVAXHIB (lot# K008679; expiration date: 05-MAR-2017 experienced a temperature excursion of >46F - <77F for 6 hours 30 minutes. Data logger was involved. There was no previous temperature excursion. On multiple unspecified dates, multiple unspecified patients were administered these improperly stored doses of vaccines. No adverse effects reported. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA011416.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant refers to unspecified number of patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of with PNEUMOVAX23 from lot # M032635 with expiry: 05-MAY-2018 and lot# M041394 with expiry: 23-MAY-2018  (dose, route and anatomical location not reported), for prophylaxis. No adverse effects reported. The vaccine lots were exposed to a temperature excursion of 32 degree Fahrenheit and 36 degree Fahrenheit for 135 hours. The vaccine did not have previous temperature excursion. It temperature excursion was determined by data logger. No product quality complaint (PQC) involved. This is one of the three reports  received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009721:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant refers to unspecified number of patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB from lot # M032149 with expiry: 18-APR-2019 and lot # M032150 with expiry 21-APR-2019 (dose, route and anatomical location not reported), for prophylaxis. No adverse effects reported. The vaccine lots were exposed to a temperature excursion of 32 degree Fahrenheit and 36 degree Fahrenheit for 135 hours. The vaccine did not have previous temperature excursion. The temperature excursion was detected by digital data logger. No product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009721:
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site nodule
Clinical narrative: Initial unsolicited report received from a medical assistant on 13 January 2017. This case is linked with 2017SA007210, 2017SA007211(same reporter,same vaccine, same event). This case involves a 18-months-old female patient who was vaccinated with doses of DAPTACEL (batch number: C5117AA, expiry date: 19 January 2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492 UNK, expiry date, dose and dose in series were not reported) both via intramuscularly in thigh on 09 January 2017. Patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination. Concomitant medications were not reported. On 10 January 2017, one day of following the vaccination, the patient had developed a knot at the injection site. The patient was seen by physician. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site nodule
Clinical narrative: Initial unsolicited report received from a medical assistant on 13 January 2017. This case is linked with 2017SA007206 and 2017SA007211 (same reporter, same vaccine). This case involves a 18-months-old female patient who was vaccinated with doses of DAPTACEL (batch number: C5117AA, expiry date: 19-JAN-2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492, expiry date, dose and dose in series were not reported) both via intramuscular route in thigh on 10 January 2017. Both vaccine given on same thigh. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 11 January 2017, one day following the vaccination, the patient developed a knot at the injection site. The patient was seen by physician. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: No adverse event
Clinical narrative: No adverse event reported.
Age: 17.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Dyspnoea, Headache, Nausea, Vomiting
Clinical narrative: About 30-45 minutes after vaccines were administered, parent reports son started vomiting, headache, nausea, and shortness of breath. These symptoms lasted for approximately 2 hours per parent.
Age: 17.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Chest pain, Dyspnoea, Nausea
Clinical narrative: About 30-45 minutes after vaccines were administered, parent reports son started vomiting, headache, nausea, and shortness of breath. These symptoms lasted for approximately 2 hours per parent.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, 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 regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient received a possibly improperly stored dose of ROTATEQ oral liquid, orally, lot# reported as M032636 with an expiration date 06-APR-2018 (dose was not reported). No adverse effects were reported. The reporter stated that the shipping carton containing the vaccine arrived 24 hours late during delivery (time frame 24 hours). No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plaque-forming units (pfu), subcutaneously (lot # L032403 with expiry date of 26-NOV-2016, dose and site of administration were not reported). No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M024261, expiration date: 30-JUL-2018 (dose and route of administration were not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion. No adverse effect was reported. Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007888: US-009507513-1701USA007886: US-009507513-1701USA007887.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product colour issue
Clinical narrative: This spontaneous report as received from a physician (the patient's mother) refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with M-M-R II subcutaneous injection (dose, lot # and expiration date were not reported), with an oragne color instead of yellow. The patient was vaccinated by an anonymous healthcare worker at an unspecified consumer value store pharmacy. No adverse effect was reported. A product quality complaint (PQC) had been filled. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M028553, expiry date 07-JUN-2018 (route of administration, dose and anatomical location were not reported). It was stored in the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour 27 minutes. Data logger was used. There was no previous excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M011832, expiration date: 25-JAN-2018 (dose was not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion. No adverse effect was reported.  Product quality compliant was not involved. This one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007887: US-009507513-1701USA007888: US-009507513-1701USA005252:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# M027879, expiration date: 24-JAN-2018 (dose and route of administration were not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion.  No adverse effect was reported. Product quality compliant was not involved. This one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments: US-009507513-1701USA005252: US-009507513-1701USA007888: US-009507513-1701USA007886:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.     On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot# M032649, expiration date: 11-NOV-2018 (dose and route of administration were not reported). The vaccine was exposed to temperature from 32 to 36 degrees Fahrenheit (also reported as 35 degrees Fahrenheit ) for 12 hours. Digital data logger was not involved and there was no previous temperature excursion. No adverse effect was reported. Product quality compliant was not involved. This one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1701USA007887: US-009507513-1701USA005252: US-009507513-1701USA007886:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Mass, Pruritus, Rash, Rash macular
Clinical narrative: This spontaneous report has been received from a 49 years old female patient reporting on herself. The patient's drug reactions included  allergy to x-ray dye. The patient's concurrent conditions included high blood pressure and acid reflux. The patient had no further pertinent medical history. Concomitant therapies reported unspecified medication for her aforementioned high blood pressure and acid reflux. Approximately in November 2016, reported as "about two months ago", the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not provided) for shingles prevention. Three days after the vaccination, on an unknown date in 2016,  the patient experienced a "large red splotch" on the back or her left arm (the same arm were the vaccine was administered), (injection site erythema)  the area was itchy and she felt "a big lump, that it was the size of half a baseball, under the skin" (upper extremity mass)(pruritus). One week later, on an also unspecified date in 2016, the patient recovered from her symptoms. On an unspecified date in January 2017 (reported as "two weeks ago"), the patient noticed a rash on the back of her head. So, she sought for medical attention by making an appointment to saw her dermatologist, who stated that the rash on the back of her head was shingles. The patient did not received treatment for the adverse events and also no laboratory diagnostics were performed. At the time of reporting, the patient had not recovered from her shingles. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 injection (lot# reported as L034335, expiration date 18-MAY-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered: between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575: US-009507513-1701USA002579.
Age: 69.0
Sex: F
Vaccine: DTOX
Symptoms: Bone pain, Condition aggravated, Dizziness, Fibromyalgia, Injection site pain
Clinical narrative: Pain at injection site, lightheadedness, muscle and bone pain, nausea.
Age: 69.0
Sex: F
Vaccine: DTOX
Symptoms: Myalgia, Nausea
Clinical narrative: Pain at injection site, lightheadedness, muscle and bone pain, nausea.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blister, Diarrhoea, Headache, Nausea, Rash
Clinical narrative: Headache on 1/17, on 01/18 noticed some red bumps on stomach before school, when he came home had more blisters on head and face.  Rash cleared up 01/23, today (1/25) has been having N/V/D.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Rash erythematous, Vomiting
Clinical narrative: Headache on 1/17, on 01/18 noticed some red bumps on stomach before school, when he came home had more blisters on head and face.  Rash cleared up 01/23, today (1/25) has been having N/V/D.
Age: 47.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Soreness in right shoulder that didn't go away with time. Pain down right arm, elbow and forearm. Normal daily activities bring pain with use of right arm. Manageable but painful.
Age: 47.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Soreness in right shoulder that didn't go away with time. Pain down right arm, elbow and forearm. Normal daily activities bring pain with use of right arm. Manageable but painful.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Skin exfoliation
Clinical narrative: PARENT CALLED CLINIC. PATIENT WAS COMPLAINING OF ITCHING & REDNESS AT INJECTION SITES. BOTH DELTOIDS HAVE "SEVERE" REDNESS, PEELING OF SKIN. REDNESS EXTENDS OUTWARDS FROM INJECTION SITES 2+ INCHES ON BOTH ARMS.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Nodule
Clinical narrative: Large rash around the injection site. Large knot in leg.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date in January 2015 (reported as "2 years ago"), the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot # and expiration date were not reported) for shingles. On an unknown date in November 2016, the patient experienced shingles. No product quality complaint was involved. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, as no contact details were provided.