chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Dizziness
Clinical narrative: Case number PHHY2015US161417 is an initial spontaneous received via Vaccine Adverse Events Reporting System (VAERS reference number: 602149) on 24 Nov 2015. This report refers to a 63 year old male patient. He had no medical history and current conditions. The patient's concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) intramuscularly in the arm on 10 Oct 2015. On 12 Oct 2015, he experienced weakness, achy joints and dizziness. He missed two days of work to recover. The outcome of the event was reported as complete recovery. The event was reported as non-serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US164784, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602286) website on 24 Nov 2015. This report refers to a 72-year-old female patient. Past medical history was not reported. The patient was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 04 Oct 2015. On 05 Oct 2015, the patient experienced 3 inch x 5 inch patch of red raised skin on upper arm below point of injection and it was gone in 4 days. Outcome of the events was reported as complete recovery. Seriousness of the event was reported as non serious and causality was not reported.
Age: 72.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US161977, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602287) website on 24 Nov 2015. This report refers to a 72 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 04 Oct 2015. On 05 Oct 2015 the patient complained of 3 inch by 5 inch patch of red raised skin on upper arm below point of injection. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2015US161980 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602287) website on 24 Nov 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Post vaccination the patient complained of red raised skin on upper arm below point of injection. The outcome, seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Mobility decreased, Pain, Swelling
Clinical narrative: Case number PHHY2015US162047, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602310) website on 24 Nov 2015. This report refers to a 70-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 28 Sep 2015. The patient experienced soreness, redness, some swelling after shot was given. The patient could not lift her arm and experienced pain from head or left to right. She also experienced fatigue. The patient applied hot and cold packs. Outcome of the event was reported as complete recovery. Seriousness of the event was reported as non serious and causality was not reported.
Age: 53.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Case number PHHY2015US162149 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 602434) on 24 Nov 2015. This report refers to a 53 year old male patient. His medical history included tuberculosis, elevated lipids, vertigo, neck fracture and shoulder pain. His current condition included hypertension and diabetes mellitus type 2. The patient's concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) in the left arm and PNEUMOVAX (other manufacturer, batch number: H020684) in the right arm on 23 Feb 2013. On 01 Mar 2013, she had vaccination site pain and redness. The events resolved. The events were reported as non-serious. The causality of the events was not reported.
Age: 56.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US167537, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602475) website on 14 Dec 2015. This report refers to a 56-year-old male patient. The patient had no medical history and current illness. Concomitant medications were none. The patient received FLUCELVAX (batch number: 173839) intramuscularly into the left deltoid on 02 Oct 2015. On 03 Oct 2015, the patient's deltoid muscle felt sore where flu shot was given and the soreness had continued at the time of reporting. Final outcome of the event was not recovered. Event was reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Case number PHHY2015US157849, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602495) website on 24 Nov 2015. This report refers to a 53 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Oct 2015. On 10 Oct 2015 the patient developed hives and welts on face, around mouth and the patient's nose was red and swollen. The case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Vomiting
Clinical narrative: Case number PHHY2015US162653, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602536) website on 24 Nov 2015. This report refers to a 9-year-female patient. Historical condition included sinus allergies. The patient had no current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal patient influenza vaccine (manufacturer and batch number: not reported) into the left arm intramuscularly on 12 Oct 2015. On 13 Oct 2015, the patient experienced headache and vomiting. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported.
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2015US167164 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 602540) on 14 Dec 2015. This report refers to a 61 year old female patient. Her historical drugs included ampicillin, hydrocodone and propylene glycol. Her current conditions included shellfish allergy. Her concomitant medications were unknown. The patient was vaccinated with FLUCELVAX (batch number: 17539) in the right arm and ADACEL (other manufacturer, batch number: U5235AA)in the left arm: both vaccines administered intramuscularly on 07 Oct 2015. On 09 Oct 2015, the patient experienced rash, hives and itching. Laboratory data was not reported. The outcome of the events was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nausea, Vaccination site rash
Clinical narrative: Case number PHHY2015US173037 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 602762) on 29 Dec 2015. This report refers to a 26 year old female patient. Her medical history and current conditions were not reported. Her concomitant medications included citalopram. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 06 Oct 2015. On 07 Oct 2015, she had a major headache, nausea and rash around the vaccination site. The events lasted for 48 hours. She was asked to sleep, have lots of water and some GATORADE and was given naproxen. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2015US173026 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 602876) on 29 Dec 2015. This report refers to a 38 year old female patient. Her medical history included hives with FLAGYL and sensitivity to fluoxetine (headaches). Her current conditions included allergies to penicillin and sulfa medications, asthma, allergies and oral allergy syndrome. Her concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 14 Oct 2015. On 15 Oct 2015, hives started at her vaccination site and she had swelling, itching, warmth and red skin. She took BENADRYL, but even though the medication was taken, the events lasted greater than 12 hours. The events outcome was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US173025, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 602899) website on 29 Dec 2015. This report refers to 51 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 22 Sep 2015. On the same day after vaccination the patient developed severe itching lead to hives on entire torso. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US173030, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602970) website on 29 Dec 2015. This report refers to a female patient of an unknown age. Medical history and current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left deltoid on an unknown date. On an unknown date after vaccination, the patient experienced prolonged severe arm pain at site of injection (left deltoid). Final outcome of the event was not recovered. Event was reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Feeling cold, Hyperhidrosis, Pyrexia
Clinical narrative: Case number PHHY2015US173673, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603150) on 29 Dec 2015. This report refers to a 51 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in right arm on 16 Oct 2015. On the same day after vaccination, the patient developed fever at a body temperature of 101 degree Fahrenheit along with chills. The patient also developed sweating at around 3:00 AM. The event fever began to subside around 9:00 AM and it was completely gone around 12:00 PM. Final outcome of all the events was complete recovery. Event was reported as non-serious. Causality was not reported.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Dizziness, Headache, Hypersomnia
Clinical narrative: Case number PHHY2015US173401, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603237) website on 29 Dec 2015. This report refers to a 13 years old female patient. Concurrent conditions included asthma, food allergies (not egg) and seasonal allergies. Concomitant medications included FLOVENT and CLARITIN. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 12 Oct 2015. On 13 Oct 2015 the patient experienced extreme fatigue. On 14 Oct 2015 morning the patient experienced muscle aches (calf muscles). On 16 Oct 2015 morning the patient experienced headache, nausea and dizziness (no vomiting). On 17 Oct 2015 the patient experienced fever of about 102.8 degrees that continued through 18 Oct 2015. Further the patient had no appetite and had just slept for 3 days straight. The patient was still asleep and was waiting to see if she had fever. On 18 Oct 2015 at 1 PM the patient experienced some mild coughing. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia
Clinical narrative: Case number PHHY2015US173401, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603237) website on 29 Dec 2015. This report refers to a 13 years old female patient. Concurrent conditions included asthma, food allergies (not egg) and seasonal allergies. Concomitant medications included FLOVENT and CLARITIN. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into right arm on 12 Oct 2015. On 13 Oct 2015 the patient experienced extreme fatigue. On 14 Oct 2015 morning the patient experienced muscle aches (calf muscles). On 16 Oct 2015 morning the patient experienced headache, nausea and dizziness (no vomiting). On 17 Oct 2015 the patient experienced fever of about 102.8 degrees that continued through 18 Oct 2015. Further the patient had no appetite and had just slept for 3 days straight. The patient was still asleep and was waiting to see if she had fever. On 18 Oct 2015 at 1 PM the patient experienced some mild coughing. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US1713632 is an initial spontaneous report via Vaccine Adverse Events Reporting System (VAERS reference number: 605528) on 29 Dec 2015. This report refers to a 5 year old female patient. Her vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) following which she had cellulitis of arm when she was at the age of 4 (see related case number: PHHY2015US001710). Her current condition included allergy to penicillin and cephalosporin. She had no concomitant medications. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm on 27 Oct 2015. On 28 Oct 2015 after vaccination, her arm was red, painful, swollen and warm to touch. She went to the emergency room. The final outcome of the event was not reported. The event was reported as non-serious. The causality of the event was not reported.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia oral
Clinical narrative: Case number PHHY2015US171200 is an initial spontaneous report from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 605893) on 29 Dec 2015. This report refers to a 36 year old female patient. She had no medical history or current illness. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 29 Oct 2015. On the same day, almost immediately after vaccination, her tongue started to go numb on the left side. She stated that her tongue was numb even after 2.5 hours. The final outcome of the event was not reported. The event was reported as non-serious. The causality of the event was not reported.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling
Clinical narrative: Case number PHHY2015US173010, is an initial spontaneous report received from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 605981) website on 29 Dec 2015. This report refers to a 9-year-old female patient. Historical condition included asthma (sounds like has mild asthma). The patient  had no current illness. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 29 Oct 2015. On the same day after vaccination at 20:45, the patient experienced upper lip swelling. The patient went to the emergency room. The patient was treated with steroids and BENADRYL. Final outcome of the event was not reported. Event was reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Case number PHHY2015US173670, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS ID: 606382) website on 29 Dec 2015. This report refers to a 53-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into right arm on 30 Oct 2015. On 01 Nov 2015 after vaccination, the patient experienced severe dizziness. The outcome of the event dizziness was reported as unknown. Seriousness of the event was reported as non-serious and causality not reported.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US172926, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606518) website on 29 Dec 2015. This report refers to a 19 years old male patient. Past medial history and concomitant medications were not reported. Current condition included vancomycin allergy. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 31 Oct 2015. On 01 Nov 2015, he broke out in hives. He was taken to the emergency room. The outcome of the event was unknown. The seriousness of the event was reported as non serious and causality was not reported.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Urticaria
Clinical narrative: Case number PHHY2015US172982, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 607156) website on 29 Dec 2015. This report refers to a 37 years old female patient. Past medical history was not reported. Concomitant medication included as trazodone (manufacturer unknown), levothyroxine (manufacturer unknown), TOPAMAX and tramadol (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 Oct 2015. On 21 Oct 2015, the patient experienced migraine and hives. The patient visited to the emergency room. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Bursitis, Mobility decreased, Musculoskeletal pain
Clinical narrative: Case number PHHY2015US173057, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 607497) website on 29 Dec 2015. This report refers to a 55 years old male patient. The patient had no medical history and no current illness. Concomitant medications were none. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) into arm an experienced shoulder pain, limited mobility and bursitis (see case: PHHY2015US173056). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into arm on 19 Oct 2015. On 29 Oct 2015 the patient presented progressively worsening shoulder pain (lower deltoid) radiating out to shoulder blade and down to wrist. Further lateral elevation and use was limited. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: 24 hours after MENVEO dose in (L) deltoid, pt. developed hives, itching, redness, warmth and swelling at injection site. Mom gave BENADRYL x 2 doses and noted improvement, child seen by MD the following day to "make sure he is ok", no c/o SOB or wheezing.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus, Pruritus
Clinical narrative: Client reported tingling all over the body with hives that began on the chest 24 hours after receiving multiple vaccines.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Client reported tingling all over the body with hives that began on the chest 24 hours after receiving multiple vaccines.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus
Clinical narrative: Client reported tingling all over the body with hives that began on the chest 24 hours after receiving multiple vaccines.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Chills, Dizziness, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: 3-4 hours after vaccination, pt with fever to 103, chills, dizziness. Rapid Flu neg.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, FLU4, MENB, MNQ
Symptoms: Chills, Dizziness, Influenza virus test negative, Pyrexia
Clinical narrative: 3-4 hours after vaccination, pt with fever to 103, chills, dizziness. Rapid Flu neg.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Injection site became red and swollen. Continuing to swell with redness area size increasing. Arm aching and general body aches throughout body, headache also. Will call MD today for advice.  Shingles vaccine to Right arm.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (doses and route of administration were not reported) lot # M015290 with an expiration date of 20-SEP-2017. No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 1.2 degree Celsius for 2 hours and 34 minutes. The previous temperature excursion was of 1.3 degree Celsius for 2 hours and 7 minutes. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow-up.; Sender's Comments: US-009507513-16111USA00080:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist student referring to a 64 year old male patient, with no drug reaction or allergies, no concomitant medication, nor medical history. On 30-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, single dose, for vaccination (dose and anatomical location were not reported), valid lot # M034765, expiration date 26-OCT-2017.  It was reported that the patient developed a one-side headache, with a tingling sensation (paraesthesia), on 01-JAN-2017. The one-side headache was resolved in one hour without requiring medical treatment and tingling sensation (paraesthesia) was reported as recovered on an unspecified date in January 2017. It was reported that the patient sought medical attention (pharmacy) to report the adverse events. The relationship between ZOSTAVAX and one-side headache, with a tingling sensation (paraesthesia) was not reported.  There was no Product Quality Complaint (PQC) involved. Additional information is not expected as there is no consent to contact the reporter.
Sex: F
Vaccine: RV5
Symptoms: Exposure via eye contact, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history and concurrent conditions were reported as none, and concomitant therapy was not provided. On 05-JAN-2017, the patient who is also a medical assistant, was administering ROTATEQ oral liquid (lot # M016919, expiration date 17-FEB-2018) for prophylaxis to a patient. During administration, the patient spit some of the vaccine into the medical assistant's eye. The nurse reported that medical assistant's eye was "burning" (eye irritation) and she "flushed her eye out with water". The "burning" resolved 5-10 minutes. Labs were not performed. The causal relationship between ROTATEQ and eye irritation was unknown. This is one of two reports from the same source MARRS: 1701USA010121. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010121:
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Herpes zoster, Paraesthesia
Clinical narrative: This spontaneous report was received from a 80 year old female patient, reporting on herself. The patient's current conditions included osteoporosis and cholesterol. The patient did not had drug reactions and allergies. Concomitant medications included atorvastatin calcium, alendronate sodium(manufacturer unknown) and penicillin. On 29-NOV-2016, the patient was vaccinated with ZOSTAVAX dose reported as 1 vaccination and route of administration reported as "vaccination"(lot # and expiration date were not provided, for prophylaxis.  Other suspect therapies included PNEUMOVAX23. Administered at the same time(product use issue).The vaccines were given in different arms. On 01-DEC-2016 (also reported as 2 days), after getting the shingles vaccination the patient came down with shingles. She said that she had experienced a burning sensation tingling on the right thigh are that spread to the "crotch area hip and butt-ox cheek are. The patient sought medical attention and was given an unspecified treatment. At the time of this report the outcome of the event was not reported. The reporter did not assessed the relationship between the event and ZOSTAVAX and PNEUMOVAX23.  Additional information has been requested.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Medical history and concomitant medications were not provided. On 11-JAN-2017,  the patient was vaccinated with M-M-R II, subcutaneous for prophylaxis (lot # and expiration date unknown).  Other suspect therapies included LIQUID PEDVAXHIB. On 11-JAN-2017, the patient was vaccinated with M-M-R II which was reconstituted with LIQUID PEDVAXHIB (considered as experienced product preparation error).  The reporter had training to administer vaccines and stated "that because in the military, there is no licensed healthcare prescriber on site as correspondence contact". No adverse effect was reported. No further information is available.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # M023169 with expiry date on 13-JUN-2018 (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47.22 degrees Fahrenheit for 5 minutes and more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47 degrees Fahrenheit for 5 minutes. Data logger was involved. There was no previous excursion reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012792.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to three unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ, lot # L035510 and expiration date 13-MAY-2017, orally, for prophylaxis (dose and frequency were not reported). The vaccines were stored under temperatures between 32 Farenheit and 36F for 888 hours and under >46°F, but <77°F for 39 hours. There were no previous temperature excursions, no data logger was involved and no adverse effects had been reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PPV, RV5
Symptoms: Apparent death, Cyanosis, Seizure like phenomena, Sudden infant death syndrome
Clinical narrative: This spontaneous report as received from an emergency medical technician refers to a 6-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient might have received following vaccines: diphtheria toxoid (+) pertussis acellular vaccine (reported as "DTaP"), pneumococcal vaccine, polyvalent (manufacturer unknown), poliovirus vaccine inactivated (reported as "IPV"), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as "HIB"), the influenza virus vaccine inactivated (reported as flu shot) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). On 17-JAN-2017, the patient was vaccinated with his "6 month vaccines". It was unknown what the specific vaccines were but the parent's told the reporter that they thought he received diphtheria toxoid (+) pertussis acellular vaccine (DTaP) possibly his third dose, pneumococcal vaccine, polyvalent (manufacturer unknown), poliovirus vaccine inactivated (reported as IPV), rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), hib conj vaccine (reported as HIB), maybe the influenza virus vaccine inactivated (reported as flu shot) and possibly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot# and expiration date were not reported) (dose regiments and route of administration were not reported for all vaccines) for prophylaxis. The reporter though that the parents must have been mistaken on the possibly measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) because it was only for children 12 months old. On the same day, the child looked like he was having seizures, he was turning blue. It was reported that he might have been experiencing a vaccine reaction or a vaccine injury or he was just a normal six month old having a reaction. The patient was in need and in a crisis. While the child was on his way to hospital he might have received intravenous (IV) fluids as a treatment. When he was in emergency room (ER) the doctors told that it was not a vaccine injury, but probably like sudden infant death syndrome (SIDS) or "something like that". It was unknown if the patient was admitted to the hospital. The parents were adamant that the boy was administered the vaccines this morning. At the time of the report, he was near death, in the R. It was unknown if there was any relevant laboratory tests performed. The outcome of the events was not reported. The relatedness between suspect vaccines and the events was not reported. The reporter considered the events to be life threatening as the patient was near death at the time of the report. Upon internal review the event of probably SIDS or "something like that" was considered to be medically significant. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 72 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 20-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 via intramuscular route in the right deltoid (lot # L012215, expiry date: 13-JAN-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Immediate post-injection reaction, Increased upper airway secretion, Injection site cellulitis, Injection site reaction
Clinical narrative: This spontaneous report was received from a 59 year old female patient (registered nurse), regarding herself. The patient's medical history included broken hip. The patient's concurrent conditions included allergy to a lot of unspecified medications and antibiotics including penicillin. On 28-DEC-2016, the patient was vaccinated with ZOSTAVAX 19,400 plaque forming units (PFU) (lot#, expiry date and dosing details not reported), subcutaneously in the right upper posterior arm for routine vaccination. Patient reported that almost immediately after vaccination, she began to develop hives and mucous in throat. Soon after, on an unknown date, she began to develop itching. She reported that her physician prescribed diphenhydramine (BENADRYL) for the treatment of hives and itching, which helped her. She also mentioned that over the next few days, her right arm began to swell from elbow to shoulder and her whole body ached. She stated that, the swelling moved up her neck and her right arm bone (humerus) also ached during the following three weeks. It was reported that, she was already taking acetaminophen (TYLENOL), tramadol hydrochloride (manufacturer unknown) and ibuprofen (manufacturer unknown) for her broken hip, which occurred before vaccination and she felt that, those medications helped with her discomfort from the adverse experience to ZOSTAVAX. The patient also had cellulitis at the ZOSTAVAX injection site and her physician prescribed levofloxacin (manufacturer unknown) for the adverse event. At the time of this report, the patient was recovering. The reporter had not assessed the causality of the events with ZOSTAVAX. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling, Pain, Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 59 year old female patient (registered nurse), regarding herself. The patient's medical history included broken hip. The patient's concurrent conditions included allergy to a lot of unspecified medications and antibiotics including penicillin. On 28-DEC-2016, the patient was vaccinated with ZOSTAVAX 19,400 plaque forming units (PFU) (lot#, expiry date and dosing details not reported), subcutaneously in the right upper posterior arm for routine vaccination. Patient reported that almost immediately after vaccination, she began to develop hives and mucous in throat. Soon after, on an unknown date, she began to develop itching. She reported that her physician prescribed diphenhydramine (BENADRYL) for the treatment of hives and itching, which helped her. She also mentioned that over the next few days, her right arm began to swell from elbow to shoulder and her whole body ached. She stated that, the swelling moved up her neck and her right arm bone (humerus) also ached during the following three weeks. It was reported that, she was already taking acetaminophen (TYLENOL), tramadol hydrochloride (manufacturer unknown) and ibuprofen (manufacturer unknown) for her broken hip, which occurred before vaccination and she felt that, those medications helped with her discomfort from the adverse experience to ZOSTAVAX. The patient also had cellulitis at the ZOSTAVAX injection site and her physician prescribed levofloxacin (manufacturer unknown) for the adverse event. At the time of this report, the patient was recovering. The reporter had not assessed the causality of the events with ZOSTAVAX. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a 2 month old patient of an unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly store dose of PEDVAX HIB 0.5 ml, first dose, intramuscularly (lot number M025194, expiration date 22-MAR-2019) for prophylaxis.  The temperature was 35°F degrees and the time frame was 10 hours (>46° F degrees but < 77° F degrees). There was no previous excursions. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ, lot # L046320 with expiry date on 29-SEP-2017 (dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47.22 degrees Fahrenheit for 5 minutes and more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47 degrees Fahrenheit for 5 minutes. Data logger was involved. There was no previous excursion reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007798:
Sex: F
Vaccine: HIBV, PPV
Symptoms: Anxiety
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways, from a contactable consumer reporting for herself. This female patient of an unspecified age (currently 72 year-old) received a single dose of a pneumococcal vaccine (unknown trade name) and a dose of P13 haemophilus influenza vaccine, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced anxiety. She recovered on an unspecified date. Pfizer is a marketing authorization holder of pneumococcal vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a physician on 16 January 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VIRUS VACCINES (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination the patient experienced heavy coughing and URI symptoms. Lab data and corrective treatment was not reported. The outcome of the events was not reported. Upon internal review this case was considered as serious due to Important Medical Event: URI symptoms. List of documents held by sender: none. Sender's Comments: This is poorly documented case as patient was vaccinated with influenza vaccine unknown manufacture following which patient had heavy coughing and upper respiratory infection symptoms. Time to onset is unknown additional information regarding patient medical history, concurrent condition, concomitant medication and diagnostic work-up- are lacking to allow adequate medical assessment. Based on the available information role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Culture throat negative, Influenza like illness, Influenza virus test negative, Malaise, Pneumonia
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 18-JAN-2017. This case is linked with 2017SA012171 (same reporter). This case involves 05 patients (age and gender reported (most are elderly) as male or female) who were vaccinated with a dose of FLUZONE HD intramuscularly and FLUZONE QIV (Batch number, expiry date site and route of administration were not reported for both vaccine) on an unspecified date. Patients did not have any illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions include rheumatological disorders. It was reported that reporter was unsure whether patient received any other vaccinations within 4 weeks of vaccinations. On an unspecified date, following vaccination, patients were ill with flu like symptoms in last two week, hospitalized with pneumonia and were very ill. On an unspecified date patient had emergency room or doctors visit. The reporter considered these events as life threatening. On an unspecified date Flu testing by laboratory and also throat Swab all Negative. Corrective treatment was not reported. Outcome of events was unknown. List of documents held by sender: none. Sender's Comments: It was reported that about 5 patients who received either INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE or INFLUENZA QUADRIVAL A-B VACCINE and experienced ill with flu like symptoms, and hospitalized with Pneumonia and are very ill. Time to onset is unknown. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Blister, Dysphagia, Endotracheal intubation
Clinical narrative: 31 year old patient with no significant past medical history received the influenza vaccine on 9/28. On 10/1 she had URI type symptoms and a rash around her eyes for which she started Durezol and tobramycin eye drops. She also began noticing a rash on her face. On 10/2 she went to an urgent care where she was diagnosed with a UTI and started oral Augmentin and received a Decadron shot. On 10/5 she was admitted to the hospital with a rash concerning Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN). The patient complained of eye pain due to swelling and blisters, oral ulcers, dysphagia/odynophagia and had difficulty swallowing. The patient also had anal and genital blisters/sloughing. A biopsy was positive for TEN and it was noted the influenza vaccine was the possible inciting event. Patient had 30% skin involvement with a skin biopsy showing full epidermis necrosis consistant with TEN. Patient was treated supportively as well as received IVIG. Patient was given aggressive fluid resuscitation w/ continued monitoring. Patient managed in MICU initially requiring vasopressors and intubation. Patient progressed well, was extubated and transferred to general medicine unit. The patient continued to progress with continued supportive care and was discharged on 11/7/16.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pain, Eye swelling, Genital blister, HIV test negative, Immunoglobulin therapy
Clinical narrative: 31 year old patient with no significant past medical history received the influenza vaccine on 9/28. On 10/1 she had URI type symptoms and a rash around her eyes for which she started Durezol and tobramycin eye drops. She also began noticing a rash on her face. On 10/2 she went to an urgent care where she was diagnosed with a UTI and started oral Augmentin and received a Decadron shot. On 10/5 she was admitted to the hospital with a rash concerning Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN). The patient complained of eye pain due to swelling and blisters, oral ulcers, dysphagia/odynophagia and had difficulty swallowing. The patient also had anal and genital blisters/sloughing. A biopsy was positive for TEN and it was noted the influenza vaccine was the possible inciting event. Patient had 30% skin involvement with a skin biopsy showing full epidermis necrosis consistant with TEN. Patient was treated supportively as well as received IVIG. Patient was given aggressive fluid resuscitation w/ continued monitoring. Patient managed in MICU initially requiring vasopressors and intubation. Patient progressed well, was extubated and transferred to general medicine unit. The patient continued to progress with continued supportive care and was discharged on 11/7/16.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Intensive care, Mouth ulceration, Odynophagia, Rash, Skin exfoliation
Clinical narrative: 31 year old patient with no significant past medical history received the influenza vaccine on 9/28. On 10/1 she had URI type symptoms and a rash around her eyes for which she started Durezol and tobramycin eye drops. She also began noticing a rash on her face. On 10/2 she went to an urgent care where she was diagnosed with a UTI and started oral Augmentin and received a Decadron shot. On 10/5 she was admitted to the hospital with a rash concerning Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN). The patient complained of eye pain due to swelling and blisters, oral ulcers, dysphagia/odynophagia and had difficulty swallowing. The patient also had anal and genital blisters/sloughing. A biopsy was positive for TEN and it was noted the influenza vaccine was the possible inciting event. Patient had 30% skin involvement with a skin biopsy showing full epidermis necrosis consistant with TEN. Patient was treated supportively as well as received IVIG. Patient was given aggressive fluid resuscitation w/ continued monitoring. Patient managed in MICU initially requiring vasopressors and intubation. Patient progressed well, was extubated and transferred to general medicine unit. The patient continued to progress with continued supportive care and was discharged on 11/7/16.