chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 30-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not reported. On 11-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # M034766, expiration date 26-OCT-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA (which had a lot # of M036459 and an expiration date of 18-JAN-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccines experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014464: US-009507513-1701USA014465: US-009507513-1701USA014466:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (which had a lot # of M020926 and an expiration date of 11-AUG-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014465: US-009507513-1701USA014466:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (which had a lot # of M026315 and an expiration date of 26-JAN-2018; however, dosage number was not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014464: US-009507513-1701USA014466:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an administrator refers to an unspecified patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of M024261 and an expiration date of 30-JUL-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccine experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008006: US-009507513-1701USA014464: US-009507513-1701USA014465.
Sex: F
Vaccine: PNC
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. This report was received via a Pfizer sales representative.  A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date as single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced raised very painful arm on an unspecified date. The patient went to the emergency room (ER). At the ER, she received a shot in the arm, described as some type of unspecified painkiller. It was relieved after that.  The outcome of raised very painful arm was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Computerised tomogram head normal, Headache, Rhinorrhoea, Sinus disorder
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for himself. A 85-year-old male patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date in 2016 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headaches and mucus, that he feels are sinus related on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included computerised tomogram: grossly clear sinuses.
Age: 33.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Reported by patient: approximately 10 minutes after Varicella vaccine and 5 minutes after Tdap given, patient reported a burning sensation between shoulder blades. At 15 minutes after 1st vaccine (Varicella) patient reported itching to upper chest. Benadryl 50mg IM given to patient at 9:32 AM Patients skin became bright red between shoulder blades and upper chest area. Patient was observed for approximately 1 hour after onset of symptoms with symptoms resolving.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Gastric disorder, Headache, Influenza like illness
Clinical narrative: Case number PHEH2016US028364, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 72-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. On next day 20 Oct 2016 the patient experienced flu like symptoms following headaches, fever, stomach issues, muscle pain, fatigue and weakness. The outcome of the events was condition unchanged. Seriousness of the events was not reported. Causality of the events was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Case number PHEH2016US028364, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 72-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. On next day 20 Oct 2016 the patient experienced flu like symptoms following headaches, fever, stomach issues, muscle pain, fatigue and weakness. The outcome of the events was condition unchanged. Seriousness of the events was not reported. Causality of the events was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Swelling of entire arm took BENADRYL and swelling subsided over next 2 days difficult to bend or use arm.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Dysarthria, Fatigue, Musculoskeletal disorder, Nuclear magnetic resonance imaging
Clinical narrative: Speech was slurring, son told me he was just tired. Went on to bed, woke up next morning dropping his regular meds, hand not working right, I took him to the ER.
Age: 0.33
Sex: F
Vaccine: DTAP, RVX
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Blood in stool at least 3 times, runny loose stools continued over the course of 2 weeks, no treatment.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: Pt. stated he was slightly dizzy after vaccinations at approximately 1:55 PM. Dizziness completely resolved per patient by 2:08 PM.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Eyelid oedema, Head discomfort, Ocular hyperaemia, Oedema peripheral
Clinical narrative: Red eyes, swollen eyelids, and swollen face. My son stated his head felt weird like he was almost floating. The next day the arm that received the injection was swollen under the right axilla, and my son complained it was hurting.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Red eyes, swollen eyelids, and swollen face. My son stated his head felt weird like he was almost floating. The next day the arm that received the injection was swollen under the right axilla, and my son complained it was hurting.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Generalised erythema, Pruritus, Rash
Clinical narrative: ***PT NOTES POSSIBLE REACTION TO VACCINES. WHOLE BODY IS RED, RASH-LIKE, ITCHING since administration. NO TROUBLE BREATHING OR RESPIRATORY ISSUES. ALSO NOTED PREVIOUS ALLERGY TO EGGS, BUT THOUGHT SHE WAS OVER THAT. Adv pt to seek medical attention, especially if symptoms get worse or any breathing issues present.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Injection was given IM route in deltoid muscle on 1/6/17. As of today, injection site is still painful.
Age: 9.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: Fatigue, fever, muscle cramps/aches, headache, stomach pains, dizziness, flushed cheeks Treatment : Advil every 6 hours for 2 days, tested negative for flu and strep throat.
Age: 9.0
Sex: F
Vaccine: TYP
Symptoms: Influenza virus test negative, Muscle spasms, Myalgia, Pyrexia, Streptococcus test negative
Clinical narrative: Fatigue, fever, muscle cramps/aches, headache, stomach pains, dizziness, flushed cheeks Treatment : Advil every 6 hours for 2 days, tested negative for flu and strep throat.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Skin lesion
Clinical narrative: Mom noted this morning while taking shorts off a large "baseball size" erythematous lesion on R lateral thigh. Pruritic with some pain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 102.5F on 31JAN2017. No Tx. Afebrile at dr visit next day. Tx at dr visit is Tylenol just in case fever comes back.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 weeks old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 17-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report was received from a physician referring a female patient of unknown age, who was a nurse also. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in January 2017 (reported as "last week"), the patient was vaccinated with a dose of ZOSTAVAX, for prophylaxis (dose, route, lot # and expiration date were not reported). On 21-JAN-2017, the patient experienced an injection site reaction that was "painful to touch", with little "blisters" and "swelling"; and was about "1-2 inches in diameter". It was stated that the patient recovered from the events on 23-JAN-2017 (also reported as 23-JAN-2016). A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 12-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, with expiration date 26-DEC-2016, for prophylaxis (dose, route and lot # were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient's medical history was not reported and there were no drug reactions/allergies. However, concomitant therapies included an unspecified monthly medication for an unspecified "bone" disorder. On 29-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX with lot number M035692 and expiration date of 07-NOV-2017 (strength, dose, route of administration and anatomical location were unknown) for immunization (prophylaxis). On the same date, the patient experienced headache. Moreover, it was reported that on 30-JAN-2017, the patient experienced swelling, redness and warmth around the injection site. The patient did not seek medical attention and there were no laboratory diagnostics studies performed as well as no treatment was given for the adverse event. No product quality complaint was involved. At the time of reporting, the patient was not recovered from the events. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash from injection site to elbow & very itchy.
Age: 49.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Local reaction
Clinical narrative: Office visit 1/30/17.  Left deltoid 3x6 cm raised rash, localized skin erythema at injection site  area itchy & sore to the touch.  Localized skin reaction.  Continue to monitor.  Return if no improvement or gets worse.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Vomiting
Clinical narrative: Vomiting. Dizziness.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Limping and complaining about leg/injection site hurting, entire leg and injection site swollen, red around injection site.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Shoulder pain that moved from site of injection in arm, to shoulder, back, front of shoulder and neck.  Immediate onset that has lasted more than 3 months.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL, FLUX, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site reaction, Injection site urticaria, Malaise, Rash macular
Clinical narrative: 24 hrs after vaccine administered developed general malaise and fatigue. 48 hrs after vaccine, blotchy hives scattered over (L) upper arm. Applied ice pack PRN and took ZYRTEC qd. Symptoms started to improve on day 5 then fully resolved on day 7 after vaccine.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase increased, Differential white blood cell count, Full blood count, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: After receiving the flu vaccine 10-24-16 AM, site of injection (upper right arm) became red, irritated w/itchy rash by the PM. After 3 day returned to facility to show and report the adverse reaction. (No tx)-red, irritated itchy rash did not clear up until after 2 weeks. After 2 weeks I began to experience numbness and tingling and warm feeling surrounding the site of injection area reported adverse reaction to Dr. during an appt on Nov. 9th, 2016. (No tx). Continue w/intensity of numbness and tingling w/increase burning pain Feb. 1, 2017. URI.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site irritation, Injection site paraesthesia, Injection site reaction, Injection site warmth, Lymphocyte percentage
Clinical narrative: After receiving the flu vaccine 10-24-16 AM, site of injection (upper right arm) became red, irritated w/itchy rash by the PM. After 3 day returned to facility to show and report the adverse reaction. (No tx)-red, irritated itchy rash did not clear up until after 2 weeks. After 2 weeks I began to experience numbness and tingling and warm feeling surrounding the site of injection area reported adverse reaction to Dr. during an appt on Nov. 9th, 2016. (No tx). Continue w/intensity of numbness and tingling w/increase burning pain Feb. 1, 2017. URI.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Neutrophil percentage increased, Nuclear magnetic resonance imaging abnormal, Pain, Rash pruritic, Upper respiratory tract infection
Clinical narrative: After receiving the flu vaccine 10-24-16 AM, site of injection (upper right arm) became red, irritated w/itchy rash by the PM. After 3 day returned to facility to show and report the adverse reaction. (No tx)-red, irritated itchy rash did not clear up until after 2 weeks. After 2 weeks I began to experience numbness and tingling and warm feeling surrounding the site of injection area reported adverse reaction to Dr. during an appt on Nov. 9th, 2016. (No tx). Continue w/intensity of numbness and tingling w/increase burning pain Feb. 1, 2017. URI.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Keratitis, Ocular hyperaemia, Ophthalmological examination abnormal
Clinical narrative: Had shot at 6:30 pm on 1/24/17. The next morning, my eyes (both) were swollen, red, throbbing and light sensitive headache went to eye doctor 1/25/17 and 1/26/17. Follow up on 1/30
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia
Clinical narrative: Had shot at 6:30 pm on 1/24/17. The next morning, my eyes (both) were swollen, red, throbbing and light sensitive headache went to eye doctor 1/25/17 and 1/26/17. Follow up on 1/30
Age: 3.0
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Pyrexia, Seizure, Upper respiratory tract infection, Viral infection
Clinical narrative: Pt seen 1/30/17 for viral illness/URI. Afebrile at visit at 1949. HIB and PREVNAR and FLUZONE QUAD 0.5 ml administered at 2012. Maternal aunt called our office on 1/31/17 1152 reported child developed fever of 101.3 degrees F this am and suffered a prolonged seizure of > 15 min 911 called, on route to ER.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site pruritus
Clinical narrative: Pt was here for follow up with PCP, MD ordered a flu vaccine for pt. This nurse administered the vaccine and shortly after the pt. c/o itching at the injection site. MD was notified and gave verbal order to administer 25mg tablet of BENADRYL, PO to pt. Pt received medication orally, and was monitored after. Pt was then given the okay to leave after the nurse witnessed that the allergic reaction had substituted.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site nodule
Clinical narrative: Grandmother reported 24 hours after receiving flu shot pt had large "lemon" size knot at injection site with some elevated temperature. Given TYLENOL, warm compresses to site.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Persistent (R) deltoid pain 6 wks after vaccine no neurological strength deficit. 50% improved.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV, FLUX, PPV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Persistent (R) deltoid pain 6 wks after vaccine no neurological strength deficit. 50% improved.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a nurse and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO (batch number 156801A, expiry date August 2017). In October 2016, the patient received the 1st dose of BEXSERO (intramuscular) 0.5 ml. In October 2016, less than a month after receiving BEXSERO, the patient experienced influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling ill such as experiencing flu like symptoms. The reporter was unable to get more information. The case was linked with cases US2016161492 and US2016GSK196396, reported by the same reporter.
Age: 39.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: N/A. Gave wrong administered vaccine. Gave Dtap instead of Tdap.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Expired product administered
Clinical narrative: Medical Assistant administered an expired vaccine to patient. Zoster vaccine expired 1/8/17, date given 1/23/17. Lead physician notified immediately. Letter mailed to patient.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to Right upper arm approximately 20x10 cm erythema cellulitis, Rx Cephalexin 250mg/ml 10ML PO BID x 5 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Within 1 hour after administration it started itching at injection site. And then it became swollen and warm surrounding injection site. During night was painful, red, itching and warm. Used hydrocortisone cream, BENADRYL OTC (PO) and ice pack. Throughout next day I had cellulitis that was extending down to elbow and wrapping around the entire upper arm. Was started on cephalexin at end of second day and warm moist cloth.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Within 1 hour after administration it started itching at injection site. And then it became swollen and warm surrounding injection site. During night was painful, red, itching and warm. Used hydrocortisone cream, BENADRYL OTC (PO) and ice pack. Throughout next day I had cellulitis that was extending down to elbow and wrapping around the entire upper arm. Was started on cephalexin at end of second day and warm moist cloth.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Localized left upper arm erythema and edema with pruritus. Antihistamine recommended OTC.
Age: 0.67
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Hives. Treated with BENADRYL.
Age: 36.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Feeling drunk
Clinical narrative: About 30 minutes after receiving vaccine, patient felt like he was "intoxicated".
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Patient received first GARDASIL vaccine, after admin patient was to wait 15 mins for adverse reaction. Upon assessment Pt stated she felt "dizzy", pale. Patient was layed down for 45 mins still C/O dizziness, water given no relief. BP within range, PEDIALYTE popsicle given after 5 mins patient stated she was no longer dizzy. Assessed by MD, ok to go home.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: MENB
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a nurse and described the occurrence of influenza-like symptoms in a 16-year-old female patient who received BEXSERO (batch number 156801A, expiry date August 2017). In October 2016, the patient received the 1st dose of BEXSERO (intramuscular) 0.5 ml. In October 2016, less than a month after receiving BEXSERO, the patient experienced influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient reported felling ill such as experiencing flu like symptoms. The reporter was unable to get more information. This case was linked with cases US2016161492 and US2016GSK196395, reported by the same reporter.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2015US173636 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 602209) on 29 Dec 2015. This report refers to a 68 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the left arm on 08 Oct 2015. She also received PREVNAR 13 (other manufacturer batch number: not reported) intramuscularly in the left arm on 09 Oct 2015. On 10 Oct 2015, her injection site was red and swollen. Her arm was hurting all night and she could not sleep and she called pharmacy. She was advised to put a cold compress on the painful area and to take ibuprofen that was prescribed by per primary care physician (PCP). An on call physician was called who said that the patient was experiencing a normal reaction and should apply cold compress and take ibuprofen or acetaminophen. The patient was called back an hour later to let her know and check on her. The patient stated that she was feeling much better than before. The patient came to the pharmacy and spoke with the pharmacist and stated that the pain did not go away and she had a red band around her arm that was spreading. The pharmacist advised her to draw a line around the red band on her hand to note the change over time and to go to the hospital right away. The patient went to the emergency room. The final outcome of the events was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass, Tenderness
Clinical narrative: Case number PHHY2015US173664, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602560) on 29 Dec 2015. This report refers to a 48 years old male patient. Past medical history was not reported. Concomitant medication included antibiotics. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on 07 Oct 2015. On 08 Oct 2015, the patient developed found large lump under left armpit. He felt very tender. The final outcome of the events was not reported. The seriousness was reported as non serious and causality not reported.
Sex: M
Vaccine: FLUC3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US009915, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602744) website on 18 Jan 2016. This report refers to a 51 years old male patient. Paste medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) into left arm, intramuscularly on 15 Sep 2015. On an unknown date, the patient experienced left arm pain and shoulder pain. The patient presented to the clinic on 14 Oct 2015 with complaints of left arm pain and shoulder pain. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLUC3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US009057, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 602745) website on 18 Jan 2016. This report refers to a 37-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly into left arm on 15 Sep 2015. On same day after vaccination, the patient complained of left arm/shoulder pain. The patient visited the clinic on 13 Oct 2015. The final outcome of the events was not reported. Seriousness of the events was reported as non-serious and causality not reported.
Age: 37.0
Sex: M
Vaccine: FLUC3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2016US009765, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 602747) on 18 Jan 2016. This report refers to a 37 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 173539) on 15 Sep 2015. He experienced left arm and shoulder pain since receiving the flu shot. Outcome of the events was reported as unknown. The events were assessed as non serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US173632, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602753) website on 29 Dec 2015. This report refers to a 46-year-old female patient. Historical conditions included fibromyalgia, blepharitis and rosacea. Concomitant medication included ibuprofen (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into right arm intramuscularly on 06 Oct 2015. On 08 Oct 2015 the patient started running a low-grade fever and been running one consistently for over a week, felt generally weak, somewhat disoriented and not well at all. The outcome of the events was condition unchanged. Seriousness was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Dysarthria, Musculoskeletal pain, Painful respiration
Clinical narrative: Case number PHHY2015US173639, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602788) on 29 Dec 2015. This report refers to a 47 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on 14 Oct 2015. At about 10:30 AM, she felt the usual symptom shoulder aches. At around 12:30 PM her shoulder and scapula became sore then it quickly progressed to left back thoracic side. It was painful to move left side and it also hurt to inhale. She was scrubbed in surgery and 2 physician noticed that there was something wrong. The surgeon asked her a couple of questions and stated that her words were slurring and that needed to excuse from my duties. The injection site was on my left upper arm, right side was not affected at any time. The final outcome of the events were reported as complete recovery. The seriousness was reported as non serious and causality not reported.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Increased tendency to bruise, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2015US173949 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603082) website on 29 Dec 2015. This report refers to a 21-year-old female patient. Historical condition included rheumatoid arthritis. Past medications included immunosuppressant and ACTEMRA. Current condition included unable to touch upper arm or lift it, required assistance showering and getting dressed. Concomitant medications included methotrexate and ACTEMRA injections. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into right arm intramuscularly and PNEUMOVAX (other manufacturer) into right arm intramuscularly on 28 Sep 2015. The patient experienced severe pain in shoulder and entire upper arm on the day of the injection on 28 Sep 2015 worsened through 01 Oct 2015. The patient was unable to touch upper arm or lift it, required assistance showering and getting dressed. Morning of 30 Sep 2015 a large rash appeared on her upper arm, not at the site of the injection but about 5 inches below and swollen, bright red, extremely tender to the touch, about the size of the palm of her hand. Evening of 30 Sep 2015 the rash had doubled in size on her arm, still below the injection site. The patient notified her doctor so we could monitor over a digital platform, sent him pictures and descriptions. Morning of 01 Oct 2015 the rash had again doubled in size covering half of her upper arm, now a darker red, still extremely swollen and very tender. Evening of 01 Oct 2015 the rash had increased in size, covering over half of her arm. Pain and swelling the same. Evening of 02 Oct 2015 the rash covered about 3/4 of her upper arm, but the swelling, red color and pain was not as intense as previous days. Morning of 03 Oct 2015 the rash and pain appeared to be fading, continued to do so over the next couple of days until it ceased entirely on 07 Oct 2015. The patient fully recovered from vaccination site rash on 07 Oct 2015 and pain on 07 Oct 2015 and rest of the events on an unknown date. Seriousness of the events was reported as non-serious and causality was not reported.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2015US173949 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603082) website on 29 Dec 2015. This report refers to a 21-year-old female patient. Historical condition included rheumatoid arthritis. Past medications included immunosuppressant and ACTEMRA. Current condition included unable to touch upper arm or lift it, required assistance showering and getting dressed. Concomitant medications included methotrexate and ACTEMRA injections. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) into right arm intramuscularly and PNEUMOVAX (other manufacturer) into right arm intramuscularly on 28 Sep 2015. The patient experienced severe pain in shoulder and entire upper arm on the day of the injection on 28 Sep 2015 worsened through 01 Oct 2015. The patient was unable to touch upper arm or lift it, required assistance showering and getting dressed. Morning of 30 Sep 2015 a large rash appeared on her upper arm, not at the site of the injection but about 5 inches below and swollen, bright red, extremely tender to the touch, about the size of the palm of her hand. Evening of 30 Sep 2015 the rash had doubled in size on her arm, still below the injection site. The patient notified her doctor so we could monitor over a digital platform, sent him pictures and descriptions. Morning of 01 Oct 2015 the rash had again doubled in size covering half of her upper arm, now a darker red, still extremely swollen and very tender. Evening of 01 Oct 2015 the rash had increased in size, covering over half of her arm. Pain and swelling the same. Evening of 02 Oct 2015 the rash covered about 3/4 of her upper arm, but the swelling, red color and pain was not as intense as previous days. Morning of 03 Oct 2015 the rash and pain appeared to be fading, continued to do so over the next couple of days until it ceased entirely on 07 Oct 2015. The patient fully recovered from vaccination site rash on 07 Oct 2015 and pain on 07 Oct 2015 and rest of the events on an unknown date. Seriousness of the events was reported as non-serious and causality was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Feeling hot, Headache, Heart rate increased
Clinical narrative: Case number PHHY2015US173665, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 603088) website on 29 Dec 2015. This report refers to a 30 years old female patient. Past medical history included as morphine allergies and migraine headache. Concomitant medications included as lisinopril (manufacturer unknown), metformin (manufacturer unknown), amitriptyline (manufacturer unknown), duloxetine (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), propranolol (manufacturer unknown) and rizatriptan (manufacturer unknown). The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Oct 2015. On the same day after vaccination, the patient experienced headache, clamminess, feeling of being hot inside but no fever, increased pulse and heart rate. The patient visited to the emergency room. 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.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Case number PHHY2015us173963 an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603107) website on 29 Dec 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date and the patient experienced felt chills and got slight fever. The outcome of the events, seriousness and causality was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Chills, Insomnia, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015us173963 an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603107) website on 29 Dec 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date and the patient experienced felt chills and got slight fever. The outcome of the events, seriousness and causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Case number PHHY2015US173961 is an initials spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number; 603107) website on 29 Dec 2015. This report refers to a 65-year-old female patient. Medical history was not reported. Concomitant medication included SYNTHROID. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 16 Oct 2015. The patient started feeling sick with chills and fever of 100 about dinner time. The patient took TYLENOL for fever but could not sleep all night. The patient fever spiked to almost 103 at 3 am. The patient took more TYLENOL. Next day the patient was feeling very weak with slight fever. On previous regular flu shots the patient would sometimes felt chills and got slight fever. This super flu shot the patient very sick with a dangerously high fever. The patient was almost ready to go to the hospital. The outcome of the events was not reported. Seriousness of the events was reported a non serious and causality was not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Chills, Insomnia, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US173961 is an initials spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number; 603107) website on 29 Dec 2015. This report refers to a 65-year-old female patient. Medical history was not reported. Concomitant medication included SYNTHROID. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 16 Oct 2015. The patient started feeling sick with chills and fever of 100 about dinner time. The patient took TYLENOL for fever but could not sleep all night. The patient fever spiked to almost 103 at 3 am. The patient took more TYLENOL. Next day the patient was feeling very weak with slight fever. On previous regular flu shots the patient would sometimes felt chills and got slight fever. This super flu shot the patient very sick with a dangerously high fever. The patient was almost ready to go to the hospital. The outcome of the events was not reported. Seriousness of the events was reported a non serious and causality was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Musculoskeletal pain, Myalgia
Clinical narrative: Case number PHHY2015US173622, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603123) on 29 Dec 2015. This report refers to a 49 years old male patient. Past medical history included got the flu shot every year. The concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (unknown manufacture, batch number: not reported) on 02 Oct 2015. On the same day after vaccination, he experienced muscle pain in my left arm. On 03 Oct 2015, (next morning) he experienced severe back and shoulder pain radiating from left arm for over 2 weeks. The patient also had muscles and joints ache all the time and grow worse with long periods of standing. The pain kept him from performing daily activities and sleeping, awaked in the night. The patient received ADVIL several times daily to function and had seen chiropractor with little relief. The final outcome of the events was reported as condition unchanged. The seriousness was reported as non serious and causality not reported.
Sex: M
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: Case number PHHY2015US173622, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603123) on 29 Dec 2015. This report refers to a 49 years old male patient. Past medical history included got the flu shot every year. The concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (unknown manufacture, batch number: not reported) on 02 Oct 2015. On the same day after vaccination, he experienced muscle pain in my left arm. On 03 Oct 2015, (next morning) he experienced severe back and shoulder pain radiating from left arm for over 2 weeks. The patient also had muscles and joints ache all the time and grow worse with long periods of standing. The pain kept him from performing daily activities and sleeping, awaked in the night. The patient received ADVIL several times daily to function and had seen chiropractor with little relief. The final outcome of the events was reported as condition unchanged. The seriousness was reported as non serious and causality not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2015US173587, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603132) website on 29 Dec 2015. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, she experienced flu like symptoms. The outcome, seriousness and causality of the events was not reported.