chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: PNC13, TTOX
Symptoms: Blood test, Diarrhoea, Fatigue, Feeling abnormal, Induration
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his/her mother. An 83-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 05Apr2017 for immunisation. The patient received it is one time every 10 years on the left arm. Medical history included hypothyroidism and diuretic. Concomitant medication included SYNTHROID at 0.088 ug 1x/day from an unspecified date and ongoing for hypothyroidism, hydrochlorothiazide (HCTZ) at 25 mg 1x/day from an unspecified date and ongoing for diuretic. The patient experienced arms swelled up and got real hard knot on 09Apr2017 with outcome of recovering, arms, itching in the arm and she keeps having itching spots here and there on 09Apr2017 with outcome of not recovered, diarrhea on 09Apr2017 with outcome of recovered, fatigue on 09Apr2017 with outcome of unknown, she has been miserable for the last 3 weeks on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test on unknown date. Reporter stated that no treatment was taken.
Age: 83.0
Sex: F
Vaccine: PNC13, TTOX
Symptoms: Nodule, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his/her mother. An 83-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 05Apr2017 for immunisation. The patient received it is one time every 10 years on the left arm. Medical history included hypothyroidism and diuretic. Concomitant medication included SYNTHROID at 0.088 ug 1x/day from an unspecified date and ongoing for hypothyroidism, hydrochlorothiazide (HCTZ) at 25 mg 1x/day from an unspecified date and ongoing for diuretic. The patient experienced arms swelled up and got real hard knot on 09Apr2017 with outcome of recovering, arms, itching in the arm and she keeps having itching spots here and there on 09Apr2017 with outcome of not recovered, diarrhea on 09Apr2017 with outcome of recovered, fatigue on 09Apr2017 with outcome of unknown, she has been miserable for the last 3 weeks on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test on unknown date. Reporter stated that no treatment was taken.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Acoustic stimulation tests normal, Aphasia, Brain injury, Brain scan abnormal, Decreased appetite
Clinical narrative: She had a fever (101 degrees), she started staring for about 2 minutes every half an hour and refused to eat. She lost all her words and has not said a single word since.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Electroencephalogram, Pyrexia, Staring, Visual acuity tests normal
Clinical narrative: She had a fever (101 degrees), she started staring for about 2 minutes every half an hour and refused to eat. She lost all her words and has not said a single word since.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blister, Eye pruritus, Injection site pain, Ocular hyperaemia, Rash
Clinical narrative: Bumps/Blisters on arm, torso, thigh, top of head and genital area. Eyes were red and itching, Pain at Injection Site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Muscular weakness, Myalgia, Nausea, Vomiting projectile
Clinical narrative: Nausea, projectile vomiting, diarrhea within 15 minutes of vaccine; muscles aches/weakness the following day and some continued N/V/D--- patient self treated with Gatorade and lots of fluids.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a adult female patient who received FLUARIX QUADRIVALENT (batch number 45ER7, expiry date unknown). On 18th December 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT, the patient experienced erythematous rash and itchy rash. On an unknown date, the outcome of the erythematous rash and itchy rash were recovered/resolved. It was unknown if the reporter considered the erythematous rash and itchy rash to be related to FLUARIX QUADRIVALENT. Additional details provided as follows: This case was reported by the patient's mother. The patient experienced a reaction after receiving the FLUARIX QUADRIVALENT. The reaction was further described as a bright fiery red rash with small little itchy bumps all over. The rash resolved within a few days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever to 101 and C/O pain at vaccine site, red and raised area, no streaking not warm to touch.
Age: 56.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain and soreness in Lt shoulder. Started after vaccines.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Unevaluable event, X-ray
Clinical narrative: See attached.
Age: 1.67
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis, Injection site erythema, Swelling
Clinical narrative: Redness and cellulitis noted to right upper arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child developed intense redness and swelling at site. Was placed on KEFLEX for potential cellulitis.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Right upper arm cellulitis - given KELFELX 500mg QID x 7 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in arm and it got worse, it continue next few days. Then on 04/24/17 Pain went away but then redness and swelling began up and down my arm this lasted till 05/01/2017.
Age: 20.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dizziness, Erythema, Lip swelling, Paraesthesia oral, Urticaria
Clinical narrative: Patient returned to Immunization department 11:15 hives on face, chest, back, R/L arms-skin red/erythema.Patient reports mouth is tingely. Lip swelling. 11:30 am patient received 50mg IM of Diphenhydramine. 0.3mg of epinephrine administered @11:43 am. Patient reported she felt lightheaded along with above symptoms after receiving epi-pen. Transported by EMS to Hospital.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Neck pain
Clinical narrative: Sharp constant pain in left side of neck started 2 days after vaccination, then pain moved 5/1/2017 to left shoulder. Constant Ibuprofen and ice pack.
Age: 65.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red and swollen (referred to as a "lump" by pt.), 2 in by 2 in, denies fever, denies any hotness to the touch. Denies pain, reports "slightly itchy".
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Immediately after vaccine pt reported feeling lightheaded/nauseated. She waited 5-10 min; began feeling better and left. She fainted before leaving store. After fainting she admitted she had fainted after a previous flu shot several years previous. RPh follow up w/pt on 5-1-17 and she is fine.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, VARCEL
Symptoms: Dizziness, Eye movement disorder, Immediate post-injection reaction, Musculoskeletal stiffness, Seizure
Clinical narrative: Pt was given all 4 vaccines and the HPV was given last an right after it was administered the pt stated he felt to faint then started having a seizure arms stiffened and legs extended and stiffened eyes rolled in back of head lasted about.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63-year-old male patient with atrial fibrillation and with no drug reactions or allergies. The patient's pertinent medical history included a myocardial infarction in February 2016. As concomitant therapies, the patient took amitriptyline hydrochloride (manufacturer unknown); butalbital; acetaminophen (+) caffeine; carvedilol; cyclobenzaprine hydrochloride; diazepam (manufacturer unknown); EFFIENT; GENERLAC; oxycodone; pantoprazole; pravastatin; tamsulosin hydrochloride, and zolpidem. On 07-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot number: M032141, expiration date: 02-OCT-2017 (Strength, anatomical location, dose, and frequency were not provided) for prophylaxis. On the same date reported as "from the time of vaccination", the patient experienced a "severe" local injection reaction characterized by redness that measured 6 to 8 inches. No treatment was given to the patient, and he did not undergo any laboratory test or diagnostic procedure. At the time of this report, the patient did not recover from the adverse event. The causal relationship between the therapy with ZOSTAVAX and the adverse event was not reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004335.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) with lot # M041510 and expiration date on 27-JUL-2017 (dose, route of administration and anatomical location were not provided), for prophylaxis; instead of VARIVAX. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Lymph node pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 60 years-old female patient, reporting on herself. The patient's did not have pertinent medical history. Her concurrent conditions included drug reaction or allergy to penicillin. Concomitant medications included losartan potassium (manufacturer unknown). On 17-APR-2017, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose and route of administration were not provided) in combination with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength and dose were not provided); the shot was administered in the fatty part of the upper left arm, for shingles prevention. After that, her left arm became swollen, and a red welt was developed around the injection site. The patient also stated that she was experiencing a little bit of soreness on the lymph gland on the side where the shot was administered. The patient sought medical attention by speaking with her physician but no laboratory diagnostics studies were performed. At the reporting time, the patient had not recovered from the peripheral swelling, injection site erythema and lymph node pain. The relatedness between the peripheral swelling, injection site erythema and lymph node pain and the vaccine was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 25-APR-2017 from a nurse who gave the phone to the physician. The physician reported that on 25-APR-2017 an improperly stored ROTATEQ was administered to an unspecified patient.  Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. The action taken was not applicable and the outcome was not reported. The physician did not rate the causal relationship. Name of vaccine involved: ROTATEQ (lot # M038207, expiration date 02-MAY-2018) Temperature: 31.1 degrees Fahrenheit Time Frame: 30 hours Was it administered: yes Previous temperature excursion: no Was call because of a "data logger"? yes No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unknown number of patients from a group of 5 patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # reporter as M042502, expiration date: 17-APR-2018), reconstituted with properly stored sterile diluent (STERILE DILUENT) (lot # and expiration date unknown) for prophylaxis (dose, frequency and route of administration, were not reported). No adverse effects were reported. The doses of the vaccines were exposed to a temperature of 6 degrees Fahrenheit (°F) to 14°F for a time frame of 21 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1704USA015107:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unknown number of patients from a group of 5 patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M038226, expiration date: 07-SEP-2018; and lot # reported as M033902, expiration date: 20-JUL-2018), reconstituted with properly stored sterile diluent (lot # and expiration date unknown), for prophylaxis (dose, frequency and route of administration, were not reported). No adverse effects were reported. The doses of the vaccines were exposed to a temperature of 6 degrees Fahrenheit (°F) to 14°F for a time frame of 21 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1704USA013521.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity received TRUMENBA, via an unspecified route of administration at 0.5 ml single on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of unknown.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal discomfort, Haematochezia, Intussusception, Small intestinal intussusception reduction, Ultrasound abdomen abnormal
Clinical narrative: Pt s/p ROTARIX 4/15/17. On evening of 4/26/17, et had abdominal discomfort. On 4/27/17 pt had vomiting and bloody stool. Seen in office and referred to ER. (+) intussusception (ileocecal) on U/S. (+) reduced w/o complication.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Pt s/p ROTARIX 4/15/17. On evening of 4/26/17, et had abdominal discomfort. On 4/27/17 pt had vomiting and bloody stool. Seen in office and referred to ER. (+) intussusception (ileocecal) on U/S. (+) reduced w/o complication.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient came to office on 4/7/17 with C/O skin rash. Patient displayed typical chicken pox rash on his trunk and upper chest. No systemic features. Developed three weeks after VARIVAX vaccine.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Lip swelling, Nausea, Swelling face, Vaccination complication
Clinical narrative: Allergic reaction to shot, lips and face began to swell felt like he was going to vomit. Stayed with patient and called 911 made sure patient was able to breathe.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema
Clinical narrative: Allergic reaction to shot, lips and face began to swell felt like he was going to vomit. Stayed with patient and called 911 made sure patient was able to breathe.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Lip swelling, Nausea, Swelling face, Vaccination complication
Clinical narrative: In pharmacy, within a few minutes of injection, patient's face turned bright red and pt was complaining of difficulty breathing. No stridor or wheezing. No treatment was given, called 911, came to ED where I am seeing patient and symptoms were self-resolving.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema
Clinical narrative: In pharmacy, within a few minutes of injection, patient's face turned bright red and pt was complaining of difficulty breathing. No stridor or wheezing. No treatment was given, called 911, came to ED where I am seeing patient and symptoms were self-resolving.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Erythema, Face oedema, Fatigue, Headache
Clinical narrative: 2nd varicella vaccine given on 1.25.17. The next day, she noted a red area, size of a quarter with itching, pain and enlargement of erythematous area. She also reported fatigue, global headaches and generalized itching, including hard palate in her mouth. She reports history of anaphylaxis and "this did not feel like it". She took RU-HIST 3 times, which helped. Assessed by medical provider in Occupational Health on 1/27/17, diagnosed with localized reaction to vaccine. On 1/28/17, evaluated at Medical Center. She reported increased swelling to injection site (left upper arm) spreading to axillary area with vesicular eruption. Treated with KENALOG 80 mg IM. ED provider also noted positive Herpes Zoster eruption. Rx given for VALTREX; ULTRACET; Amitriptyline.  On 1/31/17, returned to Lavaca Medical Center with concern of face edema "face feels like it is on fire" and "possible blister in mouth" but per ED notes: "noted facial redness/rash, but no facial edema or sores in mouth".  Given Rx for Atarax 25 mg 1-2 tabs q6h as needed.  On 3/09/17, evaluated at Concentra Medical Center, given refill of Amitriptyline and was cleared to return to work at full duty.  On 3/10/17, evaluated at Seton Occupational Health for a clearance to return to work, since she had areas that could not be covered with clothing. Provider noted- no lesions to face or neck, but had some swelling and erythema to neck and left axilla.  Diagnosis: Systemic Reaction to Varicella Vaccine  On 5/02/17-Associate did not return for follow up and resigned employment
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site swelling, Local reaction, Local swelling, Oral pruritus
Clinical narrative: 2nd varicella vaccine given on 1.25.17. The next day, she noted a red area, size of a quarter with itching, pain and enlargement of erythematous area. She also reported fatigue, global headaches and generalized itching, including hard palate in her mouth. She reports history of anaphylaxis and "this did not feel like it". She took RU-HIST 3 times, which helped. Assessed by medical provider in Occupational Health on 1/27/17, diagnosed with localized reaction to vaccine. On 1/28/17, evaluated at Medical Center. She reported increased swelling to injection site (left upper arm) spreading to axillary area with vesicular eruption. Treated with KENALOG 80 mg IM. ED provider also noted positive Herpes Zoster eruption. Rx given for VALTREX; ULTRACET; Amitriptyline.  On 1/31/17, returned to Lavaca Medical Center with concern of face edema "face feels like it is on fire" and "possible blister in mouth" but per ED notes: "noted facial redness/rash, but no facial edema or sores in mouth".  Given Rx for Atarax 25 mg 1-2 tabs q6h as needed.  On 3/09/17, evaluated at Concentra Medical Center, given refill of Amitriptyline and was cleared to return to work at full duty.  On 3/10/17, evaluated at Seton Occupational Health for a clearance to return to work, since she had areas that could not be covered with clothing. Provider noted- no lesions to face or neck, but had some swelling and erythema to neck and left axilla.  Diagnosis: Systemic Reaction to Varicella Vaccine  On 5/02/17-Associate did not return for follow up and resigned employment
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pruritus, Pruritus generalised, Rash, Rash vesicular
Clinical narrative: 2nd varicella vaccine given on 1.25.17. The next day, she noted a red area, size of a quarter with itching, pain and enlargement of erythematous area. She also reported fatigue, global headaches and generalized itching, including hard palate in her mouth. She reports history of anaphylaxis and "this did not feel like it". She took RU-HIST 3 times, which helped. Assessed by medical provider in Occupational Health on 1/27/17, diagnosed with localized reaction to vaccine. On 1/28/17, evaluated at Medical Center. She reported increased swelling to injection site (left upper arm) spreading to axillary area with vesicular eruption. Treated with KENALOG 80 mg IM. ED provider also noted positive Herpes Zoster eruption. Rx given for VALTREX; ULTRACET; Amitriptyline.  On 1/31/17, returned to Lavaca Medical Center with concern of face edema "face feels like it is on fire" and "possible blister in mouth" but per ED notes: "noted facial redness/rash, but no facial edema or sores in mouth".  Given Rx for Atarax 25 mg 1-2 tabs q6h as needed.  On 3/09/17, evaluated at Concentra Medical Center, given refill of Amitriptyline and was cleared to return to work at full duty.  On 3/10/17, evaluated at Seton Occupational Health for a clearance to return to work, since she had areas that could not be covered with clothing. Provider noted- no lesions to face or neck, but had some swelling and erythema to neck and left axilla.  Diagnosis: Systemic Reaction to Varicella Vaccine  On 5/02/17-Associate did not return for follow up and resigned employment
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Stomatitis, Vaccination complication
Clinical narrative: 2nd varicella vaccine given on 1.25.17. The next day, she noted a red area, size of a quarter with itching, pain and enlargement of erythematous area. She also reported fatigue, global headaches and generalized itching, including hard palate in her mouth. She reports history of anaphylaxis and "this did not feel like it". She took RU-HIST 3 times, which helped. Assessed by medical provider in Occupational Health on 1/27/17, diagnosed with localized reaction to vaccine. On 1/28/17, evaluated at Medical Center. She reported increased swelling to injection site (left upper arm) spreading to axillary area with vesicular eruption. Treated with KENALOG 80 mg IM. ED provider also noted positive Herpes Zoster eruption. Rx given for VALTREX; ULTRACET; Amitriptyline.  On 1/31/17, returned to Lavaca Medical Center with concern of face edema "face feels like it is on fire" and "possible blister in mouth" but per ED notes: "noted facial redness/rash, but no facial edema or sores in mouth".  Given Rx for Atarax 25 mg 1-2 tabs q6h as needed.  On 3/09/17, evaluated at Concentra Medical Center, given refill of Amitriptyline and was cleared to return to work at full duty.  On 3/10/17, evaluated at Seton Occupational Health for a clearance to return to work, since she had areas that could not be covered with clothing. Provider noted- no lesions to face or neck, but had some swelling and erythema to neck and left axilla.  Diagnosis: Systemic Reaction to Varicella Vaccine  On 5/02/17-Associate did not return for follow up and resigned employment
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient presented to pharmacy on 5/2/17 stating that she is still experiencing constant, mild muscle pain in the right arm where her FLUZONE HIGH DOSE shot was given on 10/17/2016.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of M-M-R II (human serum albumin, rHA), lot # L009544, expiration date 19-MAR-2017 for prophylaxis. The pharmacist reported that the administration of M-M-R II was a recent date after the product had expired. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 18-APR-2017 from a medical assistant who reported that improperly stored doses of VARIVAX were administered to unspecified patients from 28-MAR-2017 to 31-MAR-2017. The reporter confirmed that the sterile diluent used to reconstitute the VARIVAX was not stored improperly. No adverse effects were reported. Name of vaccine involved: VARIVAX (lot # M033905, expiration date 20-JUL-2018). Temperature and Time Frame: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit for 45 minutes. Was it administered?: Yes. Previous temperature excursion?: Yes, 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit for 12 hours and 50 minutes. Was call because of a "data logger"? Yes. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from an office manager and refers to an unknown number of adult patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the adult patients had received two doses of pediatric RECOMBIVAX HB (doses, route of administration, anatomical location, lot# and expiration date were not provided) to equal adult doses. No adverse effects reported. Product quality complaint was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001190.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and referred to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The pharmacist reported that from 21-JAN-2017 to 21-APR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # M038350, expiration date 06-DEC-2017; dose, route of administration, and frequency were not reported), for prophylaxis which were reconstituted with a properly stored sterile diluent (manufacturer unknown) (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 6°F to 14°F for a total time frame of 2 hours. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from an office manager and refers to an unknown number of adult patients of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the adult patients had received two doses of pediatric VAQTA (doses, route of administration, anatomical location, lot# and expiration date were not provided) to equal adult doses. No adverse effects reported. Product quality complaint was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010453.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood culture, Chest X-ray normal, Chills, Computerised tomogram head normal, Headache
Clinical narrative: Complaining of chills, nausea, vomiting, "worst headache of my life" sensation, fever, hypotension.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Hypotension, Nausea, Pyrexia, Vomiting, White blood cell count decreased
Clinical narrative: Complaining of chills, nausea, vomiting, "worst headache of my life" sensation, fever, hypotension.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Axillary mass, Chills, Dizziness, Fatigue
Clinical narrative: Chills, hot flashes, weak, fatigue, lightheaded, headaches. Bump under R axillary.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hot flush, Urine analysis
Clinical narrative: Chills, hot flashes, weak, fatigue, lightheaded, headaches. Bump under R axillary.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Inflammation
Clinical narrative: Patient's face became red and inflamed 4/30 in the AM. Symptoms have mostly resolved on 5/2.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Pain, Pain in extremity, Swelling
Clinical narrative: 2 weeks after ZOSTAVAX was given patient experienced redness at site, felt swelling, arthralgia, shooting pain in hand.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction on body. Pt came on 4 21 17 to mention she had allergic reaction. No treatment or hospitalization.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: Pt describes that she has nerve damage in her arm.
Age: 23.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594755) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 23 year old female patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 09-SEP-2015, the patient was vaccinated with GARDASIL 9 injection, lot # L014198, dose number 1 (dose and lot expiration date were unknown), intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (vaccinated date: 09-SEP-2015, lot # D23LP, dose number 2, intramuscularly in the right arm, dose and lot expiration date were unknown) for prophylaxis. On the same day, the patient experienced lymphadenopathy. She had swelling in lymph gland under left armpit. The outcome of the event was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Headache, Mycoplasma test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594837). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses and medical history was reported as none. On 31-AUG-2015 the patient was vaccinated with GARDASIL 9, dose 2 (route reported as needle and syringe-not specified further), in the right arm for prophylaxis. On 06-SEP-2015, the patient experienced chest pain, mycoplasma test, prolong headache and dizziness. The patient had an emergency room visit. Lab data reported as mycoplasma bacteria. The outcome of chest pain, mycoplasma test, headache and dizziness was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 594901). This spontaneous report refers to a 16 year old male patient. The patient's concurrent illnesses and medical history was reported as none. On 10-SEP-2015 the patient was vaccinated with GARDASIL 9 (dose, lot, site and route were not reported) for prophylaxis. On the same day, other suspect therapies included MENOMUNE. On 11-SEP-2015, the patient experienced gait disturbance, pain in extremity and muscular weakness.  The patient had leg pain, weakness and cannot walk well. The outcome of gait disturbance, pain in extremity and muscular weakness was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Postictal state
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597848) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included adverse reaction to the quadrivalent human papillomavirus vaccine (HPV 4). Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 29-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L007560 dose 3, intramuscularly in the left arm for prophylaxis. Code red was sent and the patient was on the exam table with generalized tonic clonic seizure lasting for 30 seconds. Then, the patient went into a postictal state for 1 minute. On 29-SEP-2015, the patient experienced generalised tonic-clonic seizure and postictal state. The outcome of generalised tonic-clonic seizure and postictal state was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Dyskinesia, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 597851) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 29-SEP-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L019286, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included FLUMIST (dose number: 6, vaccinated date:29-SEP-2015, via intranasal route, lot# U523AA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date:29-SEP-2015, intramuscularly in the left arm, lot# FJ2159; dose and expiration date unknown). Approximately 5 minutes after having received the vaccines, the patient walked out of office and had a syncopal episode lasting only a few seconds with brief jerking movements. Patient was advised to rest in office for approximately 30 minutes and was given some water and apple juice. On 29-SEP-2015, the patient experienced dyskinesia and syncope. The outcome of dyskinesia and syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Autoimmune dermatitis, Culture throat, Pyrexia, Rash, Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 598058) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 27-AUG-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L019286, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENVEO (dose number: 1, vaccinated date: 27-AUG-2015, intramuscularly in the left arm, lot# M15009; dose and expiration date unknown), BOOSTRIX (dose number: 1, vaccinated date: 27-AUG-2015, intramuscularly in the left arm, lot# 5MG55; dose and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 27-AUG-2015, intramuscularly in the right arm, lot# 42350; dose and expiration date unknown). On 09-SEP-2015, the patient experienced autoimmune dermatitis, streptococcus test negative, rash, pyrexia and culture throat. On 12-SEP-2015, the patient was seen in a urgent care. Patient was put on amoxicillin and the rash continued, so the patient visited the doctor on 16-SEP-2015. No other symptoms were noted and patient was diagnosed for autoimmune dermatitis and physician stated in notes that it could have been a reaction/side effect from the meningococcaI vaccine. Lab data included quick streptococcus test and throat culture. The outcome of autoimmune dermatitis, streptococcus test negative, rash, pyrexia and culture throat was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Rash generalised, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 602693). This spontaneous report refers to a 15 year old male patient. The patient's concurrent illnesses, medical history and other medications was reported as none. On 13-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L004014, intramuscularly in the right arm and VAQTA, lot # L007559, intramuscularly in the left arm for prophylaxis. Patient's Mom states that patient woke up on 14-OCT-2015, the morning after vaccine administration, with itchy rash all body. On 14-OCT-2015, the patient experienced hypersensitivity, rash pruritic and rash generalized. Taken to Primary Medical Doctor (PMD) who believes allergic reaction to HPV since had been given previous dose of Hep A. The patient had an emergency room visit. Given steroid injection and skin cream. Advised not to continue HPV vaccine series. The outcome of hypersensitivity, rash pruritic and rash generalized was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Body temperature increased, Discomfort, Injection site discomfort, Injection site swelling, Local swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 604203) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-OCT-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L016429, dose 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX ( vaccinated date: 20-OCT-2015, intramuscularly in the left arm, lot# 9JX2N; dose and expiration date unknown). On 20-OCT-2015, the patient experienced body temperature increased, local swelling, injection site swelling, injection site discomfort and discomfort. Patient had slight swelling and discomfort at injection site and axilla left arm. Body temperature measured 99.7 (units unspecified). The outcome of body temperature increased, local swelling, injection site swelling, injection site discomfort and discomfort was reported as recovered/resolved. Causality assessment was not reported.      Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 10.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 605111). This spontaneous report refers to a 10 year old female patient. The patient's concurrent illnesses, medical history and other medications was reported as none. On 19-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L016429, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, patient had other suspect therapies included FLUMIST QUADRIVALENT (lot# FJ2159, route: intranasal). On 21-OCT-2015, the patient experienced injection site erythema and injection site induration. Right arm with 6 cm induration and blanching erythema over right upper arm within 48 hours of vaccination, no worsening over next 24 hours. The outcome of injection site erythema and injection site induration was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 605341). This spontaneous report refers to a 17 year old female patient. The patient's concurrent illnesses was not reported. The patient had no known drug allergies (NKDA). On 27-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L023230, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, other suspect therapies included FLUZONE QUADRIVALENT (dose 2, lot# UI431AA, intramuscularly in left arm). On 27-OCT-2015, the patient experienced dizziness. Patient felt dizzy after receiving immunizations and PPD placement. Patient had patient lie down, given ice pack, juice and snack. BP was taken. Patient's symptoms resolved, cleared to leave by Registered Nurse and MD. The outcome of dizziness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 10.0
Sex: U
Vaccine: FLUN4, HPV9, MENB
Symptoms: Headache, Nausea, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 605655) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 10 year old patient of unknown gender. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications was reported as clonidine. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) dose 2, lot # L016428, via unknown route in the left arm for prophylaxis. Other suspect therapies included (e. coli) TRUMENBA (dose, frequency and lot expiration date were not reported) dose 1, lot # L13514, via unknown route in the left arm and (cold adapted ann arbor master strain) FLUMIST (dose, frequency and lot expiration date were not reported) dose 2, lot # FJ2073 via intranasal route. On unknown dates, the patient experienced headache, vomiting, streptococcus test negative, pyrexia and nausea which required emergency visit. Patient left the clinic with extreme frontal headache and visited the clinic the next day with fever of 102 (units unspecified). The outcome of headache, vomiting, streptococcus test negative, pyrexia and nausea was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: FLUN4, HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 606971) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old male patient. The patient's concomitant therapies, concurrent illness, pertinent medical history and prior vaccinations were not reported. On 22-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose number 1, (dose, frequency and lot expiration date were not reported), intramuscularly in the left arm for prophylaxis and VAQTA (lot # L018499, dose number 2, intramuscularly in the right arm, dose, frequency and lot expiration date were unknown) for prophylaxis. Other suspect therapies included FLUMIST (vaccinated date: 22-SEP-2015, lot # FJ2145, intranasal, dose number, dose, frequency and lot expiration date were unknown) for prophylaxis. On an unspecified date, 24 to 36 hours after vaccination symptoms started. He had an urticarial reaction with hives. It lasted for 10 to 14 days. Parent treated him with Claritin daily. The outcome of urticaria was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 607769). This spontaneous report refers to a 16 year old female patient. The patient's concurrent illnesses was reported as none. Other medications included Naproxen. On 18-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 and experienced headache on an unknown date and reported for 2-3 days. On 28-OCT-2015 the patient was vaccinated with GARDASIL 9 lot # L028083, dose 2, intramuscularly in the left arm for prophylaxis. After 2nd vaccination, on 29-OCT-2015 the patient experienced headache and reported for 1 week. The outcome of headache was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Pain, X-ray limb normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 608086) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 21-OCT-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot/ batch # 1077846, intramuscularly in the left arm for prophylaxis. Patient experienced pain in his left deltoid after vaccination. Patient experienced a sharp pain in that site whenever he raised his arm and it persisted for over 2 weeks. On 21-OCT-2015, the patient experienced injection site pain and x-ray limb was reported normal. Lab data included x-ray of arm and result was negative. The outcome of injection site pain and x-ray limb normal was reported as not recovered/not resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.