chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient's drug reactions/allergies included penicillin. The patient's concomitant medication and pertinent medical history was reported as none. The pharmacist reported that, on 21-SEP-2015, the patient at the age of 70 years (confirmed date of birth 18-MAY-1945), received first dose of GARDASIL 9 (lot# and strength unspecified) 0.5 ml via intramuscular route and then on 01-FEB-2016, received second dose of GARDASIL 9 confirmed lot# L019297 with expiration date 18-AUG-2017, 0.5 ml via intramuscular route as it was recommended by a physician. The pharmacist reported that approximately on an unknown date in February 2016, an unspecified time after receiving the 2nd dose of GARDASIL 9 the patient developed "redness and swelling at the injection site". The patient sought medical attention by seeing an unspecified physician. There was no treatment given for the events. Lab diagnostics studies were not performed. The outcome of the events was reported as not recovered. Product quality complaint was not involved. No further information was provided. The reporter did not provide the causality between the events and the suspect therapy GARDASIL 9. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a 69 year old female patient referring to herself who was with egg allergy. The patient's medical history included gall bladder removed at unspecified date. On 18-JAN-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported). Concomitant therapies included unspecified aspirin dose. On 19-JAN-2016 the patient experienced chills, headache, fever, fatigue and constant nausea. She took an unspecified dose of TYLENOL as treatment. Lab diagnostics studies were not performed. The patient did not seek medical attention. The therapy of PNEUMOVAX 23 was not reintroduced. The events were improved and the outcome of all the events was recovered on an unspecified date in 2016. The causality was not reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected, as no further information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' current condition and medical history was not provided. On unknown dates the patients' were vaccinated with VARIVAX (Merck) (Batch number- L036831, Expiry date-24-SEP-2017) which were improperly stored. The temperature excursion included 7.7F for 15 minutes and 42.5F for 5 hours. No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site mass
Clinical narrative: On 2/25/16 mother noticed sm. lump (R) upper thigh where 2 of the vaccines were given. No redness or tenderness when palpated. Lump smaller this morning but still palpable. No other sx. Baby alert, active not irritable. Advised to report if worsens.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Headache, fever, muscle aches other than injection site, soreness at inj. site, malaise.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose and route of administration were not provided) (lot #L029073 expiration date 19-APR-2017). The registered nurse stated that PNEUMOVAX 23 was exposed to the following temperature conditions: 34 F degrees for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Adverse reaction, Product preparation error, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of skin eruption in a 17-year-old female patient who received MENVEO (batch number M15023, expiry date 31st May 2016). On 16th February 2016, the patient received MENVEO. On 16th February 2016, less than a day after receiving MENVEO, the patient experienced skin eruption, adverse reaction and inappropriate preparation of medication. On an unknown date, the outcome of the skin eruption, adverse reaction and inappropriate preparation of medication were unknown. It was unknown if the reporter considered the skin eruption and adverse reaction to be related to MENVEO. Additional details were received as follows: The patient inadvertently received only the liquid meningococcal CYW-135 portion of the MENVEO, which led to an inappropriate preparation of the medication. The patient experienced breaking out and a reaction, which could not be clarified.
Sex: U
Vaccine: RV1
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received ROTARIX. On an unknown date, the patient received ROTARAIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to ROTARIX. Additional details were received as follows: The reporter reported that, the patient experienced an adverse event after administration of ROTARIX. The reporter did not have any information. The reporter would have a call back from a health care professional with additional information.
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified date in 1976, the patient was vaccinated with a dose of M-M-R lot # was not reported). On 02-FEB-2015, the patient was vaccinated with a dose of M-M-R II lot # reported as : Y298CC (expiration date, route and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101.8 degrees the morning after immunization that did not respond to TYLENOL for initial 8 hours and redness, swelling and pain at site of injection fever down after 10 hours and redness also improving.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Malaise
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer referring to her 20 year old daughter. The patient's concurrent conditions included whooping cough. On unknown date, the patient became pregnant. The last menstrual period (LMP) was approximately on 23-JUL-2015, and the estimated date of delivery (EDD) was 28-APR-2016. The pregnancy outcome was unknown. On an unspecified date, the patient visited to her obstetrician gynecologist (OB-GYN) to receive treatment for whooping cough. The reporter stated that approximately on 10-FEB-2016, the patient received a dose of GARDASIL (Lot number, expiration date, dose, route and anatomical location were not reported) instead of the treatment for whooping cough, the vaccine provider did not acknowledge the mistake until 2 weeks later when the patient revisited the office for another unspecified reason, on an unspecified date in February 2016, the patient did not feeling well. At the time of the report, the outcome of malaise was unknown. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Pain, Pain in extremity
Clinical narrative: Pain in body (arms, chest, legs) trouble breathing.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored doses of RECOMBIVAX HB (strength, dose and route of administration were not provided) (lot # L010565 expiration date 12-NOV-2016, lot # L033343 expiration date 13-SEP-2017 and lot # L042846 expiration date 15-SEP-2017). The registered nurse stated that RECOMBIVAX HB was exposed to the following temperature conditions: 34 F degrees for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored dose of ROTATEQ (strength and dose were not provided) (lot # L029617 expiration date 19-MAY-2017) oral. The registered nurse stated that ROTATEQ was exposed to the following temperature conditions: 34 F degrees for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown dates, the patients' were vaccinated with an improperly stored dose of VAQTA (strength, dose and route of administration were not provided) (lot # L036300 expiration date 11-APR-2016 and lot # M003011 expiration date 15-NOV-2017). The registered nurse stated that VAQTA was exposed to the following temperature conditions: 34 degree F for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored dose of ZOSTAVAX (strength, dose and route of administration were not provided) (lot # L027321 expiration date 21-OCT-2016). The registered nurse stated that ZOSTAVAX was exposed to the following temperature conditions: 7 F degrees during defrosting cycling. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 103.4, red, swelling, painful at injection site.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm felt swollen, warm to touch, developed body aches - flu like symptoms per patient.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Pain, swelling to injection site, chills, and fever, vomiting less than 24 hrs after injection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with and improperly stored dose of VARIVAX (strength, dose and route of administration were not provided) (lot # L025207 expiration date 07-JUL-2017). The registered nurse stated that VARIVAX was exposed to the following temperature conditions: 7 F degrees during defrosting cycling. There was not a previous temperature excursion. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Oedema, Skin warm
Clinical narrative: Patient received PNEUMOVAX 23 2-25-16; reports: redness, edema, warm to touch - temp 97.6 - (L) arm swollen 2x normal size from deltoid to elbow. Sent to emergency room.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site red and swollen, itchy.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 2 cm, erythema and induration 10 days after Varicella vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with and improperly stored dose of GARDASIL 9 (strength, dose and route of administration were not provided) (lot # L045711 expiration date 08-MAY-2017). The registered nurse stated that GARDASIL 9 was exposed to the following temperature conditions: 34 degrees F for an unknown period of time. Previous temperature excursion was unspecified. No adverse event was reported and no product quality issue was involved. Additional information has been requested. This is one of several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Fever 100.4, Severe deep cough (Identified as Wheezing on 2/22/16).
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Itching, redness, and lump at injection site.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pruritus, Tenderness
Clinical narrative: Swelling of glands behind right ear and jaw. Tenderness and itching.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Carbuncle, Pain
Clinical narrative: Developed group of carbuncles (7 locations) on upper back and back of neck approximately 3-5 days after receiving flu vaccine at local pharmacy. Carbuncle lasted for approximately 2 weeks with several breaking surface and becoming painful.  Carbuncles were treated at home and did not require medical attention. Carbuncles were monitored daily by myself for infection and improvement. I have no prior history of carbuncles nor had any since this occurrence. Was active and in good health at time of flu shot, and only received vaccine in anticipation of upcoming business travel and schedule for late December 2015. I do have a photo of carbuncles outbreak that I would like to make part of my adverse report. My history of obtaining the flu shot has been to get a flu shot every 1-3 years and dependent on CDC flu forecast and winter travel plans.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Noticed that my arm was hurting, swollen, itching and bright red.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in left shoulder and limited range of motion of shoulder and left arm. Still a problem as of 02/27/2016.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Right shoulder pain and limited motion of right arm.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Right shoulder pain and limited motion of right arm.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm swelling, redness, and itching.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Eye pain, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Symptoms included: severe pain in the right eye with swelling, redness, and significant tearing. Corneal Ulcer and Eye Infection in the right eye diagnosed by Dr. on 26 Feb 2016. Treated initially with antibiotic eye drops followed by antiviral pills and steroid drops.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Symptoms included: severe pain in the right eye with swelling, redness, and significant tearing. Corneal Ulcer and Eye Infection in the right eye diagnosed by Dr. on 26 Feb 2016. Treated initially with antibiotic eye drops followed by antiviral pills and steroid drops.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Symptoms included: severe pain in the right eye with swelling, redness, and significant tearing. Corneal Ulcer and Eye Infection in the right eye diagnosed by Dr. on 26 Feb 2016. Treated initially with antibiotic eye drops followed by antiviral pills and steroid drops.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination abnormal, Pain of skin, Ulcerative keratitis
Clinical narrative: Symptoms included: severe pain in the right eye with swelling, redness, and significant tearing. Corneal Ulcer and Eye Infection in the right eye diagnosed by Dr. on 26 Feb 2016. Treated initially with antibiotic eye drops followed by antiviral pills and steroid drops.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Eye pain, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Per patient: Corneal ulcer/eye infection which was diagnosed by ophthalmologist. Treatment: Antibiotic/steroid eye drops/antiviral.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Per patient: Corneal ulcer/eye infection which was diagnosed by ophthalmologist. Treatment: Antibiotic/steroid eye drops/antiviral.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination, Ulcerative keratitis
Clinical narrative: Per patient: Corneal ulcer/eye infection which was diagnosed by ophthalmologist. Treatment: Antibiotic/steroid eye drops/antiviral.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye infection, Ophthalmological examination abnormal, Pain of skin, Ulcerative keratitis
Clinical narrative: Per patient: Corneal ulcer/eye infection which was diagnosed by ophthalmologist. Treatment: Antibiotic/steroid eye drops/antiviral.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: At site of injection (upper left arm) pain began hours after injection and persists to this day, 01/27/2016. Issues include but are not limited to the following: weakness and pain in left arm above and below elbow; limited range of arm and shoulder (making getting dressed/undressed difficult; and muscle pain causing frequent sleep disturbance.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: At site of injection (upper left arm) pain began hours after injection and persists to this day, 01/27/2016. Issues include but are not limited to the following: weakness and pain in left arm above and below elbow; limited range of arm and shoulder (making getting dressed/undressed difficult; and muscle pain causing frequent sleep disturbance.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Her left arm started getting sore about 7PM. and became itchy. The next day redness started from shoulder to above the elbow and could not lift her arm easily. Patient went to a walk in clinic on 2/23/2016 and MD mis-diagnosed with cellulitis according to the second Dr she visited on 2/25/2016.  She started on Prednisone 20 mg daily for 5 days and the Dr gave her 3 more days that she picked up on 2/27/2016. The Dr gave her clindamycin on 2/23/16 which she did not take and she stated she is allergic to it. Her allergy file was updated 2/27/2016. The arm currently has a slight redness and no itching or swelling. She will take 3 more days of prednisone and does not have to return to the walkin clinic.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Swelling
Clinical narrative: Pain at injection site, swelling, headache began at 6:00 PM followed by fatigue and muscle pain. Gave ibuprofen. Symptoms continued through next day.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: PT SAYS HE EXPERIENCED NORMAL VACCINE SORENESS, STARTING THE DAY OF VACCINE.  SORENESS TURNED TO PAIN, AND HAS BEEN GETTING PROGRESSIVELY WORSE OVER PAST FEW DAYS, RADIATING TO SHOULDER, NECK, AND ARM.  PT WAS ADVISED TO SEEK MEDICAL ATTENTION ASAP, AND TO CALL WITH ANY MORE QUESTIONS.  HE EXPECTS PHARMACY TO FOLLOW UP WITH HIM.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash - red swollen - hot to the touch left shoulder and bicep.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a medical assistant referring to a 26 year old female patient who was not pregnant. Concurrent condition and medical history were not reported. Two weeks ago, on approximately 05-FEB-2016 the patient was vaccinated with the first dose of GARDASIL 9 injection (0.5 ml, intramuscular, lot# not reported) for HPV prevention. Concomitant therapy was not reported. It was reported that the patient experienced adverse reaction to first GARDASIL 9 injection. The patient experienced a 'bad reaction of swelling of injection site, hives and itchiness' on an unspecified date in February 2016. The patient went to her primary care physician for treatment (specific regimen unknown) and was advised to discontinue GARDASIL 9 second and third injection. Therapy of GARDASIL 9 was discontinued and was not reintroduced. The outcome of all the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 11 patients (also reported unspecified patients) of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. The reporter stated that patients received unspecified doses in M-M-R II (lot # L001336 with expiry date 13-JAN-2017, lot # K018965 expiry date 15-OCT-2016, lot # K004949 expiry date 04-APR-2016, lot # K024038 with expiry date 26-NOV-2016) immunization series that were improperly stored at temperature of 71 degrees F for a time frame of 40 hours (incorrect product storage). Previous temperature excursion was reported, reporter stated the time and the temperature was cumulative information from early January 2016. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. The reporter stated that doses of GARDASIL 9 (dosing details were not reported) lot # L019297 with an expiry date 18-AUG-2017 which were exposed to temperature 31.1 degree F for a time frame of 2 hours on 29-JAN-2016, were administered to unspecified patients on 18-FEB-2016. No concomitant medications were reported. No adverse effects were reported. This is one of the reports received from the same reporter (case # 1602USA011510). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. The reporter stated that doses of GARDASIL 9 (dosing details were not reported) lot # L019297 with an expiry date 18-AUG-2017 which were exposed to temperature 31.1F for a time frame of 2 hours on 29-JAN-2015, were administered to unspecified patients on 19-FEB-2016. No concomitant medications were reported. No adverse effects were reported. This is one of the two reports received from the same reporter. (case # 1602USA012422). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Developed an area of redness, 16 x 14 cm in size, 2 days after vaccines were given. Was seen and treated for this.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Blister, Injection site vesicles, Pyrexia, Rash
Clinical narrative: 24 hours after vaccine given, pt develops blisters on both legs, rash, fever.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Pain
Clinical narrative: Several days after vaccine administration patient experienced severe soreness. After that a rash developed around the administration site covering half of the patient's deltoid. Swelling other area has also occurred. Patient will be seeing PCP.
Age: 0.02
Sex: F
Vaccine: HEP
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Death/SIDS.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Inflammatory marker increased, Joint swelling, Myalgia, Peripheral swelling
Clinical narrative: Severe muscle pain, swelling in wrist, hands, ankles.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Chills, Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, chills, sweating, feeling faint, and abdominal pain with in 30 minutes of injection.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Larger than expected red area at site of injection.  Not warm to the touch.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Vaccination site rash
Clinical narrative: Mother reported patient told her the am of 2/916 he had a rash around the vaccine site.  Mother contacted our office 8 days later and said patient still had red bumpy rash around vaccine sight and that it had spread to cheeks and forehead.  He was seen in office 2/18/16 with small bumps on his arm, forehead  and cheeks.  Mom had given Benadryl, nurse practitioner changed him to Zyrtec.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a pharmacy intern via Pfizer, Inc. (MFR#2016108904) referring to a 55 years old (also reported as not yet 55) female patient with asthma. She was having pneumonia infections and on an unknown date she had already received a dose of PNEUMOVAX 23 (dose, frequency and lot# were not reported). The patient seemed to be having pneumonia infection and abnormalities (unspecified date) and also had the PNEUMOVAX 23. The outcome of the events was unknown. Causality was not reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hand-foot-and-mouth disease, Infectious mononucleosis, Mycoplasma infection, Pharyngitis streptococcal, Rash
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to a 15 year old female patient. There was no pertinent medical history. In "around September 2015" the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # was unknown) for prevention of HPV. In "around September 2015", the physician reported that the patient presented with a combination of "upper respiratory infection, strep throat and the worse hand, foot and mouth disease they have ever seen" after the dose of GARDASIL 9 injection. The patient was also been in and out of the emergency room (name and location unknown, date unspecified) and physician's office for a "variety of issues" including mycoplasma infection, mononucleosis and miscellaneous rashes. Unspecified antibiotics were given as treatment for adverse events. It was unknown if there was laboratory diagnostics performed. At the time of the report, the outcome of the adverse events was reported as "still sick". Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report has been received from a physician via a company representative, referring to a 15 year old female patient. There was no pertinent medical history. In "around September 2015" the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot # was unknown) for prevention of HPV. In "around September 2015", the physician reported that the patient presented with a combination of "upper respiratory infection, strep throat and the worse hand, foot and mouth disease they have ever seen" after the dose of GARDASIL 9 injection. The patient was also been in and out of the emergency room (name and location unknown, date unspecified) and physician's office for a "variety of issues" including mycoplasma infection, mononucleosis and miscellaneous rashes. Unspecified antibiotics were given as treatment for adverse events. It was unknown if there was laboratory diagnostics performed. At the time of the report, the outcome of the adverse events was reported as "still sick". Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 4 year old male patient. No concurrent condition, medical history or concomitant therapy was provided. On 12-JAN-2016 at 15:57, the patient was subcutaneously vaccinated in the left thigh with the first dose of improperly stored VARIVAX (lot # L025207, expiration date on 07-JUL-2017, dose unknown). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: At the beginning of the 7th day the arm got swollen, red and itchy. The area feel hot to the touch. The patient uses alcohol in the area.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Pain
Clinical narrative: Huge red area surrounding injection site and pain.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain upper, Blood test, Dehydration, Gastrooesophageal reflux disease, Haematochezia
Clinical narrative: After the vaccine (12/14/2015) and the next day he was sleeping a little more so not alarmed me, during the early hours of 12/16/2015 began with irritability, vomiting and bloody stools for this reason it take to the doctor for this time showed signs of dehydration from vomiting and stomach pain, the doctor decided to hospitalize him, ordering fasting until further instruction to conduct studies to detect these symptoms, a study of blood, ultrasound, x-rays performed contrast media, which was diagnosed intussusception, by this result he remained hospitalized for several days for treatment and observation. As adverse outcome to this result he currently suffering from gastroesophageal reflux disease for which currently still under treatment.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Irritability, Ultrasound scan, Vomiting, X-ray with contrast
Clinical narrative: After the vaccine (12/14/2015) and the next day he was sleeping a little more so not alarmed me, during the early hours of 12/16/2015 began with irritability, vomiting and bloody stools for this reason it take to the doctor for this time showed signs of dehydration from vomiting and stomach pain, the doctor decided to hospitalize him, ordering fasting until further instruction to conduct studies to detect these symptoms, a study of blood, ultrasound, x-rays performed contrast media, which was diagnosed intussusception, by this result he remained hospitalized for several days for treatment and observation. As adverse outcome to this result he currently suffering from gastroesophageal reflux disease for which currently still under treatment.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Increased pain, hardened tissue under skin at injection site, pinkish-red inflammation of the skin the size of my fist. The area also became hot.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Pt followed up in clinic approximately 1 month after injection reporting pain persisting in area of injection with sensitivity at site and surrounding area.
Age: 5.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events to report.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient received the flu shot in October, 2014. Patient has returned to the pharmacy on 2/25/16 stating that there was an adverse reaction to the vaccine, causing the patient to lose mobility in her left arm.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, tingling in arm.
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Incorrect route of drug administration, Paraesthesia
Clinical narrative: Numbness, tingling in arm.
Age: 0.76
Sex: M
Vaccine: HEP, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: I am documenting my child accidentally received 5 doses of the Hep B vaccination. I have informed his primary Pediatrician who apologized and could not offer explanation besides it was a medical error by their staff. I also spoke with the Health Dept nurse and CDC, which told me to fill out a Vaers. He has eczema and allergies. His doses include his birth dose on 7/25/14, 9/26/14, 12/1/14, 3/18/15, and an additional dose only 6 weeks later on 4/27/15.
Age: 1.52
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Injection site infection, Injection site swelling
Clinical narrative: During immunization visit as the Varicella vaccine was being injected the child moved and vaccine was injected too shallow. At the time child appeared to be OK and we planned to repeat vaccine at a later date. One week later the parent called and informed us that a week after she had taken the child to a provider after the site become swollen. The provider said to the parent that the site may have had an infection and treated the child with antibiotics. The parent said the swelling was now going down.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal rigidity, Balance disorder, Eye movement disorder, Fall, Muscle contracture
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 13 year old female patient. The patient did not have any pertinent medical history. The patient did not have drug reactions/ allergies. On 13-JAN-2016, the patient was vaccinated with 1 shot of the first dose of GARDASIL 9 lot # L019297 intramuscularly. The patient did not have any concomitant medications. On 19-JAN-2016, the patient began to experience symptoms. The patient experienced muscle contracting, eye rolling and seizure like activity. Her arms and legs twitched. She also had stomach spasms, as well as finger contractions. These episodes occurred 3-10 times a day. She also had issues with her sense of balance and equilibrium, and fell a lot. The patient sought medical attention. She had been hospitalized on 19-JAN-2016, 26-JAN-2016, 12-FEB-2016, 17-FEB-2016, 22-FEB-2016, and was just discharged the 5th time on 25-FEB-2016. The patient was treated with physical therapy, clonazepam, ABILIFY, omeprazole, and sertraline (reported as "setraline"). No Product Quality Complaint (PQC) was reported. The outcome of the events were reported as not recovered. Causality assessment was not provided. No further information was provided. The reporter considered the events serious because of hospitalization and significant disability. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle twitching, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 13 year old female patient. The patient did not have any pertinent medical history. The patient did not have drug reactions/ allergies. On 13-JAN-2016, the patient was vaccinated with 1 shot of the first dose of GARDASIL 9 lot # L019297 intramuscularly. The patient did not have any concomitant medications. On 19-JAN-2016, the patient began to experience symptoms. The patient experienced muscle contracting, eye rolling and seizure like activity. Her arms and legs twitched. She also had stomach spasms, as well as finger contractions. These episodes occurred 3-10 times a day. She also had issues with her sense of balance and equilibrium, and fell a lot. The patient sought medical attention. She had been hospitalized on 19-JAN-2016, 26-JAN-2016, 12-FEB-2016, 17-FEB-2016, 22-FEB-2016, and was just discharged the 5th time on 25-FEB-2016. The patient was treated with physical therapy, clonazepam, ABILIFY, omeprazole, and sertraline (reported as "setraline"). No Product Quality Complaint (PQC) was reported. The outcome of the events were reported as not recovered. Causality assessment was not provided. No further information was provided. The reporter considered the events serious because of hospitalization and significant disability. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Rheumatoid factor negative
Clinical narrative: Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Electrocardiogram, Grip strength decreased, Mobility decreased, Muscular weakness
Clinical narrative: Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Swelling
Clinical narrative: Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: Pt received vaccine: arm sore next day, gradually worsened to point could not raise arm. Severe muscle pain and weakness on left arm radiating up around neck and down right arm. Pt still experiencing pain and stiffness especially upon arising in AM.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Instant pain shooting all the way to forearm - sharp/burning pain. Loss of range of motion - initially recurring numbness in arm and fingers with burning and pain - subsided after 2 1/2 mo - still experience pain with limited range of motion. Vaccine injection was given in superior posterior upper arm proximal to shoulder tender to touch still to present.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Skin warm
Clinical narrative: Red blotches all on trunk. No itching but warm to the touch.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Feeling of body temperature change, Hypoaesthesia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection hurt as soon as it was injected, swollen, with heat. Pain, numbness, cold and hot feeling intensifies and the immobility of my arm, hand and shoulder has increased. Unable to sleep on left side and affecting my sleep. Ice, heat, Ibuprofen and KENALOG injection tried and failed.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Pain, Sleep disorder, X-ray
Clinical narrative: Injection hurt as soon as it was injected, swollen, with heat. Pain, numbness, cold and hot feeling intensifies and the immobility of my arm, hand and shoulder has increased. Unable to sleep on left side and affecting my sleep. Ice, heat, Ibuprofen and KENALOG injection tried and failed.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Blood test normal, Dizziness, Electroencephalogram normal
Clinical narrative: Dizzy and headache Nov. 2; Nov 3: bad headache, shaky, stomach upset, recurrence of upper (R) arm ache which had initially occurred after 2014 flu shot. Nov. 5: sx continue. Tingling (L) foot. Nov 7: awoke and severe pain in hip. Other sx continue. Nov. 8 hip pain improved. Present: (R) arm and (L) arm (2015 site) continue intermittently with pain.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Pain in extremity, Paraesthesia, Scan normal
Clinical narrative: Dizzy and headache Nov. 2; Nov 3: bad headache, shaky, stomach upset, recurrence of upper (R) arm ache which had initially occurred after 2014 flu shot. Nov. 5: sx continue. Tingling (L) foot. Nov 7: awoke and severe pain in hip. Other sx continue. Nov. 8 hip pain improved. Present: (R) arm and (L) arm (2015 site) continue intermittently with pain.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Dizzy and headache Nov. 2; Nov 3: bad headache, shaky, stomach upset, recurrence of upper (R) arm ache which had initially occurred after 2014 flu shot. Nov. 5: sx continue. Tingling (L) foot. Nov 7: awoke and severe pain in hip. Other sx continue. Nov. 8 hip pain improved. Present: (R) arm and (L) arm (2015 site) continue intermittently with pain.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in upper left arm following vaccination on 10/13/15. KENALOG 40 mg injection 11/3/15. Pain still ongoing but improving.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Dyspnoea, Injection site erythema
Clinical narrative: Patient said she was diagnosed with cellulitis on Friday. Called to report red at the injection site and she took BENADRYL. Also said she had SOB on Friday. Injection administered on Wednesday.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Night sweats, Pyrexia, Syncope
Clinical narrative: Fevers, chills, night sweats, syncope.
Age: 1.17
Sex: M
Vaccine: TYP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza, Nausea, Vomiting
Clinical narrative: Nausea and vomiting causing dehydration.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen to size of "3 tennis balls" according to patient. He went to to the ER that evening appox 8-10 hrs after receiving vaccine.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: A single hive appeared on right cheek on face at 10 AM.  Monitored for 30 min. No other hives on body or other symptoms. Pediatrician ordered 0.5 tsp (3.75mL) liquid oral pediatric diphenhydramine which the mother administered.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Crying, Dyskinesia, Musculoskeletal stiffness, Skin warm
Clinical narrative: On 2/24/16 Mom called and stated approximately 24 hrs. after receiving immunizations patient was lying on his back when his Rt. arm went up perpendicular to his head and Rt. leg became stiff. Only lasted about 5 seconds. He continued this 5-10 time in an hour. He would cry out. Also happened 3 timers when he was asleep. Color remained good. No trouble breathing. No change in eyes. He has been happy and eating good. Temp on 2/23/16 at 6:00PM was 100.8. She thinks he may have had a temp earlier as "he felt warm". She called his primary doctor and was told to call us.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site reaction, Rash erythematous
Clinical narrative: As mother was leaving office after shots she noticed a red raised rash on right leg. This was immediately after MMR and Varicella were given in that leg. Area was about 2 inches in diameter, red raised rash. No other areas on body. No wheezing, bandage removed. Ice applied.