chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of unknown.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cardiac arrest, Cardiac disorder, Injection site haemorrhage, Injection site mass, Presyncope
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Pfizer) on 24 November 2015. Manufacturing control number - 2015393559. This case involves a 72-year-old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, dose, dose number and route of administration were not reported) in arm and a dose of PREVNAR 13 (batch number, expiration date, dose, dose number and route of administration were not reported) in the arm on 30 October 2015. Both vaccines administered together but in different arms. The patient's medical history and concomitant medication were not reported. On an unspecified day in November 2015, few days following the vaccination, the patient developed an injection site reaction described as a lump the size of a goose egg. On an unspecified date, the patient also suffered from vagal nerve response and developed weird heart things and heart stopped. Approximately a week later patient reported bleeding at injection site, reporter thought it occurred on 6 November 2015, but was unsure. It was reported that, patient stated his heart stopped four times in the ambulance, caller is unclear regarding these details. On an unspecified date, the patient was hospitalized two weeks later vaccination and he was still in hospital. Laboratory investigations and corrective treatment were not reported.  The patient was recovering from the events of weird heart things, injection site reaction described as a lump the size of a goose egg and; however the outcome of the event of bleeding at injection site, vagal nerve response and heart stopped were unknown. List of documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Minor weakness first in the back side of left knee progressing to the back of the right knee.  Weakness and then pain progressing and now including the calf and thigh muscles bilaterally but worse on the left side.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Erythema of area where vaccine administered, local reaction, Claritin prescribed w/ good effect.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Neuropathy peripheral, Peroneal nerve palsy
Clinical narrative: This spontaneous report was received from a medical assistant referring to approximately 15 year old male patient. Pertinent medical history and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with GARDASIL injection, route of administration defaulted to intramuscular (lot number, expiration date, frequency, strength and dose number were not reported). Concomitant medications were unspecified by the reporter. On an unknown date, the patient experienced headache, drop foot on right foot and degradation of nerves on the left foot after vaccinated with GARDASIL. It was confirmed that it was GARDASIL not GARDASIL 9. The patient sought medical attention via seeing multiple physicians and was admitted to an unspecified hospital for an unspecified length of time. The outcome of headache, drop foot on right foot and degradation of nerves on the left foot was reported as not recovered. Upon internal review drop foot on right foot was considered to be a medically significant event. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: (L) arm cellulitis, fever, warm to touch, erythema, swelling. Treated with Z pak with no relief - on cephalexin 500 Q 8 hrs.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Drug administered at inappropriate site
Clinical narrative: Patient received Tdap on 10/19/15. Felt injection was given too high. Was diagnosed with bursitis 1 week later. Treated with ibuprofen. If no improvement, will receive steroid injection.
Age: 51.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient received Tdap on 10/19/15. Felt injection was given too high. Was diagnosed with bursitis 1 week later. Treated with ibuprofen. If no improvement, will receive steroid injection.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given flu injection for a 3 yr old.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient said she had a sore arm/shoulder for a couple weeks. No swelling but a muscle ache - could not raise arm above shoulder.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Vomiting
Clinical narrative: 11-10-15 patient called clinic after returning home, after receiving HepB vaccine in clinic this afternoon. Reported had vomiting three times, and prior to vomiting, friend reported she fainted for 3 seconds and had jerking movements. Advised to go to ER/notify MD. Called patient back on 11-13-15 to follow up. Reported recovered on 11-10-15 and did not seek medical attention.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure measurement, Loss of consciousness, Snoring
Clinical narrative: Pt. passed out after flu shot and started snoring for approximately 2 seconds then awake monitored and watched blood pressure for 15-20 min. 1st reading 100/60 pulse 66 2nd reading 107/57 pulse 57.
Age: 18.0
Sex: M
Vaccine: FLUN4, HEPA, HPV9, MENB, MNQ
Symptoms: Chills, Influenza virus test negative, Pain, Pain in extremity, Tremor
Clinical narrative: Within 2 1/2 hrs, developed shaking chills, whole body ached. Went to E.D. Left arm remains sore 11/30/15 and regular visit to physician office.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Ear discomfort, Hypoacusis
Clinical narrative: The patient said she was "in perfect health" before the vaccine. After the vaccine was administered she suffered from a plugged ear and feels she is no hearing well.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot taken at pharmacy on Nov. 18, 2015 in muscle right arm. Woke up Nov. 19, 2015 right arm swollen, fever, red color from top of arm to elbow. Started taking BENADRYL tabs every 4 hours and apply BENADRYL salve to arm 3 day till arm looked normal.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased eye contact, Dizziness, Drug screen negative, Dysarthria
Clinical narrative: Vaccine administered at 1115. At 1130 another adult in waiting area summoned for help verbalizing he thought she was going to pass out. LPN first one to the patient and called for assistance when patient not responding. Pt with eyes open and looking at staff, but noticed full body weakness and not speaking. 2 person carry to treatment and called for code blue adult. Placed on treatment bed. Remained incoherent. No loss of consciousness. BP 122/76 HR 88. O2 sats 100% on room air. After 3 minutes was able to tell us her first name. Slurred speech. Not making eye contact. Transferred via gurney to ED.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Incoherent
Clinical narrative: Vaccine administered at 1115. At 1130 another adult in waiting area summoned for help verbalizing he thought she was going to pass out. LPN first one to the patient and called for assistance when patient not responding. Pt with eyes open and looking at staff, but noticed full body weakness and not speaking. 2 person carry to treatment and called for code blue adult. Placed on treatment bed. Remained incoherent. No loss of consciousness. BP 122/76 HR 88. O2 sats 100% on room air. After 3 minutes was able to tell us her first name. Slurred speech. Not making eye contact. Transferred via gurney to ED.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEP, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: See Doctors note.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: Headaches concentrated on the right side that come and go.
Age: 29.0
Sex: M
Vaccine: FLUN4
Symptoms: Burning sensation, Rash erythematous, Rash vesicular
Clinical narrative: PT had a vesicular, moist, erythemic rash directly below the left nostril from nare to vermilian border complained of burning sensation.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Pallor, Syncope
Clinical narrative: After receiving the vaccines, client suddenly appeared pale and fainted. He was lowered to the floor and legs were elevated. Client responded within two minutes. He was oriented X3. Client said before he fainted he felt weak and dizzy. His vital signs were taken. BP: 103/74 Pulse: 65 Respiration was WNL. Client was assisted to a chair and offered orange juice. (Mom said he had no breakfast). At 9:43 am, client was taken to the Emergency Room via wheel chair to be evaluated by a physician. He was accompanied by RN and his mother.
Age: 12.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Injection site erythema, Myalgia, Nasopharyngitis, Pain, Peripheral swelling
Clinical narrative: Child's arm swollen twice size on (L) (25.5cm) than (R) (21cm) erythema patches underside (L) arm from armpit to mid arm. Pain, myalgia, warmth, no redness at injection site.
Age: 12.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Skin warm
Clinical narrative: Child's arm swollen twice size on (L) (25.5cm) than (R) (21cm) erythema patches underside (L) arm from armpit to mid arm. Pain, myalgia, warmth, no redness at injection site.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: Swelling of arm and redness reaction at site of injection. Recommended BENADRYL and ice. Checked in on 11/25/15- arm is significantly better and just sore at site of injection.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Muscle spasms, Pyrexia
Clinical narrative: Patient experienced severe chills and muscle cramps, low grade fever the night of the shots. Subsided by next day.
Age: 22.0
Sex: M
Vaccine: FLUN4
Symptoms: Disorientation, Loss of consciousness
Clinical narrative: (+) loss of consciousness for 20-30 min. SNM awoke disorientated.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Nodule, Pain in extremity, Sleep disorder
Clinical narrative: Pt called 12/7/15 - said shot hurt on administration and hours later had a knot on arm. Arm still hurts 2 days later - she can't sleep on it and has no strength in the arm. She is using a heating pad - that feels good.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm red and swollen below elbow.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Arthralgia, Chills, Injection site pain, Injection site pruritus, Malaise
Clinical narrative: Intense soreness at sight of injection to the touch lasted 2 days - followed by intense itching - had to use BENADRYL for 4-5 days. Malaise within hours - chills  - shooting pains in arms and joints. Had 2 previous bouts of Lyme and shooting pains down arms successfully treated with doxycycline took 2 round of Lyme vaccine and on record found got Lyme disease
Age: 65.0
Sex: F
Vaccine: FLUX, PNC
Symptoms: Pain, Pain in extremity
Clinical narrative: Intense soreness at sight of injection to the touch lasted 2 days - followed by intense itching - had to use BENADRYL for 4-5 days. Malaise within hours - chills  - shooting pains in arms and joints. Had 2 previous bouts of Lyme and shooting pains down arms successfully treated with doxycycline took 2 round of Lyme vaccine and on record found got Lyme disease
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Peripheral swelling, Pyrexia
Clinical narrative: Dizzy - fever - swollen arm went to hospital and dr office after hospital.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Contusion, Musculoskeletal stiffness
Clinical narrative: Appearance of bruise on arm w/symptoms of stiffness.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Left shoulder pain, started after PREVNAR 13, had not which resolved but pain in upper left arm persistent.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Paraesthesia, Tenderness
Clinical narrative: The patient states that her arm had muscle pain at the injection site after vaccination that worsened days later resulting in tingling down the arm and to the right pinky finger. The arm is painful to lay on. She has not seen a doctor about it yet.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling with redness approximately 2-3" in diameter intense itching for 6 days.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site pain, Lumbar puncture normal, Musculoskeletal stiffness, Nausea
Clinical narrative: Pain Lt arm (site), fever 102 degrees F, headache, neck stiffness, nausea.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pain Lt arm (site), fever 102 degrees F, headache, neck stiffness, nausea.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: 6" x 4" warmth and erythema upper rt arm with several fluid filled blisters.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Pt had pain in shoulder. After 2 weeks of pain she went to the ER for treatment. She has been doing PT.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphagia, Ear pain, Oropharyngeal pain, Swelling face, Swollen tongue
Clinical narrative: Face swelled, tongue swollen, throat tight hard to swallow, sore throat with pain radiating out and up into ears.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Throat tightness
Clinical narrative: Face swelled, tongue swollen, throat tight hard to swallow, sore throat with pain radiating out and up into ears.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Acute respiratory distress syndrome, Extracorporeal membrane oxygenation, Pneumonia
Clinical narrative: Developed pneumonia in both lungs, followed by ARDS and placed on ECMO.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Metabolic function test
Clinical narrative: Sudden onset of fatigue and anorexia s/p PREVNAR 13 vaccination.
Age: 1.23
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on legs. Gradually spread all over trunk and limbs. 11-30-15 - mom was called rash was completely gone by 11-25-15.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Flu shot was administered into her left arm. It swelled up around injection site and it became red and hardened. It stayed like that for about 2 wks. Patient also experienced flu-like symptoms as well.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, MMRV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was in office for 1 yr well check. MMR and MMRV were both administered at this visit. Nurse recognized error while logging vaccines into EMR. Mom notified the following day and informed of possible reactions to watch for. Understanding was voiced. No adverse reactions reported thus far.
Age: 84.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Body temperature increased, Limb discomfort, Muscle tightness, Rash
Clinical narrative: Patient reports diffuse rash on arms, legs, temp > 101 degrees, tight muscles with heavy legs, joint aches. Started 3 days after shot. Pt saw MD not sure if its related to shots of something else. MD originally thought it could be gout but was not.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Pt states at the site of injection, the area is swollen, red, hard lump and warm to the touch. Pt states reaction has gotten larger as the days progress.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Mass
Clinical narrative: Client developed a lump right after injection was administer. He denied any, SOB, resp distress. No treatment applied to injection site. Client ask to hang around for 10-20 mins.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Neck pain, Pain in jaw
Clinical narrative: 12/1/15 patient received HPV9, 1st dose. That evening and for 4 days after severe headache. Now has neck/jaw pain. Advised rest, fluids, ibuprofen.  Offered follow up appt.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: Oct. 1, 2015 had flu shot, had pain from shot which never went away, the pain is from dull and constant to sudden sharp and severe pain. No treatment yet. Will talk to MD.
Age: 1.57
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Dec 5th - Hives (L) thigh. Both facial cheeks, took to urgent care-Loratadine, prednisone started at 830 pm. Dec 6th - hives on both arms and (R) leg, took to hospital was given BENADRYL and continue with other tx and BENADRYL as needed.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: There was a white, raised mark at the injection site surrounded by a large purplish-red hot area on the affected arm. The patient was diagnosed with early cellulitis. She was given a Kenalog injection by her doctor and was given a prescription for Doxycycline 100mg #14 1 bid for 7 days.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Vomiting and fever 102 F, dry cough, rhinorrhea.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Client said she had pain in her left arm a few days after receiving the Hepatitis B vaccine in March. She said it got better, but she started getting more pain in the month of May. Client went to the ER on October 21, 2015 due to pain in her left arm because she had difficulty extending her left arm upward. Client's diagnosis from ER was "Myalgia".
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, MMR, PNC13, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Fluid-filled blister (1 mm) noted on lateral aspect of patient's Left thigh.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling surrounding injection site, diffuse itching sensation.  Treated with Benadryl, swelling not improved, itching has improved.  Swelling treated with Prednisone course on 12/7/15.
Sex: M
Vaccine: MMR
Symptoms: Death
Clinical narrative: This spontaneous report was retrieved from a social network via Pfizer (assigned manufacturer control number: 2015420009) and was originally reported by the uncle of a male patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient started therapy with TYLENOL and MOTRIN (for both therapies indication, dose, frequency, route of administration, lot number and expiration date were not provided). Subsequently, the patient was vaccinated with M-M-R II (dose, dose number, route of administration, lot number and expiration date were not provided). Other suspect therapies included SARA (indication, dose, frequency, route of administration, lot number and expiration date were not provided). Concomitant medication was not reported. According to the reporter, on an unknown date, SARA and M-M-R II "killed" his nephew. The reporter stated that he was life flighted to hospital and died. It was also reported that the patient was alive and flew to a county hospital and died. It was unknown if an autopsy was performed. The cause of death was also unknown. Additional information is not expected, since the reporter's details were not provided.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician via field employee referring to a 30 year old female. There was no concurrent condition or medical history reported. On unknown dates the patient was vaccinated with full three dose series of unidentified Merck HPV vaccine (name and lot number not provided). After the three dose series completed, on 05-OCT-2015, the patient performed a routine examination which included pap smear and other standard tests. The patient tested positive for HPV type 16 it was not known if the patient contracted HPV type 16 prior to administration of GARDASIL or after. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 28 year old male patient. The patient was vaccinated with his first dose of GARDASIL (dose, route and lot number not provided) in 2013 and his second dose of GARDASIL (dose, route and lot number not provided) on 03-DEC-3015 in the office. No adverse effect was reported. There was no product quality issues (PQC). Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 19-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015 (reported as since an unspecified date in October 2015), the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L008578, expiration date 14-DEC-2016, route of administration default to oral, dose was not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. In approximately 2015 (reported as since an unspecified date in October 2015), the patients were vaccinated with doses of improperly stored PEDVAXHIB injection (lot # L009649 with expiration date 29-NOV-2017 and lot # L012837 with expiration date 11-MAR-2018, dose, and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ [lot # L001316, Expiry date: 10-NOV-2017; Lot # L009119 Expiry date: 17-DEC-2016]. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to at least 15 unspecified patients of unknown demographics. Information regarding their medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012521, expiry date: 01-FEB-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 [lot # L013429, Expiry date: 21-JUL-2017]. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 40-year-old female patient who received FLUARIX (batch number 2SN22, expiry date 30th June 2016). On 20th November 2015, the patient received FLUARIX .5 ml. On 20th November 2015, less than a day after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX. Additional details were provided as follows: The patient experienced left arm soreness after the vaccination with FLUARIX vaccine. The nurse reported that the patient had planned to continue follow-up with the physician.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 2 red spots, swelling, sensitive to pressure on those areas.
Sex: U
Vaccine: TDAP
Symptoms: Condition aggravated, Cough
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cough aggravated in a patient who received DTPa (Reduced antigen). Concurrent medical conditions included cough (the patient suffered with cough for a week). On an unknown date, the patient received DTPa vaccine. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced cough aggravated. On an unknown date, the outcome of the cough aggravated was unknown. It was unknown if the reporter considered the cough aggravated to be related to DTPa vaccine. Additional details were provided as follows: The patient was suffering with a cough a for a week and just received a tdap shot because he had removed a metal particle from his eye. The patient did not know how long ago he had a tetanus shot, but at the time of reporting, the cough seemed to be a little worse. The patient was asking whether the vaccine had anything to do with his cough worsening.
Age: 47.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PREVNAR 13 given to right deltoid. Pt caled 4 days later, c/o of sore arm, couldn't lift arm. Saw Dr. Oct 20, 2015 for arm.
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Burning sensation, Inflammation, Joint range of motion decreased
Clinical narrative: This case was reported by a consumer via call representative and described the occurrence of joint pain in an adult female patient who received RABAVERT. On an unknown date, the patient received RABAVERT at an unknown dose. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced joint pain, inflammation localized, burning foot and joint range of motion decreased. On an unknown date, the outcome of the joint pain, inflammation localized, burning foot and joint range of motion decreased were unknown. It was unknown if the reporter considered the joint pain, inflammation localized, burning foot and joint range of motion decreased to be related to RABAVERT. Additional details were provided as follows: The patient complained of severe joint pain in all extremities (left knee) and was not able to stretch leg. The patient also reported that her foes like they were on fire and base of foot were inflamed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain in extremity, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received FLULAVAL (batch number 7754S, expiry date June 2016). On 16th November 2015, the patient received FLULAVAL .5 ml. In 2015, less than a month after receiving FLULAVAL, the patient experienced injection site pain. On 16th November 2015, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain and wrong injection technique were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL. Additional details were provided as follows: This case was reported by a pharmacist, who himself was the patient. The patient complained that her arm was hurt after receiving FLULAVAL QIV vaccine. The patient also believed that the FLULAVAL vaccine was administered in the bursa sac, which led to wrong injection technique. On 2nd December 2015, the patient visited the orthopedic and received Cortisone shots. The patient wanted to know whether she needs to be revaccinated. The reported batch number (77545) for FLULAVAL vaccine did not exist and was updated to 7754S as per the sales database.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza like illness, Injection site pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pain at injection (2-3 days); vomiting; Low grade fever; Flu-like symptoms, dry cough, runny nose.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pain at injection (2-3 days); vomiting; Low grade fever; Flu-like symptoms, dry cough, runny nose.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Menorrhagia, Menstruation irregular
Clinical narrative: Patient's mother stated that since the vaccine in July her menstrual cycle has been irregular and heavy bleeding. She had a period 9/29/15 -> 10/4/15 then 10/18/15 -> 11/01/15 and another 11/21/15 -> 12/2/15.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Blood test, Cellulitis, Erythema, Injection site mass
Clinical narrative: Received vaccines 11 AM 11/24. Late evening c/o sore arm. 11/25 fever 102.5, knee and hip pain, body aches. Arm warm to touch and still painful. TX with ADVIL and ALEVE. 11/26 sx continue, arm red. Went to ER at 8:30A Dx cellulitis tx with doxy and TYLENOL. Fever 102. 11/27 sx continue, went to PCP - changed Rx to Z-PAK. 11/28 redness worse adm to hospital tx with IV clindamycin. Discharged 11/29 after 4 txs., continue with oral clindamycin. Sxs resolving. 12/1 PCP appt for lump at injection site.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Received vaccines 11 AM 11/24. Late evening c/o sore arm. 11/25 fever 102.5, knee and hip pain, body aches. Arm warm to touch and still painful. TX with ADVIL and ALEVE. 11/26 sx continue, arm red. Went to ER at 8:30A Dx cellulitis tx with doxy and TYLENOL. Fever 102. 11/27 sx continue, went to PCP - changed Rx to Z-PAK. 11/28 redness worse adm to hospital tx with IV clindamycin. Discharged 11/29 after 4 txs., continue with oral clindamycin. Sxs resolving. 12/1 PCP appt for lump at injection site.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: After the shot of HPV vaccine the first shot I got a bad body rash that was extremely itchy.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Chest pain, Heart rate increased, Pyrexia
Clinical narrative: Pt received a high dose flu shot on 12/04/15. Later that day he experienced increased blood pressure (163/102) and increased heart rate (91). He felt very weak, feverish, sluggish, had chest pain, and felt like he was about to have heart attack or stroke. He continued to feel worse through the evening. He came into the pharmacy the next day, feeling better, but he wanted to report his experience.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Sluggishness
Clinical narrative: Pt received a high dose flu shot on 12/04/15. Later that day he experienced increased blood pressure (163/102) and increased heart rate (91). He felt very weak, feverish, sluggish, had chest pain, and felt like he was about to have heart attack or stroke. He continued to feel worse through the evening. He came into the pharmacy the next day, feeling better, but he wanted to report his experience.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient claims that she has had a significant amount of arm pain after the vaccine that has not subsided prior to her report date of 12/5/15.  Per her physician, she has described it as a dull, aching pain with swelling.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, and dizziness after receiving vaccine in Employee Health clinic. Employee Health gave ondansetron (details unavailable) for symptom relief.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: After receiving flu vaccine she had pain in left arm, gradual weakness and loss of range of motion.  Numbness in fingers left hand.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Reported redness around the injection site developing into a rash and low grade fever. Dr prescribed Augmentin for treatment on 12/7/15.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Anti-cyclic citrullinated peptide antibody positive, C-reactive protein increased, Polyarthritis, Red blood cell sedimentation rate increased
Clinical narrative: Caused reactive polyarthritis.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Erythema, Pruritus generalised, Rash generalised, Rash maculo-papular
Clinical narrative: Woke up with itching of left arm on 12/2/15, progressed to generalized itching and rash by the evening of 12/2. Went to ER, ER Dr thought maybe chicken Pox. Seen at office 12/3 with a maculo/papular rash most pronounce on left arm, but also seen on right arm, chest, face and ankles. Treated with Zyrtec and Pepcid. Itch gone by 12/5. Follow-up visit 12/7 back to baseline except faint pink marks remain.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing
Clinical narrative: Mild flushing over anterior chest.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Throat tightness
Clinical narrative: Tightness in throat, facial swelling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Red, swollen, local reaction where shot was given.
Age: 34.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Swelling, redness, pain and fever. Fevers up to 105F with spreading redness and pain over the arm in the following days. Pt seen 12/7/2015 for follow up, started on Keflex for possible cellulitis.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I administered an adult dose of Havrix instead of the pediatric/adolescent dose.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Pt said his left arm was still sore from shot he got in Sept. He said he mentioned it to his Dr today at visit. He said Dr said we might have poked or pinched nerve. He said his arm was sore to lift and sleep on. Prescriptions for prednisone and triamcinolone were given. Technique used to give shot was to feel shoulder then make C with left hand and give shot in middle of C with right hand.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Body temperature increased, Headache
Clinical narrative: Persistent headache and abd discomfort; also had temp of 102.6; went to ER initially on 12/4 and then Hospital on 12/5/2015.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen arm at site of vaccine.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Ear discomfort, Fatigue, Tinnitus
Clinical narrative: Ringing in ears, dizziness, clogged ears, fatigue.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Mobility decreased
Clinical narrative: Patient unable to move arm for 24 hours, patient complains of bruising on upper arm.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Decreased appetite, Headache, Muscle spasms, Pyrexia
Clinical narrative: Bad headache, fever, muscle spasms in hands, dark vision, shaking, not hungry, hips are sore.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Tremor, Visual impairment
Clinical narrative: Bad headache, fever, muscle spasms in hands, dark vision, shaking, not hungry, hips are sore.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Irritability, Pruritus, Urticaria
Clinical narrative: Forty eight hours after receiving vaccine, pt broke out in hives on her legs. Mother reports red, raised spots in the area where her shots were given. A couple days later, pt was irritable and itching the rash. One week post vaccines, pt has bumps where the vaccines were given, itching, redness, and hives are no longer there.
Age: 1.02
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Irritability, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Approx 9 days after receiving his one year vaccines the patient developed a rash all over his body. Worse on chest and back but noted on extremities and a couple on his face. Pink or red spots. It was smooth and not raised. He was cranky but ate and drank ok. He also developed a fever 102.6 at the highest.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal disorder
Clinical narrative: Notified on 12/7/2015 at 1300. Patient states that she had continues pain at injection site since receiving injection; limiting the use of her arm.  Told her to go to primary MD but stated that she could not get appt.  Instructed to go to urgent care.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema, Throat irritation
Clinical narrative: THROAT SWELLING, THROAT FEELING SCRATCHY. BENADRYL 25MG IM GIVEN. SYMPTOMS RESOLVED BY 10:40AM.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Neuralgia
Clinical narrative: Pt reported having redness, soreness and infection at the injection site.  Pt also reported nerve pain on her torso similar to shingles pain without blisters.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site scab, Injection site swelling
Clinical narrative: Pt noticed that there was a raised bloody scab at the site which started to bleed.  I examined the site and there was a raised area in the area that we would vaccinate with a scab on it.  It did not look infected but she received the vaccine almost 2 months ago.  Pt is unaware of any other injury to this area.  This is the first time she received the high dose flu vaccine.  I recommended that she receive the regular flu shot in the future.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: When woke up 12/2/2015, had hives (1/2 to 2 inch diameter) scattered all over body and face. Afebrile; no other symptoms or problems noted except slight runny nose.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dizziness, Eye pain
Clinical narrative: Nausea, convulsions, sore red eyes, high fever, joint and body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, patient stated could hear heart rate banging in head, dizziness, weakness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flatulence, Headache, Nausea, Ocular hyperaemia
Clinical narrative: Nausea, convulsions, sore red eyes, high fever, joint and body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, patient stated could hear heart rate banging in head, dizziness, weakness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations, Pharyngeal oedema, Pyrexia, Seizure
Clinical narrative: Nausea, convulsions, sore red eyes, high fever, joint and body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, patient stated could hear heart rate banging in head, dizziness, weakness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Muscular weakness
Clinical narrative: Within a couple of hours, my shoulder hurt at the injection site. Over the next few days, it was as if I had pulled a muscle in my shoulder. I experienced significant discomfort and decreased mobility for the next month. Now, six weeks later, I am almost completely recovered, with very minor remaining mobility limitation and muscle weakness.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: Employee recieved pre-employment vaccine on 12/4/15, reports symptoms began as soon as she woke up on 12/5/15 of severe vertigo, nausea, and headache.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Upper-airway cough syndrome
Clinical narrative: Post nasal drip, cough, runny nose.  (cold like symptoms)
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Impaired work ability, Muscular weakness, Musculoskeletal pain, Nausea
Clinical narrative: Aching in injection arm and shoulder, 100.4°F fever, nausea, body aches, fatigue through 11/14/15. Continuing intermittent arm and shoulder pain, muscle weakness in arm and shoulder, body aches, fatigue through present, 12/07/15. I intend to consult my physician this week as my job performance is being adversely affected.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Aching in injection arm and shoulder, 100.4°F fever, nausea, body aches, fatigue through 11/14/15. Continuing intermittent arm and shoulder pain, muscle weakness in arm and shoulder, body aches, fatigue through present, 12/07/15. I intend to consult my physician this week as my job performance is being adversely affected.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Migraine
Clinical narrative: Developed headache; progressed to migraines the following week as of today 12/7/15 the headache is still not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Large red swollen area that feels warm and itchy.  About 2 inches in diameter.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe upper right arm pain. I have tried muscle creams and heating pad with no relief.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Facial pain, Lip swelling, Neuralgia, Swelling face
Clinical narrative: Swelling left side of face left side of nose left side of lips left eye swelled shut hives by 11/19/2015 facial pain facial nerve.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Swelling left side of face left side of nose left side of lips left eye swelled shut hives by 11/19/2015 facial pain facial nerve.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Blood count, Blood electrolytes, Fall, Gait disturbance
Clinical narrative: Runny Nose, Stopped talking, Stopped smiling, he couldn't walk without falling, woke every 30 minutes screaming and stiff, seizures  Lasted for 8 days.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Inflammatory marker test, Liver function test, Musculoskeletal stiffness, Rhinorrhoea, Screaming
Clinical narrative: Runny Nose, Stopped talking, Stopped smiling, he couldn't walk without falling, woke every 30 minutes screaming and stiff, seizures  Lasted for 8 days.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Seizure
Clinical narrative: Runny Nose, Stopped talking, Stopped smiling, he couldn't walk without falling, woke every 30 minutes screaming and stiff, seizures  Lasted for 8 days.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Causing menstruation cycle to be delayed a significant amount of time.  Period was expected Nov 28 and it is now Dec 7. Taken multiple pregnancy tests and all are negative.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Carpal tunnel syndrome, Hypoaesthesia, Nerve conduction studies abnormal, Pain in extremity
Clinical narrative: Had Prevnar 13 shot, 1 m ago then 1 week later left hand went numb in the 1st 3 digits, then 1-2 weeks later right hand. Burns and hurts, feels like could shake it off. Digits 1-3. Had been weeding in the garden, and using clippers also.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Local redness warmth.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Nausea, Vomiting
Clinical narrative: Localized swelling, redness and induration at injection site 24 hrs after and persistent nausea/vomiting 48 hrs after injection that lasted D4 requiring medical consult.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Pt was given incorrect vaccinations.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Urticaria
Clinical narrative: 11.22.15 received FLUARIX PFS quad vaccine. 11.30.15 pt experienced welts/hives on back/left side (same side as Flu vaccine).
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haematoma, Injection site pain, Injection site swelling, Pain
Clinical narrative: (L) uppre arm, injection site swelling, hematoma, soreness, discoloration from elbow to shoulder. Painfull to fully extend arm. Still showing symptoms as of Dec 7, 15 medication taken IBU 800 mg every 8 hours from 12-4 till now.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient stated that he right arm was red and swollen following the FLUZONE HD vaccine administration on 11-9-2015. The symptoms resolved within 2 weeks without drugs.