chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sore throat in a 46-year-old male patient who received FLULAVAL QUADRIVALENT. Concomitant products included LIPITOR and NORVASC. On 12th September 2017, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In September 2017, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced sore throat and swollen glands. The patient was treated with Z-PAK. On an unknown date, the outcome of the sore throat and swollen glands were recovering/resolving. The reporter considered the sore throat and swollen glands to be possibly related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient was the pharmacist. At 11:00 hours, the patient received a FLULAVAL injection in the left deltoid. About 4 days after receiving the vaccine, the patient developed a sore throat and swollen glands. The patient happened to had routine blood work done while this was happening and everything came back to normal. He had not been to his doctor for these symptoms, but he did have a Z-PAK prescription called in, but that did not help the symptoms. At the time of this report, the patient was experiencing the symptoms, but they were slightly better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Left arm was swollen around injection site; there are bruises after 2 days. Patient took some pain medication OTC for pain. Patient cannot remember which pain medication she took.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Red, swollen, pox blister developed-blister broke-call MD-Dr. = primary care MD - she wanted pt to call to be seen by her.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Urticaria
Clinical narrative: Patient presented with hives day of vaccine and is experiencing hives throughout her body after 5 days. She has failed therapy with BENADRYL and prednisone.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient had swelling of arm (right) that lasted about 3 days with pain. Was starting to subside when reported worse with PNEUMOVAX arm.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Amino acid level, Areflexia, Blood creatine phosphokinase, Blood thyroid stimulating hormone, CSF test
Clinical narrative: Two days after the vaccines the patient was evaluated for suspected seizure at the ER (9/14). The following day (9/15)-office visit for lethargy and ER follow-up. Patient was lethargic and hypotonic, referred to the ER and hospitalized (9/15-9/23/17). Patient became areflexic and diagnosed with Guillain-Barre Syndrome. She was treated with IVIG and improved. Discharged home with physical therapy. Tone improved but not back to normal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Computerised tomogram normal, Culture, Electroencephalogram normal, Electromyogram normal, Full blood count
Clinical narrative: Two days after the vaccines the patient was evaluated for suspected seizure at the ER (9/14). The following day (9/15)-office visit for lethargy and ER follow-up. Patient was lethargic and hypotonic, referred to the ER and hospitalized (9/15-9/23/17). Patient became areflexic and diagnosed with Guillain-Barre Syndrome. She was treated with IVIG and improved. Discharged home with physical therapy. Tone improved but not back to normal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Guillain-Barre syndrome, Hypotonia, Immunoglobulin therapy, Lethargy, Lumbar puncture normal
Clinical narrative: Two days after the vaccines the patient was evaluated for suspected seizure at the ER (9/14). The following day (9/15)-office visit for lethargy and ER follow-up. Patient was lethargic and hypotonic, referred to the ER and hospitalized (9/15-9/23/17). Patient became areflexic and diagnosed with Guillain-Barre Syndrome. She was treated with IVIG and improved. Discharged home with physical therapy. Tone improved but not back to normal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate, Seizure
Clinical narrative: Two days after the vaccines the patient was evaluated for suspected seizure at the ER (9/14). The following day (9/15)-office visit for lethargy and ER follow-up. Patient was lethargic and hypotonic, referred to the ER and hospitalized (9/15-9/23/17). Patient became areflexic and diagnosed with Guillain-Barre Syndrome. She was treated with IVIG and improved. Discharged home with physical therapy. Tone improved but not back to normal.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Patient reported black and blue about 2 inch in diameter at site on injection. Patient reported incident to RPh on 10-6-17.
Age: 5.0
Sex: F
Vaccine: FLU4, HEP, HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Pt. rec'd Hep A, Hep B and Quad FLULAVAL at O.V. on 10/04/17. Seen again on 10/05/17 for reported S/S "hives/rash on trunk/arms/legs. Afebrile. Mom gave BENADRYL and rash resolved after 10/05/17 O.V. Mom provided phone pics to PCP of rash/hives.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid became red and swollen the morning after receiving the flu vaccine. Mother administered TYLENOL at home. Advised ice pack.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (L) arm swelling and mild erythema.
Age: 66.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 19/9/17 11:00 AM patient came in and said flu shot given in left arm was done wrong. Patient said it "hurt like heck" when given and patient cannot lift arm up (past naval). Patient has MD visit this week.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient complains of radiating pain in arm had shot then sore arm. Pain went away then came back. Pain went away then came back. Patient stated she did sleep on it. Will wait 2 days before going to MD office/throbbing pain in the right shoulder and radiating it to the neck.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None states
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Back pain, Cold sweat, Injection site discomfort, Pain in extremity
Clinical narrative: Injection-site discomfort-left deltoid. Backache. Legs ache. Cold sweats. Sx began 48 hours after vax given one day prior to visit.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Cough, Diarrhoea, Headache
Clinical narrative: Dry cough, headache, intermittent nausea and diarrhea, head congestion, upset stomach, chills, fever 101.7 to 102. All symptoms lasted 8 hours.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Sinus congestion
Clinical narrative: Dry cough, headache, intermittent nausea and diarrhea, head congestion, upset stomach, chills, fever 101.7 to 102. All symptoms lasted 8 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Extreme swelling, redness and discomfort.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Redness and hot below site of injection and swelling, sore throat, runny nose.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 5in x 7.5in area of erythema and warmth over (R) deltoid. (site of injection). No induration.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Pt had ZOSTAVAX on the 5th. Site started to itch Friday then became a shingles  spot approximately 3 x 3 inches around site Sat. Site improved some Sun was still red in center.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Redness and swelling on right arm between shoulder and elbow. Pt is also having muscle soreness in right arm. Recommended ZYRTEC tab and Hydrocortisone 1% cream.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and painful left arm. Went to the emergency room and a prescription for NORCO 3/325 mg for prescribed.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Headache
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 47-year-old male patient, who was vaccinated once with FLUZONE QUADRIVALENT via intramuscular route (batch number: UT5899KA, expiry date: 30-Jun-2019) and PNUEMOVAX (batch number, expiry date, route, dose not reported) on 31-Aug-2017 in right deltoid. Patient medical history and concomitant medications were not reported. On 01-Sep-2017, one day following the vaccination, the patient experienced fever over 101 degree F with chills, sweating, and ache in lower back, hips and right arm. Patient required doctor visit on an unknown date. Lab test not reported. Patient required no corrective treatment. Patient did not recovered from events. Documents held by sender: none.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Influenza, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 47-year-old male patient, who was vaccinated once with FLUZONE QUADRIVALENT via intramuscular route (batch number: UT5899KA, expiry date: 30-Jun-2019) and PNUEMOVAX (batch number, expiry date, route, dose not reported) on 31-Aug-2017 in right deltoid. Patient medical history and concomitant medications were not reported. On 01-Sep-2017, one day following the vaccination, the patient experienced fever over 101 degree F with chills, sweating, and ache in lower back, hips and right arm. Patient required doctor visit on an unknown date. Lab test not reported. Patient required no corrective treatment. Patient did not recovered from events. Documents held by sender: none.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Arthralgia, Back pain, Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 47-year-old male patient, who was vaccinated once with FLUZONE QUADRIVALENT via intramuscular route (batch number: UT5899KA, expiry date: 30-Jun-2019) and PNUEMOVAX (batch number, expiry date, route, dose not reported) on 31-Aug-2017 in right deltoid. Patient medical history and concomitant medications were not reported. On 01-Sep-2017, one day following the vaccination, the patient experienced fever over 101 degree F with chills, sweating, and ache in lower back, hips and right arm. Patient required doctor visit on an unknown date. Lab test not reported. Patient required no corrective treatment. Patient did not recovered from events. Documents held by sender: none.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 47-year-old male patient, who was vaccinated once with FLUZONE QUADRIVALENT via intramuscular route (batch number: UT5899KA, expiry date: 30-Jun-2019) and PNUEMOVAX (batch number, expiry date, route, dose not reported) on 31-Aug-2017 in right deltoid. Patient medical history and concomitant medications were not reported. On 01-Sep-2017, one day following the vaccination, the patient experienced fever over 101 degree F with chills, sweating, and ache in lower back, hips and right arm. Patient required doctor visit on an unknown date. Lab test not reported. Patient required no corrective treatment. Patient did not recovered from events. Documents held by sender: none.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Back pain, Chills, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 47-year-old male patient, who was vaccinated once with FLUZONE QUADRIVALENT via intramuscular route (batch number: UT5899KA, expiry date: 30-Jun-2019) and PNUEMOVAX (batch number, expiry date, route, dose not reported) on 31-Aug-2017 in right deltoid. Patient medical history and concomitant medications were not reported. On 01-Sep-2017, one day following the vaccination, the patient experienced fever over 101 degree F with chills, sweating, and ache in lower back, hips and right arm. Patient required doctor visit on an unknown date. Lab test not reported. Patient required no corrective treatment. Patient did not recovered from events. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eyelid oedema, Peripheral swelling, Pruritus, Rash generalised, Swelling face
Clinical narrative: Rash, Itching, Back of throat itching. She went to the emergency room both Friday and Saturday for symptoms. She received steroid treatment and antihistamine treatment. Patient is unsure if the reaction was due to the vaccine or something outside. She said she had also been working outside.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Urticaria
Clinical narrative: Rash, Itching, Back of throat itching. She went to the emergency room both Friday and Saturday for symptoms. She received steroid treatment and antihistamine treatment. Patient is unsure if the reaction was due to the vaccine or something outside. She said she had also been working outside.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: Rash, Itching, Back of throat itching. She went to the emergency room both Friday and Saturday for symptoms. She received steroid treatment and antihistamine treatment. Patient is unsure if the reaction was due to the vaccine or something outside. She said she had also been working outside.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Cough, Fatigue, Headache
Clinical narrative: Extremely bad flu like symptoms including headache, fever, cough, runny nose, sneezing, tired, insomnia, nauseous. First symptoms occurred on Thursday Oct 5 after vaccine administered on Tuesday Oct 3. Shot was in left arm and there was some tenderness for several days at the shot area. not certain that symptoms are directly related to the vaccine. Fact that I have not had any illness of this kind for the past year, and that the symptoms are occurring shortly after the vaccine, makes me suspect that it is possibly related to vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site pain, Insomnia, Malaise, Nausea
Clinical narrative: Extremely bad flu like symptoms including headache, fever, cough, runny nose, sneezing, tired, insomnia, nauseous. First symptoms occurred on Thursday Oct 5 after vaccine administered on Tuesday Oct 3. Shot was in left arm and there was some tenderness for several days at the shot area. not certain that symptoms are directly related to the vaccine. Fact that I have not had any illness of this kind for the past year, and that the symptoms are occurring shortly after the vaccine, makes me suspect that it is possibly related to vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Extremely bad flu like symptoms including headache, fever, cough, runny nose, sneezing, tired, insomnia, nauseous. First symptoms occurred on Thursday Oct 5 after vaccine administered on Tuesday Oct 3. Shot was in left arm and there was some tenderness for several days at the shot area. not certain that symptoms are directly related to the vaccine. Fact that I have not had any illness of this kind for the past year, and that the symptoms are occurring shortly after the vaccine, makes me suspect that it is possibly related to vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Hot, rash, hurt and swollen at injection site even after 15 days.
Age: 63.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Chills
Clinical narrative: 60 hrs post vaccine I developed teeth chattering chills. Lasted approx 3 hours.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Induration, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Erythema, Induration, Pain radiating to R shoulder and into R hand. UE edema.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A couple hours after getting the flu shot, the injection site was swollen and a little res. By the end of the day it was warm to the touch. The following days the swelling got worse and it was even warmer. She was exhausted and got a low grade fever.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 36 hours after vaccine given, employee noted large raised, reddened and hot area around injection site. Employee notes that the site was also itchy. Extended in size to 5" x 5", when she presented back to Employee Health 54 hours after injection. States she had no reaction to 1st dose, one month earlier.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Have had severe pain in my left arm at the site of the injection now for 3 weeks. This is limiting my range of motion and I cannot do some normal daily activities without severe pain (taking off a shirt, etc.).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: Joint pain, tiredness, weakness, chills, leg pain, aching muscles, stomach ache.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Joint pain, tiredness, weakness, chills, leg pain, aching muscles, stomach ache.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Feeling cold, Feeling hot, Injection site pain
Clinical narrative: Throat felt odd, pain at the site of injection that day. Unable to sleep until CPAP removed. Fever, very red face, hot, cold, swollen and painful wrists and other joints. In bed sleeping. Can't take anything for pain because of his heart meds (we're unsure what is safe until we see his heart doctor again).
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Joint swelling, Pyrexia, Throat irritation
Clinical narrative: Throat felt odd, pain at the site of injection that day. Unable to sleep until CPAP removed. Fever, very red face, hot, cold, swollen and painful wrists and other joints. In bed sleeping. Can't take anything for pain because of his heart meds (we're unsure what is safe until we see his heart doctor again).
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Upper leg and knee of injection site became swollen (twice the size of the other leg) was red, hot and tender. Went to Urgent Care 10/7/17 when patient unable to bend knee after trying BENADRYL at home. Pt given prescription for Dexamethasone. Swelling and redness greatly decreased after second dose of steroid.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Muscular weakness, Swelling
Clinical narrative: Employee began having severe pain and slight swelling in the left armpit around 9 pm of the same evening of the day on which she  received her flu shot in the left deltoid at 11am. The injection site is also tender but there is no redness or swelling apparent at the site. The employee has tried using ibuprofen for relief at home without success. After reporting to work today, she c/o being unable to help lift any patients or objects of any substantial weight. She is in constant armpit pain at a level of 6-7/10 coupled with weakness of the entire left upper extremity. She has been sent to Employee Health Services for further evaluation in the Emergency Department.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Diplopia, Vision blurred
Clinical narrative: I have blurred/double vision in my right eye.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Muscular weakness, Pain, Tenderness
Clinical narrative: Began with pain and tenderness, progressed to excruciating pain, improved slightly but still has no strength in arm and cannot raise it.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Cough, Mechanical ventilation, Respiratory disorder
Clinical narrative: Mother states increased cough/elevated temperature/respiratory issues after flu vaccine. Taken to ED on 9/3/17 and placed on ventilator (patient already had tracheostomy-cerebral palsy patient).
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Heart rate increased, Malaise
Clinical narrative: Patient reported headache, increasing heart rate and generally not feeling well @ 45 minutes post injection. She reported she took OTC Benadryl  which she carries with her, and called her PCP, Dr. who provided a prescription for Prednisone which she filled at the retail pharmacy at this hospital.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test, Dysstasia, Electrocardiogram, Fatigue
Clinical narrative: Onset of severe fatigue and weakness/numbness; could barely stand and get around; had to hold onto to something. Called after 2 1/2 hrs. They said go to the ER did and after 3 hrs. sent home to take it easy for several days. Wish refunded of ER visit since due to shot and nothing wrong other than reaction.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: Onset of severe fatigue and weakness/numbness; could barely stand and get around; had to hold onto to something. Called after 2 1/2 hrs. They said go to the ER did and after 3 hrs. sent home to take it easy for several days. Wish refunded of ER visit since due to shot and nothing wrong other than reaction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site discolouration, Limb discomfort, Loss of personal independence in daily activities, Pain
Clinical narrative: Upon initiation of shot, patient had immediate discomfort/pain in the left arm. Felt like a regular shot, then in doing regular activity, by day 3 and on that the arm is sore and she does not want to perform activities. Inconsistent times of discomfort with varying arm movements. There is a small green discolored area on the left deltoid, appears to be healing bruise.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Upon initiation of shot, patient had immediate discomfort/pain in the left arm. Felt like a regular shot, then in doing regular activity, by day 3 and on that the arm is sore and she does not want to perform activities. Inconsistent times of discomfort with varying arm movements. There is a small green discolored area on the left deltoid, appears to be healing bruise.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2017-10-04.
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Chills, Erythema, Injection site erythema, Peripheral swelling
Clinical narrative: Patient wanted both immunizations in the same arm. Utilized the upper deltoid for the FLUCLVAX and lower portion of the deltoid for the PNEUMOVAX.  Patient did not report any symptoms until 9/28/17.  Patient reported symptoms started the day after the immunizations with her arm swelling up "like a balloon" and she experienced chills and feeling of generalized weakness for the next few days.  Five days later when she reported to the pharmacy her arm was still a little red but not swollen. The central part of the redness looked like the reaction would have come from the pneumovax which was the lower portion of the deltoid.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: Mother reports that she noticed this morning swelling of her son's left upper arm at the site of flu vaccine administration. States swelling started the morning of 10/10/17. States vaccine was given the morning of 10/9/17 at Clinic.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthropod sting, Asthenia, Burning sensation, Discomfort
Clinical narrative: Reports when she got the shot it hurt so bad. A lot of pressure. Arm was sore for quite a while. Took 4 advil and by 2:30 was feeling great. Came home picked up husband got something to eat. 3:30 started feeling funny. Sore stomach, dizzy. Got home and that's when is started hitting. Sick to stomach. Felt her entire body was burning and stingy. Felt like heat wanted to escape thru mouth. Did not take her temp. Felt loopy. Headache. Tired. No vomiting. States she couldn't lay down and get comfortable. At midnight took mylanta, layed back down. Continued with dizziness. When getting up tues morning, continued with dizziness and feeling loopy. All other symptoms subsided. Did not feel safe to drive so she called in sick to work. Pt states she has had reaction to sulfate in the past, and wondered if sulfate was in the injection. Learned that there is no sulfate in the flu vaccine. States she slept all day Tuesday. Wednesday felt tired, weak and started moving around, went golfing, rode a cart. When got done golfing slept all night. Thursday was feeling a little better. A little lightheaded but not to bad. Feeling lightheaded up till Saturday and again today and also feeling tired. States her boss and 'health nurse' has recommended that she call her PCP and report this. States she has never had a reaction with a flu shot. Reports she did get stung by a bee 9/22/17. No recent change in medication. Has recently started weigh watchers (about 3 weeks). Has been cutting portions. Was 191.4 and now 188.4lbs. States she felt fine before the flu shot. Husband also wants to report right shoulder spasms that was happening before the flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Reports when she got the shot it hurt so bad. A lot of pressure. Arm was sore for quite a while. Took 4 advil and by 2:30 was feeling great. Came home picked up husband got something to eat. 3:30 started feeling funny. Sore stomach, dizzy. Got home and that's when is started hitting. Sick to stomach. Felt her entire body was burning and stingy. Felt like heat wanted to escape thru mouth. Did not take her temp. Felt loopy. Headache. Tired. No vomiting. States she couldn't lay down and get comfortable. At midnight took mylanta, layed back down. Continued with dizziness. When getting up tues morning, continued with dizziness and feeling loopy. All other symptoms subsided. Did not feel safe to drive so she called in sick to work. Pt states she has had reaction to sulfate in the past, and wondered if sulfate was in the injection. Learned that there is no sulfate in the flu vaccine. States she slept all day Tuesday. Wednesday felt tired, weak and started moving around, went golfing, rode a cart. When got done golfing slept all night. Thursday was feeling a little better. A little lightheaded but not to bad. Feeling lightheaded up till Saturday and again today and also feeling tired. States her boss and 'health nurse' has recommended that she call her PCP and report this. States she has never had a reaction with a flu shot. Reports she did get stung by a bee 9/22/17. No recent change in medication. Has recently started weigh watchers (about 3 weeks). Has been cutting portions. Was 191.4 and now 188.4lbs. States she felt fine before the flu shot. Husband also wants to report right shoulder spasms that was happening before the flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: Reports when she got the shot it hurt so bad. A lot of pressure. Arm was sore for quite a while. Took 4 advil and by 2:30 was feeling great. Came home picked up husband got something to eat. 3:30 started feeling funny. Sore stomach, dizzy. Got home and that's when is started hitting. Sick to stomach. Felt her entire body was burning and stingy. Felt like heat wanted to escape thru mouth. Did not take her temp. Felt loopy. Headache. Tired. No vomiting. States she couldn't lay down and get comfortable. At midnight took mylanta, layed back down. Continued with dizziness. When getting up tues morning, continued with dizziness and feeling loopy. All other symptoms subsided. Did not feel safe to drive so she called in sick to work. Pt states she has had reaction to sulfate in the past, and wondered if sulfate was in the injection. Learned that there is no sulfate in the flu vaccine. States she slept all day Tuesday. Wednesday felt tired, weak and started moving around, went golfing, rode a cart. When got done golfing slept all night. Thursday was feeling a little better. A little lightheaded but not to bad. Feeling lightheaded up till Saturday and again today and also feeling tired. States her boss and 'health nurse' has recommended that she call her PCP and report this. States she has never had a reaction with a flu shot. Reports she did get stung by a bee 9/22/17. No recent change in medication. Has recently started weigh watchers (about 3 weeks). Has been cutting portions. Was 191.4 and now 188.4lbs. States she felt fine before the flu shot. Husband also wants to report right shoulder spasms that was happening before the flu vaccine.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Within 2 hrs of vaccine, developed red, raised induration from right shoulder extending down to near his elbow. Assoc sx include rigors, shaking chills. These sx continued for about 48 hrs when they fully resolved.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dysphonia, Fatigue, Headache, Myalgia
Clinical narrative: 102 fever, extreme fatigue, muscle aches, headache, hoarseness, cough.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: 102 fever, extreme fatigue, muscle aches, headache, hoarseness, cough.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Brief syncopal episode.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Herpes zoster
Clinical narrative: Arm pain on day following vaccine which worsened into severe headache, fatigue, weakness, sore throat, diarrhea by day 3. Arm pain became severe with constant headache until rash developed 8 days later. Rash extends length of arm up to left side of neck, inclulding shoulder. Diagnosed with shingles by PCP in same arm as vaccine. I am otherwise healthy, haven't been sick in years.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain in extremity, Rash
Clinical narrative: Arm pain on day following vaccine which worsened into severe headache, fatigue, weakness, sore throat, diarrhea by day 3. Arm pain became severe with constant headache until rash developed 8 days later. Rash extends length of arm up to left side of neck, inclulding shoulder. Diagnosed with shingles by PCP in same arm as vaccine. I am otherwise healthy, haven't been sick in years.
Age: 0.67
Sex: M
Vaccine: PNC13
Symptoms: Agitation, Cough, Crying, Pyrexia
Clinical narrative: Patient got extremely agitated and cried all the time for 2 weeks, he also had a fever of about 104 for 4 days and got a really bad cough 3 days after the shot.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Eye movement disorder, Febrile convulsion, Pyrexia, Tremor
Clinical narrative: Mother reported Fever 104-105F, rolled eyes, started shaking, apnea. Diagnosed at ER as febrile seizures. Fever continued until 10/8, but not as high as 10/4.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: Patient had diarrhea after immunization and a metallic taste, patient said she was taking other medication as well. No treatment outcome resolved.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Nausea
Clinical narrative: Sweats, nausea, fatigue, feeling "weird".
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Hi I am a travel nurse. I was told to contact you as I had a reaction to the flu shot that I received on Thursday October 5th. Within an hour of receiving the vaccine I felt dizzy and light headed which lasted approx 3 hours. My cheeks, neck and chest became red and hot to touch worsening throughout the day. I had facial swelling (no shortness of breath) and swelling to the hand on the arm I which I received the vaccine. Also the middle and ring fingers on that same hand we're very painful. It took a multiple doses of Benadryl over the next 24 hours for the reaction to subside.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Hi I am a travel nurse. I was told to contact you as I had a reaction to the flu shot that I received on Thursday October 5th. Within an hour of receiving the vaccine I felt dizzy and light headed which lasted approx 3 hours. My cheeks, neck and chest became red and hot to touch worsening throughout the day. I had facial swelling (no shortness of breath) and swelling to the hand on the arm I which I received the vaccine. Also the middle and ring fingers on that same hand we're very painful. It took a multiple doses of Benadryl over the next 24 hours for the reaction to subside.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Pharyngeal oedema
Clinical narrative: Chest tightness, breathing problems, throat swelling.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Feeling cold, Peripheral swelling, Skin discolouration
Clinical narrative: Patient had severe right arm swelling with purplish discoloration of arm and cool extremity. Worsened over the 1st 24 hours. Put on prednisone and symptoms resolved in 24 hours.
Age: 57.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red Swollen arm.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Purpura, Rash macular, Vasculitis
Clinical narrative: Bilateral splotches on lower extremities, primarily calves, with scattered non-blanching subdermal hemorrhagic patches, varying in size from tmm-1cm. Diagnosed with vasculitis. Advised it will resolve on its own. Told to return if rash worsens, joint swelling/pain, abdominal pain or change in urine color.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Patient called stating that starting mid night of the day she received shot she presented with fever of 100.6F lasting about 24 hours, swelling of arm lasting about 24 hours, itchy eyes and swelling of face (no issues breathing or swelling of throat) lasting about 3 days. No medical treatement or appointment with health care professional sought.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Influenza like illness, Injection site induration, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Flu like symptoms for 24 hours post-vaccine; then 48 hours post-vaccine: nausea and a large (approx. 8" x 3") welt on upper left arm -- hot to the touch, hard, painful.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea
Clinical narrative: Flu like symptoms for 24 hours post-vaccine; then 48 hours post-vaccine: nausea and a large (approx. 8" x 3") welt on upper left arm -- hot to the touch, hard, painful.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This is the 2nd time this has happened. Also happened last year. I have taken flu shots since the 1990s, and it seems I'm just now becoming sensitive to it. My arm below the injection site was red, itchy, swollen, and hot to the touch. It was an area about the size of a deck of cards; it spread to the outside of my arm. After warm compresses and ibuprofen, it stopped/went away in about 5 days.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient currently in her early twenties. The patient's pertinent medical history, concomitant medications and drug allergies were unknown. On an unknown date (reported as "while in her school years"), the patient was vaccinated with GARDASIL (concentration, number of doses, route of administration, lot number and expiration date were unspecified). On an unknown date, the patient had positive test for human papilloma virus. The outcome of the event is unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot # reported as N027883 (verified to be invalid) with expiry date 15-APR-2019, lot # N000238 with expiry date 25-OCT-2019 and lot # M036058 with expiry date 19-MAY-2019 (dose was not specified) for prophylaxis. Administered doses of LIQUID PEDVAXHIB underwent temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 10 days. Data Logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA007903: US-009507513-1709USA013076:
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous initial report was received from a pharmacist concerning his unknown age and gender child. The patient's medical history, current conditions and concomitant medications were not reported. The pharmacist reported that on an unspecified recent date, his child was vaccinated orally with a dose of ROTATEQ (strength, dose, frequency, lot number and expiration date were not provided), indicated for prophylaxis. The pharmacist also reported that the patient vomited shortly after receiving the vaccine dose. The patient did not received treatment for this event. At the time of this report the outcome of the vomiting was recovered, also reported as "The current status of the patient is unknown". The patient did not seek medical attention. The causal relationship between the vaccination with ROTATEQ and the vomiting event was not reported. There was no PQC involved.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old male patient. The patient did not have any drug reactions or allergies. His pertinent medical history and concomitant medications were not reported. On 02-OCT-2017 (reported as 2 days ago), the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (site of administration, dose, lot number and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) solution for injection (strength, dose, frequency, indication, lot number and expiration date were not reported). On 03-OCT-2017, the patient experienced fever, redness and hardness around the injection site. The affected area around the injection site was about the size of a palm of a hand. The patient sought medical attention as he spoke to the pharmacist. No lab diagnostic studies were performed. No treatment was given for the events. Product quality complaint was not involved. The outcome of fever, redness and hardness around the injection site was reported as not recovered. The relatedness between the events and the vaccination with ZOSTAVAX was not reported. No additional information was provided.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Medical assistant and refers to a 66-year-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 03-OCT-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for prophylaxis (lot# and expiration date were not reported). Other suspect therapies included sterile diluent (administered in approximately 03-OCT-2017, subcutaneously for prophylaxis; dose, frequency, lot# and expiration date were not reported). On the same day, the patient experienced redness, warmth, swelling, and itchiness at the injection site, which was also described as "a raised area about 8 inches by 1 inch." On the same day, the patient phoned to the office once again to report that symptoms were worsening. Consequently, the nurse practitioner instructed patient to take BENADRYL. It was also reported that the patient received the treatment for the events. Action taken with ZOSTAVAX and sterile diluent was not reported. The outcome of the events was unknown. The relatedness between the events and suspect therapies was not reported.
Sex: M
Vaccine: VARCEL
Symptoms: Crohn's disease
Clinical narrative: This spontaneous report was received from a patient's father via a company representative and refers to his son -a male patient of unknown age. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was enrolled in an unknown clinical trial and was vaccinated with VARIVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed Crohn's disease. The patient was diagnosed at the age of 17 but the father reported that he noticed issues prior the official diagnosis. The outcome of the event was unknown. The relatedness between Crohn's disease and the suspect drug was not reported. The reporter was wondering whether the event could potentially be related to the patient receiving the vaccine. The reporter mentioned that both of his sons participated in the unknown clinical trial involving VARIVAX. Upon internal review, the event of Crohn's disease was determined to be medically significant.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Borrelia test positive, Lyme disease, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable nurse. A 11-years-old male patient received on 31Aug2017 TRUMENBA (lot number: R94916, Exp date Jan2018), intramuscular in left deltoid at 0.5 ml, single for immunisation. Medical history was none. Concomitant medication included the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP IMMUN, Lot number: GS22H, Expiration date: 21Mar2018, Manufacturer: GlaxoSmithKline) on 31Aug2017 at 0.5ml single intramuscular injection into the left deltoid for immunisation. The patient was supposed to receive MENACTRA for prevention of meningitis ACY and W but was given TRUMENBA instead which was for prevention of meningitis B. The patient was diagnosed with Lyme disease on 03Oct2017. The reporter mentioned that the patient had some current issues going on that she did not know if they were as a result of receiving the meningococcal group b rlp2086 vaccine or another issue. She later explained that the patient was diagnosed with Lyme disease on 03Oct2017. The reporter did not share when the patient started to experience the concurrent issues that let up to his diagnosis of Lyme disease. The reporter finally considered Lyme disease medically significant and to be unrelated to meningococcal group b rlp2086 vaccine. The patient was seen at physician office due to the events. On 29Sep2017 lab test were performed, results were as follows. Lyme total antibody test: Positive for Lyme disease. Lyme antibody IGG: Positive for Lyme 18, 30, 39, 41, 66, bands. Lyme antibody IGM: Positive for Lyme disease 41, 23 bands.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 74.0
Sex: M
Vaccine: CHOL
Symptoms: Product use issue
Clinical narrative: A spontaneous case report was received from a nurse for two patients (husband and wife) on 12-Jul-2017. Based on the information obtained from the nurse, two individual case safety reports PVX201707-000601 (PVX2017-2334; husband) and PVX201707-000602 (PVX2017-2343; wife) were created and cross-linked in the database. This case report describes an elderly male patient who "took Vaxchora in his 70's". The patient was receiving oral Vaxchora for an unknown indication. It was reported that the patient was administered Vaxchora in the age of 70's on 11-Jul-2017. The action taken with VIVOTIF with respect to the event "took Vaxchora in his 70's" was not applicable. The clinical outcome of the event "took Vaxchora in his 70's" was unknown. Company's comment: The causality of the event "product use in unapproved population" was considered as not applicable.; Reporter's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.; Sender's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.
Age: 73.0
Sex: F
Vaccine: CHOL
Symptoms: Product use issue
Clinical narrative: A spontaneous case report was received from a nurse for two patients (husband and wife) on 12-Jul-2017. Based on the information obtained from the nurse, two individual case safety reports PVX201707-000601 (PVX2017-2334; husband) and PVX201707-000602 (PVX2017-2343; wife) were created and cross-linked in the database. This case report describes an elderly female patient who "took Vaxchora in her 70's". The patient was receiving oral Vaxchora for an unknown indication. It was reported that the patient administered Vaxchora in the age of 70's on 11-Jul-2017. The action taken with Vaxchora with respect to the event "took Vaxchora in her 70's" was not applicable. The clinical outcome of the event "took Vaxchora in her 70's" was unknown. Company's comment: The causality of the event "product use in unapproved population" was considered as not applicable.; Reporter's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.; Sender's Comments: The causality of the event "product use in unapproved population" was considered as not applicable.