chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Cough, Fatigue, Herpes zoster, Injection site reaction
Clinical narrative: Patient had flu-like symptoms including sore throat, fever, and cough. Symptoms lasted two days and were self resolving.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rash erythematous, Swelling face
Clinical narrative: Patient had flu-like symptoms including sore throat, fever, and cough. Symptoms lasted two days and were self resolving.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Palpitations, Pyrexia
Clinical narrative: Severe flu-like symptoms ( extreme fever and chills), states her heart felt like it was going to "beat out of her chest" was aware of possible side effects but did not contact overnight pharmacy or MD.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: Body aches, muscle aches, fatigued.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV1
Symptoms: Crying, Diet refusal, Hyperhidrosis, Screaming
Clinical narrative: Screaming crying to the point he would be dripping sweat and not breathing while crying for hours at a time. Not drinking his bottles and screaming during feedings. It has been 5 days since his shots and they want to blame his thrush but he ate just fine when it was covering his mouth he now only has a few little spots on one side of his cheeks I cant imagine it being because of the thrush. Inconsolable for hours at a time before finally giving up and just going to sleep.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Immediate post-injection reaction, Injection site discolouration, Peripheral swelling
Clinical narrative: Burning sensation immediately. Arm swollen, bright red, hot for a full week. Arm still purple at injection site after two weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Burning sensation immediately. Arm swollen, bright red, hot for a full week. Arm still purple at injection site after two weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Axillary pain, Body temperature increased, Fatigue, Oedema peripheral
Clinical narrative: Temp-102 x's 2 days- Fatigue-Weakness- Left armpit sore swollen.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Insomnia, Nausea, Sneezing
Clinical narrative: Nausea, sleeplessness, loss of appetite, sneezing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Came in to office on 7/2/18 with fading urticaria that started the evening before he came in.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Dyspnoea, Fatigue, Frustration tolerance decreased
Clinical narrative: Day 1: in bed all day, total effort to get up to use restroom, loss of appetite, total fatigue-slept most of day, shot site was red, warm and raised (site was size of 2 50 cent pieces). Day 2 same as Day 1. Day 3 both hips hurt and walked with effort but bent over. Did get dressed for part of day but stayed home. Day 4 not as much fatigue as I sat up some, hips still hurt and walked bent over, redness remains at injection site with swelling down some. If I walked any distance I had to sit down and catch my breath due to fatigue. Also these continued symptoms brought on frustration. Day 5 morning nap, walked with a cane due to hips hurting, redness at injection site remains, still tired and not doing much except sitting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: Day 1: in bed all day, total effort to get up to use restroom, loss of appetite, total fatigue-slept most of day, shot site was red, warm and raised (site was size of 2 50 cent pieces). Day 2 same as Day 1. Day 3 both hips hurt and walked with effort but bent over. Did get dressed for part of day but stayed home. Day 4 not as much fatigue as I sat up some, hips still hurt and walked bent over, redness remains at injection site with swelling down some. If I walked any distance I had to sit down and catch my breath due to fatigue. Also these continued symptoms brought on frustration. Day 5 morning nap, walked with a cane due to hips hurting, redness at injection site remains, still tired and not doing much except sitting.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Day 1: in bed all day, total effort to get up to use restroom, loss of appetite, total fatigue-slept most of day, shot site was red, warm and raised (site was size of 2 50 cent pieces). Day 2 same as Day 1. Day 3 both hips hurt and walked with effort but bent over. Did get dressed for part of day but stayed home. Day 4 not as much fatigue as I sat up some, hips still hurt and walked bent over, redness remains at injection site with swelling down some. If I walked any distance I had to sit down and catch my breath due to fatigue. Also these continued symptoms brought on frustration. Day 5 morning nap, walked with a cane due to hips hurting, redness at injection site remains, still tired and not doing much except sitting.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Nausea, fever, chills - went to bed and stayed there for one day. Arm swollen and red and rashy below injection site. Itches. Very sensitive to touch. Still that way 4 days later, though much improved. Applied ice pack several times per day.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea, fever, chills - went to bed and stayed there for one day. Arm swollen and red and rashy below injection site. Itches. Very sensitive to touch. Still that way 4 days later, though much improved. Applied ice pack several times per day.
Age: 21.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Pt. reports developed severe pain in left arm and flu like symptoms approximately 3 hours after receiving vaccination.
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. On 08-JUN-2018, the patient was vaccinated with M-M-R II, subcutaneous injection, lot # M032487, expiry date: 05-JUL-2018 for prophylaxis (reported as vaccine) whose dose was not reported. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) via subcutaneous route whose indication, lot number and expiry date were not reported. On 15-JUN-2018 reported as after 7 days of vaccination the patient developed rash. It was reported that patient had seen the health care provider. No lab diagnostics or studies were performed and no treatment was given for the adverse event. The outcome of rash was reported as not recovered. The reporter did not provide the causal relationship of adverse event with M-M-R II vaccine and sterile diluent (MERCK STERILE DILUENT). There was no product quality complaint (PQC) involved in the report.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Rash macular, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX (batch number NR4Z4, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, skin warm, stinging, skin blotches and erythema of extremities. The patient was treated with ICE PACK (NO MEDICATION). On an unknown date, the outcome of the pain in arm, skin warm, stinging, skin blotches and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, skin warm, stinging, skin blotches and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left deltoid. The patient experienced pain in arm and a warm, red, stinging blotch on the back of arm that took about 2 and a half weeks to go away. The symptoms did fully resolve. She applied ice to the affected area and did not seek medical attention. The health care professional was not the person who administered the vaccine. The reporter had trouble reading the lot or expiry number of what was scanned in his system. The reported SHINGRIX batch number (NR424) did not exist in the sales database and was updated to NR4Z4.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Pain, Pulse abnormal
Clinical narrative: Extremely tired for 4 days after injection. 1st day after tired all day, slept 10 hours that night. 2nd day spent most of the day sleeping, approx 8 hours during morning and afternoon and another 8 hours that evening. 3rd day very tired, slept 2 hours in afternoon, then another 8 hours that night.  Also had throbbing in my chest, heavy pulse like I feel when fighting a virus or bacterial infection.   Luckily this occurred over a weekend and I had nothing important scheduled those days I am quite upset that the pharmacist did not provide written or verbal warning  of possible side effects lasting 2-3 days. The CDC web site warns "The side effects may affect your ability to do normal daily activities for 2 to 3 days. About 1 out of 6 people had side effects that prevented them from doing regular activities." That is pretty significant, certainly worth a warning I am very concerned about going through this again for the 2nd dose.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction to DTAP vaccine - swelling / knotting at injection site, fever at site, hurts to straighten leg or to touch it - Ice, TYLENOL PRN, BENADRYL for itching.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pruritus
Clinical narrative: Local reaction to DTAP vaccine - swelling / knotting at injection site, fever at site, hurts to straighten leg or to touch it - Ice, TYLENOL PRN, BENADRYL for itching.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: Myalgia, erythema around the injection site that keeps spreading, itching at site of injection, started almost immediately after vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Joint range of motion decreased, Myalgia, Nausea
Clinical narrative: Patient reports on 06/19/2018 she experienced severe headaches, muscle aches, and nausea. On 06/22/2018 she reports hip pain and limitation in range of motion. On 06/27/2018 she reports presentation of painful cold sores inside the mouth between the cheek and gums.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Oral pain
Clinical narrative: Patient reports on 06/19/2018 she experienced severe headaches, muscle aches, and nausea. On 06/22/2018 she reports hip pain and limitation in range of motion. On 06/27/2018 she reports presentation of painful cold sores inside the mouth between the cheek and gums.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient experience soreness in arm 6-28-18 and complained of headache starting 6-29-18. On 6-29-18, patient woke up with flu like symptoms - fever, headache and overall aches. On 6-30-18, patient noticed the rash starting to appear. The rash is mainly on one side of injection site, slightly warm and slightly itchy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient experience soreness in arm 6-28-18 and complained of headache starting 6-29-18. On 6-29-18, patient woke up with flu like symptoms - fever, headache and overall aches. On 6-30-18, patient noticed the rash starting to appear. The rash is mainly on one side of injection site, slightly warm and slightly itchy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Influenza like illness, Injection site pain, Rash
Clinical narrative: Patient said she had an allergic reaction to the vaccination which consisted of a rash that started on the lower body which spread to her chest area (NO breathing issues), mild flu like symptoms and local arm pain at the injection site. Patient went to a walk in clinic on 6-30-18 to be evaluated and the prescriber prescribed a course of keflex and for patient to take benadryl for a diagnosis of rash and other nonspecific skin eruption. On 6-31-18 I called patient to see how she was doing and she said she was doing much better.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Feeling abnormal, Nuclear magnetic resonance imaging normal, Tinnitus
Clinical narrative: My daughter has had dizzy spells everyday since June 5, 5 days after receiving the HPV vaccine. She had very brief ringing in her left ear on June 5 and 6 that only lasted a few seconds and one other day near the end of June. Sometimes she only has one dizzy spell a day and sometimes more. She also states that she feels "off" and feels like her eyes are crossing. My daughter had an MRI which was negative. The Dr. has now recommended we go to see an ENT if the dizziness doesn't go away. My daughter still has dizziness at least once a day to this present day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dermatitis bullous, Drug eruption
Clinical narrative: Bullous drug eruption large fluid filled blisters in 1 arm. Dr gave valcyclovir and prednisone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Chills, Diarrhoea, Dizziness
Clinical narrative: 1:30 in the morning of Friday June 29th, 2018, I awoke with severe body shaking and chills and nausea. Did not know what was going on. My son rushed me to the ER in town, and the nurse and doctor there gave me warm blankets, and took 5 vials of blood. I suddenly threw up before they could give me some nausea meds. Took my temperature and it was 101.1 They then started an IV in case of what results came back, as well as give me a shot of meds for the nausea and a headache. Also gave me some TYLENOL for the fever and headache, but the TYLENOL did not seem like it was helping much. I did not throw up anymore, but still was groggy and I was dizzy and felt weak. Went home at 5 am to try to sleep. Did not feel myself all day Friday June 29, 2018. Finally felt somewhat better on Saturday June 30, 2018, but still not fully well. I have been experiencing diarrhea on Sunday night July 1, 2018 and all day Monday July 2, 2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: 1:30 in the morning of Friday June 29th, 2018, I awoke with severe body shaking and chills and nausea. Did not know what was going on. My son rushed me to the ER in town, and the nurse and doctor there gave me warm blankets, and took 5 vials of blood. I suddenly threw up before they could give me some nausea meds. Took my temperature and it was 101.1 They then started an IV in case of what results came back, as well as give me a shot of meds for the nausea and a headache. Also gave me some TYLENOL for the fever and headache, but the TYLENOL did not seem like it was helping much. I did not throw up anymore, but still was groggy and I was dizzy and felt weak. Went home at 5 am to try to sleep. Did not feel myself all day Friday June 29, 2018. Finally felt somewhat better on Saturday June 30, 2018, but still not fully well. I have been experiencing diarrhea on Sunday night July 1, 2018 and all day Monday July 2, 2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Urine analysis normal, Vomiting
Clinical narrative: 1:30 in the morning of Friday June 29th, 2018, I awoke with severe body shaking and chills and nausea. Did not know what was going on. My son rushed me to the ER in town, and the nurse and doctor there gave me warm blankets, and took 5 vials of blood. I suddenly threw up before they could give me some nausea meds. Took my temperature and it was 101.1 They then started an IV in case of what results came back, as well as give me a shot of meds for the nausea and a headache. Also gave me some TYLENOL for the fever and headache, but the TYLENOL did not seem like it was helping much. I did not throw up anymore, but still was groggy and I was dizzy and felt weak. Went home at 5 am to try to sleep. Did not feel myself all day Friday June 29, 2018. Finally felt somewhat better on Saturday June 30, 2018, but still not fully well. I have been experiencing diarrhea on Sunday night July 1, 2018 and all day Monday July 2, 2018.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Within 24 hours red, swelling at site of injection. On June 27, 2018, two days later, the arm was still red, warm to touch in an area of 100mm x150mm. No fever or breathing difficulties. Reported only that arm was tender.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Mobility decreased, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: 2:30 pm received vaccine, 3:30 couldn't lift arm, nausea, loss of appetite, fever, swelling, hives, weakness in arm and to this day, 7/2, her arm still hurts per patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: 2:30 pm received vaccine, 3:30 couldn't lift arm, nausea, loss of appetite, fever, swelling, hives, weakness in arm and to this day, 7/2, her arm still hurts per patient.
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Altered state of consciousness, Electrocardiogram abnormal, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: After 5 minutes of finishing all the immunization, patient reports feeling very nauseous and going to pass out. Patient became very diaphoretic, pulses weak, and loss consciousness for less than 10 second with no seizure activity noticed at that time. EPI injection given activated 911 call and patient pulse weak and thread 30s and BP 80/60s, alert and oriented and but very pale looking and second dose of Epinephrine is given and HR became 40-50s, BP is 90/62. EMS came and 12 lead EKG done, sinus bradycardia 40s, BP 100/70s, 500 ml fluid bolus given and transfered the patient to the emergency room.
Age: 26.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Pallor, Pulse abnormal, Sinus bradycardia
Clinical narrative: After 5 minutes of finishing all the immunization, patient reports feeling very nauseous and going to pass out. Patient became very diaphoretic, pulses weak, and loss consciousness for less than 10 second with no seizure activity noticed at that time. EPI injection given activated 911 call and patient pulse weak and thread 30s and BP 80/60s, alert and oriented and but very pale looking and second dose of Epinephrine is given and HR became 40-50s, BP is 90/62. EMS came and 12 lead EKG done, sinus bradycardia 40s, BP 100/70s, 500 ml fluid bolus given and transfered the patient to the emergency room.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity
Clinical narrative: Site reaction. Arm was hard and swollen and red for about 2 weeks. Said it hurt to lay on that arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Tenderness
Clinical narrative: Patient experienced tenderness and pain the next day. Two days later she reported a rash around the injection area about 2 inches in diameter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hallucination, Insomnia, Myalgia, Pain
Clinical narrative: Hallucinations, sleeplessness, whole body aches and pains (joints, muscles).  Symptoms lasted about 5 hours, approximately 12 hours after vaccination.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Back pain, Chest pain, Dizziness, Flushing
Clinical narrative: Patient almost immediately began experiencing severe lower back pain, radiating through both arms and extending into her chest. She felt nauseous, flushed, and light-headed and was experiencing a great deal of anxiety. She was escorted to a chair and the immunizing pharmacist stayed with her until the symptoms subsided. She refused multiple offers to call for EMS. After symptoms subsided, she left the pharmacy and returned a short time later to report a dull headache. I phoned her later in the evening to check on her condition and she reported that she still had the headache, but otherwise, all symptoms had subsided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Patient almost immediately began experiencing severe lower back pain, radiating through both arms and extending into her chest. She felt nauseous, flushed, and light-headed and was experiencing a great deal of anxiety. She was escorted to a chair and the immunizing pharmacist stayed with her until the symptoms subsided. She refused multiple offers to call for EMS. After symptoms subsided, she left the pharmacy and returned a short time later to report a dull headache. I phoned her later in the evening to check on her condition and she reported that she still had the headache, but otherwise, all symptoms had subsided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Faeces soft, Loss of consciousness, Retching
Clinical narrative: Soft bowels, dry heaving, dizziness and passing out.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swollen and sore injection site in the late afternoon (still sore on 7/2/2018),  fever, splitting headache, nausea - all in the early morning around 2am 7/1/2018.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash with itching.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT DEVELOPED SOON AFTER VACCINE--POUNDING HEADACHE, FEVER, RIGHT ARM PAINFUL, BODY ACHES,RIGHT UPPER ARM SWOLLEN. PATIENT STARTING TO FEEL BETTER AT DAY 3.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Patient reports having had significant flu-like symptoms starting morning after vaccine. She describes sweating, chills, and malaise and had a hard red lump at injection site that is warm to the touch. Patient presented 2 days after adverse reaction with continued redness and swelling at injection site. Patient was instructed to take Benadryl and OTC NSAID to reduce redness and pain. Patient advised to go to urgent care if site redness increases or fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Patient reports having had significant flu-like symptoms starting morning after vaccine. She describes sweating, chills, and malaise and had a hard red lump at injection site that is warm to the touch. Patient presented 2 days after adverse reaction with continued redness and swelling at injection site. Patient was instructed to take Benadryl and OTC NSAID to reduce redness and pain. Patient advised to go to urgent care if site redness increases or fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: The site of injection was extremely sore--to the point where I couldn't lift my arm without severe pain. I developed a fever of 102 degrees, a very bad headache, muscle ache and extreme fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The site of injection was extremely sore--to the point where I couldn't lift my arm without severe pain. I developed a fever of 102 degrees, a very bad headache, muscle ache and extreme fatigue.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Ear infection, Erythema, Injected limb mobility decreased, Injection site pain, Lymphadenopathy
Clinical narrative: Patient had pain at injection site next day and loss of range of motion in arm without pain. Three days later the pectoral muscle was greatly swollen as was the lymph node in the left armpit the size of an egg. Redness in the armpit occurred and continued down the inner bicep to the elbow, no fever was experienced. Six days after vaccination the swelling in lymph node and pectoral muscle subsided but still had pain and loss of range of motion and developed an ear infection.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Muscle swelling
Clinical narrative: Patient had pain at injection site next day and loss of range of motion in arm without pain. Three days later the pectoral muscle was greatly swollen as was the lymph node in the left armpit the size of an egg. Redness in the armpit occurred and continued down the inner bicep to the elbow, no fever was experienced. Six days after vaccination the swelling in lymph node and pectoral muscle subsided but still had pain and loss of range of motion and developed an ear infection.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Poor quality sleep, Visual impairment
Clinical narrative: PATIENT REPORTS STOMACH UPSET (NO VOMITING), EXTREME FATIGUE, VISUAL DISTURBANCE (BLACK SPOTS OBSTRUCTING VISION), PT REPORTS HE DID NOT SLEEP WELL DURING THE NIGHT. GOT UP IN THE MORNING FEELING BETTER BUT STILL TIRED. PT RETURNED TO BED AND SLEPT UNTIL 11 AM-UPON WAKING HE FELT BETTER.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Skin discolouration
Clinical narrative: Patient reported the next day having purple bumpy rash on right leg below knee to ankle on calf and shin that was very itchy and felt like a sunburn pain. He went to doctor office and was diagnosed with shingles and treated with a steroid injection and given Valacyclovir 1 gram 1 tab twice a day for 7 days with subsequent resolution. He wants to know if this was indeed shingles rash or was this an adverse reaction to the vaccination? and should he get the second dose or not?
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Nausea, Pain in extremity
Clinical narrative: Severe arm pain, nausea, malaise. Went to CNP and was diagnosed with acute shingles. Patient presented 7/2/18 with prescriptions for. Valacyclovir, Norco, and Lidocaine-HC 3-0.5 kit.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Herpes zoster
Clinical narrative: Severe arm pain, nausea, malaise. Went to CNP and was diagnosed with acute shingles. Patient presented 7/2/18 with prescriptions for. Valacyclovir, Norco, and Lidocaine-HC 3-0.5 kit.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Laboratory test normal, Myalgia, Rash
Clinical narrative: DISTRESS, FACIAL RASH, MUSCLE ACHES.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fluctuance, Injection site erythema, Injection site induration, Skin reaction
Clinical narrative: Erythema and induration on both upper arms, in the shape of the deltoid muscle. The right side has a small amount of fluctuance. Skin reaction to the MENVEO immunization reviewed supportive care and reasons for to call back.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Pyrexia
Clinical narrative: HA W/I 24 hrs. Fever W/I 24 hrs. Muscle pain W/I 24 hrs. Red ring 3 days after.
Age: 75.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, redness, swelling itching knots where shot was giving fever in arms. Skin peeling in on arms.
Age: 75.0
Sex: F
Vaccine: PNC13, TD
Symptoms: Skin exfoliation, Skin warm
Clinical narrative: Pain, redness, swelling itching knots where shot was giving fever in arms. Skin peeling in on arms.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Immediate post-injection reaction, Lip swelling, Sneezing, Urticaria
Clinical narrative: Pt developed hives, swollen lips, sneezing with 10 min of vaccine. Was give subcutaneous epinephrine and all symptoms resolved within 5 minutes. 25mg BENADRYL given orally as well.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: None. Patient given Rotavirus oral immunization that was two days expired. No reaction.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Cough, Headache, Rash generalised, Rash pruritic
Clinical narrative: 06/28/18 - Patient woke with diffuse itchy rash. 2 - 3 days prior to visit, experienced temp to 102 degrees, headache, and cough. She has taken ibuprofen and acetaminophen. Today's visit was Rx'd prednisone. Rash improved as of 7/2/18. Parent states she recently took Amox. for Dental procedure.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Vaccines given 6/25/18. Mother reported high fever of 104.5 degrees F. Gave TYLENOL suppository fever went down. Reported patient was lethargic and fever of 100.2 degrees F on 6/26/18.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash started lower left arm, today is on his legs, not on his back or trunk.
Age: 24.0
Sex: F
Vaccine: HPVX, TDAP, VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Pt states on 6/18/18 received Tdap in (R) deltoid. Had redness, swelling, erythema, and induration. Induration still present 07/02/18.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Loss of consciousness, Syncope, Visual impairment
Clinical narrative: Pt was sitting in office check-out area, stated she felt "her hands go numb", "saw spots then blacked out". Remembers opening eyes as she heard her name being called and saw herself lying on floor. Pt was assisted to nearby chair where she proceeded to faint again. Was carried to exam room #2 until EMS arrived. BP 80's/50's at this time. Discharge home from Dr. office.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Diarrhoea, Erythema, Full blood count
Clinical narrative: Pt states Friday evening she began to feel nauseous. She has diarrhea and the (L) arm was red and swollen. Pt reports she could feel a knot at injection site. Seen in clinic on 7-2-18, CXR and CBC ordered. Rest.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Nausea, Peripheral swelling
Clinical narrative: Pt states Friday evening she began to feel nauseous. She has diarrhea and the (L) arm was red and swollen. Pt reports she could feel a knot at injection site. Seen in clinic on 7-2-18, CXR and CBC ordered. Rest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Patient has the following symptoms (pain, redness, swelling, myalgia, fatigue and fever for the past 3 days).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient has the following symptoms (pain, redness, swelling, myalgia, fatigue and fever for the past 3 days).
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pruritus, Rash generalised
Clinical narrative: 3 days post-injection patient experienced rash/redness/soreness at injection site. Over next couple days rash spread over entire body. Treated herself with BENADRYL and Cortisone cream. Getting better but still itchy. No current PCP so recommended Urgent Care if not better or doesn't clear. Rash getting better.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Extremely flu like symptoms: achy all over, neck ached, fever 101, chills-hot & cold, itchy all over but especially sides of face, fitful sleep with repeated wakening every hour, several random, quick zinger like pain from left arm injection site towards sternum. Felt as bad as when had measles when I was 4 years old. At 5 am next morning sitting in kitchen decided, perhaps, food (yogurt) would make me feel better. Stood up and immediately thought "I feel so awful I need to sit on the floor right now." Next thing I knew my head bounced off the floor. Felt so awful, decided to just lay of floor. After several minutes head laying in something wet..thinking what did elderly husband spill on floor that didn't get noticed...pushed my self up on elbows, felt liquid on head, looked and saw blood. Managed to get up, sit in chair, grab tissue put pressure on side of head near eye. Called 911. Transported to Hospital. Three stitches in right eyebrow. CT scan, chest x-ray in ER room, 36 hours in clinical care decision unit of hospital. Diagnosis: Head concussion.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Chest pain, Chills, Computerised tomogram
Clinical narrative: Extremely flu like symptoms: achy all over, neck ached, fever 101, chills-hot & cold, itchy all over but especially sides of face, fitful sleep with repeated wakening every hour, several random, quick zinger like pain from left arm injection site towards sternum. Felt as bad as when had measles when I was 4 years old. At 5 am next morning sitting in kitchen decided, perhaps, food (yogurt) would make me feel better. Stood up and immediately thought "I feel so awful I need to sit on the floor right now." Next thing I knew my head bounced off the floor. Felt so awful, decided to just lay of floor. After several minutes head laying in something wet..thinking what did elderly husband spill on floor that didn't get noticed...pushed my self up on elbows, felt liquid on head, looked and saw blood. Managed to get up, sit in chair, grab tissue put pressure on side of head near eye. Called 911. Transported to Hospital. Three stitches in right eyebrow. CT scan, chest x-ray in ER room, 36 hours in clinical care decision unit of hospital. Diagnosis: Head concussion.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Concussion, Electrocardiogram, Feeling abnormal, Feeling of body temperature change, Influenza like illness
Clinical narrative: Extremely flu like symptoms: achy all over, neck ached, fever 101, chills-hot & cold, itchy all over but especially sides of face, fitful sleep with repeated wakening every hour, several random, quick zinger like pain from left arm injection site towards sternum. Felt as bad as when had measles when I was 4 years old. At 5 am next morning sitting in kitchen decided, perhaps, food (yogurt) would make me feel better. Stood up and immediately thought "I feel so awful I need to sit on the floor right now." Next thing I knew my head bounced off the floor. Felt so awful, decided to just lay of floor. After several minutes head laying in something wet..thinking what did elderly husband spill on floor that didn't get noticed...pushed my self up on elbows, felt liquid on head, looked and saw blood. Managed to get up, sit in chair, grab tissue put pressure on side of head near eye. Called 911. Transported to Hospital. Three stitches in right eyebrow. CT scan, chest x-ray in ER room, 36 hours in clinical care decision unit of hospital. Diagnosis: Head concussion.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Middle insomnia, Neck pain, Pain, Pruritus generalised
Clinical narrative: Extremely flu like symptoms: achy all over, neck ached, fever 101, chills-hot & cold, itchy all over but especially sides of face, fitful sleep with repeated wakening every hour, several random, quick zinger like pain from left arm injection site towards sternum. Felt as bad as when had measles when I was 4 years old. At 5 am next morning sitting in kitchen decided, perhaps, food (yogurt) would make me feel better. Stood up and immediately thought "I feel so awful I need to sit on the floor right now." Next thing I knew my head bounced off the floor. Felt so awful, decided to just lay of floor. After several minutes head laying in something wet..thinking what did elderly husband spill on floor that didn't get noticed...pushed my self up on elbows, felt liquid on head, looked and saw blood. Managed to get up, sit in chair, grab tissue put pressure on side of head near eye. Called 911. Transported to Hospital. Three stitches in right eyebrow. CT scan, chest x-ray in ER room, 36 hours in clinical care decision unit of hospital. Diagnosis: Head concussion.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Suture insertion, Troponin, Urine analysis
Clinical narrative: Extremely flu like symptoms: achy all over, neck ached, fever 101, chills-hot & cold, itchy all over but especially sides of face, fitful sleep with repeated wakening every hour, several random, quick zinger like pain from left arm injection site towards sternum. Felt as bad as when had measles when I was 4 years old. At 5 am next morning sitting in kitchen decided, perhaps, food (yogurt) would make me feel better. Stood up and immediately thought "I feel so awful I need to sit on the floor right now." Next thing I knew my head bounced off the floor. Felt so awful, decided to just lay of floor. After several minutes head laying in something wet..thinking what did elderly husband spill on floor that didn't get noticed...pushed my self up on elbows, felt liquid on head, looked and saw blood. Managed to get up, sit in chair, grab tissue put pressure on side of head near eye. Called 911. Transported to Hospital. Three stitches in right eyebrow. CT scan, chest x-ray in ER room, 36 hours in clinical care decision unit of hospital. Diagnosis: Head concussion.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Insomnia, Middle insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old female patient who experienced left shoulder pain, unable to use and lift her arm due to the pain/ pain wakes her up from sleep, while she received vaccine ADACEL. The patients past medical history, medical treatment, vaccination and family history were not provided.Patient has NKDA. On 30-May-2018, the patient received a 0.5ml dose of suspect ADACEL lot U5798AB, expiry date 15 Nov 2019 via unknown route in the left deltoid. The patient developed a non-serious left shoulder pain (musculoskeletal pain) one day following the administration of ADACEL. The patient developed a non-serious unable to use and lift her arm due to the pain/ pain wakes her up from sleep (injected limb mobility decreased) one day following the administration of ADACEL. Patient had not yet sought medical advice for this issue. Pharmacist advised patient to go to her physician for treatment. The patient developed a non-serious unable to use and lift her arm due to the pain/ pain wakes her up from sleep (sleep disturbed) one day following the administration of ADACEL. Final diagnosis was unable to use and lift her arm due to the pain/ pain wakes her up from sleep and left shoulder pain. Lab data was not provided. The patient was treated with IBUPROFEN for Pain. Outcome of events was reported as unknown. List of documents held by sender- none.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old female patient who experienced left shoulder pain, unable to use and lift her arm due to the pain/ pain wakes her up from sleep, while she received vaccine ADACEL. The patients past medical history, medical treatment, vaccination and family history were not provided.Patient has NKDA. On 30-May-2018, the patient received a 0.5ml dose of suspect ADACEL lot U5798AB, expiry date 15 Nov 2019 via unknown route in the left deltoid. The patient developed a non-serious left shoulder pain (musculoskeletal pain) one day following the administration of ADACEL. The patient developed a non-serious unable to use and lift her arm due to the pain/ pain wakes her up from sleep (injected limb mobility decreased) one day following the administration of ADACEL. Patient had not yet sought medical advice for this issue. Pharmacist advised patient to go to her physician for treatment. The patient developed a non-serious unable to use and lift her arm due to the pain/ pain wakes her up from sleep (sleep disturbed) one day following the administration of ADACEL. Final diagnosis was unable to use and lift her arm due to the pain/ pain wakes her up from sleep and left shoulder pain. Lab data was not provided. The patient was treated with IBUPROFEN for Pain. Outcome of events was reported as unknown. List of documents held by sender- none.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Nausea, Pain in extremity
Clinical narrative: I got the Shingles - Horribly.  All on the left side of my head. I would like to speak to someone regarding this because I am VERY upset.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Herpes zoster
Clinical narrative: I got the Shingles - Horribly.  All on the left side of my head. I would like to speak to someone regarding this because I am VERY upset.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Patient's injection site started swelling up shortly after injection. Patient was given 50 mg diphenhydramine injection in opposite arm, and the affected injection site was iced.
Age: 21.0
Sex: M
Vaccine: JEV1
Symptoms: Contusion, Thrombophlebitis
Clinical narrative: Pt states that after getting JEV vaccine earlier in the day on 2 Jul 18 he noticed that night that he had bruising about 3-4 inches above the injection site. Pt was seen in clinic today by a provider and was diagnosed with thrombophlebitis. Pt was told to follow up if the Sx didn't resolve.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever, muscle aches, pain behind right thigh, fatigue, soreness at left arm.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Sudden onset of uncontrollable shaking for 30 to 45 minutes, slight nausea, light headedness. I was about to transport my husband to ER when symptoms subsided as quickly as they started. My husband felt feverish, but had no fever. Left upper arm was slightly swollen and sore at 6:00 AM this morning.  My husband felt slightly off after the first vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Sudden onset of uncontrollable shaking for 30 to 45 minutes, slight nausea, light headedness. I was about to transport my husband to ER when symptoms subsided as quickly as they started. My husband felt feverish, but had no fever. Left upper arm was slightly swollen and sore at 6:00 AM this morning.  My husband felt slightly off after the first vaccination.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Cold sweat, Pallor, Syncope, Tremor
Clinical narrative: Pt with syncope within 5 minutes post vaccination- pale, clammy, "shaking." Within a few seconds pt began to have color return to face and become more oriented to self and place. Pt monitored until returned to baseline.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Muscle spasms
Clinical narrative: Within several hours the muscular pain traveled all the way down my arm to my hand; I experienced pain and cramping. Ibuprofen helped. By 10pm I began feeling fluish: headache, other muscular aches, very fatigued and chilled (by the morning of the next day). Still feeling like I have the flu by 9am on 7/3.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Within several hours the muscular pain traveled all the way down my arm to my hand; I experienced pain and cramping. Ibuprofen helped. By 10pm I began feeling fluish: headache, other muscular aches, very fatigued and chilled (by the morning of the next day). Still feeling like I have the flu by 9am on 7/3.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure during breast feeding, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's medical history included pregnancy and parity. No information was provided regarding the patient's concurrent conditions. Concomitant therapies included STERILE DILUENT. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient had her titers done for measles, mumps and rubella and they were low (measles antibody negative), (mumps antibody test negative) and (rubella antibody negative). The physician also reported that the patient was breastfeeding (maternal exposure during pregnancy). No further information was provided. The outcome of measles, mumps and rubella antibody negative and maternal exposure during pregnancy was unknown. At the time of the report, the casual relationship between measles, mumps and rubella antibody negative and maternal exposure during pregnancy with M-M-R II was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 15-JUN-2018, the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II therapy type rHA, subcutaneously (lot# M029229 and expiry date 08-JUN-2018). No adverse effects were reported. There was no product quality compliant reported.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Injection site reaction, Muscle atrophy
Clinical narrative: This spontaneous report was received from a pharmacist referring to an elderly female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). On an unknown date, the pharmacist stated that the patient was frail (asthenia), without much muscle mass or tissue at the injection site (muscle atrophy) and had to go to an unspecified hospital due to injection site pain. It was unknown whether the patient was admitted to the hospital as well as if she received any treatment for the adverse events or if any laboratory study was performed. At the reporting time, the outcome of muscle atrophy, asthenia and injection site pain was unknown (discrepant information also reported as "Dechallenge: yes"). The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Underdose, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant via company representative concerning a 6 month old patient of unknown gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown by the reported. On an unknown date, the patient was vaccinated with the second dose of ROTATEQ vial, orally for routine vaccination (strength, dose, dosage schedule, lot # and expiry date were not provided).  On an unknown date (reported as after receiving second dose of ROTATEQ, the patient threw it all up (vomiting; underdose). The outcome of vomiting was reported as recovered. The reporter's causality assessment between ROTATEQ and vomiting was not reported.