chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Imaging procedure, Laboratory test normal, Magnetic resonance imaging normal, Motor dysfunction
Clinical narrative: I was 45 minutes into a zumba class. I started yawning repeatedly, which is very unusual for me. My feet were not obeying orders. I stopped to drink some water and left the studio in case I was dehydrated or overheated; neither helped. I went back into the studio but was unable to keep up with the music so I sat on the floor until the class ended. I started feeling better but my classmates took me to the ER at Hospital, where a series of doctors, nurses, and techs did a number of examinations, labs, and images over the next five hours. They all showed normal results and I was released.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Neurological examination normal, Urine analysis normal, X-ray normal, Yawning
Clinical narrative: I was 45 minutes into a zumba class. I started yawning repeatedly, which is very unusual for me. My feet were not obeying orders. I stopped to drink some water and left the studio in case I was dehydrated or overheated; neither helped. I went back into the studio but was unable to keep up with the music so I sat on the floor until the class ended. I started feeling better but my classmates took me to the ER at Hospital, where a series of doctors, nurses, and techs did a number of examinations, labs, and images over the next five hours. They all showed normal results and I was released.
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not experience any symptoms; a four month old infant was inadvertently administered one dose of GARDASIL 9; This spontaneous report was received from a physician referring to a 4-month-old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 30-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 1, (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  It was reported that the patient did not experience any symptoms.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Prolonged redness; Swelling; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for immunisation. The two vaccines were administered in the same arm. The patient's medical history and concomitant medications were not reported. The patient experienced prolonged redness and swelling both on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient developed redness on L thigh treated with Cephelexin.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: patient had rash over chest and arms 4 hours after vaccine, took allegra and rash subsided
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Headache, Pyrexia, Vision blurred
Clinical narrative: Fever and bursitis of shoulder one day after. headache and blurred vision 3 days afterwards.
Age: 2.08
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MMRV, PNC13
Symptoms: Injection site erythema, Irritability, Rash macular, Rash pruritic, Vaccination site pain
Clinical narrative: red macular rash w/ pruritis after vaccine, increased fussing after vaccine. Red, swollen, tender ring @ vaccine site on (L) leg.
Age: 2.08
Sex: F
Vaccine: DTAPHEPBIP, FLU4, MMRV, PNC13
Symptoms: Vaccination site swelling
Clinical narrative: red macular rash w/ pruritis after vaccine, increased fussing after vaccine. Red, swollen, tender ring @ vaccine site on (L) leg.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Condition aggravated, Crying, Eczema
Clinical narrative: Behavior change, change in cry, eczema breakout
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient reports after second dose of Shingrix, she initially experienced injection site pain and redness.  She said that resolved but unsure of how long it took.  She also states that she has had tremor, extreme fatigue, trouble breathing at times, and becomes easily fatigued upon exertion.  She says she has not been able to perform normal activities of daily living to the same capacity that she was once able to prior to receiving the second dose of the vaccine.  She said that she did not have complications after the first dose of Shingrix, only the second.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Patient reports after second dose of Shingrix, she initially experienced injection site pain and redness.  She said that resolved but unsure of how long it took.  She also states that she has had tremor, extreme fatigue, trouble breathing at times, and becomes easily fatigued upon exertion.  She says she has not been able to perform normal activities of daily living to the same capacity that she was once able to prior to receiving the second dose of the vaccine.  She said that she did not have complications after the first dose of Shingrix, only the second.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reported that there was redness and swelling encompassing most of the outer portion of the right arm between shoulder and elbow lasting over the course of several days (vaccinated Saturday 12/21 and cleared up approximately 12/25). Per the advice of their neighbor who is a pharmacist, they treated Patient with Benadryl until resolved. Reaction was reported to immunizing pharmacy when other family members stopped in to receive their influenza vaccines.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Feeling hot, Injection site pain
Clinical narrative: I have been experiencing internal heat on Left shoulder, where the flu shot was given.  The heating in my shoulder has expanded toward my back part of the same shoulder. I some times feel very hot in cold temperatures and if I lay my left arm on a cold table. it feels hot internally. If that make sense. I talk with my doctor and explained it to her and nothing she could do to help. There is no bruising, rash or pain. I have full mobility of my arm.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Decreased appetite, Dysphagia, Salivary hypersecretion
Clinical narrative: c/o difficulty swallowing, hyper salivation, loss of appetite (decreased # 20). Symptoms started last week of Sept. 2019 - ER visit, 4 clinic visits  -feeling better now; still c/o salivation
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Swelling, Tenderness
Clinical narrative: Patient has been experiencing a nasty reaction to the vaccine, has had redness, swelling of 5 inches in diameter, and has tenderness, burning, itching, and pain at the injection site for over 5 days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient has been experiencing a nasty reaction to the vaccine, has had redness, swelling of 5 inches in diameter, and has tenderness, burning, itching, and pain at the injection site for over 5 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site pain, Rash erythematous, Skin warm
Clinical narrative: pain at injection site-red rash that is warm to the touch
Age: 91.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic, Renal function test normal
Clinical narrative: Patient got itchy rash on back, arms and legs (not on face and stomach) starting one week after receiving vaccines. Rash is continuing to get worse. Saw dermatologist who wanted patient to see PCP for follow up regarding kidney function. PCP complete lab work and stated kidney function was normal. Neither felt vaccines were the cause. Patient has appointment with another dermatologist for another evaluation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Tendon injury
Clinical narrative: Right after injection, the patient felt the pain on the injection site. Apparently, the injection went to the tendon area of the patient. She tried to resist the needle and probably  in the process, I might have hit the tendon. She was in so much pain that in the same evening she went to the emergency room. It was confirmed by the doctor that the tendon was hit. She was given Naproxen 500mg to take.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Exposure via skin contact, Needle issue
Clinical narrative: NEEDLE LEAKED FROM VACCINATION - PT RECEIVED SOME VACCINE AND SOME DRIPPED DOWN HER ARM.  IT WAS DIFFICULT TO TELL WHETHER OR NOT THE PATIENT RECEIVED A THERAPEUTIC DOSE
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Continuous pain in arm (muscle). Patient reported to a doctor and got referred to a specialist. Seeing specialist on 01.02.2020. Will follow up with us.
Age: 60.0
Sex: U
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Tenderness
Clinical narrative: patient experiencing pain in shoulder - hurts when Lifting - hurts when sleep on it. pain when lifting she was going to follow up with us in January 2020.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pt experiencing pain in arm, shoulder + neck since injection - pt confirmed not given high on arm near shoulder + pain started immediately after injection
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: swollen, painful, large Red Rash (larger than typical swelling from inj).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Heart rate increased, Insomnia
Clinical narrative: Extreme shivering for approx. 5 hours then fever of 100.5.  Excruciating pain over entire body with movement.  Headache.  Rapid heartbeat lasting all night.  Inability to sleep.  Symptoms reduced by next morning (10am); weakness; headache.  Pain gone by 1/1/20.  Second time I've experienced this.  Had milder reaction in 2018 but had also two flu shots in less than 6 months.  (Not sure why that occurred.  PA suggested it in July; I forgot and got one at Pharmacy.  When I had such a violent reaction, I looked through my paperwork and found the flu shot listed with other shots I had at the same time.  Assumed the violent reaction to the December, 2018, flu shot was because I had a previous one less than 6 mos. earlier.  This year the reaction was similar but more intense.)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme shivering for approx. 5 hours then fever of 100.5.  Excruciating pain over entire body with movement.  Headache.  Rapid heartbeat lasting all night.  Inability to sleep.  Symptoms reduced by next morning (10am); weakness; headache.  Pain gone by 1/1/20.  Second time I've experienced this.  Had milder reaction in 2018 but had also two flu shots in less than 6 months.  (Not sure why that occurred.  PA suggested it in July; I forgot and got one at Pharmacy.  When I had such a violent reaction, I looked through my paperwork and found the flu shot listed with other shots I had at the same time.  Assumed the violent reaction to the December, 2018, flu shot was because I had a previous one less than 6 mos. earlier.  This year the reaction was similar but more intense.)
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Pyrexia
Clinical narrative: Symptoms occurred almost immediately- aching joints, fever, chills, soreness at injection site - last for 3 days
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Hypertension, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Extreme pain, muscle weakness in right arm so severe that I could not move my arm, extreme vertigo, tremors throughout body and in hands, fingertip numbness both hands, fever, chills, fatigue, high blood pressure. The walk in clinic doctor thought I was having a stroke (I wasn't).
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Pain in extremity, Pyrexia, Tremor, Vertigo
Clinical narrative: Extreme pain, muscle weakness in right arm so severe that I could not move my arm, extreme vertigo, tremors throughout body and in hands, fingertip numbness both hands, fever, chills, fatigue, high blood pressure. The walk in clinic doctor thought I was having a stroke (I wasn't).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: SORENESS IN THE AREA.  ITCHING AND RASH
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm,  fever 101 , chills, and aching muscles, flu like symptons
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea, Palpitations
Clinical narrative: Patient presented to Clinic today 1/1/2020. She reports she received the 2nd dose of her Shingrix vaccine yesterday 12/31/2019 at 12:30 noon at another location. She reports starting yesterday at about 5:30 pm she experienced chills, nausea (no vomiting), intermittent dizziness and racing heart rate when lying down. She denies rash, shortness of breath, chest pain, or trouble swallowing.  She denies a similar reaction after getting the first shingrix vaccine. She is allergic to cefzil, clavulanic acid and ofloxacin, and gets GI upset with higher doses of acetaminophen.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Expected redness/soreness roughly 24 hours after injection, not at site but medial to site. However, in early AM on January 1st, significant itching occurred along red area (medial aspect of L arm above biceps).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Bedridden, Chills, Headache
Clinical narrative: Flu-like-fever, chills aching joints, congestion, severe headaches, weakness. Bedridden for 24 hours
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia, Respiratory tract congestion
Clinical narrative: Flu-like-fever, chills aching joints, congestion, severe headaches, weakness. Bedridden for 24 hours
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyskinesia
Clinical narrative: Patient reported chills several hours after her injection. Following chills, the patient reported jerking of her jaw. The jerking continued and affected her entire right side of her body. She consulted emergency services at her senior living facility and was evaluated. She did not seek further emergent care and her symptoms resolved by the following day.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Evening of vaccination developed left deltoid and neck pain that progressed to multiple muscle, joint and skin pain.  Alternating chills/sweats and severe fatigue.  Very similar to influenza without the respiratory symptoms.  This lasted approximately 2 days, then developed nausea and diarrhea with intermittent fatigue and chills/sweats.  Day 5 I feel better, but still have sweats, diarrhea and intermittent nausea.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Neck pain, Pain of skin
Clinical narrative: Evening of vaccination developed left deltoid and neck pain that progressed to multiple muscle, joint and skin pain.  Alternating chills/sweats and severe fatigue.  Very similar to influenza without the respiratory symptoms.  This lasted approximately 2 days, then developed nausea and diarrhea with intermittent fatigue and chills/sweats.  Day 5 I feel better, but still have sweats, diarrhea and intermittent nausea.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram head normal, Computerised tomogram thorax normal, Electrocardiogram normal, Facial bones fracture
Clinical narrative: The following day, December 11, 2019.  I became very nauseous in the morning and went to the bathroom, I fainted and my husband found me lying on the floor.  He called 911, squad came and took me to Hospital
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Groin pain, Magnetic resonance imaging abnormal, Nausea, Pelvic fracture, Stress fracture
Clinical narrative: The following day, December 11, 2019.  I became very nauseous in the morning and went to the bathroom, I fainted and my husband found me lying on the floor.  He called 911, squad came and took me to Hospital
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: The following day, December 11, 2019.  I became very nauseous in the morning and went to the bathroom, I fainted and my husband found me lying on the floor.  He called 911, squad came and took me to Hospital
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain, Injection site scar, Injection site vesicles
Clinical narrative: Patient stated that 3-4 days after getting the flu shot she experiences pain at the injection site. The patient also stated that within a couple days of the pain, the site developed a small blister which then left a scar. She said she was not in pain but just experienced mild discomfort. She did not seek medical attention. She just used bacitracin and soap and water to keep clean.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Feeling cold, Pain in extremity
Clinical narrative: patient described having pain down her legs and being cold/shivering
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Extremely sick feeling, pain in entire  left arm, neck and shoulder.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dizziness, Hyperhidrosis, Hypersomnia, Pyrexia
Clinical narrative: Received vaccine at 1:30 pm on Friday. Around midnight started fever and chills. At 8:00 am Saturday morning I felt fine upon waking and went downstairs to kitchen at which point I felt myself go dizzy and faint. Profuse sweating and vomiting followed. Did not go to urgent care but slept off and on all day and night. Woke up Sunday and felt fine.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Syncope, Vomiting
Clinical narrative: Received vaccine at 1:30 pm on Friday. Around midnight started fever and chills. At 8:00 am Saturday morning I felt fine upon waking and went downstairs to kitchen at which point I felt myself go dizzy and faint. Profuse sweating and vomiting followed. Did not go to urgent care but slept off and on all day and night. Woke up Sunday and felt fine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: patient is complaint of left shoulder pain since the flu shot. The pain started since 12-1-2019 (date of flu shot). Now she can't lift her arm above her shoulder. Patient said after Pharmacy corporate contact her to arrange MD visit, she will like to go see MD and get medical evaluation
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Anxiety, Arthralgia, Blood thyroid stimulating hormone normal, Cardiac flutter, Cardiac monitoring normal
Clinical narrative: Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Chest X-ray normal, Decreased appetite, Dizziness, Dyspnoea, Electromyogram normal
Clinical narrative: Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Fatigue, Fibrin D dimer normal, Fibromyalgia, Food allergy, Full blood count normal
Clinical narrative: Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Headache, Myalgia, Nausea, Neuropathy peripheral, Postural orthostatic tachycardia syndrome
Clinical narrative: Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Age: 13.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Ultrasound scan normal, Vitamin B12 normal
Clinical narrative: Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient called pharmacy describing red arm from elbow to injection site/shoulder. Area swollen, couldn't tell if it was warm to the touch or not. No fever. Had acute diarrhea, not sure if it was related to the vaccine or not.  Arm is sore to move. Symptoms started about an hour after IMZ administered. 24 hours later, patient still symptomatic. Patient stated they had used an icy hot patch to the area after administration when symptoms began. Explained that regular ice packs should be used, patient also taking ibuprofen. Explained description of symptoms over the phone, did not see the reaction in person. Will be following up with primary care physician in the morning. MD not in the office today (it is a holiday).
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The site of injection became increasingly sore throughout the day. By evening, the entire upper arm was swollen, red, and hard. It was hot and painful to the touch and I was unable to move my arm more than a few inches. I felt feverish but did not have a thermometer to verify.  The swelling began to subside after approximately 30 hours.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: The site of injection became increasingly sore throughout the day. By evening, the entire upper arm was swollen, red, and hard. It was hot and painful to the touch and I was unable to move my arm more than a few inches. I felt feverish but did not have a thermometer to verify.  The swelling began to subside after approximately 30 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Rash
Clinical narrative: rash on right arm and nausea
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEP, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt is new pt who came to us under immunized.  We are in the process are catching up the patient.  I had written out the order for the vaccines for Pentacel, PCV 13 and Hep B.    However the staff member who pulls the vaccines pulled the Quadracel instead.  No adverse effects are expected.  The quadracel in approved 4 yrs and up.  The patient is 2 and 11 months.  We contacted agency and dose will not need to be repeated.  No problems were noted from the event.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe arm pain, hurts at site and to lift arm. Low grade temp. feeling tired and weak.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe arm pain, hurts at site and to lift arm. Low grade temp. feeling tired and weak.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphthous ulcer, Discomfort, Oral pain
Clinical narrative: The next morning after receiving my flu vaccination my mouth started to feel sore.  Over the next couple of days I developed 6+ canker sores on the inside of my mouth, a couple under my tongue, a couple along the inside of my lower lip and a couple along the inner part of my upper lip.  I have never had more than 1 canker sore at once and haven't had a single canker sore in several years, I can't even remember the last time I had one.   After a few days of severe discomfort and having to adjust my diet, I finally got a mouth rinse for mouth sores and that eventually helped relieve symptoms.  The canker sores have cleared up.  Maybe it is totally unrelated, but these mouth sores seemed oddly coincidental to receiving the flu vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Lethargy, Myalgia
Clinical narrative: First day: Chills, then spiked fever to 101.3, muscle aches, painful upper left arm, some redness at injection site Second day: general lethargy, muscle aches, fever returned in evening
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First day: Chills, then spiked fever to 101.3, muscle aches, painful upper left arm, some redness at injection site Second day: general lethargy, muscle aches, fever returned in evening
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site warmth, Lymphadenopathy
Clinical narrative: Red at injection site day of vaccine followed by heat, induration. Temp 102 the following day, 100 the next day. Adenopathy in right axilla
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Paraesthesia
Clinical narrative: Right hand has pins and needles after a dose in my right arm.; This is a spontaneous report from a contactable consumer reporting for himself. This 81-year-old male received on 13Dec2019 a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in the right arm for immunization. Medical history included ongoing hearing impaired. Concomitant medications were not reported. Two weeks before pneumococcal 13-val conj vac (dipht crm197 protein) vaccination (unspecified date in 2019), the patient received an influenza shot for immunization and had no problem. On 14Dec2019, the patient reported that his right hand had pins and needles after dose in his right arm. It was not hurting but it was getting worse. He had no swelling in the right arm where he got the injection. He always sleeps on his right side and never had this happen before. He said that the pins and needles are happening more frequently. When he lifts his arms up and move around or submerges it in warm water, the pins and needles go away. Outcome was not recovered. Information on the batch number has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no symptoms; patient received unspecified dose in VAQTA series that was improperly stored; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On 01-NOV-2019, the patient received unspecified dose in hepatitis a vaccine, inactivated (VAQTA) series (lot # S009562 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported as 26-JUL-2020, but upon internal validation established as 05-MAY-2019; dose, strength and route were unknown) for prophylaxis that was improperly stored (incorrect product storage). The vaccine was exposed to temperature excursion at 48 degrees Fahrenheit for 30 minutes. There were previous temperature excursions at 50.4 degrees Fahrenheit for 30 minutes and at 47.3 degrees Fahrenheit for 30 minutes. The data logger was involved. The patient has reported no symptoms.
Age: 50.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient reported the second dose ofGARDASIL was due and she has not gotten it yet because she may have to pay out of pocket for it; Patient reported the second dose ofGARDASIL was due and she has not gotten it yet because she may have to pay out of pocket for it; Patient reported her physician recommended Gardasil 9 at the age of 50; This spontaneous report as received from a 50-year-old female pharmacist referring to herself. The patient's medical history included carcinoma in situ and papilloma viral infection. (HPV). Her concomitant medications and her drug reactions or allergies were not reported.       On 20-OCT-2019 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) (product administered to patient of inappropriate age).    In December 2019, the patient reported that she not gotten to vaccinated with second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) because she had to pay out of pocket for it (product dose omission and circumstance or information capable of leading to medication error).
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: fever; vomiting; dirreha; muscle weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 3rd November 2019, the patient received the 2nd dose of Shingles vaccine. In November 2019, less than a week after receiving Shingles vaccine, the patient experienced fever, vomiting, diarrhea and muscle weakness. On an unknown date, the outcome of the fever, vomiting, diarrhea and muscle weakness were unknown.   It was unknown if the reporter considered the fever, vomiting, diarrhea and muscle weakness to be related to Shingles vaccine.  Additional details were received as follows: The patient had the second dose of shingles vaccine and experienced fever, vomiting and diarrhea , muscle weakness. The patient asked whether the events were normal.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: shivering; soreness; feel bad; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, pain and malaise. On an unknown date, the outcome of the shivering, pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the shivering, pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient received Shingrix vaccine and felt bad, no fever but shivering and soreness. The patient asked, how long did the side effects last.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; woke up tired; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not have any reactions from the first dose).   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced headache, tiredness and shivering. On an unknown date, the outcome of the headache, tiredness and shivering were not recovered/not resolved.   It was unknown if the reporter considered the headache, tiredness and shivering to be related to Shingrix.  Additional details were provided as follows: The reporter reported that, after vaccination, the patient woke up tired with a headache and shivering. The patient asked, how long the side effects would last. The patient stated that, did not have adverse reaction after 1st dose of Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The day bofore reporting, the patient received dose of Shingrix and now had lots of muscle pain. The patienty stated that, had no side effects from 1st dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Pain
Clinical narrative: body aches; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and upset stomach. On an unknown date, the outcome of the general body pain and upset stomach were unknown.   It was unknown if the reporter considered the general body pain and upset stomach to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had general body pain and upset stomach. The reporter asked how long might the side effects last.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had side effects. The patient gave blood every 2 months and just gave blood day before reporting.  The patient had one month before the 6 month period was up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of Shingles 24 hours post vaccination; This case was reported by a physician via sales rep and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had outbreak of shingles. the reporter asked Outbreak of Shingles 24 hours post vaccination was related. The reporter did not know the date exactly of occurrence.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Nausea
Clinical narrative: Shingle blisters on Right foot (toes); Nausea; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles and nausea. On an unknown date, the outcome of the shingles and nausea were unknown.   It was unknown if the reporter considered the shingles and nausea to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and 2 weeks post injection developed Shingle blisters on my Right foot toes. The reporter not sure whether to have the 2nd dose and asked was this a common side effect. This was not listed on side effects of the shot.  The patient also had nausea the night of shot.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swellling; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site swelling and redness after 1st dose of Shingrix. For the tolerence of 2nd dose refer case US2019234359, reported by same reporter for same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Felt like I had a 36 hour flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received shingles vaccine for a couple days and felt like had a 36 hour flu, at least was forewarned about it. Better than shingles itself.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received Shingrix on 8/1/19 and 11/29/19 then was subsequently diagnosed with Shingles; This case was reported by a other health professional via out of hour services and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 19th December 2019, 20 days after receiving Shingrix and 140 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Drug hypersensitivity, Rash morbilliform, Rash pruritic, Rash vesicular
Clinical narrative: itchy spots on skin / chest, breast, back, arms, back and front / what looked like measles or chicken pox on various parts of her body; sensitive to one of the components in Shingrix; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult female patient who received Herpes zoster (Shingles vaccine) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Zostavax (had infection with live shingle shot(zostavax) about 5 to 7 years ago). Concomitant products included medication unknown (Other Medications).   On 30th August 2019, the patient received the 1st dose of Shingles vaccine (intramuscular). On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced itchy rash and drug hypersensitivity. On an unknown date, the outcome of the itchy rash and drug hypersensitivity were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and drug hypersensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The reporter stated that, prior to vaccination had no skin issue. After vaccination with dose of Shingles vaccine, had spot looks like measles or chicken pox on various parts of the body. The patient had scraping done by a dermatologist and stated that, was highly sensitive to one of the components in Shingrix shot. The reporter stated that, the doctor advised to not to get the second shot in the series. The reporter stated that, had spot on chest, breast, back, arms, back and front of legs and couple spots on face and currently on back. The patient reported that the spot came and went and location varies and were very itchy. The patient did not changed soap or detergent or medications. The patient stated that nothing has changed in the past 3 months and did not have this skin condition prior to vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: half of the dose leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. On 13th December 2019, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse administered Shingrix to the patient but half of the dose leaked out.  The patient only received 0.25ml of the dose which led to accidental underdose. The reporter did not had additional information at the time of reporting. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Injection site warmth
Clinical narrative: warm to touch / Injection site at Right deltoid warm to touch; expired drug given; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number M17056, expiry date 31st March 2019) for prophylaxis.   On 11th December 2019, the patient received Menveo. On 11th December 2019, less than a day after receiving Menveo, the patient experienced injection site warmth and expired vaccine used. On an unknown date, the outcome of the injection site warmth and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site warmth to be related to Menveo.  Additional case details were reported as follows: The patient received vaccine in right deltoid. On 11th December 2019, the patient inadvertently administered an expired dose of Menveo. The injection site at right arm was warm to the touch. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Inappropriate schedule of product administration, Influenza, Pain, Product administered at inappropriate site
Clinical narrative: body ache; mimicked the flu; other symptoms but didn't elaborate on what those; Inappropriate schedule of vaccine; inappropriate site of vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1.5 - 2 years ago) and Flu vaccine with an associated reaction of influenza (received on an unknown date, refer link case for same). Concurrent medical conditions included epilepsy and aneurysm cerebral.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced general body pain, flu symptoms, adverse event, drug dose administration interval too long and vaccine administered at inappropriate site. On an unknown date, the outcome of the general body pain, flu symptoms, adverse event, drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the general body pain, flu symptoms and adverse event to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in his left shoulder, which led to inappropriate site of vaccine administration. Following day he immediately experienced complete body aches which mimicked the flu. After days, other symptoms started but he did not elaborate on what those symptoms. Two weeks prior to getting the second dose of the Shingrix, he had the flu shot. He claims that he was feeling worse by the day and he believes that the Shingrix vaccine is going to kill him. The reporter did not consent to follow up. The patient threatened legal action but refused to provide any additional details.