chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Redness, bumps and bruise at/around injection site. Headache, fatigue, nausea, cough, stiffness.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Musculoskeletal stiffness, Nausea
Clinical narrative: Redness, bumps and bruise at/around injection site. Headache, fatigue, nausea, cough, stiffness.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia, Swelling
Clinical narrative: Patient described symptoms of Bell's Palsy, confirmed by doctor and suggested that it may be from the flu shot as they did not find anything from other tests. Signs of numbness in face occurred approximately 13 days later. Patient was given medication from hospital to help with the swelling and an antiviral.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient presented to pharmacy with sore arm. It had been sore for 2 weeks. Seems to be getting worse. Patient will be visiting PCP on Friday. May have been injected too high.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness
Clinical narrative: This is just for doucmentation reasons, this reaction has happened in the past to patient when giving blood or getting vaccines, patient has fainted. We were well aware of this, unfortunately, patient's doctor's office does not do in office. Patient got both vaccines and was about to faint, head went back, and asked for ammonia inhalant. Once inhalant under nose, patient startled and was fine. Got her to breathe and talk to me. We sat for 20 minutes and patient was fine and walked out of pharmacy. I do believe this was not a vaccine related reaction, but patient being extremely nervous and anxious.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Contusion, Dyspnoea, Injection site erythema, Injection site induration
Clinical narrative: 11/2: No pain from shot until about 2 hours later, then swelling, redness in 4" circle on upper right arm, muscle contraction and minor pain (level 2-3) in upper right arm. No pain or swelling in left arm. 11/3: Increased swelling, larger area of redness encircling upper right arm (6-8"), prolonged extreme muscle contraction and pain (level 5-6) in right upper arm, minor itching at edges of redness, overall body aching and joint pain (level 4-5); general feeling of illness, minor difficulty breathing. Extreme muscle contraction described: my upper arm looked like a Popeye cartoon character's arm, a large 6" area of rock hard muscles. 11/4 Continued swelling, 4" band of redness encircling upper right arm, continued muscle contraction and pain (level 5-6) in upper right arm, signs of generalized bruising (blue) in muscle contraction area, overall body aching and joint pain (level 4-5), general feeling of illness. Took antihistamine and TYLENOL to address breathing and joint pain. 11/5 Lessened swelling and muscle contraction and pain (level 3-4) in upper right arm, generalized bruising (green/yellow) in muscle area, continued with antihistamine and TYLENOL, (pain levels reduced). 11/5 Called pharmacy and reported issues.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Malaise, Muscle contracture
Clinical narrative: 11/2: No pain from shot until about 2 hours later, then swelling, redness in 4" circle on upper right arm, muscle contraction and minor pain (level 2-3) in upper right arm. No pain or swelling in left arm. 11/3: Increased swelling, larger area of redness encircling upper right arm (6-8"), prolonged extreme muscle contraction and pain (level 5-6) in right upper arm, minor itching at edges of redness, overall body aching and joint pain (level 4-5); general feeling of illness, minor difficulty breathing. Extreme muscle contraction described: my upper arm looked like a Popeye cartoon character's arm, a large 6" area of rock hard muscles. 11/4 Continued swelling, 4" band of redness encircling upper right arm, continued muscle contraction and pain (level 5-6) in upper right arm, signs of generalized bruising (blue) in muscle contraction area, overall body aching and joint pain (level 4-5), general feeling of illness. Took antihistamine and TYLENOL to address breathing and joint pain. 11/5 Lessened swelling and muscle contraction and pain (level 3-4) in upper right arm, generalized bruising (green/yellow) in muscle area, continued with antihistamine and TYLENOL, (pain levels reduced). 11/5 Called pharmacy and reported issues.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: 11/2: No pain from shot until about 2 hours later, then swelling, redness in 4" circle on upper right arm, muscle contraction and minor pain (level 2-3) in upper right arm. No pain or swelling in left arm. 11/3: Increased swelling, larger area of redness encircling upper right arm (6-8"), prolonged extreme muscle contraction and pain (level 5-6) in right upper arm, minor itching at edges of redness, overall body aching and joint pain (level 4-5); general feeling of illness, minor difficulty breathing. Extreme muscle contraction described: my upper arm looked like a Popeye cartoon character's arm, a large 6" area of rock hard muscles. 11/4 Continued swelling, 4" band of redness encircling upper right arm, continued muscle contraction and pain (level 5-6) in upper right arm, signs of generalized bruising (blue) in muscle contraction area, overall body aching and joint pain (level 4-5), general feeling of illness. Took antihistamine and TYLENOL to address breathing and joint pain. 11/5 Lessened swelling and muscle contraction and pain (level 3-4) in upper right arm, generalized bruising (green/yellow) in muscle area, continued with antihistamine and TYLENOL, (pain levels reduced). 11/5 Called pharmacy and reported issues.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Seizure, Vomiting
Clinical narrative: Within a few minutes of receiving FLUMIST in clinic, patient experienced vomiting and a provoked seizure. Patient was evaluated by a physician afterward. No other treatment of follow-up was needed.
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has significant redness, warmth and swelling at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Local redness unresolved 5 days after injection, initial swelling/warmth resolved within 3 days.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pyrexia, Tenderness
Clinical narrative: Low grade fever 12 hours after injection for about 4 hours. Sever shoulder pain with restricted movement lasted 48 hours. Shoulder still very tender to touch.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling in injection site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling in injection site.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Immediate post-injection reaction, Urticaria
Clinical narrative: Patient had an immediate raised welt and within minutes felt faint and sweaty. Did not complain of shortness of breath but did state that he felt like he was going to faint. The wife sat with him and kept checking his breathing. He did not have SOB but his pulse was racing and she asked me to call EMS due to history of high blood pressure and wanted to make sure he was not going to get worse.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Patients arms are both swollen and inflammed a day after and she called again 2 weeks later to state they still were.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: The husband came in to Rx on 10/30/18 to ask if it was normal for both of them feeling shoulder pain and could not lift up the arm after the vaccination. The husband said the Patient was sitting beside the RPh when the vaccine was administered. However, they felt pain on the arm and could not fall asleep that night. They took OTC ibuprofen and used heat pads and ice bags. It had been 5 days, but they were not getting better. So the husband came in Rx to ask. When following up with the husband on the phone later, the Pt was by the phone. She stated that she had Ibuprofen for 3 days till Sunday. The husband was observed at Rx that he could not lift up the arm to 90 degree, and no side movement of the arm. The RPh advised the husband to talk with the Pt and they needed to find a way to get their arm function back first. An incident report was filed internally on 10/31/2018.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: PATIENT EXPERIENCED A RASH.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pain, redness and warm to the touch injection site, Headache, jaw pain, generalized muscular and rib cage pain, Tired and sleepy. The day after injection per pt she took two doses of Tylenol and recuperated on the 2nd day after injection.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal chest pain, Myalgia, Pain in jaw, Somnolence
Clinical narrative: Pain, redness and warm to the touch injection site, Headache, jaw pain, generalized muscular and rib cage pain, Tired and sleepy. The day after injection per pt she took two doses of Tylenol and recuperated on the 2nd day after injection.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Blindness, Chills, Cold sweat, Dizziness
Clinical narrative: I woke up the morning after receiving the flu shot and became clammy, feverish, and severely overheated soon after, and my eyes started to black out/lose sight. I headed for my bedroom to lie down and I fainted, falling to the ground halfway there. Soon after coming to, I grew very thirsty and had a family member bring me water, but then became nauseous and threw up several times. My stomach was also upset at the time, and after the vomiting stopped, I had severe chills and continuous nausea, accompanied by a headache. Today, the nausea is still slightly present and I'm slightly dizzy, along with body pain caused by fainting and hitting the floor.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Fall, Feeling hot, Headache, Nausea, Pain
Clinical narrative: I woke up the morning after receiving the flu shot and became clammy, feverish, and severely overheated soon after, and my eyes started to black out/lose sight. I headed for my bedroom to lie down and I fainted, falling to the ground halfway there. Soon after coming to, I grew very thirsty and had a family member bring me water, but then became nauseous and threw up several times. My stomach was also upset at the time, and after the vomiting stopped, I had severe chills and continuous nausea, accompanied by a headache. Today, the nausea is still slightly present and I'm slightly dizzy, along with body pain caused by fainting and hitting the floor.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Syncope, Thirst, Visual impairment
Clinical narrative: I woke up the morning after receiving the flu shot and became clammy, feverish, and severely overheated soon after, and my eyes started to black out/lose sight. I headed for my bedroom to lie down and I fainted, falling to the ground halfway there. Soon after coming to, I grew very thirsty and had a family member bring me water, but then became nauseous and threw up several times. My stomach was also upset at the time, and after the vomiting stopped, I had severe chills and continuous nausea, accompanied by a headache. Today, the nausea is still slightly present and I'm slightly dizzy, along with body pain caused by fainting and hitting the floor.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin irritation
Clinical narrative: Patient reported multiple irritated areas about 1-2 inches away from the injection site on the right arm. She took BENADRYL and placed ice on the area. She has not reported back since our last conversation to inform me of any further problems or complications.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: The Pt came in to Rx on 10/30/18 to ask if it was normal for both of him and his wife feeling shoulder pain and could not lift up the arm after the vaccination. The Pt could not remember exactly if the RPh was standing or squade down when administering the vaccine. He did remembered that the RPh asked him if he was toughing up his muscle because she really needed to push hard to complete the injection. The Pt felt pain on the arm and could not fall asleep that night. He took OTC ibuprofen and used heat pads and ice bags. It had been 5 days, but he was not getting better. So the Pt came in Rx to ask. At Rx the Pt was observed that he could not lift up the arm to 90 degree, and no side movement of the arm. When following up with the Pt on the phone later, the Pt stated that he used Ibuprofen for 3 days till Sunday. The following-up RPh advised the Pt to talk with the wife and they needed to find a way to get their arm function back first. An incident report was filed internally on 10/31/2018.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Periorbital swelling, Swelling face, Urticaria
Clinical narrative: Symptoms began with the left side of my upper lip swelling about 2 hrs after the vaccine. The swelling spread across the full upper lip, and the inner orbit area of my left eye. The left side of my face looked as if it had swelled a bit. I had a welty rash on my thighs, stomach and inner arms. The rash went away after two 50mg doses of BENADRYL 4 hrs apart. The facial swelling took a full 24 hrs and 25 mg of BENADRYL every 3 to 5 hrs.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chills, Tremor
Clinical narrative: Shaking, chills, temp of 101, lower back pain. Treated with ibuprofen and hydration. Resolved in 1 day.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Localized redness, warmth, itchiness, with 1 inch knot at injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeling cold, Headache, Injection site pain
Clinical narrative: About 2 hrs after the shot, pain and swelling at the injection site, with pain slowly going up the arm to neck and head. By evening, whole body ached, shivering, loss of appetite. Around 4 AM on the 7th started to get a migraine, took OTC aspirin/acetaminophen combo. Felt much better through most of the 7th. Around 6 PM pain in head, neck, shoulders, legs returned. Some feeling of cold and still no appetite.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Migraine, Neck pain, Pain, Pain in extremity
Clinical narrative: About 2 hrs after the shot, pain and swelling at the injection site, with pain slowly going up the arm to neck and head. By evening, whole body ached, shivering, loss of appetite. Around 4 AM on the 7th started to get a migraine, took OTC aspirin/acetaminophen combo. Felt much better through most of the 7th. Around 6 PM pain in head, neck, shoulders, legs returned. Some feeling of cold and still no appetite.
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain around injection site within 10 hrs. Redness around injection sight (3" diameter) within 24 hrs. Headache, tired feeling within 18 hrs, Slight fever within 24 hrs. Belly pain, upset stomach within 24 hrs.
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain around injection site within 10 hrs. Redness around injection sight (3" diameter) within 24 hrs. Headache, tired feeling within 18 hrs, Slight fever within 24 hrs. Belly pain, upset stomach within 24 hrs.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported cellulitis in the left arm. Started with a fever the evening of vaccine administration then her arm started swelling. She went to see her doctor and was given cephalexin to treat cellulitis. Swelling has already improved according to patient.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received her vaccine at 5 PM and called the pharmacy around 7 PM saying her arm was red, swollen, and sore. I instructed her to use an ice pack and to take either Tylenol or Motrin. I called her at 8:40 PM and she said the ice had helped and her arm looked better.
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: PATIENT REPORTED TINNITUS AND PARTIAL HEARING LOSS OCCURRING APPROXIMATELY ONE HOUR AFTER RECEIVING VACCINES. PATIENT RECEIVED FIRST DOSE ZOSTER (SHINGRIX)  WITHOUT ANY ADVERSE EFFECTS. PATIENT REPORTED "95%" SYMPTOM IMPROVEMENT APPROXIMATELY 6 HOURS LATER.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Influenza like illness, Myalgia
Clinical narrative: Red rash, sore muscle on left arm, flu like symptoms, aches and pains for couple of days with headache and some chills at night, lack of appetite, stayed home and rested about 48 hrs and practically all symptoms gone.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Red rash, sore muscle on left arm, flu like symptoms, aches and pains for couple of days with headache and some chills at night, lack of appetite, stayed home and rested about 48 hrs and practically all symptoms gone.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Skin disorder
Clinical narrative: Swelling, redness, hot to touch in area of shot in the form of a 5" by 4" itchy oval. Applied light application of pink BENADRYL lotion occasionally to site over the one week period of the event. Area started out pink then increased to red over the course of the week until it started to subside near the end of the event. It seemed also that a skin spot that had cleared previously in my scalp reoccurred at this time (Oct 5, 2018). I do have an appt. Nov 29 to check this out.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient experienced redness above injection sites and raised area she considered like hives towards the neck and not at injection site of right arm where she got PREVNAR. Said there were red lines. Experienced within an hour of getting shot. Reported it around 4 in afternoon. Advised to contact Dr after making sure no difficulty breathing. Told her they would probably suggest BENADRYL and that is what MD told her. She took BENADRYL. Pharmacist called her at 8 PM and she was better but tired. Not itching as much.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Within one day after administration in my left arm, a large area of redness and swelling appeared and continued for about a week. At that time, my left arm began to tingle from shoulder to fingers. At first, about three or four times a day and at peak about 10 times a day, ( peak about two weeks) and gradually fewer per day over the course of more than two months.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fibula fracture, Loss of consciousness, Pyrexia, Surgery
Clinical narrative: Chills, fever, passed out and broke right leg fibula and tibia.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tibia fracture
Clinical narrative: Chills, fever, passed out and broke right leg fibula and tibia.
Age: 1.0
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Red dots on face and right arm appeared after given MMR and influenza vaccines. The following day rash gone on face but still had lingering rash on right arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Induration, Skin warm
Clinical narrative: Positive warm and indurated (R) worse than (L) no fever or pus. Not particularly painful No difficulty breathing or swallowing using arms normally.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema multiforme, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient is here for evaluation of a rash that started after she received immunizations at a well-child check yesterday. She is here with mom and day. They indicate that yesterday shortly after the visit she had "a few red spots", these progressed over the course of yesterday and were more prominent today. They stated she felt warm at home, but they did not take her temperature. They have tried a bit of topical hydrocortisone with minimal effect, they have not given her any antihistamines. Yesterday she received her first dose of FLUZONE, her first dose of HAVRIX, her first dose of PEDVAX, her fourth dose of PREVNAR, and  her firs dose of PROQUAD. Review of Systems -mom and dad report that since yesterday, she has been eating well, drinking well, no bowel or bladder concerns, she has continued to be normally playful. I discussed with mom and dad that the exam is most consistent with erythema multiforme, which is listed as a possible adverse reaction for PROQUAD, HAVRIX, or PREVNAR.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Erythema and swelling.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dysgeusia, Feeling abnormal, Flushing, Tremor
Clinical narrative: Received shot 0710A - at 845Am became flushed, dizzy, strange feeling in head, lightheaded and had metallic taste in mouth. Became shaky. Symptoms lasted 30 min - subsided slowly over next 2 hours.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Inappropriate schedule of product administration, Irritability, Pyrexia, Skin warm
Clinical narrative: She had just had her 2nd PEDIARIX one week earlier on 10/2/18 and was in for HIBERIX and PREVNAR but also incorrectly got a PEDIARIX. I told mom of error. Followed up. She had mild fever -felt warm on and off and a little cranky, on and off for a day, But then did well and fine since.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This spontaneous case, initially received from other health professional on 25-Oct-2018, concerns a 45-year-old, adult female patient. The patient underwent chemotherapy in past (reported as less than 8 weeks of completing chemotherapy). The patient did not receive any concomitant medication. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252234 and expiry date: 30-Jun-2019). On an unspecified date in Oct-2018, within 24 hours of vaccination, the patient developed pneumonia. On 20-Oct-2018, the patient was admitted to the hospital and was discharged on 23-Oct-2018. The patient was also febrile. At the time of this report, the patient had not recovered from the events (still febrile). The reporter assessed this case as serious due to hospitalization.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: Heart attack/was hospitalized.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Patient was reporting heavy rash and lots of pain, she said she had it for a few days after the vaccine. She said she never had a reaction before. She said it was a good portion of her arm. She did not say she went to the MD or not.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient was given vaccine in the muscle and patient came on 11/7 to report a rash that has developed under the injection site. Told patient to follow up with MD when possible. (Patient has not gone to see the MD yet).
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Paraesthesia, Peripheral swelling, Skin tightness
Clinical narrative: (L) arm from shoulder to elbow very swollen, tight, red, hot to the touch, painful, tingling sensation at times.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Skin warm
Clinical narrative: (L) arm from shoulder to elbow very swollen, tight, red, hot to the touch, painful, tingling sensation at times.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, MMR, VARCEL
Symptoms: Febrile convulsion, Lethargy, Malaise, Pyrexia
Clinical narrative: Within a few hours of vaccines, she was sick, lethargic, and had a high temp. 10 days later, she had a "fever seizure", according to hospital.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site warmth, Pain in extremity
Clinical narrative: Patient's arm was bruised and sore. She said it was hurting the day after and that it was not hurting today (11/7/18). Stated that it only hurt when applied pressure to arm and that fever was only around shot area.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Reaction to flu shot. Flu shot given in left arm 10-5-18 at 06:35. At 0500 on 10-6-18, reddened bump over injection site with itching and reddened rash across right upper chest, arm, abdomen, back and legs. PO BENADRYL at HS on 10-6-18. On 10-7-18, reddened itchy rash cont'd. PO BENADRYL on 10-7-18 at HS. On 10-8-18, rash less red, still itching, bump decreased.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Furuncle, Injection site infection, Injection site reaction
Clinical narrative: Patient came in pharmacy Oct 28, 2018 asking fro topical preparation for infected boil on left upper arm. Advised patient to go to urgent care. Patient prescribed cephalexin for treatment-patient states boil resulted from vaccine.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever increased fussiness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Grip strength decreased, Insomnia, Joint lock, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: 08/29/2018 Arm very sore-(R) hand stiff-joints catching and locking in (R) hand; very weak, not able to grasp items or pick up items. Very painful, trouble sleeping.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: 08/29/2018 Arm very sore-(R) hand stiff-joints catching and locking in (R) hand; very weak, not able to grasp items or pick up items. Very painful, trouble sleeping.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Injection site erythema, Injection site swelling, Injection site warmth, Throat irritation
Clinical narrative: Warm swollen area where the shot was given. Scratchy throat and some coughing. Shot was Monday, Wednesday afternoon noticed the swollen red area. Ice and medicine.
Age: 0.17
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Decreased appetite, Injection site pain, Injection site rash, Nausea
Clinical narrative: Pain - rash at sight of injection continued pain x 3 wks. Nausea, loss of appetite R arm - shingles. L arm Pneumococcal Polysaccharide 23 valent.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (L) thigh started on KEFLEX and worsened sent to ED 11/4/18 admitted for IV Abx. Clindamycin given.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab, Swelling
Clinical narrative: Localized raised area with rash/scab areas size of silver dollar. Treated by cleansing site daily and applying triple antibiotic oint.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt. complained of a rash with extreme itching on the left upper arm above the elbow which lasted for 1 day then resolved with no further treatment.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient states once shot was given, the vaccine hurt and made the patient clench his teeth. The patient stated that his arm has been sore ever since he received the vaccine. The patient states he is able to move arm up/down and around, but with pain. The patient has been taking OTC pain medications for relief.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Irritability, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Pt came into office w/ 1 day H/o fever essential w/ maculopapular rash in the torso and extremities. Tmax 100.5 degrees F (plus) fussiness - no vom/diarrhea - good appetite and urine output - No known sick contacts. Pt given TYLENOL 160 mg/5 ml (4-5 ml q 6 hrs); MOTRIN 100 mg/5 ml (5ml q 6-8 hrs prn).
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 80-year-old male patient who received SHINGRIX (batch number M77B4, expiry date August 2018) for prophylaxis. On 24th August 2018 20:00, the patient received the 1st dose of SHINGRIX(intramuscular). In August 2018, 19 hrs after receiving SHINGRIX, the patient experienced chills, tiredness, fever and pain. On an unknown date, the outcome of the chills, tiredness, fever and pain were recovered/resolved. It was unknown if the reporter considered the chills, tiredness, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. On 25th August 2018 at 15:00, the patient experienced some side effects. All events were subsided the following day at around 3 pm and they lasted about 24 hours.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 80-year-old male patient who received SHINGRIX (batch number M77B4, expiry date August 2018) for prophylaxis. On 24th August 2018 20:00, the patient received the 1st dose of SHINGRIX(intramuscular). In August 2018, 19 hrs after receiving SHINGRIX, the patient experienced chills, tiredness, fever and pain. On an unknown date, the outcome of the chills, tiredness, fever and pain were recovered/resolved. It was unknown if the reporter considered the chills, tiredness, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. On 25th August 2018 at 15:00, the patient experienced some side effects. All events were subsided the following day at around 3 pm and they lasted about 24 hours.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Balance disorder, Blood pressure decreased, Dizziness, Pallor
Clinical narrative: After receiving the routine vaccination for prevention of influenza the patient experienced dizziness. B.P. decrease and had pale skin and E.M.T. was called. The pt was sent to E.R. diagnosed vasovagal attack. After observation the pt was stable and D/C home with F/U Appt. For follow up on 10/1/18, the pt was clinically stable, with normal vital signs.
Age: 10.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood pressure decreased, Dizziness, Pallor, Presyncope
Clinical narrative: After receiving the routine vaccination for prevention of influenza the patient experienced dizziness. B.P. decrease and had pale skin and E.M.T. was called. The pt was sent to E.R. diagnosed vasovagal attack. After observation the pt was stable and D/C home with F/U Appt. For follow up on 10/1/18, the pt was clinically stable, with normal vital signs.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS, MMR, VARZOS
Symptoms: Herpes zoster disseminated, Polymerase chain reaction positive, Varicella virus test positive
Clinical narrative: Hospital MD reported to us patient had disseminated chickenpox and has recovered.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS, MMR, VARZOS
Symptoms: Disseminated varicella zoster vaccine virus infection
Clinical narrative: Hospital MD reported to us patient had disseminated chickenpox and has recovered.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (4 years before reporting date) and shingles (2 years before reporting date). Concomitant products included SHINGRIX. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 10 hrs after receiving SHINGRIX, the patient experienced shivering, injection site erythema and fever. On 19th October 2018, the patient experienced injection site pain. On 20th October 2018, the patient experienced arthralgia, activities of daily living impaired, walking difficulty, fatigue, headache and back pain. The patient was treated with ALEVE and TYLENOL. On 21st October 2018, the outcome of the injection site pain, arthralgia, activities of daily living impaired, shivering, walking difficulty, fever, headache and back pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site pain, arthralgia, activities of daily living impaired, shivering, injection site erythema, walking difficulty, fever, fatigue, headache and back pain to be related to SHINGRIX. Additional information received as follows: The 1st dose of SHINGRIX received on the left deltoid. At 6:00 pm, the patient received the 2nd dose of SHINGRIX on the left deltoid. The reporter indicated that within four hours of receiving the SHINGRIX vaccine, the patient's arm became sore at the injection site. On 19th October 2018, at 10:30 pm when the patient went to bed at the night after receiving the second SHINGRIX vaccine, she could tell that her arm felt very sore. She woke up at 4:00 am and was shivering. She knew she had a fever at that point but did not take her temperature. Also, she had an incredible headache, and had back and hip pain. On 20th October 2018, at 7:00 am she took her temperature and it was 103.5 degrees F. She felt like her head was going to explode and it was difficult to walk into the kitchen. She reported that she was having joint pain, especially in her larger joints. She took ALEVE and TYLENOL, even though it was difficult for her to open the bottles, and noted that her temperature at 10:00 am was 102 degrees F, and 101 degrees F by 1:00 pm. The soreness lasted for approximately four days. On 20th October 2018, at 4:00 pm on Saturday, she was feeling much better although she was feeling fatigued. On 21 October 2018, Sunday, all symptoms other than fatigue were resolved. She stated that it took 12 to 18 hours for the fatigue to resolve after the other symptoms resolved. Till the reporting time, she reported that her left deltoid was sore, red, and tender to the touch since receiving the second dose of the product.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Gait disturbance
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (4 years before reporting date) and shingles (2 years before reporting date). Concomitant products included SHINGRIX. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 10 hrs after receiving SHINGRIX, the patient experienced shivering, injection site erythema and fever. On 19th October 2018, the patient experienced injection site pain. On 20th October 2018, the patient experienced arthralgia, activities of daily living impaired, walking difficulty, fatigue, headache and back pain. The patient was treated with ALEVE and TYLENOL. On 21st October 2018, the outcome of the injection site pain, arthralgia, activities of daily living impaired, shivering, walking difficulty, fever, headache and back pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site pain, arthralgia, activities of daily living impaired, shivering, injection site erythema, walking difficulty, fever, fatigue, headache and back pain to be related to SHINGRIX. Additional information received as follows: The 1st dose of SHINGRIX received on the left deltoid. At 6:00 pm, the patient received the 2nd dose of SHINGRIX on the left deltoid. The reporter indicated that within four hours of receiving the SHINGRIX vaccine, the patient's arm became sore at the injection site. On 19th October 2018, at 10:30 pm when the patient went to bed at the night after receiving the second SHINGRIX vaccine, she could tell that her arm felt very sore. She woke up at 4:00 am and was shivering. She knew she had a fever at that point but did not take her temperature. Also, she had an incredible headache, and had back and hip pain. On 20th October 2018, at 7:00 am she took her temperature and it was 103.5 degrees F. She felt like her head was going to explode and it was difficult to walk into the kitchen. She reported that she was having joint pain, especially in her larger joints. She took ALEVE and TYLENOL, even though it was difficult for her to open the bottles, and noted that her temperature at 10:00 am was 102 degrees F, and 101 degrees F by 1:00 pm. The soreness lasted for approximately four days. On 20th October 2018, at 4:00 pm on Saturday, she was feeling much better although she was feeling fatigued. On 21 October 2018, Sunday, all symptoms other than fatigue were resolved. She stated that it took 12 to 18 hours for the fatigue to resolve after the other symptoms resolved. Till the reporting time, she reported that her left deltoid was sore, red, and tender to the touch since receiving the second dose of the product.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (4 years before reporting date) and shingles (2 years before reporting date). Concomitant products included SHINGRIX. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 10 hrs after receiving SHINGRIX, the patient experienced shivering, injection site erythema and fever. On 19th October 2018, the patient experienced injection site pain. On 20th October 2018, the patient experienced arthralgia, activities of daily living impaired, walking difficulty, fatigue, headache and back pain. The patient was treated with ALEVE and TYLENOL. On 21st October 2018, the outcome of the injection site pain, arthralgia, activities of daily living impaired, shivering, walking difficulty, fever, headache and back pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site pain, arthralgia, activities of daily living impaired, shivering, injection site erythema, walking difficulty, fever, fatigue, headache and back pain to be related to SHINGRIX. Additional information received as follows: The 1st dose of SHINGRIX received on the left deltoid. At 6:00 pm, the patient received the 2nd dose of SHINGRIX on the left deltoid. The reporter indicated that within four hours of receiving the SHINGRIX vaccine, the patient's arm became sore at the injection site. On 19th October 2018, at 10:30 pm when the patient went to bed at the night after receiving the second SHINGRIX vaccine, she could tell that her arm felt very sore. She woke up at 4:00 am and was shivering. She knew she had a fever at that point but did not take her temperature. Also, she had an incredible headache, and had back and hip pain. On 20th October 2018, at 7:00 am she took her temperature and it was 103.5 degrees F. She felt like her head was going to explode and it was difficult to walk into the kitchen. She reported that she was having joint pain, especially in her larger joints. She took ALEVE and TYLENOL, even though it was difficult for her to open the bottles, and noted that her temperature at 10:00 am was 102 degrees F, and 101 degrees F by 1:00 pm. The soreness lasted for approximately four days. On 20th October 2018, at 4:00 pm on Saturday, she was feeling much better although she was feeling fatigued. On 21 October 2018, Sunday, all symptoms other than fatigue were resolved. She stated that it took 12 to 18 hours for the fatigue to resolve after the other symptoms resolved. Till the reporting time, she reported that her left deltoid was sore, red, and tender to the touch since receiving the second dose of the product.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (4 years before reporting date) and shingles (2 years before reporting date). Concomitant products included SHINGRIX. On 19th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 10 hrs after receiving SHINGRIX, the patient experienced shivering, injection site erythema and fever. On 19th October 2018, the patient experienced injection site pain. On 20th October 2018, the patient experienced arthralgia, activities of daily living impaired, walking difficulty, fatigue, headache and back pain. The patient was treated with ALEVE and TYLENOL. On 21st October 2018, the outcome of the injection site pain, arthralgia, activities of daily living impaired, shivering, walking difficulty, fever, headache and back pain were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the injection site pain, arthralgia, activities of daily living impaired, shivering, injection site erythema, walking difficulty, fever, fatigue, headache and back pain to be related to SHINGRIX. Additional information received as follows: The 1st dose of SHINGRIX received on the left deltoid. At 6:00 pm, the patient received the 2nd dose of SHINGRIX on the left deltoid. The reporter indicated that within four hours of receiving the SHINGRIX vaccine, the patient's arm became sore at the injection site. On 19th October 2018, at 10:30 pm when the patient went to bed at the night after receiving the second SHINGRIX vaccine, she could tell that her arm felt very sore. She woke up at 4:00 am and was shivering. She knew she had a fever at that point but did not take her temperature. Also, she had an incredible headache, and had back and hip pain. On 20th October 2018, at 7:00 am she took her temperature and it was 103.5 degrees F. She felt like her head was going to explode and it was difficult to walk into the kitchen. She reported that she was having joint pain, especially in her larger joints. She took ALEVE and TYLENOL, even though it was difficult for her to open the bottles, and noted that her temperature at 10:00 am was 102 degrees F, and 101 degrees F by 1:00 pm. The soreness lasted for approximately four days. On 20th October 2018, at 4:00 pm on Saturday, she was feeling much better although she was feeling fatigued. On 21 October 2018, Sunday, all symptoms other than fatigue were resolved. She stated that it took 12 to 18 hours for the fatigue to resolve after the other symptoms resolved. Till the reporting time, she reported that her left deltoid was sore, red, and tender to the touch since receiving the second dose of the product.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Arthralgia, Bone pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm from shoulder to elbow starting approx. 11 hrs after vaccination.    Excruciating pain during the night for 2 weeks, severe pain during the day. Went to primary Dr. 10/30, noticed warmness on shoulder, ordered x-ray. Dr. visit 11/2 after x-ray of middle arm. Still severe pain. Went to Orthopedic Dr. 11/7, ordered x-ray of shoulder. Orthopedic Dr. prescribed prescription anti-inflammatory medication Meloxicam. Severe pain has subsided as of 11/8, but still pain and stiffness from shoulder to middle arm.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Musculoskeletal stiffness, Skin warm, X-ray limb
Clinical narrative: Severe pain in left arm from shoulder to elbow starting approx. 11 hrs after vaccination.    Excruciating pain during the night for 2 weeks, severe pain during the day. Went to primary Dr. 10/30, noticed warmness on shoulder, ordered x-ray. Dr. visit 11/2 after x-ray of middle arm. Still severe pain. Went to Orthopedic Dr. 11/7, ordered x-ray of shoulder. Orthopedic Dr. prescribed prescription anti-inflammatory medication Meloxicam. Severe pain has subsided as of 11/8, but still pain and stiffness from shoulder to middle arm.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Dyspnoea
Clinical narrative: Difficulty breathing. Felt like an severe asthma flare up probably would. Lasted all night. I was better in the morning. Unknown what type of Influenza vaccine it was.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site red, tender, and swollen. Temp was 100.4 even with over the counter medications. Provider sent in KEFLEX 500 mg BID x7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Chills, Impaired work ability, Influenza virus test negative, Injection site pain
Clinical narrative: Sore arm at injection site, chills, fever, muscle weakness; started on Tuesday night, had trouble sleeping, muscles in arms and legs hurt; by morning, I felt too ill to go to work; progressed throughout day on Wed; went to Urgent Care late Wed afternoon; had x-rays of lung, flu test.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Malaise, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Sore arm at injection site, chills, fever, muscle weakness; started on Tuesday night, had trouble sleeping, muscles in arms and legs hurt; by morning, I felt too ill to go to work; progressed throughout day on Wed; went to Urgent Care late Wed afternoon; had x-rays of lung, flu test.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Fatigue nausea head ache.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Migraine, Nausea, Oropharyngeal pain
Clinical narrative: Fatigue nausea sore throat migraine.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No ill effect, pt came back to receive the full dose on 11-7-18.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Inflammation, Pain
Clinical narrative: Pain, inflammation.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache
Clinical narrative: Violent shivering, major head ache, overall weakness.