chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient stated arm is extremely sore and it has been over 1 week now. Her neck on that side is also very stiff. Her symptoms are slightly improving but she stated still more sore than usual.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Infection, Peripheral swelling, Skin warm
Clinical narrative: Left arm began to swell and feel warm beginning on 9/30/18 at 9:00pm.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Chills, Lethargy, Night sweats, Oropharyngeal pain
Clinical narrative: Reaction started 2-3 hours post vaccination. Patient developed a severe sore throat with tightening, stomach cramps after eating at8 pm, and later that evening had chills and body aches and could barely move. She was able to sleep but developed severe sweating for part of the night. Patient said she had to have someone carry her to bed. She has a lingering but improving sore roof of her mouth and lethargy.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Stomatitis, Throat tightness
Clinical narrative: Reaction started 2-3 hours post vaccination. Patient developed a severe sore throat with tightening, stomach cramps after eating at8 pm, and later that evening had chills and body aches and could barely move. She was able to sleep but developed severe sweating for part of the night. Patient said she had to have someone carry her to bed. She has a lingering but improving sore roof of her mouth and lethargy.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Bed rest, Chills, Dry mouth, Hypokinesia
Clinical narrative: Reaction started 2-3 hours post vaccination. Patient developed a severe sore throat with tightening, stomach cramps after eating at8 pm, and later that evening had chills and body aches and could barely move. She was able to sleep but developed severe sweating for part of the night. Patient said she had to have someone carry her to bed. She has a lingering but improving sore roof of her mouth and lethargy.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Night sweats, Oropharyngeal pain, Pain, Throat tightness
Clinical narrative: Reaction started 2-3 hours post vaccination. Patient developed a severe sore throat with tightening, stomach cramps after eating at8 pm, and later that evening had chills and body aches and could barely move. She was able to sleep but developed severe sweating for part of the night. Patient said she had to have someone carry her to bed. She has a lingering but improving sore roof of her mouth and lethargy.
Age: 82.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Injection site induration, Injection site reaction, Muscle tightness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt's son called complaining that his moms neck is hurting (stiff neck), and the site of the shot is very hard (muscle is very tight). Pt was told that it is normal to get reaction to shingrix and it may last 7-10 days. She was told she can take a pain killer appropriate to her medication list. She was told we would follow up with her the next day.
Age: 82.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Tooth loss
Clinical narrative: Pt's son called complaining that his moms neck is hurting (stiff neck), and the site of the shot is very hard (muscle is very tight). Pt was told that it is normal to get reaction to shingrix and it may last 7-10 days. She was told she can take a pain killer appropriate to her medication list. She was told we would follow up with her the next day.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chills, Dyspnoea, Groin pain, Immediate post-injection reaction
Clinical narrative: Patient said she could not breathe within seconds of receiving the pneumococcal shot. She said she had a sharp pain in her back that traveled to the groin area within five minutes. Approximately 2 hours after the pneumococcal shot she felt weakness in her legs and had chills. By the following day she felt fine.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness
Clinical narrative: Patient said she could not breathe within seconds of receiving the pneumococcal shot. She said she had a sharp pain in her back that traveled to the groin area within five minutes. Approximately 2 hours after the pneumococcal shot she felt weakness in her legs and had chills. By the following day she felt fine.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain
Clinical narrative: Patient states she noticed erythema at injection site and thought she has an infection on Sunday Oct 7th. She went to the emergency room where the doctor circles area of erythema about 2.5 inches radius and prescribed her antibiotics doxycycline. At observation on Oct 9th 2018 the erythema has reduced from circled area down to size of quarter. She states that she has not picked up or taken the antibiotics and reports no fever or any other size adverse effects other than achiness. She states she has be icing the area with ice packs since Friday. We recommended her to stop the ice and use arm normally.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Pallor, Presyncope, Tonic convulsion
Clinical narrative: Patient experienced a brief (less than 15 second) tonic seizure 30-60 seconds after receiving HPV vaccine. He was seated. The seizure began immediately after receiving a second vaccine (influenza).  I was present for entire event. He responded to my questions within 30 seconds. He was conversing and describing his feelings within a minute. He then had a brief vagal reaction (while seated) with diaphoresis and pallor but that was self-limited and brief and without any tonic movements. At that point we had him lie supine for 10 -15 minutes. He was observed for 25 minutes total. He left the office ambulating and stating he felt normal.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site indentation, Pain
Clinical narrative: Patient complains of soreness and fading bruise on arm; and a red indentation on injection site.
Age: 82.0
Sex: M
Vaccine: HEPA
Symptoms: Myalgia
Clinical narrative: Soreness in the muscle in the arm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles two days after receiving second and final SHINGRIX vaccine.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Pruritus, Rhinorrhoea
Clinical narrative: Patient reports itchy eyes, runny nose and itching to upper back approx. 3 hours after receiving  influenza vaccine. There were no evidence of injection site swelling, redness, itching or pain. There were no reports or evidence of hives or respiratory distress. The patient was referred to the Hospital's Center for Employee Health and Wellness Clinic for further follow-up by a Medical Provider. The pt was prescribed a Loratadine 10 mg X1 and Medrol dose pack per NP. The pt reported taking the Medrol dose pack and itching was relieved within 2 days post vaccination.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came back to the Pharmacy after one hour of receiving the flu shot. He has a bruise (swelling) on his upper side of left hand. The inject site was normal, no swelling, no sign of any bruising. Patient was able to move his arm normally but he was feeling soreness on his left hand. Patient did not experience any anaphylactic reaction. We gave him ice to put on it. Patient went to his doctor, but they could not figure out and advised him to come back after couple days. I called the patient after few hours to follow up and he told me that its still there but better than before.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizure at 4:30am. Fever has not stopped (102.00) even on TYLENOL and ADVIL.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Woke up in the next morning at 8am feeling feverish, injection site was red and warm to touch with a fever peaking in evening to 101.3 F. Midday symptoms progressed to feeling achy (flu-like symptoms). May 24th, fever subsided, Pt had an appt with dr and md prescribed prednisone and antibiotic for symptoms of the shot. Pt did not fill bc he started feeling better as day went on. May 25th, pt felt better after much rest May 26th, felt almost asymptomatic.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation
Clinical narrative: Intense inflammation around the imz site and flowing over to inside of the arm.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Patient described feeling muscle aches approximately 6 hours after receiving the vaccination followed by extreme fatigue and headache over the next two days. She said by Sunday she was starting to feel better only to have her headache come back on Monday.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain in extremity, Swelling
Clinical narrative: Patient woke up with a very sore left arm. She called asking if it should be this sore. Explained that the PNEUMOVAX can be sore, but she continued to describe an abnormal swelling. The patient was advised to see call her md. Staff saw her today and diagnosed her with cellulitis which she says she believes was definitely caused by the PNEUMOVAX 23. She prescribed her cephalexin 500mg every 6 hours for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Local redness and swelling of right thigh. Hot to the touch. Doctor prescribed the patient CHILDREN'S BENADRYL 12.5MG/5mL. Frequency being 4 (four) times daily PRN for allergies, leg rash.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Gait disturbance, Head injury, Loss of consciousness, Malaise
Clinical narrative: Patient states she experienced nausea, malaise, dizziness, and fainting "blacking out" twice which resulted in hitting her head twice. She needed assistance walking as a result of dizziness. She took several days to recover from this.
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Nausea, Syncope
Clinical narrative: Patient states she experienced nausea, malaise, dizziness, and fainting "blacking out" twice which resulted in hitting her head twice. She needed assistance walking as a result of dizziness. She took several days to recover from this.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Continuous positive airway pressure, Intensive care, Lymphadenopathy, Neck mass, Obstructive airways disorder
Clinical narrative: I woke up the next day with a golf ball sized lump behind my knee. I went back to the doctor and they diagnosed it as a bakers cyst. They did a ultra sound on it. 2 months later, they were going to do an MRI, but the day that the MRI was scheduled, I woke up that morning and the lump was completely gone from my knee and it had moved to the right side of my neck. 2 days later, it was so big that it cut my air passage off. If I didn't have a CPAP machine to force air into my lungs, I wouldn't be writing this today. I spent 3 days in ICU at Hospital. And of course they said that I had a lymphoid gland swelled.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Synovial cyst, Ultrasound scan abnormal
Clinical narrative: I woke up the next day with a golf ball sized lump behind my knee. I went back to the doctor and they diagnosed it as a bakers cyst. They did a ultra sound on it. 2 months later, they were going to do an MRI, but the day that the MRI was scheduled, I woke up that morning and the lump was completely gone from my knee and it had moved to the right side of my neck. 2 days later, it was so big that it cut my air passage off. If I didn't have a CPAP machine to force air into my lungs, I wouldn't be writing this today. I spent 3 days in ICU at Hospital. And of course they said that I had a lymphoid gland swelled.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, redness, pain, unable to move arm. The redness/pain started by 10/7. Patient presented to the ED by 10/8. She was diagnosed with cellulitis and is being treated with antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Immediate post-injection reaction, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called pharmacy stating her arm was red, hard, swollen and painful.. She noticed it almost immediately after vaccination. She has been icing it today and some of the swelling has gone down, but the hardness remains. Pt called at about 745pm. She will continue to ice, possibly try a warm compress to increase circulation, keep moving arm and will try some ibuprofen. Pt will call pharmacy back this evening or morning if any further help is needed or will go to urgent care or ER if needed. Pt is keeping eye on arm.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Alpha 1 foetoprotein amniotic fluid, Exposure during pregnancy, Ultrasound scan
Clinical narrative: I was 13 weeks pregnant with a due date of 7/27/2018. This was an IVF pregnancy. I had already had 2 healthy normal ultrasounds for this pregnancy and embryo screening at the time of embryo transfer. My water broke 1/21/18. I went straight to the ER. I was told no hope of saving the pregnancy and lost the pregnancy later that evening. I had never had a miscarriage before and no difficulty getting pregnant in the past. This was my third pregnancy.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Inflammation, Rash, Rash pruritic
Clinical narrative: Patient reports excrutiating lower back pain that required her to sit with a heating pad pressed the area. She also has a rash that wraps around the left side of her waist band that is inflammed and itchy. Patient is using BENADRYL CREAM on the affected area. If it doesn't clear up in another day she will go to the doctor.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Mild redness, and warm to the touch.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Blood test normal, Influenza like illness, Rash pruritic, Urticaria
Clinical narrative: Flu like symptoms for 2 days, not severe. 2 weeks later itchy rash back of head moving over two weeks to top of back, chest and legs. Rash was not easy to diagnose by dermatologist (3 total visits). After 3 weeks of undetermined rash, hives (clearly a urticaria rash) developed over 60% of body. Hives lasted 6 weeks. Treated with steroids, antihistamines to no effect. After 11 weeks skin is 90% clear with residual itch. Cannot find any other cause for urticaria and was the first lifetime hives outbreak. Cannot find any evidence of similar reactions and the vaccine was the only change to food, environment, etc.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Pain, Swelling
Clinical narrative: Patient had pain/swelling 3-4 hours after immunization, then went to ED of local hospital at about 9 PM. Patient was treated for an allergic reaction and released at 12:16 AM. Patient was treated with steroid in the hospital followed by oral steroids at home. Patient symptoms have improved with treatment. Will continue to monitor patient.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient reports the next morning (7/10/18) he woke up and had fever of about 101 degrees, body aches and chills. The symptoms lasted for about 24 hours.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Fever of 103.0 - received shot at 2:25pm. Fever started 3-4 hours later and went up to 103.0 that evening. Fever continued into the next day and went up to 102.3. Weakness - started 2-4 hours after shot and continued into the next day. Dizziness - started 2-4 hours after the shot and continued to the next morning. Lightheaded - 2-4 hours after the shot and continued into the next morning.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: The patient stated on 10/09/2018 that her left arm has been sore to the point that she cannot lift her arm as she normally does. She stated that she feels swollen "knot" under her arm. The patient is following up with her primary physician 10/11/2018 at a scheduled appointment.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Bruising around injection site and redness, swelling, & heat below site of injection. Pain in upper left arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Injection site pain, Nausea
Clinical narrative: 2 hours after shot became dizzy when moving and standing. At worst point also became nauseous. These symptoms lasted about 5 hours. The injection site was also painful to touch during this time.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth and swelling, treatment antibiotics, physician possible diagnosis of abcess.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Pt received vaccination on 10/06/18 and reported low grade fever with body aches and mucus in chest. Pt called back on 10/09/18 at 5pm stating she was doing much better and no longer had a fever. Pt called 10/09/18 8:30pm stating she discovered 3 red spots one where the barrier was and 2 smaller ones below. Advised to apply cool packs to sight and to notify her doctor if they progressed.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Paraesthesia
Clinical narrative: Musculoskeletal pain, extreme fatigue, fever, chills, headache. Pt describes "pins and needles" feeling in body. Pt placed on 24 hr rest.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Musculoskeletal pain, extreme fatigue, fever, chills, headache. Pt describes "pins and needles" feeling in body. Pt placed on 24 hr rest.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Patient reported she began having achiness, headache, and nausea the evening of the administration of the vaccine. She was cold and has gluteal achiness. Around 2 am she had a fever of about 101.3 degrees. She consulted with a family member (in the medical field) and took some medications to help with her symptoms. The symptoms have slowly subsided and today she was feeling more back to herself.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient reported she began having achiness, headache, and nausea the evening of the administration of the vaccine. She was cold and has gluteal achiness. Around 2 am she had a fever of about 101.3 degrees. She consulted with a family member (in the medical field) and took some medications to help with her symptoms. The symptoms have slowly subsided and today she was feeling more back to herself.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Influenza like illness, Injection site erythema
Clinical narrative: After patient got home after the imz she felt lightheaded but attributed it to not having eaten yet.  She says the shoulder of imz got red and very hot. She went to sleep early. She woke up in the night to use restroom and experienced extreme vertigo. The next day, patient had diarrhea, fever/chills, arm pain for two days and couldn't keep anything down. She said they were flu-like symptoms. Yesterday was the first day she was symptom free.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pyrexia, Vertigo, Vomiting
Clinical narrative: After patient got home after the imz she felt lightheaded but attributed it to not having eaten yet.  She says the shoulder of imz got red and very hot. She went to sleep early. She woke up in the night to use restroom and experienced extreme vertigo. The next day, patient had diarrhea, fever/chills, arm pain for two days and couldn't keep anything down. She said they were flu-like symptoms. Yesterday was the first day she was symptom free.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site nodule, Injection site pruritus, Limb discomfort
Clinical narrative: The patient called the pharmacy saying she experienced an adverse reaction the day after she received her flu shot. She stated a hard knot formed at the injection site the day after she received her shot. Her arm felt very heavy. The area of skin near the injection was itchy.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness/swelling o n(L) thigh - 1 day after receiving Flu vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Patient said a small rash (round) started on her Right arm on Sunday 10/7/18. It became larger and itchy and started to spread down. It's itchy. So she went to see Dr. today. She was prescribed Prednisone 10mg BID x5days. Also BENADRYL cream apply on rash, Also BENADRYL 25mg twice a day for itching. She says the rash is getting better. She had been putting ice on it and will start medicine today. She says it's starting to improve now. I asked Pt to call us and the MD if it's getting worse.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Mass, Pain in extremity, Somnolence
Clinical narrative: Red lump, red streaks, excessive sleepiness sore arm. Came in for office visit 10/09/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: Fever at night. Woke up next morning complaining of pain in (R) leg - refused to walk for 2-3 hours and resolved. Completely normal exam in clinic.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Nausea, Night sweats
Clinical narrative: Complaints of swelling and pain at injection site then began having nausea from increased pain. Had night sweats. Continues to have pain - no redness.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left armpit.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Localized - 6 cm x 3 cm erythema, edema, pain, @ (L)eft deltoid injection site.
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous case, initially received on 04-Oct-2018 reported by other non-health professional and concerns a male patient of an unspecified age. On an unspecified date, the patient was administered FLUCELVAX QIV [dose, route of administration, anatomical location, batch number, expiry date: not reported]. On an unspecified date, after vaccination, the patient experienced Guillain-Barre syndrome. At the time of this report, the outcome of the event was not reported.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: Sweating, chills, joint pain in hands and knees.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain, Skin reaction, Skin warm
Clinical narrative: Patient has had flu vaccines before but this time she had more of a localized skin reaction. Day 1 was soreness. Day 2-4 involved redness, swelling, and heat. Day 5 when the patient came to us at Pharmacy she had redness and heat. She says it was getting better but was still concerned and wanted to report and make us aware.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient has had flu vaccines before but this time she had more of a localized skin reaction. Day 1 was soreness. Day 2-4 involved redness, swelling, and heat. Day 5 when the patient came to us at Pharmacy she had redness and heat. She says it was getting better but was still concerned and wanted to report and make us aware.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Generalized hives improved with Benadryl. Sent to allergist for further evaluation.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient stated her forearm was numb. Injection site was her left deltoid. Patient stated only her forearm was numb. Pt was called next day. Mom stating pt was ok, and forearm no longer numb.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Vaccination site rash
Clinical narrative: Rash at site of vaccination vesicular rash by parents description left thigh.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm the evening of the injection. The pain radiated into his left wrist and leg affecting his walking ability. Symptoms improved the next day per patient's report.
Age: 63.0
Sex: F
Vaccine: FLUR4, PPV, FLUR4, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm started swelling, was hot and sore. It kept spreading until it wrapped all the way around my upper arm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema of 17 cm with 6 cm induration extending over lt deltoid region from just below shoulder to above lt elbow at injection site in lt arm.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction to Tdap right deltoid 2 x 2.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema
Clinical narrative: Small/medium size redness present to LD. No open areas, no pain. Diphenhydramine 1% cream topical applied.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Urticaria
Clinical narrative: Received vaccine 10/04/18. Experienced flu-like symptoms starting 10/05/18. On 10/06/18 woke up in the morning covered in hives and inoculation arm/deltoid very red.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives - generalized on trunk. BENADRYL has helped the itch and rash and has lessened the next morning but not completely cleared.
Sex: U
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red injection site, warm to touch and itchy only at FLUAD injection site.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: The patient reported bruising and soreness in the upper left arm. He noted his arm was hurting. It has improved since he noticed it on 10/8/18.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain lower, Back pain, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced pain in right shoulder, lower back, arms, both leg (especially more severe pain on right leg), and lower right abdomen. Patient complained hard to get out of bed in the morning. Patient tried TYLENOL, and it helped a little bit but not much. Patient is still in pain as of 10/9/18.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #758994), received from a health care professional, concerning an 11 year old male patient. The patient pertinent medical history included asthma. His concurrent conditions and concomitant medications were not reported. On 27-JUN-2018, the patient was vaccinated with the first dose of his 11 year old vaccines which included GARDASIL 9 intramuscularly in his right arm for prophylaxis, lot #N020352 and expiration date 10-APR-2020 (strength and frequency were not reported); on the same date the patient was also vaccinated with ADACEL intramuscularly in his left arm, lot #C5228AA (strength, frequency, indication and expiration date were not reported) and with MENACTRA intramuscularly in his left arm, lot #U5948AB (strength, frequency, indication and expiration date were not reported). On the same date, after the vaccination, the patient laid back on the exam table and experienced immediate post-injection reaction and pallor. The healthcare professional got wet cool towels to put on the patient's face and back part of the neck, and removed the pillow from behind the patient's head. within seconds the patient's color started to return to normal. The healthcare professional made the patient laid with his feet elevated for approximately 10 to 15 minutes. The patient informed then to the healthcare professional that he did not eaten anything all day. At the time of reporting, the patient recovered from immediate post-injection reaction and pallor.  The causal relationship between the vaccination with GARDASIL 9, ADACEL and MENACTRA was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Body temperature, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Headache, Pyrexia, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 75-year-old female patient received PREVNAR 13 at single dose for immunization on 31Aug2018. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced shortness of breath, fever, cough, fatigue, weight loss and headache. The events were evaluated at the emergency room. The patient received as treatment albuterol nebulizer along with Iputropin nebulizer, cipro followed by Augmentin and Promethazine with codeine for cough. The outcome of the events was unknown. Information on the batch number has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hypoaesthesia, Lip swelling, Speech disorder, Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lip swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis.  On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than an hour after receiving SHINGRIX, the patient experienced lip swelling and tingling lips. On 18th July 2018, the patient experienced headache. On an unknown date, the outcome of the lip swelling, headache and tingling lips were unknown. It was unknown if the reporter considered the lip swelling, headache and tingling lips to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The physician's office received a note that, the patient experienced swollen, tingling lips within an hour after receiving SHINGRIX and on the next day of vaccination, the patient developed headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Lip swelling, Paraesthesia oral
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lip swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis.  On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than an hour after receiving SHINGRIX, the patient experienced lip swelling and tingling lips. On 18th July 2018, the patient experienced headache. On an unknown date, the outcome of the lip swelling, headache and tingling lips were unknown. It was unknown if the reporter considered the lip swelling, headache and tingling lips to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The physician's office received a note that, the patient experienced swollen, tingling lips within an hour after receiving SHINGRIX and on the next day of vaccination, the patient developed headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia oral, Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lip swelling in a 67-year-old female patient who received SHINGRIX for prophylaxis.  On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than an hour after receiving SHINGRIX, the patient experienced lip swelling and tingling lips. On 18th July 2018, the patient experienced headache. On an unknown date, the outcome of the lip swelling, headache and tingling lips were unknown. It was unknown if the reporter considered the lip swelling, headache and tingling lips to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The physician's office received a note that, the patient experienced swollen, tingling lips within an hour after receiving SHINGRIX and on the next day of vaccination, the patient developed headache.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Headache, Malaise, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 70 years old male patient who experienced congestion, malaise, throat pain, headaches, cough and nasal drip, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 23-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB via intramuscular route in the left deltoid. On 25-Sep-2018, the patient developed a non-serious congestion, malaise, throat pain, headaches and nasal drip 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for congestion, as Unknown for malaise, as Unknown for throat pain, as Unknown for headaches, as Unknown for cough and as Unknown for nasal drip.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 70 years old male patient who experienced congestion, malaise, throat pain, headaches, cough and nasal drip, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 23-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB via intramuscular route in the left deltoid. On 25-Sep-2018, the patient developed a non-serious congestion, malaise, throat pain, headaches and nasal drip 2 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for congestion, as Unknown for malaise, as Unknown for throat pain, as Unknown for headaches, as Unknown for cough and as Unknown for nasal drip.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient developed a fever of 102 and had severe local swelling at the site of injection in the right arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient came back to see us on 10/9/18. Says the rash that has appeared on patient's arm has been red and big for a week now. The rash looks like it could be more than 6 inches long in length radiating from the site of injection and going down toward the elbow. Patient was told to try putting on benadryl ointment or cortisone cream to alleviate the rash. Patient will come back in a couple of days to let us know how far it goes down.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Development of Shingles rash on 9/30/2018. Patient seen in clinic on 10/3/2018 and treated with a 7-day course of valacyclovir.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Middle insomnia, Swelling, Tenderness
Clinical narrative: Pain at site of injection so severe that it woke me up the evening after I received the injection. I had to take naproxen it was so painful. The pain has diminished but 6 days later it is still tender. In addition I had a red and swollen patch about 3 inches in diameter. That subsided  morning, six days post-dose but was still present yesterday.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hyperhidrosis, Pruritus, Swelling
Clinical narrative: Patient's right arm began itching and became red and swollen. Patient developed a hot sweat all over body. Patient did not spike a temperature and was given BENADRYL to help relieve itching. Patient symptoms resolved in 25-30 minutes.
Sex: U
Vaccine: HPV9, MNQ, TDAP
Symptoms: Altered state of consciousness, Anxiety, Dizziness, Heart rate increased
Clinical narrative: Information has been received from a physician via a company representative referring to a child patient of unknown gender and age. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP) and MENVEO. Information about pertinent medical history and lab reaction/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. It was reported that the patient after getting vaccinated while still being at the clinic "got very dizzy" and was "close to passing out" but did not completely pass out. The patient experienced "heart rate increased" and the patient had "anxiety" as well. It was unknown if the patient was receiving their first, second or third dose in the GARDASIL 9 series at that time so frequency was unspecified. The outcome of events was unknown. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. There was no intervention to prevent serious criteria. The causality was not provided.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapies included PREVNAR in "2013 and 2015". In "2005", the patient received her first dose of PNEUMOVAX 23 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. On 13-SEP-2018 the patient might have received a second dose of PNEUMOVAX 23 (intramuscular, strength, dose, frequency, batch/lot # and expiration date were not reported.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 12-year-old male patient. The patient had no medical history, concurrent conditions, concomitant therapies and drug reactions or allergies. On 08-SEP-2009, the patient was vaccinated with the first dose of VARIVAX subcutaneously (dose, lot # and expiration date not provided) reconstituted with sterile diluent (lot #, expiration date not provided). On 27-SEP-2011, the patient was vaccinated with a second dose of VARIVAX subcutaneously (dose, lot # and expiration date not provided) (lot#, expiration date not provided). On 19-SEP-2018, the patient's varicella level was invalid. The patient sought medical attention. No laboratory tests were performed. The patient did not receive treatment for the event. The patient did not recover at the time of the report. The causality assessment between the event and VARIVAX was not reported.
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a female patient, in her sixties, via company representative. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. In September 2009 (reported as "9 years ago"), the patient was vaccinated with PNEUMOVAX 23, lot # 1426Y, for prophylaxis (strength, dose, route of administration and expiration date were not reported). In September 2009, after the vaccination (reported as "almost immediately"), the patient experienced redness, swelling fever and chills, which she carried them over for the next two days, before disappearing, as she recovered from the events. The patient did not seek medical attention, and it was unknown if the patient received any treatment for the adverse events, or if laboratory diagnostic studies were performed. The causal relationship between the events and PNEUMOVAX 23 was not reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Blood test, Carpal tunnel syndrome, Orthosis user, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female consumer of currently 70 years old referring to herself. The patient had none pertinent medical history, drug reactions/allergies.  Concomitant therapies included unspecified medication for high cholesterol. On an unspecified date in October 2011, the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (route, lot number and expiration date was not reported) for prophylaxis. Two weeks after the vaccination date, in October 2011, the patient experienced swelling in the hands and as per the patient, they looked like sausages and by Christmas in 2011 t(reported as by Christmas) he patient's hands were in carpal tunnel brace. In January (unspecified year), the patient went to a walking care facility and from there was sent to a rheumatologist after that to a neurologist, she had a carpal tunnel (carpal tunnel syndrome) but they could not figure out why there was swelling and the patient was treated for rheumatoid arthritis. At the time of the report, the patient had an autoimmune disease, and she was diagnosed with scleroderma when her hands started curling, she was treated with an anti-rejection treatment (unspecified). The patient was hospitalized for scleroderma on an unspecified date in 2016 for 3 or 4 days. The patient had a blood test done (unspecified date). The outcome of scleroderma,  autoimmune disease, rheumatoid arthritis and carpal tunnel syndrome was reported as not recovered.  The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review, the events scleroderma, rheumatoid arthritis and autoimmune disease were determined to be medically significant.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Scleroderma
Clinical narrative: This spontaneous report was received from a female consumer of currently 70 years old referring to herself. The patient had none pertinent medical history, drug reactions/allergies.  Concomitant therapies included unspecified medication for high cholesterol. On an unspecified date in October 2011, the patient was vaccinated with ZOSTAVAX dose 1, 0.65 ml (route, lot number and expiration date was not reported) for prophylaxis. Two weeks after the vaccination date, in October 2011, the patient experienced swelling in the hands and as per the patient, they looked like sausages and by Christmas in 2011 t(reported as by Christmas) he patient's hands were in carpal tunnel brace. In January (unspecified year), the patient went to a walking care facility and from there was sent to a rheumatologist after that to a neurologist, she had a carpal tunnel (carpal tunnel syndrome) but they could not figure out why there was swelling and the patient was treated for rheumatoid arthritis. At the time of the report, the patient had an autoimmune disease, and she was diagnosed with scleroderma when her hands started curling, she was treated with an anti-rejection treatment (unspecified). The patient was hospitalized for scleroderma on an unspecified date in 2016 for 3 or 4 days. The patient had a blood test done (unspecified date). The outcome of scleroderma,  autoimmune disease, rheumatoid arthritis and carpal tunnel syndrome was reported as not recovered.  The causality between the events and the therapy with ZOSTAVAX was not reported. Upon internal review, the events scleroderma, rheumatoid arthritis and autoimmune disease were determined to be medically significant.