chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 28-DEC-2015, prescribed by a physician and distributed at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 16-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as a severe case of herpes zoster, also known as shingles. The patient was also treated by another physician (date unknown) for ongoing and painful symptoms associated with shingles and resulting complications (unspecified). The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient's upper arm was red and swelling to the extent her upper arm was twice the size of unaffected arm.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: 8 days of high fever.
Age: 1.17
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Got chicken pox from vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented the morning after getting vaccinated with redness and a bit of swelling at the injection site. I informed the patient that injection site reactions can occur with this vaccine. I told her if she feels bad she can either take an over the counter NSAID or APAP. Also mentioned that if the site is irritated that she can place a cool pack on the site for 15 mins. She knows to keep an eye on it and if it worsens or spreads to take some BENADRYL and go to her PCP.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Limb mass, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient has hard lump on arm. It is hot and sore. Complains of fever.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site turned red and hot to touch 31/2" x 21/2" instructed to take BENADRYL as directed and put cold compress on it.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Large raised red injection site reaction with bruising on the outer edge this is one day after injection.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Initial normal flu shot reaction. Localized pain in upper arm. No lump, not warm. Hurts more when she does any ROM or if she over uses her arm it will hurt in the resting position. Ibuprofen intermittently. Since Saturday: 800 mg Ibuprofen Q 8 hours. Forearm area. Days that she is better. Other days not. Reports tenderness to palpation in L upper forearm region, no palpable mass or lump; tender to palpation at biceps tendon, ROM intact but she reports pain with arm above head in the forearm region again, painful with infraspinatus strength testing against resistance.  Pain is still not resolved. Pt scheduled for ultrasound this week.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site hurt and swollen the size of a softball. Advised to take BENADRYL as directed and apply cold compress.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt had pain in her left shoulder after administration of the vaccine and was unable to lift her arm to be perpendicular with her body. She came in and reported the event almost 3 weeks after the vaccine was given. No swelling or redness was ever seen after the vaccine was given. However, the patient was taking the proper measure to try to help with the pain and irritation such as Aleve, ice/heat to the shoulder.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Sleep disorder, Swelling
Clinical narrative: Pain in afternoon of 11/2/17. Woke at 11:00 PM that night with pain. 11/3/17 AM woke with redness, pain, swelling the size of a silver dollar. This progressively got larger to the size of a baseball, had redness, pain, warm to touch. No fever. 11/6/17 - pain free today, swelling is very minimal. Mom feels it will be back to normal by tomorrow.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Bacterial infection, Erythema, Peripheral swelling, Swelling
Clinical narrative: Patient had swelling that spread, area was also red, it became swollen all across arm Dx w/bacterial infection.
Age: 23.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Bacterial infection, Injection site rash, Injection site swelling
Clinical narrative: Patient had swelling that spread, area was also red, it became swollen all across arm Dx w/bacterial infection.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Rash
Clinical narrative: Within 2 hours of vaccine mother reports temp 102, and a rash.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented to office with swelling, redness and warm to touch at injection site.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site plaque, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Approx. 3 x 4 area of raised erythematous plaque on left deltoid corresponding with injection site location. Low grade fever 99.5 and 1 episode of emesis. Tx: BENADRYL topical/oral, ibuprofen/TYLENOL OTC/PRN, cool compress.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Patient is complaining of weakness in legs and dizziness since receiving her flu shot on 10/8/17.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: "Progressively gotten worse over time with range of motion to extreme pain".
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to pharmacy 72 hours after administration, injection site is hot, swollen, red, and formed a knot on arm. Patient says it started about 12 hours after injection.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mobility decreased, Oedema, Pain, Peripheral swelling
Clinical narrative: After the injection Friday she immediately complained of pain which worsened as the day went on. By the evening her arm was mildly swollen, warm, and markedly tender. In the morning she was a bit worse and this worsened somewhat during the day, with erythema, warmth, tenderness, and edema. She has exhibited no systemic signs and besides not being able to move her arm has been in good spirits. The same thing happened last year, but did not extend past her elbow. It is more severe this year.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Tenderness
Clinical narrative: After the injection Friday she immediately complained of pain which worsened as the day went on. By the evening her arm was mildly swollen, warm, and markedly tender. In the morning she was a bit worse and this worsened somewhat during the day, with erythema, warmth, tenderness, and edema. She has exhibited no systemic signs and besides not being able to move her arm has been in good spirits. The same thing happened last year, but did not extend past her elbow. It is more severe this year.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Delirium, Dizziness, Eye swelling, Injection site urticaria
Clinical narrative: Patient claims 103 degrees, hives at injection site, dizziness, eyes red and swollen, delirium, muscle aches and pain. Patient claims reaction started Thursday about 5 PM and ran thru weekend. Patient did not call her doctor or visit an ER. Called this Pharmacy about 3 PM on 11/6/17 to report the above that she believes were caused by FLUZONE.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Ocular hyperaemia
Clinical narrative: Patient claims 103 degrees, hives at injection site, dizziness, eyes red and swollen, delirium, muscle aches and pain. Patient claims reaction started Thursday about 5 PM and ran thru weekend. Patient did not call her doctor or visit an ER. Called this Pharmacy about 3 PM on 11/6/17 to report the above that she believes were caused by FLUZONE.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Significant Swelling and redness on 1/2 of upper arm noticed late 11-4. Returned to pharmacy on 11-6, swelling had decreased but redness continued.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Intense chills: 10pm, 12hrs; Intense joint aches (including knees, spine, fingers): 10pm, 12hrs; Intense headache: 10pm, 16hrs; Dizziness: 10pm, 24 hrs; Nausea: 10pm, 12 hrs.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site mass, Injection site pruritus, Injection site reaction, Skin erosion
Clinical narrative: Patient reports horrible pain in shoulder joint that has not subsided for over 2 weeks. She claims she developed a huge itchy bump at the injection site that eventually burst and appeared as a nickel sized circle of raw skin. No report of fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had swelling, and warmth at injection site, and a fever for 2 days.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient began to "not feel well" starting around 10 PM the evening she was vaccinated (Friday). Saturday morning she still was not feeling well and thought she might have fever. She also had a headache. She slept "all day" and is normally very active. Her arm also hurt and the injection site of the BEXSERO was swollen, red, painful, and hard. She took her temperature Saturday afternoon and it was 100.5. She began feeling nauseated sometime on Saturday as well, and vomited around 8:00 PM. Sunday she felt about the same, still had nausea, fever, headache, and injection site pain. She vomited again around 5:30 PM. Monday she has not vomited, but still does not feel well.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Patient began to "not feel well" starting around 10 PM the evening she was vaccinated (Friday). Saturday morning she still was not feeling well and thought she might have fever. She also had a headache. She slept "all day" and is normally very active. Her arm also hurt and the injection site of the BEXSERO was swollen, red, painful, and hard. She took her temperature Saturday afternoon and it was 100.5. She began feeling nauseated sometime on Saturday as well, and vomited around 8:00 PM. Sunday she felt about the same, still had nausea, fever, headache, and injection site pain. She vomited again around 5:30 PM. Monday she has not vomited, but still does not feel well.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient's experienced swelling at injection site; redness in arm from shoulder to elbow; pain in arm.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient presented with rash from elbow to wrist and received prednisone prescription for it on 11/6/2017.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Soreness, redness, swelling and a lump to left deltoid where Injection was administered. Patient complained of fever, and soreness throughout entire body, stated he couldn't even get out of bed or move.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness, redness, swelling and a lump to left deltoid where Injection was administered. Patient complained of fever, and soreness throughout entire body, stated he couldn't even get out of bed or move.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exfoliative rash, Injection site reaction, Rash erythematous
Clinical narrative: Red, scaly rash at site of injection.
Age: 44.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Axillary mass, Erythema, Muscular weakness, Pyrexia, Swelling
Clinical narrative: Fever of 102, swelling, redness, weakness of the arm, and lumps in the arm pit (swollen lymph nodes?).  Patient went to the ER and received a steroid shot and were given prescriptions for keflex and prednisone.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Body temperature increased, Fatigue, Myalgia, Swelling
Clinical narrative: Increased fatigue, increased temperature, joint and muscle pain and swekking for 24 hours.
Age: 33.0
Sex: F
Vaccine: FLU4, HEPAB, PPV, TDAP
Symptoms: Erythema, Nausea, Nodule, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT COMPLAINED OF NAUSEA, VOMITING, FEVER. LEFT ARM WAS RED, SWOLLEN AND HAS A KNOT.
Age: 33.0
Sex: F
Vaccine: FLU4, HEPAB, PPV, TDAP
Symptoms: Vomiting
Clinical narrative: PATIENT COMPLAINED OF NAUSEA, VOMITING, FEVER. LEFT ARM WAS RED, SWOLLEN AND HAS A KNOT.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Migraine, Muscular weakness, Myalgia
Clinical narrative: Muscle ache, muscle weakness, fever, fatigue, migraine, chills, night sweats. I took ibuprofen for the fever. Symptoms lasted for 4 days.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Night sweats, Pyrexia
Clinical narrative: Muscle ache, muscle weakness, fever, fatigue, migraine, chills, night sweats. I took ibuprofen for the fever. Symptoms lasted for 4 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest discomfort, Diarrhoea, Electrocardiogram, Fatigue
Clinical narrative: Friday approx 4:30 pm received the vaccine by 6:30 pm I got extremely sick, diahrea, exhaustion, sick feeling radiating through my whole body. Felt this way throughout the night. Saturday called the doctor was instructed to take Tylenol and alternate with Advil, took 2 Tylenol tried to do some housework, got extremely exhausted, sick feeling, tightness in my chest. Called doctors 12:30 and was instructed to go to the ER. Finally by 5:00 pm I started to get something relief from the symptoms. Laid low Sunday and Monday. Went to work on Tuesday.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Friday approx 4:30 pm received the vaccine by 6:30 pm I got extremely sick, diahrea, exhaustion, sick feeling radiating through my whole body. Felt this way throughout the night. Saturday called the doctor was instructed to take Tylenol and alternate with Advil, took 2 Tylenol tried to do some housework, got extremely exhausted, sick feeling, tightness in my chest. Called doctors 12:30 and was instructed to go to the ER. Finally by 5:00 pm I started to get something relief from the symptoms. Laid low Sunday and Monday. Went to work on Tuesday.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient came back a month after receiving the vaccine stating that this vaccine has given him muscle soreness that has still not gone away. It is only around the site of the immunization.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Sleep disorder
Clinical narrative: She describes immediate burning pain throughout her left upper arm/shoulder as the vaccine was being injected. Points to fullest area of mid-deltoid as injection site. Pain has not resolved, she thinks it might actually be a little worse since she tried to do some stretches thinking it might help. Pain is worst when she reaches across her body and up to grab her seatbelt, also hurts to lift or pull, and aches when she sleeps on her left side.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dyspepsia, Malaise, Pyrexia
Clinical narrative: Patient reported feeling ill, chills, heartburn and fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: We had a lady come get her second pneum. shot the 23 on Monday morning. She called Tuesday saying her arm swelled about 4 hours later and it was red and itched. When she called the swelling had stopped --These are all listed side effects of the vaccine I told to keep any eye on it and she can contact her provider--I followed up with her the next day Wednesday-she said the swelling had gone down and she was able to sleep on that side but it was not completely gone--she did attempt to call her doctor around 4 clock and not heard anything back. Today (Thursday) she was shopping and stopped by the pharmacy--her arm was still swollen and had red patches and she stated she had again reached out to the doctor and was waiting- I told her it may be allergic to vaccine and she have the doctor advise her what do next. Friday she came in again and talk to different pharmacist and stated arm was moving normally and red patches were not at site of injection. The pharmacist advise pt to take BENADRYL.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Drug administered at inappropriate site, Joint range of motion decreased, Pain, Rotator cuff syndrome
Clinical narrative: Patient experienced severe pain and decreased range of motion starting the morning after administration. Patient has tried rest and NSAIDs with minimal relief now almost 4 weeks after administration. Patient with likely incorrect administration-into joint space-and with resultant bursitis and supraspinatus tendonitis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in underarm area, patient reports it feels like a swollen lymph node in her left armpit. No redness or pain. First time getting a flu shot. She noticed it the day after receiving vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Musculoskeletal pain, Neck pain, Skin warm
Clinical narrative: Patient reported pain in shoulder and neck area and also the occurrence of headache. She also repots that her neck is hot to the touch.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site cellulitis, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Ten hours after the vaccination was given, the customer's arm was swollen, hot, and sore at the vaccination site. She called me at pharmacy and asked what to do. I told her to put ice on it. And go see a doctor if it wasn't better the next day. On 11/3/17 patient went to an urgent care facility. The doctor there gave her a cortisone shot of some type. I called her in the evening on 11/3/17. She told me it wasn't any better, actually worse. The swelling seemed to be going down her arm. I told her to go to a doctor. On 11/4/17, patient went to her own doctor. The doctor said it was vaccine induced cellulitis. The doctor gave her a prescription for azithromycin to be taken 2 times a day. She did not fill it at this pharmacy, so I do not know the dosage or days supply. I phoned patient at 6pm on 11/4/17 and told me that her arm was very hot and swollen, with the cellulitis. The doctor told her that a very small percentage of people get a vaccine induced cellulitis from PNEUMOVAX 23. On 11/6/17 I called patient again to check on her. She said it had been improving while on the antibiotic.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Headache, Inappropriate schedule of drug administration, Nasal congestion
Clinical narrative: Given the second dose of hepatitis A vaccine 1 month after first dose. Patient is experiencing nasal congestion past two month with no relief. She also complains of headache on left side, and stomach ache frequently.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Fluid intake reduced
Clinical narrative: Varicella shot was injected in his thigh on 11/02/2017 and on 11/04/2017 he started running fevers, face swelling, dizziness, weakness, fatigue, loss of appetite, wouldn't drink fluids, red bumps appeared and started multiplying every day, itching, soreness, scabbing, throwing up, fevers every day, body covered in chicken pox.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pain, Pruritus, Pyrexia, Rash erythematous, Scab
Clinical narrative: Varicella shot was injected in his thigh on 11/02/2017 and on 11/04/2017 he started running fevers, face swelling, dizziness, weakness, fatigue, loss of appetite, wouldn't drink fluids, red bumps appeared and started multiplying every day, itching, soreness, scabbing, throwing up, fevers every day, body covered in chicken pox.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Swelling face, Varicella post vaccine, Vomiting
Clinical narrative: Varicella shot was injected in his thigh on 11/02/2017 and on 11/04/2017 he started running fevers, face swelling, dizziness, weakness, fatigue, loss of appetite, wouldn't drink fluids, red bumps appeared and started multiplying every day, itching, soreness, scabbing, throwing up, fevers every day, body covered in chicken pox.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Disorientation, Dizziness, Heart rate irregular
Clinical narrative: Around 10:45/11 am, I began to feel like my heart was sporadically beating erratically. It continued to get worse until about 1:30 with the erratic beating occurring more and more frequently. The employee health nurse was able to hear the erratic beating. This has never happened in my life. I was planning on going to ED if it was still happening at 2 pm, but between 1:30 and 2, the erratic beating started to become less frequent. By 2, it had almost diminished. It was scary, and around 1, I was starting to feel disoriented and a little faint. After 2, it was like if happened. It hasn't happened since.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Erythema, Retching, Swelling, Tenderness
Clinical narrative: Redness, swelling tenderness of his arm and his dry heaving in the morning.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient says that later in the evening of 10/20/17 he spiked a slight fever, did not give the temperature as he did have thermometer.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Activated partial thromboplastin time, Full blood count, Haematochezia, Occult blood, Prothrombin time
Clinical narrative: Blood streaked stools within 48 hours after vaccination.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. came in day after vaccine with redness, pain and warm injection site. Recommended ice, pain reliever and ZYRTEC. She is to contact primary for further instructions. Dr. was also faxed.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Drug administered to patient of inappropriate age, Product storage error
Clinical narrative: Patient outreach event. Received an adult dose of Hep A. The vaccines were stored in an electric portable cooler. The Hep A adult was stored in the wrong section and paramedic student administering the dose did not see it was a large dose.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient explained she felt nausea on Friday (11-3-17) night. She woke on 11-4-17 with a fever of 102.7 degree F. She went to an urgent care where she was diagnosed with cellulitis. Her left arm is swollen and painful. She also had body aches. She was given a prescription for cephalexin, naproxen and ZOFRAN. As of today, 11-6-17 she has taken 2 dosed of cephalexin.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient explained she felt nausea on Friday (11-3-17) night. She woke on 11-4-17 with a fever of 102.7 degree F. She went to an urgent care where she was diagnosed with cellulitis. Her left arm is swollen and painful. She also had body aches. She was given a prescription for cephalexin, naproxen and ZOFRAN. As of today, 11-6-17 she has taken 2 dosed of cephalexin.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Hypoaesthesia, Muscular weakness, Myalgia
Clinical narrative: I got my flu shot on Tue Oct 10-2017 around 4:30 pm. About 30 mins later my left arm started feeling numb and weak with so pain. Wed I had muscle aches and chills but no fever. Thurs started feeling weakness a little more in left arm. Friday I started feeling more dizziness.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Palpitations, Pyrexia
Clinical narrative: At 3AM with fever (101 degrees) and chills. 81 mg. aspirin and used cool washcloth to bring fever down. 5AM still had fever and palpatations. Took 2 more low dose aspirins. Nitro lingual spray for palp. also cool cloth. Symptoms seemed to go away. By 8:30AM normal.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Tenderness
Clinical narrative: Left arm redness tenderness 5 x 4.5 in.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Pt said the bruising around the immunizing area (of the size of a golf ball). Staff at Dr was informed.
Age: 11.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: Pt's. grand mom states pt. L-arm was red and swollen. She also states pt. C/O HA, nauseated.
Age: 1.5
Sex: F
Vaccine: FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Patient with bilateral localized redness, swelling at the site of injection on exam, left thigh measuring 1 inch diameter, area of raised ecchymosis. Right thigh measuring 3 inch x 2.5 inch area of ecchymosis, no increase warmth noted, tender to palpation.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None stated.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Pt states itching rash on chest beneath bilateral breasts, behind bilateral knees, inside wrist, but none at knees or breasts.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient received the Flu vaccination at work. In the Left deltoid and it was sore and painful but the symptoms got worse over the next 6 weeks. Her main complaint is left deltoid pain. She denies any fever or chills.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Limb injury, Muscle spasms, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Patient remembers pain during administration. Overnight, experienced muscle spasm, shakes and fever. Experienced (L) shoulder pain for one month. On 11/6/17, visited doctor and discovered possibly caused by SIRVA - shoulder injury related to vaccine administration. Left shoulder pain - MD has ordered Xray/MRI for further eval.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vaccination complication, X-ray limb
Clinical narrative: Patient remembers pain during administration. Overnight, experienced muscle spasm, shakes and fever. Experienced (L) shoulder pain for one month. On 11/6/17, visited doctor and discovered possibly caused by SIRVA - shoulder injury related to vaccine administration. Left shoulder pain - MD has ordered Xray/MRI for further eval.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site nerve damage, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: The reaction was not to the drug itself. When the injection was administered, the nerve was hit by the needle causing swelling, pain, tingling, numbness in the (R) arm/hand.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Injection site swelling, Skin irritation
Clinical narrative: Shot rec'd 10/18/17 - 10/21/17 R-arm started itching, turned red and was swollen in 6 inch circle around site. This continued for 10 days. Days 5, 6, 7, I took 2 ibuprofen and 1 ALEVE each day to reduce inflammation and irritation. I saw Dr. on Day 12 and I felt fine then.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Injection site swelling, redness, itched all over - reported by patient to us on 10/23/17.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Patient reported swelling, redness, itching around injection site. Patient stated redness and swelling spreading and area warm to touch. Patient denied fever. Stated legs felt weak day of vaccine. Antihistamine recommended and follow up with PCP.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13 Lot No: S43277 Exp Date: Sep2018, intramuscular in Left arm on 26Oct2017 in the afternoon at 0.5 ml, single for immunisation (Preventive since 73 years old).  Medical history was none. On the same date the patient received FLUZONE Lot No: UI87AA, Exp Date 10May2018, intramuscular in Right arm for immunization. The patient experienced left arm swollen, red, and hot to touch on 28Oct2017 with outcome of not recovered. It was a couple days when all the events started and was reported as worsened. The patient stated that last night was miserable.  A nurse practitioner at facility felt like the patient needs to be seen soon as possible and is concerned  about cellulitis compartmentalizing, but at the time of the report the patient was not visited yet.  The reporter assessed the events as medically significant and related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of Vaccination site related events cannot be excluded, considering the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13 Lot No: S43277 Exp Date: Sep2018, intramuscular in Left arm on 26Oct2017 in the afternoon at 0.5 ml, single for immunisation (Preventive since 73 years old).  Medical history was none. On the same date the patient received FLUZONE Lot No: UI87AA, Exp Date 10May2018, intramuscular in Right arm for immunization. The patient experienced left arm swollen, red, and hot to touch on 28Oct2017 with outcome of not recovered. It was a couple days when all the events started and was reported as worsened. The patient stated that last night was miserable.  A nurse practitioner at facility felt like the patient needs to be seen soon as possible and is concerned  about cellulitis compartmentalizing, but at the time of the report the patient was not visited yet.  The reporter assessed the events as medically significant and related to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of Vaccination site related events cannot be excluded, considering the temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt initially had soreness. Soreness went away. Then pt developed redness to upper arm approximately 5 inches in length on 11/4-11/6. 11/5-11/6 now warm to touch. Pt will be seeing MD on 11/07/17.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Cellulitis, Injection site erythema, Injection site haemorrhage, Pyrexia
Clinical narrative: Pt presented to the ER with c/o of fever and worsening 12 x 5 cm area of faint erythema over the right deltoid x 2 days, just inferior to a small echymosis from  vaccine site. The vaccine site and the anterior half of the red patch is markedly tender, but there no induration or fluctuance. No extremity edema noted. Pt diagnosed with cellulitis and admitted to hospital for IV vancomycin and IV UNASYN. Cellulitis improved over the course of the 6 day hospitalization, without developing an abscess. Anticipated DC to home on 11.07.17.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination site pain
Clinical narrative: Pt presented to the ER with c/o of fever and worsening 12 x 5 cm area of faint erythema over the right deltoid x 2 days, just inferior to a small echymosis from  vaccine site. The vaccine site and the anterior half of the red patch is markedly tender, but there no induration or fluctuance. No extremity edema noted. Pt diagnosed with cellulitis and admitted to hospital for IV vancomycin and IV UNASYN. Cellulitis improved over the course of the 6 day hospitalization, without developing an abscess. Anticipated DC to home on 11.07.17.
Age: 14.0
Sex: F
Vaccine: DTAP, MENB
Symptoms: Cold sweat, Feeling hot, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Immediately after both injections patient became hot, clammy, pale and then passed out for 30+ seconds. She was given ice packs and allowed to recover before leaving the health department.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 09-OCT-2017, the patient was inadvertently vaccinated with an expired dose of properly stored M-M-R II with lot number L039613 and expiration date on 08-OCT-2017 (dose, dose number and anatomical location were not provided), administered subcutaneously for prophylaxis. No adverse effects were reported. Follow up information was received from the vaccine provider referring to a 34 years old female patient on 31-OCT-2017. On 09-OCT-2017, the patient was vaccinated with M-M-R II single dose vial on the left arm. The primary care physician followed up and spoke with the patient. The patient responded no adverse reactions. No prescription drug treatment for the experience was required. The patient would be following up in clinic on 13-NOV-2017.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, regarding an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-OCT-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB PED 10x3 DS (lot #, dose, frequency were not reported)  for prophylaxis. However no adverse event were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blindness, Cognitive disorder, Emotional distress, Eyelid ptosis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Impaired driving ability, Impaired work ability, Injury
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Lip pain, Memory impairment, Migraine, Neurosurgery, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Physical disability, Quality of life decreased, Rash, Trigeminal neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-NOV-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) for the prevention of shingles. Within the week, the patent began to exhibit symptoms of shingles, including pain and rash on the right side of her body within three days of the vaccination. The painful rash continued to spread until the patient visited her physician, and was diagnosed with shingles on 21-JAN-2013. The pain and symptoms spread to the patient's head, including decreased eyesight in her right eye, pain in her jaw and lip, and headaches. The patient was subsequently diagnosed with trigeminal neuralgia, which required neurosurgery. The patient's injuries continue to this day. As a direct and proximate result defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using this product, including cognitive issues, poor memory, drooping eye and vision loss, inability to drive, physical pain, inability to work on a routine basis, and migraines. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX.  The events of herpes zoster, trigeminal neuralgia, cognitive issues, poor memory, drooping eye, vision loss, inability to drive, physical pain, inability to work on a routine basis, migraines and mental and emotional distress were considered disabling.   Upon internal reviewtrigeminal neuralgia, which required neurosurgery and vision loss were considered medically significant events.  Additional information has been requested.