chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Inflammation, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Severe swelling of left arm and pain from shoulder to elbow (first 48 hours), plus extending below elbow to fingers after 48 hours. Area was very swollen, hard and warm. Took Acetaminophen (1000 mg every 6 hours) for pain - offered almost no relief. After 24 hours RPh suggested BENADRYL and ice pack. Ice pack was applied and reduced inflammation slightly. There was also headache and fever for the first 24 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Severe swelling of left arm and pain from shoulder to elbow (first 48 hours), plus extending below elbow to fingers after 48 hours. Area was very swollen, hard and warm. Took Acetaminophen (1000 mg every 6 hours) for pain - offered almost no relief. After 24 hours RPh suggested BENADRYL and ice pack. Ice pack was applied and reduced inflammation slightly. There was also headache and fever for the first 24 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Contusion, Induration, Injection site nodule, Pain, Peripheral swelling
Clinical narrative: Severe swelling of left arm and pain from shoulder to elbow (first 48 hours), plus extending below elbow to fingers after 48 hours. Area was very swollen, hard and warm. Took Acetaminophen (1000 mg every 6 hours) for pain - offered almost no relief. After 24 hours RPh suggested BENADRYL and ice pack. Ice pack was applied and reduced inflammation slightly. There was also headache and fever for the first 24 hours.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Severe swelling of left arm and pain from shoulder to elbow (first 48 hours), plus extending below elbow to fingers after 48 hours. Area was very swollen, hard and warm. Took Acetaminophen (1000 mg every 6 hours) for pain - offered almost no relief. After 24 hours RPh suggested BENADRYL and ice pack. Ice pack was applied and reduced inflammation slightly. There was also headache and fever for the first 24 hours.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm, deltoid, was red, largely swollen and hot to touch. The reaction occurred 5 days after vaccine administration. Patient came to the office for an appointment on 10/24/17 and it was assessed by MD. MD prescribed patient Cephalexin to cover for cellulitis.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Broke out in hives on arms and legs 1-2 hours after injection. The next day had swelling, redness around the site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swollen size of his fist, red and hot to touch. Advised BENADRYL, HC cream, cold compress mom called and spoke with RN and she sent Dr a pic from phone.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Injection site discomfort, Paraesthesia
Clinical narrative: Day of vaccine typical site discomfort on Tuesday by Thursday had tingling in right lower thigh and knee by Sunday quarter size welt inner thigh (right) Monday -saw MD confirmed case of shingles pt believes flu shot caused shingles.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, FLU4, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: On 09/25/2017 Patient was accidently given KINRIX (dtap/Ipv) .5ml by MA the order was for PEDIARIX (dtap/Ipv/hepB).5ml.However once the Medical Assistant discovered the errors she immediately notified the provider and health Center manager we contacted GSK Manufacturer company of the vaccine. GSK informed us that the dose is still counted as valid it should not harm the patient patient just needed another Hepatitis B vaccine. Also received a fax with information about that was discussed over the phone Dr informed the parents of the error all questions where answered patient received Hep B vaccine on 10/02/2017.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness and swelling and soreness - went to ER. Prescribe CLINDAMYCIN - 450 mg TID.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Pt. developed a rash below injection site about "4x2" with fever approximate 100.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Pallor, Posture abnormal
Clinical narrative: After shot was given Mom reports she slid out of the chair and was quite pale and eyes rolled back. We laid her down and gave juice. She was awake and alert for 3 minutes. She waited 10 minutes and then went home.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: Pt. reported feeling dizzy, faint, sweating, seeing spots. Her lips turned white. She stayed this way for approx. 10 mins. Recovered and walked out on her own volition. (Mom was present).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: Patient received a flu shot, after administered, the shot/needle was removed and she bled. It was compressed and bandaged.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Myoclonus
Clinical narrative: Myoclonic jerks arms, shoulders - started 4-6 hours after receiving flu vaccine.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Pt's developed a rash under injection site after 24 hrs size 6x3 inches.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin warm
Clinical narrative: That evening when I went to bed my arm was so hot and itching was so bad. I finally fell asleep. I woke up a while later and my scalp was itching. Today is 10/20/17 and rash is finally fading, but arm still itches.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Patient said she had pain in the entire arm. She had purple patch on the arm. Patch was not at the injection site. She went to her primary care who told her the fluid may have travelled down the arm causing pain and patch. Patient said it got better with time.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Cough, Culture throat negative, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Woke up with major sore throat, cough. Fever, achiness and just a feeling of pure sickness. Total time of sickness was 14 days but still have bad cough.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Woke up with major sore throat, cough. Fever, achiness and just a feeling of pure sickness. Total time of sickness was 14 days but still have bad cough.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Several hours after the vaccine the left arm began to swell from the elbow to the shoulder. There was pain and redness in the swelling area. The swelling and redness resolved over the next few days and was completely resolved by 10/25/2017. Did not experience any nausea, vomiting, or shortness of breath.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Nurse who administered vaccine injected high in the deltoid, possibly irritating the joint. Pain in the left shoulder  x 2 weeks. Pain with ROM.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Muscular weakness, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient called to complain that she had been expressing pain in her muscle close to her left shoulder since 10/14/2017 when she received a flushot along with her husband. She reported that her husband experienced 2 days of pain that had since resolved. Patient described the pain as radiating down her arm when she moves it, and her arm feels weak with straining. Patient states that there is no discoloration in the area, but there is heat. Patient had flushots in the past with no problem. I have not been able to reach her primary care physician.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Skin warm, Tenderness, X-ray
Clinical narrative: Experienced right arm warmth, tenderness and inability and pain with raising arm above 90 degrees, started on 10/17/17.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Student passed out after receiving.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient initially called on 10/20/2017 and reported a large red swollen painful area at injection site. On 10/25/17 she reported the injection site to be itchy.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Painful red, hard swelling at site of injection on left upper arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported having swelling, pain, redness, and a red line on inside of upper arm on the left arm. She reported it to the pharmacist on 10/25/17. Said the swelling and pain had decreased since the day before.  Patient said her eye doctor doesn't want her to take antihistamines so she did not. Patient said she took some TYLENOL for the pain. I recommended monitoring and if the swelling and redness do not clear to go to the doctor and they can prescribe something for it.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site pain
Clinical narrative: Pain in left arm where vaccine was given lasting 5 weeks.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on upper torso after getting flu shot few days. Managed with OTC products.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Chest X-ray, Cough
Clinical narrative: 4 hours after receiving Flu immunization, pt kept coughing for 10 days, went to ER 10/22/17, pt received azithromycin and hydrocodone for possible sinus infection. Went back 10/23/17 for albuterol and prednisone. PERCOCET Rx for painful cough and did chest Xray.
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin disorder
Clinical narrative: This spontaneous report was received a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2017, also reported as "this past Saturday" the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in October 2017, also reported as "now" the patient experienced an streaky, painful rash about 2 inches below the injection site on an unspecified arm. The outcome of the event painful rash about 2 inches below the injection site was reported as not resolved. Additionally, the reporter did not provide causality assessment between the events and therapy with PNEUMOVAX 23.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Polymerase chain reaction positive, Rash, Scab
Clinical narrative: Information has been received from the authors of the literature article entitled as stated below, concerning to a healthy 3-year-old immunocompetent boy with a 4-day history of a progressive, mildly pruritic, painless rash on his right thigh. He was afebrile and otherwise asymptomatic. Despite the use of hydrocortisone 1% cream, the rash had spread. On an unknown date, he had received a single dose of the VARIVAX at 12 months of age. On physical examination, his rash showed clusters of clear vesicles on an erythematous base. The rash extended from the lower back, wrapped around the right lateral and anterior thigh, and ended on his lateral pubis in an L2 dermatomal distribution. The varicella zoster polymerase chain reaction (PCR) performed on specimen from his right thigh lesions was positive for vaccine-strain zoster. On the day of the visit, he started a 7-day course of acyclovir 45 mg/kg three times a day. Within 4 days the lesions were crusting over and the rash subsequently resolved without sequelae. This report is linked to MARRS 1710USA013161 from the same literature article. Sender's Comments: US-009507513-1710USA013161.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Information has been received from the authors of the literature article entitled as stated below, concerning to a healthy 3-year-old immunocompetent boy with a 4-day history of a progressive, mildly pruritic, painless rash on his right thigh. He was afebrile and otherwise asymptomatic. Despite the use of hydrocortisone 1% cream, the rash had spread. On an unknown date, he had received a single dose of the VARIVAX at 12 months of age. On physical examination, his rash showed clusters of clear vesicles on an erythematous base. The rash extended from the lower back, wrapped around the right lateral and anterior thigh, and ended on his lateral pubis in an L2 dermatomal distribution. The varicella zoster polymerase chain reaction (PCR) performed on specimen from his right thigh lesions was positive for vaccine-strain zoster. On the day of the visit, he started a 7-day course of acyclovir 45 mg/kg three times a day. Within 4 days the lesions were crusting over and the rash subsequently resolved without sequelae. This report is linked to MARRS 1710USA013161 from the same literature article. Sender's Comments: US-009507513-1710USA013161.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-OCT-2011, the patient was vaccinated with the first dose of GARDASIL, on 13-DEC-2011,  the patient was vaccinated with the second dose of GARDASIL and on 22-MAY-2012, the patient was vaccinated with the third dose of GARDASIL (doses, route of administration, lot# and expiration dates were not reported for any of vaccines administered). On 06-OCT-2017, the patient was vaccinated with the fourth dose (an extra dose) of GARDASIL 9 (dose and route of administration were not reported) lot# N004798 and expiration date: 31-OCT-2019. No adverse effects were reported. No causality assessment was provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pain, Rash vesicular
Clinical narrative: Information was received on 23-OCT-2017 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 20-DEC-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-OCT-2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of his persistent and painful symptoms. The patient experiences chronic neuralgia and permanent nerve pain secondary to his shingles infections. 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 and pain and suffering and other damages. Chronic neuralgia and permanent nerve pain was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-MAY-2011 the patient was vaccinated with ZOSTAVAX, (lot#, expiration date and route not specified), as recommended for routine adult health maintenance and for the prevent ion of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-NOV-2015 the patient was treated by a healthcare provider for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster and post-herpetic neuralgia, a chronic condition of nerve pain and permanent damage secondary to shingles. The patient has been prescribed acetaminophen and hydrocodone (NORCO), lidocaine, valacyclovir (VALTREX), gabapentin, acetaminophen and oxycodone (PERCOCET) for the management of his painful condition.  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, and pain and suffering and other damages. Post-herpetic neuralgia was considered to be disabling. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash, Rash papular, Rash pruritic, Varicella virus test positive
Clinical narrative: Information has been received from the authors of the literature article, concerning to a 2-year-old healthy immunocompetent girl with a 4-day history of a moderately painful, pruritic rash on the left leg, accompanied by intermittent fevers 4 days before presentation. She attended daycare but had no history of contact exposure. Past history was notable for eczema and cradle cap after birth. She had received a single dose of VARIVAX at 12 months of age. Physical examination revealed coalescing papulovesicles along the left lower leg, most prominent along the left shin and calf in an L4 dermatomal distribution, with occasional lesions on the left posterior thigh and one on the left buttock. Varicella zoster PCR was positive for vaccine-strain varicella zoster virus (VZV). The child was started on a 7-day course of acyclovir 30 mg/kg three times a day, with complete resolution of the rash 10 days after the office visit. This report is linked to MARRS 1710USA005866, from the same literature article. Sender's Comments: US-009507513-1710USA005866.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site pain
Clinical narrative: Pain at site of vaccination. Red itchy, swollen entire arm till elbow for 2 days. Then go away in 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Skin exfoliation, Urticaria
Clinical narrative: Mom states that she noticed the day after his immunizations were given that he developed wheals and hives that affected his hands. Mom was advised by Pharmacist to give BENADRYL. Mom denies breathing problems. Patients skin on fingers and hands are peeling off.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Approximately 6 hrs after influenza vaccine began experiencing tingling/swelling to upper lip that progressed to the lower lip by the am.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: (R) arm swollen red warm to touch seen 10/25/17 dx cellulitis.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Major swelling of  (right) arm, hot to touch, painful to touch, itching. Visited primary care MD. Took prednisone x 5 days, and CLINDAMYCIN 300 mg BID. Cleared up after. Same arm as PNEUMOVAX shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Hypersensitivity
Clinical narrative: Two days ago got 4 yr immunes. Woke up the next day covered in hives. Treated with BENADRYL. No oropharynx symptoms. No shortness of breath or increased work of breathing. Also complains of abdominal pain. No vomiting. No new exposure to soaps, detergents, lotions, foods, clothes. No fever. No cough, runny nose, nasal congestion. No sore throat. Diagnosed - immunization reaction/primary allergic reaction. Advised - ZYRTEC Q day and BENADRYL Q 6 hrs prn. Symptoms may last for one week or longer. Call if last greater than 3 wks.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red swelling of arm (Right).
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of seizure in a 16-year-old male patient who received MENVEO. Co-suspect products included GARDASIL. On 16th September 2017, the patient received MENVEO and GARDASIL. On 16th September 2017, 10 min after receiving MENVEO, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The patient received MENVEO and the GARDASIL at the same time. The patient went to school the next day. No additional information was provided.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Metabolic function test, Urine analysis, Visual impairment
Clinical narrative: Seven hours after admin of Tdap experienced back pain, followed by headache and visual disturbance. Headache has resolved, visual disturbance persists.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient started experiencing pain, itchy at injection site (right deltoid) on 10-23-17 at 7 pm. Injection site is swollen and she experienced pain.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Major swelling of right arm, hot to touch, painful to touch. Visited primary care who gave Rx for prednisone x 5 days and clindamycin 300 mg. Cleared up in following days.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash from neck down.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Fever, chills, nausea, fainting and weakness as well as bright red swollen left arm at the injection site.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Syncope
Clinical narrative: Fever, chills, nausea, fainting and weakness as well as bright red swollen left arm at the injection site.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site paraesthesia, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: The patient reported that her right arm was swollen to the size of a silver dollar shortly after receiving the vaccination. Patient recalls the flu shot being given to her in her right arm rather than the PREVNAR, though I have recorded the vaccinations as our records reflect. Patient told us that her right arm has not only was swollen and painful, but that she has not been able to lift her arm for the past month, as it has been 23 days since receiving the shot. She told us she took BENADRYL after going to the urgent care where they told us she was having a reaction to the flu shot and sent her on her way. After 2 weeks of taking BENADRYL she stopped taking it and the swelling has went down the but her arm is still heavy and there is tingling from the injection site up to her neck.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vaccination complication
Clinical narrative: The patient reported that her right arm was swollen to the size of a silver dollar shortly after receiving the vaccination. Patient recalls the flu shot being given to her in her right arm rather than the PREVNAR, though I have recorded the vaccinations as our records reflect. Patient told us that her right arm has not only was swollen and painful, but that she has not been able to lift her arm for the past month, as it has been 23 days since receiving the shot. She told us she took BENADRYL after going to the urgent care where they told us she was having a reaction to the flu shot and sent her on her way. After 2 weeks of taking BENADRYL she stopped taking it and the swelling has went down the but her arm is still heavy and there is tingling from the injection site up to her neck.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Urticaria
Clinical narrative: Patient presented to pharmacy today with rash in 2 spots, looking like welt, little raised, no itching. Patient stated she feels ok in good health today. I suggested BENADRYL topical.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration
Clinical narrative: Local induration and erythema.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Patient felt like she was going to faint. She got very pale and dizzy.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine
Clinical narrative: Within 1 minute post administration of vaccine patient had an onset of ocular migraine which she has a history of.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Within 36 hours of injection patient experienced tenderness, edema, and erythema encompassing left deltoid.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash around the entire arm vaccine was injected in.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Symptoms reported were itchiness on 10/19/17 by patient's Mom, then 10/20/17 patient had red upper left arm, came in to office to see Dr. Exam left upper arm had erythema extending over deltoid, some warmth, no drainage, Left shoulder full range of motion, no pain with movement. Treatment. Injection site reaction: warm compresses. Outcome: Follow up call to Mom, fully resolved by Sunday 10/22/17, no redness, no swelling, no symptoms.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, HEPA, RV5
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Nurse giving vaccination injected high in the deltoid causing pain  in arm and  shoulder. Pain with use of arm.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: Nurse giving vaccination injected high in the deltoid causing pain  in arm and  shoulder. Pain with use of arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Patient is complaining of neuralgia.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: ARM SITE PAIN AFTER INJECTION -- PERSISTENT THROUGH PRESENT.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Impaired work ability, Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: ARM SITE PAIN AFTER INJECTION -- PERSISTENT THROUGH PRESENT.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Sleep disorder, X-ray limb
Clinical narrative: ARM SITE PAIN AFTER INJECTION -- PERSISTENT THROUGH PRESENT.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis allergic
Clinical narrative: Generalized allergic dermatitis (rash) noted on patient's trunk. Treated with a 3 day course of prednisone 20mg PO daily, cetirizine 10mg PO daily for 7 days, and ranitidine 150mg PO twice daily for 7 days.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Vaccination was given high in the deltoid and resulted in pain in shoulder with use for 2 weeks.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site reaction, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Injection site reaction. Patient states arm is tender, warm, and swollen. There is no bruising and it is not red.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Vaccination was given high in the deltoid resulting in left shoulder and arm pain x 14 days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Vaccination was given high in the deltoid muscle which resulted in left arm and shoulder pain with decreased range of motion for 2 weeks.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported itching, redness, and warmth at the injection site beginning a couple of hours after vaccination.
Sex: U
Vaccine: HPV9
Symptoms: Wrong patient received medication
Clinical narrative: This spontaneous report was received from a physician, referring to an unspecified 11 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The physician reported that on an unspecified date the patient inadvertenly was vaccinated with GARDASIL 9 (strength, dose, route of administration, frequency, lot number and expiration date were not reported) for prophylaxis; and the vaccine was not intended to be administered to this patient.  The physician denied any adverse effect reported by the patient. There was no PQC involved.
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic shock, Contraindicated product administered, Food allergy
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 3 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not reported. In 2014, the patient was vaccinated with the 1st dose of M-M-R II (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. On the same date, after the patient's vaccination, he experienced a "really bad" anaphylactic shock. Due to this, the patient was hospitalized for an unspecified period of time under treatment for the reaction. Subsequently, it was found out that the patient was allergic to gelatin (contraindicated product administered). At the time of the report, the outcome of anaphylactic shock was reported as recovered on an unspecified date. Additionally, causality was not provided between the adverse event and vaccination with M-M-R II. Anaphylactic shock was considered to be life threatening and serious due to hospitalization by the reporting pharmacist and medically significant upon internal review.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 23-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 14-NOV-2007 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed prednisone (manufacturer unknown) and VALTREX, for management of his painful 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 23-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 01-JAN-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
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 or about 23-AUG-2012 the patient was vaccinated with ZOSTAVAX, (lot#, expiration date and route not specified), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-OCT-2016 the patient was treated by a health care provider for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles. The patient has been prescribed VALTREX for management of her painful 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, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 23-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-OCT-2009 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-MAY-2015, the patient was treated at a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles. On or about 04-JUN-2015, the patient sought subsequent treatment for ongoing and worsening symptoms which was then diagnosed as post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to shingles infections. The patient has been prescribed acetaminophen, VICODIN and FAMVIR for management of her persistent and painful 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 and pain and suffering, and other damages. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Pain, Rash
Clinical narrative: Pt developed symptoms 10/13/17 and came to our pharmacy at 10/18/17. Pt had rash left upper eyelid area and left forehead and head. Pt also had pain. We suggested to go to urgent care or ER. She went to a few urgent care but she wasn't treated because her insurance was not accepted. She made an appointment with her PCP at 10/24/17 instead.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Chills, Gaze palsy
Clinical narrative: Mom describes that around 7pm the day of vaccination, she began to have movement of her arms and legs that she describes as a "shivering" motion or what most people do when they have chills. She had a "blank" look in her eyes, and they were unable to get her attention or make eye contact with her. This happened intermittently for about 40-60 minutes. She later went to bed and seemed normal when she woke up the next morning.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: PATIENT DID NOT APPEAR TO BE ALLERGIC TO THE VACCINE; PATIENTS ARM APPEARED RED IN A CIRCULAR MOTION THAT MIMICKED THE SIZE OF THE INJECT SAFE BARRIER BANDAGE. WAITED WITH PATIENT FOR APPRX. 15 MINUTES. ITCHING SEEMED TO LESSEN. PATIENT DID NOT WANT OTC BENADRYL BUT USED BENADRYL CREAM. WAITED 10 MORE MINUTES - PATIENT SAID MUCH BETTER. FOLLOWED UP WITH PHONE CALL 3 HOURS LATER AND PATIENT SAID OK.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: That evening began experiencing swelling and discomfort of entire L arm. Came to the doctor's office this morning for evaluation, still with marked swelling, discomfort, minimal erythema and warmth.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Peripheral swelling, Skin discolouration, Syringe issue
Clinical narrative: Upon beginning to administer the vaccine; the plunger stopped abruptly and I was unable to complete vaccine with that dose; after the patient left, when I tried pushing the plunger again, I had to use quite a bit of force to get it to move, and then only a little vaccine squirted out the needle. I had never encountered this issue and as a result I became a little flustered. The patient immediately began to bleed, which ran down her arm prior to me swabbing it up. The patient's arm started to swell and discolor almost immediately. The second vaccine that I prepared was compromised by me as I uncapped the needle and set it exposed on counter to go get another alcohol swab; the husband of the patient noticed this and pointed it out to me. I was obtained a new vaccine and successfully administered to patient.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea
Clinical narrative: Report that client experienced difficulty breathing and sought emergency medical treatment several hours after vaccination.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Pyrexia
Clinical narrative: THE INJECTIONS WERE GIVEN ON 10/23/17 AT APPROX. 5:00PM. ON 10/25/17 AT APPROX: 10:00AM THE PT DEVELOPED A FEVER. FEVER STARTED AT 101.4 AND UP TO 103.5. PATIENT'S MOTHER WAS INSTRUCTED TO USE TYLENOL AND IBUPROFEN AND PUSH FLUIDS. MOTHER WAS TOLD TO BRING PT IN TO BE SEEN IF HAVING FURTHER/ONGOING CONCERNS.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: PT IS UNABLE TO LIFT ARM, FEELS NUMB, PAINFUL, UNABLE TO MOVE, STARTED ON 10/23/17 AND NOTIFIED US ON 10/25/17.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling hot, Throat tightness, Vision blurred
Clinical narrative: Participant received immunization at 1:00 PM, returned to the nurse at 1:50 PM stating that she had started experiencing difficulty breathing, dizziness, blurred vision. The nurse noted labored respirations, and the participant noted she was beginning to have "warm feeling all over and her throat was beginning to feel tight". Patient's BP was 132/92 at this time. Call placed to 911. At 2:04 PM, nurse administered Epinephrine 0.5cc IM injected into deltoid. 2:12 PM respirations 34-38, decreased but somewhat labored. 2:17 PM, respirations at 28 / min, pt able to speak without SOB, able to swallow with no difficulty. At 2:15 EMS arrived and took over care. Participant felt better, declined EMS taking her to ER. She notes that she took BENADRYL orally at home and had no further issues. She also was requested to contact her Primary Care physician, as of today 10/25/17, she noted it was not necessary as she felt better. Again encouraged to share the occurrence with her Primary Care so that this will be included in her records. Patient noted that she has never had a reaction previously to any other medication.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Neuralgia, Spinal pain
Clinical narrative: Patient a few minutes immediately felt uneasy after injection. States immediately felt dizzy, said pain down her spine and nerves. There was no issues of breathing, no injection site reaction.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Muscle tightness, Neck pain
Clinical narrative: Within approximately an hour of the injection a sharp shooting pain was felt at the injection site, not muscular but deeper. This continued until the 9-20-17 when the pain radiated up to the right shoulder and up the right side of the neck. Again sharp shooting pain and sometimes burning sensation at the neck. Ibuprofen/ALEVE was started at this time alternating. The pain continued and became worse with nerve pain shooting down the right arm, numbness and tingling in the right hand. Pain was a 9/10 most of the time. A neurologist was contacted and then was referred to a neurosurgeon. The nerve pain affected the right side with numbness. Muscular tension occurred down the spine bilaterally including the neck.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuralgia, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Within approximately an hour of the injection a sharp shooting pain was felt at the injection site, not muscular but deeper. This continued until the 9-20-17 when the pain radiated up to the right shoulder and up the right side of the neck. Again sharp shooting pain and sometimes burning sensation at the neck. Ibuprofen/ALEVE was started at this time alternating. The pain continued and became worse with nerve pain shooting down the right arm, numbness and tingling in the right hand. Pain was a 9/10 most of the time. A neurologist was contacted and then was referred to a neurosurgeon. The nerve pain affected the right side with numbness. Muscular tension occurred down the spine bilaterally including the neck.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Oedema, Pruritus, Rash
Clinical narrative: Rash, eczema, itching.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: HOT, RED, SWOLLEN ARM X3WKS. UNABLE TO LIFT ARM.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen red area on entire upper arm. Warm to touch. Keeps progressing further to a larger area.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal paraesthesia
Clinical narrative: Pt came back to rx reporting of tingling sensation in her throat. Pt was administered a dose of BENADRYL and then went to the clinic. Pt was administered an EPIPEN at the clinic. Pt heart rate, BP, and breathing were monitored at the clinic until the pt felt safe to leave.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site mass, Loss of consciousness, Pruritus
Clinical narrative: Patient passed out after an hour of getting the shot. Patient had a lump and redness around the injection site. She called her dr and he advised her to please heat over it. It resolved the lump, but redness and itching down the left arm continues. The arm is also warm and has a burning sensation. We advise the patient to see her Dr.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Patient passed out after an hour of getting the shot. Patient had a lump and redness around the injection site. She called her dr and he advised her to please heat over it. It resolved the lump, but redness and itching down the left arm continues. The arm is also warm and has a burning sensation. We advise the patient to see her Dr.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site vesicles, Rash
Clinical narrative: Patient had rash on the rash on the trunk and chest that appeared 2 days after the immunization.  Patient stated that the injection site blistered, but there were no signs of this at the time. The injection site looked normal at the time of arrival.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Laboratory test, Nephrolithiasis, Postural orthostatic tachycardia syndrome
Clinical narrative: POTS, Kidney Stones, Chronic fatigue; still undergoing tests to determine all causes but she hasn't "been right" since the shot.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: PT REPORTED TIGHTENING OF THROAT. NURSE PRACTITIONER AT CLINIC MADE DETERMINATION THAT EPIPEN WAS NOT NEEDED, SINCE THAT WAS THE ONLY ADR. PATIENT REQUESTED TO BE SEEN AT CLINIC. PATIENT WAS ALLERGIC TO PHENOL.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Peripheral swelling, Rash pruritic, Skin warm
Clinical narrative: Pt couldn't raise arm, was raised, hot, itchy rash about the size of a grapefruit, lasted 4 days and was painful.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure measurement, Dizziness, Eye movement disorder, Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: After giving vaccines, child felt dizzy and faint. Reclined on exam table. Mother called for help and child was observed to have seizure like activity very briefly. Noted that eyes rolled back in head and had stiffening of left arm with rolling of arm medially to body. This lasted for approximately 10 to 15 seconds. Child was then briefly drowsy but responded to questions and started vocalizing. Child recovered quickly and was able to leave the office with no complaints in about 20 minutes.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After giving vaccines, child felt dizzy and faint. Reclined on exam table. Mother called for help and child was observed to have seizure like activity very briefly. Noted that eyes rolled back in head and had stiffening of left arm with rolling of arm medially to body. This lasted for approximately 10 to 15 seconds. Child was then briefly drowsy but responded to questions and started vocalizing. Child recovered quickly and was able to leave the office with no complaints in about 20 minutes.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Rash erythematous, Skin warm, Swelling
Clinical narrative: Pt stated red rash, warm to touch, painful, hard to lift arm, no itching but swollen last 2 days.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nausea, Retching
Clinical narrative: A few minutes after receiving the vaccination, she began to feel nauseous with dry heaves. 4:13 pm BP (right arm) = 108/68. 4:25 pm BP (right arm) = 118/80. After resting for 45 minutes she felt better and went home. 10/25/17, 6:45 pm, followed up with patent and she stated she had no further reactions except for "feeling a little under the weather" for the last few days.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Patient felt faint about 25 min after vaccination. Patient continued to feel unwell for about 2 hours after vaccination. Patient left the facility with a mild headache, but had otherwise recovered.