chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypersomnia, Malaise, Nausea, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 04-Oct-2017. This case involves a 68-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date and site of administration were not reported) via intramuscular route on 19-Sep-2017. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, one day following the vaccination, the patient developed fever chills and malaise she slept about 20 hours. On 21-Sep-2017, two day following the vaccination, the patient experienced nausea and vomited. The patient's laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. (It took a full week to feel better). List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 04-Oct-2017. This case involves a 68-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number, expiry date and site of administration were not reported) via intramuscular route on 19-Sep-2017. The patient's medical history and concomitant medications were not reported. On 20-Sep-2017, one day following the vaccination, the patient developed fever chills and malaise she slept about 20 hours. On 21-Sep-2017, two day following the vaccination, the patient experienced nausea and vomited. The patient's laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. (It took a full week to feel better). List of documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Malaise, Skin discolouration, Throat tightness
Clinical narrative: Complaint of not feeling well skin greyish white, clammy with beaded sweat, vital signs P: 85, BP 110/70 alert oriented response to verbal command. No hives/edema noted c/o throat feeling tight. Epinephrine 0.25 ml given at 12:00 PM. Physical condition showed improvement. Ambulance personnel arrived at scene. Patient transported to hospital.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Somnolence
Clinical narrative: Approx 5 minutes after receiving the vaccine, the patient became pale and sleepy. she did not lose consciousness. 6:10 pm  BP 80/60, P 72. She rested with her parents and about 10 minutes later she was feeling better, more alert and less sleepy. 6:20 pm BP 80/60, P 72. No change in vitals but she felt better and her color improved. Mother stated she hadn't eaten recently and this has happened in the past when she doesn't eat. It also happens when she has blood drawn. 6:25 patient fully recovered, was fully alert and oriented and left with parents. She was advised to follow up with doctor.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Middle insomnia, Nausea, Palpitations
Clinical narrative: Approximately 9:00 PM on 10/16/17 associate began to feel nauseated, heart began racing, Chest felt heavy. Facial itching and swelling began approximately 9:15 PM. Benadryl 1 pill by mouth and one puff of albuterol Inhaler taken @ 9:30 PM. Symptoms subsided approximately 10:00 PM. During the nigh she woke up a couple of times. Facial swelling had subsided but itching continued. Chest continued to feel achy, heart racing had subsided. This morning 10/17/17 Chest slightly achy, facial itching minimal.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling face
Clinical narrative: Approximately 9:00 PM on 10/16/17 associate began to feel nauseated, heart began racing, Chest felt heavy. Facial itching and swelling began approximately 9:15 PM. Benadryl 1 pill by mouth and one puff of albuterol Inhaler taken @ 9:30 PM. Symptoms subsided approximately 10:00 PM. During the nigh she woke up a couple of times. Facial swelling had subsided but itching continued. Chest continued to feel achy, heart racing had subsided. This morning 10/17/17 Chest slightly achy, facial itching minimal.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Internal itching in neck and upper chest area, lasting for 8-9 days.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Migraine, Throat irritation
Clinical narrative: 2 day post flu shot, woke up with swollen eyes, very bad migraine, this continued. By day 4, it reached its worst, I was to only sleep. 6 days pot shot my throat started to feel itchy, I was prescribed a med that has helped a bit, still feeling a bit swollen through the eyes. Today marks a complete week from getting the flu shot.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: MA accidentally mixed vaccine with diluent meant for varicella. Patient has no adverse reactions reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: Patient became dizzy/lightheaded six minutes post injection. She was ambulating to the front desk and instead sat in a chair in the lobby. This nurse observed her to be pale and clammy, placed a chair under her feet to elevate her legs, she was coherent and continued to articulate, blood pressure was obtained in her left arm at 98/68. Within three minutes of feeling faint, the patient stated she felt well enough to leave and refused additional care.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site rash, Swelling
Clinical narrative: Rash at injection site, swelling/redness.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Sore, swollen, red puffy, 2 inch in diameter. Treating with tylenol and claritin and will ice. Outcome unknown at this point.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: States she had a rash on face, torso, and both arms shortly after receiving the shot and lasted about 30 minutes. Nothing after that and no other issues.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: When I had my annual flu vaccine, the injection was unusually painful. The soreness in my left deltoid has not gotten better over the past year. My understanding is there are others experiencing the same symptoms. I do not want to get another flu vaccine and would like to know how to decline the vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Much pain in left deltoid with a "knot" and swelling. States it was also red and warm to touch. (Had shot 10/11/17). States it was very painful and is still very sore today, 10/17/17. And is taking Tylenol .  Denies a knot still being there. No redness or warmth noted at site today. Has not missed work.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose, Dysphagia, Electrocardiogram, Palatal swelling, Pharyngeal oedema
Clinical narrative: Swollen throat, gradually spreading from throat to palate, difficult to swallow, beginning immediately after leaving pharmacy. Stopped at ambulance station. Treated with IV SOLU-MEDROL and BENADRYL. Discharged home around 4:30pm.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A 14 month old was given an adult dose of Hep A vaccine. HAVARIX Hep A. No adverse event occured.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, erythematous bump at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given PENTACEL when she should have been given KINRIX there was no adverse reaction but the wrong vaccine was administered.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Oral pruritus, Pruritus generalised, Tongue pruritus
Clinical narrative: Generalized pruritis without a rash. More predominant to perioral area, tongue, palate, and to hands.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Painful swelling which spread locally to cover most of lateral upper arm, lasting 2-3 days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain at site persisting after one month.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain from shoulder down to fingertips, numbing feeling in fingertips, swelling in fingers Prednisone 13 day.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth at site measuring 4cm.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PPV, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Echo virus infection, Fatigue, Pyrexia
Clinical narrative: I am unsure if I got the correct brand of each shot. Reactions: Friday at about 5 o'clock patient starting running a low grade fever. It never went over 100.9. Saturday the fever returned around 4 o'clock. Again low grade. Sunday the fever returned around 3. All three days he was more tired than usual and loss of appetite. Monday he woke up with small pinpoint red dots on his face, trunk, and back, legs and arms. His appetite returned. Today, Tue the 17th of October, the spots are still present. He is more tired than normal and clingy. Just as children who are sick.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PPV, VARCEL
Symptoms: Rash erythematous
Clinical narrative: I am unsure if I got the correct brand of each shot. Reactions: Friday at about 5 o'clock patient starting running a low grade fever. It never went over 100.9. Saturday the fever returned around 4 o'clock. Again low grade. Sunday the fever returned around 3. All three days he was more tired than usual and loss of appetite. Monday he woke up with small pinpoint red dots on his face, trunk, and back, legs and arms. His appetite returned. Today, Tue the 17th of October, the spots are still present. He is more tired than normal and clingy. Just as children who are sick.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and Redness.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: CSF protein increased, Facial paresis, Guillain-Barre syndrome, Muscular weakness, Neurological examination
Clinical narrative: Facial weakness, tinnitus, limb weakness extensive neuro work up, felt to have AIDP.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Facial weakness, tinnitus, limb weakness extensive neuro work up, felt to have AIDP.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Crohn's disease
Clinical narrative: This spontaneous report was received from the patient's mother, referring to her son, a 17 year old male patient with asthma. The patient had none allergy or drug reactions. Concomitant therapies included XOLAIR. On an unknown date, the patient was vaccinated with GARDASIL 9 or with GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prevention from human papillomavirus (HPV) for both. It could not be confirmed which one was administered. On an unknown date, after receiving the unspecified dose of the vaccine series, the patient developed Crohn's disease. It was reported in addition that, none laboratory diagnostics studies were performed, it was unknown whether treatment was given for the adverse event. At the reporting time, the outcome of the patient for Crohn's disease was unknown and the causality assessment between the suspect products and the event was unknown. Upon internal review the event of Crohn's disease was considered to be medically significant.
Sex: M
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 male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 06-JAN-2012, patient was vaccinated with ZOSTAVAX, 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 27-OCT-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles, which had also caused the secondary and painful diagnosis of post-herpetic polyneuropathy (a chronic condition of nerve pain and damage brought on by zoster infections). The patient has been prescribed gabapentin, duloxetine and hydrocodone-acetaminophen for management of his symptoms and pain. 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: 71.0
Sex: F
Vaccine: FLU4, PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 71-year-old female patient of an unspecified race/ethnicity received PREVNAR 13 (Lot Number S58702, Expire date Aug2019, NDC number 0005197102), intramuscular at 0.5 ml single in the left deltoid on 03Oct2017 13:17, BOOSTRIX (Lot Number 7ZZ3Z, Expire date 30Nov2019, NDC number 58160084252), intramuscular at 0.5 ml, single in the right deltoid on 03Oct2017, both for immunization. Medical history included asthma. Concomitant medication included influenza vaccine (Lot Number UI848AB, Expire date 18Apr2018) intramuscular in the right deltoid on 03Oct2017 for immunization. On 03Oct2017, the patient experienced injection site was red and painful with outcome of not recovered, pain from her neck down to the injection site with outcome of unknown. The events injection site was red and painful were assessed as serious (IME) by reporter. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of "injection site was red and painful" cannot be fully excluded considering the known adverse event profile of PREVNAR 13.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Mental status changes
Clinical narrative: This is a spontaneous report from a contactable nurse. An 89-year-old female patient received the  PREVNAR 13, intramuscularly in the right deltoid on 03Oct2017 at 0.5 ml, single for immunization. The patient medical history was not reported. There were no concomitant medications. On 11Oct2017, the patient experienced cellulitis and from the cellulitis she had altered mental status. Therapeutic measures were taken as a result of cellulitis and from the cellulitis she had altered mental status, and included treatment with ceftriaxone (ROCEPHIN) injection. The clinical outcome of the events, cellulitis and from the cellulitis she had altered mental status, was unknown.; Sender's Comments: The vaccination with PREVENAR 13 might play a contributory role in triggering the occurrence of cellulitis requiring antibiotic therapies in the patient considering the plausible time 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: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injected limb mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable health care professional (medical assistant) calling on behalf of the physician. A 53-year-old female patient of an unspecified ethnicity received PREVNAR 13 (NDC number: 0005-1971-01, Lot Number: S39564, Expire Date: Sep2018), via an unspecified route of administration on 26Sep2017 16:30 at 0.5 ml, single in left deltoid for prevention, administered in a Physician's office. Prior vaccinations (within 4 weeks), patient's medical history and family medical history were none. The patient's concomitant medications included supplements (unspecified). Approximately 9 hours later, on 27Sep2017, the patient experienced dizziness, nausea, and a fever of 101.0 degrees. These side effects lasted about 1 1/2 days. She also had a severely sore left arm to the point that it affected her range of motion for 5 days. The outcome of the events was recovered. The caller stated that the doctor expressed that it could potentially be possible that the side effects are related to the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced redness and swelling of arm from wrist to shoulder on an unspecified date with outcome of unknown, which caused patient's hospitalization. No follow-up attempts possible. No further information expected. Sender's Comments: A causal association between administration of PREVNAR 13 and the onset of events cannot be fully 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: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Localised infection
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot number S39564, Expiry date Sep 2018, NDC number 00005197101), via an unspecified route of administration at single dose on 04Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced left arm and shoulder are infected on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of the events included an antibiotic.; Sender's Comments: Vaccination with PREVNAR 13 might play a contributory role in triggering the occurrence of infection at left arm and shoulder considering the plausible time 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.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 63-year-old female patient received PREVNAR 13 for immunization at single dose on unknown date. Concomitant medications and medical conditions were unknown. The patient experienced vaccination site swelling. The patient was told to use ice, along with Ibuprofen, as treatment. The outcome of the event was reported as recovering.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse reporting for him/herself via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced pain when vaccine was injected on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Peripheral swelling, Rash, Skin warm, Urticaria
Clinical narrative: Initial unsolicited report received from nurse via pharmacist on 03 Oct 2017. This case is linked with 2017SA192800 and 2017SA195913 (Same lot number). This case involves female patient (Age was not reported and reporter thinks that gender was female) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5936LA, expiry date: 30 Jun 2018, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had arm swollen, welps and spots on arm, area warm and dizzy. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited case received from a consumer on 05 Oct 2017. This case involves four-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, one day after the vaccination, patient had a bruised, raised arm that was hot to the touch. Relevant lab tests and corrective treatment were not reported. Outcome of the events were not reported. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis, Hypoaesthesia, Injection site induration, Injection site pain
Clinical narrative: This initial serious spontaneous case, was received on 25-Sep-2017, from a Pharmacist, concerning a 52-year-old female patient. On 22-Sep-2017, the patient received ALFURIA (batch number: XT32208 (as reported), expiry date: Jun-2018, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid). On 23-Sep-2017, the patient woke up with numbness in the left side of her face, had pain at the site of injection and it was hard. It was reported that, the patient had consulted the doctor and the doctor stated that, the patient had Bell's palsy and the events would recover on its own without any treatment. At the time of this report, the outcome of the event was not recovered. Follow-up received from the reporter on 03-Oct-2017: The patient's current condition, route of administration of suspect product and anatomical location were updated. Narrative amended accordingly. Significant case correction received on 03-Oct-2017: The case was upgraded from non-serious to serious. The Bell's palsy which was current condition was taken as an event. The Narrative was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Fasciitis, Peripheral swelling, Rash macular
Clinical narrative: This initial serious spontaneous case  was received on 05-Oct-2017, from other health professional, concerning a female patient of unspecified age. The patient's current conditions included rosacea and gluten intolerance. The patient had no concomitant medications. On an unspecified date (10 years ago), the patient was administered with INN Flu Vaccine  Seasonal  (dose, route of administration: subcutaneous, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On unspecified date after vaccination, the patient had her arm swelled up to 3 times the other arm, big red splotch to below elbow and lost her arm (as reported). The patient was hospitalized and diagnosed with fasciitis. The treatment medication included unspecified IV steroids. The patient was admitted for 7 days and was discharged as the patient recovered from the events. At the time of discharge, SOLU-MEDROL was given. The report was considered as serious due to hospitalization.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site bruising, Injection site discolouration, Injection site dryness, Injection site pain
Clinical narrative: Local and systemic reaction to flu vaccine. Developed headache within one hour, Lt. arm pain with bruising across most of upper Lt. arm. Dark circle at injection site with dry peeling skin.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction, Skin exfoliation
Clinical narrative: Local and systemic reaction to flu vaccine. Developed headache within one hour, Lt. arm pain with bruising across most of upper Lt. arm. Dark circle at injection site with dry peeling skin.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chromaturia, Dizziness
Clinical narrative: Severe fatigue, upper abdominal pain, back pain, frequent urination, dark colored urine, lightheadedness, weakness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pollakiuria, Urine analysis normal
Clinical narrative: Severe fatigue, upper abdominal pain, back pain, frequent urination, dark colored urine, lightheadedness, weakness.
Age: 97.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient apparently developed severe arthralgias and swollen joints approximately 2 days following administration of the high dose influenza vaccine for seniors. This was administered by a local home health agency operated by a local county health department.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Confusional state, Injection site bruising, Injection site erythema, Injection site reaction
Clinical narrative: Injection site reaction. Patient had confusion day after injection. Arm hurting. Redness and bruising on upper arm around injection site. On Saturday patient developed cellulitis, according to daughter and physician phoned in Z-PAK. Patient seems Ok now.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Injection site reaction. Patient had confusion day after injection. Arm hurting. Redness and bruising on upper arm around injection site. On Saturday patient developed cellulitis, according to daughter and physician phoned in Z-PAK. Patient seems Ok now.
Age: 63.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Lymphadenopathy, Measles, Rash
Clinical narrative: Pt sts she has not been feeling her normal self since receiving the MMR vaccine. Pt woke up today with a rash on her trunk, back, and arms. Also swollen glands on both sides of neck.  Dr. is diagnosing rash as Measles.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling of injections site.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Dyspnoea, Injection site pruritus, Injection site rash
Clinical narrative: Employee was given mandatory MMR vaccine in back of left arm. Employee began to have an itchy rash on bicep area of same left arm where vaccine was given within ten minutes after vaccine administered. That was proceeded by intermittent dry cough for 10 minutes which became worse and was accompanied by some shortness of breath. Employee was then immediately taken to the hospital emergency room via wheelchair by writer and checked-in to be seen/treated. Employee was immediately placed in a Bay for triage and treatment. Employee could still talk and was alert & oriented but continued to have intermittent shortness of breath with the dry cough.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA, PNC13
Symptoms: Abnormal behaviour, Injection site pain, Urticaria, Weight bearing difficulty
Clinical narrative: Child wouldn't bear weight on legs that evening after vaccines were given, next morning child woke up with hives all over body and continued to complain of leg pain. Child just layed around for few days after vaccines.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Gait disturbance, Headache, Tremor
Clinical narrative: Dizzy, unsteady gait, tremors, headache.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Injection site reaction, Pruritus generalised, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red welt like rash at site of injection about 3x1 in, three small bumps on left leg behind knee and on inner thigh, small pimple like and raised and red, one has scabbed over already. Pt awoke itching all over at 4am and noticed the reactions, itching has localized and is much less now.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Scab, Urticaria
Clinical narrative: Itchy red welt like rash at site of injection about 3x1 in, three small bumps on left leg behind knee and on inner thigh, small pimple like and raised and red, one has scabbed over already. Pt awoke itching all over at 4am and noticed the reactions, itching has localized and is much less now.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Pityriasis rosea, Rash
Clinical narrative: Rash. Pityriasis Rosea.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Diarrhoea
Clinical narrative: Patient experienced stomach upset, stomach pain, and diarrhea 1 week after receiving the vaccine. Pt went to the hospital and they treated him for the diarrhea there and let him go. Patient then got worse and recently developed chills. Pt was then advised to go back to the hospital to get re-evaluated.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Pt has seen her pcp re: pain. pP was given a 'steroid' shot by her pcp. md states shot was given 'too high' on arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches, Chills, low grade fever, my arm couldn't move the pain was so bad, could not lay on it for three days.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Blister
Clinical narrative: PT PRESENT TO THE CLINIC ON THE 17OCT2017. PT STATED THAT AFTER HIS VACCINE HE DEVELOPED A BLISTER AND WANTED TO KNOW IF THAT WAS NORMAL. PT STATED HE HAD NO OTHER SIGNS OR SYMPTOMS.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Tachycardia, Tachypnoea
Clinical narrative: Generalized pruritis, tachycardia (HR~100), tachypnea.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt stated right arm was swollen over 3 inches, red (sunburn looking), and painful. Recommended patient to apply ice and take BENADRYL. Report back later today. Reaction started next morning after receiving vaccine.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient had received PCV13 (PREVNAR) the year before on 10/20/2015. The PPSV23 was given 10/11/2016, 9 days early according to recommendations to space these vaccines by 12 months. CDC was contacted when this was reviewed and advised that no further doses need to be given, but recommended a VAERS report to be filed to document the error in spacing. Staff were reminded of spacing to be reviewed when scheduling appointments, and move them further out to allow for recommended intervals.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Flushing, Immediate post-injection reaction
Clinical narrative: Donor became hot, flushed and dizzy immediately after immunization. Donor made a full recovery within 5 minutes.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Discomfort, Injection site pain, Insomnia, Pain
Clinical narrative: After lying down for the night severe burning and throbbing pain from the left shoulder to elbow, especially at the injection site. Unrelieved with MOTRIN or TYLENOL. Unable to sleep at all for lack of comfortable positioning.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Patient states after receiving flu shot, later that evening  her left hand (left arm is site of flu shot) began to tingle as if it were falling asleep, she states that during the day when she is using her hands its fine but when she about to go to sleep/evening times is when it really bothers her. It tingles and burns.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Lip pruritus, Lip swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Received flu vaccination at around 1000 on 10/6/17. States "About 30-45 minutes later my arm started itching and I had hives on my upper arm. It progressed down my arm and my digits were swollen and itchy. I self-medicated with BENADRYL." On 10/7/18 he states both of his hands and upper lip were swollen and itchy so he went to ER where they gave him a prescription for Prednisone for 5 days. He states the prednisone worked well and he is asymptomatic at this time.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 23 year old client received a high dose flu vaccine, contacted facility at 4:00pm and client is doing well.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug administered at inappropriate site
Clinical narrative: Vaccine was administered incorrectly. It was given too posteriorly and into the joint.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Next day sore arm and shoulder, persisting 9+ days. I also question whether this is actually rotator cuff tendinitis.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Musculoskeletal stiffness, Nasopharyngitis, Pain
Clinical narrative: 10/4/17 0300 hrs. left arm, left neck and left chest were stiff. 10/4/17 1000 hrs. chills, cold, face flushed. No fever. 10/5/17 woke up feeling better. Minimal stiffness in left arm, and minimal aches.
Age: 46.0
Sex: F
Vaccine: FLUC4, TDAP
Symptoms: Lymph gland infection
Clinical narrative: Patient developed a lymph node infection which she believes is due to administration technique. Patient was given Z-pak on 10/16/17 and she believes it is helping.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Febrile seizure. 3-minute tonic clonic seizure associated with fever up to 102.4
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Disorientation, Enuresis, Eye movement disorder, Loss of consciousness
Clinical narrative: Patient left Pediatrics and was taken by mother to the flu station nurse in the lobby area for Influenza vaccine. There she suffered apparent first seizure episode with eye rolling, stiffening of arms and arching of back with extension of neck over a period of 10 minutes in the lobby at facility. There was brief loss of consciousness and enuresis noted. This all occurred 45 seconds to 1 minute after Influeniza vaccine was administered by nurse. There is no h/o allergies, adverse reaction to vaccines and/ or previous seizure as per mother. Patient regained consciousness but was disoriented and confused for approximately 15 minutes before being able to state her name and location. She was initially pale on re-exam but with full spontaneous respirations and regular heart rhythm with steady rate. Ambulance service was called for transport to ER.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Opisthotonus, Pallor, Seizure
Clinical narrative: Patient left Pediatrics and was taken by mother to the flu station nurse in the lobby area for Influenza vaccine. There she suffered apparent first seizure episode with eye rolling, stiffening of arms and arching of back with extension of neck over a period of 10 minutes in the lobby at facility. There was brief loss of consciousness and enuresis noted. This all occurred 45 seconds to 1 minute after Influeniza vaccine was administered by nurse. There is no h/o allergies, adverse reaction to vaccines and/ or previous seizure as per mother. Patient regained consciousness but was disoriented and confused for approximately 15 minutes before being able to state her name and location. She was initially pale on re-exam but with full spontaneous respirations and regular heart rhythm with steady rate. Ambulance service was called for transport to ER.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Extreme pain in arm. Back of forearm. (Not at injection site). Also front of and back of lower arm. Elbow. Tingling of arm do to pinky and ring finger. Family physician Dr. prescribed Prednisone 10 mg for 8 days (decreasing dosage).
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Child started having very high fever at 6:30am on 10/15/17 of 104.8 degrees F. Stayed around this temperature most of the day and at about 8:30pm temperature spiked to 107 degrees F. This was followed by a febrile seizure. At 4:00pm 10/17/17 fever is still around 103.5.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Daughter called our pharmacy on Saturday 10/14/17, told us that the patient was hospitalized shortly after receiving the vaccine. I believe the daugher indicated the patient had swelling of her arm and has a generalized malaise from being administered two vaccine (the patient also received a high dose fluzone that same time in a different arm).
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Arm so sore that I needed help dressing for two weeks. Now, I just use it with the pain.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Myelitis transverse, Urinary incontinence
Clinical narrative: Information has been received from a physician regarding a 3 year old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient received an unspecified dose of M-M-R II, subcutaneous for prophylaxis (anatomical location, lot number and expiration date were not reported). On an unknown date, the patient did not have the ability to tell when he had to urinate; the reporter felt that it qualified as transverse myelitis. The reporting physician stated that, on an unspecified date the patient had recovered from the myelitis transverse. The causal relationship between myelitis transverse and M-M-R II was not provided. Upon internal review, myelitis transverse was considered to be medically significant.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Blood HIV RNA increased, CD4 lymphocytes normal
Clinical narrative: Information was received in a published literature article. This case concerns to a 72-year-old male patient, who had a history of well controlled type 2 diabetes mellitus on insulin, hypertension, stage 3 chronic kidney disease, oxygen dependent chronic obstructive pulmonary disease, a recent history of stage 1a adenocarcinoma of the lung surgically resected in January 2013, and current tobacco use. He has a history of hepatitis C virus and had been successfully treated with interferon and ribavirin alone. He had a distant history of heroin abuse and had been stable on methadone assisted treatment since the early 1990s. The patient continued care with frequently rescheduled or missed visits, he was determined in April 2014 to have an undetectable hepatitis B virus (HBV) DNA level. The patient was found to be not immune. In July 2014, the patient received the first dose and again in November 2015, the patient received the second dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown), (lot number, expiration date, dose, anatomical location and route were not reported), for prophylaxis. Between 2013 and 2015, his HIV RNA level ranged from 210 to 3539 copies/ml and his CD4+ absolute cell count was between 772 and 1425 cells/ml. He was offered antiretroviral therapy (ART) multiple times and declined because of his multiple other health conditions and already extensive pill burden. He received a surveillance chest CT in February 2015 which showed no recurrence of his lung cancer.
Sex: M
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 male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-NOV-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 16-AUG-2016 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, or shingles. Because of the severity of his condition, the patient sought subsequent treatment from another physician for ongoing and worsening shingles symptoms. The patient has been prescribed acyclovir for management of his 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.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This initial spontaneous report was received from a third party claims administrator and refers to a female patient of unknown age. Medical history and concomitant medications were not provided. On 26-SEP-2017, the patient was vaccinated with ZOSTAVAX in the left arm at a pharmacy (dose, route and lot # not provided). After the vaccine (exact date not specified), the patient experienced adverse effects: rash, itchy to touch. The outcome of the event was unknown. Causality was assessed as related to ZOSTAVAX. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Visual impairment
Clinical narrative: Child described "shaky vision" shortly after getting vaccine (not nystagmus) which went away; started again 9/19/17 and happening more frequently for 1-2 minutes. Had normal ophthalmology, ENT and neurology consults at hospital; form submitted at mom's request.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hyperhidrosis, Malaise, Posture abnormal, Syncope
Clinical narrative: Patient fainted for a few seconds. His mom and a technician helped him to a seat in our waiting room. He was then talking to us saying he felt fine. We were already calling 911 and they were on their way. I ran for EPIPEN but he said he felt fine. It wasn't an allergic reaction. The EMT did not use a EPIPEN either. I gave an MENACTRA injection to patient. The technician who entered the vaccination into the computer she did not go through the questions with him and mom using the immunization tool. When I went in the room with him I went over the vacs with him and everything was ok. I asked again if he ever had a severe reaction with a vaccine before. His mom said no. I then administered the shot and asked if he was okay as I do with all vaccinations. He said he was fine. I then gave the vac to a technician to make a copy of and for school. At that time I heard yelling as he fell over into his mom's arms. His mom sat him on a chair in our waiting room. I yelled to call 911 and ran for the EPIPEN. When I came out he was talking to us and said he was fine. I did not use the EPIPEN due to him saying he had no problem breathing and just felt sick. I went for the blood pressure machine and gave him a ice pack because he was sweating. The ambulance arrived and his blood pressure was fine. We advised him to get checked out due to a heart rate of 50. He is a football player and when I asked him he ate at all today he said "no". He kept saying he was fine as EMT's spoke with him. They decided to take him to the ER to get checked. The mom then called me and said he was doing fine and the doctor in the ER did not feel this was due to the vaccination. They felt it was syncope.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted for a few seconds. His mom and a technician helped him to a seat in our waiting room. He was then talking to us saying he felt fine. We were already calling 911 and they were on their way. I ran for EPIPEN but he said he felt fine. It wasn't an allergic reaction. The EMT did not use a EPIPEN either. I gave an MENACTRA injection to patient. The technician who entered the vaccination into the computer she did not go through the questions with him and mom using the immunization tool. When I went in the room with him I went over the vacs with him and everything was ok. I asked again if he ever had a severe reaction with a vaccine before. His mom said no. I then administered the shot and asked if he was okay as I do with all vaccinations. He said he was fine. I then gave the vac to a technician to make a copy of and for school. At that time I heard yelling as he fell over into his mom's arms. His mom sat him on a chair in our waiting room. I yelled to call 911 and ran for the EPIPEN. When I came out he was talking to us and said he was fine. I did not use the EPIPEN due to him saying he had no problem breathing and just felt sick. I went for the blood pressure machine and gave him a ice pack because he was sweating. The ambulance arrived and his blood pressure was fine. We advised him to get checked out due to a heart rate of 50. He is a football player and when I asked him he ate at all today he said "no". He kept saying he was fine as EMT's spoke with him. They decided to take him to the ER to get checked. The mom then called me and said he was doing fine and the doctor in the ER did not feel this was due to the vaccination. They felt it was syncope.
Age: 96.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Right arm rash/swollen (2 days after immunization).
Age: 84.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented to clinic 2 days after receiving the flu/pneumonia vaccines with the following complaint: Brief Assessment of Chief Complaint: Pt reports elevated blood pressure at home this am. Pt took his atenolol and Lisinopril at 1145 this am. BP 136/105 in triage and 180/80 at 1445. Pt also has redness and swelling of left upper arm. Pt states he had a pneumonia vaccine on 10/12/17 and started to swell and itch shortly after administration.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Spinal myelogram
Clinical narrative: Legs got weaker trouble walking/using cane then walker now having physical therapy starting 10/13/17 5 days infusion in hospital of unknown meds diagnosis: Guillain-Barre Syndrome.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Walking aid user
Clinical narrative: Legs got weaker trouble walking/using cane then walker now having physical therapy starting 10/13/17 5 days infusion in hospital of unknown meds diagnosis: Guillain-Barre Syndrome.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Headache, Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: Vaccine received at 1400 hrs. on 10/3/17. At 2000 hrs. on 10/3/17, experienced headache, nausea, vertigo, extreme weakness. I needed help even to get out of bed to get to the bathroom. I felt like I was going to  to take me to the walk in clinic, but I felt too terrible to even do that. It lasted for 2 days.