chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Urine analysis normal
Clinical narrative: This case was reported by a consumer and described the occurrence of Lyme disease in a 18-year-old female patient who received MENVEO (batch number M15099, expiry date 31st March 2017). Concomitant products included ZOLOFT and Multivitamin. On 18th April 2016, the patient received MENVEO. In June 2016, 61 days after receiving MENVEO, the patient experienced joint pain. On an unknown date, the patient experienced Lyme disease (serious criteria GSK medically significant), walking difficulty, fibromyalgia, mycoplasma infection and general body pain. The patient was treated with Antibiotic and Pain Medication. On an unknown date, the outcome of the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain were unknown. It was unknown if the reporter considered the Lyme disease, joint pain, walking difficulty, fibromyalgia, mycoplasma infection and general body pain to be related to MENVEO. Additional details were provided as follows: At the time of the vaccination, the patient was taking ZOLOFT 50 mg and a multivitamin. In June 2016, approximately 2 months after vaccination, the started having pains in her joints and within one week she was bedridden in pain. The patient went to many doctors and still had no answer as to what was wrong with her. Doctors had suggested Lyme, fibromyalgia and mycoplasma disease. They had tried every pain medication and nothing touches the pain. They tried viral meds and antibiotics for Lyme as well. The patient had all tests done including a spinal tap, EMF, blood, urine, and test comes back normal. The patient has been in pain 24 by 7. She could barely walk. The pain was in total body.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a pharmacist, via a company representative, concerning an approximately 81 year old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 in the arm (strength, dosage schedule, route, lot number and expiration date were not reported). On the same date, an unspecified dose of influenza virus vaccine (reporter as "flu"), was also administered in the same arm, on the same date (strength, dosage schedule, route, lot number and expiration date were not reported). Other concomitant medications were not reported. On an unknown date, the patient developed a "really bad reaction" and was sedated in the hospital. The reporter was not sure about the reaction details. It was reported that unspecified treatment was given for the adverse event. The outcome of the adverse event was unknown at the time of reporting. The relatedness between the adverse event and therapy with PNEUMOVAX 23 was not reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Rash localized to R Deltoid. Pain at injection site. Advised to take OTC BENADRYL.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site reaction, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: And chills, local site reaction, warm, swollen arm.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Erythema multiform and urticaria pruritus. Diphenhydramine 50 mg once.
Age: 20.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Evening after vaccination -> (L) arm pain - flu/pneumococcal site, (L) leg pain, fever. Fever 103-104 -daily for first 4 days after vaccine, swollen upper (L) arm/hot to touch area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Developed arm soreness within few hours of vaccination approximately 12 hours after vaccination, severe arm pain, swelling to shoulder/deltoid/trapezius. Place on anti-inflammatory medication and 7-day course of antibiotics.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Neck pain, Pruritus, Pyrexia
Clinical narrative: Itching, redness (size of a hand). Pain around neck and should. Low grade fever.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis L upper arm. Rx Clindamycin.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Cold sweat, Decreased appetite, Dizziness, Headache
Clinical narrative: Muscle achiness for 1-2 days post vaccination. Severe headache, nausea, vomiting fever, dizziness, blurred vision, loss of appetite, upset stomach, cold sweats.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Muscle achiness for 1-2 days post vaccination. Severe headache, nausea, vomiting fever, dizziness, blurred vision, loss of appetite, upset stomach, cold sweats.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had injection site reaction, with site swollen and red.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Vaccination site ulcer
Clinical narrative: Generalized rash started 8/29/16 - no treatment. Ulceration at vaccine site on (L) thigh 8/19/1-> AMOXIL.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Head injury, Headache, Loss of consciousness
Clinical narrative: Pt told mother he wasn't feeling well, head hurt, light headed, passed out on floor, hit forehead right side on door frame. Pt woke up immediately, clammy skin. At 1415 BP 104/75, HR 75, R 20, Paris canal. At 1430 pt coherent BP 96/67, HR 71. Monitored pt for 30 min. Shot given 1355, passed out at 1400. Pt went home.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: Pt told mother he wasn't feeling well, head hurt, light headed, passed out on floor, hit forehead right side on door frame. Pt woke up immediately, clammy skin. At 1415 BP 104/75, HR 75, R 20, Paris canal. At 1430 pt coherent BP 96/67, HR 71. Monitored pt for 30 min. Shot given 1355, passed out at 1400. Pt went home.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Extremes welling at injection site and entire arm, reaching axillary area. Shoulder pain,
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Lymphadenopathy, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Extremes welling at injection site and entire arm, reaching axillary area. Shoulder pain,
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: Extremes welling at injection site and entire arm, reaching axillary area. Shoulder pain,
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Balance disorder, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 30 min after injection, started feeling dizzy, lightheaded, sweating, N+V multiple times. Felt S/S all day long and next day only has lightheadedness and dizzy. "Off Balance".
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Balance disorder, Diplopia, Disturbance in attention, Dizziness, Hyperhidrosis
Clinical narrative: 30 min after injection, started feeling dizzy, lightheaded, sweating, N+V multiple times. Felt S/S all day long and next day only has lightheadedness and dizzy. "Off Balance".
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Nausea, Neuritis, Pallor, Vestibular neuronitis, Vision blurred
Clinical narrative: 30 min after injection, started feeling dizzy, lightheaded, sweating, N+V multiple times. Felt S/S all day long and next day only has lightheadedness and dizzy. "Off Balance".
Age: 48.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Vomiting
Clinical narrative: 30 min after injection, started feeling dizzy, lightheaded, sweating, N+V multiple times. Felt S/S all day long and next day only has lightheadedness and dizzy. "Off Balance".
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Patient has had consistent muscle pain since day of injection localized to arm that injection was administered in.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Back pain, Pain in extremity, Sciatica
Clinical narrative: Sciatica type pain radiating from lower back down to the calf/feet.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, TDAP
Symptoms: Blood glucose normal, Hyperhidrosis, Posture abnormal, Syncope
Clinical narrative: Patient discharged after vaccinations and had a syncopal episode. Mother stated patient was sweating then hunched over. Nursing staff notified. Physician went out to check patient and he was responsive without any seizure activity. Vitals (BP 105-70 Pulse 92 Blood sugar 90)
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Feeling hot
Clinical narrative: Mom reports Pt's head feels hot and weak appearing. No fever. No acute sx.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Slight swelling, itchiness and redness at inj site no fever.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Felt dizzy and lightheaded the morning after injection which worsened for few hours then began to less in intensity. Symptoms have gradually reduced since 9/28/16 and currently feels symptoms very slightly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: While working on 9/28/16 "smelled strange smell" then began to get H/A, dizzy, nauseated and then vomited x 5. Has continued to feel very tired, no appetite, achy, slight H/A and nasal drainage. No cause for odor was found in her work environment.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Parosmia, Rhinorrhoea, Vomiting
Clinical narrative: While working on 9/28/16 "smelled strange smell" then began to get H/A, dizzy, nauseated and then vomited x 5. Has continued to feel very tired, no appetite, achy, slight H/A and nasal drainage. No cause for odor was found in her work environment.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Increased redness, warmth, soreness and slight edema that started day after injection and lasted x 2 days. ADVIL and icepacks were given and applied.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Nodule, Peripheral swelling, Pyrexia
Clinical narrative: Headaches, swelling and knot noted on arm. High fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Neck mass
Clinical narrative: Left arm upper arm deltoid redness, warm to the touch, small lump, painful. Left side of neck lump.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool after receiving ROTATEQ vaccine (+) occult blood also. Blood in stool started 3 days after receiving vaccine. Still (+) occult blood on 09/26/16.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, hot, swollen, sore, Temp 99.0 today 9/23/16.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Feeling abnormal, Lethargy, Somnolence
Clinical narrative: Lethargic, sleeping a lot, could barely hold up head, spacy. 3 QDS.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Patient had an allergic reaction after administration. Patient received diphenhydramine and prednisone.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt rec'd vaccination 3 days. Today the injection site is very swollen/red. She has used diphenhydramine/cortisone ointments.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Vision blurred
Clinical narrative: Loss/of vision for about 1 1/2 hrs (blurred vision)
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Diarrhoea, Feeling cold, Nausea, Pyrexia
Clinical narrative: Nausea/vomiting, fever/chills, watery stools, abd-cramps.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Nausea/vomiting, fever/chills, watery stools, abd-cramps.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU4, HIBV, MMR
Symptoms: Dyskinesia, Electroencephalogram
Clinical narrative: Jerking spell - possible seizure vs night terror.
Sex: M
Vaccine: DTAP, FLUX, MMRV
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a physician referring a 4 year old male patient. Current conditions included developmentally delayed, the patient's medical history was not reported. On 15-SEP-2016, the patient was vaccinated with (Oka-Merck)  PROQUAD (lot number, expiration date, concentration, dose, frequency and via were reported as unknown), other suspect therapies included (unspecified) Influenza virus vaccine (lot number, expiration date, concentration, dose, frequency and via were not reported) and DAPTACEL (lot number, expiration date, concentration, dose, frequency and via were not reported) that were administered simultaneously in the same date were indicated. No concomitant medications were reported. On 15-SEP-2106, during a visit to the physician's office, the patient experienced a brief episode of vomiting. No laboratories or studies were performed. At the time of the report, the outcome of vomiting was unknown. The causality between (Oka-Merck) PROQUAD and the adverse event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-JUL-2016, the patient was vaccinated with "about half" of the dose of ZOSTAVAX vial 19400 PFU, lot # L032403 (expiry date: 26-NOV-2016), subcutaneously. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Follow up information was received from the pharmacist on 19-SEP-2016. The patient was a 60-year old female of unknown occupation and race. The patient's concurrent conditions included morphine allergy. No concomitant medications pertinent to the events were reported. ZOSTAVAX was purchased with public funds and the patient was vaccinated at a pharmacy on 19-JUL-2016 at about 17:00 in the left arm. It was the patient's first dose of ZOSTAVAX. The patient had no laboratory tests performed, illnesses at time of vaccination or adverse events prior to vaccination. It was reported that the syringe leaked and the patient received partial dose of ZOSTAVAX. A signed informed consent was obtained. Additional information is not expected as all relevant information has already been received. Report's and patient's details, products, events and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not informed. It was reported that on 27-SEP-2016, the patient was administered an improperly stored dose of VARIVAX lot # M025867, expiration date 24-MAY-2018, (dosage was not provided), administered per subcutaneous route. Concomitant therapies were not informed. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a 60 year old male patient reporting on himself. Concurrent conditions included blood pressure and type 2 diabetes. On 27-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (Lot number, expiration date, dose and route were not provided). Concomitant therapies included metformin, fenofibrate and ramipril. The patient stated that he has a red spot (injection site erythema) and a rash at the injection site. The patient added that "when he fold his arms, he could feel the heat" at the injection site. The area was also a little itchy. He could not confirmed exactly when the adverse reaction began, but the patient said that today, on 29-SEP-2016, it was most noticeable. No Product quality complaint was involved. The patient did not seek medical attention, no treatment was given and no laboratory diagnostics studies were performed. At the time of reporting the patient had not recovered from of injection site pruritus, injection site warmth, injection site rash and injection site erythema. The reporter did not assessed the relatedness between ZOSTAVAX and the aforementioned events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous repot as received from a healthcare professional refers to a patient of unknown age and gender,. Information concerning the patient's concurrent conditions, medical history or concomitant medication was not provided. On an unknown date, the patient was vaccinated with improperly stored VARIVAX lot # L013067with expiration date on 14-APR-2017. The vaccine was exposed to a temperature of -7.9C for 46 hours and 4 minutes and this excursion was discovered due to a digital data logger. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Product use issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 20 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 18-AUG-2016, the patient was vaccinated with the first dose of M-M-R II lot # L027591, expiration date 23-JUL-2017, intramuscularly. Concomitant therapy information was not provided. In 2016, the patient experienced injection site pain. It was reported that at the time of the report, the patient was still experiencing pain at the injection site from the M-M-R II administration, so the outcome of injection site pain was reported as not recovered. The pharmacist did not assess the relationship of the injection site pain to M-M-R II. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: DTAP, PPV
Symptoms: Viral titre decreased
Clinical narrative: Information has been received from the authors in a published literature article regarding a 7 year old male patient with no significant past medical history except for recurrent streptococcal infections. In this article was described the patient with common variable immunodeficiency (CVID-like humoral immune deficiency and associated pure red cell aplasia (PRCA)) who developed progressive marrow aplasia despite several immunomodulatory agents. On an unknown date, the patient was vaccinated with 23-valen pneumococcal vaccine (manufacturer unknown) and with DTaP (manufacturer unknown) booster (doses, Lot No. and anatomical location of administration were not reported). The patient developed protective titers against diphtheria, tetanus, and multiple pneumococcal serotypes; however, on an unknown date, his protective antibody titers was short-lived (viral titre decreased). The outcome of viral titre decreased was unknown. The reporter considered viral titre decreased to be related to 23-valent pneumococcal vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, indication, dose number, lot number, expiration date and route were not reported) after having completed on an unknown date the three dose series with GARDASIL (indication, dose number, lot number, expiration date and route were not reported). However, at the time of the report it was unknown how many doses of GARDASIL 9 were administered to the patient. No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to three patients of unknown age and gender. The patients' medical histories, concurrent conditions and drug reactions were not reported. On 07-SEP-2016, the patients were vaccinated with an improperly stored dose of PROQUAD (which had a lot # L017140 and expiration date on 13-NOV-2016) (dose number, dose and route were not reported). Concomitant medication information was not provided. No adverse event were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient c/o redness and swelling around site of injection (left arm, between deltoid area and above elbow). Pharmacist on duty followed with physician, nurse recommended ice pack and BENADRYL.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Myalgia, Nausea, Pain
Clinical narrative: Severe nausea, emesis, diarrhea, myalgias, arthralgias (severe). Never had this constellation of symptoms before. Husband had same food all day and did not get sick. Worst total body pain of my life. Resolved within 8 hours.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Severe nausea, emesis, diarrhea, myalgias, arthralgias (severe). Never had this constellation of symptoms before. Husband had same food all day and did not get sick. Worst total body pain of my life. Resolved within 8 hours.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Extremely painful muscle aches. Could barely walk.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Contusion, Immune thrombocytopenic purpura, Petechiae
Clinical narrative: At 7pm, we noticed petechiae on his lower legs and feet and heavy bruising on his lower legs. No treatment.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, redness, pain incorporating whole girth of upper arm NOT AT INJECTION SITE. Initial involvement lasted 48 hours, took another 48 for symptoms to subside to the point that I did not need pain medication.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Patient states has red welts (size of a quarter) warm to the touch around the site of injection. No other symptoms reported.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Pt felt faint--immediately after she had been given the FLUZONE-QUAD shot got up to go to the Dad--then fainted-fell back-hit her head.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Describes low frequency ringing in bilateral ears.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Genital herpes, Rash
Clinical narrative: Apparent Genital Herpes on penis. Rash and small blisters. 10 days  used Preparation H. Also Back pains started several days later.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: PT INDICATED SORE/STIFF ARM, WITH PAIN/STIFF IN NECK AREA AND HEADACHE, WITH TINGLING IN ARM AND FINGERS.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Nausea, Pyrexia
Clinical narrative: PT INDICATED SEVERE COLD CHILLS/FEVER WEAKNESS, NAUSEA OVERNIGHT THROUGH THE FOLLOWING DAY.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dizziness, Feeling hot, Nausea
Clinical narrative: After receiving the Prevnar-13 vaccine the patient reported feeling warm. The patient was given cold cloth for her forehead and stated she felt better initially. Her husband was called over and the patient leaned against him as she stated she was now dizzy. The patient coughed in a manner that implied she may vomit, and when asked the patient confirmed she was nauseous. EMS was called and arrived a few minutes later. At the time EMS arrived the patient stated she was feeling better. After being evaluated by EMS the patient declined further treatment. Approximately fifteen minutes had passed since the immunization at this time. The patient stated she had felt dizzy after a previous influenza immunization three years prior, but had successfully been vaccinated for influenza twice since then, so thought the previous reaction was a fluke.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Muscular weakness, Rash erythematous
Clinical narrative: The patient had the ZOSTAVAX IMZ administered on Tuesday, Sept 27th. Today, Friday Sept 30th, she came in and showed me a red circular rash around the injection site stating it hot to the touch. I felt the area and it was warm. Additionally, the pt stated her arm was very week, "like I lifted weights and over-exerted". I told her she should consider going to the MD. I also advised her to apply a cold pack to the area of concern 4 times daily for 10-15 minutes and take ibuprofen for the next 3 days to assist with the swelling. She said she wanted to wait until Monday to call the doctor to see if the symptoms improved. I told the patient I would contact her MD, which I left a detailed message with office staff including that I advised the patient to be seen if symptoms do not improve. I told her I would follow up with her on Monday to see how her symptoms were.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction, red/hard/hot bump, sized between baseball and golf ball.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Anaphylactic shock, Vaccination complication
Clinical narrative: Anaphylactic Shock. Administered SOLU-MEDROL, PEPCID, epinephrine. Had repeated rebound anaphylactic events over the next 7 days requiring ER treatment and lifesaving efforts. Hospitalized due to anaphylaxis from vaccine from 08/19/2016 to 08/21/2016.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: RED HOT KNOT AT AREA OF INJECTION SITE.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: Patient reported to the pharmacy on 10/1/2016 that she had developed an allergic reaction to the immunization. She showed her vaccination site and it was red and swollen. She states that she was feverish starting the night of the immunization.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Feeling of body temperature change, Malaise
Clinical narrative: Patient began feeling unwell (experiencing loss of appetite, nausea, and weakness) around lunchtime after receiving FLUZONE HD in the morning on 9/29/2016. He experienced diarrhea throughout the evening and one bout in the morning on 9/30/2016. Patient felt alternately hot and cold as if he had a fever but did not have one on checking with a thermometer (98.6F). Patient was counseled to treat his symptoms as needed (with rest, fluids, ibuprofen or acetaminophen) and seek medical attention if symptoms persisted or worsened. Negative for shortness of breath, rash, or hives. Patient began to feel "almost back to normal 100%" by the afternoon on 9/30/2016.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Patient began feeling unwell (experiencing loss of appetite, nausea, and weakness) around lunchtime after receiving FLUZONE HD in the morning on 9/29/2016. He experienced diarrhea throughout the evening and one bout in the morning on 9/30/2016. Patient felt alternately hot and cold as if he had a fever but did not have one on checking with a thermometer (98.6F). Patient was counseled to treat his symptoms as needed (with rest, fluids, ibuprofen or acetaminophen) and seek medical attention if symptoms persisted or worsened. Negative for shortness of breath, rash, or hives. Patient began to feel "almost back to normal 100%" by the afternoon on 9/30/2016.
Age: 42.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain, Rash
Clinical narrative: Patient reported on 09/30 that he had experienced pain, limited mobility in arm/shoulder, and large rash following immunizations. I am not exactly sure when adverse event first began but he was feeling better on 9/30. Patient was instructed to contact doctor and go to ER as he still had large rash on 9/30.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma
Clinical narrative: 1 and 1/2 in x 1 and 1/2 hematoma quickly developed for small framed elderly female. Patient did not have any numbness or pain.  Instructed patient to ice and watch for signs of symptoms of numbness or increase in swelling and if so to seek medical attention.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient's arm swelled significantly enough to be of concern and go to the hospital er for treatment. According to patient, she was given steroids and antihistamines to control reaction.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Started as extremely painful around the injection site and couldn't move arm. Then it went on to be red from the injection site to his chest, and he had a fever. As of today's follow-up, it's still very painful and he's been put on an antibiotic per his doctor.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccine. Was treated with 2L of oxygen, orange juice, and crackers.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Starting 9/28 PM redness at site left arm, 9/29/16 PM some swelling. On 9/30/16 PM more swelling and pt went to ER.
Age: 53.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT STARTED DEVELOPING A RASH AND HIVES AFTER RECEIVING THE SHOT. IT BECAME NOTICEABLE ON 9/29/16. SHE THOUGHT IT WAS GETTING WORSE SO SHE WENT TO THE EMERGENCY ROOM.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced moderate swelling and redness in the upper left arm at and around where the two vaccines were administered.  Scope of morbidity limited to area between elbo and shoulder.  No reported febrile response.  Patient visited primary care physician but no treatment was necessary, condition resolved on its own.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site pain, Rash, Rash erythematous, Sleep disorder
Clinical narrative: Patient complained of burning at the time of injection and was advised to use ice/Tylenol and to call if symptoms persisted. She called later that night asking if it was okay to use Naproxen instead (yes). On 9/30/16 she developed a red rash adjacent to the vaccine administration site. The patient was also unable to sleep due to pain. On 10/1/16 the rash moved down her arm, further away from the injection site, so the patient went to the Urgent Care and was give Keflex/Norco and told to use Benadryl.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site reaction
Clinical narrative: Patient complained of burning at the time of injection and was advised to use ice/Tylenol and to call if symptoms persisted. She called later that night asking if it was okay to use Naproxen instead (yes). On 9/30/16 she developed a red rash adjacent to the vaccine administration site. The patient was also unable to sleep due to pain. On 10/1/16 the rash moved down her arm, further away from the injection site, so the patient went to the Urgent Care and was give Keflex/Norco and told to use Benadryl.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives all over body, no trouble breathing, treated with oral Cetirizine 10 mg.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient noted that arm was somewhat painful at injection site and warm around injection site the next day but that they had a better reaction than previous vaccine they received. No treatment has been requested at this time, they just wanted to make me aware.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER 39.2 C, HEADACHE.
Age: 0.08
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eczema, Food allergy, Haematochezia, Loss of consciousness, Milk allergy
Clinical narrative: Baby slept heavily for 6 hours. Woke screaming and screamed for three days, passing out for 30 minute periods. Bit mom's nipples and shook head back and forth. The next week, he started having bloody stool, which turned out to be life-threatening allergies to tree nuts and dairy. The week after, severe eczema developed on a majority of his body and lasted for a year.
Age: 0.08
Sex: M
Vaccine: DTAP, IPV
Symptoms: Radioallergosorbent test positive, Screaming
Clinical narrative: Baby slept heavily for 6 hours. Woke screaming and screamed for three days, passing out for 30 minute periods. Bit mom's nipples and shook head back and forth. The next week, he started having bloody stool, which turned out to be life-threatening allergies to tree nuts and dairy. The week after, severe eczema developed on a majority of his body and lasted for a year.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: Patient came in with a rash on upper torso, neck, face and scalp.  Patient did not have any difficulty breathing.  Told patient to take Benadryl (which I showed where it was on the shelves) and visit an urgent care for immediate evaluation.
Age: 0.75
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Abasia, Balance disorder, Dysstasia, Labyrinthitis, Lethargy
Clinical narrative: Within a few hours, patient spiked a fever of 103 degrees. The doctor was notified and we were told it was a normal reaction after vaccinating. The next day, she became almost totally lethargic, unresponsive to most light and sound. Patient had shrill screams, indicating she was in severe pain. She had lost most common learned words like, "mommy, daddy, dog, cup, ball" etc. In addition, she lost motor skills, and was unable to stand on her own, keep her balance or take small steps. Approximately 2 days later, patient had been seen by an emergency room (not primary care), diagnosed with an inner ear infection, Amox was RX, but we refused and cured naturally with garlic oil drops. Her infection cleared within 12 hours. Patient stayed in her lethargic state for almost 2 weeks.
Age: 0.75
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Motor dysfunction, Pain, Pyrexia, Screaming, Speech disorder
Clinical narrative: Within a few hours, patient spiked a fever of 103 degrees. The doctor was notified and we were told it was a normal reaction after vaccinating. The next day, she became almost totally lethargic, unresponsive to most light and sound. Patient had shrill screams, indicating she was in severe pain. She had lost most common learned words like, "mommy, daddy, dog, cup, ball" etc. In addition, she lost motor skills, and was unable to stand on her own, keep her balance or take small steps. Approximately 2 days later, patient had been seen by an emergency room (not primary care), diagnosed with an inner ear infection, Amox was RX, but we refused and cured naturally with garlic oil drops. Her infection cleared within 12 hours. Patient stayed in her lethargic state for almost 2 weeks.
Age: 0.75
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Within a few hours, patient spiked a fever of 103 degrees. The doctor was notified and we were told it was a normal reaction after vaccinating. The next day, she became almost totally lethargic, unresponsive to most light and sound. Patient had shrill screams, indicating she was in severe pain. She had lost most common learned words like, "mommy, daddy, dog, cup, ball" etc. In addition, she lost motor skills, and was unable to stand on her own, keep her balance or take small steps. Approximately 2 days later, patient had been seen by an emergency room (not primary care), diagnosed with an inner ear infection, Amox was RX, but we refused and cured naturally with garlic oil drops. Her infection cleared within 12 hours. Patient stayed in her lethargic state for almost 2 weeks.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Rash
Clinical narrative: Rash on stomach, injection site feels warm and swollen.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Nodule
Clinical narrative: Developed large elevated knot on arm after receiving flu shot, no other symptoms reported.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Erythema, Fatigue, Headache, Pyrexia, Skin warm
Clinical narrative: Large welt, redness, hot, fever, fatigue, headache starting 10 hrs after vaccine and lasting for 10 hrs.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Urticaria
Clinical narrative: Large welt, redness, hot, fever, fatigue, headache starting 10 hrs after vaccine and lasting for 10 hrs.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Patient right arm is red around the injection site, that started 5 days after the injection.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Severe body aches in all extremeties including ribs and feet.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Nodule, Pruritus, Skin warm, Swelling
Clinical narrative: 10cm circumference swelling and redness. Complaining of hot and itching. Hard nodule in the middle. Went to pediatrician after 48 hours of no improvement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling redness hotness soreness at injection site.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Retching
Clinical narrative: Extreme dizziness (unable to walk to restroom without assistance from restaurant server and wife) & nausea.  Lasted for about 30 minutes.  Left restaurant after about 30 minutes of heaves with some saliva and a little bile in bathroom, went home and went to bed.  One instance of heaves with some saliva on the way home.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Headache, Muscular weakness, Pyrexia
Clinical narrative: Whole body muscle weakness; low-grade fever; headache; fatigue. When to bed and slept--drank fluids.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness, nausea, blurred vision that lasted 3 days.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoacusis
Clinical narrative: PATIENT CALLED PHARMACY THIS MORNING STATING THAT SHE HAS EXPERIENCED PARTIAL HEARING LOSS IN THE LEFT EAR (SAME SIDE AS VACCINE ADMINISTERED).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient reported soreness in her arm within an hour after vaccination. Within 48 hours of vaccination, patient reports numbness in arm of vaccination and also weakness when grasping or holding objects.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Feeling abnormal, Injected limb mobility decreased, Injection site erythema
Clinical narrative: I woke up and the site of injection on my arm was very swollen and red with severe pain all the way up my arm and shoulder. Unable to life anything or do anything. I also have diarrhea and chills, fever and feel horrible. I had vaginal bleeding and I am post menopausal. I am a liver patient.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Postmenopause, Pyrexia
Clinical narrative: I woke up and the site of injection on my arm was very swollen and red with severe pain all the way up my arm and shoulder. Unable to life anything or do anything. I also have diarrhea and chills, fever and feel horrible. I had vaginal bleeding and I am post menopausal. I am a liver patient.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Vaginal haemorrhage
Clinical narrative: I woke up and the site of injection on my arm was very swollen and red with severe pain all the way up my arm and shoulder. Unable to life anything or do anything. I also have diarrhea and chills, fever and feel horrible. I had vaginal bleeding and I am post menopausal. I am a liver patient.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Patient reports feeling warm.  Injection site is not red, swollen, or irritated looking.  Had patient sit and apply an ice pack to the injection site.  Patient also reported pain in the ring & pinky finger of his right arm.  Patient was advised to sit and hold ice pack for 15min - patient got up at 12:18 and reported that he felt fine.  I visibly checked the injection site prior to his getting up, and again at approx 12:50p - no reaction, swelling, or redness visible.
Age: 56.0
Sex: F
Vaccine: JEVX
Symptoms: Back pain, Vertigo, Vomiting
Clinical narrative: Vertigo began at 0530, continued through next day with vomiting and back pain.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Hyperhidrosis, Myalgia, Tremor
Clinical narrative: Shaking, chills, sweats, freezing, myalgia.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: Paint injection site, rash swelling and itching the following day at injection site and rash on both arms.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Extreme soreness in the left arm. Difficultly with mobility.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest discomfort, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Pt returned to clinic about 30 min after receiving her flu shot with a red rash on her left upper arm, left neck and chest towards her right side. Her BP was 180/110, HR 115. Pt's BP remained elevated and she started feeling some chest pressure and a lump in her throat. No wheezing or SOB. EMS was activated and transported pt to ED where she was treated with IV BENADRYL and eventually released.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body
Clinical narrative: Pt returned to clinic about 30 min after receiving her flu shot with a red rash on her left upper arm, left neck and chest towards her right side. Her BP was 180/110, HR 115. Pt's BP remained elevated and she started feeling some chest pressure and a lump in her throat. No wheezing or SOB. EMS was activated and transported pt to ED where she was treated with IV BENADRYL and eventually released.
Age: 31.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling redness reported, advanced quickly.  Patient reported to doctor and is currently being treated with doxycycline.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Granulocyte count increased, Injection site erythema, Injection site mass
Clinical narrative: Patient woke up with fever of 102 degrees F, severe body aches, and weakness, with intermittent dizziness.  After Tylenol and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours.  Around 1:00 PM, Advil was taken, and temperature dropped to 99 degrees.  By approximately 5:00 PM, temperature was back to 102 degrees.  Other symptoms persisted throughout the day.  The next day, 09/29/2016, the patient woke up at 5:00 AM with a fever of 102 degrees, and continued aches and weakness.  Around 7:30 AM, patient noticed a large, raised, red bump that was hot to the touch, approximately 2 inches below the injection site and the size of a golf ball.  Fever went down with Advil, and began to raise back to 101 degrees around 1:00 PM.  The red lump continued to spread, now to the size of a large softball.  Patient returned to the doctor at 3:00 PM, where temperature was 101 degrees.  Doctor recommended icing the arm and monitoring to see if it spread.  Blood was drawn to determine if infection was present.  On Friday, 09/30/2016, patient woke up at 5:00 AM to a normal temperature but weak.  The rash had spread very little but began to itch.  As of today, patient is waiting to hear back from the doctor as to whether an allergy pill may help.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Injection site warmth, Lymphocyte count decreased, Pain, Pyrexia
Clinical narrative: Patient woke up with fever of 102 degrees F, severe body aches, and weakness, with intermittent dizziness.  After Tylenol and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours.  Around 1:00 PM, Advil was taken, and temperature dropped to 99 degrees.  By approximately 5:00 PM, temperature was back to 102 degrees.  Other symptoms persisted throughout the day.  The next day, 09/29/2016, the patient woke up at 5:00 AM with a fever of 102 degrees, and continued aches and weakness.  Around 7:30 AM, patient noticed a large, raised, red bump that was hot to the touch, approximately 2 inches below the injection site and the size of a golf ball.  Fever went down with Advil, and began to raise back to 101 degrees around 1:00 PM.  The red lump continued to spread, now to the size of a large softball.  Patient returned to the doctor at 3:00 PM, where temperature was 101 degrees.  Doctor recommended icing the arm and monitoring to see if it spread.  Blood was drawn to determine if infection was present.  On Friday, 09/30/2016, patient woke up at 5:00 AM to a normal temperature but weak.  The rash had spread very little but began to itch.  As of today, patient is waiting to hear back from the doctor as to whether an allergy pill may help.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash pruritic, White blood cell count
Clinical narrative: Patient woke up with fever of 102 degrees F, severe body aches, and weakness, with intermittent dizziness.  After Tylenol and rest, the fever dropped to 101 degrees, but again went up to 102 after a few hours.  Around 1:00 PM, Advil was taken, and temperature dropped to 99 degrees.  By approximately 5:00 PM, temperature was back to 102 degrees.  Other symptoms persisted throughout the day.  The next day, 09/29/2016, the patient woke up at 5:00 AM with a fever of 102 degrees, and continued aches and weakness.  Around 7:30 AM, patient noticed a large, raised, red bump that was hot to the touch, approximately 2 inches below the injection site and the size of a golf ball.  Fever went down with Advil, and began to raise back to 101 degrees around 1:00 PM.  The red lump continued to spread, now to the size of a large softball.  Patient returned to the doctor at 3:00 PM, where temperature was 101 degrees.  Doctor recommended icing the arm and monitoring to see if it spread.  Blood was drawn to determine if infection was present.  On Friday, 09/30/2016, patient woke up at 5:00 AM to a normal temperature but weak.  The rash had spread very little but began to itch.  As of today, patient is waiting to hear back from the doctor as to whether an allergy pill may help.
Age: 1.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Hypotonia, Injection site pain, Injection site reaction, Irritability, Screaming
Clinical narrative: Extremely irritable and unable to weight bear on vaccinated leg. Leg became limp and she would scream if we touched it.