chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site - red circle (kept getting bigger) hard, hot to touch and very sore. No fever.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Hypotension, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt rec'd FLUZONE at approximately 3:40 pm 9/20. Husband called 9/21 to report that pt had fever, vomiting, nausea, low BP unsteadiness. I called pt approximately 2 pm and she said she was feeling much better. The most severe symptoms were through the night.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient came in 9/21/17 complaining of Right shoulder pain that had already resolved, but now complained of pain in left knee. Patient was advised to visit MD for checkup to rule out causes.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Immediate bleeding. Immediate swelling and purple hematoma at injection site-about 3/4 inch wide. Immediately administered cold pack.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: Pt's. (L) arm swelled from elbow to shoulder where she rec'd the SQ injection.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local site reaction reported 09-28-17 (2) days after injection given 09-26-17 redness at injection site -> has gotten better ea. day since initial reaction 09/27-17
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Rash/warm to touch 7 days post vaccine. 5 x 2 1/2 inch oval Right Deltoid.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Vision blurred
Clinical narrative: Pt said night of vaccine she got dizzy and blurry vision. She went to ER she still feels dizzy and one eye is blurry. Going to see neurology.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Sinusitis
Clinical narrative: 9/16 Local ecchymosis and mild swelling at injection site, tender at site and distal to site redness is from top of site to 1 cm below the site and redness extends 11 cm towards lateral posterior upper arm as well and no pruritic.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, redness, pain, warm to touch all with in the 1st 24 hours and cont for the past 4 days, by day 4 redness "going down" per patient.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: Patient got her flu shot evening of 9-26-17 woke up this morning with swollen lips/doctor told her to come to pharmacy and pick up BENADRYL and to monitor allergic symptoms/she's previously had the flu shot with no reaction in the past.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling on left deltoid area at injection site.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash pruritic, Varicella post vaccine
Clinical narrative: Pt came into office with chicken pox. Pt presented with fever and itching rash with vesicles.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to pharmacy on 9-28-17 with a large red spot on her (L) arm. She said it was raised and hard last night. It hurts less now but is now a large red spot bigger than a tennis ball. Advised her to take Ibu/BENADRYL and will check in w/her on Monday.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site reaction
Clinical narrative: Pt seen by another pharmacist on 9/11 to fill antibiotics for injection site reaction. The pharmacist that saw pt said pt had inflammation on arm at injection site.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt has kidney shaped red, raised, hot area to right thigh 60 cm x 30 cm. Edges were marked. Instructed to give BENADRYL 12.5mg/5mL - 4 mL twice daily for 1-2 days. Ibuprofen every 6-8 hrs. Apply ice to area 10-15 minutes several times per day. If not improved or is larger, more firm/hot to touch return to clinic for further evaluation.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm - suggested patient to go to the MD and was prescribed MEDROL DOSEPAK and KEFLEX.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Patient given the HPV9 vaccine #2 on 9/25/17 at 11 AM. Patient complained his (R) arm was sore, showed his mother on 9/27/17. He came into office at 11:00 AM on 9/28/17, was given MOTRIN and monitored for 15 mins before leaving.
Age: 13.0
Sex: M
Vaccine: DTAP, HEPA, HPV9, MNQ
Symptoms: Dysstasia, Ecchymosis, Laboratory test, Mobility decreased, Muscular weakness
Clinical narrative: Patient reported loss of use of his legs on Friday 9/22/17, was seen at Hospital Emergency Room. Patient came to clinic on 9/25/17 with continued leg weakness, leg swelling and ecchymosis of legs.  Patient collapsed in clinic and was unable to stand, bear weight or move legs.  Was transported to  Hospital ER.  Patient was then transported from ER to Hospital where he remains hospitalized without a definitive diagnosis as of this date. Hospital was notified of immunization status.
Age: 13.0
Sex: M
Vaccine: DTAP, HEPA, HPV9, MNQ
Symptoms: Peripheral swelling, Syncope, Weight bearing difficulty
Clinical narrative: Patient reported loss of use of his legs on Friday 9/22/17, was seen at Hospital Emergency Room. Patient came to clinic on 9/25/17 with continued leg weakness, leg swelling and ecchymosis of legs.  Patient collapsed in clinic and was unable to stand, bear weight or move legs.  Was transported to  Hospital ER.  Patient was then transported from ER to Hospital where he remains hospitalized without a definitive diagnosis as of this date. Hospital was notified of immunization status.
Age: 45.0
Sex: U
Vaccine: FLU4
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache, Myalgia
Clinical narrative: Myalgias tachycardia dyspnea mild chest pain headache dizziness and vertigo fever (after Aleve 400mg and Tylenol) was 102.
Age: 45.0
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Tachycardia, Vertigo
Clinical narrative: Myalgias tachycardia dyspnea mild chest pain headache dizziness and vertigo fever (after Aleve 400mg and Tylenol) was 102.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 29-AUG-2017, the patient was inadvertently vaccinated with one expired dose of ROTATEQ (expiration date: 23-AUG-2017; dose, route of administration, and lot# were not provided). There was no adverse effects.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 2 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 15-SEP-2017, both patients were vaccinated with expired doses of GARDASIL 9 Lot # L014198 expired since 05-SEP-2017 for prophylaxis (dose, strength and route were not reported). No adverse effects were reported.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PPV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 2 year old female patient. The patient's concurrent conditions, medical history and allergies were not reported. On 13-SEP-2017, the patient was vaccinated with an unspecified improperly stored dose of VARIVAX, lot number M033905 with expiration date 28-JUL-2018, for prophylaxis (strength, dosage schedule, route and anatomical location were not reported), which was reconstituted with a properly stored sterile diluent (STERILE DILUENT). Concomitant therapies included M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, pneumococcal conj vaccine (unspecified), and hepatitis a virus vaccine (unspecified). No adverse event was reported. The administered dose experienced a temperature excursion of 15 to 46 degree Fahrenheit for 1 hour and 20 minutes;it was also reported that due to a natural event the VARIVAX was transported from the physician's facility to another in a refrigerator container instead of a freezer, and the container temperature was 40 degree Fahrenheit for 40 minutes for both outgoing and return trips, data logger was involved. No previous temperature excursion was reported. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA012166:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified amount of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. From 31-AUG-2017 until 21-SEP-2017, the patients were vaccinated with improperly storage doses of PROQUAD lot number N010866 with expiration date 01-OCT-2018, for prophylaxis (strength, dosage schedule, route of administration and anatomical location were not reported). No adverse events were reported. The vaccine doses were exposed to a temperature of 15 degree Fahrenheit (°F) to 46 °F (22.5 °F) for 4 hours and 1 minute. Previous temperature excursion was of -15 °F to 46 °F for 12 hours and 7 minutes. The data logger was involved. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA011291.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The reporter stated that, on an unknown date, the patient received an improperly stored vaccine, but she could not remember which lot number was administered among the following: ZOSTAVAX lot # N012493, expiry date 17-MAR-2019 (anatomical location, dose and route were not reported) for prophylaxis; or VARIVAX lot # N012132, expiry date 17-APR-2019 or lot # N014631, expiry date 17-MAR-2018 (anatomical location, dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). It was reported that, on an unspecified date, the unspecified vaccine was exposed to a temperature between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 40 minutes. The reporter stated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse, via a company representative, regarding an 82 year old female patient. The patient's medical history included breast cancer and colon malignancies. The subject's concurrent condition included rheumatoid arthritis. Concomitant therapies included methotrexate (manufacturer unknown) and prednisone (manufacturer unknown). In 2009, the patient was vaccinated with ZOSTAVAX injection (dose, lot number and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). According to the reporter, the patient had an active case of shingles at the time of reporting (reported as "now"). The reporter did not provide a causality assessment between the event and the suspect products.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to 5 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N012614, expiration date 16-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. The vaccines were reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of vaccines experienced the temperature excursion of 23.1 degrees Fahrenheit for 11 hours. Digital data logger was involved. There were no previous excursions reported.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: 2 days after getting the FLUZONE high-dose flu shot I began feeling nauseous, followed by diarrhea and the chills. I continue to still have these symptoms 5 days after injection.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Fatigue, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Received the pneumonia shot in right arm. Arm is badly swollen in shot area, itching, painful to use, feeling a bit tired, redness.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient was not actually seen in the office, but mom sent Dr. a message reporting a bump like rash that appeared the next morning. Started with about a dozen spots, noticed a few more the next day, then seemed to resolve shortly after that. No fever or other symptoms that mom noticed.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Painful muscles in left arm. Injection was given in left arm. Arthritic pain in knee joints. Started within 14 hours of injection.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Excessive redness and swelling at injection site, severe itching over entire body. Ice applied to site, loratadine 10 mg given.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling and redness at the injection site. Pain when lifting arm.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Hypertension, Urticaria
Clinical narrative: I received a flu shot. I do not know which one you list is the one that was administered. I would have to ask my doctor. Within a few days I developed hives on the trunk of my body. While they have lessened, I now have them on my face and arms as well. They tend to subside after 8-10 hours sometimes with the assistance of my topical psoriasis medication.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itching, swelling, redness, and warm at injection site.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Seizure
Clinical narrative: PATIENT EXPERIENCED PALENESS, SWEATING, DIZZINESS, LIGHTHEADEDNESS. SHE FELT THAT SHE HAD A SEIZURE.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Feeding disorder, Feeling hot, Gait disturbance, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: The day following my inoculation with flu vaccine (above) and polio vaccine (S51635 X10/18) I was unable to move. I ached all over, got out of bed with great difficulty, was unsteady walking in my apartment, could not engage in my usual activities or eat, found it difficult to lower myself onto the toilet seat and spent much of the next 24 hours in bed for the relief of just lying down or napping.  Although I did not detect a fever through hand on forehead, I seemed to be very heated internally, my breath came up very hot. The next morning I had lost two pounds but in every way felt energetic and fine, back to normal, taking my usual exercise class, walking outside at least 4 miles to shop. I have been getting the flu shot every year for many years and have never had such a reaction.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Weight decreased
Clinical narrative: The day following my inoculation with flu vaccine (above) and polio vaccine (S51635 X10/18) I was unable to move. I ached all over, got out of bed with great difficulty, was unsteady walking in my apartment, could not engage in my usual activities or eat, found it difficult to lower myself onto the toilet seat and spent much of the next 24 hours in bed for the relief of just lying down or napping.  Although I did not detect a fever through hand on forehead, I seemed to be very heated internally, my breath came up very hot. The next morning I had lost two pounds but in every way felt energetic and fine, back to normal, taking my usual exercise class, walking outside at least 4 miles to shop. I have been getting the flu shot every year for many years and have never had such a reaction.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site mass, Injection site pain, Myalgia, Pain
Clinical narrative: Patient is having left arm pain, body aches, joint and muscle pain, lump and tenderness at injection site, red spots on upper arm.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Patient is having left arm pain, body aches, joint and muscle pain, lump and tenderness at injection site, red spots on upper arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Discomfort, Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Patient called to inform us of the following adverse event with her vaccination. 9/22(Fri)- Patient received vaccination. States shortly afterwards right arm was red and in a lot of pain. 9/23(Sat)- patient states arm was red, painful,and now developed a fever. She called her doctor which told her to take ADVIL and BENADRYL. She followed her doctors advise and took ADVIL and BENADRYL. 9/25(Mon)- Patient states arm was getting worse. Now arm is extremely hot and the redness was not only at injection site but now it's a good portion of her arm. She re-called her doctor to inform her of her status. She was told to go to either a Urgent Care or the hospital. Patient decided to go to the hospital.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient called to inform us of the following adverse event with her vaccination. 9/22(Fri)- Patient received vaccination. States shortly afterwards right arm was red and in a lot of pain. 9/23(Sat)- patient states arm was red, painful,and now developed a fever. She called her doctor which told her to take ADVIL and BENADRYL. She followed her doctors advise and took ADVIL and BENADRYL. 9/25(Mon)- Patient states arm was getting worse. Now arm is extremely hot and the redness was not only at injection site but now it's a good portion of her arm. She re-called her doctor to inform her of her status. She was told to go to either a Urgent Care or the hospital. Patient decided to go to the hospital.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Influenza like illness, Mobility decreased
Clinical narrative: Patient called to inform us of the following adverse event with her vaccination. 9/22(Fri)- Patient received vaccination. States shortly afterwards right arm was red and in a lot of pain. 9/23(Sat)- patient states arm was red, painful,and now developed a fever. She called her doctor which told her to take ADVIL and BENADRYL. She followed her doctors advise and took ADVIL and BENADRYL. 9/25(Mon)- Patient states arm was getting worse. Now arm is extremely hot and the redness was not only at injection site but now it's a good portion of her arm. She re-called her doctor to inform her of her status. She was told to go to either a Urgent Care or the hospital. Patient decided to go to the hospital.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient called to inform us of the following adverse event with her vaccination. 9/22(Fri)- Patient received vaccination. States shortly afterwards right arm was red and in a lot of pain. 9/23(Sat)- patient states arm was red, painful,and now developed a fever. She called her doctor which told her to take ADVIL and BENADRYL. She followed her doctors advise and took ADVIL and BENADRYL. 9/25(Mon)- Patient states arm was getting worse. Now arm is extremely hot and the redness was not only at injection site but now it's a good portion of her arm. She re-called her doctor to inform her of her status. She was told to go to either a Urgent Care or the hospital. Patient decided to go to the hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac stress test, Laboratory test, Rash
Clinical narrative: This spontaneous report was received from a 63-year-old female patient with an allergy to penicillin and sulfur, who was reporting on herself. The patient was not pregnant at the time of this report. The patient's pertinent medical history and concurrent conditions included: asthma, acid reflux and unspecified surgeries. On 15-AUG-2017, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported) for prevention of shingles. Concomitant medication included unspecified inhaler. On 17-AUG-2017, reported as two days after getting the shot, the patient experienced rash on her arm and leg. Lab diagnostics studies included: unspecified stress test medications and "Upper gastrointestinal (GI)" (both performed on an unknown dates): results not provided. The patient sought medical attention. It was reported that there was no treatment given for the adverse event, however the patient stated that she was taking over the counter BENADRYL and unspecified eczema medication. The outcome of the event of rash on her arm and leg as well as the relatedness between the event and ZOSTAVAX were not reported. Additional information is not expected since there was no consent to further contact.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report received from a non-contactable pharmacist via a Pfizer sales representative. The pharmacist reported similar events for 3 patients. This is the 2nd of 3 reports.  A patient of unspecified age 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 administering Prevnar 13 on an unspecified date with outcome of unknown. Therapeutic measures were not taken as a result of the event. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017420663 Same reporter/drug/event, different patient;US-PFIZER INC-2017420662 Same reporter/drug/event, different patient.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Severe local swelling, redness and systemic signs of illness, fever 103, chills, body aches.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Patient received the flu shot at our pharmacy. The day after administration, the patient stated she had swelling, redness, and a lump under her skin at the injection site. This lasted for several days and then went away.
Sex: U
Vaccine: DTAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via Social Media and described the occurrence of vaccination failure in an unspecified number of patients who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be related to DTaP vaccine. Additional details were provided as follows: The age at the time of vaccination was not reported. The reporter stated that, actually, suspect vaccine was not working. The patients who are vaccinated against pertussis (DTaP) were becoming asymptomatic and were spreading whooping cough. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The reporter had not given consent to contact them further.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Thrombosis
Clinical narrative: Patient received a high dose flu shot FLUAD and returned before the 4 week interim asking for a PNEUMOVAX 23 5 days later. She requested it to be given in the same arm. The day following her arm became red, swollen, hot, and tender only from the pneumonia shot down to just below the elbow. Ultrasound at the doctor's office revealed a blood clot. Unsure of length. Patient recovered.
Age: 86.0
Sex: F
Vaccine: FLUA3
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Patient received a high dose flu shot FLUAD and returned before the 4 week interim asking for a PNEUMOVAX 23 5 days later. She requested it to be given in the same arm. The day following her arm became red, swollen, hot, and tender only from the pneumonia shot down to just below the elbow. Ultrasound at the doctor's office revealed a blood clot. Unsure of length. Patient recovered.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received these vaccines at well visit in 2016. Due to error in abstracting paper chart to EMR, repeat doses of TDAP and MENACTRA were ordered and administered in error. Parent notified by MD of vaccination error, Mother denies any adverse effects or reaction to vaccinations.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness
Clinical narrative: SORENESS TO SITE BEGAN IMMEDIATELY. PT ATTEMPTED IBUPROFEN FOR FIRST FEW DAYS, THEN STOPPED (DID NOT WANT TO TAKE MEDICATION ROUTINELY). PT CONTACTED HEALTH CLINIC THIS MORNING (09/29/2017) REPORTING CONTINUED MODERATE SORENESS ("NOT SEVERE") AND SOME WEAKNESS TO LEFT HAND (DESCRIBED AS SIMILAR TO THE WEAKNESS AFTER IT FALLS ASLEEP AND BEGINS TO WAKE (NO TINGLING/PRICKLING FEELING).
Age: 47.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Headache, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Within seconds of receiving both vaccine updates, I started experiencing left side facial tingling and a dull headache. I rested and seemed to dull effect. My tongue then became numb and tingling. The facial tingling resolved the next morning and tongue symptoms persists. After a week, my lower and upper lip started to tingling on both sides and feel tingling at left cheek. I have no headache or dizziness. No facial paralysis, swelling, or changes in speech. I contacted Occupation Health to report my symptoms on 9/27/17. I proceeded to see my own doctor on 9/28/17 for evaluation of persisting and progression tongue and facial symptoms.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: 8-12 HOURS AFTER RECEIVING VACCINE. VOMITING X 8.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Intensive care, Laboratory test normal, Lumbar puncture normal
Clinical narrative: Fever and intractable seizure requiring emergency room visit and hospitalization in intensive care unit.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever and intractable seizure requiring emergency room visit and hospitalization in intensive care unit.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Large (baseball size) area of redness and swelling. Area was hot to the touch and very tender/painful.  This started on Wednesday morning (the injection was received Monday evening. As of Friday morning, area is still swollen, redness is improving but still feels hot to the touch. Treated with ice packs and Tylenol. Was seen at urgent care for an unrelated issue but I asked the physician her opinion. She felt this is an adverse reaction to the vaccine and encouraged me to report it. The injection was given approximately 1 in above my left elbow.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Large (baseball size) area of redness and swelling. Area was hot to the touch and very tender/painful.  This started on Wednesday morning (the injection was received Monday evening. As of Friday morning, area is still swollen, redness is improving but still feels hot to the touch. Treated with ice packs and Tylenol. Was seen at urgent care for an unrelated issue but I asked the physician her opinion. She felt this is an adverse reaction to the vaccine and encouraged me to report it. The injection was given approximately 1 in above my left elbow.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Feeling hot, Flushing, Injection site rash, Injection site urticaria
Clinical narrative: I am not sure if the vaccine was called "FLUARIX," that may not be correct. The flu clinic said my daughter received a Glaxo Smith Kline quad prefilled syringe without preservatives, Lot # 27LY3. The day after the vaccine, she developed a rash with hives at the site of the injection, then a half hour to an hour later, she also developed facial flushing, felt hot all over, and her throat tightened (lump in throat, voice became hoarse voice higher pitched). She was treated with antihistamines, epi pen, and prednisone. First went to an urgent care clinic, then to the ER. Symptoms diminished after treatment.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: I am not sure if the vaccine was called "FLUARIX," that may not be correct. The flu clinic said my daughter received a Glaxo Smith Kline quad prefilled syringe without preservatives, Lot # 27LY3. The day after the vaccine, she developed a rash with hives at the site of the injection, then a half hour to an hour later, she also developed facial flushing, felt hot all over, and her throat tightened (lump in throat, voice became hoarse voice higher pitched). She was treated with antihistamines, epi pen, and prednisone. First went to an urgent care clinic, then to the ER. Symptoms diminished after treatment.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness (9" diameter around injection site), warmth to area. Tx "advised cold compresses at 20 min intervals, 600mg MOTRIN every 8 hours as needed for pain for the next 3 days. Ok to also take 10mg ZYRTEC once daily to help with itching. Advised to follow up if child develops a fever, reaction gets significantly worse in size and color and for any drainage from site."
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: States developed left deltoid redness, swelling and itching about 24 hours after event.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4X24T, expiry date 20th May 2018). On 20th September 2017, the patient received FLUARIX QUADRIVALENT. On 20th September 2017, less than a hour after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved. The reporter considered the tingling of extremity to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The healthcare professional reported that she was at work clinic and had administered FLUARIX QIV. The patient received the vaccine on the left arm. The patient experienced tingling in arm down to finger tips in the left arm. It happened within minutes after administering. It had been almost an hour after administration, but it did not resolve. No additional side effects were reported.
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a patient who received Meningococcal B vaccine. In August 2017, the patient received Meningococcal B vaccine. On an unknown date, less than a month after receiving Meningococcal B vaccine, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown. It was unknown if the reporter considered the fever and myalgia to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, 4 weeks ago, the patient received Meningitis-B vaccine at a different location and came into their office on 22nd November 2017 and was complaining of myalgia and fever. The healthcare professional was not sure if it was GlaxoSmithKline's BEXSERO and did not want to report patient identifiers.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: Patient received FLUZONE HD injection in left deltoid. After removing needle, the site started bleeding and within 1 minute, a large lump formed under the skin at injection site.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pain, Tremor
Clinical narrative: Patient complained of nausea, shakes, aches, pain and dizziness. Fever unknown. Recommended: fluids, rest, OTC APAP or ibuprofen for fever.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Numbness in both arms from shoulder down lasting ~15-20 mins, body weakness afterwards, shaking of both hands, hands with muscle rigidity. Following these, experienced bad diarrhea, abdominal cramps, lasting also for about 15 mins. After patient took a warm shower and tried to relax, she felt better and most symptoms subsided.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle rigidity, Tremor
Clinical narrative: Numbness in both arms from shoulder down lasting ~15-20 mins, body weakness afterwards, shaking of both hands, hands with muscle rigidity. Following these, experienced bad diarrhea, abdominal cramps, lasting also for about 15 mins. After patient took a warm shower and tried to relax, she felt better and most symptoms subsided.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Disorientation, Dyskinesia, Psychomotor hyperactivity, Speech disorder
Clinical narrative: Patients husband reported abnormal movements, speach, weakness and disorientation, hyperactivity.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Painful red.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site rash, Injection site swelling, Swelling
Clinical narrative: PATIENT CALLED OFFICE 2 DAYS AFTER RECEIVING VACCINE COMPLAINING OF SWELLING THAT STARTED ON PREVIOUS DAY. PATIENT SEEN BY MD IN OFFICE. RASH, WHICH STARTED ON LEFT UPPER ARM HAD GRADUALLY WORSENED AND SPREAD TO ELBOW. MD NOTED RASH TO BE CHARACTERIZED BY SWELLING, REDNESS, AND PAIN (JOINT PAIN). PATIENT WITH NO OTHER SYMPTOMS. PATIENT TREATED WITH RANITIDINE 150MG BID, CETIRIZINE 10MG DAILY, AND DIPHENHYDRAMINE 25-50MG AT BEDTIME FOR 1 WEEK.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia, Pruritus
Clinical narrative: PATIENT RECEIVED VACCINE ON 9/19/2017. PATIENT CALLED OFFICE ON 9/21 STATING HE HAD PAIN AT INJECTION SITE AS WELL AS REDNESS AND SWELLING FOR OVER A DAY. PATIENT INSTRUCTED TO TREAT WITH ICING/COLD COMPRESS, AND ACETAMINOPHEN AND IBUPROFEN.PATIENT RETURNED TO OFFICE 9/22. PAIN RESOLVED, BUT REDNESS/SWELLING HAD WORSENED. PATIENT COMPLAINED OF "MILD TINGLING" IN LEFT FIFTH AND ULNAR SIDE OF FOURTH FINGER, BUT NO WEAKNESS OR PAIN NOTED. PATIENT INSTRUCTED TO CONTINUE IBUPROFEN/ELEVATE ARM AND ICE ONLY 15MIN BID. PATIENT RETURNED TO OFFICE ON 9/23. REDNESS/ERYTHEMA DIMINISHED, FAINTER WITH MILD ITCHING. TINGLING/PAIN RESOLVED. CONTINUE TREATMENT.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Dysstasia, Flushing, Immediate post-injection reaction
Clinical narrative: Flushing, Nausea, Dizziness, Shortness of breath, Difficulty standing /sitting up. Occurred immediately after vaccine (about 1-2mins). Given Zofran 4mg SL and Benadryl 25mg. EpiPen was available for use but not needed. EMTs were alerted.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea
Clinical narrative: Flushing, Nausea, Dizziness, Shortness of breath, Difficulty standing /sitting up. Occurred immediately after vaccine (about 1-2mins). Given Zofran 4mg SL and Benadryl 25mg. EpiPen was available for use but not needed. EMTs were alerted.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Swelling face, Urticaria
Clinical narrative: 9/14 (day of vaccination) patient experienced dizziness and swelling of face - patient took BENADRYL. 9/15 patient experienced hives from head to toe.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot# M035147 with expiration date: 25-OCT-2017 (dose, route of administration and anatomical location were not reported) for prophylaxis that was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine doses were stored at 5.9 degrees Fahrenheit (F) for 45 minutes and at 8.3F for 1 hour and 30 minutes; a digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 2 patients of unknown age and gender. On unknown dates, the patients received the first dose of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. The authors considered the events to be related to M-M-R II. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA014639: US-009507513-1709USA014640.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse and refers to a 25 year old patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In March 2017, the patient was vaccinated with the first dose GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). In August 2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). There were no adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 67 year old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 16-SEP-2017 (reported as "10 days ago"), the patient was vaccinated with VARIVAX and sterile diluent (manufacturer unknown), for prophylaxis; instead of ZOSTAVAX (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported for neither of them). No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency, and route of administration were unspecified) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown). no adverse effects were reported. The lot number for the vaccines were as follows: M033910 (expiration date: 17-OCT-2017), N014942 (expiration date was unspecified) and lot# reported as M105925 (expiration date was unspecified). It was reported that there were multiple unspecified excursions since February 2016, and that it was found because of a digital data logger. No product quality complaint was involved.  Lot# M105925 was verified to be an invalid lot number for ZOSTAVAX.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 27-SEP-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose and route not reported) (lot # L036851 and expiration date 23-SEP-2017) for prophylaxis. There were no adverse events.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 221 patients of unknown age and gender. On unknown dates, the patients received two doses of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA012424:US-009507513-1709USA014640.