chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical, drug and allergy history or concurrent conditions. On unknown dates, the patients received improperly stored doses of LIQUID PEDVAXHIB lot # M032149 (dose and route of administration were not reported) for prophylaxis. The doses of LIQUID PEDVAXHIB were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (20.9°C) during a time frame of 1 hour 27 minutes, which was detected by the data logger. There was no prior temperature excursion. Neither adverse events, nor product quality complaints were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011988: US-009507513-1709USA011849.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally (dose, lot# and expiration date were not reported). There were no adverse symptoms reported. The temperature excursion and its time for administered doses of vaccine was unknown by the reporter. It was unknown if data logger was involved. There was an unspecified number of multiple ongoing excursions since April 2017. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011987: US-009507513-1709USA011849: US-009507513-1709USA011986:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager refers to unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ lot # M044397, expiration date: 20-JUN-2018, (route unspecified) for prophylaxis. Temperature: 32 ° F to 35 ° F, time frame: 37 hours. There was no previous temperature excursion. No adverse effects reported. Call was because of a data logger. No product quality complaint was involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA011647.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of unspecified age (reported as 65, Unit: unknown), and ethnicity received PREVNAR 13 via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The patient experienced "pain at the injection site" on unspecified date. Event took place after use of product. Outcome of the event was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable physician via a Company representative. A 17 year-old female patient of an unspecified race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced generalized malaise on 03Jun2017. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Initial unsolicited report received from a pharmacist (consumer) on 08-Sep-2017. This case involves a 50-year-old female patient who was vaccinated with a first dose of ADACEL (Batch number: U5654AA, expiry date: 27-APR-2019) in left arm via intramuscular route on 06-Sep-2017. Illness at time of vaccination: None, Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Not Provided. Any other vaccinations within 4 weeks of vaccinations noted above reported as none. On 06-Sep-2017, same day following the vaccination, the patient felt off she has tiredness and lightheadedness, patient said it went away and then came back last night with numbness to the left side of face including eye ear and top of head. Numbness on the top of her head, left eye and facial numbness, left sided tingling, lightheaded. Patient went to the emergency room as instructed by the nurse line of her insurance and they did testing and all were negative they told her it was a vaccine reaction and that she needed to be seen and evaluated by her primary provider for follow up she is awaiting a call back from them about an appointment. Patient was looking for info on course of action post AE and longevity of symptoms advised her everyone is individual and we can't provide info on this that she is following the right course of action with seeing her PCP who will evaluate her ER visit findings and make recommendations from there. EKG, CT scan, Blood work, all normal results. The patient received corrective treatment was not reported. On an unspecified date, patient was recovered from event tiredness and lightheadedness. The patient was not recovered from other events. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist (consumer) on 08-Sep-2017. This case involves a 50-year-old female patient who was vaccinated with a first dose of ADACEL (Batch number: U5654AA, expiry date: 27-APR-2019) in left arm via intramuscular route on 06-Sep-2017. Illness at time of vaccination: None, Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): Not Provided. Any other vaccinations within 4 weeks of vaccinations noted above reported as none. On 06-Sep-2017, same day following the vaccination, the patient felt off she has tiredness and lightheadedness, patient said it went away and then came back last night with numbness to the left side of face including eye ear and top of head. Numbness on the top of her head, left eye and facial numbness, left sided tingling, lightheaded. Patient went to the emergency room as instructed by the nurse line of her insurance and they did testing and all were negative they told her it was a vaccine reaction and that she needed to be seen and evaluated by her primary provider for follow up she is awaiting a call back from them about an appointment. Patient was looking for info on course of action post AE and longevity of symptoms advised her everyone is individual and we can't provide info on this that she is following the right course of action with seeing her PCP who will evaluate her ER visit findings and make recommendations from there. EKG, CT scan, Blood work, all normal results. The patient received corrective treatment was not reported. On an unspecified date, patient was recovered from event tiredness and lightheadedness. The patient was not recovered from other events. List of documents held by sender: none.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: One day post immunizations rash started on chest and has spread to back. Macular rash on chest. Give teaspoon of BENADRYL for itching.
Age: 1.25
Sex: M
Vaccine: MMR, PNC13
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 9-8-2017 - pt. started a rash on legs, arms, upper part of back, lower back and abdomen also fever. He presented with rash. It is located diaper area, on the arms and on the legs. It is located on the upper back, on the lower back, on the left upper back and on the upper abdomen. It is described as acute, intermittent and expanding. The color is described as pink and red. The symptom is sudden in onset. The symptom started 2-3 days ago. The complaint is mild to moderate. Important triggers include no known triggers.
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site urticaria, Local reaction, Swelling
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 31-MAY-2017 and concerns a female patient of unspecified age. On an unspecified date, the patient received Influenza Virus Vaccine Polyvalent (dose, route of administration, anatomical site, batch number, expiration date: not reported). On an unspecified date, the patient experienced local reaction, which included hives and swelling at the general area of injection. Also the patient had swelling in the arm pit of the injection arm. Her health care provider advised her to refuse influenza vaccination in future. The patient recovered from the adverse event on an unspecified date. The reporter assessed the causality of the events and the influenza vaccine as related. This report was not serious. Significant case correction was received on 14-Jun-2017: New event was added (swelling in the arm pit of the injection arm). Description to be coded was updated for the events local reaction, which included hives (from hives to injection site hives) and swelling (from swelling to injection site swelling) at the general area of injection. Causality assessment of the events was updated from unassessable to related.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram abnormal, Hypersensitivity, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: 1 hour after receiving PNEUMOVAX patient developed severe left arm pain and swelling, was admitted to Hospital, CT showed extensive fat stranding consistent with inflammation and possible infection. Note that pt had experienced similar but milder sx after receiving PCV-13 in April 2017. This history suggests an allergic reaction (not infection) because of the previous sx and the rapid onset of sx after vaccine administration.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall
Clinical narrative: Pt and mom standing at the nurses station waiting for updated vaccination record when all of a sudden a thud was heard. Pt was on the floor and asked mom why did you push me mom repeatedly. Mom stated honey I didn't push you, I think you fainted. Pt was then taken to an exam room vitals obtained and wnl, a cool cloth was given to pt and pt is now resting on the exam table with mom at her side. The reaction took place about 5 minutes after receiving the vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red raised bump, hot to touch at injection site. Also 5 days in bed with exhaustion, weakness and body pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Red raised bump, hot to touch at injection site. Also 5 days in bed with exhaustion, weakness and body pain.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Pharyngeal oedema, Pruritus, Swelling face, Wheezing
Clinical narrative: Wheezing, swollen face, swollen throat, itchiness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Hot to the touch reddened area that grew to be softball size over the course of 3 days. Went to a walk-in facility on 9/2/17 and was diagnosed with cellulitis, and given antibiotics. Prior to the going to the walk in, they used ice and MOTRIN.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema
Clinical narrative: PT presented to pharmacy with his right arm below deltoid muscle and above the elbow which was red. But not hot.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Kawasaki's disease
Clinical narrative: 16 year old male developed what was treated as Kawasaki's disease.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Hypersensitivity, Throat irritation, Urticaria
Clinical narrative: Had not received the adeno yet. 18 Y/O FEMALE WITH ALLERGIC REACTION after 20 mins. of receiving immunizations. She developed hives and throat itching. She had no difficultly breathing. Given 50 mg IM of BENADRYL was returned her living area for the remainder of the day. To follow up with an allergists.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Influenza like illness, Respiratory distress, Throat tightness
Clinical narrative: Patient reported having flu like symptoms and slight respiratory distress (in throat closing up) roughly about 6 hours after receiving the immunizations. Advised patient to take 2 of the diphenhydramine 25mg caps every 6 hours if having trouble breathing. Followed up with the patient the next day and he stated that he still felt like having the flu-like symptoms, but no trouble breathing at all.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pruritus generalised, Pyrexia
Clinical narrative: Patient developed fever, itchiness over body, bump on arm and swelling redness that spread from injection site, contacted md and they administered a steroid shot and zyrtec for the allergic reaction. Doctor told patient this was an allergic reaction.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Left arm is red (like a sun burn), hot to the touch, and itchy. Arm is also sore/tender and painful to the touch. It is red and swollen from the shoulder to the elbow. Ice helps with the pain. also experiencing a low grade fever and body aches.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Pyrexia, Skin warm, Tenderness
Clinical narrative: Left arm is red (like a sun burn), hot to the touch, and itchy. Arm is also sore/tender and painful to the touch. It is red and swollen from the shoulder to the elbow. Ice helps with the pain. also experiencing a low grade fever and body aches.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling abnormal, Feeling cold, Injection site pain, Injection site swelling
Clinical narrative: Mild soreness and swelling at injection site. Woken in the middle of the night with throbbing arm pain. In the morning patient was cold with the chills no fever and his hand felt funny. He was very itchy. The rash started a little before noon. The doctor on call recommended BENADRYL 50mg every 6 hours. In the afternoon the bottom lip swelled patient's wife called the Dr back and the Dr on call recommended an ice pack. If worse go to the ER. Pt went to ER and received two Epinephrine shots and was observed for 6 hours. He is still on the BENADRYL and will take for a few more days. He is still a little itchy. The majority of the itchiness is gone.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Lip swelling, Pain, Pain in extremity, Pruritus, Rash
Clinical narrative: Mild soreness and swelling at injection site. Woken in the middle of the night with throbbing arm pain. In the morning patient was cold with the chills no fever and his hand felt funny. He was very itchy. The rash started a little before noon. The doctor on call recommended BENADRYL 50mg every 6 hours. In the afternoon the bottom lip swelled patient's wife called the Dr back and the Dr on call recommended an ice pack. If worse go to the ER. Pt went to ER and received two Epinephrine shots and was observed for 6 hours. He is still on the BENADRYL and will take for a few more days. He is still a little itchy. The majority of the itchiness is gone.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Mild soreness and swelling at injection site. Woken in the middle of the night with throbbing arm pain. In the morning patient was cold with the chills no fever and his hand felt funny. He was very itchy. The rash started a little before noon. The doctor on call recommended BENADRYL 50mg every 6 hours. In the afternoon the bottom lip swelled patient's wife called the Dr back and the Dr on call recommended an ice pack. If worse go to the ER. Pt went to ER and received two Epinephrine shots and was observed for 6 hours. He is still on the BENADRYL and will take for a few more days. He is still a little itchy. The majority of the itchiness is gone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient called and stated that they had an injection site reaction. The site was very itchy, hot, hard. There was also some redness.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness/rash at injection site and warm to touch.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: The wrong vaccine was given to a patient while she was due for Tdap and IPV, she was given KINRIX which is DTAP and IPV combined. She is out of the age range for this vaccine at 17, where this is only used for 6 years and under. The lead CMA in this office reached out to agency and it was discussed with their education department on what steps to follow in this error. This was documented in agency in the patient's chart as received. Agency let us know that the patient will need to return in 4 weeks in order to be adequately protected against tetanus.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Chest X-ray normal, Culture urine negative, Full blood count normal, Metabolic function test normal
Clinical narrative: Fever T max 104 F on 7/27/17 at 10:00 am. Went to the emergency room and was admitted for observation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Viral test negative
Clinical narrative: Fever T max 104 F on 7/27/17 at 10:00 am. Went to the emergency room and was admitted for observation.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug hypersensitivity, Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: Patient's left arm was very sore, red, hot to the touch,w/ a rash (size of tennis ball). Right arm had a small rash and was warm to the touch but not swollen. After 2 doses of benadryl, patient is feeling better.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Disorientation, Gait inability, Headache, Hypersomnia
Clinical narrative: Disoriented when woke up on 9/17, chills, headache & shaking, incoherent, unable to walk, unable to phone for help. Slept on & off most of day. Unable to speak coherently until mid-afternoon. Felt better next day until late afternoon when shaking started again, lasted prox 1 hr. Went to local after-hours clinic, diagnosed reaction to flu shot. Prescribed 2 325mg Tylenol every 6 hrs. Feeling better after 7 days.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Incoherent, Tremor, Vaccination complication
Clinical narrative: Disoriented when woke up on 9/17, chills, headache & shaking, incoherent, unable to walk, unable to phone for help. Slept on & off most of day. Unable to speak coherently until mid-afternoon. Felt better next day until late afternoon when shaking started again, lasted prox 1 hr. Went to local after-hours clinic, diagnosed reaction to flu shot. Prescribed 2 325mg Tylenol every 6 hrs. Feeling better after 7 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Nausea and vomiting times one incident about 10:30PM 9-22-17. Arm red, swollen, and painful down to forearm continuing until present.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient received the following vaccines in error: HPV, MCV-4 MENVEO and Tdap. Patient was only to receive FLUARIX. Provider counseled parent and observed patient for 15 minutes post injection. Patient had no signs or symptoms of an adverse reaction.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Imogam Rabies-HT was expired the time of administration and not noticed before injection.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Myalgia
Clinical narrative: Left shoulder local rash(5x5cm), no prutitus, mild local muscle pain+, no general sx, started on Satureday 9/23/17. This patient took Tylenol po once on Saturday, and pain resolved. Rash became smaller and got better.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle disorder
Clinical narrative: Patient's muscle was knotted up.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Large (1.5 inch diameter) raised welt lasting 6 days, itching lasting 5 days, pain on day 6.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: On 09/21/2017 patient's arm was swollen from the shoulder down to the crease of her arm a few hours after getting the vaccine. Accompanied with pain. Around 7 pm. patient took TYLENOL extra strength when the pain began and every 4 to 6 hours after that. Patient also used cool compress and warm compress to help with the pain. Patient tried to move arm as much as she could however the pain was almost too bad to even lift her arm. Symptoms continued until 09/23/2017.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Pain in arm that has resulted in limited use of arm; arm seems to be getting better, but I still have trouble with certain movement like taking off my shirt, scratching my back, raising my hand. With past flu shots, my arm would hurt for a day or two. This time, the pain was more intense, resulted in limited use of arm, and is taking longer to go away.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient has experienced redness, soreness, swelling, and the right arm is warm to the touch. Patient stated that they felt some pain in their right shoulder upon movement. She has applied ice to her arm and has also taken Naproxen to decrease the swelling.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: PATIENT STATES RASH AND SWELLING DEVELOPED AROUND ARM AND SOUGHT CARE AT URGENT CARE FACILITY AND WAS PRESCRIBED STEROIDS.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Pt given FLUARIX quad injection complained of immediate pain.
Age: 17.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient came in for no shots no school with mother and was given MMR and Varicella SQ in the back of the arms. Patient was advised to wait 15 minutes just to make sure patient does not have any allergic reactions. Patient went and waited in the lobby. After a few minutes later patient had a red reaction around both MMR and Varicella injection sites. Dr. advised to take over-the-counter hydrocortisone cream and CLARITIN and to go to a doctor's office or ER if it became more severe and then patient left.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: The next morning, patient developed a rash on his left arm that itched at first but did not last long.  He had not had any reactions to previous flu vaccines as far as he could recall.  He said he did not take any medications, like Benadryl, to resolve the issue as it is starting to get better on its own.  I informed patient if the rash started getting worse again, he should let a healthcare professional know.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Paresthesias in right arm and leg. Treated with ice.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Lip swelling, Swollen tongue
Clinical narrative: Received seasonal flu vaccine on 9/14/2017 approximately 3pm. Awakened the next am (9/15/2017) with a swollen tongue, lips, flushed face. Took antihistamine upon waking, Reported incident to Employee Health Office at 915a, at this time stated the swelling had subsided. Encouraged to go to ER for work up, however patient declined going.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient experienced syncope following MCV vaccination. Was lying down with no injury, monitored for 15 minutes. Vital signs were stable.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site mass, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Patient reported that the morning after receiving the vaccines, she woke up with achey joints and fever. She said the site of the injection had a lump and was warm to the touch. She said over the next day, she developed a hives only on the arm where the vaccine was given (left arm).
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: No adverse event
Clinical narrative: No adverse events noted.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled, was red and warm to the touch. Uncomfortable.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Chills, Laboratory test, Myalgia, Pyrexia
Clinical narrative: Chills, fever, muscle aches, joint pain. Patient went to emergency room and primary care doctor.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site warmth, Urticaria
Clinical narrative: Arm was warm at injection site and patient developed redness and hives on arm and scalp.
Age: 52.0
Sex: F
Vaccine: FLU4, MMR, PPV, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Starting morning of 9/23/17 (patient was vaccinated on 9/22/2017), patient developed nausea and had symptoms of nausea/vomiting, fever of 102, headache, and very sore arm (in the arm in which she received FLUARIX and PNEUMOVAX). Patient reported that she had symptoms on all day on 9/23/17 and 9/24/17. On 9/25/17, patient stated that she has noticed improvement overall.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Injection site started to itch and turned red and hot the morning after vaccines received. By the second day the area of irritation had migrated down the arm toward the elbow. By the third day the reaction subsided and was only visible as a slight pink color.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Per patient, symptoms started at night on the day the shot was given. Started with a small bruise, swelling, a little tender, hot to the touch. Bruise spreads downward on the left arm, still hot to the touch; swelling has gone down; not much pain. Patient did not receive any treatment yet.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Red and swollen. Responds to ibuprofen. Pt thinks sensitivity. Is not concerned.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Loose stools. Blotchy, swollen, warm site on her arm.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Extra dose administered, Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Loose stools. Blotchy, swollen, warm site on her arm.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC13
Symptoms: Injection site warmth, Irritability, Mouth ulceration
Clinical narrative: Loose stools. Blotchy, swollen, warm site on her arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: On Monday Sep 18 the patient began to feel tired. On Tuesday Sep 19 the patient began to sweat and had to lie down on the bed because she felt she was going to faint (similar to vasovagal syndrome), also had nausea. On Wednesday Sep 20 the patient had nausea. On Thursday Sep 21 the patient began to have vertigo in addition to nausea. On Friday Sep 21 the patient felt tired, nauseous, and with vertigo, so that day in the afternoon, I decided to take her to Dr., our primary care physician.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Induration, Injection site swelling
Clinical narrative: Patient received influenza vaccine (FLULAVAL) on left deltoid. Right away I noticed swelling at the injection site. Patient developed quarter size induration without pain or tenderness. No redness. Patient was observed for 30 minutes in the office and no further symptoms reported.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX on 9/22/2017. On 9/24/17 her right arm at the site of the ZOSTAVAX injection was red, swollen, warm to the touch, and painful. She was also feeling a little lightheaded. The size of the redness on her arm was approx 1 x 3 inches. On 9/25/2017 her arm was still red, swollen, warm and painful. The size of the red area on her arm had increase to approx 2 x 4 inches. She had taken BENADRYL at bedtime on 9/24/2017. We called her doctor on 9/25/2017 to let her know of the reaction that had occurred. We will continue to monitor patient's arm every day.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Malaise, Pain, Peripheral swelling
Clinical narrative: Day of vaccine - that night large swelling to deltoid area: 1.5 in by 3.5 in. Very painful. That swelling remained for a week and actually moved to the front of the arm. 3 days later diarrhea started and continued for 10 days. 1 week later: General Malaise, body aches, fever, extreme fatigue, swelling to arm continued. Severe diarrhea continued.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Pt had PREVNAR 9/2016 and accidentally got PREVNAR again 9/24/2017 when she should have and wanted to get PNEUMOVAX. Haven't been able to get ahold of pt yet to see if any symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Skin warm, Swelling
Clinical narrative: Redness, swelling, hard nodule, hot to touch.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient woke up with severe arm pain in the shoulder, she was unable to move the shoulder at the time of reporting.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: Patient presented with red rash like spots on upper left arm, more on the side of the PNEUMOVAX administration site. Arm was also reported by patient as sore and unable to move.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Possible cellulitis. Redness and swelling in arm.
Age: 50.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Dizziness, Dyspnoea, Seizure, Syncope, Tremor
Clinical narrative: Patient got the flu shot first and was ok but after we administer the hepatitis A vaccine the patient started to faint/ experience what I saw as seizure (tremors and shaking) it resolved on it own within a couple of minutes where the patient was alert and he said he is very lightheaded then shortly he had another seizure episode but this time it was followed with gasping of air/difficulty breathing. We administered the EPIPEN right away. Within another 2-3 minutes he was alert again we laid him on the floor on his left side, he was fully alert and aware of what happened to him. In the meantime 911 was called they came over and checked him. He was back to work the same day and we kept monitoring his blood pressure/ condition all day. He was ok the whole day.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient experienced nausea and dizziness for 30 minutes after administration.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling
Clinical narrative: Itching started 30 min after swelling started (eye and lip) at 930-10p. BENADRYL brought down swelling, helped itching.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Body temperature decreased, Body temperature increased, Headache
Clinical narrative: Temp sub-normal, 96.5 degrees then 101 degrees, then 97 degrees severe abdominal cramping and headache. Went to clinic after several days of this.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: 29 yo patient receiving Typhoid vaccine (live) developed hives after the second dose. Patient took BENADRYL without improvement and went to the emergency room where prednisone and ZANTAC were given. Status improved. And hives. Prednisone actual dose unknown, Ranitidine actual dose unknown.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Incorrect dose given to patient - no adverse events occurred - please advise as to when to re-vaccinate.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: It appears injection given in the smallpox scar area of (L) arm/deltoid. Large red area (appx 3"x5") with warmth in area below injection site on upper (L) arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M17004, expiry date 31st October 2018). Concomitant products included ADACEL and GARDASIL. On 13th September 2017, the patient received MENVEO. In September 2017, less than a week after receiving MENVEO, the patient experienced injection site welling, injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site tenderness and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling, injection site tenderness and injection site erythema to be possibly related to MENVEO. Additional details were reported as follows: On 13th September 2017, the patient concomitant products included ADACEL in left arm (batch number U5810AB, expiry date 22nd November 2019 and GARDASIL. In right arm (batch number N013695, expiry date 21st March 2019). In September 2017, the patient had an injection site reaction after receiving MENVEO. The patient had swelling, tenderness, and a quarter sized area of erythema. The health care professional did not have dose number in any of the vaccines series and time or date of onset of event was not collected.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in an unspecified number of adult patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced rash and dizziness. On an unknown date, the outcome of the rash and dizziness were unknown. The reporter considered the rash and dizziness to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not applicable. This case was reported by field representative on behalf of health care professional. The field representative received email from the health care professional stating that, multiple patients experienced rash and dizziness after receiving FLULAVAL. No patient-specific details were provided for the individual patients therefore it was filled under one report.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm pain, tingling, burning started 3 hours after received flu shot. Described (L) elbow to little finger arm swelling for 24 hours. Symptoms started to resolve 40 hours post vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blood magnesium, Blood phosphorus, Electrocardiogram, Electroencephalogram abnormal, Eye movement disorder
Clinical narrative: Mother called on 9/21/17 @ 10:48 am stating that patient had reaction on vaccine site given on 9/18/17. He had red raised bump bigger than size of a quarter and it is swollen. Mother was offered an appointment to bring patient in same day, but she denied and wanted Dr. to return her a call. She took the patient to urgent care towards end of day when Dr. returned a call. Mother witnessed a seizure (described as rolling of eyes backwards with sleepiness. Was evaluated at hospital but EEG was normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Full blood count, Metabolic function test, Seizure, Somnolence, Vaccination site reaction
Clinical narrative: Mother called on 9/21/17 @ 10:48 am stating that patient had reaction on vaccine site given on 9/18/17. He had red raised bump bigger than size of a quarter and it is swollen. Mother was offered an appointment to bring patient in same day, but she denied and wanted Dr. to return her a call. She took the patient to urgent care towards end of day when Dr. returned a call. Mother witnessed a seizure (described as rolling of eyes backwards with sleepiness. Was evaluated at hospital but EEG was normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Vaccination site swelling
Clinical narrative: Mother called on 9/21/17 @ 10:48 am stating that patient had reaction on vaccine site given on 9/18/17. He had red raised bump bigger than size of a quarter and it is swollen. Mother was offered an appointment to bring patient in same day, but she denied and wanted Dr. to return her a call. She took the patient to urgent care towards end of day when Dr. returned a call. Mother witnessed a seizure (described as rolling of eyes backwards with sleepiness. Was evaluated at hospital but EEG was normal.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Body temperature increased, Neck pain, Pain, Rash
Clinical narrative: Pain started next day radiating to neck, torso and abdomen. Temperature went up 102 during the weekend. Lasted 24 hours. Rash spreading to chest, neck and left arm.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives/reaction after flu shot.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 21-Aug-2017, concerning a 64-year-old, elderly, female patient. It was reported that FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, approved for use in persons 65 years of age and older and not approved for use in adults 18-64 years of age. On 19-Aug-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number: 178501, expiry date: unspecified date in Apr-2018, anatomical location: not reported). As the patient was below 65 years, considered as inappropriate age at vaccination. The patient did not experience any adverse event after administration of vaccine. The outcome of the events was not reported. The pharmacist considered the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Rash
Clinical narrative: This initial serious spontaneous case, was received via company on 20-Jul-2017, reported by other health professional (nurse) concerning a female patient of unknown age. This initial serious spontaneous case, was received on 20-Jul-2017, reported by other health professional and concerns a female patient of unknown age. The patient's concomitant medication included MDV (dosage unspecified) with unknown preservative, taken, since an unspecified date. On an unspecified date in 2001 or 2002 (as reported) in the afternoon, the patient (nurse) was administered with influenza virus vaccine polyvalent (dose, route of administration, anatomical location, batch number, trade name, manufacturer was not reported). On the same day, in the late evening, after administration of INN Flu Vaccine Seasonal, the patient experienced rash allergic reaction (as reported) which required a visit to the emergency room. On an unknown date, the patient recovered from the event.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This non-serious initial spontaneous case, was received from a pharmacist on 15-Aug-2017, concerning a patient of unspecified age and gender. On an unspecified date, (reported as years ago), the patient was administered with INN Flu Vaccine Seasonal (influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination the patient developed redness and selling at the injection site. The outcome of the events was not reported.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, Feeling cold, Malaise, Muscle tightness
Clinical narrative: After administration of shots, he said he is not feeling well and feeling neck tightening or something happening in body. Called 911 and paramedics arrived.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Pain, Swelling, Tenderness
Clinical narrative: Symptoms started approximately 24 hours after vaccination he developed chills and body aches. She also developed raised, erythematous patch on (R) arm with tenderness to touch.
Age: 51.0
Sex: U
Vaccine: FLUC4
Symptoms: Hypersensitivity, Injection site rash, Rash
Clinical narrative: Allergic type rash on arm (inj site) neck, and trunk. Lasts 2 days but better today almost gone. Pt came by to inform me.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Vaccination complication
Clinical narrative: Had severe rash just below injection site and states was very painful. Rash was about 6 inches wide and firm covered must of her arm. She came to me to look at it on 9-22-17 she said she went to emergency room and they told her it was a reaction to vaccine and possible infection. She said they gave her antibiotics.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, MMRV
Symptoms: Injection site swelling
Clinical narrative: Mother reports shots were given around 10 AM. She noticed swelling on patient's left thigh down to his knee around 5 or 6 pm. States he could have had it sooner but he had long pants on. No other signs/symptoms, no Tx given.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: On 9/13/16 patient's father reported that after patient had received vaccines during the day of 5/11/2017 in our clinic that he had a seizure that evening. He reported that he had a fever of 100-101 degrees. Reports infant was taken to emergency room that evening and that his pediatrician is also aware of this event. He did not report any other information.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: Whelps, hives, itching.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: Patient was experiencing itchiness around the site of injection for 5+ days. Placed anti itch cream on site daily at least BOD x 5 days.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Cough
Clinical narrative: Chest pain, dry cough.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Flu vaccine at 11:30 am woke from nap at 2:30 pm with hives over torso and buttocks. Hives improved with BENARDYL.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Warm hard lump at inj site. Afebrile. Not painful.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Blood culture, C-reactive protein, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Rash started on 9-10-17; fever started 9-8-17; nasal D/C.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash, Red blood cell sedimentation rate, Rhinorrhoea, Viral test
Clinical narrative: Rash started on 9-10-17; fever started 9-8-17; nasal D/C.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Limb injury, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Pain immediately felt in (L) arm. Next day it hurt so bad. Tingling in fingers started. Hard time lifting arm, still present. Band aid was far up on arm almost to curve part of shoulder. Has tried pain medication, rest and heat w/no relief. Pt diagnosed with SIRVA.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Vaccination complication
Clinical narrative: Pain immediately felt in (L) arm. Next day it hurt so bad. Tingling in fingers started. Hard time lifting arm, still present. Band aid was far up on arm almost to curve part of shoulder. Has tried pain medication, rest and heat w/no relief. Pt diagnosed with SIRVA.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: 48 hours after Iz-MENVEO presented in office with 4-5 cm oval red, indurated area with expanding area of redness beyond marked area of initial redness treated for cellulitis with KEFLEX.
Age: 69.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 3 days after FLUAD (L) and ZOSTAVAX (R) pt presented with red, itchy hands/palms, non itchy welts on torso (6-10 up to 3/4" in diameter). No SOB, no redness at injection sites. Pt tried Calamine lotion. RPh suggested sm amt topical BENADRYL cream and call PMD. Seek med attention if any SOB or swelling, difficulty swallowing. Checked back 9/17 11AM. Pt said rash, itch red palms and welts went away after about 2 hr later.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site red, warm, hard and tender per patient. Induration and erythema measured at 30mm x 50mm on 9/15/17 at 3 pm. Patient took ZYRTEC in morning, BENADRYL at bedtime, Ibuprofen as needed, and applied ice packs several times a day as directed.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient received 2 vaccines in her right arm. It was sore later that day and continued to worsen into the next day. She went to the ER on 9/16/17 and received pain med and a sling to wear.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Injection site erythema, Insomnia, Malaise, Nasal congestion
Clinical narrative: Received Flu shot (L) arm 9/5/17. Developed malaise, sleeplessness-remained afebrile. Symptoms progressed to upper respiratory; nasal congestion and sore throat. Then developed mild low back pain and broke out in fine macular red rash on trunk of body from neck to waist. Increased redness noted at injection site. Rash also noted upper arm and in antecubital areas. Denies change in appetite, nausea, problems breathing or itching of rash. Remained afebrile. Symptoms resolved on own. ZYRTEC recommended-none used by employee.