chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age (also reported as under 65 year-old). The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown by reporter. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient received at the same time PNEUMOVAX 23 for the prevention of pneumococcal disease (strength, dose, route, Lot # and expiration date were not reported); ZOSTAVAX for the prevention of shingles (strength, dose, route, Lot # and expiration date were not reported) and an unspecified influenza virus vaccine (strength, dose, frequency, route, indication, Lot # and expiration date were not reported). On an unknown date, also reported as after receiving all the vaccines, the patient developed a localized site reaction that was warm to the touch (injection site warmth), painful (injection site pain), and had red streaks going from the site to the inside of the patient's arm (injection site erythema and injection site streaking). The patient visited the physician's office and received treatment for the adverse experiences. At the reporting time, the patient was recovered from injection site streaking, injection site erythema, injection site pain and injection site warmth. The causality assessment between the events and vaccination with ZOSTAVAX; PNEUMOVAX 23 and the unspecified influenza virus vaccine was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002496: US-009507513-1712USA002494: US-009507513-1712USA002495:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 03-NOV-2017, the patient was inadvertently vaccinated with a properly stored dose of expired M-M-R II (lot # M021731 with expiration date of 29-OCT-2017; strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assessment referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 24-MAY-2017, the patient was inadvertently vaccinated with one pediatric dose of VAQTA (lot # N012324, expiration date: 05-APR-2018) (frequency and route of administration were not provided) instead of one adult dose, for prophylaxis. No adverse effects were reported.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Arthralgia, Back pain, Condition aggravated, Insomnia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 19 year old male patient. No information on his concurrent conditions was reported. The patient's medical history included scoliosis and back pain. The patient received the full three dose regimen of GARDASIL (exact doses, route of administration, lot# and expiry dates were not reported) for prophylaxis on the following dates: 09-MAY-2014, 11-JUL-2014, and 02-JAN-2015. The patient was unaware if he had completed GARDASIL series and on 28-NOV-2017, he was vaccinated with a dose of GARDASIL 9 lot # N022727, expiry date 12-06-2020 (exact dose and route of administration were not reported) for human papilloma virus (HPV). On the next day physician became aware that patient had previously completed series of GARDASIL on dates mentioned above. The patient also received the TRUMENBA, lot# R56659, expiry date 31-JAN-2019 on the same day. Concomitant therapies included ALEVE taken as needed. In the evening of 28-NOV-2017, the patient experienced back pain. On a scale of 1 to 10, the pain was reported by the patient as a "7". The patient had difficulty sleeping and woke up with severe joint and back pain. The patient sought medical attention. The physician advised patient to take TYLENOL or ibuprofen to pain control and ordered blood work (complete blood count and Thyroid-Stimulating Hormone (TSH)) on 29-NOV-2017. The outcome of the events was reported as not recovered. The causality assessment between all events and GARDASIL 9 and GARDASIL was not reported. The reporter determinated that severe joint and back pain level was causing significant disability.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Arthralgia, Back pain, Insomnia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 19 year old male patient. No information on his concurrent conditions was reported. The patient's medical history included scoliosis and back pain. The patient received the full three dose regimen of GARDASIL (exact doses, route of administration, lot# and expiry dates were not reported) for prophylaxis on the following dates: 09-MAY-2014, 11-JUL-2014, and 02-JAN-2015. The patient was unaware if he had completed GARDASIL series and on 28-NOV-2017, he was vaccinated with a dose of GARDASIL 9 lot # N022727, expiry date 12-06-2020 (exact dose and route of administration were not reported) for human papilloma virus (HPV). On the next day physician became aware that patient had previously completed series of GARDASIL on dates mentioned above. The patient also received the TRUMENBA, lot# R56659, expiry date 31-JAN-2019 on the same day. Concomitant therapies included ALEVE taken as needed. In the evening of 28-NOV-2017, the patient experienced back pain. On a scale of 1 to 10, the pain was reported by the patient as a "7". The patient had difficulty sleeping and woke up with severe joint and back pain. The patient sought medical attention. The physician advised patient to take TYLENOL or ibuprofen to pain control and ordered blood work (complete blood count and Thyroid-Stimulating Hormone (TSH)) on 29-NOV-2017. The outcome of the events was reported as not recovered. The causality assessment between all events and GARDASIL 9 and GARDASIL was not reported. The reporter determinated that severe joint and back pain level was causing significant disability.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concomitant medication, drug reaction or allergies was reported. On 30-NOV-2017, the patient was vaccinated with ZOSTAVAX injection, lot # N021171, expiration date: 01-NOV-2018 (also reported as 01-SEP-2018)(dose was not reported) reconstituted in sterile diluent (lot#023305, exp. date: 12-JAN-2019) for prophylaxis. The dose of vaccine was inadvertently administered via a intramuscular route rather than recommended subcutaneous route. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-FEB-2014, the patient received ZOSTAVAX (lot number, dosage, and route of administration not provided), for its intended purpose the prevention of shingles. On or about 01-DEC-2015, the patient suffered from a shingles outbreak in addition to chronic pain, rash, and lesions to various parts of the body. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of the condition. The patient has sustained severe and permanent personal injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Shingles outbreak was determined disabling. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002495: US-009507513-1712USA002496: US-009507513-1711USA007577:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1711USA007577: US-009507513-1712USA002496: US-009507513-1712USA002494.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 25-OCT-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot number N011867 and expiration date of 08-NOV-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 9°C to 25°C with a time frame of 1 hour. There was no information regarding previous temperature excursion nor data logger involved. There was not product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002495: US-009507513-1711USA007577: US-009507513-1712USA002494:
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Loss of personal independence in daily activities, Pain in extremity, Tendonitis
Clinical narrative: Patient reported to writer on 11/30/17 that his left arm still hurts from flu shot that he had received on 10/19/17. Patient thinks flu shot was given too high. He stated that he is only 24yrs old and he should not have this kind of pain from a flu shot he had a month ago. Writer did refer him to his primary care physician even though he did not want to go because he does not want to pay the deductible on his insurance. Participant claims he is having trouble with things such as putting on his own seat belt in his car. Writer spoke with patient again on 12/4/17 regarding left arm. Patient stated that he has gone to urgent care and he is taking MOTRIN for 5 days and applying ice to his arm for 5 days. Patient claims that MD at urgent care stated he had "Tendinitis".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Erythema, Skin warm, Swelling
Clinical narrative: SWELLING, RED HOT TO THE TOUCH, BLISTERING.
Age: 0.58
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Following the 7 month old's well child check in room #3, he was supposed to receive his third dose of the DTaP, Pneumococcal and rotavirus vaccines, in addition to his first influenza vaccine. RN was supposed to enter a different room (#4) and administer the MMR, Varicella, and Hepatitis A vaccines to a 12 month old patient. The nurse entered the wrong room (#3) and identified the patient by the wrong first name (no last name or DOB). It has been disputed whether or not the mother heard or confirmed the wrong name for the patient. The child's mother proceeded to hold the child while Nurse administered the wrong vaccines to the child. There were no immediate adverse effects nor have there been any reported to date (5 days later). The mistake was realized by the nursing staff and reported to the physicians within the hour, although the patient and his mother had been allowed to leave with an immunization record containing the wrong vaccines. In a follow up phone call that evening I personally notified the parents via phone and we have since met in person to discuss possible adverse effects, the child's future immunization schedule, and a review of the practice's protocol for identifying patients and administering vaccines. I have also filed a incident report with our parent organization and personally reviewed the protocol and best practices separately with our entire office staff.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Redness and swellig - broke out with vesicles.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 12 month old patient of unknown gender.The patient's medical history, concomitant medications and drug reactions/allergies were not reported. On 09-NOV-2017, the patient was vaccinated with M-M-R II subcutaneous injection, lot # L041455 and expiration date 22-OCT-2017 for prophylaxis (dose number, frequency,route and therapy type were not provided). On 09-NOV-2017, the patient received an expired dose of M-M-R II (expired product administered). No adverse effects (no adverse event) reported. At the reporting time, the outcome of expired product administered is unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a 60 year old female patient who was referring to herself. The patient concurrent conditions were allergies, allergy to ragweed, oak, mold, dust and mildew. The patient's concomitant medications included allergy shots, NEXIUM for acid reflux, LYRICA for neuropathy and vitamins. On 08-NOV-2017, the patient was vaccinated with ZOSTAVAX to prevent shingles (dose, route, lot number and expiration date were not provided). Other suspect therapies included sterile diluent. On 09-NOV-2017, the patient's arm from the injection site down to the elbow was red and felt hot. The patient put ice on it, however it did not help. The patient stated there was no rash. On 10-NOV-2017, she went to the pharmacy where she had vaccine administered and was advised to talk with her physician. There was no laboratory diagnostic studies performed. The patient present status was not recovered. The relatedness between the event and suspect therapies was not reported.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Pt broke out with vesicles on left thigh (VARIVAX) given with redness 3 weeks after immunizations given.
Age: 79.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash macular
Clinical narrative: The patient's left arm (PNEUMOVAX 23) was extremely sore to the point that she described being unable to move her arm. She also noted red blotches on her upper arm. Symptoms lasted about 2 days. Patient had stated that her arm was very sore after the PREVNAR 13 so had chosen to get the PNEUMOVAX 23 in her non-dominant arm in case she had a similar reaction. She described this reaction as much more severe. Patient did not seek treatment or report the adverse reaction until 5 days after it resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness that is still unresolved. No mark or swelling.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Migraine, Pallor, Vomiting
Clinical narrative: Around 2 weeks later patient suffered severe migraine and vomiting. This has now occurred 3 more times since the first. Patient never did suffer from headaches/migraines beforehand. Each time the migraine happens, patient's complexion turns white, left hand goes a little numb and then she throws up and sleeps the rest of the day. This all usually happens around 9am when she's at school.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Conjunctivitis bacterial, Conjunctivitis viral, Eye discharge, Eye inflammation, Lacrimation increased
Clinical narrative: Rash appeared on left arm November 3rd AM. Eye was red. matted and watery when getting up November 4th at 8 AM. was that way till November 11 when I went to see Dr. November 11 went to Optometrist, Dr, diagnosed as bacterial conjuctivitis and received Ofloxacin eye drops prescription. November 16 went back to Optometrist, Dr. as eye was inflamed and matted again - received Tobramycin/Dexamethasone Susp. eye drops prescription. November 24 went to Dr. as eye was inflamed and matted again and received Polycin Ophthalmic Ointment. November 29 went back to Dr as eye was inflamed and matted again. Diagnosed as Viral Conjunctivitis. Was told to use Over the Counter Systane Moisturizing eye drops. December 5 - Called Dr.'s office, eye inflamed and matted again. Told to use no preservative over the counter eye drops.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Ocular hyperaemia, Rash
Clinical narrative: Rash appeared on left arm November 3rd AM. Eye was red. matted and watery when getting up November 4th at 8 AM. was that way till November 11 when I went to see Dr. November 11 went to Optometrist, Dr, diagnosed as bacterial conjuctivitis and received Ofloxacin eye drops prescription. November 16 went back to Optometrist, Dr. as eye was inflamed and matted again - received Tobramycin/Dexamethasone Susp. eye drops prescription. November 24 went to Dr. as eye was inflamed and matted again and received Polycin Ophthalmic Ointment. November 29 went back to Dr as eye was inflamed and matted again. Diagnosed as Viral Conjunctivitis. Was told to use Over the Counter Systane Moisturizing eye drops. December 5 - Called Dr.'s office, eye inflamed and matted again. Told to use no preservative over the counter eye drops.
Age: 47.0
Sex: M
Vaccine: MMRV
Symptoms: Measles antibody negative, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 47 year old male patient. The patient's concurrent conditions, drug reactions/allergies and concomitant medication were not reported. The patient's medical history included vaccination as a child but there were no records. On 02-NOV-2017, the patient was inadvertently vaccinated with PROQUAD (strength and dosage schedule were not reported) lot number: M049123 (expiration date: 13-JUN-2017) for prophylaxis instead of M-M-R II (strength, indication, dosage schedule and lot number were not reported). The patient needed to show immunity to measles so titers were drawn to assess immunity in November 2017, resulting low according to the reporter. Additionally, an unspecified treatment was given for the adverse event. The outcome of low measles titers was unknown, however the patient was doing fine at the time of reporting. The relatedness between the event and PROQUAD was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: This initial spontaneous report was received from Licensed Practical Nurse (LPN) via a field employee and refers to a female patient who was 9 or 10 years old. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with GARDASIL 9. Specifics about the dose, lot # and administration schedule were unknown, but the LPN did state that the patient received at least one dose of GARDASIL 9. In approximately 2016 (reported as about a year ago), the patient developed an unspecified adverse reaction after receiving GARDASIL 9. She saw a physician for the event. The outcome of the adverse event was unknown. The LPN did not provide causality assessment. The mother of the patient requested clinic medical records and planned to speak with a lawyer. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Administer FLUARIX on 10-30-17. Patient to Emergency room on 11-2-17 with rash under left arm pit and rash on left leg.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: The patient answered all screening questions and received the appropriate flu vaccination. After receiving the vaccination, the pharmacist instructed the patient to stay seated until they were ready while their documentation was printed. The patient stood up and proceeded to faint backwards into the partition dividing the immunization area. The pharmacist and technician rushed over to assist the patient and the patient's partner. The patient was conscious the entire time and both he and his partner denied repeated requests to contact 911. We offered other services to the patient, including blood pressure checks but all were denied except an ice pack and cold fluids. The pharmacist stayed with patient while they recovered and helped him to a sitting position when he was ready. This took about 10 minutes. After continuing to observe, the patient was assisted to a chair where they sat and drank more fluids and recovered. Repeated requests to call 911, the physician or perform blood pressure checks were denied as the patient stated they "were fine and just embarrassed". When the patient was ready after another 10 minutes, they asked to leave. The pharmacist assured the patient was stable and would not be driving or performing any other taxing duties. The patient was instructed to contact his PCP or 911 should he have any other symptoms.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: Brain natriuretic peptide normal, C-reactive protein normal, Cardiac stress test normal, Chest discomfort, Cough
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: Coxiella test, Coxsackie virus test negative, Cytomegalovirus test negative, Diarrhoea, Dizziness
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Exercise tolerance decreased, Fibrin D dimer normal, Full blood count normal
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: HIV test negative, Heart rate increased, Herpes simplex test negative, Influenza virus test negative, Metabolic function test normal
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Palpitations, Parvovirus B19 test negative, Poliovirus test negative, Red blood cell sedimentation rate normal
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 28.0
Sex: F
Vaccine: FLU4, SMALL
Symptoms: Respiratory rate increased, Troponin normal, Tunnel vision
Clinical narrative: 28 yo female received SPV (PMC VV03-019-C) and IIV (SKB 2GM7P) on 05 SEP 2017 in preparation for move. She states on Sat 16 SEP (day 11) she experienced increased heart beating sensation "out of my chest" and she noted increased breathing, although not truly SOB. She states on Monday she was shopping and became dizzy and experienced tunnel vision. She noted she had decreased activity tolerance such as climbing the stairs, (although was not working out due to pending move), and a dry cough. Her spouse reminded her of the SPV brochure, so after reviewing the recommendations she made an appointment to be seen on Tuesday. PCP sent her to ER and evaluation demonstrated positive troponins and abnormal EKG (ER reported as "non-scary R prime pattern, cardiologist later stated was WNL; report lost), but normal cardiac echo. She was referred to cardiology who did another echo and they collected lab work. She was discharge on ibuprofen 800 mgs po 3x day. She does recall diarrhea on Sunday 17 SEP which lasted 3-4 days. No nausea, emesis, or nasal stuffiness. She denies ever having an EKG prior to this event. She developed mild chest tightness, c/o palpitations and was placed on colchicine by cardiology on 28 SEP 17. Cardiac MRI, event monitor, repeat troponins, repeat echo WNL. Viral studies not consistent with alternate viral etiology. Symptoms fully resolved on follow-up on 02 NOV 17. 'Troponin was negative, stress test was normal, reaching 12 min, >85% MPHR without limitation.' Per note "Cardiac MR without evidence of acute inflammation or scarring. Stress test today with good exercise tolerance. Troponin is negative today as it was last visit. Patient is clear to exercise at own pace for 6 months. She should have a follow up, per HA with cardiology at 6 months. At that time she will have repeat EKG, troponin and stress test; as patient is moving.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: She called this morning 1115 am to say that her arm was swollen up twice its usual size. No shortness or breath, just "local" swelling and redness. Advised her to put ice pack on it and take pain reliever and call back. Phoned back at 240pm and reported that it's no better. She has "no elbow" and is allergic to BENADRYL. Still no breathing issues. Advised to continue ice and pain reliever. Reassured patient.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: "Sore Throat with golf ball in it", Headache, slight fever, generalized aches/pain. Seen at Urgent care and given Toradol for pain. Chest and lungs clear at examination but later reports shortness of breath.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of foreign body
Clinical narrative: "Sore Throat with golf ball in it", Headache, slight fever, generalized aches/pain. Seen at Urgent care and given Toradol for pain. Chest and lungs clear at examination but later reports shortness of breath.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis is the diagnosis and provider prescribed Keflex TID.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain, Weight bearing difficulty
Clinical narrative: Severe pain similar to what is expected after receiving a tetanus vaccine was present in my left arm at site of injection. Pain continued for a week. It started to subside and became a dull pain. Two weeks after dull pain started, the pain became severe again with no explanation. Motion continued to be limited during the entire time, with arm motions towards the front of the body and away from the body affected. Muscle weakness and inability to lift objects present. This pain is still present today.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Heart rate increased, Hypotension, Postural orthostatic tachycardia syndrome
Clinical narrative: Dizziness, fever, fainting, ER visit for fluids, unable to stand for long periods, low BP, high pulse (average 110-120 heart rate upon standing).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Syncope, Tilt table test positive
Clinical narrative: Dizziness, fever, fainting, ER visit for fluids, unable to stand for long periods, low BP, high pulse (average 110-120 heart rate upon standing).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Patient reported extreme weakness and pain to left arm after receiving PVC 13 vaccine. Pain and weakness to left arm progressed throughout the afternoon and evening, by evening she reported she was unable to lift her left arm. Denies fever, swelling and redness at injection site. Pain and weakness resolved within 24-36 hours after immunization had been administered.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Bursitis, Pain
Clinical narrative: Per the Life Services Manager: Suffering with pain from her vaccine. She has seen her doctor and started therapy. Her doctor and therapist explained that it?s an inflammation of the shoulder bursa.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: R upper arm pain persisting X 5 weeks.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: He has been experiencing pain when moving his arm out to the side since the injection date, but it has been slowly improving. He has been taking Tylenol as needed but has not sought medical treatment because the pain does not affect his daily functions.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 3 x 5 cm redness and swelling with itching at the site (seen 2 days after vaccine for initial treatment), given loratadine and topical Caladryl, resolved by 3 days after vaccine.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 17 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 Injection, 0.5 ml, intramuscular (lot # and expiration date were not reported) for prophylaxis. Later, on 13-NOV-2017, the patient received GARDASIL Injection, lot # M034780, expiration date 15-APR-2019 (dose and route not reported), as the second dose of the vaccination regimen. No adverse effects were reported and no PQC was involved.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from a consumer on 20-NOV-2017. This case involves a 09-year-old female patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number was unknown, expiry date, dose, dose in series and site of administration was not reported) via intramuscularly on 17-NOV-2017 at 03:30 PM. Patient's medical history and concomitant medications were not reported. No other vaccines received at that time of vaccination. No illness at the time of vaccination. On 17-NOV-2017 at evening, few hours post vaccination, patient began complaining of pain to the area and then she developed a 7cm in diameter area that had erythema and induration and was warm to the touch. Lab tests were not reported. As corrective treatment, physician when contacted told to treat with Motrin, Tylenol, Benadryl and ice as needed. It was reported that area remains at this time (not recovered), but induration and pain is improving (recovering). List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Broke out with vesicles 2 wks after immunization given.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Nausea
Clinical narrative: Patient developed headache that evening and woke up next day with worsening headache and nausea. Instructed to call family doctor.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis: Original therapy due to be Clindamycin. Dr. will be changing to another antibiotic.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, VARCEL
Symptoms: Rash vesicular, Swelling
Clinical narrative: Vesicular rash noted and swelling after IMM. Maybe related or may be viral exanthem.
Age: 40.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: Initially pain/redness/swelling in injection site (left shoulder) as expected. However on the third day the pain migrated to the muscle in my left armpit. This continued for perhaps a week, then migrated into the muscle on the back of the shoulder near the armpit. It continues to hurt now nearly a month later, and I cannot left my left arm straight out to the side without extreme pain.  Light stretching and exercise has had no effect. Resting it also has had no effect.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Pt called our office 12/4/17 following her vaccination on Friday 12/1/17. Pt reported that her right arm starting "swelling up like balloon" beginning Friday evening and went on through Saturday at work. She also stated "my heart was racing" and had some pain from the swelling, denies shortness of breath or difficulty breathing. Pt did not take self in to be seen or notify our office until Monday 12/4/17, when pt stated that the swelling had subsided, there was no longer any pain and she did not feel the need to be seen.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Heart rate increased, Hyperhidrosis, Injection site erythema
Clinical narrative: Dizziness, lightheadedness, nausea, tinnitus, mild throat constriction, rapid heart rate, clammy sweaty skin, and redness around injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Throat tightness, Tinnitus
Clinical narrative: Dizziness, lightheadedness, nausea, tinnitus, mild throat constriction, rapid heart rate, clammy sweaty skin, and redness around injection site.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of pain down the arm with swelling and redness. When examined there was minor swelling and no noticeable redness.  Patient claimed the intense pain kept her from sleeping.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain
Clinical narrative: Patient reports intense pain a few hours following injection. Patient reports pain that radiated all the way into her neck.
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: RED, SWELLING, FEVER ON SITE, HARD LUMP.
Age: 69.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Erythema, Injection site mass, Skin warm, Swelling
Clinical narrative: RED, SWELLING, FEVER ON SITE, HARD LUMP.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Dysgeusia, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediate metallic taste, (L) arm swollen x4 days, fatigue, fever, joint pain, nausea and diarrhea. Resolved by time of 2nd follow up (by phone) 12/5/17.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Immediate metallic taste, (L) arm swollen x4 days, fatigue, fever, joint pain, nausea and diarrhea. Resolved by time of 2nd follow up (by phone) 12/5/17.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Gait disturbance, Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: Cramp in right calf for about 4 days. Then pain when to both legs, making it real hard to walk. After about 8 days pain added to both shoulders and arms. This is when I stated going back to my doctor.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Cramp in right calf for about 4 days. Then pain when to both legs, making it real hard to walk. After about 8 days pain added to both shoulders and arms. This is when I stated going back to my doctor.
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Gingival swelling, Mouth swelling, Rash generalised
Clinical narrative: Later in the day patient had swelling of gums and mouth and a rash on body. She took over the counter antihistamines. The next morning she called the pharmacy. I recommended she go to PCP but she said feeling better.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm, large, red, raised circular area around the injection site, about 4-5 inches in circumference. Left deltoid.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: ARM SWELLED FROM ELBOW TO NECK RED INFLAMED PAINFUL THE NEXT DAY. TOLD TO ICE AND WATCH IF NOT BETTER SEE DOCTOR. WENT TO DOCTOR AND STARTED ON ABT. 95% BETTER TODAY.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Pain in extremity, Peripheral swelling
Clinical narrative: THE DAY FOLLOWING THE VACCINATION, THE PATIENT REPORTED HER ENTIRE ARM SWELLED AND WAS PAINFUL. SHE WAS ALSO RUNNING A TEMP. OF 102.2 (AT MD VISIT). THE PATIENT WAS ADMITTED TO THE HOSPITAL BY APRN ON 11/28/17 AND WAS DISCHARGED ON 12/4/17.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: So the reason for this is that the MMR was expired on 12/3/2017 and this was given to the patient on 12/4/17, there has be nor reaction or anything and we will re vaccinate the child in the 28 days. I was told by agency that I needed to send in this form. Mother of the child is aware on this issue and has scheduled to have her daughter brought in next month for us to re due the vaccine.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia, Urticaria
Clinical narrative: Patient reports hives to face, fever, aches and chills for 3-4 days after receiving the influenza vaccine. Also stated he had a similar reaction to the vaccine the year before.