chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit intermittently for 120 days and also 15 to 46 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because no consent was given for further contact. Sender's Comments: US-009507513-1703USA013763.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot# M041212, expiry date: 21-JUN-2019; lot# reported as M026306, expiry date: 30-APR-2018 (dose, route and site of administration were not reported). No adverse effects were reported. The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013756: US-009507513-1703USA013757: US-009507513-1703USA013755:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M024680, expiration date 18-MAY-2018 (dose and route of administration were not reported) for prophylaxis. The VARIVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions of 7.7 degrees Fahrenheit for 1 hour and 30 minutes, 9.9 degrees Fahrenheit for 1 hour and 30 minutes, 8.2 degrees Fahrenheit for 30 minutes, 13.3 degrees Fahrenheit for 1 hour and 30 minutes, 7.7 degrees Fahrenheit for 1 hour and 8.8 Fahrenheit degrees for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009513507-1703USA013690: US-009513507-1703USA013753.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M022400, expiration date 01-NOV-2017 (dose and route of administration were not reported) for prophylaxis. The PROQUAD was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions of 7.7 degrees Fahrenheit for 1 hour and 30 minutes, 9.9 degreees Fahrenheit for 1 hour and 30 minutes, 8.2 degrees Fahrenheit for 30 minutes, 13.3 degrees Fahrenheit for 1 hour and 30 minutes, 7.7 degrees Fahrenheit for 1 hour and 8.8 Fahrenheit degrees for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested. ; Sender's Comments: US-009513507-1703USA013690: US-009513507-1703USA013738:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot# M047658, expiry date: 28-OCT-2017, lot# M032492, expiry date: 02-MAR-2018; lot# M021124, expiry date: 02-FEB-2018; lot# M039202, expiry date: 11-MAR-2018, (dose, route and site of administration were not reported). No adverse effects were reported. The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013727:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot# M033337, expiry date: 13-APR-2018, lot# M031651, expiry date: 30-FEB-2018, orally (dose was not reported). No adverse effects were reported.     The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger. Additional information has been requested. Sender's Comments: US-009507513-1703USA013727: Original Case : 1703USA013727.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# M037771, expiry date: 21-FEB-2019, lot# M039642, expiry date: 03-JUL-2019, lot# M035487, expiry date: 23-FEB-2019, lot# M022077, expiry date: 10-MAR-2019, (dose, route and site of administration were not reported). No adverse effects were reported. The temperature was total time in the range of 9°C to 25°C for 3 hours. There was no previous temperature excursion. The call was because of data logger.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013727:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit intermittently for 120 days and also 15 to 46 degrees Fahrenheit for 1 hour. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected because no consent was given for further contact.; Sender's Comments: US-009507513-1703USA013715:
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Rec'd 12 yr. IMM. 3/23/17 at office. (RT) arm with redness, edema and warmth beginning that PM. Also with smaller area redness only to (LT) arm. Tx with BENADRYL and Ibuprofen with 6 degree area of redness outlined; to return if S/S worsen.
Age: 19.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Cough, Dyspnoea, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever, malaise, muscle aches (onset 2 hours post vaccines); fever resolved 4 day and later cough developed with 24 hours of vaccines, w/dyspnea
Age: 30.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Was supposed to administer the TDAP vaccine, gave DTAP-IPV vaccine by mistake.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Mom called in to office and said patient's arm was red at site of injection. Mom sent a picture to Dr.'s phone. Redness appeared to be 3x3 inch circle of redness on right deltoid area.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Hair disorder, Headache
Clinical narrative: Headache, Nausea, Shaking, Dizziness, Sleepy/fatigue.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Laboratory test, Liver function test, Nausea, Skin disorder, Somnolence
Clinical narrative: Headache, Nausea, Shaking, Dizziness, Sleepy/fatigue.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Tremor
Clinical narrative: Headache, Nausea, Shaking, Dizziness, Sleepy/fatigue.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Irritability
Clinical narrative: Infant developed irritability and blood in stools 4 days after vaccination continued with fussiness for 1 week after vaccines. Blood resolved after a few days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: ZOSTAVAX administer, injection site reaction 1-2 in diameter swelling and redness with pain radiating up and down her upper arm. Pt states swelling and redness continued to expand.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Anxiety, Urticaria
Clinical narrative: On 03/24/17 at 3:50 pm. Pt was administered vaccines GARDASIL, BEXSERO and MENACTRA. Pt. started to get hives around neck and chest area. Pt. was very anxious after vaccines.
Sex: U
Vaccine: HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-MAR-2017 from a medical assistant regarding multiple patients. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, multiple patients were administered improperly stored doses of VAQTA (lot # M036459, expiration date 18-JAN-2018) and ROTATEQ (lot # M014731, expiration date 05-FEB-2018).  No adverse effects were reported. Temperature : between 32 degrees Fahrenheit and 35 degrees Fahrenheit Time frame: 10 minutes Previous temperature excursion: yes: 47 degrees Fahrenheit to 77 degrees Fahrenheit for 15 minutes Was call because of a "data logger"? no Lot # M014731 has been verified as valid for ROTATEQ. No further information is expected.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a physician regarding his daughter, a 16 year old female who received her third dose of GARDASIL 9 injection on 17-MAR-2017 and has had a headache for 72 hours. The physician stated "it has begun to subside". No further information was reported. Causality was not provided. Patient present status was noted as 'not recovered'. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a female patient of unknown age, non pregnant. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date the patient was vaccinated with a dose of GARDASIL, intramuscularly, for prophylaxis, (dose, frequency, lot number and expiration date were not provided).        On an unspecified date in 2013, the patient experienced multiple sclerosis. The patient sought medical attention during an office visit. There was no hospitalization and no life threatening situation.  No product quality complaint (PQC) was involved. At the time of reporting, the outcome of multiple sclerosis was unknown. The causal relationship between GARDASIL and multiple sclerosis was not provided.  Upon internal review, multiple sclerosis was determined to be medically significant. Additional information is not expected as no consent to contact the physician was provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unspecified dates, the patients were administered several doses of improperly stored GARDASIL 9 injection (lot # M041990 with expiration date at 28-JUN-2019; dose, route of administration and anatomical location were not reported), for prophylaxis. The administered doses of vaccine were exposed to a temperature between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) for 28 minutes. There was a prior temperature excursion reported (date unspecified) during which vaccine was exposed to a temperature between 47 degrees Fahrenheit (F) and 77 degrees Fahrenheit (F) for 64 minutes. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date,  the patient was vaccinated with one of the improperly stored doses of VAQTA lot # M047658, expiration date 28-OCT-2017 (strength, dose number, route and anatomical location was not provided) for prophylaxis or RECOMBIVAX HB lot # M037248, expiration date on 21-FEB-2019 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The doses of VAQTA and RECOMBIVAX HB were in temperature of 50.7 °F (Fahrenheit ) degree for 45 minutes. There was no previous temperature excursion available. No adverse effect was reported and digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, administration route, lot number, expiration date and anatomical location were not reported) for prophylaxis. On an unknown date, the patient developed an unspecified injection site reaction (reported as "it was much worse than this one (reported on MARRS# 1703USA010172)). The outcome of the event was reported as fully recovered (on an unknown date) and the causality between the vaccination with ZOSTAVAX and the event was unknown. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010172:
Sex: F
Vaccine: HPVX, MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 13-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history was not reported. The concomitant medications included human papilloma vaccine (HPV) via an unspecified route of administration on an unspecified date for immunization. Approximately 1.5hours post vaccination she presented with headache with outcome of unknown. No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site streaking
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 19-year-old patient of an unspecified ethnicity and gender received 3 doses of TRUMENBA (Lot # R65027, exp Sep2017) via an unspecified route of administration at single dose: the 1st dose on 17Aug2016, the 2nd dose on 25Nov2016 and the 3rd dose on 21Mar2017 (Lot R65027 Exp Sep2017) for immunisation. The patient medical history and concomitant medications were not reported. The patient returned on 22Mar2017 with cellulitis at injection site with streaking with outcome of unknown.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: HPV given 1/27/16. Second dose. Pt seen in office for petechiae on 3/29/16 Blood test results positive for low platelets. Pt referred to Hematology with probable diagnosis of ITP. Diagnoses confirmed 4/4/16. Pt still treated by Hematology for ITP 3/1/17.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Pt developed fever, headache, diarrhea 5 days after injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: 5 inch 0.5 in redness, blisters with induration present at injection site (L) thigh. Warmth present. Tender with exam.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 9 days after vaccination patient still with C/O pain in arm at site of injection at times making it difficult to us or lift.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Electromyogram, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Left shoulder pain, numbness, tingling. Treated by Urgent care, Primary care, Emergency Dept, Sports Med and PT.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, X-ray
Clinical narrative: Left shoulder pain, numbness, tingling. Treated by Urgent care, Primary care, Emergency Dept, Sports Med and PT.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: FEVER TO 102.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Electromyogram, Fall, Hypoaesthesia
Clinical narrative: Severe pain in right upper back near inside of shoulder blade, tingling down my right arm and numbness in my thumb and first two fingers. Went for a deep tissue massage 10/21/16, did not help, saw my physician Dr. on 10/24/16 who referred me to Neurology for an EMG test on 11/1/16 which the Neurologist concluded Parsonage Turner Syndrome. Started Gabapentin. Got dizzy from the Gabapentin and fell down my stairs 11/26/16.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Severe pain in right upper back near inside of shoulder blade, tingling down my right arm and numbness in my thumb and first two fingers. Went for a deep tissue massage 10/21/16, did not help, saw my physician Dr. on 10/24/16 who referred me to Neurology for an EMG test on 11/1/16 which the Neurologist concluded Parsonage Turner Syndrome. Started Gabapentin. Got dizzy from the Gabapentin and fell down my stairs 11/26/16.
Age: 1.92
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: RAISED RASH - STARTED ON TRUNK THEN SPREAD TO FACE, NECK, ARMS AND LEGS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: PATIENT CALL AT 1:25PM TO OFFICE WITH COMPLAINTS OF HEAT, SWELLING AND PAIN AT INJECTION SITE LEFT DELTOID. UNABLE TO LIFT ARM PROPERLY. PATIENT INSTRUCTED TO COME TO OFFICE, SHE DID SO AND WAS SEEN IMMEDIATELY BY THE NURSE AND SUBSEQUENTLY BY A PROVIDER WHO PRESCRIBED ANTIBIOTICS FOR CELLULITIS DIAGNOSIS, THIS OCCURED THE DAY AFTER INJECTION.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Bed rest, Chills, Fatigue, Headache
Clinical narrative: Fever 101.0, chills, headache severe, joint pain, muscle pain, vomiting, nausea, fatigue. Treated with ale e Advil and bed rest.
Age: 34.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever 101.0, chills, headache severe, joint pain, muscle pain, vomiting, nausea, fatigue. Treated with ale e Advil and bed rest.
Age: 20.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Anxiety, Depression, Feeling hot, Nausea
Clinical narrative: Pt. c/o nausea after immunization. Pt denied any dizziness, pallor good. Given juice, crackers, she refused. BP 104/78, R 12, P 72.  Pt. states she was getting hot, repeatedly requested medication for pain, advised to have a seat, patient refused and left without further care. Patient returned later on 3/24/17 and subsequent call to 911 to send her to ER. When patient returned to have TST read on 3/27/17 she reported that they diagnosed her with anxiety and depression in ER and was following up with her doctor. Appeared in much improved spirits and with no observable impairment.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Blood test normal, Disturbance in attention, Endocrine test normal, Fatigue
Clinical narrative: Extreme Persistent Fatigue despite adequate rest, weakness, weight loss, brain fog, difficulty concentrating/attention, headaches, GI disturbances.
Age: 23.0
Sex: F
Vaccine: HPVX
Symptoms: Feeling abnormal, Gastrointestinal disorder, Gastrointestinal examination normal, Headache, Weight decreased
Clinical narrative: Extreme Persistent Fatigue despite adequate rest, weakness, weight loss, brain fog, difficulty concentrating/attention, headaches, GI disturbances.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site warmth
Clinical narrative: Right arm had a knot and was warm to touch where the BEXSERO Vaccine was given. Also, pt having trouble raising her arm and moving it around.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patient received the full 3 doses series of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. It was reported that the three doses might have been administered outside the schedule indicated in the prescribing information. It was unknown if the vaccines of GARDASIL 9 were administered too late or too early. No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Feeling hot, Hypoaesthesia, Muscular weakness, Neck pain
Clinical narrative: As soon as vaccine given, patient felt pain in neck on (L) side - same side as vaccine admin. Then saw "blackout lines", felt very warm, couldn't feel left side of arm, neck and had trouble breathing. All lasted about 45 seconds and everything became back to normal except left with pain and (L) neck weakness in area, no tingling in arms.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 14 cm x 7 cm area on posterior (L) arm of warmth and erythema, and edema. 2 cm circular induration at injection site. Entire area was pruritic and tender to palliation. Dx of cellulitis and allergic reaction to vaccine. Treated with doxycycline and oral steroids. Pt. was improving 48 hours later.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 14 cm x 7 cm area on posterior (L) arm of warmth and erythema, and edema. 2 cm circular induration at injection site. Entire area was pruritic and tender to palliation. Dx of cellulitis and allergic reaction to vaccine. Treated with doxycycline and oral steroids. Pt. was improving 48 hours later.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: 14 cm x 7 cm area on posterior (L) arm of warmth and erythema, and edema. 2 cm circular induration at injection site. Entire area was pruritic and tender to palliation. Dx of cellulitis and allergic reaction to vaccine. Treated with doxycycline and oral steroids. Pt. was improving 48 hours later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site 9 cm x 13 cm swollen area. TYLENOL PRN, BENADRYL and ice packs to site.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness to (L) LE day following vaccine. Pt reports that it is tender. Area measures 1.5" x 1.25". Treated with KEFLEX (250/5) 4 mL PO TID x 10 days. F/U 1 week.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Blood pressure decreased, Body temperature decreased, Dizziness, Gait disturbance, Nausea
Clinical narrative: Minutes after receiving Tdap, HPV and MCV4 vaccinations, patient had difficulty walking out to car and had to sit down due to lightheadedness, nausea, and felt like he was going to faint. We immediately took him back into the doctor's office where he had to lay down for about 30 minutes and was monitored by doctor and nurses due to low blood pressure. At one point he was at 82/52 BP.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Pallor
Clinical narrative: Minutes after receiving Tdap, HPV and MCV4 vaccinations, patient had difficulty walking out to car and had to sit down due to lightheadedness, nausea, and felt like he was going to faint. We immediately took him back into the doctor's office where he had to lay down for about 30 minutes and was monitored by doctor and nurses due to low blood pressure. At one point he was at 82/52 BP.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Emotional distress, Injection site erythema, Injection site induration
Clinical narrative: Pt was inconsolable per mom the evening after the vaccinations. Upon presentation to PCP 03/29/2017 pt was positive for single red induration on the ULT. Treating with TYLENOL.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Cerebrovascular accident, Eyelid function disorder, Facial paralysis, Facial paresis
Clinical narrative: STROKE LIKE SYMPTOMS. WENT TO ER, DIAGNOSED WITH BELL'S PALSY. WEAKENED MUSCLE ON ONE SIDE OF THE FACE. HAVE TROUBLE CLOSING ONE SIDE OF THE EYE. PATIENT RECOVERING GRADUALLY.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: On 31JAN2017 patient was 4 months old and was given a KINRIX (DTaP/IPV). KINRIX is only indicated/licensed for use in ages 4 years-6 years.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Received partial dose.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Firm, red rash on R upper arm.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient claims had swelling and pain for a few days at injection site.
Age: 0.25
Sex: M
Vaccine: DTAP
Symptoms: Eczema, Rash
Clinical narrative: Began breaking out in a rash over the next few days much worse than what it was prior to Dtap. Doctor confirmed eczema the following week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: She had the shot on 27th and she just noticed this morning had a about 4 inches of red mark around.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abasia, Blood glucose normal, Petit mal epilepsy
Clinical narrative: Absence seizure lasting a minute, could not walk, unaware of surroundings, no treatment.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Less than 24 hrs after injection pt C/O redness, swelling at site of injection, nausea,  vomiting, body aches, fever. 36 hours after injection, vomiting stopped, nausea, redness, body aches, and fever reduced.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Less than 24 hrs after injection pt C/O redness, swelling at site of injection, nausea,  vomiting, body aches, fever. 36 hours after injection, vomiting stopped, nausea, redness, body aches, and fever reduced.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site haemorrhage, Injection site pain, Loss of personal independence in daily activities, Weight bearing difficulty
Clinical narrative: This NICU nurse advised she was given her annual influenza vaccine on 9/13/2016 during shot-ex. She advised she was standing when vaccine given to upper portion of her left arm about 1-2 finger breaths below shoulder. She stated the site did bleed and required a band-aid. She returned to work and noted the site was sore for then next few days and began taking MOTRIN 800 mg orally. This eased the pain, but she advised pain worsened if no NSAIDs taken over next week. She advised over the last 10-12 days she has been having increasing difficulty dressing herself, lifting arm over head or at 90 degree angle, has difficulty lifting her purse due to weight or anything over 15 lbs. She denied any fever, site redness or swelling, trauma, recent travels or insect bites. ----10/6/16: this ICU nurse advised while on oral steroids (preferred oral vs IM) and using heat and oral MOTRIN her pain was markedly improved, though still present, she could use her arm and do mild ROM exercises. She completed her 5 day short burst on Sunday and over next 48 hours pain increased to point she could not lift arm over head to remove scrubs and she C/O pain with lifting/moving items over 10-15 lbs, especially with extension of her arm. MOTRIN is not controlling the pain any longer. She denies any weakness, paresthesia, numbness, discoloration to nail beds/skin, no stiffness in shoulder/elbow, no recent trauma or travels, no bug bites or past issues with her arm. Pain, unspecified.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: This NICU nurse advised she was given her annual influenza vaccine on 9/13/2016 during shot-ex. She advised she was standing when vaccine given to upper portion of her left arm about 1-2 finger breaths below shoulder. She stated the site did bleed and required a band-aid. She returned to work and noted the site was sore for then next few days and began taking MOTRIN 800 mg orally. This eased the pain, but she advised pain worsened if no NSAIDs taken over next week. She advised over the last 10-12 days she has been having increasing difficulty dressing herself, lifting arm over head or at 90 degree angle, has difficulty lifting her purse due to weight or anything over 15 lbs. She denied any fever, site redness or swelling, trauma, recent travels or insect bites. ----10/6/16: this ICU nurse advised while on oral steroids (preferred oral vs IM) and using heat and oral MOTRIN her pain was markedly improved, though still present, she could use her arm and do mild ROM exercises. She completed her 5 day short burst on Sunday and over next 48 hours pain increased to point she could not lift arm over head to remove scrubs and she C/O pain with lifting/moving items over 10-15 lbs, especially with extension of her arm. MOTRIN is not controlling the pain any longer. She denies any weakness, paresthesia, numbness, discoloration to nail beds/skin, no stiffness in shoulder/elbow, no recent trauma or travels, no bug bites or past issues with her arm. Pain, unspecified.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Rash, Urticaria
Clinical narrative: About 1 and a half hour, after vaccination patient got a rash on the left side of his face with hives. Dr. examined patient then recommended they give the child children's BENADRYL. When called later that day mom said the rash was not gone, but better. On 3/30/17 Mom called to report the rash comes back when the BENADRYL wears off.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: About 1 and a half hour, after vaccination patient got a rash on the left side of his face with hives. Dr. examined patient then recommended they give the child children's BENADRYL. When called later that day mom said the rash was not gone, but better. On 3/30/17 Mom called to report the rash comes back when the BENADRYL wears off.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Antinuclear antibody negative, Blood copper normal, Blood immunoglobulin A normal, Blood pressure increased, Blood thyroid stimulating hormone normal
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Borrelia test negative, Bronchitis, C-reactive protein normal, CSF test normal, Chlamydia test negative
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Complement factor C3, Complement factor C4, Complement factor normal, Cytomegalovirus test negative, Dermatitis
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyslipidaemia, Electromyogram abnormal, Electrophoresis protein normal, Exostosis, Full blood count normal
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hypertension, Inguinal hernia, Joint stiffness, Laboratory test normal, Lentigo
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Loss of personal independence in daily activities, Lumbar puncture normal, Lumbar radiculopathy, Muscle atrophy, Muscle contractions involuntary
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Muscle spasms, Myalgia, Mycoplasma test positive, Myositis, Nephrolithiasis
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Neurodermatitis, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Presbyopia
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).
Age: 38.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Spinal X-ray abnormal, Spinal osteoarthritis, Thyroxine free normal
Clinical narrative: Patient questions if current health issues were related to past influenza vaccinations, specifically H1N1 in 2009. Patient advised he recalls no immediate reactions following any vaccination other than a sore arm prior to and since receipt of H1N1. Last vaccines given were in 2011 w/o adverse reactions (Typhoid Vi, Td and Influenza vaccination). He recalls in 2009 he was bitten by a tick on his inner left thigh and recalls that same week given flu vaccine and that this BP was elevated (during physical). He recalls he completed a cardiology eval for c/o tightness in his left arm that persisted for a few months. He advised he would have episodic tingling to various spots to left toes, calf, quadriceps, fingertips, and that his arm/leg would ache with muscles appearing to "whither". These sensations slowly resolved. In Nov/Dec 2010, the weakness/numbness and tingling returned but now to entire left side and he was having muscle spasms. (Patient is right hand dominant). Duration is reported as lasting a few seconds to minutes, worse with exercise. Over last 2 years (2014-2016) he has had multiple workups and no definitive diagnosis. He advised episodes occurred daily in 2009 but now (2017) occurs maybe once a week. He finds while he remains ready and can do his job, his ability to do long distance triathlons is affected (tingling/pain in calves/quads, and fingertips/toes).