chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: White blood cell count increased
Clinical narrative: At approximately 3:00am on 10/04/16, patient awoke with her chest feeling heavy. She felt that her heart was beating heavily. She went back to sleep then awoke again shaking and feeling cold, heart still felt like it was beating fast/strong. She again fell back to sleep. She awoke at 6:00 AM(when she normally would prepare for work) but felt very tired and weak, her chest still felt heavy. She had recently (7/30/16) suffered a stroke so she was worried that something serious was happening. Her right arm at the site where she had received the PREVNAR 13 vaccine was red and raised. She measured her blood pressure and found it to be 144/102 (her usual reading would be 135/75), her heart rate was 113 (her usual was appx 70). She took her blood pressure medication and a low dose aspirin. She called 911. The EMT found her to have a low grade fever (100.3). She was given an EKG. She was told that she was having PVC's at the rate of 1 every 5 seconds. Her blood work and stress test were normal. She had an elevated WBC which was expected due to her fever. Doctor diagnosed her to have had an adverse reaction to her PREVNAR 13 vaccine. Over time, (2-3 hours) she felt better and her symptoms went away. She was discharged.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Cataplexy, Crying, Sleep study
Clinical narrative: Patient had a second HPV 9 shot on 8/18/16 and a wk after the second shot is when the cataplexy set in. We were not supposed to have the sleep study until 11/29/16. But I called them crying telling them I could no longer wait.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Pt got flu shot on 10/3/16 came on 10/6/16 with about a 4x4" welt which it seemed like blood had leached under the skin. It had started to clear from injection site down but patient was concerned.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Swelling on inner arm and extended to elbow area. Painful that she could not raise her arm, little rash on inner arm and red. Pt was treated w/ an antibiotic and Ibuprofen.
Age: 10.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Wrong drug administered
Clinical narrative: (None-symptoms). DTaP administered instead of Tdap. Physician notified; health dept. contacted.
Age: 18.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Diarrhoea, Hyperhidrosis, Malaise
Clinical narrative: Sweating all night at home, reports diarrhea, feels ill but went school - educated mom may give TYELNOL/Ibuprofen, BENADRYL
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Rash to both left and right thighs, red, hard raised areas at site of injection.
Age: 35.0
Sex: M
Vaccine: FLU4, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: None. Patient received PCV 13 in error, should have received PPV 23. Elt tobacco use.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Complains of tenderness in left deltoid muscle and induration  - has not redness, swelling, rash.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient given flu vaccine at 10 am 10/10/16. Developed hive over ankle at 5 pm 10/10/16. Hives progressed over the next 16 hours to cover face, trunk, limbs. Some hives were very large. They waxed and waned but totally resolved with BENADRYL. No SOB, wheeze, stridor, GI or pt changes.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Diplopia, Dizziness, Headache
Clinical narrative: Reported double vision, dizziness, frontal headache "8" on a 10.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysarthria, Feeling drunk, Mobility decreased
Clinical narrative: At the night after the immunization, pt felt like hungover and C/O slurry speech. Pt could not move her arm and felt weak. Pt had same side effect last yr with PREVNAR 13 and FLUZONE HD. She was not sure of PREVNAR or FLUZONE causing the side effect.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pruritus
Clinical narrative: Pt felt itching on his right arm 10/3/16 late night when he was sleeping. He scratched his arm and developed rash on his right arm. Rash was about 6mm length when he came into the pharmacy. The rash diminished after he applied the pack over it. The rash was almost gone on 10/6/16.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Loss of consciousness, Nausea, Pallor
Clinical narrative: Patient c/o pain at injection site then passed out approximately 5 minutes later. After rest/monitoring approximately 1 hour released in good condition. No adverse Rx at IM site. Vitals WNL. Patient fatigued, N/V, pale.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient c/o pain at injection site then passed out approximately 5 minutes later. After rest/monitoring approximately 1 hour released in good condition. No adverse Rx at IM site. Vitals WNL. Patient fatigued, N/V, pale.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Pt. received vaccination 9/9/16. On 9/11/16 started having flu like symptoms which got worse over time. Went to PCP to get TAMIFLU 10/10/16.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives - (moderate).
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Right (arm shoulder neck upper back) tingles, redness, swelling sensation.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis to (R) thigh, red swollen, painful. Evaluated at Urgent Care.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Pyrexia, Retching
Clinical narrative: 5 hrs post vaccination pt experienced, chills, sweats, fever 102 degrees - dry heaving. 8-10 - after treatment with analgesics - fever decreased to 99.8. 24 hr complete resolution of adverse symptoms.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site scab, Injection site scar, Injection site vesicles
Clinical narrative: Developed skin erythema on site of injection 2 days after, then progress to blister, scabbing and scarring.
Age: 86.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Entire upper arm swollen, erythematous, tender and painful on right arm. Pt. has hx of latex allergy.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No reactions seen in clinic. Pt was given KINRIX which is for ages 4-6, Pt is only 5 months.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Malaise, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Got flu vaccine on Wed 9/28/16. On 9/29 in am began vomiting, horrible stomach ache, stiff neck and horrible body aches. As day went on, on 9/29 all symptoms got worse vomiting at work all day. Nausea all the time and body aches . Had to take 9/30 off because I was so sick.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Got flu vaccine on Wed 9/28/16. On 9/29 in am began vomiting, horrible stomach ache, stiff neck and horrible body aches. As day went on, on 9/29 all symptoms got worse vomiting at work all day. Nausea all the time and body aches . Had to take 9/30 off because I was so sick.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, warm area noted 24 hours after FLUZONE given. Remained for 24 hours then seen in clinic. Given BENADRYL 25 mg PO. Redness slightly decreased.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Discomfort and slight pinkness at inj site day after flu shot area warm to touch. Has tennis ball sized lump at site of inj.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctival hyperaemia, Cough, Eye discharge, Eyelid oedema, Hyperhidrosis
Clinical narrative: Approximately 2 hrs after flu vaccine given developed persistent cough, then myalgias, nausea, diaphoretic. Eyes developed discharge, lid swelling and conjunctival infection. Cough resolved in approximately 2 hrs, VSS, symptoms gone in approximately 24 hrs.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea
Clinical narrative: Approximately 2 hrs after flu vaccine given developed persistent cough, then myalgias, nausea, diaphoretic. Eyes developed discharge, lid swelling and conjunctival infection. Cough resolved in approximately 2 hrs, VSS, symptoms gone in approximately 24 hrs.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site haemorrhage, Injection site swelling, Skin warm
Clinical narrative: Pt. arm is red and warm to touch. Site has some swelling and ecchymoses. The site on upper arm is 65 mm vertical and 60 mm horizontal.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Pt arm is red and warm to touch, redness has hard tissue under the skin (hard as a golf ball). Red site is 70mm horizontal and 60mm vertically. Site is tender to touch.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Site of upper left arm, deltoid muscle has a very hard lump under the skin 35mm x 35mm in a circular shape. Site is very tender to touch.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: 10/8/16 Headaches, dizzy, tired. 10/09/16 Dizzy, stiff neck during the day. 10/09/16 Fever onset in evening. 10/10/16 Fever, photophobia, neck pain, frontal headache, malaise.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Neck pain, Photophobia, Polymerase chain reaction, Pyrexia, Streptococcus test negative
Clinical narrative: 10/8/16 Headaches, dizzy, tired. 10/09/16 Dizzy, stiff neck during the day. 10/09/16 Fever onset in evening. 10/10/16 Fever, photophobia, neck pain, frontal headache, malaise.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: Pt arm is red and warm to touch. Site starts 110mm from top of shoulder/arm. Redness is 75mm vertical and 55mm horizontal.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration
Clinical narrative: Pt left arm (upper) has hard band at injection site band width is 80mm x 35mm vertical. Tissue in measured site is extremely hard. Pt description is "hard as a rock". PHN agrees.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Approx. 5 minutes later patient developed hives and itching above and below injection site (left deltoid) 5-10 minutes patient felt itches all over (stomach area). I gave her a diphenhydramine 50mg/ml injection on her right deltoid and called 911. EMT came and took her to hospital. 10/08/16 4:58pm patient called us and said she came home last night and she is ok now.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient received FLUZONE HD 3:45-4:00 pm on 10/07/16. 10/08/16 at 9:15 am patient called and said he developed hives around 11 pm last night so he went to the ER. He got prescriptions for prednisone 60 mg for 4 days and BENADRYL as needed. As of this morning he said he has no more hives and feeling fine back to normal. He wanted to know if he still needs to take the prednisone.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Flu shot while I was seated. Pain in shoulder at onset. Pain intensified and continued to this day. Have had 2 courses of physical therapy and two cortisone shots. Pain continues. Doctors now prescribing surgery.
Age: 2.0
Sex: U
Vaccine: DTAP, FLU4, HEPA, HIBV, PNC13
Symptoms: Erythema, Gait disturbance, Skin warm, Swelling
Clinical narrative: Was evaluated in urgent care two days after vaccines received and started on antibiotics for red, swollen, hot left leg. Initially couldn't walk on leg, was evaluated in clinic 5 days later, swelling better, still with redness.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored doses of PNEUMOVAX 23 (M022086 expiry date: 09-OCT-2017 and L040053 expiry date: 10-MAY-2017) (route of administration not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with first dose of ZOSTAVAX (lot #, dose, route and site of administration were not reported). Approximately one year after the first dose, the patient received second dose of ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored doses of PEDVAXHIB lot # M001814, expiry date: 15-OCT-2018 (route of administration was not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored doses of ROTATEQ, orally (L039638 expiry date: 23-AUG-2017, L046320 expiry date: 29-SEP-2017 and M019690 expiry date: 02-NOV-2017, lot reported as: L033637 expiry date: 06-JUN-2017). No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified 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 PEDVAXHIB (lot # M020101, expiration date: 07-MAR-2019) (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 37 patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown dates, patients were vaccinated with improperly stored VARIVAX (35 of them were vaccinated with lot # L042267, expiry date 27-OCT-2017 and 2 of them with lot # M005971, expiry date 02-FEB-2018) (route and site of administration, dose and strength were not reported). No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. The patient was not allergic to any drug. On 18-JUL-2016 the patient was vaccinated with ZOSTAVAX (dosing details were not reported) (lot # L046897, expiry date: 23-FEB-2017) in the right arm for vaccination. There were no concomitant medications administered by the patient. On an unknown date in 2016 after vaccination the patient had a quarter size red mark that does not itch or hurt at the injection site. The patient did not receive any treatment for the event. The outcome of the event was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, frequency and route of administration were not reported) with lot number of M007963 and expiration date of 15-AUG-2017. No adverse effects were reported. No further information was provided. Additional information has been requested. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, frequency and route of administration were not reported) with lot number of M007963 and expiration date of 15-AUG-2017. No adverse effects were reported. No further information was provided. Additional information has been requested. This is one of the several reports received rom the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (public health nurse) referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L038522 with expiration date 11-AUG-2017; dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 22-AUG-2016, the patient received first dose of GARDASIL 9 (lot#, expiry date, dose, route and site of administration were unspecified). On 22-SEP-2016, the patient inadvertently received as second dose GARDASIL lot# K011562, expiry date 08-APR-2017 (dose, site and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Chest pain, Dizziness, Syncope, Tachycardia
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (route of administration, lot number and expiry date were not reported). No concomitant therapy was reported. On an unknown date, after receiving Gardasil 9 (confirmed that not GARDASIL), the patients experienced syncope, dizziness, chest pain and/or tachycardia. At the time of the report, the outcome of syncope, tachycardia, dizziness and chest pain was not reported. Relatedness between syncope, tachycardia, dizziness, chest pain and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reaction/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses GARDASIL 9 (lot # was reported as M00764 with expiration date 30-JAN-2018; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD (lot # was reported as M034933 with expiration date 11-MAR-2017; dose and route were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 27-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5ml, lot # K024976, expiration date 09-JUN-2016) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored GARDASIL 9 (route of administration was not reported) (L037554 expiry date: 25-DEC-017, M011840 expiry date: 01-FEB-2018, L023905 expiry date: 27-MAY-2017 and L037003 expiry date: 27-MAY-2017.) No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # L010598, expiry date: 06-AUG-2016 (route of administration was not reported). No concomitant therapy was reported. The patient did not experience any adverse effect. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Maternal exposure before pregnancy, Pain
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers on herself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Approximately in 2009 (reported as "approximately 7 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and expiry date were not reported) 1 injection, intramuscular. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were not reported. The pregnancy outcome was outcome pending. On an unknown date (reported as "recently"), the patient experienced "shingles-like" pain "all over, especially in her feet and thighs". No treatment was given. The patient did not seek medical attention. The outcome of "shingles-like" pain "all over, especially in her feet and thighs" was reported as not recovered/not resolved (reported as "still occurring"). The relatedness between vaccination with ZOSTAVAX and "shingles-like" pain "all over, especially in her feet and thighs" was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Erythema, Flushing, Oedema peripheral, Petechiae
Clinical narrative: 9/20 - 9/27/16 - Pt. started having joint pain (knees and ankles) and edema in feet and ankles. 9/22/16 - 9/25/16 - Pt. had rash on stomach, neck, petechial rash without itching and bright red flushed look on face and neck.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 9/20 - 9/27/16 - Pt. started having joint pain (knees and ankles) and edema in feet and ankles. 9/22/16 - 9/25/16 - Pt. had rash on stomach, neck, petechial rash without itching and bright red flushed look on face and neck.
Age: 5.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No s/s- Treatment consist of informing pt's mother-we called family next day to check on child was reported to be fine. Without s/s of fever or redness (L) arm.
Age: 5.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No s/s- Treatment consist of informing pt's mother-we called family next day to check on child was reported to be fine. Without s/s of fever or redness (L) arm.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date, the patient was vaccinated subcutaneously with the first dose of ZOSTAVAX injection (dose, lot # and expiration date were not reported). On 07-OCT-2016, the patient was vaccinated subcutaneously with the second dose of ZOSTAVAX injection (dose, lot number and expiration date were not reported). No adverse effects were reported. There was no product quality complain involved.  Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Drug administration error, No adverse event
Clinical narrative: No known adverse reactions. Reporting this due to the fact the clinical staff administered two vaccines on the same day that should not have been administered together.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant referring to an adult patient of unknown age and gender. Information regarding pertinent medical history, drug reactions/allergies or concomitant medication was not reported. On 05-OCT-2016, the adult patient was vaccinated with a pediatric dose of RECOMBIVAX HB (strength: 5/0.5 microgram/ml, lot # M000442 with expiration date 31-MAR-2018), intramuscularly (inappropriate schedule of drug administration and incorrect dosage administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, might between 07-SEP-2016 and 22-SEP-2016, the patients were vaccinated with doses of frozen ZOSTAVAX (lot #, expiration date, dose and route were not reported). It was reported that the vaccine was reconstituted with improperly stored sterile diluent (lot # K024556 with expiration date 01-OCT-2017; lot # M019199 with expiration date 16-OCT-2018; lot # K019030 with expiration date 21-AUG-2017; lot # L044085 with expiration date 29-MAY-2018). The sterile diluent was improperly stored at -0.1 Celsius (C) for cumulative 131 hours. There was previous temperature excursion: 15 C for 15 hours. Data logger was involved. ZOSTAVAX was properly stored. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, might between 07-SEP-2016 and 22-SEP-2016, the patients were vaccinated with doses of frozen VARIVAX (lot #, expiration date, dose and route were not reported). It was reported that the vaccine was reconstituted with improperly stored sterile diluent (lot # K024556 with expiration date 01-OCT-2017; lot # M019199 with expiration date 16-OCT-2018; lot K019030 with expiration date 21-AUG-2017; lot # L044085 with expiration date 29-MAY-2018). The sterile diluent was improperly stored at -0.1 Celsius (C) for cumulative 131 hours. There was previous temperature excursion: 15 C for 15 hours. Data logger was involved. VARIVAX was properly stored. No adverse event was  reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth of RUE over deltoid region.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Body temperature increased, Contusion, Pain in extremity, Vomiting
Clinical narrative: Leg pain, temp 99.0, bruising on right. Vomited x 1.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Deafness bilateral
Clinical narrative: Pt rec'd pneumo shot and lost hearing in both ears for 4 days and hears again now. Was concerned maybe about ear wax/infection? No S/S beyond hearing loss.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Fear, Hyperventilation
Clinical narrative: He got dizzy, stiff, rolled his eyes, got pale and fell on exam table. He was scared, hyperventilation and holding his mom. After maybe about 30 min. of resting got better and left.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: He got dizzy, stiff, rolled his eyes, got pale and fell on exam table. He was scared, hyperventilation and holding his mom. After maybe about 30 min. of resting got better and left.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Hyperventilation, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: He got dizzy, stiff, rolled his eyes, got pale and fell on exam table. He was scared, hyperventilation and holding his mom. After maybe about 30 min. of resting got better and left.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: He got dizzy, stiff, rolled his eyes, got pale and fell on exam table. He was scared, hyperventilation and holding his mom. After maybe about 30 min. of resting got better and left.
Age: 7.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Red, raised itchy rash at injection site within an hour or so of getting DTaP and VARICELLA injections. No mucus membrane or respiratory involvement. This may have happened before with PREVNAR (hives at site within a week).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Patient developed all over body itching about 1 hr. after vaccine. Patient took BENADRYL.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Pass out.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had pneumonia vaccine applied to (L) upper arm on Friday, October 7, 2016. Developed redness and pain and swelling on Sunday October 9, 2016 at site of injection. Pain, swelling and redness have increased since then. Patient evaluated on 10/11/16. Area of swelling measures 16cm x 18cm *not at site of Influenza vaccine*.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness/Pink itchy area around immunization site approximately 3x5 per patient's sister.
Age: 2.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Pruritus, Rash generalised
Clinical narrative: Head to toe rash morning after immunization. Cleared within 12 hours, Pruritis. Used "Itch Eraser" on spots (contains 5% baking soda).
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Rotator cuff syndrome, Ultrasound Doppler
Clinical narrative: Painful injection. Prolonged period of soreness, then ongoing pain. Mimics a rotator cuff injury.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC, FLUX, PNC13
Symptoms: Ex-tobacco user, Pneumococcal infection
Clinical narrative: Initial unsolicited report received from a consumer on 04 Oct 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (frequency once, batch number, expiration date, route, dose not reported) and dose of PREVENAR 13 (Frequency once, batch number, expiration date, route, dose not reported) on Dec 2009. Medical history revealed that patient was a smoker. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Concomitant medications were reported as none. On Dec 2009, following the vaccination, the patient still got the disease (pneumococcal infection) and also reported that the flu turned into pneumonia. On Dec 2009, the patient was hospitalized (reported as two or three week later) for 10 days. Lab data was not reported. Corrective treatment included breathing treatment. The patient's was recovered from the event (reported as fine now). List of documents held by sender: none. Sender's Comments: This case concern female patient who received INFLUENZA VACCINE simultaneously with PNEUMOCOCCAL POLYSACCHARIDE VACCINE and developed flu, pneumococcal infection and pneumonia. No other relevant information is provided. Based on available information role of vaccine cannot be assessed.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC, FLUX, PNC13
Symptoms: Influenza, Pneumococcal infection, Pneumonia
Clinical narrative: Initial unsolicited report received from a consumer on 04 Oct 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (frequency once, batch number, expiration date, route, dose not reported) and dose of PREVENAR 13 (Frequency once, batch number, expiration date, route, dose not reported) on Dec 2009. Medical history revealed that patient was a smoker. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Concomitant medications were reported as none. On Dec 2009, following the vaccination, the patient still got the disease (pneumococcal infection) and also reported that the flu turned into pneumonia. On Dec 2009, the patient was hospitalized (reported as two or three week later) for 10 days. Lab data was not reported. Corrective treatment included breathing treatment. The patient's was recovered from the event (reported as fine now). List of documents held by sender: none. Sender's Comments: This case concern female patient who received INFLUENZA VACCINE simultaneously with PNEUMOCOCCAL POLYSACCHARIDE VACCINE and developed flu, pneumococcal infection and pneumonia. No other relevant information is provided. Based on available information role of vaccine cannot be assessed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Injection site pain, Paraesthesia, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 08-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), (dose, route of administration were unknown) with lot # M003487 and expiration date 21-APR-2016. Concomitant therapies included levothyroxine sodium (manufacturer unknown), liothyronine sodium, multivitamins and vitamin D3 with calcium. The reporter stated that, on 16-SEP-2016, the patient developed unspecified pain and then, on an unspecified date in September 2016, developed rash. On 21-SEP-2016, the patient called the physician's office and on 22-SEP-2016, she was brought in the office and was diagnosed shingles. No laboratory diagnostics studies were performed for the adverse event. The nurse stated that the patient "self administered" an over-the-counter cortisone cream with unspecified effect on unspecified dates. Moreover, the patient was prescribed VALTREX 1g three times daily for 7 days for treatment. The nurse requested a lot check. No product quality complaint was involved. On 27-SEP-2016, it was reported that the patient was recovering from the adverse event. The causality between ZOSTAVAX and herpes zoster was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 08-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), (dose, route of administration were unknown) with lot # M003487 and expiration date 21-APR-2016. Concomitant therapies included levothyroxine sodium (manufacturer unknown), liothyronine sodium, multivitamins and vitamin D3 with calcium. The reporter stated that, on 16-SEP-2016, the patient developed unspecified pain and then, on an unspecified date in September 2016, developed rash. On 21-SEP-2016, the patient called the physician's office and on 22-SEP-2016, she was brought in the office and was diagnosed shingles. No laboratory diagnostics studies were performed for the adverse event. The nurse stated that the patient "self administered" an over-the-counter cortisone cream with unspecified effect on unspecified dates. Moreover, the patient was prescribed VALTREX 1g three times daily for 7 days for treatment. The nurse requested a lot check. No product quality complaint was involved. On 27-SEP-2016, it was reported that the patient was recovering from the adverse event. The causality between ZOSTAVAX and herpes zoster was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 year old female patient. The patient's concurrent conditions and medical history were not reported. On 08-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), (dose, route of administration were unknown) with lot # M003487 and expiration date 21-APR-2016. Concomitant therapies included levothyroxine sodium (manufacturer unknown), liothyronine sodium, multivitamins and vitamin D3 with calcium. The reporter stated that, on 16-SEP-2016, the patient developed unspecified pain and then, on an unspecified date in September 2016, developed rash. On 21-SEP-2016, the patient called the physician's office and on 22-SEP-2016, she was brought in the office and was diagnosed shingles. No laboratory diagnostics studies were performed for the adverse event. The nurse stated that the patient "self administered" an over-the-counter cortisone cream with unspecified effect on unspecified dates. Moreover, the patient was prescribed VALTREX 1g three times daily for 7 days for treatment. The nurse requested a lot check. No product quality complaint was involved. On 27-SEP-2016, it was reported that the patient was recovering from the adverse event. The causality between ZOSTAVAX and herpes zoster was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Pain in extremity, Tremor
Clinical narrative: Initial unsolicited case received from a pharmacist on 04 Oct 2016. This case involves a 69 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI691AB Expiry date: 30 Apr 2017) intramuscularly in left deltoid on 04 Oct 2016. The patient illness at time of vaccination was reported as none and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as no known allergies (nka). The patient concomitant medications were not reported. (It was reported as the patient had just discontinued antidepressant medication). On 04 Oct 2016 two hours after vaccination the patient had tremors in both legs, felt cold and left arm was hurt. The patient lab data and corrective treatment was not reported. The outcome of the event was not recovered at the time of this report. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Feeling cold, Pain in extremity, Tremor
Clinical narrative: Initial unsolicited case received from a pharmacist on 04 Oct 2016. This case involves a 69 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI691AB Expiry date: 30 Apr 2017) intramuscularly in left deltoid on 04 Oct 2016. The patient illness at time of vaccination was reported as none and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as no known allergies (nka). The patient concomitant medications were not reported. (It was reported as the patient had just discontinued antidepressant medication). On 04 Oct 2016 two hours after vaccination the patient had tremors in both legs, felt cold and left arm was hurt. The patient lab data and corrective treatment was not reported. The outcome of the event was not recovered at the time of this report. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Rash erythematous, Rash generalised, Rash morbilliform, Varicella post vaccine
Clinical narrative: Patient came in on 9/26/16, received a DTaP, IPV, MMR, and VARICELLA on 9/30/16 she came in and was diagnosed with VARICELLA w/o complications.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient came in on 9/26/16, received a DTaP, IPV, MMR, and VARICELLA on 9/30/16 she came in and was diagnosed with VARICELLA w/o complications.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 03 October 2016. This case involves a 81-year-old male patient who was vaccinated with a dose Fluzone Hd (batch number: UI703AA, expiration date: 08 August 2017 and dose were not reported) intramuscularly in the left deltoid on 30 September 2016. Patient had no Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as Diabetic, pacemaker, defibrillator and allergic to betablockers. It was also reported that patient blood sugar level usually runs about 130 (units not reported). Concomitant medications were not reported. On 30 September 2016, two hours following the vaccination, the patient broke out with a red rash, with little red bumps, fluid filled bumps widespread over the body and rash which was very itchy. Patient went to Urgent Care and required emergency room or doctor visit. Lab data included blood sugar which was up to 416 (units not reported) on an unspecified date (on Saturday). The patient received corrective treatment with an injection and was prescribed betamethasone cream. On an unspecified date patient recovered from the events. It was also reported that patient was feeling better today. List of documents held by sender: none.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Initial unsolicited report received from a consumer on 03 October 2016. This case involves a 81-year-old male patient who was vaccinated with a dose Fluzone Hd (batch number: UI703AA, expiration date: 08 August 2017 and dose were not reported) intramuscularly in the left deltoid on 30 September 2016. Patient had no Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as Diabetic, pacemaker, defibrillator and allergic to betablockers. It was also reported that patient blood sugar level usually runs about 130 (units not reported). Concomitant medications were not reported. On 30 September 2016, two hours following the vaccination, the patient broke out with a red rash, with little red bumps, fluid filled bumps widespread over the body and rash which was very itchy. Patient went to Urgent Care and required emergency room or doctor visit. Lab data included blood sugar which was up to 416 (units not reported) on an unspecified date (on Saturday). The patient received corrective treatment with an injection and was prescribed betamethasone cream. On an unspecified date patient recovered from the events. It was also reported that patient was feeling better today. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Bone pain, Chills, Feeling cold, Pain, Pyrexia
Clinical narrative: Fever 101.5. Body aches. Bones hurt. Feeling of being freezing cold and severe shivering.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: Dveloped rash under left arm which progressed in 4 days to left breast and left scapular area. Visited employy health RN. Sent to PCP. Diagnosed with shingles on 10-3-16 by PCP.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Rash, Urticaria
Clinical narrative: Welt, rash, shingles, lower right leg.