chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has bene received from a certified medical assistant concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 03-MAR-2015 the patient was vaccinated with VARIVAX (Merck), subcutaneously (dose, strength, frequency and lot number were not provided) which was improperly stored (Incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since an unspecified date in 2015, an unspecified number of patients were vaccinated with (Oka/Merck) VARIVAX, subcutaneously (lot# reported as K015994, dose, strength and frequency were not provided) which underwent supported temperature excursion. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site vesicles
Clinical narrative: This spontaneous report as received form a physician via a company representative refers to an elderly (greater than 65-year-old) female patient. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming unit (PFU) injection, 0.65 ml, subcutaneously (lot# and expiry date unspecified). No concomitant medications were reported. Subsequently, on an unspecified date (reported as: "2 days later" after vaccination), the patient sought medical attention and consulted the physician because she was experiencing an injection site adverse effect. The physician reported that she determined that the patient's injection site appeared to have "25 zoster-like blisters", and she diagnosed the condition as shingles. The physician collected an unspecified specimen from the patient's vesicles, and she submitted the specimen for confirmation of shingles to an unspecified laboratory. The physician prescribed unspecified antibiotic and an unspecified antiviral medication for treatment of the patient's vesicles. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 53 year old female patient with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, "when the patient was child" the patient was vaccinated with a dose of MMR II (route, dose, lot# and expiration date were not provided). On 24-FEB-2015, the patient was vaccinated inadvertently with a "booster dose" of MMR II, intramuscular (dose, lot# and expiration date were not reported). On the same date, after received the vaccine, the patient experienced vomiting. Concomitant therapies included ZOLOFT and MOBIC. The outcome of vomiting was reported as recovered/resolved on 24-FEB-2015. The reporter physician considered that the vomiting was related to the concomitant medications, and not related with MMR II. Additional information is not expected since there is not authorization to contact the physician.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received regarding a case in litigation for PROFECIA (MARRS # 1404USA007875) form a physician via medical records concerning a male patient (age not reported), non-smoker, who had reported at an office visit on 10-NOVEMBER-2011 that he received additional "Hep B vaccine" (Hepatitis B Vaccine (Recomninant)) (manufacturer not specified) (No date(s) of vacciantion(s) were reported) after he came up with "negative surface antibody" and now wishes to be retested to see whether that has converted, for example (i.e) to verify immunity status. No further information is available. All available medical records will be provided upon request.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: (R) lateral thigh 3x3.5 cm mildly erythematous area with induration and mild swelling, no warmth, nontender.
Age: 53.0
Sex: F
Vaccine: HEPAB, MMR, PNC13
Symptoms: Urticaria
Clinical narrative: Had injections on 2/17/15 and 2 days later noticed welts on her lower arms.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Musculoskeletal pain, Pyrexia, Swelling
Clinical narrative: Red, painful, swollen left shoulder, systemically fever present. No CP/SOB and no N/V/D
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This literature marketed report as received from a physician refers to 52 patients of unknown age with HIV diagnosis. Individuals with HIV infection often have early waning of protective antibody following hepatitis B virus (HBV) vaccination. HIV viraemia at the time of vaccination may limit the durability of serum anti-HBV surface antibody (HBsAb) levels. The author included patients who had no history of prior HBV infection. On an unknown date the patients were vaccinated with RECOMBIVAX HB. A total of 186 vaccine responders were identified and out of that HBsAb was waned in 52 patients. The cumulative proportion of patients with sustained HBsAb is greater than or equal 10 IU/L was 83% at 2 years and then dropped to 56% at 5 years. The median time to loss of protective HBsAb in all patients were occurred at 8.3 years. The author was not able to evaluate the association between antibody waning and vaccine dose. The clinical significance of vaccinated HIV infected patients with HBsAb waning below 10 IU/L was unclear. The outcome of event was unknown. Additional information has been requested.
Age: 1.37
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Otitis media, Pyrexia, Rash papular
Clinical narrative: Pt with fever 102 degrees post vaccine -> (B) otitis media -> AMOXIL 11 days post vaccination, pt with temp 100.1 previous OM but developed papular rash to chest -> neck -> cheeks -> trunk; spared extremities. Abx's d/c but rash progressed in few of the papular vesicles; no pustules. Rash resolved 5 days.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch started 3/5/15.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash started within 12 hours whole body, itch resolved over 1-2 weeks.
Age: 1.44
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Altered state of consciousness, Cyanosis, Electroencephalogram normal, Eye movement disorder, Hypotonia
Clinical narrative: Pt received PCV-13 and Hep A on 2.20.15. On 2.22.15 he had an episode of altered consciousness w/eyes rolled back, limp, perioral cyanosis. No tonic/clonic movements, no choking, sudden onset of fever noted 102 degrees. Evaluated by EMT after 911 call not transported to ER.
Age: 1.44
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt received PCV-13 and Hep A on 2.20.15. On 2.22.15 he had an episode of altered consciousness w/eyes rolled back, limp, perioral cyanosis. No tonic/clonic movements, no choking, sudden onset of fever noted 102 degrees. Evaluated by EMT after 911 call not transported to ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at site (L). Site 6 1/2" x 51/2" leg circumference 14" (R) L circum, 12 1/2". Treatment-BACTRIM.
Age: 1.21
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 1 year old patient of unknown gender with no pertinent medical history/drug allergies or drug reactions reported. On 24-FEB-2015, the patient was vaccinated inadvertently and simultaneously with the first doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # K007800, expiration date 29-NOV-2015) and VARIVAX (Merck) 0.5ml, subcutaneous (lot# K007785, expiration date 28-MAY-2016) which was considered to be an overdose. No adverse effects and product quality issue (PQC) reported. The outcome of overdose was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 20-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported), which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Pt c/o right arm hurting, said pain was shooting through it. Mom said she took pt. to ER, there she received a MOTRIN and was instr. to see MD. Mom took her home and gave her TYLENOL. Pt. said pain eased off, it is just sore. Inst. mom to give her MOTRIN every 6 hours today and tomorrow and apply ice pack. 2-26-15 mom brought pt in this am with her c/o pain in (R) arm and sore neck. pt texted whole visit. Instr mom to try heat to site and see her MD.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age (reported as an employee at her hospital). The patient believed that she was vaccinated with M-M-R II as a child but she could not produce written immunization record for previous doses and to meet hospital's requirement. On 02-FEB-2015, the patient was vaccinated with a dose (reported as the first dose) of M-M-R II (0.5 ml, subcutaneous (SQ), lot# and expiration date were not reported) and on 23-FEB-2015, the patient was vaccinated with an additional dose (reported as the second dose) of M-M-R II (0.5 ml, subcutaneous (SQ), lot# and expiration date were not reported). It was reported that, two doses were administered less than 28 days apart and that the second dose was administered too soon. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. Patient's medical history and current conditions were not provided. On 25-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Approximately on February 2015, the patient experienced headache, injection site pain, injection site erythema, injection site warmth, injection site swelling and injection site induration. Patient was treated with TYLENOL. The outcome of headache, injection site pain, injection site erythema, injection site warmth, injection site swelling and injection site induration was reported as not recovered. Patient sought medical attention via speaking with physician. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. Patient's medical history and current conditions were not provided. On 25-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Approximately on February 2015, the patient experienced headache, injection site pain, injection site erythema, injection site warmth, injection site swelling and injection site induration. Patient was treated with TYLENOL. The outcome of headache, injection site pain, injection site erythema, injection site warmth, injection site swelling and injection site induration was reported as not recovered. Patient sought medical attention via speaking with physician. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. The patient was reported to be indicated for ZOSTAVAX but received (Oka/Merck) in error on 04-MAR-2015. No adverse experience has been reported. No product quality complaint (PQC) was involved. Reporter considered the event as not related to (Oka/Merck) VARIVAX. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a 7 month old female patient. On 29-DEC-2014 the patient was inadvertently vaccinated with one dose of VAQTA (dose, frequency, route, lot # and expiry date unspecified). No adverse effects were noted. No product quality complaint (PQC) was involved. The reporter considered adverse event, drug administered to patient of inappropriate age to be not related to VAQTA. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified refers to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a physician reporting on herself, a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and dose not provided), via intramuscular route. On an unknown date the patient experienced pain at the injection site. At the time of the report, the patient's outcome was unknown. 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 Licensed Vocational Nurse refers to multiple unspecified patients of unknown ages and genders. On unspecified dates, the patient were vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MMR, FLUX, MMR
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report as received from a physician, via other company Pfizer, refers to a currently 54 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, strength, dose, route and frequency was not reported). On an unknown date, the patient experienced drug hypersensitivity. The outcome of drug hypersensitivity was not reported. The relatedness between therapy with M-M-R II and the patient's event was not reported. This is one of several reports related to the same patient. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MMR, FLUX, MMR
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician, via other company Pfizer, refers to a currently 54 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, strength, dose, route and frequency was not reported). On an unknown date, the patient experienced drug hypersensitivity. The outcome of drug hypersensitivity was not reported. The relatedness between therapy with M-M-R II and the patient's event was not reported. This is one of several reports related to the same patient. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 06-FEB-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. No current or historical conditions were reported. On 26-FEB-2015, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (route, dose, Lot# and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical condition were reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (route, dose, Lot# and expiration date not reported). The doses of RECOMBIVAX HB were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. The other report is MARRS# 1503USA000906. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical conditions were reported. On an unknown date the patients were vaccinated with GARDASIL (route, dose, lot# and expiration date not reported). The doses of GARDASIL the patient received were improperly stored. No adverse effects were reported. This is one of two reports from the same reporter. The other report is MARRS# 1503USA000932. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since an unspecified date in 2015, an unspecified number of patients were vaccinated with VARIVAX (Merck), subcutaneously (lot# J012773, expiration date 09-OCT-2015, dose, strength and frequency were not provided) which underwent supported temperature excursions (Incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. Since an unspecified date in 2015, an unspecified number of patients were vaccinated with VARIVAX (Merck), subcutaneously (lot# reported as K005427, dose, strength and frequency were not provided) which underwent supported temperature excursions (Incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse referring to a 72 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On unspecified date of 2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, lot # 0468AE, expiration date 04-APR-2013, subcutaneously. Information regarding concomitant medication was not reported. On 27-FEB-2015 the patient was diagnosed with shingles. The patient was seen by her physician and she was prescribed an unspecified antiviral for treatment of the event on the same day. The outcome of the event was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Underdose, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 10 year old patient of unknown gender. On 12-FEB-2015, when the patient was indicated for her/his second dose of (Oka/Merck) VARIVAX, she/he was vaccinated with a dose of ZOSTAVAX injection, 0.5 ml (lot number and expiry date were not reported), subcutaneously. The reporter stated that she withdrew 0.5ml from the vial for injection and gave to the patient, but not the 0.65ml as per ZOSTAVAX dosage recommendations. No adverse experience reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 13 year old female patient. On 23-DEC-2014 the patient was vaccinated with a dose of GARDASIL which was post non-supported excursion (lot # K005083, expire date 04-NOV-106, 0.5 ml) intramuscularly. No adverse effects were noted. This is one of several cases reported by 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 certified medical assistant concerning a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 03-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneously (dose, strength, frequency and lot number were not provided) which was improperly stored (incorrect product storage). Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Very red and swollen injection site reaction. Redness began to travel down arm into bicep area, Very sore to touch and move. Shoulder and elbow ROM = 100%.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Anxiety, Feeling hot, Flushing
Clinical narrative: Approximately 15 mins after injection, felt very hot, flushed, anxious. Symptoms resolved 15 mins after taking BENADRYL 25mg.
Age: 22.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Dizziness, Hyperacusis, Nausea, Photophobia
Clinical narrative: Dizziness, nausea, sensitivity to light/ sound, upset stomach.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Injection site erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Right arm is red, swollen, hot to touch, itching, fatigue, stiffness in neck. Redness has spread past injection site to entire upper arm and wraps around to inner arm.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Skin warm
Clinical narrative: Right arm is red, swollen, hot to touch, itching, fatigue, stiffness in neck. Redness has spread past injection site to entire upper arm and wraps around to inner arm.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Adacel TDaP given IM prior to planned d/c home 3/6/15 at 1714. At her vax reassessment at 1744 the pt reported nausea and btwn then and 1800 was dry heaving. After a walk and cooling down nausea persisted and MD was notified- Zofran order was obtained. Zofran PO was given @ 1815 and pt immediately vomited. She vomited 3 times within the next 30 mins, temp was 97.6. Pt reports chills starting @ 2145 after her shower. Vomiting continued til 2200. Temps following were: 2210: 99.4, 0215: 99.2, 0540: 99.4 (none prior exceeded 98.2)- BPs remained within normal range of pt prior to IM vaccine.  Headache started @ 0200 (rated 8/10 at am assessment), Tylenol was given @ 0744 and pt reported resolution of h/a and sweating a lot during her morning nap following the med.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Retching, Vomiting
Clinical narrative: Adacel TDaP given IM prior to planned d/c home 3/6/15 at 1714. At her vax reassessment at 1744 the pt reported nausea and btwn then and 1800 was dry heaving. After a walk and cooling down nausea persisted and MD was notified- Zofran order was obtained. Zofran PO was given @ 1815 and pt immediately vomited. She vomited 3 times within the next 30 mins, temp was 97.6. Pt reports chills starting @ 2145 after her shower. Vomiting continued til 2200. Temps following were: 2210: 99.4, 0215: 99.2, 0540: 99.4 (none prior exceeded 98.2)- BPs remained within normal range of pt prior to IM vaccine.  Headache started @ 0200 (rated 8/10 at am assessment), Tylenol was given @ 0744 and pt reported resolution of h/a and sweating a lot during her morning nap following the med.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Influenza like illness, Nausea, Pain, Peripheral swelling
Clinical narrative: Had flu like reactions, fever, nausea, chills, swelling, entire forearm swollen, very sore, etc then hives after fever broke.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Had flu like reactions, fever, nausea, chills, swelling, entire forearm swollen, very sore, etc then hives after fever broke.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Crying, Insomnia, Lethargy, Pallor, Retching
Clinical narrative: She woke up vomiting uncontrollably and shaking. Each time I tried to clean her up she would vomit and have to start over. She continued vomiting/dry heaving till 5am the next morning, the entire time she was very pale and cried a lot, only sleeping in small intervals. I took her back to the doctor the next day for them to check her and they said she might have caught a stomach bug. She perked up and did ok on the day of 03/06/2015 so I thought that she was on the mend. But the next morning 03/07/2015 when I woke up I realized that she was still sleeping in exactly the same position that I had put her in the night before. She was hard to wake up and very pale. I got her up and changed her diaper and then all she would do is lay her head over on me and try to go back to sleep. This is HIGHLY unusual for my daughter who is VERY active. She offered to drink a small amount and then is now continuing to sleep 5 hours later. She is fever free and has some color returning but is lethargic to the point that I felt it was necessary to report her reaction. Her doctor's office still seems to think that she may have been coming down with a virus when she was vaccinated. She received the Hep A booster. That is the ONLY vaccine she received on her visit that day.
Age: 1.56
Sex: F
Vaccine: HEPA
Symptoms: Somnolence, Tremor, Vomiting
Clinical narrative: She woke up vomiting uncontrollably and shaking. Each time I tried to clean her up she would vomit and have to start over. She continued vomiting/dry heaving till 5am the next morning, the entire time she was very pale and cried a lot, only sleeping in small intervals. I took her back to the doctor the next day for them to check her and they said she might have caught a stomach bug. She perked up and did ok on the day of 03/06/2015 so I thought that she was on the mend. But the next morning 03/07/2015 when I woke up I realized that she was still sleeping in exactly the same position that I had put her in the night before. She was hard to wake up and very pale. I got her up and changed her diaper and then all she would do is lay her head over on me and try to go back to sleep. This is HIGHLY unusual for my daughter who is VERY active. She offered to drink a small amount and then is now continuing to sleep 5 hours later. She is fever free and has some color returning but is lethargic to the point that I felt it was necessary to report her reaction. Her doctor's office still seems to think that she may have been coming down with a virus when she was vaccinated. She received the Hep A booster. That is the ONLY vaccine she received on her visit that day.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 100.5 degrees, headache, muscle pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Injection site swelling
Clinical narrative: PATIENT NOTICED SWELLING AT THE INJECTION SITE ABOUT 8 HOURS AFTER ADMINISTRATION. SWELLING INCREASED NEXT MORNING. PATIENT SEEN IN ER, TREATED FOR CELLULITIS NO FEVER NOTED.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Influenza
Clinical narrative: Flu symptoms.
Age: 1.49
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Encephalitis
Clinical narrative: Encephalitis.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, nausea.
Age: 73.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Patient states shingles vaccine set off his arthritis in other arm, he didn't think it caused because he had arthritis before, but said it might have set this spot off.
Age: 0.24
Sex: F
Vaccine: IPV, TDAP
Symptoms: Crying, Injection site erythema, Injection site movement impairment, Pain
Clinical narrative: The baby cried and cried unusually with tremendous pain for about 4 hours. The baby's thigh area around the place, where vaccine was given, became reddish in color and became stiff (area about 5 cm in diameter).
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Chills, Fatigue, Fine motor skill dysfunction
Clinical narrative: 03/02/2015 Pain at injection site, tenderness, slight swelling and redness developed over the course of the first day. Injection site stiffening and warm to the touch. 03/03/2015 Previous days' symptoms persist and continue to escalate. Swelling goes from the size of a quarter in the morning to a half dollar by the evening of day 2, 03/03/2015.  New symptoms include pain in the left pollicis muscles, problems grasping with left hand/ diminishing fine motor skills in left hand, pain in left mandibular joint, extreme fatigue to the point of canceling work, nausea, headache, fever at 101.4 degrees Fahrenheit by the afternoon, chills, sore throat and cough with phlegm. 03/04/2015 Similar to day 2, 03/03/2015. Fine motor skills in left hand have returned, but pain is still slight in pollicis muscles of left hand, fever has been maintained at 100 degrees Fahrenheit and under.  Swelling, pain, redness and stiffening at injection site are now the size of a softball in circumference and hot to the touch. Still had to cancel work from exhaustion.  Cough with phlegm worse. Nausea and stomach pain present. 03/05/2015 No hand issues or fever. Swelling has partially decreased to the size of a baseball. Injection site's redness has deepened to a reddish-brown. Injection site itches and hot to touch.  Uncontrollable coughing and sneezing. Suspected cellulitis at injection site by OB-GYN Dr. and asked to come in the next day for a quick observation. 03/06/2015 "Redness" fading but same size.  Still tender, skin is stiff and itchy at injection site between the size of a 1/2 dollar and baseball. Uncontrollable coughing and sneezing. Diagnosed with cellulitis at injection site by Dr. at 5:15 PM. Prescribed antibiotic. 03/07/2015 Day of VAERS report. Injection site problems persist, as well as uncontrollable coughing and sneezing, now suffering with laryngitis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Headache, Injected limb mobility decreased, Injection site cellulitis, Injection site erythema
Clinical narrative: 03/02/2015 Pain at injection site, tenderness, slight swelling and redness developed over the course of the first day. Injection site stiffening and warm to the touch. 03/03/2015 Previous days' symptoms persist and continue to escalate. Swelling goes from the size of a quarter in the morning to a half dollar by the evening of day 2, 03/03/2015.  New symptoms include pain in the left pollicis muscles, problems grasping with left hand/ diminishing fine motor skills in left hand, pain in left mandibular joint, extreme fatigue to the point of canceling work, nausea, headache, fever at 101.4 degrees Fahrenheit by the afternoon, chills, sore throat and cough with phlegm. 03/04/2015 Similar to day 2, 03/03/2015. Fine motor skills in left hand have returned, but pain is still slight in pollicis muscles of left hand, fever has been maintained at 100 degrees Fahrenheit and under.  Swelling, pain, redness and stiffening at injection site are now the size of a softball in circumference and hot to the touch. Still had to cancel work from exhaustion.  Cough with phlegm worse. Nausea and stomach pain present. 03/05/2015 No hand issues or fever. Swelling has partially decreased to the size of a baseball. Injection site's redness has deepened to a reddish-brown. Injection site itches and hot to touch.  Uncontrollable coughing and sneezing. Suspected cellulitis at injection site by OB-GYN Dr. and asked to come in the next day for a quick observation. 03/06/2015 "Redness" fading but same size.  Still tender, skin is stiff and itchy at injection site between the size of a 1/2 dollar and baseball. Uncontrollable coughing and sneezing. Diagnosed with cellulitis at injection site by Dr. at 5:15 PM. Prescribed antibiotic. 03/07/2015 Day of VAERS report. Injection site problems persist, as well as uncontrollable coughing and sneezing, now suffering with laryngitis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Laryngitis
Clinical narrative: 03/02/2015 Pain at injection site, tenderness, slight swelling and redness developed over the course of the first day. Injection site stiffening and warm to the touch. 03/03/2015 Previous days' symptoms persist and continue to escalate. Swelling goes from the size of a quarter in the morning to a half dollar by the evening of day 2, 03/03/2015.  New symptoms include pain in the left pollicis muscles, problems grasping with left hand/ diminishing fine motor skills in left hand, pain in left mandibular joint, extreme fatigue to the point of canceling work, nausea, headache, fever at 101.4 degrees Fahrenheit by the afternoon, chills, sore throat and cough with phlegm. 03/04/2015 Similar to day 2, 03/03/2015. Fine motor skills in left hand have returned, but pain is still slight in pollicis muscles of left hand, fever has been maintained at 100 degrees Fahrenheit and under.  Swelling, pain, redness and stiffening at injection site are now the size of a softball in circumference and hot to the touch. Still had to cancel work from exhaustion.  Cough with phlegm worse. Nausea and stomach pain present. 03/05/2015 No hand issues or fever. Swelling has partially decreased to the size of a baseball. Injection site's redness has deepened to a reddish-brown. Injection site itches and hot to touch.  Uncontrollable coughing and sneezing. Suspected cellulitis at injection site by OB-GYN Dr. and asked to come in the next day for a quick observation. 03/06/2015 "Redness" fading but same size.  Still tender, skin is stiff and itchy at injection site between the size of a 1/2 dollar and baseball. Uncontrollable coughing and sneezing. Diagnosed with cellulitis at injection site by Dr. at 5:15 PM. Prescribed antibiotic. 03/07/2015 Day of VAERS report. Injection site problems persist, as well as uncontrollable coughing and sneezing, now suffering with laryngitis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: 03/02/2015 Pain at injection site, tenderness, slight swelling and redness developed over the course of the first day. Injection site stiffening and warm to the touch. 03/03/2015 Previous days' symptoms persist and continue to escalate. Swelling goes from the size of a quarter in the morning to a half dollar by the evening of day 2, 03/03/2015.  New symptoms include pain in the left pollicis muscles, problems grasping with left hand/ diminishing fine motor skills in left hand, pain in left mandibular joint, extreme fatigue to the point of canceling work, nausea, headache, fever at 101.4 degrees Fahrenheit by the afternoon, chills, sore throat and cough with phlegm. 03/04/2015 Similar to day 2, 03/03/2015. Fine motor skills in left hand have returned, but pain is still slight in pollicis muscles of left hand, fever has been maintained at 100 degrees Fahrenheit and under.  Swelling, pain, redness and stiffening at injection site are now the size of a softball in circumference and hot to the touch. Still had to cancel work from exhaustion.  Cough with phlegm worse. Nausea and stomach pain present. 03/05/2015 No hand issues or fever. Swelling has partially decreased to the size of a baseball. Injection site's redness has deepened to a reddish-brown. Injection site itches and hot to touch.  Uncontrollable coughing and sneezing. Suspected cellulitis at injection site by OB-GYN Dr. and asked to come in the next day for a quick observation. 03/06/2015 "Redness" fading but same size.  Still tender, skin is stiff and itchy at injection site between the size of a 1/2 dollar and baseball. Uncontrollable coughing and sneezing. Diagnosed with cellulitis at injection site by Dr. at 5:15 PM. Prescribed antibiotic. 03/07/2015 Day of VAERS report. Injection site problems persist, as well as uncontrollable coughing and sneezing, now suffering with laryngitis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Sneezing, Temporomandibular joint syndrome
Clinical narrative: 03/02/2015 Pain at injection site, tenderness, slight swelling and redness developed over the course of the first day. Injection site stiffening and warm to the touch. 03/03/2015 Previous days' symptoms persist and continue to escalate. Swelling goes from the size of a quarter in the morning to a half dollar by the evening of day 2, 03/03/2015.  New symptoms include pain in the left pollicis muscles, problems grasping with left hand/ diminishing fine motor skills in left hand, pain in left mandibular joint, extreme fatigue to the point of canceling work, nausea, headache, fever at 101.4 degrees Fahrenheit by the afternoon, chills, sore throat and cough with phlegm. 03/04/2015 Similar to day 2, 03/03/2015. Fine motor skills in left hand have returned, but pain is still slight in pollicis muscles of left hand, fever has been maintained at 100 degrees Fahrenheit and under.  Swelling, pain, redness and stiffening at injection site are now the size of a softball in circumference and hot to the touch. Still had to cancel work from exhaustion.  Cough with phlegm worse. Nausea and stomach pain present. 03/05/2015 No hand issues or fever. Swelling has partially decreased to the size of a baseball. Injection site's redness has deepened to a reddish-brown. Injection site itches and hot to touch.  Uncontrollable coughing and sneezing. Suspected cellulitis at injection site by OB-GYN Dr. and asked to come in the next day for a quick observation. 03/06/2015 "Redness" fading but same size.  Still tender, skin is stiff and itchy at injection site between the size of a 1/2 dollar and baseball. Uncontrollable coughing and sneezing. Diagnosed with cellulitis at injection site by Dr. at 5:15 PM. Prescribed antibiotic. 03/07/2015 Day of VAERS report. Injection site problems persist, as well as uncontrollable coughing and sneezing, now suffering with laryngitis.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Woke around 8am Saturday March 7th 2015... Noticed patient was trying to scratch through diaper... I changed diaper and noticed small red bumps all of legs and on stomach. Throughout day bumps have appeared more now under arms back of legs and face. Contacted doctor, was told watch for fever and gave advice on public interactions and possible oatmeal bath! It is currently the evening of March 7th 2015 and it's bedtime for patient. No fever is showing on thermometer... But we are continuing to monitor situation.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Herpes zoster, Neuralgia, Peripheral swelling, Screaming
Clinical narrative: Whole arm swelled, red hot. Cold packs and on March 5, 2015 started an out break of shingles inside the cranium behind left ear area. Causing screaming pain on facial and head nerves 5, 6 and 7. Being treated with prednisone, cyclovera and oxycodone for the next 2 weeks. Over vaccinated!
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Skin warm
Clinical narrative: Whole arm swelled, red hot. Cold packs and on March 5, 2015 started an out break of shingles inside the cranium behind left ear area. Causing screaming pain on facial and head nerves 5, 6 and 7. Being treated with prednisone, cyclovera and oxycodone for the next 2 weeks. Over vaccinated!
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. It was reported that since 30-JUL-2014 the patients were vaccinated with ROTATEQ (dose, frequency, lot# and expiry date unknown) orally for prophylaxis, which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. It was reported that since 30-JUL-2014 the patients were vaccinated with GARDASIL (dose, frequency, lot# and expiry date unknown) intramuscularly, which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 08-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2106). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the varicella virus vaccine live (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with varicella virus vaccine live (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 09-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 21-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.