chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Initial unsolicited report received from a physician on 8 September 2015. This case involves a 36 years old female patient who was vaccinated with a first dose of Flu vaccine (batch number, dose, route and site of administration were not reported) on an unspecified date in 2014. Illness at time of vaccination and concomitant medications were not reported. On an unspecified date in 2014, within three hours following the vaccination, the patient experienced coughing and wheezing, and then became disoriented, "feeling of doom". The patient sent to emergency room and the patient was treated for anaphylaxis. It was reported that "Patient states since this reaction has not "felt well" after eating eggs." Lab data was not reported. The patient received corrective treatment with oral dose with BENADRYL. The outcome of events were unknown. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm of injection was swollen, warm to the touch, and had red patches.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test, Decreased appetite, Full blood count, Headache, Pain
Clinical narrative: Fever to 103 degrees F beginning 4-6 hours after receiving dose of FLUZONE. Also c/o HA, decreased appetite, body aches. Physical exam unremarkable.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, West Nile virus test
Clinical narrative: Fever to 103 degrees F beginning 4-6 hours after receiving dose of FLUZONE. Also c/o HA, decreased appetite, body aches. Physical exam unremarkable.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Headache, Pain in extremity, Pyrexia
Clinical narrative: 3 hours after flu shot-101 degree fever with headache chills and arm pain. Still miserable 24 hrs later.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Endocrine test abnormal, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: Started to sweat, thought losing mind, freezing cold, body would not keep warm. Went to doctor who sent me to a specialist who ran test-endocrine system was off. Been on testosterone injections ever since.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Laboratory test normal, Lumbar puncture normal, Muscular weakness, Nuclear magnetic resonance imaging brain
Clinical narrative: Started with severe headache, blurry vision and left leg weakness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging spinal, Vision blurred
Clinical narrative: Started with severe headache, blurry vision and left leg weakness.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness at injection site.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Pt woke up day after vaccination with rash and itching. Pt's left arm was swollen where if she touched her arm, there would be an slight indent. Patient took 2 tablets of Benadryl 25 mg. Upon examination on 9/17/15 her arm was not swollen, and it was not red.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Erythema, Swelling
Clinical narrative: Pain, swelling, erythema day after injection; refractory symptoms on day 2 despite ibuprofen and cold compresses. Treated with cephalexin (KEFLEX) 250 MG capsule po 4xd x 10 days; diphenhydramine (BENADRYL) 25 mg capsule po q6hprn.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Patient returned to clinic 9/14/15 complaining of left arm being very sore & red with knot at injection site where TDAP was given.  States that on 9/11, she noticed a quarter sized red area that progressed to a silver dollar size firm and tender area at injection site.  Patient denies fever.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Redness, swelling, warmth at injection site with general malaise.  Treated with Keflex with gradual improvement.
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of swelling, redness and pain to injection site on left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site extravasation, Injection site pain, Vaccination site swelling
Clinical narrative: Patient described burning on injection, some "regurgitation" of vaccine after injection was noted. Mild redness and swelling noted at vaccine site on recheck few minutes after vaccination. Pt denied itching or other sx (including problems breathing). Called patient to follow up few hours after vaccination (4:40 PM) - no redness noticable, no other sx.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Pt reports that am of 9/18/15 she noticed a red, puffy, warm spot twice as large as a silver dollar BELOW Injection site, and believes is due to receipt of flu shot on 9/16/15.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, Fatigue, Pain, Swelling, Redness around the site of injection.
Age: 9.0
Sex: F
Vaccine: FLU3, TDAP, TYP
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Administered IM Typhoid vaccine by SQ route. No adverse reaction from patient although she did say it stung.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Reports symptoms of low grade fever (<100F), chills, achiness, fatigue, pain and tenderness on left arm at site of injection.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Reports symptoms of low grade fever (<100F), chills, achiness, fatigue, pain and tenderness on left arm at site of injection.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: The patient reported that his arm became red and warm and it continued to spread throughout the day.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, nausea, vomiting, pain to injection site (rigth aram) and entire arm. Numbness to entire arm, left neck and left side of face.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Fever, nausea, vomiting, pain to injection site (rigth aram) and entire arm. Numbness to entire arm, left neck and left side of face.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained of pain in her arm from the shoulder at the site of injection to the elbow. The pain gets continuously worse and the patient cannot move her arm. Patient is no longer in the state and is advised to seek medical attention. Tried to reach patient as of 9/18/15 with no response to phone calls.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Pain, decreased mobility left shoulder ongoing to present time.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Upper arm bruised extending from shoulder to elbow.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Rash macular
Clinical narrative: Normal soreness of deltoid muscle after IM injection, but several days later red blotch rash developed just below injection site last thru to report date of 9/18/15. Aprox. size 3 inches by 4 inches.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Cold sweat, Dizziness, Nausea
Clinical narrative: Patient became nauseous, dizzy, weak, clammy. Cold compresses and had patient lay down and we elevated her feet. Monitored blood pressure and after 15 minutes she was fine.
Age: 36.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Blister, Urticaria
Clinical narrative: HIVES WITH SOME BLISTERS.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site nodule
Clinical narrative: BLEEDING AND NODULE FORMATION UNDER INJECTION SITE.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at sight of injection. Hot to the touch. When patient came in 9/16/15 it had been about 24 hours since patient had received the flu shot, the red area was about the size of a half dollar. Patient said she didn't feel bad, no soreness in the arm. I told her to take Benadryl and to keep a close eye on it, if the redness got bigger or she started seeing red areas other than at the injection sight or feeling itchy especially in the throat area to contact her doctor.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site mass, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient received High Dose influenza vaccine (FLUZONE HD) on 9/16/15; called 9/18/15 to report development of large hard lump the size of her palm at injection site, rash on underside of arm, and warmth with swelling thru-out upper arm. She does not report pain.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Had shot on Friday afternoon felt sore Friday night. Very sore over the weekend, and still today two weeks later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Laboratory test
Clinical narrative: Right thigh edema, redness and heat. Patient states it is painful to bear weight on his right leg also. Dr evaluated with ultrasound-revealed no hematoma or clots. Performed labs. Offered supportive care.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Ultrasound scan normal, Weight bearing difficulty
Clinical narrative: Right thigh edema, redness and heat. Patient states it is painful to bear weight on his right leg also. Dr evaluated with ultrasound-revealed no hematoma or clots. Performed labs. Offered supportive care.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Pyrexia, Rash, Swelling
Clinical narrative: Pt reported hx of swelling, rash, light temperature and stomach upset. Pt went to ER and dr prescribed BACTRIM DS. Pt got both vaccines on the same arm at same site.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain, Underdose
Clinical narrative: Patient jerked her arm and said ouch when the vaccine was injected (after the needle was in). Needle popped out of her arm and vaccine spewed. Questionable dose was actually administered.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Skin infection, Tenderness
Clinical narrative: Pt presented to doctor's office after complaining to pharmacy about tender/red skin near site of injection that traveled down her arm. Redness start away from site of injection further down her arm.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: None stated.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Patient received PREVNAR 13 injection in right arm on Monday September 14 2015 at 11:25am. He noticed this morning (Wednesday September 16 2015) that he had a rash approx. 2x3 inches on his right arm and it was warm to the touch. Patient presented to pharmacy at approx. 12:45 pm to report reaction. Recommended that patient apply cool compress, use BENADRYL cream or hydrocortisone cream if itching is present. He mentioned he had a second generation antihistamine at home so I recommended that he take one antihistamine daily. Recommended that patient monitor reaction and verify that it resolves within 1-2 days. Told him to call me if reaction worsens or does not go away.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of MMR II lot # J013131 expiration date 10-OCT-2015, Lot # J016234 expiration date 19-DEC-2015, Lot # K021152 expiration date 02-NOV-2016 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that agency requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Breast swelling, Computerised tomogram, Injection site pain, Muscle spasms
Clinical narrative: This spontaneous report was received from a consumer reporting on herself as a currently 69 year old female patient with Codeine allergy. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling, musculoskeletal pain, muscle spasms, arthralgia, breast swelling and injection site pain. The patient received treatment with Flexeril. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Peripheral swelling, X-ray
Clinical narrative: This spontaneous report was received from a consumer reporting on herself as a currently 69 year old female patient with Codeine allergy. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling, musculoskeletal pain, muscle spasms, arthralgia, breast swelling and injection site pain. The patient received treatment with Flexeril. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: 3-4" area of redness and hard lump, warm to touch 9-10-15 in the AM - persisted x 24 hours, treated with antibiotics and BENADRYL; immediate improvement.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Given in left deltoid. Had developed large amount of erythema, heat, and pain at injection site. Prescribed KEFLEX 250mg 1 po qid x7 days.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with unspecified number of doses of ROTATEQ, orally (dose, frequency and indication were not reported). The patient were vaccinated after the age of 8 months and 0 days. No adverse events have been reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever 100, swelling, redness and pain to Rt deltoid starting 9/15/15. Mild nausea. Office visit 9/17/2015 - less pain, sl redness.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of VAQTA lot # J016216 expiration date 18-AUG-2016, Lot # K026529 expiration date 02-JUN-2017, Lot # K005958 expiration date 02-MAR-2017 (dose and route were not reported). No co-suspect and concomitant therapies were reported. The nurse reported that Department of Health requested glycol thermometer readings that showed improper storage of the vaccine. Doses of vaccine may have been administered to an unspecified number of patients on unspecified dates. Nurse also stated according to the Sensitronic thermometer there had not been a temperature excursion in this refrigerator. No adverse effects reported. This is one of several reports 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L024123, expiry date 30-DEC-2016; lot # L010141, expiry date 24-SEP-2016). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Pruritus, Vaccination site swelling
Clinical narrative: Patient discovered redness and swelling at vaccine site/(L) arm/deltoid. Moderate in size surrounding site, irregular shape, 8 1/2 cm L x 7 cm W. Patient noticed approximately 21 hours after injection ("woke up next AM with itching).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Patient reported soreness and stiffness in the elbow of arm the vaccine was administered.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt had cellulitis around site of inj. (R) delt KEFLEX was given at time of visit on 9/17/15.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated orally with improperly stored doses of oral, ROTATEQ (dose, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis in arm patient received vaccine. Treated with KEFLEX 500mg x7 days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 06-MAY-2015, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored GARDASIL injection (lot # K011562 with expiration date 08-APR-2017 and lot# K023432 with expiration date 18-JUN-2016; dose, strength and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (L) post. forearm red, swollen, (approx 1 1/2 in diam.) and warm to touch. Rec. ice pack and TYLENOL.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 20-AUG-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K004483 with expiration date of 16-AUG-2015, dose and strength unknown) intramuscularly. No adverse reactions had been reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin irritation
Clinical narrative: Arm swelled and became red and irritated. Reaction began same evening. He had done nothing to treat it. Recommended ice and ibuprofen.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 10-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for administered dose was not specified by reporter, lot # may include: lot # L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016 or lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Injection site erythema
Clinical narrative: Pt got PNEUMOVAX due to new dx of rheumatoid arthritis. 1 day after vaccine got temp 101, redness at site resolved  - for several days had severe (L) wrist pain resolved with ALEVE.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Pt. received flu and ZOSTAVAX on 9-16-15 flu (L) arm ZOSTAVAX - (R) arm. 9-18-15 pt. stated reaction started night she received the vaccine. 9-16-15 she came in for apt - c/o red rash to (R) arm see by dr.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: ER visit: diagnosis cellulitis. Redness, swelling, TTP, warm, 2 tone redness. Blister. Treatment: Diphenhydramine PO 25mg, Doxy PO 100mg BID.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: ER visit: diagnosis cellulitis. Redness, swelling, TTP, warm, 2 tone redness. Blister. Treatment: Diphenhydramine PO 25mg, Doxy PO 100mg BID.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, redness and itching. Area is extensive, trailing down the arm 5 inches in diameter. Advised patient to take BENADRYL and contact the doctor.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Nausea, Secretion discharge
Clinical narrative: Headache. Nausea. Chills. Sneezing. Mucus. Ears ringing. Fatigue/ ADVIL BENADRYL Lots of sleep 10 days. Airborne.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Sneezing, Tinnitus
Clinical narrative: Headache. Nausea. Chills. Sneezing. Mucus. Ears ringing. Fatigue/ ADVIL BENADRYL Lots of sleep 10 days. Airborne.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student (with Pharm. D. degree) to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not specified. On an unknown date 2 years after the 1st dose, the patient was inadvertently vaccinated with the second dose of PNEUMOVAX23 injection, 25/0.5 (dose, route of administration, lot# and expiration date were not reported). No adverse effects reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red, warm area, with pain.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site nodule, Injection site swelling, Local reaction, Muscle spasms
Clinical narrative: Cramping in lower legs, fever 102, chills, pain. Pt went to ER. Given antibiotic. Swelling noted in left arm from shoulder to elbow. Pt followed up with primary physician 9/7/15. Reinforced dx of local reaction. 9/18/15, pt still has nodule at site, but resolving.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Cramping in lower legs, fever 102, chills, pain. Pt went to ER. Given antibiotic. Swelling noted in left arm from shoulder to elbow. Pt followed up with primary physician 9/7/15. Reinforced dx of local reaction. 9/18/15, pt still has nodule at site, but resolving.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Electrocardiogram, Loss of consciousness, Pregnancy test urine negative, X-ray
Clinical narrative: Patient received HPV9 on 8/28/15. Went to urgent care on 8/29/15 to obtain x-ray to check progress of her scoliosis and it was there before the procedure was done that she passed out and was sent to the ER.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Rash macular
Clinical narrative: ER report diffuse rash across abdomen/chest/neck. Macular rash - blanching no breathing difficulty. Received BENADRYL and prednisone with improvement.
Sex: U
Vaccine: RV5
Symptoms: Aspiration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, approximately in 2014 (also reported as about a year ago), the patient aspirated after an unspecified dose of ROTATEQ (route, lot # and expiration date not reported). The outcome of the event was not reported. The relatedness between the event and ROTATEQ was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX23. No adverse event was reported. The outcome was unknown. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a primary care physician (PCP), as part of a marketing research program, and refers to unspecified group of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose, route of administration and indication were not reported). The respondent told the patients, that some people who got the vaccination got a rash at injection site. The outcome of the rash at injection site was unknown. The relatedness between the event of rash at injection site and the ZOSTAVAX was not reported. Additional information is not expected, as the reporting physician did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous, (dose, frequency, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient suffered a lot of injection site pain. The patient called the pharmacist, on an unspecified date, to sought medical attention. The outcome of injection site pain was unknown. The reporter did not assess the relationship between ZOSTAVAX and injection site pain. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L007226, expiration date 03-MAR-2017, Lot # L015047 expiration date 29-APR-2017 (dose and route were not reported). No co-suspect and concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly GARDASIL. No adverse event was reported. The outcome was unknown. This is one of the 4 reports received 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of oral, ROTATEQ (lot # L000571; expiration date 26-JUL-2016) route default as oral (doe and strength were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the reporter stated that 4 doses of improperly GARDASIL 9, lot number L007560, expiration date 15-JUN-2017, (dose, route, anatomical location were not reported) were administered to the patients. Thre was no concomitant medication reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of GARDASIL (lot # K007264; expiration date 02-MAR-2017) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated with unspecified number of improperly stored doses of VAQTA (lot # K012457; expiration date 04-JUN-2017) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was no concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 05-AUG-2015, the patients were vaccinated  with unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L004754, expiration date 10-NOV-2016) (dose, strength and route of administration were not reported). It was reported that the doses were exposed to temperatures outside of the recommended range. There was not concomitant medication reported and no adverse effects were reported. Additional information has been requested. This is one of four reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 22-AUG-2015 the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot number reported as "L021608", expiration date 10-SEP-2016 (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Ataxia, Dizziness, Dyspnoea
Clinical narrative: Pt received Tdap vaccine at 11:40. At noon pt. became dizzy, short of breath and developed ataxia. Vitals stable (O2 98%, pulse 71, blood pressure 121/80, resp rate 28). Transferred to emergency dept at 12:40 as symptoms persisted. Tdap contains bovine casein/extract and pt allergic to mammalian meats.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On 14-SEP-2015, the patient was vaccinated with the first dose of an improperly stored dose of MMR II (lot # K003806, expiration date 13-MAR-2016) 0.5 ml, subcutaneous (anatomical location of administration was not reported). There was no concomitant medication reported. Additionally, no adverse effects were reported after improperly stored vaccine was administered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA, 25/0.5 (unknown Units), lot # L007559, expiration date- 01-JUN-2017, lot # L001627, expiration date- 11-NOV-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. 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: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 06-MAY-2015, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored (Merck) VARIVAX injection (lot # L012036 with expiration date 07-APR-2017 and lot# K021935 with expiration date 10-NOV-2016; dose, strength and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L016428, expiry date 27-JUL-2017). Concomitant medications were not reported. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not specified. On 17-SEP-2015, the patient was vaccinated with the expired dose of ZOSTAVAX injection, expiration date January 2015 (dose, route of administration and lot# were not reported). No adverse effects were reported. Additional information is not expected as no reporter contact information was provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a consumer refers to a 63 year old male patient with high blood pressure and with no drug reactions or allergies. On 31-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported. Concomitant therapies included LOTREL. On 01-SEP-2015, the patient experienced injection site swelling. He also reported that within two more days (in September 2015), he had been experiencing a burning, tingling sensation on both hands, both legs, face and both ears- he described the feeling as a "nerve sensation" and his face and both ears felt like they had sunburn. The patient sought medical attention via talking to the pharmacist. No lab diagnostic studies were performed. Treatment given for adverse events included BENADRYL. The patient also reported that the injection site reaction had resolved on an unknown date in September 2015, but not the other symptoms. Relatedness between the events and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The initial spontaneous report was received from a medical assistant to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 06-MAY-2015, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored ROTATEQ, oral solution (lot # K020181 with expiration date 24-JUN-2016 and lot # K013861 with expiration date 18-MAY-2016; dose and strength were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. 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 nurse regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L004014, expiration date - 04-MAR-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown ages and genders. There were no concomitant medications, concurrent conditions or medical history reported. The reporter stated that since 05-MAY-2015,, the patients were inadvertently vaccinated with unspecified number of doses of improperly stored RECOMBIVAX HB injection (lot # J005891 with expiration date 20-SEP-2015; dose, strength and route were not provided). Product quality complaint (PQC) was not involved. No adverse effects were reported. This is one of several reports received 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 was received from a nurse regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # K004773, expiration date 22-FEB-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. 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: This initial spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Merck) VARIVAX (dose and route of administration were not reported) that was improperly stored. While lot # for administered dose was not specified by reporter, lot # my include: lot # L016125 with expiration date 06-MAY-2017 or lot # L015046 with expiration date 29-APR-2017. No adverse effects were reported. 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 nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified dose in the ROTATEQ (lot # K001831, expiry date: 21-OCT-2015) immunization series that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA008456, 1509USA009767, 1509USA009768 and 1509USA009766 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received PNEUMOVAX23 (lot # K007826, expiry date: 03-FEB-2016) that was stored improperly. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. The case is also related to 1509USA008456, 1509USA009767, 1509USA009766 and 1509USA009769 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients received unspecified doses VAQTA (lot# J912456, expiry date: 04-JUN-2017, five doses) that were improperly stored. Nurse stated that the dates of administration was presently unknown. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1509USA008456, 1509USA009766, 1509USA009768 and 1509USA009769 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 03-SEP-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX injection (lot # J009730, expiry date 07-AUG-2015; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received 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 was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies was provided. On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for adminsitered dose was not specified by reporter, lot # may include: L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016 or lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. Additional information has been requested.