chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received on 12-JUL-2017 from a pharmacist (Pharm D) and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The pharmacist reported that the patient was administered a dose of PNEUMOVAX 23, intramuscular (Site of administration not reported), on 04-MAY-2015 for prophylaxis and another dose of PNEUMOVAX 23 intramuscular (Site of administration not reported) on 05-JUL-2017 for prophylaxis. No adverse effects reported. No further information was provided. Additional information is not expected as reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 12-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M039453 expiration 19-DEC-2017, subcutaneous for prophylaxis on 11-JUL-2017. No adverse effects reported. The vaccines were stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for the time frame of 4 hours and at 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 1 hour. There were no previous temperature excursions. The call was made because of a data logger. No further information was provided. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified number of patients of unknown age. On 26-JUL-2017, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (Lot number: N012615), subcutaneous for prophylaxis, which was reconstituted with properly stored sterile diluent. On 26-JUL-2017, the patients experienced incorrect product storage. The administered doses were exposed to a temperature between 6°F to 14°F for 1 hour (digital data logger) with one previous temperature excursion at a temperature between 6°F to 14°F  for 2 hours and 45 minutes (digital data logger). No adverse effects were reported.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is 1st of three reports. A patient of an unknown age and gender received PREVNAR 13 (LOT S06823, Exp. date May2018) at single dose for immunization on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown. It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same LOT which had the white substance. Sender's Comments: Linked Report(s): US-PFIZER INC-2017327829 Same reporter/drug/event, different patient; US-PFIZER INC-2017327828 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the second of three reports. A patient of an unknown age, race, ethnicity and gender received PREVNAR 13 (lot S06823, expiry date May2018) at single dose for immunisation on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown. It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same lot which had the white substance. Sender's Comments: Linked Report(s): US-PFIZER INC-2017327795 Same reporter/drug/event, different patient; US-PFIZER INC-2017327829 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. This medical assistant reported similar events for 3 patients. This is the third of three reports. A patient of an unknown age and gender received PREVNAR 13 (LOT S06823, Exp. date May2018) at single dose for immunization on an unknown date. Medical history and concomitant medication were not reported. On an unknown date the patient experienced cellulitis. The outcome of the event was unknown.It was reported that some pneumococcal 13-val conj vaccines contained a white substance, however it was unknown if the patient had received or not the same Lot which had the white substance; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017327828 Same reporter/drug/event, different patient;US-PFIZER INC- 2017327795 Same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 80-90-year-old patient received the second dose of PREVNAR 13 at single dose on 24Jul2017 for immunization. The patient had received the first dose on 18Jul2017. Medical history and concomitant medication were not reported. On unknown date the patient experienced some redness in the site of injection. The outcome of the event was unknown.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site warmth, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17 year-old male patient of unspecified race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date in Jan2016 for immunization. The patient medical history and concomitant medications were reported as none. The patient experienced arm reaction red swelling and it was warm to the touch at place of injection on an unspecified date. Outcome of the events was unknown. The patient's mother was afraid to continue the series.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (mother) reported that a male patient of unknown age and ethnicity/race received on 27Jul2017 a single dose of TRUMENBA for immunization. In Jul2017 the patient had upper arm swelling and fever at 99.6 F. Outcome was unknown.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient brought in a letter 3 days after the vaccine had been given, stating that she had some pain, redness and swelling at the injection site 2 hours after injection. Later in the day, she states she experienced fatigue and a fever. By the next day, she states her fever and fatigue was less, and by day three, it was gone. Today, a week later, patient reports no issues at all.
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 57mm x 37mm erythemic, hard indurated, warm area.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: Throat tingling, and tongue swollen about 10 min later after getting the shot.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Pain
Clinical narrative: Extreme body aches. Fever (101.9) - 3 days. Upper respiratory issues (prolonged coughing all night/day). Shortness of breath (cannot exercise). Pressure on chest above heart. Feelings of heart palpitations. Exhaustion. Cannot sleep well.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Poor quality sleep, Pyrexia, Respiratory symptom
Clinical narrative: Extreme body aches. Fever (101.9) - 3 days. Upper respiratory issues (prolonged coughing all night/day). Shortness of breath (cannot exercise). Pressure on chest above heart. Feelings of heart palpitations. Exhaustion. Cannot sleep well.
Age: 10.0
Sex: U
Vaccine: HEP, IPV, TDAP
Symptoms: Asthenia, Blood glucose normal, Irritability, Pallor
Clinical narrative: 08-01-17, 1:00PM, VACCINES ADMINISTERED PER PARENTS REQUEST. IMMEDIATE REACTION NORMAL. PARENTS REPORTED WHILE WALKING OUT THE BLDG, CLIENT FELT WEAK, LIPS PALE. CLINIC NURSES TOOK VITALS, GLUCOSE, O2. BP (LA, SITTING)=92/62, RR=24, TEMP=97.8, P=56, O2=100, GLUCOSE=99. RESPONDING WHEN SPOKEN TO. DETAILS IN VAERS RPT. LIPS PINK, CLIENT REMAINS STABLE WHEN PARAMEDICS TOOK CLIENT TO ER FOR MORE OBSERVATION. 08-02-17, 5:00PM, MOM ON THE PHONE STATED ?ALL OK, HE'S LITTLE CRANKY?, YESTERDAY AT ER COUPLE HOURS FOR OBSERVATION, EVERYTHING OK.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Antinuclear antibody, Back pain, Blood 25-hydroxycholecalciferol, Blood creatine phosphokinase
Clinical narrative: Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Cytomegalovirus test, Differential white blood cell count, Fatigue
Clinical narrative: Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count, Headache, Metabolic function test, Myalgia, Nausea
Clinical narrative: Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Neuralgia, Red blood cell sedimentation rate, Rheumatoid factor, Somnolence, Spinal X-ray
Clinical narrative: Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Thyroxine
Clinical narrative: Patient has been experiencing extreme fatigue (including excessive daytime sleepiness), difficulty awakening, bilateral leg muscle pain, nerve pain (pain shooting down his right leg that he explains as "throbbing"), nausea, headaches and abdominal pain that radiates to his back. Symptoms have slowing been progressing and getting worse over the course of the summer.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Tremor
Clinical narrative: Advised woman yelling "help me" from parking lot. Grandmother stated she was talking to child then her eyes rolled back into her head and she became stiff and shaky." EMS called to site to assess child.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: RED WELT AT INJECTION SITE.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: Focal Seizure...unknown date since my son didn't tell us until his grand mal seizure on Feb 25, 2017, which was 4 days after the meningitis shot.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Partial seizures
Clinical narrative: Focal Seizure...unknown date since my son didn't tell us until his grand mal seizure on Feb 25, 2017, which was 4 days after the meningitis shot.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Feeling jittery, Headache, Tremor
Clinical narrative: Headache, shaking, jittery approx. a two hours after vaccine. By tree hours later he was feeling himself. He has not had any further problems.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Pain
Clinical narrative: Patient is an employee and was scheduled to receive her 3rd final dose of Hepatitis B vaccine series. 1 ml administered. Shortly after receiving vaccine the employee had complaints of dizziness which did not subside. Employee further began to develop throbbing chest pain. Vital signs remained stable. EMS called for hospital transport.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Left thigh warm to touch, redness and inflammation noted at site of injection. Doctor prescribed Benadryl and advised to apply ice.
Age: 74.0
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope/ light headedness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness at injection site at 24 hours, doubled in size at 48 hours. Went to nurse and was prescribed BACTRIM for indication of cellulitis.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Patient developed moderately painful vesicles on both arms, reported to our urgent care 2 days later and prescribed acyclovir course.
Sex: U
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Hive/rash at injection site within 10 minutes. Treated with BENADRYL. Hive/rash began to shrink within 30 minutes after dose of BENADRYL.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient reports that she vomited within 10 minutes of getting the vaccine and had nausea for the remainder of the day. After 2 hours, she developed a fever of 102 degrees. These symptoms resolved later that evening. She had a PPD on 7/26/17 and a Tdap on 5/18/17. She describes getting anxious prior to getting vaccines. In the past, she has had muscle pain following vaccination. This is her first vaccine reaction with nausea/vomiting and fever. Patient reported that she felt better on 8/1/2017 and did not need to see a doctor.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: I received the vaccine for shingles, ZOSTAVAX. the site of the injection is very red, swollen, itchy, painful, hot and has developed a lump. It's been about 36 hours since I've received the vaccine and my arm is continuing to get worse. The affected area is currently approximately 8 inches x 6 inches oval. I will be speaking with my doctor today.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: I received the vaccine for shingles, ZOSTAVAX. the site of the injection is very red, swollen, itchy, painful, hot and has developed a lump. It's been about 36 hours since I've received the vaccine and my arm is continuing to get worse. The affected area is currently approximately 8 inches x 6 inches oval. I will be speaking with my doctor today.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: Headache, neck pain and fever following administration of HPV vaccine on 7/28/17.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: RN (Contract Staff) gave ZOSTER instead of Varicella to a 3 month old child. Notified Pharmacy, MD, and agency w/I 1 hour of occurrence. Instructed by agency to complete VAERS. MD to follow-up with parent and patient. Nurse manager informed regarding administering RN.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Generalized urticaria rash onset 8/1/17 otherwise NL exam. Seen 8/2/17. Rx: Hydroxyzine and to F/U.
Age: 26.0
Sex: F
Vaccine: DTP, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: And cellulitis.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Skin irritation
Clinical narrative: Inspection of injection site on left deltoid reveals approximately 2 in diameter of reddened area with 2 3 cm areas of light purple in the center. Patient denied any difficulty breathing or swallowing, she states that last night the site was itchy and slightly painful. She believes that the redness at the injection site has worsened since last night. She denies pain or itching at this time. Skin irritation. Diphenhydramine 50 mg once.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient was given BOOSTRIX injection. About 10-15 minutes after injection pt was in his car to leave when he "passed out" per wife. Wife ran back into the office to get help. Patient was in car laying back-once staff got to car-he was pale, sweating. Pulse and heart normal as well as blood pressure.
Age: 22.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Syncope, Tongue disorder
Clinical narrative: After receiving TDaP/Varicella felt faint and did faint - ammonia applied and C/O feeling like tongue was sticking to roof of mouth - BENADRYL 4tsp. administered - was able to swallow without difficulty.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness for approximately 60 seconds. No extended treatment required.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Large red area/hot to touch/itches.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Urticaria
Clinical narrative: 2 days after injection pneumonia 23 stated had welts on arm and nasal cong. When she presented still had the welts but decreased in size. No other symptoms. To take BENADRYL 7/21 PM and 7/22 AM. To call 911 with any difficulty breathing or breaking out more.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Pt called indicating large, itchy, red welt with heat size of her hand. RPh referred to MD to rule out infection or other. Pt says no time to see MD. Wanted RPh to suggest OTC. RPh suggested cold compress and MD follow-up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt. reports 2 hr. after administration fever at 102 F and chills, whole body ache, swelling, soreness, redness at site of administration which continued for one week. Then resolved.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Pt. reports 2 hr. after administration fever at 102 F and chills, whole body ache, swelling, soreness, redness at site of administration which continued for one week. Then resolved.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: TDaP to (L) Delt 7/24 and PPD to (L) lower forearm at same visit. Pt in for PPD reading clear induration to (L) lower FA and (L) upper arm noted with erythema, warm to touch and pt with c/o itchiness. PCP eval Rx hydroxyzine.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) upper arm 3.5 x 2.5 inch red, warm, swollen area 6/10 pain. Feels tired and has headache.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site warmth
Clinical narrative: (R) upper arm 3.5 x 2.5 inch red, warm, swollen area 6/10 pain. Feels tired and has headache.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea, Pruritus, Rash erythematous
Clinical narrative: Headaches, nausea, red spots over body. Itching. Saw Doctor was given steroids. Took 2 wks. to recover.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Tenderness at injection site. Warm w/itching 7/25/17 pm w/itching and erythema w/hives 7/26/17 PM.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Chills last night with localized injection site reaction w/noted today lethargy and HA, nausea. Injection site is red, swollen and warm to touch.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Lethargy, Local reaction, Nausea
Clinical narrative: Chills last night with localized injection site reaction w/noted today lethargy and HA, nausea. Injection site is red, swollen and warm to touch.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Ultrasound scan normal, Urinary system x-ray normal, Vomiting
Clinical narrative: Vomit and diarrhea.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Rotator cuff repair, Rotator cuff syndrome
Clinical narrative: Swelling and pain in right arm with rotator cuff issues. Pt had rotator cuff repair surgery in Feb. 2017.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Brachial plexopathy, Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Soreness in neck, arms, shoulder in Jan '17. 2/15/17 work up in excruciating pain; went to AED. Developed Parsonage Turner Syndrome (brachial plexopathy) diagnosed by neurologist.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Neuralgia, Peripheral swelling, Pruritus
Clinical narrative: Patient had slight upper arm swelling, itching, chills and left sided nerve pain along ribcage. Some redness around immunization site. Swelling ran along back of (L) arm.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh, at administration site of varicella vaccine, is reddened with swelling, hard and warm to touch. Instructed parent to alternate cold and heat therapy, use TYLENOL or ibuprofen for any discomfort as needed. Re-check in clinic in a couple of days if symptoms persist.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Pain, Syncope
Clinical narrative: (7/30/17) Pt complained that later in the day after vaccine she fainted. Did not seek medical attention but called 8/1/17 stating she felt weak with pain worsening and red swollen area of shot stating it was in a square pattern.
Age: 68.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Back pain, Dysstasia, Electrocardiogram normal, Muscle spasms, Musculoskeletal pain
Clinical narrative: Got PVX #2 and #3 he PA/B from nurse. Went to wait room, Sat, approximately 5-10 min later got low back ache, thorax muscle ache, shoulder ache and leg ache, muscle spasm, difficulty standing d/t pain. LVN an RN eval'd. they did EKG, EKG ok.
Age: 68.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Got PVX #2 and #3 he PA/B from nurse. Went to wait room, Sat, approximately 5-10 min later got low back ache, thorax muscle ache, shoulder ache and leg ache, muscle spasm, difficulty standing d/t pain. LVN an RN eval'd. they did EKG, EKG ok.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness. Diphenhydramine 25 mg once.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient was given vaccine 7-26-17. Returned to pharmacy and stated arm had swelled from elbow to shoulder, but had since resolves. Arm on 8-2-17 was warm to touch redness was roughly in size of a palm. Patient was going to continue to monitor and use ice packs.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Gave two doses of polio in opposite legs.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Injection site plaque, Injection site rash, Platelet count normal
Clinical narrative: Started 3 days ago (7/14/17) with rash on legs and now on abd and arms. Urticarial erythematous papules and plaques coalescing on legs erythematous papules on arms and abdomen. No involvement of palms or soles of feet. No blisters, no execration, no itch, no temp, no mucosal involvement. Looks very consistent of urticarial drug reaction. Exanthematous but no new meds.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash papular, Urticaria, White blood cell count normal
Clinical narrative: Started 3 days ago (7/14/17) with rash on legs and now on abd and arms. Urticarial erythematous papules and plaques coalescing on legs erythematous papules on arms and abdomen. No involvement of palms or soles of feet. No blisters, no execration, no itch, no temp, no mucosal involvement. Looks very consistent of urticarial drug reaction. Exanthematous but no new meds.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Influenza like illness, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Patient notified pain at the injection site and whole arm and flu-like symptoms. She informs she had a fever but temp unknown. Patient receives cephalexin 250 QID with cellulitis diagnosis 8/2/17.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Blood pressure decreased, Dizziness, Ear discomfort, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient was given MENACTRA vaccine and GARDISIL 9 vaccine in opposite arms. Approximately 2 minutes later patient had syncopal episode from apparent orthostatic hypotension. No evidence of seizure. Patient reports feeling lightheadness prior to syncope. Lost consciousness for 5 seconds. Upon awakening reports dizziness and ear pressure. Patient was diaphoretic and pale. Improved with ice packs, water, and ENSURE after 15-20 minutes.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Orthostatic hypotension, Pallor, Syncope
Clinical narrative: Patient was given MENACTRA vaccine and GARDISIL 9 vaccine in opposite arms. Approximately 2 minutes later patient had syncopal episode from apparent orthostatic hypotension. No evidence of seizure. Patient reports feeling lightheadness prior to syncope. Lost consciousness for 5 seconds. Upon awakening reports dizziness and ear pressure. Patient was diaphoretic and pale. Improved with ice packs, water, and ENSURE after 15-20 minutes.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Hyperhidrosis, Hypotension, Pallor, Syncope
Clinical narrative: Patient was given MENACTRA vaccine and GARDISIL 9 vaccine in opposite arms. Approximately 2 minutes later patient had syncopal episode from apparent orthostatic hypotension. No evidence of seizure. Patient reports feeling lightheadness prior to syncope. Lost consciousness for 5 seconds. Upon awakening reports dizziness and ear pressure. Patient was diaphoretic and pale. Improved with ice packs, water, and ENSURE after 15-20 minutes.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hypotension, Vision blurred
Clinical narrative: The patient is an 11 y.o male adolescent presented to clinic with his father to receive his HPV#2 vaccine. His Physical Exam was within normal limit. HPV vaccine given. 3 minutes later he had blurry vision and hypotension BP=62/40 on left arm, repeated on right arm BP=70/46, Heart rate=73/min Respiratory rate=18/min, no difficulty breathing, no loss of conscience, No rash, O2 saturation=100%. Patient observed in the nurse's room and few minutes later he mentioned that he is better and seeing better. No medication given. 10 minutes later he was back to normal according to him. Given a cup of juice and we continued observation of clinical and vital signs for more than 45 minutes.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, DTAP, FLU4
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site oedema, Vaccination site pruritus
Clinical narrative: Erythema and edema at vaccine site posterior deltoid, appeared day following vaccination. Allergic.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, DTAP, FLU4
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Erythema and edema at vaccine site posterior deltoid, appeared day following vaccination. Allergic.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Swelling face, Urticaria, Viral test negative
Clinical narrative: Blisters all over both hands, wrists, arms, stomach, both upper and lower thighs, behind both knees, both calfs, top and between toes and fingers, into genital area and face. Blistering was so  traumatic that the skin turn purple and black in wrist, arm and thigh areas.  Blisters cone and go, but never ends.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Skin discolouration, Viral test negative
Clinical narrative: Blisters all over both hands, wrists, arms, stomach, both upper and lower thighs, behind both knees, both calfs, top and between toes and fingers, into genital area and face. Blistering was so  traumatic that the skin turn purple and black in wrist, arm and thigh areas.  Blisters cone and go, but never ends.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Breast pain, Crying, Erythema, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old female patient. Patient with no drug reactions or allergies. On 22-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot number: N010106, expiration date: 15-NOV-2018 administered in an unspecified arm, intramuscularly for prophylaxis. Concomitant therapies included topiramate, estradiol, albuterol sulfate(PROAIR), acetaminophen, aspirin, caffeine(FIORINAL) and meloxicam(MOBIC). It was reported that after the administration of PNEUMOVAX 23, the patient "immediately had difficulty stopping the bleeding from the injection site". The primary reporter also reported that the patient "almost immediately started feeling numbness, tingling and throbbing pain in the arm and also had difficulty lifting the arm right away". It was also reported that the patient "passed out at work yesterday, (27-JUL-2017), 5 days following the injection". The pharmacist stated that they advised the patient to "put ice on the arm and take an unspecified dose of acetaminophen(TYLENOL) as treatment for the pain in the arm". The primary reporter reported that the patient said that the "arm was a lot better now but was still not completely recovered". The outcome of loss of consciousness was unknown. The causality between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event Loss of consciousness was considered as medically significant. This is one of two reports received from the same source (MARRS linked report 1708USA000454).; Sender's Comments:  US-009507513-1708USA000454:
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old female patient. Patient with no drug reactions or allergies. On 22-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot number: N010106, expiration date: 15-NOV-2018 administered in an unspecified arm, intramuscularly for prophylaxis. Concomitant therapies included topiramate, estradiol, albuterol sulfate(PROAIR), acetaminophen, aspirin, caffeine(FIORINAL) and meloxicam(MOBIC). It was reported that after the administration of PNEUMOVAX 23, the patient "immediately had difficulty stopping the bleeding from the injection site". The primary reporter also reported that the patient "almost immediately started feeling numbness, tingling and throbbing pain in the arm and also had difficulty lifting the arm right away". It was also reported that the patient "passed out at work yesterday, (27-JUL-2017), 5 days following the injection". The pharmacist stated that they advised the patient to "put ice on the arm and take an unspecified dose of acetaminophen(TYLENOL) as treatment for the pain in the arm". The primary reporter reported that the patient said that the "arm was a lot better now but was still not completely recovered". The outcome of loss of consciousness was unknown. The causality between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event Loss of consciousness was considered as medically significant. This is one of two reports received from the same source (MARRS linked report 1708USA000454).; Sender's Comments:  US-009507513-1708USA000454:
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Weight bearing difficulty
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old female patient. Patient with no drug reactions or allergies. On 22-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot number: N010106, expiration date: 15-NOV-2018 administered in an unspecified arm, intramuscularly for prophylaxis. Concomitant therapies included topiramate, estradiol, albuterol sulfate(PROAIR), acetaminophen, aspirin, caffeine(FIORINAL) and meloxicam(MOBIC). It was reported that after the administration of PNEUMOVAX 23, the patient "immediately had difficulty stopping the bleeding from the injection site". The primary reporter also reported that the patient "almost immediately started feeling numbness, tingling and throbbing pain in the arm and also had difficulty lifting the arm right away". It was also reported that the patient "passed out at work yesterday, (27-JUL-2017), 5 days following the injection". The pharmacist stated that they advised the patient to "put ice on the arm and take an unspecified dose of acetaminophen(TYLENOL) as treatment for the pain in the arm". The primary reporter reported that the patient said that the "arm was a lot better now but was still not completely recovered". The outcome of loss of consciousness was unknown. The causality between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event Loss of consciousness was considered as medically significant. This is one of two reports received from the same source (MARRS linked report 1708USA000454).; Sender's Comments:  US-009507513-1708USA000454:
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site haemorrhage, Loss of consciousness, Mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old female patient. Patient with no drug reactions or allergies. On 22-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot number: N010106, expiration date: 15-NOV-2018 administered in an unspecified arm, intramuscularly for prophylaxis. Concomitant therapies included topiramate, estradiol, albuterol sulfate(PROAIR), acetaminophen, aspirin, caffeine(FIORINAL) and meloxicam(MOBIC). It was reported that after the administration of PNEUMOVAX 23, the patient "immediately had difficulty stopping the bleeding from the injection site". The primary reporter also reported that the patient "almost immediately started feeling numbness, tingling and throbbing pain in the arm and also had difficulty lifting the arm right away". It was also reported that the patient "passed out at work yesterday, (27-JUL-2017), 5 days following the injection". The pharmacist stated that they advised the patient to "put ice on the arm and take an unspecified dose of acetaminophen(TYLENOL) as treatment for the pain in the arm". The primary reporter reported that the patient said that the "arm was a lot better now but was still not completely recovered". The outcome of loss of consciousness was unknown. The causality between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event Loss of consciousness was considered as medically significant. This is one of two reports received from the same source (MARRS linked report 1708USA000454).; Sender's Comments:  US-009507513-1708USA000454:
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 40 year old female patient. Patient with no drug reactions or allergies. On 22-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot number: N010106, expiration date: 15-NOV-2018 administered in an unspecified arm, intramuscularly for prophylaxis. Concomitant therapies included topiramate, estradiol, albuterol sulfate(PROAIR), acetaminophen, aspirin, caffeine(FIORINAL) and meloxicam(MOBIC). It was reported that after the administration of PNEUMOVAX 23, the patient "immediately had difficulty stopping the bleeding from the injection site". The primary reporter also reported that the patient "almost immediately started feeling numbness, tingling and throbbing pain in the arm and also had difficulty lifting the arm right away". It was also reported that the patient "passed out at work yesterday, (27-JUL-2017), 5 days following the injection". The pharmacist stated that they advised the patient to "put ice on the arm and take an unspecified dose of acetaminophen(TYLENOL) as treatment for the pain in the arm". The primary reporter reported that the patient said that the "arm was a lot better now but was still not completely recovered". The outcome of loss of consciousness was unknown. The causality between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review the event Loss of consciousness was considered as medically significant. This is one of two reports received from the same source (MARRS linked report 1708USA000454).; Sender's Comments:  US-009507513-1708USA000454:
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Diet refusal, Discomfort, Insomnia, Irritability
Clinical narrative: Crying, whining, can't get comfortable, won't eat, won't sleep, fever over 100.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Crying, whining, can't get comfortable, won't eat, won't sleep, fever over 100.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Ultrasound scan, Vomiting, X-ray
Clinical narrative: Constant vomiting after feeding or even when she is not feeding. Vomiting hours after eating.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received on 14-JUL-2017 from a pharmacist (Pharm D) and refers to a 67-year-old male patient. Concomitant medication was simvastatin (manufacturer not reported). No information about the patient's medical history, concurrent conditions, drug reactions or allergies was provided. The pharmacist reported that on 11-JUL-2017, the patient was administered PNEUMOVAX 23, (Lot number reported as N000463, expiration date reported as 19-OCT-2018) (dose, route, and site of administration were not reported) to prevent pneumonia and developed redness and pain at the injection site "few hours later". The patient was treated with ice and ibuprofen at an urgent care center on the same day. Patient has recovered. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 17-JUL-2017 from a medical assistant regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUL-2017 the patient was inadvertently administered an expired dose of GARDASIL lot # L040460, expiration 27-MAY-2017 intramuscular for the prevention of HPV. No adverse effects reported. Additional information was received on 17-JUL-2017 from a medical assistant via a company employee. The medical assistant confirmed the administered expired vaccine as GARDASIL not GARDASIL 9. No further information was reported. Additional information was received on 18-JUL-2017 from the physician. The physician called to confirm the expired GARDASIL and requested information from post-expiry memo as to how long the potency is supported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received on 12-JUL-2017 from consumer via a company representative regarding a female patient of unknown age, reported as over 65 years old. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, reported as two weeks ago, the patient was vaccinated with ZOSTAVAX (lot number and expiration unknown), subcutaneous for the prevention of shingles. The patient reported that when she returned to work "shortly" after being administered the ZOSTAVAX injection "two weeks ago" at a pharmacy, she noticed that the injection site was very red and warm to the touch. The redness and warmth lasted for about one week. The patient applied ice to the injection site. The patient also reported a little itching at the injection site, but "nothing uncontrollable". The patient took no medication for the adverse event. No further information provided. The outcome of application site warmth, injection site pruritus and injection site erythema is unknown. The causality was not reported. Additional information is not expected. No consent to contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Thrombosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information on concurrent conditions, allergies, medical history and concomitant medications were unknown. On 25-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, (dose, frequency were not reported, lot number, expiry date were unknown) for vaccination. In July 2017, the patient experienced redness and swelling at unspecified injection site and that injection site was warm to touch. Pharmacist reported that on 26-JUL-2017, patient was seen at a clinic and was then seen in an unspecified emergency room at an unspecified hospital in an unspecified location. Pharmacist reported that patient was then evaluated for a blood clot at an unspecified site on the same day. It was unknown if this unspecified patient was admitted to unspecified hospital. The outcome of events was unknown. No further information was provided. It was unknown if any lab diagnostics were performed. No product quality compliant (PQC) was involved. Upon internal review, thrombosis was considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II lot # M028131 for prophylaxis, which was stored in the range of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 9 hours and 48 minutes. Previous temperature excursion was reported: 47 Fahrenheit degrees to 77 Fahrenheit degrees for 1 hour and 6 minutes and 32 Fahrenheit degrees to 35 Fahrenheit degrees for 4 hours. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: This spontaneous report has been received from a 73 year old female patient referring to herself.  The patient's concurrent condition, concomitant medication and medical history were not provided. In 2012, the patient was vaccinated with ZOSTAVAX (one time injection, lot# and expiration date were not known) for shingles (prophylaxis). On 04-JUL-2017, the patient experienced shoulder and right chest pain with bumps. She went to the doctor and was advised she had the shingles. No treatment was given to the patient. The outcome of shingles was unknown. The causality between ZOSTAVAX and  shingles was unknown.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from the patient's father referring to an 8 month old male patient. Information regarding medical history, concurrent condition or concomitant medication was not provided. On 02-MAY-2017 the patient was vaccinated with an expired dose of ROTATEQ (lot # M042822, expiration date 01-SEP-2016, dose and route unspecified) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Depression
Clinical narrative: This spontaneous report as received from a consumer refers to a 23 year old female patient. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1, intramuscular for prophylaxis.  Other suspect therapies included GARDASIL. On an unknown date the patient experienced depression and anxiety. The outcome of depression and anxiety is unknown.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 years old female patient. In September 2009, the patient was vaccinated with ZOSTAVAX, one dose, for shingles prevention. On 24-JUL-2017, the patient experienced herpes zoster. The outcome of herpes zoster was reported as resolving. The causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included dexamethasone sodium phosphate (DECADRON). On 28-JUL-2017, 5 days after onset of therapy the patient experienced contraindicated product administered. On an unknown date the patient experienced no adverse event. The outcome of contraindicated product administered and no adverse event is unknown. The reporter considered contraindicated product administered to be not related to M-M-R II and dexamethasone sodium phosphate (DECADRON). The reporter considered no adverse event to be not related to dexamethasone sodium phosphate (DECADRON) and M-M-R II.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On unspecified dates in July 2017, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# M031574, expiration date 11-NOV-2018, lot# M037248, expiration date 21-FEB-2018, lot# N002202, expiration date 04-NOV-2019; dose and route unknown) for prophylaxis. The vaccines were stored under 35F for 1.5 hours. There was previous temperature excursion under 35F for 3.5 hours and 34F for 2 hours. The call was because of a data logger. No adverse effects reported. The storage occurred between 07-JUL-2017 and 31-JUL-2017. This is one of several reports received form the same source. Sender's Comments: US-009507513-1708USA001320.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On 01-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # L016428 for prophylaxis. On 01-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.