chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Pyrexia, Regressive behaviour, Rhinorrhoea, Viral test negative
Clinical narrative: Rhinorrhea, cough and fever starting on 5/29; 6 days of high fevers including Tmax > 42 degrees Celsius on 6/3, seen in ED on that date, no evidence of other infectious source other than possible viral URI; self-resolved after this time and returning to normal self at time of reporting today ~1 week; parental concern for loss of some verbal expression/single words; regaining general verbal skills with resolution but not some specific words; also previously waving spontaneously to people and not now, but otherwise social engaged and will wave on command.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Dyskinesia, Epilepsy, Eye movement disorder, Infantile spasms
Clinical narrative: Starting April 26th the patients legs started kicking like riding a bike. This happened around 1-2 times a day. Starting May 5th when her legs would kick her hands started making moving rhythmically as well. This would happen 2-3 times a day. Starting May 9th her eyes started going back and forth during the movements with legs and arms. She started having 4-5 a day.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient was a follow up from the ED from the day before with possible reaction/insect bite per ED notes. Today (06/15/17) site was red and warm to touch 3cm x 3cm. No other illness to report.  Sulfamethoxazole-Trimethoprim was prescribed. Mom was also instructed to do a cool compress to area and to return if getting worse.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, mild swelling at injection site. Total diameter approx 2". Warm to the touch, patient complains of itch.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Asthenia, Back pain, Chest discomfort, Chills
Clinical narrative: Headache, myalgias, lightheadedness, severe fatigue, weakness, squeezing chest and upper back pain, nausea, chills, sweats, abdominal discomfort. Had to miss 2 days of work. 6/15/17 at 10:30 AM mostly improved but not yet at baseline.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: Headache, myalgias, lightheadedness, severe fatigue, weakness, squeezing chest and upper back pain, nausea, chills, sweats, abdominal discomfort. Had to miss 2 days of work. 6/15/17 at 10:30 AM mostly improved but not yet at baseline.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: Headache, myalgias, lightheadedness, severe fatigue, weakness, squeezing chest and upper back pain, nausea, chills, sweats, abdominal discomfort. Had to miss 2 days of work. 6/15/17 at 10:30 AM mostly improved but not yet at baseline.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swollen, red.
Age: 57.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Myalgia, Rash erythematous, Urticaria, Vaccination site reaction, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a pharmacy intern referring to a 57 year old female patient. The patient's concomitant medications, medical history and drug reactions/allergies were reported as none. On 13-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, administered subcutaneously in the back of her left arm (lot # M035696 with and expiration date of 07-NOV-2017; strength was not provided), for prophylaxis (reported as recommended age for vaccination). On the same date, about 5 minutes after vaccine administration, the patient developed a 2 inch red rash at the site of vaccination. Then, in the evening, the rash spread 6 to 8 inches. On an unknown date in May, the rash became red, swollen and formed into a welt. In addition, the patient continued to have muscle aches for the a few days. It was reported that the patient did not seek medical attention. Laboratory diagnostics studies were not performed and the patient did not received any treatment for the events. On 23-MAY-2017 (reported as within 10 days of vaccination), the patient recovered from the vaccination site rash, vaccination site urticaria, vaccination site swelling and vaccination site erythema. The causal relationship between all above mentioned events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist, referring to 2 patients of unknown ages and genders. The patients' medical history, concomitant medications and drug reaction or allergies were not reported. On 08-JUN-2017, the patients were vaccinated with M-M-R II, albumin status unknown; and with VARIVAX (dose, frequency, administration route, lot number, expiration date and indication were not reported for both vaccines). A sterile diluent (manufacturer unknown) (lot number and expiration date were not reported) was used in the vaccination. It was reported that on 08-JUN-2017, the patients were diagnosed with cellulitis after receive M-M-R II and VARIVAX. The pharmacist also reported one additional patient, who experienced the same reaction after vaccination and went to an emergency room (the patient's experience was captured in MARRS# 1706USA006319). The patients' outcome was reported as not recovered. The pharmacist stated that he was unsure whether the cellulitis was caused by the M-M-R II or the VARIVAX. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested. Sender's Comments: US-009507513-1706USA006319.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Muscle tightness
Clinical narrative: Patient states that around 7:30PM on 6/14 she felt onset of migraine headache and tenseness in her shoulders and neck. She states that she had previously had migranes, but it has been years. She feels that the vaccine may have triggered the headache. Patient took tramadol which she normally uses for other indication and ibuproffen and symptoms resolved.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Irritability, Local reaction, Skin exfoliation, Staphylococcal scalded skin syndrome
Clinical narrative: Fussy infant with left leg skin peeling from thigh to calf after giving a bath and placing him for a nap.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Asthenia, Computerised tomogram abdomen normal, Discoloured vomit, Dizziness
Clinical narrative: On 6-13-17 mother calls to report that child had emergency room visit several hours after vaccines given on 6/5/17. She reports fever of 104.5, emesis x 1 that was black in color, abdominal pain, dizzy, and weakness. Emergency findings were negative, child received fluids and had a negative CT scan of abdomen. Symptoms resolved. I did call the Infection Preventionist at the hospital, and she reports that there was no record of fever in the emergency, and that testing was negative. It was reported to the emergency staff that the abd. pain had started in the morning prior to the vaccine visit. There was no mention during the vaccine visit here of any discomfort or fever.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: On 6-13-17 mother calls to report that child had emergency room visit several hours after vaccines given on 6/5/17. She reports fever of 104.5, emesis x 1 that was black in color, abdominal pain, dizzy, and weakness. Emergency findings were negative, child received fluids and had a negative CT scan of abdomen. Symptoms resolved. I did call the Infection Preventionist at the hospital, and she reports that there was no record of fever in the emergency, and that testing was negative. It was reported to the emergency staff that the abd. pain had started in the morning prior to the vaccine visit. There was no mention during the vaccine visit here of any discomfort or fever.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Blister, Cold sweat, Hot flush, Hyperhidrosis, Injection site erythema
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site swelling, Nausea, Pharyngeal erythema, Pharyngeal oedema, Rash erythematous
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash generalised, Rash pruritic, Streptococcus test negative, Urticaria, Vomiting
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Chills, Enlarged uvula, Erythema, Hyperhidrosis, Peripheral swelling
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pharyngeal oedema, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Anaphylactic reaction, Streptococcus test negative, Throat irritation, Urticaria
Clinical narrative: Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Myoclonic epilepsy
Clinical narrative: Myoclonic Seizure for approximately 7 hours.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Decreased appetite, Gait disturbance, Hypoaesthesia, Injection site erythema, Injection site pustule
Clinical narrative: Patient received both BOOSTRIX and PNEUMOVAX 23 in right arm. At time of injection there was no site reaction. Approximately 6 hours later her whole right side of her body went numb (body locked.) The numbness lasted 3 days and the most intense numbness was within the first 24 hours. Patient states her muscles would not extend, she could hardly walk, she had no appetite, and could hardly speak. She was very sore for at least a week. She had a fever for 3-4 days over 103 degrees fahrenheit. She has had the Tdap vaccine 3 times before with the last one being in 2007. Patient states she had a postule on the tetanus site on the day of injection and was there for 7 days. She states it looked like a whitehead but was not sore and she had redness less than the size of a dime.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Muscle contractions involuntary, Pain, Pyrexia
Clinical narrative: Patient received both BOOSTRIX and PNEUMOVAX 23 in right arm. At time of injection there was no site reaction. Approximately 6 hours later her whole right side of her body went numb (body locked.) The numbness lasted 3 days and the most intense numbness was within the first 24 hours. Patient states her muscles would not extend, she could hardly walk, she had no appetite, and could hardly speak. She was very sore for at least a week. She had a fever for 3-4 days over 103 degrees fahrenheit. She has had the Tdap vaccine 3 times before with the last one being in 2007. Patient states she had a postule on the tetanus site on the day of injection and was there for 7 days. She states it looked like a whitehead but was not sore and she had redness less than the size of a dime.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Note from provider at appointment on 5/5/17: pt complains of pain in RT shoulder where Tdap was given 2 weeks ago. Pt states injection was very painful when given. Pt states she has had some decreased ROM in the last 2 weeks, now improving. Recommended ice and tylenol x 1 week, if not resolved pt to call clinic for further evaluation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Swelling/inflammation and redness at injection site. BENADRYL and KEFLEX.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Rash erythematous, Rash papular, Viral rash
Clinical narrative: Seen 6/13/17 at PCP office for fever (intermittent) x 2 wks (102 degrees F max) and rash x 1 day. (Pink papular to trunk, back, bi-lat cheeks, chin and under eyes. Rec'd 12 mo vacc. at local HD on 5/30/17. DX at PCP with rash - viral -vs- MMR. No TX - monitor; RTC if worsens.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Induration, Pruritus
Clinical narrative: Since after the vaccination, there has been a small area of subcutaneous induration, non tender, not warm. not erythematous but it has remained pruritic since then.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Peripheral swelling, Pyrexia
Clinical narrative: Client vomited several times and had a low fever (100.2). She developed swelling above her right wrist to above her right shoulder which was warm and tender. Client was given cool packs, BENADRYL and CLARITIN. Symptoms started the evening after vaccination.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Skin warm, Tenderness, Vomiting
Clinical narrative: Client vomited several times and had a low fever (100.2). She developed swelling above her right wrist to above her right shoulder which was warm and tender. Client was given cool packs, BENADRYL and CLARITIN. Symptoms started the evening after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: 3 inch long, 1.5 inch wide area of erythema on Rt. upper arm around area of injection, and inferiorly. Mom noticed redness last night 6/8/17.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given morning of 6/12/17. Pt states she developed redness/swelling in (L) arm from shoulder to elbow. She came to office on 6/13/17.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Head injury, Loss of consciousness, Syncope, Tinnitus
Clinical narrative: Grandma called to report patient "fainted" at home around 1230 pm. Hit her head on lampshade and floor. Got on couch to recover. Stated she felt dizzy and ringing in her ears prior to passing out. Had not eaten all day except some water. Patient alert and oriented. Encouraged to drink SPRITE and have snack and rest. Grandma to call physician about hitting her head. Advised to go to ER or call primary physician if symptoms not resolved. Advised Grandma that this is a side effect from vaccines. Grandma understanding.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Swollen red area, started at 1&1/2 x 1&1/2 and grew to 3x3 by Tuesday. No temperature was hard on 6-12-17, but not as hard on 6-13-17. She was using ice packs and her physician was going to order an antibiotic and possibly a low dose steroid, after researching low dose steroid use before ZOSTAVAX shot .
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Swollen red area, started at 1&1/2 x 1&1/2 and grew to 3x3 by Tuesday. No temperature was hard on 6-12-17, but not as hard on 6-13-17. She was using ice packs and her physician was going to order an antibiotic and possibly a low dose steroid, after researching low dose steroid use before ZOSTAVAX shot .
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Administration site rash
Clinical narrative: Rash developed around administration site.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased
Clinical narrative: 102 degrees F Temp. 12 hours after administration.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Loss of consciousness, Pain
Clinical narrative: Pt son said patient's joint's were hurting and he felt achy. No treatment at this time. If he felt worse would see Dr. Went to see Dr. later same evening. Dr. sent him home, son said he passed out and got ambulance. Dr. sent him home again. Currently at home resting on day after.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Rt thigh - area red, warm - area increased in size and developed a lg. red lump.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Rt. thigh - area red, warm - area increased in size and developed a lg. red lump.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient received TDaP on 6/12, within a few hours after receiving vaccine pt. noted redness to injection site and body aches. On 6/14 patient in clinic to see gynecologist. Reported left deltoid red, swollen and painful to touch. Seen by Family Practice MD, Dx: cellulitis, prescribed FLAGYL and BACTRIM DS.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired Hepatitis A given. Expired 6/11/17. Given 6/14/17. Left thigh, lot # 4235D. Man. GSK. Mom aware pt need to come back for Hep A as this shot didn't count.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen at injection site on right thigh.
Sex: U
Vaccine: MENB
Symptoms: Local reaction, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a patient who received BEXSERO (batch number 164501A, expiry date April 2018) and (batch number 165401A, expiry date April 2018). This case was associated with a product complaint. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced local reaction and product complaint. On an unknown date, the outcome of the local reaction and product complaint were unknown. It was unknown if the reporter considered the local reaction to be related to BEXSERO. Additional details were reported as follows: The patient developed a local reaction after receiving a dose of BEXSERO. One of the reactions was severe enough, it required the patient to follow up with an orthopaedic doctor. The healthcare provider was on a tight schedule and it didn't have time to go through the adverse event details with the reporter. The physician said she would try and call back on Tuesday, 6th June 2017 with more details. This case is one of the 3 cases which were reported by the same reporter for the patients who received the same  lot of BEXSERO. The batch number reported for BEXSERO could 165401A or 1645401A, clarification has been requested for the same. No further details were given.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: The child came in. Develop swelling, pain, erythema after vaccine adm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anal fissure, Haematochezia, Irritability
Clinical narrative: Pt. seen 6/6/17 at PCP office for 2 mo. WCE REC'D 2 mo immunizations. Developed increased fussiness next PM. Seen again at PCP office 6/7/17 PM. During OV PT had a 'bloody stool' and was referred to ED to R/O intussusception R/T oral vaccine. ED DX with anal fissure - D/C'd home. FU PCP OV on 6/9/17.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: "Large rash that is warm to the touch on the top of (R) arm and that arm is swollen at injection site." Also says arm is sore.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site induration, Injection site pain, Muscle spasms, Neck pain
Clinical narrative: Black color at site of injection, tender and hard at site of injection, pain into neck and spasm into chest.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Irritability, Ultrasound abdomen normal, Vomiting
Clinical narrative: Pt. seen at PCP on 2/13/17 for 2 mo WCE and rec'd routine 2 mo vaccinations. Seen in OV 2/15/17 with c/o vomiting and blood in stool x 2 (2/14/17). Afebrile; fussy/irritable. Sent for ABD. U.S. - normal. Pt. recovered; PCP considering no 2nd dose; none given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient woke up from his nap with redness surrounding the vaccine area hot to touch and fever of 101.6 progressed to swollen shoulder and upper arm and very stiff. Later that night the area became harder flesh colored with grey tone and a ring of redness around it with pronounced veins traveling from area to neck and chest. Called dr. On call and she advised me to give him motrin and benadryl and left message for patient's dr, and was called back when open of following day scheduled right away to come in and check area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin discolouration, Vaccination site warmth, Vasodilatation
Clinical narrative: Patient woke up from his nap with redness surrounding the vaccine area hot to touch and fever of 101.6 progressed to swollen shoulder and upper arm and very stiff. Later that night the area became harder flesh colored with grey tone and a ring of redness around it with pronounced veins traveling from area to neck and chest. Called dr. On call and she advised me to give him motrin and benadryl and left message for patient's dr, and was called back when open of following day scheduled right away to come in and check area.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: FEVER STARTED THE EVENING OF THE VACCINE ADMNISTRATION AND HAS CONTINUED SINCE. TREATED WITH TYLENOL. RASH BEGAN AT APPROXIMATELY 8 AM ON 6/13/17. THE RASH BEGAN OVER THE BILATERAL LOWER EXTREMETIES AND NOW INCLUDES  TRUNK, ARMS AND FACE.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during breast feeding, Pyrexia
Clinical narrative: The 6 weeks old child, who is breastfed by previously vaccinated mother (on 06/12/2017), had fever of 99.5 F. The temperature decreased to normal the following morning.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: Patient stated she woke up 2 days after she had the GARDASIL 9 vaccine with swelling at the injection the site on the left arm the "size of an egg," with pain all down the arm, tingling in the fingers, and hives on the left arm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness, pain, swelling, itching on entire left arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Injection site reaction w/redness, throbbing, large welt, itching and pain. Occurred day after shot. No treatment other than ice.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache 6 hrs after receiving - recommend IBU 400 mg.
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to (L) thigh around injection site 24 hours after immunization. Treated with Clindamycin for possible cellulitis by Dr.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Next day results in muscular pain at site of shot, then got hot and itchy.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Cellulitis, Injection site cellulitis, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Later in the evening (R) arm whole vaccine was placed became swollen and hot to touch, cellulitis formed.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Skin warm
Clinical narrative: Later in the evening (R) arm whole vaccine was placed became swollen and hot to touch, cellulitis formed.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm became swollen, red and hot to touch on 6/15/17.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant via Pfizer and refers to a 72 year old female patient. The patients concurrent conditions included hyperlipidaemia and hypertension. On 20-MAR-2017 at 09:38, the patient was vaccinated with a first dose of PNEUMOVAX 23 0.5 ml, intramuscularly in the left deltoid (lot # M036728, expiry date 20-MAY-2018). Concomitant therapies included potassium chloride (KLOR-CON), hydrochlorothiazide, atorvastatin, levothyroxine sodium (SYNTHROID), ramipril, amlodipine, cyanocobalamin(manufacturer unknown), aspirin(manufacturer unknown) and folic acid. On 21-MAR-2017, the patient experienced redness and soreness of left deltoid around the injection site diagnosed as allergic reaction. The patient received loratadinum (Claritine) as a treatment. The outcome of the event was unknown (also reported as the caller believed that these events had resolved at the present time, but the caller could not be for certain. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant via Pfizer and refers to a 72 year old female patient. The patients concurrent conditions included hyperlipidaemia and hypertension. On 20-MAR-2017 at 09:38, the patient was vaccinated with a first dose of PNEUMOVAX 23 0.5 ml, intramuscularly in the left deltoid (lot # M036728, expiry date 20-MAY-2018). Concomitant therapies included potassium chloride (KLOR-CON), hydrochlorothiazide, atorvastatin, levothyroxine sodium (SYNTHROID), ramipril, amlodipine, cyanocobalamin(manufacturer unknown), aspirin(manufacturer unknown) and folic acid. On 21-MAR-2017, the patient experienced redness and soreness of left deltoid around the injection site diagnosed as allergic reaction. The patient received loratadinum (Claritine) as a treatment. The outcome of the event was unknown (also reported as the caller believed that these events had resolved at the present time, but the caller could not be for certain. The reporter considered the event to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Dyspnoea, Feeling hot, Injection site pain, Insomnia
Clinical narrative: Chronic Daily pain in region of Deltoid muscle only. Pain is worse if she moves arm in a certain way. Physical therapy and pain management planned.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: Chronic Daily pain in region of Deltoid muscle only. Pain is worse if she moves arm in a certain way. Physical therapy and pain management planned.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Chronic Daily pain in region of Deltoid muscle only. Pain is worse if she moves arm in a certain way. Physical therapy and pain management planned.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Death
Clinical narrative: Unknown - Notified by subpoena for records from coroner of child's death on day following vaccinate administration.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. No information on patients concurrent conditions, medical history and concomitant medications was provided. On 19-MAY-2017, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M040271, expiry date: 30-APR-2018 (dose was not provided). The product was stored in 0 Celsius degrees for 6 hours. The digital data logger was involved. There was no previous temperature excursions. Product quality issue was not involved. No adverse effects were reported. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative and refers to a 1-year-old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On 17-MAY-2017, the patient was vaccinated with a dose of VARIVAX injection (dose, route, lot number or expiration date were not reported), for prevention of chickenpox. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a bumpy, pox-like rash across her body, consisting of 15 to 20 bumps. The patient's mother stated that the rash might actually be mosquito bites, but she was not certain. The patient's mother sought medical attention by contacting the physician. No treatment was given for the events and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered at the time of this report. The causality assessment between the events and therapy with VARIVAX was not provided. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact the patient's physician.; Sender's Comments:  US-009507513-1706USA004798: US-009507513-1706USA004797:
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office staff member, concerning a 35 year-old female patient. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, by an unspecified provider. It was reported, that the administration was outside the prescribing limits of age. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning an unknown number of patients, of unspecified ages and genders.  The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (lot # M045204, expiration date: 11-NOV-2018; lot# M042495, expiration date: 19-OCT-2017; lot# M041081, expiration date: 06-OCT-2018) (dose, frequency and route of administration were not reported). No adverse effect was reported in any of the patients. It was reported that on an unspecified date, the vaccines were exposed to a temperature of 8.6 Farentheit degrees for 45 minutes. A prior temperature excursion was not reported. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.; Sender's Comments: US-009507513-1705USA009998:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. From 01-MAY-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M015698 and expiration date on 26-SEP-2017 (route and dose were not reported) for prophylaxis, which were diluted with a sterile diluent (MRK) injection lot number L007564 and expiration date on 19-NOV-2017, which was not improperly stored. The reporter stated that, the data logger registered that during 36 minutes, the temperature under the vaccine was stored was -14° Celsius degree to -10° Celsius degree, there was not prior temperature excursion and no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012139.
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 06-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL 9 (lot # M014929 with expiration date 27-MAY-2017) (dose, strength, frequency, route of administration and anatomical location were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates in 2017 (reported as since 20-APR-2017), the patients were vaccinated with VARIVAX (lot #: M025867 with expiration date: 24-MAY-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at following temperatures and time frames: on 20-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 54 minutes, on 21-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 44 minutes, on 22-APR-2017 at temperature greater than  6°F but less than 14°F for 3 hours and 12 minutes, on 23-APR-2017 at temperature greater than  6°F but less than 14°F for 2 hours and 49 minutes, on 02-JUN-2017 at temperature greater than  6°F  but less than 14°F for 7 hours and 51 minutes. There was no previous temperature excursion and this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes. There were two separate temperature excursions, one on 03-FEB-2017 and the second on 18-APR-2017. No adverse effects were reported. No product quality complaint was involved. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA010916.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstitute with properly stored sterile diluent (MERCK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes (the reporter also stated that there were two separate temperature excursions: the first on 03-FEB-2017 and the next on 18-APR-2017, and the vaccine was deemed to still be viable). No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a field representative referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route and lot# were not reported). On an unknown date, after the patient received ZOSTAVAX, the patient developed shingles (unspecified location). The outcome of herpes zoster was unknown. The relationship between the event and ZOSTAVAX were not reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 15 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 19-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
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 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot# M039904, expiration date 26-SEP-2018 and lot# M028130, expiration date 03-JUN -2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between 9 to 25 degrees Celsius for 1 hour and 41 minutes. The vaccine experienced previous temperature excursion between 9 to 25 degrees Celsius for 25 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1706USA007129: US-009507513-1706USA007130:
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 3 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 01-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 13 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 25-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784: