chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Middle insomnia, Mobility decreased, Muscle spasms, Musculoskeletal pain
Clinical narrative: Thursday, 9/6/12: Got the shot done around lunch time. I didn't really have any issues this day. Slight pain in my shoulder before I went to bed, but nothing to complain about. Friday, 9/7/12: Woke up at 3 am because of my arm hurting so bad. Couldn't get back to sleep. The only way that I could manage to get through the day was with pain pills. My arm still hurt, but it was much better. Saturday, 9/8/12: Woke up again at 3 am in pain from my arm. I couldn't use my left arm to get myself into or out of bed. It hurt so bad. I had to take pain pills to get through this day. Sunday, 9/9/12: My arm still had this red welt on it that felt hot, so I decided to google reactions to the Pneumovax vaccination because I was starting to get really paranoid at this point. I read that it could be an allergic reaction, so I took a Benadryl mid-day & before bed. I only needed pain pills in the AM for this day. My arm still had the red welt on it, but it got worst as the day went on (color, size, & pain level). I'm assuming this is due to the Benadryl from the night before wearing off. Overall, my arm was sore and itchy, but it was at a manageable level of pain without pain pills just as long as no one bumped into that area on my arm. I took Benadryl before bed. Tuesdy, 9/11/12: The welt now looks more like a bruise. The pain level is probably back to the pain I felt last Thursday night, right after I got the shot. 9/12/12-9/16/12-Still have slight red circle on arm from vaccination. Stomach issues: -Had massive diarehha, cramping, and nausea the weekend after the shot. As of now, I'm still having really bad acid reflux issues and chewed up food coming back up that hasn't been swallowed properly. I have had quite a few spells of reactive hypoglycemia, which I hadn't had in a long time.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity, Pruritus, Regurgitation, Skin warm
Clinical narrative: Thursday, 9/6/12: Got the shot done around lunch time. I didn't really have any issues this day. Slight pain in my shoulder before I went to bed, but nothing to complain about. Friday, 9/7/12: Woke up at 3 am because of my arm hurting so bad. Couldn't get back to sleep. The only way that I could manage to get through the day was with pain pills. My arm still hurt, but it was much better. Saturday, 9/8/12: Woke up again at 3 am in pain from my arm. I couldn't use my left arm to get myself into or out of bed. It hurt so bad. I had to take pain pills to get through this day. Sunday, 9/9/12: My arm still had this red welt on it that felt hot, so I decided to google reactions to the Pneumovax vaccination because I was starting to get really paranoid at this point. I read that it could be an allergic reaction, so I took a Benadryl mid-day & before bed. I only needed pain pills in the AM for this day. My arm still had the red welt on it, but it got worst as the day went on (color, size, & pain level). I'm assuming this is due to the Benadryl from the night before wearing off. Overall, my arm was sore and itchy, but it was at a manageable level of pain without pain pills just as long as no one bumped into that area on my arm. I took Benadryl before bed. Tuesdy, 9/11/12: The welt now looks more like a bruise. The pain level is probably back to the pain I felt last Thursday night, right after I got the shot. 9/12/12-9/16/12-Still have slight red circle on arm from vaccination. Stomach issues: -Had massive diarehha, cramping, and nausea the weekend after the shot. As of now, I'm still having really bad acid reflux issues and chewed up food coming back up that hasn't been swallowed properly. I have had quite a few spells of reactive hypoglycemia, which I hadn't had in a long time.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness, Urticaria
Clinical narrative: Thursday, 9/6/12: Got the shot done around lunch time. I didn't really have any issues this day. Slight pain in my shoulder before I went to bed, but nothing to complain about. Friday, 9/7/12: Woke up at 3 am because of my arm hurting so bad. Couldn't get back to sleep. The only way that I could manage to get through the day was with pain pills. My arm still hurt, but it was much better. Saturday, 9/8/12: Woke up again at 3 am in pain from my arm. I couldn't use my left arm to get myself into or out of bed. It hurt so bad. I had to take pain pills to get through this day. Sunday, 9/9/12: My arm still had this red welt on it that felt hot, so I decided to google reactions to the Pneumovax vaccination because I was starting to get really paranoid at this point. I read that it could be an allergic reaction, so I took a Benadryl mid-day & before bed. I only needed pain pills in the AM for this day. My arm still had the red welt on it, but it got worst as the day went on (color, size, & pain level). I'm assuming this is due to the Benadryl from the night before wearing off. Overall, my arm was sore and itchy, but it was at a manageable level of pain without pain pills just as long as no one bumped into that area on my arm. I took Benadryl before bed. Tuesdy, 9/11/12: The welt now looks more like a bruise. The pain level is probably back to the pain I felt last Thursday night, right after I got the shot. 9/12/12-9/16/12-Still have slight red circle on arm from vaccination. Stomach issues: -Had massive diarehha, cramping, and nausea the weekend after the shot. As of now, I'm still having really bad acid reflux issues and chewed up food coming back up that hasn't been swallowed properly. I have had quite a few spells of reactive hypoglycemia, which I hadn't had in a long time.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Started on 9/3/12 redness, swelling to site, warm to the touch, rash below injection site, itching still warm to the touch 2 days post vaccine now the size of a hand.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Paraesthesia, Skin warm
Clinical narrative: Left arm swollen, red, and warm to the touch. Fingers on left had are tingling slightly. No Dr. Seen
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Pain in extremity, Tremor
Clinical narrative: Sore left arm, shaking, shortness of breath that lasted for 3 hours. Did not go see Dr.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia
Clinical narrative: 911 called, light headness, tingling in right hand.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Pruritus, Tremor, Vision blurred
Clinical narrative: Feeling light headed, shaky, cold sweats, blurred vision, itchy below her knees.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Induration, Injection site warmth, Local swelling, Pain
Clinical narrative: Redness, swelling, swollen area on left arm is hard, injection site is very warm to touch and left arm hurts to move.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, swollen area on left arm is hard, injection site is very warm to touch and left arm hurts to move.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal pain, Myalgia, Oedema, Skin warm
Clinical narrative: Deltoid and shoulder red, hot, edema, pain. Redness streeaking all the way to elbow and under arm.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right arm red, swollen, hot to the touch, has chills.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Headache, Pain in extremity, Swelling
Clinical narrative: Redness, slight swelling, pain in both arm, slight headache and dizzy.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Lip swelling, Sensory disturbance
Clinical narrative: Upper lip swelled up and felt real strange. Patient went to ER. By the time she got there the swelling subsided.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Balance disorder, Dizziness
Clinical narrative: I was given flu shot on 09/11/2012 at 03:20PM. After flu shot was given, in the early morning about 5:30am, on the 09/12/12, I felt so dizziness, I could not walk because unbalance walking. It has been continuing happen to me for 04 days. I went ermergency at hospital. I had stay there about 02 hours. I was given one tablet Meclizine. Then doctor released me to home. But the dizziness continued happen to me until now. I need help for treatment. But I don't have health insurance or medical that coverage.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Frequent bowel movements, Urinary tract infection
Clinical narrative: I was given flu shot on 09/11/2012 at 03:20PM. After flu shot was given, in the early morning about 5:30am, on the 09/12/12, I felt so dizziness, I could not walk because unbalance walking. It has been continuing happen to me for 04 days. I went ermergency at hospital. I had stay there about 02 hours. I was given one tablet Meclizine. Then doctor released me to home. But the dizziness continued happen to me until now. I need help for treatment. But I don't have health insurance or medical that coverage.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Oedema peripheral
Clinical narrative: Right arm swelled with hard, warm bump in location of injection.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema
Clinical narrative: Right arm swelled with hard, warm bump in location of injection.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Mobility decreased
Clinical narrative: Unable to lift arm from shoulder. Swelling at site.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient called the pharmacy after closing and left a voice mail complaining of a low grade fever, chills, and aches. Upon receiving the patient's message, I called him and he said that he was feeling much better this morning. He said is daughter was with him, and he was going to rest the entire day.
Age: 38.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Hyperhidrosis, Injection site swelling, Skin warm
Clinical narrative: Sweating, red and hot to touch, swelling of right deltoid.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Red bumps, itchy. Currently located primarily on back, back of arms, rump.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Intense pain and redness at injection site. Beginning shortly after injection and continuing through reported date to us of 09/14/2012.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash pruritic, Swelling
Clinical narrative: Approximately 3 to 4 days after the flu shot was administered, the patient noticed a rash on her arm(raised round bumps). The rash started on her arms, then moved to her leg and also on her back. Rash was itchy and sore. The bumps swelled up.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Migraine, Oedema peripheral, Skin warm
Clinical narrative: Migraine in the evening of the 8/27/12, red hot swollen arm. Seen Dr. for cellulitis. Was given Prednisone and Bactrim.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Migraine, Oedema peripheral, Skin warm
Clinical narrative: Migraine in the evening of the 8/27/12, red hot swollen arm. Seen Dr. for cellulitis. Was given Prednisone and Bactrim.
Age: 12.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Body temperature increased, Diarrhoea, Erythema, Feeling hot
Clinical narrative: Warm and achy, temp 101, right arm hot and red, nauseous, diarrhea. Right arm was red from the shoulder to the elbow. Went to Urgent care. Dr. diagnosis bacterial infection. Prescribed Keflex.
Age: 12.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Nausea, Pain, Skin warm
Clinical narrative: Warm and achy, temp 101, right arm hot and red, nauseous, diarrhea. Right arm was red from the shoulder to the elbow. Went to Urgent care. Dr. diagnosis bacterial infection. Prescribed Keflex.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Pain in right arm with a slight raised mass noted at injection site about the size of a dime.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Gait disturbance, Hemiparesis
Clinical narrative: Weakness in right side - could not walk straight without holding on to something - dizzy.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Angioedema
Clinical narrative: Went to urgent care about 3:30 PM was diagnosed with Angioedema of lips. Steriod  shot and prescription.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Swelling and dark discoloration of right arm which received the PNEUMOVAX vaccination.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Body temperature increased, Feeling hot, Muscular weakness
Clinical narrative: Patient received vaccine on 9/11/12 and 2 days later, she called pharmacy complaining that she has terrible pain in her neck, shoulders, wrist, arms, fingers, back and no strength in her arms, and feels very warm. Her temp was 101 F.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, White blood cell count increased
Clinical narrative: Patient received vaccine on 9/11/12 and 2 days later, she called pharmacy complaining that she has terrible pain in her neck, shoulders, wrist, arms, fingers, back and no strength in her arms, and feels very warm. Her temp was 101 F.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site rash, Skin lesion
Clinical narrative: Redness, rash injection site 10-15 mins after shot. Scattered lesions (red, flat) chest & back. Removed Band-aid, cool compress injection site. Monitor x 15+ mins. redness, rash, lesions resolved. Vital signs WNL. Denies itch, trouble breathing.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Daughter (age 5) received VARIVAX (varicella vaccine) on 8/31/12. One week later, patient - father - developed clinical chickenpox with widespread typical lesions. He received valacyclovir and had no complications during recovery. This appears to be a case of vaccine associated varicella from a child (vaccinee) to parent.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Skin reaction
Clinical narrative: Localized skin reaction. Area, where given was swollen (golf ball size), hot, & red. Lasted a couple days then resolved. Patient told to use BENADRYL & hydrocortisone for itching & ibuprofen for swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness & swelling at site of injection & it was hot to the touch. Patient told to take BENADRYL for swelling.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Tenderness
Clinical narrative: Pt was given PNEUMOVAX in left deltoid & FLUZONE HD in right deltoid on 9/14/12. Called pharmacy 9/16/12 saying she had developed tenderness under the armpit & arm broke out in a rash extending to armpit on left arm.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Blood test, Injection site rash
Clinical narrative: She was feeling weak and she notice little rash at injection site left arm where ZOSTAVAX administered. After 2 days Dr. prescribed prednisone as treatment and she is ok now.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient's husband (a physician) diagnosed cellulitis in the right shoulder after vaccination.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Area of redness 1 1/2" x 2" on (L) deltoid, slightly warmer to the touch; itchiness noted.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt. had injection site swelling, entire width of arm and about 1 inch above and below injection site.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: TC from pt 9/4/12 to report she has had pain in (L) deltoid since 6/27/12. Denies having any redness, swelling, hematoma or any marks on arm after injection. Has not sought medical care. Pt referred to urgent care ctr for assessment by MD, Pt seen 9/5/12 at urgent care.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypersomnia
Clinical narrative: Extreme perspiration, thought I was fainting. Managed to get to the bed, called my son. Slept on/off 24 hrs. Dizziness for 3 days.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Varicella
Clinical narrative: Chicken pox disease.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Choking, Dysphonia, Oral administration complication
Clinical narrative: Mom states that baby choked during adm of ROTARIX. And since adm pt had a "horse voice".
Age: 1.73
Sex: F
Vaccine: HEPA, MMR
Symptoms: Urticaria
Clinical narrative: Hives on extremities, trunk, worse when heat or pressure applied to skin. No other symptoms or signs.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Pt obtained vaccine (ZOSTAVAX) in left arm. She went to ER 2 days later b/c it was red & swollen. Dx with cellulitis treated with KEFLEX 500 BID x 10 days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Adverse event
Clinical narrative: Immunization administered (L) deltoid. Pt rested head on nurse's shoulder. Pt alert & oriented. Cold compress applied to pt's neck & forehead pt given juice & crackers.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Painful red and swollen with possible infection at the injection site x2 wks right deltoid. Treated with cephalexin and valacyclovir. Caused by ZOSTAVAX.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV2
Symptoms: Syncope
Clinical narrative: Patient age 13 yr. 4 months seen for follow-up on acne and allergic rhinitis. Given HPV2 - sat in room for 5 minutes then on way to lobby stopped in bathroom - fainted while washing hands and again en route to exam room. Full recovery in 30 minutes.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called the office 1 day post injection (Friday) stating that her (R) arm was red, hot and swollen from the elbow up to the clavicle. Also very painful. When called to follow up Monday morning pt was still c/o pain but all other sx cleared on Sunday.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a registered nurse, for GARDASIL, Pregnancy Registry product, refers to a 14 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 GARDASIL on 04-AUG-2011. On 22-DEC-2011, the patient was vaccinated with the second dose of GARDASIL. Subsequently, the patient became pregnant with an LMP of 15-JUN-2012 and an EDD of 22-MAR-2013. Initial exposure to GARDASIL was at 7 weeks. On 07-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot # 670049/1171AA). Concomitant medications included: vitamins (unspecified) (vitamins (unspecified)). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 10 years old female patient. The patients mother stated that the patient was vaccinated with one dose of 1.0 ml GARDASIL (lot# unknown) today(07-SEP-2012) at her physician's office. No other co-suspects were reported. No concomitant medications were reported. The mother reported that while the physician was examined the patient and her sister, the physician picked up two syringes from a tray and administered both of them to the patient. The mother reports that when she inquired what the patient received, the physician was informed by his nurse that both of the syringes contained one dose of GARDASIL. Both doses of GARDASIL were administered into the patient's left arm. The mother stated that the patient did not exhibit any redness or other adverse effects to her injection site; she also reported that the patient had not reported any adverse effect. The patient sought medical attention by consulted pharmacist. Additional information has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 4 months old patient. On 04-SEP-2012 the patient received a dose of ROTATEQ (lot # 669085/1659Z) orally that expired on 29-AUG-2012. No adverse effects had been demonstrated or reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a 68 years old female patient with high blood pressure. Drug reactions/allergies included condeince, oxycodine, sulfa and myacin drugs. The patient was vaccinated with one time ZOSTAVAX subcutaneously in 2009 (exact date and lot # were unspecified). Concomitant medications included DIOVANN, pravastatin and ALLEGRA. In June 2012, the patient got shingles after getting the vaccine in 2009. She stated that she was still suffering from the postherpetic neuralgia (PHN). Pain killers were given as treatment for the adverse events. The patient thought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from two nurses' conversation refers to a 65 years old patient with fever at vaccination time. The patient was vaccinated with PNEUMOVAX23. Lot#, date and route were unspecified. It was reported that PNEUMOVAX23 gave the patient reaction of swelling in the arm on 31-AUG-2012. The outcome of swelling in the arm was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (MARRS 1209USA001828). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old female patient. The patient was vaccinated with ZOSTAVAX on approximately 17-AUG-2012, "3 weeks go". Lot# and route were unspecified. On approximately 19-AUG-2012, "2-3 days after vaccination", the patient developed a spot on her arm and a spot on her chest. No medical treatment was prescribed. The outcome of patient was unknown. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from two nurses' conversation refers to a 65 years old patient. The patient was vaccinated with PNEUMOVAX 23. Lot #, date and route were unspecified. It was reported that PNEUMOVAX 23 gave the patient reaction of swelling in the arm on 31-AUG-2012. The outcome of swelling in the arm was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source (MARRS 1209USA004430). Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via Novartis and was assigned manufacturer report number S2012US04359 refers to a female patient of unknown age. The patient was vaccinated with M-M-R II lot number not provided. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced adverse event (unspecified) while on M-M-R II. The outcome of adverse event (unspecified) was unknown. It was unspecified if the patient had sought medical attention. This was originally reported by an unspecified source working in a pharmacy. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient. The patient was vaccinated SC with a dose of 0.65 ml ZOSTAVAX to her left deltoid on 30-AUG-2012 for prevention of shingles. No other co-suspects were reported. No concomitant medications were reported. On 30-AUG-2012 the patient experienced side effects at the injection site that included pain on a 4 out of 10 pain scale, swelling, redness, itching and hard like a ping pong ball under the skin. No treatment information was reported. It was unknown if there is any relevant laboratory data. On 02-SEP-2012 the patient's signs and symptoms on pain on a 4 out of 10 pain scale, swelling, redness, itching and hard like ping pong ball under skin had not recovered but were improving. On 02-SEP-2012 it was unknown if the patient continued to take ZOSTAVAX. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Oedema peripheral, Rash macular
Clinical narrative: This spontaneous report as received from a healthcare worker (C.M.A.) refers to a 68 years old female patient with hypercholesterolemia and rosacea. The patient's medical history included shingles. The patient had "no known allergies" to drug. On 07-SEP-2012 the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot # not reported) intramuscularly into the left deltoid. It was reported that the patient also received a dose of TDAP into the right arm during the same visit. On 10-SEP-2012 the patient sought for medical attention by calling the practice to report that she was experiencing redness, blotchiness, and pain at the PNEUMOVAX23 injection site, and a swollen left hand. No treatment was given. The outcome was reported as not recovered. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from an 84 years old female consumer refers to herself with high blood pressure, drug allergy to aspirin and sulfa. The patient's medical history included shingles two years ago, on 09-FEB-2010. The patient was vaccinated with a dose of ZOSTAVAX subcutaneous on 28-AUG-2012. No other co-suspects were reported. Concomitant medications included NEXIUM, EFFEXOR and EVISTA. On 28-AUG-2012 the patient came down with chickenpox. The patient had sought medical attention and was treated by a physician. The generic VALTREX was given for the adverse event. The outcome of chickenpox was unknown. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product quality issue, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as an pharmacy technician) refers to a patient of unknown age. The reporter stated that a patient was inadvertently administered one dose of 0.5 ml VARIVAX (Merck) (lot# unknown) subcutaneous in instead of ZOSTAVAX at doctor's office on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown that if the patient had sought medical attention. The reported stated in a direct shipment from Merck there was one vial of VARIVAX (Merck) within a ZOSTAVAX box of 10. 9 was ZOSTAVAX and one vial was VARIVAX (Merck). Should be 10 pack of ZOSTAVAX only. Product quality complaint was filed. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Oedema peripheral, Swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of generalized swelling in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, according to the child's mother, the subject experienced generalized swelling. Swelling involved the hands, legs and feet. It was noted that the mother additionally reported that her child (the subject) looked as if she was "puffy all over." The sales representative reported that the subject's physician commented that she did not characterize the child as having generalized swelling reaction. The outcome of the event was not reported and it was noted that the event was considered to be unrelated to treatment with ROTARIX. Follow-up received on 16 September 2011 from the physician: The subject had no relevant medical history. Concomitant vaccinations included INFANRIX PENTA (GlaxoSmithKline), ACTHIB (non-GSK), and PREVNAR (non-GSK), given on 29 July 2011. On 29 July 2011 the subject received 2nd dose of ROTARIX (0.2 mL, oral). The lot number was reported as AF1FB203A; however based on a safety lot number review, the lot number was undated to A41FB203A. On 30 July 2011, one day after vaccination with ROTARIX, the subject experienced generalized swelling. The event resolved on 02 August 2011. The physician did not consider the event to be associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included cough and stuffy nose. Concurrent vaccination included PEDIARIX; GlaxoSmithKline; intramuscular; unknown given on 16 September 2011; Hib (non-gsk); Merck; intramuscular; unknown given on 16 September 2011; PREVNAR 13 (non-gsk); Wyeth; intramuscular; unknown given on 16 September 2011. There were no concurrent medications. On 16 September 2011 the subject received 1st dose of ROTARIX (oral). On 20 September 2011, 4 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was taken to the emergency room. It was unknown if relevant diagnostic tests or laboratory tests were performed. The subject was hospitalised for 1 day. On an unspecified date in September 2011, the intussusception was resolved.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site nodule, Irritability, Local reaction, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of irritability in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combines ;;unknown given on 25 October 2011; ACTHIB (non-gsk) ;Sanofi Pasteur MSD; unknown given on 25 October 2011; PREVENAR13 (non-gsk) ;Wyeth Labs;unknown given on 25 October 2011. On 25 October 2011 at 11:30 the subjects received a second dose of ROTARIX (intramuscular, right thigh) and experienced inappropriate route of vaccination. The subject was given ROTARIX intramuscularly instead of by the indicated oral route of administration. On either 25 or 26 October 2011, less than one week after vaccination with ROTARIX, the subject experienced irritability. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 21 November 2011. It was reported that the event of irritability began the day of ROTARIX administration, 25 October 2011. Resolution occurred on 27 October 2011. It was noted that the subject should get her 2nd dose of ROTARIX 28 days from the date initially given.
Age: 0.34
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration, Irritability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of irritability in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combines ;;unknown given on 25 October 2011; ACTHIB (non-gsk) ;Sanofi Pasteur MSD; unknown given on 25 October 2011; PREVENAR13 (non-gsk) ;Wyeth Labs;unknown given on 25 October 2011. On 25 October 2011 at 11:30 the subjects received a second dose of ROTARIX (intramuscular, right thigh) and experienced inappropriate route of vaccination. The subject was given ROTARIX intramuscularly instead of by the indicated oral route of administration. On either 25 or 26 October 2011, less than one week after vaccination with ROTARIX, the subject experienced irritability. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 21 November 2011. It was reported that the event of irritability began the day of ROTARIX administration, 25 October 2011. Resolution occurred on 27 October 2011. It was noted that the subject should get her 2nd dose of ROTARIX 28 days from the date initially given.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by the father of the subject (his daughter) and described the occurrence of pain in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Dtap vaccine, Hepatitis B vaccine, SYNFLORIX (unspecified), Polio vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Gripe baby water and MYLICON. On 30 April 2012 at 12:00 the subject received 1st dose of ROTARIX by injection. This was an inappropriate route of vaccination. ROTARIX is indicated for oral administration. On 30 April 2012 the subject also received 1st dose of Dtap vaccine (unknown manufacturer), 2nd dose of Hepatitis B vaccine (unknown manufacturer), 1st dose of Pneumococcal Conjugate vaccine-unspecified (unknown manufacturer) and 1st dose of Polio vaccine (other manufacturer). On 30 April 2012, immediately after vaccination with ROTARIX vaccine, Dtap vaccine, Hepatitis B vaccine, Pneumococcal Conjugate vaccine and Polio vaccine, the subject experienced pain. Fussiness was also reported. It was noted that the subject had colic prior to vaccinations, but the child was a little more fussy than normal following vaccinations. Pain resolved by 01 May 2012. The outcome of fussiness was not known. It was additionally reported that the vaccines were given at multiple sites and it was not known which limb was vaccinated with ROTARIX vaccine. The father of the subject stated that he was returning to the physician's office on the day of reporting to have ROTARIX administered orally. In the father's opinion, the event pain was possibly related to ROTARIX, Dtap vaccine, Hepatitis B vaccine, Pneumococcal conjugate vaccine and Polio vaccine. Attribution of the event of fussy to the vaccinations was unknown.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Irritability, Pain
Clinical narrative: This case was reported by the father of the subject (his daughter) and described the occurrence of pain in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Dtap vaccine, Hepatitis B vaccine, SYNFLORIX (unspecified), Polio vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Gripe baby water and MYLICON. On 30 April 2012 at 12:00 the subject received 1st dose of ROTARIX by injection. This was an inappropriate route of vaccination. ROTARIX is indicated for oral administration. On 30 April 2012 the subject also received 1st dose of Dtap vaccine (unknown manufacturer), 2nd dose of Hepatitis B vaccine (unknown manufacturer), 1st dose of Pneumococcal Conjugate vaccine-unspecified (unknown manufacturer) and 1st dose of Polio vaccine (other manufacturer). On 30 April 2012, immediately after vaccination with ROTARIX vaccine, Dtap vaccine, Hepatitis B vaccine, Pneumococcal Conjugate vaccine and Polio vaccine, the subject experienced pain. Fussiness was also reported. It was noted that the subject had colic prior to vaccinations, but the child was a little more fussy than normal following vaccinations. Pain resolved by 01 May 2012. The outcome of fussiness was not known. It was additionally reported that the vaccines were given at multiple sites and it was not known which limb was vaccinated with ROTARIX vaccine. The father of the subject stated that he was returning to the physician's office on the day of reporting to have ROTARIX administered orally. In the father's opinion, the event pain was possibly related to ROTARIX, Dtap vaccine, Hepatitis B vaccine, Pneumococcal conjugate vaccine and Polio vaccine. Attribution of the event of fussy to the vaccinations was unknown.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by the father of the subject (his daughter) and described the occurrence of pain in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Dtap vaccine, Hepatitis B vaccine, SYNFLORIX (unspecified), Polio vaccine. A physician or other health care professional has not verified this report. Concurrent medications included Gripe baby water and MYLICON. On 30 April 2012 at 12:00 the subject received 1st dose of ROTARIX by injection. This was an inappropriate route of vaccination. ROTARIX is indicated for oral administration. On 30 April 2012 the subject also received 1st dose of Dtap vaccine (unknown manufacturer), 2nd dose of Hepatitis B vaccine (unknown manufacturer), 1st dose of Pneumococcal Conjugate vaccine-unspecified (unknown manufacturer) and 1st dose of Polio vaccine (other manufacturer). On 30 April 2012, immediately after vaccination with ROTARIX vaccine, Dtap vaccine, Hepatitis B vaccine, Pneumococcal Conjugate vaccine and Polio vaccine, the subject experienced pain. Fussiness was also reported. It was noted that the subject had colic prior to vaccinations, but the child was a little more fussy than normal following vaccinations. Pain resolved by 01 May 2012. The outcome of fussiness was not known. It was additionally reported that the vaccines were given at multiple sites and it was not known which limb was vaccinated with ROTARIX vaccine. The father of the subject stated that he was returning to the physician's office on the day of reporting to have ROTARIX administered orally. In the father's opinion, the event pain was possibly related to ROTARIX, Dtap vaccine, Hepatitis B vaccine, Pneumococcal conjugate vaccine and Polio vaccine. Attribution of the event of fussy to the vaccinations was unknown.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This case was reported by a healthcare professional (nurse), via a sales representative, and described the occurrence of inappropriate route of vaccination in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer;unknown;unknown given on an unspecified date. On 8 June 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown site) and experienced inappropriate route of vaccination. The subject was administered "full pediatric dose" of ROTARIX by intramuscular injection instead of orally as indicated. Upon following received from the healthcare professional on 29 June 2012, it was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0983047A, A0983050A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases. Concurrent vaccination included dtpa-polio-hib (non-gsk);non-GSK manufacturer;intramuscular;unknown given on 30 April 2012; hepatitis B vaccine recombinant; manufacturer unspecified;unknown;unknown given on 30 April 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;unknown;unknown given on 30 April 2012. On 30 April 2012 (previously reported incorrectly as 8 June 2012), the 2-month-old female subject received 1st dose of ROTARIX intramuscularly and experienced inappropriate route of vaccination. Less than a day after vaccination with ROTARIX, on 30 April 2012, the subject experienced injection site soreness and injection redness that resolved on the same day (30 April 2012). The healthcare professional did not consider the events as serious and noted them as "routine adverse effects from any injection". The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. The ROTARIX series was reintroduced and administered orally on 13 June 2012 and the symptoms did not recur.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Irritability, Pain
Clinical narrative: This case was reported by a healthcare professional (nurse), via a sales representative, and described the occurrence of inappropriate route of vaccination in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer;unknown;unknown given on an unspecified date. On 8 June 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown site) and experienced inappropriate route of vaccination. The subject was administered "full pediatric dose" of ROTARIX by intramuscular injection instead of orally as indicated. Upon following received from the healthcare professional on 29 June 2012, it was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0983047A, A0983050A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases. Concurrent vaccination included dtpa-polio-hib (non-gsk);non-GSK manufacturer;intramuscular;unknown given on 30 April 2012; hepatitis B vaccine recombinant; manufacturer unspecified;unknown;unknown given on 30 April 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;unknown;unknown given on 30 April 2012. On 30 April 2012 (previously reported incorrectly as 8 June 2012), the 2-month-old female subject received 1st dose of ROTARIX intramuscularly and experienced inappropriate route of vaccination. Less than a day after vaccination with ROTARIX, on 30 April 2012, the subject experienced injection site soreness and injection redness that resolved on the same day (30 April 2012). The healthcare professional did not consider the events as serious and noted them as "routine adverse effects from any injection". The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. The ROTARIX series was reintroduced and administered orally on 13 June 2012 and the symptoms did not recur.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, DTAP, HEP, IPV, PPV, RV1, DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse), via a sales representative, and described the occurrence of inappropriate route of vaccination in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included dtpa-polio-hib (non-gsk); non-GSK manufacturer;unknown;unknown given on an unspecified date. On 8 June 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown site) and experienced inappropriate route of vaccination. The subject was administered "full pediatric dose" of ROTARIX by intramuscular injection instead of orally as indicated. Upon following received from the healthcare professional on 29 June 2012, it was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0983047A, A0983050A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases. Concurrent vaccination included dtpa-polio-hib (non-gsk);non-GSK manufacturer;intramuscular;unknown given on 30 April 2012; hepatitis B vaccine recombinant; manufacturer unspecified;unknown;unknown given on 30 April 2012; pneumococcal vaccines (non-gsk); non-GSK manufacturer;unknown;unknown given on 30 April 2012. On 30 April 2012 (previously reported incorrectly as 8 June 2012), the 2-month-old female subject received 1st dose of ROTARIX intramuscularly and experienced inappropriate route of vaccination. Less than a day after vaccination with ROTARIX, on 30 April 2012, the subject experienced injection site soreness and injection redness that resolved on the same day (30 April 2012). The healthcare professional did not consider the events as serious and noted them as "routine adverse effects from any injection". The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. The ROTARIX series was reintroduced and administered orally on 13 June 2012 and the symptoms did not recur.