chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pruritus, Scab
Clinical narrative: Zostavax on 9/5/12. On 9/25/12 was prescribed and started taking Valtrex for a facial peel to be done 9/26/12. On 9/29/12, developed multiple clusters of fluid filled blisters that drain, scab over then she gets more of them. No pain, only itching at site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Extreme dizziness, pain in shoulder, neck, arm (right).  Tingling in right hand and wrist.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Pain
Clinical narrative: Started with headache and body aches. Progressed to rigors one hour later. Self treated with Tylenol. Rigors ceased by midnight but had temperature of 101.7. Symptoms resolved by morning
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Left neck and collar bone stiffness and pain; left lower back pain. Continued throughout night, helped minimally with ibuprofen.
Age: 48.0
Sex: F
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Asthenia, Fatigue, Feeling of body temperature change, Heart rate increased, Pyrexia
Clinical narrative: Tired, weak, hot/cold throughout the day of vaccine, and felt like she was having a fever. Rash and increased pulse.
Age: 48.0
Sex: F
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Rash
Clinical narrative: Tired, weak, hot/cold throughout the day of vaccine, and felt like she was having a fever. Rash and increased pulse.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis contact, Drug hypersensitivity, Injection site rash, Rash, Rash erythematous
Clinical narrative: Received shot prior evening - woke up with rash on left arm near injection site that migrated across chest, up face and towards right eye. Similar appearing rash in groin area. Rash appeared to be contact dermatitis - red vesicular in appearance.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Rash vesicular
Clinical narrative: Received shot prior evening - woke up with rash on left arm near injection site that migrated across chest, up face and towards right eye. Similar appearing rash in groin area. Rash appeared to be contact dermatitis - red vesicular in appearance.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Started feeling poorly the night of vaccination. Next day area of sight turned red, edema, warm, painful. Went to ER, gave her Keflex.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Excoriation, Fall, Loss of consciousness, Syncope
Clinical narrative: Patient fainted in the waiting room about 5 minutes after receiving Gardasil injection.  Patient slid to floor from a chair, sustaining an abrasion to the temple.  Patient regained consciousness immediately and was able to walk supported to an exam table to recover.  Patient's abrasion was treated and bandaged.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Vertigo
Clinical narrative: Severe vertigo, some muscle aches and malaise. No fever. Vertigo and malaise has lasted more than 10 days. Muscle aches are improved.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever/chills/headache and muscle aches. Treated with Tylenol. Symptoms resolved by morning.
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood culture, Cough, Differential white blood cell count, Epstein-Barr virus test, Full blood count
Clinical narrative: 12 mo vaccines administered on 09-10-12. Pt. seen again in office for cough, cong., runny nose & fever (102), on 09-20-12. (s/s began 9-19-12). Dx with (B) OM & placed on AMOXIL that day. Pt. seen again on 9-28-12 for low-grade temp & rash on trunk, scalp, buttocks & extremities (no itching) which began 9-27-12. Admitted by PCP to hospital on 9-29-12 D/T worsening rash. Dx > serum sickness secondary to Abx (Mom is requesting VAERS report - feels vaccines --> serum sickness).
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Liver function test, Mycoplasma test, Otitis media, Pyrexia, Rash
Clinical narrative: 12 mo vaccines administered on 09-10-12. Pt. seen again in office for cough, cong., runny nose & fever (102), on 09-20-12. (s/s began 9-19-12). Dx with (B) OM & placed on AMOXIL that day. Pt. seen again on 9-28-12 for low-grade temp & rash on trunk, scalp, buttocks & extremities (no itching) which began 9-27-12. Admitted by PCP to hospital on 9-29-12 D/T worsening rash. Dx > serum sickness secondary to Abx (Mom is requesting VAERS report - feels vaccines --> serum sickness).
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea, Serum sickness, Urine analysis
Clinical narrative: 12 mo vaccines administered on 09-10-12. Pt. seen again in office for cough, cong., runny nose & fever (102), on 09-20-12. (s/s began 9-19-12). Dx with (B) OM & placed on AMOXIL that day. Pt. seen again on 9-28-12 for low-grade temp & rash on trunk, scalp, buttocks & extremities (no itching) which began 9-27-12. Admitted by PCP to hospital on 9-29-12 D/T worsening rash. Dx > serum sickness secondary to Abx (Mom is requesting VAERS report - feels vaccines --> serum sickness).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient was given FLUZONE High dose at 12:00 pm after 10 minutes she was nauseated & threw up was pale in color & sweating & difficulty breathing & almost passed out. Called 911 who came & took pt to the hospital.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient was given FLUZONE High dose at 12:00 pm after 10 minutes she was nauseated & threw up was pale in color & sweating & difficulty breathing & almost passed out. Called 911 who came & took pt to the hospital.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Cough, Fatigue, Immune system disorder, Influenza like illness
Clinical narrative: Three times in my life, after I receive the flu shot, 1985, 1994 and 2006, 2 weeks after I receive the flu shot, I come down with flu like symptoms, that are intermittent for 6-8 months, cough, fatigue, fever, aches, that result is many days of lost hospital work. Doctors do not believe this was caused by the flu shot. It has taken me an entire life time to figure out the name for this which is "vaccine induced immune dysfunction".  Dr. agrees that this condition exists.  Conventional medical doctors do not. I cannot receive the mandatory flu vaccine at my hospital due to the potential loss of work days, in a very strict attendance policy system.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Three times in my life, after I receive the flu shot, 1985, 1994 and 2006, 2 weeks after I receive the flu shot, I come down with flu like symptoms, that are intermittent for 6-8 months, cough, fatigue, fever, aches, that result is many days of lost hospital work. Doctors do not believe this was caused by the flu shot. It has taken me an entire life time to figure out the name for this which is "vaccine induced immune dysfunction".  Dr. agrees that this condition exists.  Conventional medical doctors do not. I cannot receive the mandatory flu vaccine at my hospital due to the potential loss of work days, in a very strict attendance policy system.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Severe migraine for 12 hours post injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site pruritus, Skin warm
Clinical narrative: Intense itching at injection site. Induration of 3x3 area very red, hot and hard.
Age: 1.07
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Hyporesponsive to stimuli, Hypotonia, Pyrexia
Clinical narrative: Decreased responsiveness, extremities limp, fever.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain after injection lasting days. Will need cortisone injection.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Muscular weakness, Paraesthesia
Clinical narrative: Racing pulse (over 100 bpm); tingling of hands and feet; weakness.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives and itching.  Broke out on hives on my left arm near injection - hives/rash broke out on my back and down my right arm and legs.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Burning sensation, Pruritus
Clinical narrative: 9/21 burning in neck that went on for 2 days with itching 10/1 neck area burning that moved into shoulder up behind ear and behind left eye 10/2 occasionally hurts at cheekbone
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Patient states unable to lift left arm on the day of the injection. Also, noticed to feel limited range of motion. Injection site was swollen and hot for 2 days. Noticed large bruising of left upper arm.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Joint swelling, Mobility decreased, Pain
Clinical narrative: Event began with general body aches on the first day and then the next day fatigue and swelling of the left knee so that it became difficult to bend the leg.  Other joints ached.  The swelling of the left knee ended about 5-7 days later but was followed by a lesser swelling of the right knee.  Fatigue lasted about a week.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: Weakness, fever, muscle aches, runny nose, hoarseness, coughing, runny nose, itchy eyes, extremely tired.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Weakness, fever, muscle aches, runny nose, hoarseness, coughing, runny nose, itchy eyes, extremely tired.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Pain, Swelling
Clinical narrative: Pain, swelling in the left arm. Went to the ER.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient displays a large red rash at injection site that began the night after injection.  It is itchy and hot to the touch.  Injection was given lower in the arm than normal.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Day 1 post injection noted lumps - swollen area to site with itching and redness, warm to touch. Day 2 post injection site red and warm to touch.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on both legs.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Panic attack, Rash erythematous
Clinical narrative: Panic attacks, red pinpoint spots on arms and legs.
Age: 61.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effect occurred.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I woke up about 8am with Red, raised, hot swelling, shooting pain down arm from where shot was given about the size of a dollar bill.  Headache, fatigue, neck pain.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Neck pain
Clinical narrative: I woke up about 8am with Red, raised, hot swelling, shooting pain down arm from where shot was given about the size of a dollar bill.  Headache, fatigue, neck pain.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Headache, achy joints, fatigue.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: This was not an adverse event, just a patient complaint about the redness associated with intradermal Fluzone shot. He said it was sore and red and he was unhappy about experience. Guest received refund and was reassured after I explained side effects of vaccine and that redness is normal.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Chills, Injection site pain, Injection site urticaria, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, aches, large hives at site of injection, pain at and around site of injection.
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Started with the hand of the injected arm going numb and feeling cool and tingly. This ascended up past the shoulder (at 4pm), up the neck(5:30 pm), and further to the level of nose (6pm). PCP instructed me to go the ER. ER had never seen this reaction before, but was unconcerned about it. Sent home with nothing. Overnight the symptoms started to recede. The next morning, approximately 21 hours post onset, only parts of the arm were still having the tingling numbness. Symptoms were fully resolved at 3pm on 9/29/12, approx. 25 hours post administration of influenza vaccine.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcus test negative, Urticaria
Clinical narrative: Legs were covered with hives and moved to arms. Went to doctor's office at 10:50 AM and the hives were disappearing. It's now 8:40 PM and she has more hives on arms and a couple appeared on her face.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Throat tightness, shortness of breath, urticaria. Treatment: Albuterol nebulizer treatment, Benadryl, Epinephrine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Insomnia, Malaise, Pyrexia
Clinical narrative: Severe chills, restlessness, fever to 102.1.  Also with general malaise for more than 12 hours after onset of symptoms.  Treated symptoms with Advil, rest and fluids by mouth.  Unable to go to work the next day due to inability to sleep.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Restlessness
Clinical narrative: Severe chills, restlessness, fever to 102.1.  Also with general malaise for more than 12 hours after onset of symptoms.  Treated symptoms with Advil, rest and fluids by mouth.  Unable to go to work the next day due to inability to sleep.
Age: 0.28
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Immune system disorder, Irritability, Malaise, Pyrexia
Clinical narrative: Chicken pox rash, we took her to the doctor and they said it was an allergic reaction, it was a chicken pox rash. She had the rash for 2 weeks and then her immune system crashed. Constant fevers, throwing up for 2 more weeks. New allergies to things we could not yet identify. Really irritable. For the next 2 years she was sick every 2-3 weeks with some major health problem, we had to take her back into the doctor every time she got sick with anything because her symptoms were more severe than a normal baby's symptoms would be.
Age: 0.28
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Vomiting
Clinical narrative: Chicken pox rash, we took her to the doctor and they said it was an allergic reaction, it was a chicken pox rash. She had the rash for 2 weeks and then her immune system crashed. Constant fevers, throwing up for 2 more weeks. New allergies to things we could not yet identify. Really irritable. For the next 2 years she was sick every 2-3 weeks with some major health problem, we had to take her back into the doctor every time she got sick with anything because her symptoms were more severe than a normal baby's symptoms would be.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Husband called 10/1/12 & said patient had a swollen & red right arm that redness reached down to her elbow. Husband said he will call her physician & see if she should be seen. He said the reaction was from the pneumonia vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: C/O entire arm red, with raised rash, warm to touch, ache.
Sex: U
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to a patient aged "15 to 18 months". The patient was vaccinated with dose 1, 0.5 ml PROQUAD (merck), SC (site of administration and lot # not reported) in 2011 ("about a year ago"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a week after immunization, the patient experienced febrile seizure. It was reported that the children had to go to the hospital (name/location unspecified) but the patient duration at the hospital was unknown by the reporter. No treatment information was reported. The outcome of febrile seizure was reported as recovered/resolved. The relatedness for febrile seizure is unknown for PROQUAD (Merck). This is one of several reports from the same source (MARRS# 1210USA000981). Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hypersensitivity, Maternal exposure during pregnancy, Pharyngeal oedema, Rash
Clinical narrative: Rash; hives, throat swelling, vomiting, diarrhea.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria, Vomiting
Clinical narrative: Rash; hives, throat swelling, vomiting, diarrhea.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a 53 years old male pharmacist. On 13-SEP-2012, the pharmacist went to administer the patient with ZOSTAVAX (lot number reported as 0070AE expiry 03-APR-2013) and the syringe plunger auto retracted and the ZOSTAVAX splashed into his left eye. He immediately used an eyewash to flush both of his eyes for at least 15 minutes. No adverse events were reported. Lot number verification has been requested. ZOSTAVAX splashed into the eye was considered to be medically significant by the reporter. The is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: This spontaneous report as received from a Licensed Practical nurse refers to two patients aged "15 to 18 months". The patients were vaccinated with dose 1, 0.5 ml PROQUAD, SC (site of administration and lot # not reported) in 2011 ("about a year ago"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a week after immunization, the patients experienced febrile seizure (medically significant). No treatment information was reported. The outcome of febrile seizure was reported as recovered/resolved. The relatedness for febrile seizure is unknown for PROQUAD (Merck). Upon internal review febrile seizures were considered medically significant. This is one of several reports from the same source (MARRS # 1210000193). Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Swollen tongue, Urticaria
Clinical narrative: Employee came to employee Health Dept complaining of nausea, hives and tongue feels swollen. Ambulated to Emergency dept with Employee Health staff.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Oedema peripheral, Pain
Clinical narrative: Arm swollen, pain, bruising/black area on hand (left).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: "Softball" sized swelling at injection site, 2 days after injection given per physician's office.
Age: 13.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness & swelling to right posterior upper arm started within 24 hours worsening next 24 hours. Red area approx 9 cm diameter soft, non-tender. Watchful waiting RTD if symptoms worsening. Pt dad stated that the tetanus shot was given in the fatty area.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Rash, swelling, pain on right. Arm a few hours after receiving PNEUMOVAX. Pt used MOTRIN, CLARITIN and ice. Pt getting better after 2 days.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Vaccination complication
Clinical narrative: Rash, swelling, pain on right. Arm a few hours after receiving PNEUMOVAX. Pt used MOTRIN, CLARITIN and ice. Pt getting better after 2 days.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient called stating severe pain in her arm where vaccine was given. I told her she should go to urgent care. The patient later called me to tell me she was returning to urgent care for additional antibiotics.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Pt reports her left arm is sore and 2 days after the immunization she has developed a circular redness around immunization site the size of a half dollar coin.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Pt had a flu shot in left arm & pneumonia shot in right arm. Called to inform next day swollen arm from flu shot & hives down arm. Took BENADRYL now fine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Following flu vaccine, developed approx 3 1/2 cm round area - red, hot to touch, itchy, sore if pressed. Resolved by 10/01/12.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath. Rapid heart rate. BP 114/73 P. 85 T. 97.8 O2 Sat 99%. BENADRYL 2 - 25mg tabs given -> resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Pt got a bruise from vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Injection site swelling, Injection site warmth
Clinical narrative: T 102 within 24 hours of administration (about 12 hours after). Swollen, warm (L) thigh 3 cm larger in circumference than (R) leg. No site redness at 0930 10/3/12. T 100.3 after MOTRIN in office.
Age: 1.8
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Dehydration, Gastroenteritis rotavirus, Microscopy, Rotavirus test positive
Clinical narrative: Information has been received from a physician, author of the article, regarding a healthy 22-month-old boy presented (patient #1) who presented with a history of 11 episodes of nonbloody, nonbilious emesis occurring over a 2-hour period. He was treated with oral ondansetron, orally rehydrated, and discharged. The patient returned 8 hours later with persistent vomiting. Because he was tachycardic and dehydrated, he received intravenous fluids overnight and was discharged the next day. Although the patient had received no doses of rotavirus vaccine, his infant sibling received a second dose of ROTATEQ 7 days prior to the patient's illness onset. The VP7 G1 gene of ROTATEQ component strain WI79-9 (G1P [5]) (99.9% identity in 839 bases sequenced) and the VP4 P[8] (100% identity in 835 bases) and VP6 I2 (100% identity in 338 bases) genes from RV5 strain WI79-4 (G6P[8]) were detected in a fecal specimen obtained 2 days after illness onset. Rotaviruses and unidentified particles 30-40 nm in diameter were observed. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include apparent transmission of an ROTATEQ vaccine-reassortant-strain from a vaccinated infant to an unvaccinated sibling (patient 1). Although these findings suggest potentially unusual transmission or vaccine replication processes, the contribution of the vaccine or vaccine-reassortant strain to patient's illness is unclear. Patient's illness was clinically consistent with rotavirus acute gastroenteritis (AGE) and occurred after exposure to a younger sibling who had recently received ROTATEQ. This patient's history of exposure and subsequent illness is similar to a prior report of sibling transmission of the same vaccine-derived G1P [8] strain [8], supporting the likely linkage between this vaccine reassortant strain and patient's illness. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.8
Sex: M
Vaccine: RV5
Symptoms: Secondary transmission, Tachycardia, Vomiting
Clinical narrative: Information has been received from a physician, author of the article, regarding a healthy 22-month-old boy presented (patient #1) who presented with a history of 11 episodes of nonbloody, nonbilious emesis occurring over a 2-hour period. He was treated with oral ondansetron, orally rehydrated, and discharged. The patient returned 8 hours later with persistent vomiting. Because he was tachycardic and dehydrated, he received intravenous fluids overnight and was discharged the next day. Although the patient had received no doses of rotavirus vaccine, his infant sibling received a second dose of ROTATEQ 7 days prior to the patient's illness onset. The VP7 G1 gene of ROTATEQ component strain WI79-9 (G1P [5]) (99.9% identity in 839 bases sequenced) and the VP4 P[8] (100% identity in 835 bases) and VP6 I2 (100% identity in 338 bases) genes from RV5 strain WI79-4 (G6P[8]) were detected in a fecal specimen obtained 2 days after illness onset. Rotaviruses and unidentified particles 30-40 nm in diameter were observed. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include apparent transmission of an ROTATEQ vaccine-reassortant-strain from a vaccinated infant to an unvaccinated sibling (patient 1). Although these findings suggest potentially unusual transmission or vaccine replication processes, the contribution of the vaccine or vaccine-reassortant strain to patient's illness is unclear. Patient's illness was clinically consistent with rotavirus acute gastroenteritis (AGE) and occurred after exposure to a younger sibling who had recently received ROTATEQ. This patient's history of exposure and subsequent illness is similar to a prior report of sibling transmission of the same vaccine-derived G1P [8] strain [8], supporting the likely linkage between this vaccine reassortant strain and patient's illness. Additional information has been requested. This is one of several reports received from the same source.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: After patient was injected with influenza into (Rt) deltoid, IM patients arm, site of injection, immediately started to swell up into about a 40mm circle around injection site. Dr. came in and advised to place an ice pack. Ice pack was placed and monitored for 15 min. Patient denied prior reactions to flu injection. Also denied any SOB, itching or chest pain.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Adenovirus test positive, Bronchiolitis, Diarrhoea, Laboratory test normal, Microscopy
Clinical narrative: Information has been received from a physician, author of the article, regarding a 4-month-old boy (patient 2) who presented with a 4-day history of rhinorrhea and nonbloody diarrhea, a 3 days of fever. The patient was wheezing and tachypneic with an oxygen saturation of 95%. He was diagnosed with bronchiolitis, treated with levalbuterol and vaponephrine, and observed overnight. The patient received his first dose of ROTATEQ 11 days before illness onset. Genetic analysis of a fecal specimen obtained 9 days after illness onset detected the VP7 G1 gene of ROTATEQ strain W179-9 (G1P[5]) (100% identity in 854 bases) and the VP4 P[8] gene from RV5 strain W179-4 (G6P[8]) (100% identity in 835 bases). The VP6 I2 gene detected matched that of RV5 component strains W179-9 (G1P[5]), SC2-9 (G2P[5]), W178-8 (G3P)[5]), and BrB-9 (G4P[5]) (100% identity in 342 bases). The VP3 M2 gene matched the sequence of strains W179-4 (G6P[8]), W 178-8 (G3P[5]), and BrB-9 (G4P[5]) (100% identity 500 bases). This strain appears to be a double reassortant with either the W179-9 (G1P[5]) VP7 and VP6 genes inserted onto a W179-4 (G6P[8]) backbone or the VP4 of W179-4 (G6P[8]) and VP3 of W179-4 (G6P[8]), BrB-9 (G4P[5]), or W178-8 (G3P[5]) inserted onto a W179-9 (G1P [5]) backbone. Rotaviruses and adenoviruses were observed by EM. Real-time PCR was positive for adenovirus group F; all other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included ROTATEQ vaccines-reassortant strain in a recently vaccinated child (patient 2). Patient had upper respiratory symptoms accompanied by vomiting or diarrhea, and his illness was less typical of rotavirus disease alone. Additionally, detection of adenovirus group F in patient 2 specimen provides a plausible alternate etiology. Additional information has been requested. This is one of the several reports received from the same source.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Polymerase chain reaction, Pyrexia, Respiratory disorder, Rhinorrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician, author of the article, regarding a 4-month-old boy (patient 2) who presented with a 4-day history of rhinorrhea and nonbloody diarrhea, a 3 days of fever. The patient was wheezing and tachypneic with an oxygen saturation of 95%. He was diagnosed with bronchiolitis, treated with levalbuterol and vaponephrine, and observed overnight. The patient received his first dose of ROTATEQ 11 days before illness onset. Genetic analysis of a fecal specimen obtained 9 days after illness onset detected the VP7 G1 gene of ROTATEQ strain W179-9 (G1P[5]) (100% identity in 854 bases) and the VP4 P[8] gene from RV5 strain W179-4 (G6P[8]) (100% identity in 835 bases). The VP6 I2 gene detected matched that of RV5 component strains W179-9 (G1P[5]), SC2-9 (G2P[5]), W178-8 (G3P)[5]), and BrB-9 (G4P[5]) (100% identity in 342 bases). The VP3 M2 gene matched the sequence of strains W179-4 (G6P[8]), W 178-8 (G3P[5]), and BrB-9 (G4P[5]) (100% identity 500 bases). This strain appears to be a double reassortant with either the W179-9 (G1P[5]) VP7 and VP6 genes inserted onto a W179-4 (G6P[8]) backbone or the VP4 of W179-4 (G6P[8]) and VP3 of W179-4 (G6P[8]), BrB-9 (G4P[5]), or W178-8 (G3P[5]) inserted onto a W179-9 (G1P [5]) backbone. Rotaviruses and adenoviruses were observed by EM. Real-time PCR was positive for adenovirus group F; all other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included ROTATEQ vaccines-reassortant strain in a recently vaccinated child (patient 2). Patient had upper respiratory symptoms accompanied by vomiting or diarrhea, and his illness was less typical of rotavirus disease alone. Additionally, detection of adenovirus group F in patient 2 specimen provides a plausible alternate etiology. Additional information has been requested. This is one of the several reports received from the same source.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Tachypnoea, Vomiting, Wheezing
Clinical narrative: Information has been received from a physician, author of the article, regarding a 4-month-old boy (patient 2) who presented with a 4-day history of rhinorrhea and nonbloody diarrhea, a 3 days of fever. The patient was wheezing and tachypneic with an oxygen saturation of 95%. He was diagnosed with bronchiolitis, treated with levalbuterol and vaponephrine, and observed overnight. The patient received his first dose of ROTATEQ 11 days before illness onset. Genetic analysis of a fecal specimen obtained 9 days after illness onset detected the VP7 G1 gene of ROTATEQ strain W179-9 (G1P[5]) (100% identity in 854 bases) and the VP4 P[8] gene from RV5 strain W179-4 (G6P[8]) (100% identity in 835 bases). The VP6 I2 gene detected matched that of RV5 component strains W179-9 (G1P[5]), SC2-9 (G2P[5]), W178-8 (G3P)[5]), and BrB-9 (G4P[5]) (100% identity in 342 bases). The VP3 M2 gene matched the sequence of strains W179-4 (G6P[8]), W 178-8 (G3P[5]), and BrB-9 (G4P[5]) (100% identity 500 bases). This strain appears to be a double reassortant with either the W179-9 (G1P[5]) VP7 and VP6 genes inserted onto a W179-4 (G6P[8]) backbone or the VP4 of W179-4 (G6P[8]) and VP3 of W179-4 (G6P[8]), BrB-9 (G4P[5]), or W178-8 (G3P[5]) inserted onto a W179-9 (G1P [5]) backbone. Rotaviruses and adenoviruses were observed by EM. Real-time PCR was positive for adenovirus group F; all other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences included ROTATEQ vaccines-reassortant strain in a recently vaccinated child (patient 2). Patient had upper respiratory symptoms accompanied by vomiting or diarrhea, and his illness was less typical of rotavirus disease alone. Additionally, detection of adenovirus group F in patient 2 specimen provides a plausible alternate etiology. Additional information has been requested. This is one of the several reports received from the same source.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: (R) upper ext. visual lesion: macule red, oval, isolated, localized where Varicella #2 was given. Tx: OTC BENADRYL and local ice packs, schedule f/u visit if not improved in 2 days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Developed numbness & tingling bilateral hands & feet approximately 18 hrs. after receiving FLUARIX vaccine (TIV) Lot # AFLUA698BA, GlaxoSmithKline. Symptom persist through today (10/3/12).
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Warm, red area below vaccine admin. site about the size of the hand.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Malaise, Pain, Pruritus, Swelling face
Clinical narrative: Generalized body aches, malaise, fatigue, and right facial swelling and itching.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Pyrexia, Rash, Skin warm
Clinical narrative: Fever, rash on chest, back, neck, (R) arm, warm to touch, sensitivity reaction.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Urinary incontinence
Clinical narrative: Seizure, loss of bladder control on 10/2 10 at 10:30 AM. Mother reports child having seizure. She did not seek medical attention for her child. Did not speak to a doctor until 6 1/2 hours after the seizure. Unclear whether seizure was MD diagnosed. No others adverse effects per mother.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation
Clinical narrative: Information has been received from a registered pharmacist (R.Ph.) concerning an 80 year old female patient. The patient's pertinent medical history and drug reactions or allergies were unknown. On 01-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (lot # and expiration date were not reported). The pharmacist reported that on an unknown date, the patient developed inflammation following vaccination with ZOSTAVAX. The patient was given MEDROL DOSE PACK as treatment for the event. The patient sought medical attention by contacting the physician. There was no intervention to prevent serious criteria. At the time of the report, the patient had not recovered from the inflammation following vaccination. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a 68 years old female patient with no pertinent medical history or drug reactions/allergies who on 15-SEP-2012 was vaccinated with a dose of ZOSTAVAX, 0.65 mL, subcutaneously (lot # 0364AE, expiration date on 16-MAR-2016). Concomitant therapy included FLUZONE. On 18-SEP-2012, the patient developed an egg size welt at the injection site "for 5 days". On an unspecified date, the patient developed a low grade fever that never was over 101F for "3-4 days". The patient was treated with TYLENOL for the fever and ice on the injection site if needed. No laboratory tests were performed. The patient called the pharmacist. The pharmacist stated that the patient's egg size welt at the injection site was getting better every day. At the time of the report, the event outcome for egg size welt a the injection site was recovering and the event outcome for low grade fever was unknown. The relatedness for had an egg size welt at the injection site and low grade fever was unknown for ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Coeliac disease, Hypoaesthesia, Neuropathy peripheral, Pain
Clinical narrative: This spontaneous report as received from an approximately 76 years old male patient with thyroid disease, neuropathy and gluten allergy refers to himself. The patient's medical history included prostate cancer 12 years ago. The patient was vaccinated SC. with a dose of ZOSTAVAX (lot number unspecified"about 4 years ago", in approximately 2008. No other co-suspects were reported. Concomitant medications included SYNTHROID, calcium and vitamins (unspecified). The patient reported that, about 2 and and half years ago, in appropriate March 2010, he was diagnosed with neuropathy in the lower extremities causing him numbing and pain. He also said he was being considered for celiac disease. He broke out in blistering type rash on his upper body mostly and seemed to get better with a gluten free diet. The outcome of neuropathy in the lower extremities and celiac disease was unknown. The patient had sought unspecified medical attention. Patient did blood work very often and other studies for Neuropathy. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from an approximately 76 years old male patient with thyroid disease, neuropathy and gluten allergy refers to himself. The patient's medical history included prostate cancer 12 years ago. The patient was vaccinated SC. with a dose of ZOSTAVAX (lot number unspecified"about 4 years ago", in approximately 2008. No other co-suspects were reported. Concomitant medications included SYNTHROID, calcium and vitamins (unspecified). The patient reported that, about 2 and and half years ago, in appropriate March 2010, he was diagnosed with neuropathy in the lower extremities causing him numbing and pain. He also said he was being considered for celiac disease. He broke out in blistering type rash on his upper body mostly and seemed to get better with a gluten free diet. The outcome of neuropathy in the lower extremities and celiac disease was unknown. The patient had sought unspecified medical attention. Patient did blood work very often and other studies for Neuropathy. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 3 patients of unknown ages whose on an unspecified dates was vaccinated with an expired dose of PNEUMOVAX 23 during the time period of 14-SEP-2012 through 18-SEP-2012. The PNEUMOVAX 23 had an expiration date of 14-AUG-2012. No symptoms were reported. Additional information has been requested. Follow up information was provided during a phone call on 26-SEP-2012 stating the health care professional could not supply the dates of vaccination or dates of events. Follow up received on 26-SEP-2012 reported that the 59 year old male patient received an expired dose of PNEUMOVAX 23 (lot # 669382/1490Z) on 13-SEP-2012. The source case 1209USA008402 was split into three cases. This case is also linked to case 1210USA000520.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL in March 2012 (dose, site of administration and lot # not reported). No adverse events reported. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 83 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX on 31-DEC-2008 (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-SEP-2012 the patient developed shingles, 1345 days after onset of therapy. The patient sought unspecified medical attention and was treated with acyclovir and prednisone. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Antibody test, Blood test, Decreased appetite, Dizziness, Headache
Clinical narrative: Information was received from a patient's mother regarding her 9 years old son who on 12SEP2012, was vaccinated with his first dose of GARDASIL, 0.5ml intramuscularly. It was reported that 3 days after receiving GARDASIL, he experienced dizziness, headaches, fever, and vomiting. The patient has also had loss of appetite and has lost 8 pounds. The patient had been to physician's office five times and had also gone to hospital emergency room and was given ZOLFRAN and sent home. It was reported the patient has had extensive blood work and blue titer test meningitis (results not reported). At the time of this report it was noted that the patient has not recovered. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Laboratory test, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Information was received from a patient's mother regarding her 9 years old son who on 12SEP2012, was vaccinated with his first dose of GARDASIL, 0.5ml intramuscularly. It was reported that 3 days after receiving GARDASIL, he experienced dizziness, headaches, fever, and vomiting. The patient has also had loss of appetite and has lost 8 pounds. The patient had been to physician's office five times and had also gone to hospital emergency room and was given ZOLFRAN and sent home. It was reported the patient has had extensive blood work and blue titer test meningitis (results not reported). At the time of this report it was noted that the patient has not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. On 21-SEP-2012 the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot #: 669579/0595AA) which was expired on 30-AUG-2012. No adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient aged greater than 65 years. The patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose and route not reported) on an unspecified date. On an unknown date the patient experienced a severe reaction at the injection site after administration of ZOSTAVAX. Hospitalization was not required. It was not known if the patient sought for medical attention. At the time of this report the severe reaction at the injection site had resolved. This is one of several reports received from a same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) on an unspecified date. On an unknown date the patient experienced a local reaction at the injection site after administration of ZOSTAVAX. Hospitalization was not required. It was not known if the patient sought for medical attention. At the time of this report the injection site reaction had resolved. This is one of several reports received from a same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report received from a doctor of pharmacy refers to 3 patients of unknown age. The patient were vaccinated subcutaneously with a dose of ZOSTAVAX (lot  # and dose not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. It was reported that the 3 patients were vaccinated with ZOSTAVAX and after 3-4 days of the administration of the drug, all 3 patients came down with herpes zoster (date unspecified). No treatment information was reported. The outcome of came down with herpes zoster was unknown. The relatedness for the event was not provided for ZOSTAVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report additional information will be provided if available.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient received an expired dose of PNEUMOVAX 23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. This is one of several reports from the same source. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: The pharmacist reported that on 05-SEP-2012, the patient received a dose of PNEUMOVAX 23 (Lot# 669579/0595AA) that expired on 30-AUG-2012. The PNEUMOVAX 23 was ordered for the patient by the physician. At the time of this report the patient was not reporting or demonstrating any adverse effects. The outcome of the event was unknown. The event was not related to PNEUMOVAX 23. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Biopsy, Blood test, Coeliac disease, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 78 years old female with depression, migraines, Gastrooesophageal reflux disease (GERD), and allergy to small pox vaccine and gluten. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (Lot# and dose not reported) "about 4 years ago" in September 2008. Concomitant medications included PROZAC, magnesium chloride, PRILOSEC, vitamins including calcium (unspecified) and cyanocobalamin, and minerals (unspecified), CENTRUM SILVER. In September 2010, "about 2 years" after the patient received ZOSTAVAX she was diagnosed with celiac disease. She broke out with "pimples" on her back, legs, and scalp as well as her face. They were painful and she continued to break out to date, just not as bad. She also fainted this week in September 2012. The patient sought for unspecified medical attention. Biopsies were performed 2 years ago, also blood work (results not reported). The patient was given aloe vera cream for treatment and avoided perfumed products and took gluten free diet. The patient's status was not reported. Additional information has been requested.