chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache
Clinical narrative: Patient asked if any reactions to Flu vaccine in past, she reported, flu symptoms, denies any allergies to eggs. 30 minutes after reports headache, dizziness - went to ED.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Abdominal discomfort, Erythema multiforme, Vomiting
Clinical narrative: Per father, child seen at medical facility on 9-9-14 with Dx of erythema multiforme. Father also reported GI upset with vomiting and that child had been treated by mother with prednisone and hydrocortisone cream.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site pain, Palpitations
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 26 year old female patient with ZITHROMAX allergy and no pertinent medical history. On 04-SEP-2014 the patient was vaccinated with GARDASIL dose 3 (dose, lot # unknown). There were no concomitant medications. In the evening of 04-SEP-2014 the patient complained that she had pain in her left arm at injection site and that she felt her heart racing. When she woke up on 05-SEP-2014 she stated that she could not lift her left arm for three hours as if it was paralyzed. This symptom resolved itself throughout the day but came back every morning since the vaccine was administered. The patient stated that she still was not able to move her left arm every morning for approximately three hours and she slowly started to regain sensation in the arm and was able to go on with her daily activities. She did have another episode of her heart racing on an unspecified date and this resolved on an unspecified date in September 2014. The patient visited the nurse practitioner on 11-SEP-2014 and stated that she had been treating the arm with warm compresses and taking ibuprofen on unspecified dates. The nurse practitioner prescribed ADVIL as needed and cool compresses. The nurse practitioner also observed the injection site and stated that it was black and blue in appearance on 11-SEP-2014. The outcome of could not lift her left arm for three hours as if it was paralyzed, injection site was black and blue in appearance and pain in her left arm at injection site was reported as not recovered. Upon internal review, the event of could not lift her left arm for three hours as if it was paralyzed was considered to be medically significant. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Only dizziness
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC13
Symptoms: Muscular weakness, Myelitis transverse, Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Transverse myelitis. 9/2/14 - left arm weakness. 9/6/14 - right leg weakness. 9/8/14 - increased weakness, neck pain, poor head control.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC13
Symptoms: Posture abnormal
Clinical narrative: Transverse myelitis. 9/2/14 - left arm weakness. 9/6/14 - right leg weakness. 9/8/14 - increased weakness, neck pain, poor head control.
Age: 34.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Pyrexia, Vaccination site pain
Clinical narrative: After returning home from the clinic where the vaccines were administered, patient noted the left arm (site of vaccination) became painful, hot, red, and swollen. The patient developed fever (up to 103.8 F) and chills. Diagnosed as cellulitis and treated with antibiotics with improvement.
Age: 34.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: After returning home from the clinic where the vaccines were administered, patient noted the left arm (site of vaccination) became painful, hot, red, and swollen. The patient developed fever (up to 103.8 F) and chills. Diagnosed as cellulitis and treated with antibiotics with improvement.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Eye pruritus, Pruritus generalised, Rash, Throat irritation
Clinical narrative: After patient received vaccines he developed a rash which he initially developed itch to the throat and around the eyes. Patient then developed a mild itch that intensified to the body. Patient was given BENADRYL 5g po then followed by epinephrine 0.3 sq. Observed patient for 2 hrs and improved.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Appearance of a very red, edematous, warm 5 cm area where vaccine was given. Pt responded to course of antihistamine and mupirocin.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Fever. Cellulitis.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Axillary pain, Burning sensation, Chest discomfort, Dizziness, Oedema peripheral
Clinical narrative: Fever. Cellulitis.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: Fever. Cellulitis.
Age: 34.0
Sex: F
Vaccine: ANTH, IPV, MMR, MNQ, TYP
Symptoms: Headache
Clinical narrative: Headache following AVA.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Rash
Clinical narrative: Patient reported a painful rash on abdomen the morning after the flu shot. Doctor thought there may have been a connection to getting the flu shot.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Rash/whelps to BUE, chest, face and head; No SOB or facial swelling. Treated with PO BENDARYL allowed to sit in office x 3o min. Rash resolved.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site to left lateral thigh. Treatment perscription for child Ibuprofen 6mls every 6 to 8 hrs as need for pain.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest X-ray, Chills, Cough, Dyspnoea, Erythema
Clinical narrative: Coughing, Mucus, Sinus drainage, Extreme pain, redness and swelling in left shoulder. Shortness of breath, chills and sweating. Headache. Pneumonia.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Hyperhidrosis, Musculoskeletal pain, Paranasal sinus hypersecretion, Pneumonia
Clinical narrative: Coughing, Mucus, Sinus drainage, Extreme pain, redness and swelling in left shoulder. Shortness of breath, chills and sweating. Headache. Pneumonia.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Secretion discharge, Swelling
Clinical narrative: Coughing, Mucus, Sinus drainage, Extreme pain, redness and swelling in left shoulder. Shortness of breath, chills and sweating. Headache. Pneumonia.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: I got a shingles vaccine on 4/10/14. I take care of my father in a nursing home, brush teeth, wash hands and face. He developed shingles a week later 4-17-14. Developed in right eye. Father 86 yrs old. Congestive heart failure, diabetic, NPH.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: Patient was given vaccine injections in left deltoid, several minutes after she became pale. Placed in chair, patient passed out, was unresponsive for several minutes. BP 120/80  Pulse 88.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Severe and movement limiting stiffness of entire body.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Muscle twitching
Clinical narrative: Pt had seizure after administration of vaccine. Hands were twitching per mom. Pt felt dizzy. Pt is alert and oriented X3. VS WNL.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever for two days after receiving the immunization.  Headaches, malaise, body aches, and fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Pt complained of large 4" by 4" red imflamed wheal at injection site, painful and swollen.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Within an hour of vaccine developed large flare reaction approximately 3 inches by 2 inches with erythema, induration, pruritis and pain.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Pt developed rash about 2 inches around where vaccine was admin.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Blood test, Hypoaesthesia, Pyrexia, Rash
Clinical narrative: Pt mother called Health Dept on 9/2/14 stating that pt had rash, fever, arthralgia, and numbness of right hand approximately 2 weeks after injection at VARIVAX chickenpox vaccine dose #2. Pt went to ER and Rheumatologist for evaluation with providers stating was from CPX vaccine. All symptoms have resolved approximately 1 week after onset.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash morbilliform
Clinical narrative: Generalised fine erythematous rash, morbilliform on trunk and intraarticular.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Gait disturbance, Muscle spasms, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Fever, leg cramps, calf pain and tenderness.  Lasted a few days and resolved.  Noted difficulty walking (toe-walking) due to calf pain.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Toe walking
Clinical narrative: Fever, leg cramps, calf pain and tenderness.  Lasted a few days and resolved.  Noted difficulty walking (toe-walking) due to calf pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Heart rate increased
Clinical narrative: Swelling of the injection area, arm turned red, shortness of breath then difficulty breathing, fast heart beat, dizziness and weakness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling of the injection area, arm turned red, shortness of breath then difficulty breathing, fast heart beat, dizziness and weakness.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at injection site.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Pain, Pain in extremity, Swelling
Clinical narrative: Throbbing sharp pain, swelling, warmness, shooting pain to fingers, pain with movement.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: RASH - 8cm x6cm raised red urticarial area on the right arm. Appears at the sight of the Menveo?
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Nausea, Neck pain, Pain in extremity, Tenderness
Clinical narrative: Pt. noticed soreness that radiated up her arm to her clavicle and neck area. approx. 1600 noted nausea and warmness that resolved within a half hour. Injection site was wnl, and not tender. Pt denies need for outside treatment.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Electrocardiogram, Lip swelling, Pruritus, Rash
Clinical narrative: ITCHING THAT BEGAN TO EARS.  RASH/ITCHING SPREAD TO BACK AND THEN FACE.  MILD SWELLING TO UPPER LIP.  DENIES SWELLING OF TONGUE; DENIES DIFFICULTY BREATHING OR SHORTNESS OF BREATH.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pain in arm from elbow to shoulder. Arm swollen and red (rash) on tricep.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Feeling hot, Irritability, Vomiting
Clinical narrative: Vomited x1, feels warm, fussy.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Swollen tongue
Clinical narrative: Wheal over site, erythematous, pruritic. Subjective tongue swelling.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Autism, Diarrhoea, Influenza, Pyrexia
Clinical narrative: Severe diarrhea, fever & flu symptoms.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Headache, Nausea, Pruritus
Clinical narrative: Woke up scratching my neck.  It felt hot and itching.  When I checked it was red with welts.  Later I got a headache and nausea.  I took fexafenadine twice that day, called the allergist that I go to on the 9/15.  I was told not to come in for allergy shots for that week and to continue to take fexafenadine for the rest of the week.  If it got worse come in to see a Doctor.  I took two fexafenadine on 9/15 and dropped down to one one 9/16.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Woke up scratching my neck.  It felt hot and itching.  When I checked it was red with welts.  Later I got a headache and nausea.  I took fexafenadine twice that day, called the allergist that I go to on the 9/15.  I was told not to come in for allergy shots for that week and to continue to take fexafenadine for the rest of the week.  If it got worse come in to see a Doctor.  I took two fexafenadine on 9/15 and dropped down to one one 9/16.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Fever - 99.9; Chills, muscle aches; chest tightness; headache, soreness at injection site.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever - 99.9; Chills, muscle aches; chest tightness; headache, soreness at injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Swelling
Clinical narrative: Headache, nausea, swelling, general aches and pains. Patient self treating with acetaminophen.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP
Symptoms: Bacterial infection, Drain placement, Incisional drainage, Injection site nodule, Injection site reaction
Clinical narrative: Large nodule under skin where Hep B vaccine was administered gradually turned into a fluctuant fluid collection, ultrasound showed a seroma, did not resolve after 2.5 months, incision and drainage was required by a pediatric surgeon with drainage of frank pus and placement of a drain for 7 days, culture with gram + cocci.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP
Symptoms: Purulent discharge, Seroma, Ultrasound scan abnormal
Clinical narrative: Large nodule under skin where Hep B vaccine was administered gradually turned into a fluctuant fluid collection, ultrasound showed a seroma, did not resolve after 2.5 months, incision and drainage was required by a pediatric surgeon with drainage of frank pus and placement of a drain for 7 days, culture with gram + cocci.
Age: 28.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced redness, swelling, and warm to the touch on his right arm where he received the Fluvirin and pneumonia vaccines on Friday 9/12/14 at around 9 pm.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Lethargy, Listless, Myalgia
Clinical narrative: RASH ALL OVER BODY, EXTREME SORENESS OF MUSCLES IN BACK OF NECK AND DOWN THE BACK, LOSS OF APPETITE, LETHARGY, LISTLESSNESS, FELT FAINT AFTER A WALK ON 09/14/2014.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: RASH ALL OVER BODY, EXTREME SORENESS OF MUSCLES IN BACK OF NECK AND DOWN THE BACK, LOSS OF APPETITE, LETHARGY, LISTLESSNESS, FELT FAINT AFTER A WALK ON 09/14/2014.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over and itching.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Had the pneumonia vaccination on Friday.  Saturday a.m. nauseated, lungs hurt to take a breathe, headache with a red bump at the injection site.  Sunday the bump turned in a 8x3 raised bump and was very hot to the touch with a very stiff neck.  Went to Urgent Care on Sunday with a differential of either shingles or adverse reaction to the pneumonia vaccination or the flu vaccination (I've had the flu shot every year w/o any problems).  Today, Tuesday, the rash has grown and is still very hot to the touch.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Painful respiration, Rash
Clinical narrative: Had the pneumonia vaccination on Friday.  Saturday a.m. nauseated, lungs hurt to take a breathe, headache with a red bump at the injection site.  Sunday the bump turned in a 8x3 raised bump and was very hot to the touch with a very stiff neck.  Went to Urgent Care on Sunday with a differential of either shingles or adverse reaction to the pneumonia vaccination or the flu vaccination (I've had the flu shot every year w/o any problems).  Today, Tuesday, the rash has grown and is still very hot to the touch.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity, Skin infection
Clinical narrative: When patient woke up on 9-3-14, left arm was red and swollen and painful. Patient went to doctor and received an antibiotic. Dr. felt patient got skin infection from vaccination.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Right arm cellulitis treated with antibiotics (AUGMENTIN prescribed then BACTRIM).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient received PNEUMOVAX 23 vaccine and reported major pain in arm the next day. She said pain from 1-10 was a 29 and excruciating.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: 11:25 - Client received GARDASIL #2 IM. Immediately c/o seeing spots, dizziness, diaphoretic. Head lowered between knees. Unresponsive. Lowered to floor. Placed in supine, Trendelenburg position. Regained consciousness about one minute. Wet cloth to forehead. Crackers and fluids given. Full recovery noted.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment
Clinical narrative: 11:25 - Client received GARDASIL #2 IM. Immediately c/o seeing spots, dizziness, diaphoretic. Head lowered between knees. Unresponsive. Lowered to floor. Placed in supine, Trendelenburg position. Regained consciousness about one minute. Wet cloth to forehead. Crackers and fluids given. Full recovery noted.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Patients primary provider states that patient had an episode of bloody stools on 9-14-14, which is 2 days after the vaccination was administered.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: (L) arm/leg "twitching" with uncontrolled movements. Unable to illicit on exam in office. No rotation tremor. Neurologically patient intact. Hand jerks to side spontaneously, patient has dropped items due to the twitching. The sxs have started improving.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Patient called back this evening - noting that the injection site was slightly red but inflamed. "Swelled up" per pt. She was advised to place a cold pack on for 15 minutes and take TYLENOL or ibuprofen. If it worsened to come and see us or her physician.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Rash, Skin warm
Clinical narrative: Rash on torso, pt fussy, felt warm.
Age: 1.58
Sex: F
Vaccine: HEPA, HIBV, PNC13, TDAP
Symptoms: Injection site reaction
Clinical narrative: Pt came in for her 2 year well child check and mom informed that on 3-31-14 pt had reaction to injection. Got a Tdap and not the DTap with site reaction.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse symptoms. Last years Influenza vaccine given (R) deltoid in error. 9/16/14 3:15pm.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Pt had some initial pain from inj for a few days then resolved - but less than 1 wk later she experienced deltoid and left arm pain with arm movement. Pain to elbow. Relatively comfortable with arm at rest. Area in question non tender, no erythema, no visible swelling.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient experienced urticaria on arms, chest, back. Occurred approximately 30 mins after administration. Patient notified pharmacy the following day. Patient was itchy and the hives had spread. Patient was given BENADRYL 25mg one time dose. Primary physician was notified.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Localize injection site reaction swelling, hot to touch.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Lung disorder
Clinical narrative: Lung problem.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Heart rate increased, Injection site discomfort, Malaise, Nausea, Painful respiration
Clinical narrative: 09-08-14 - Sent to ER from MD office - treated and released. 09-09-14 - Went to PCP - had ambulance transport - increased HR/severe pain - respiration. 9/6/14 Overnight - sick all weekend nausea, sleepy - slight site discomfort.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Somnolence
Clinical narrative: 09-08-14 - Sent to ER from MD office - treated and released. 09-09-14 - Went to PCP - had ambulance transport - increased HR/severe pain - respiration. 9/6/14 Overnight - sick all weekend nausea, sleepy - slight site discomfort.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local reaction
Clinical narrative: Localized reaction (Rt deltoid) to PNEUMOVAX. Patient reported to PCP after 72 hrs. Patient advised to take BENADRYL by PCP after office treatment.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Skin warm
Clinical narrative: Patient got shot 8/29, 8/30 arm was very warm to touch and started to bruise. It isn't as sore today 9/2 and bruise has gone down patient said. patient stopped in and reported today 9/2/14.
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Alopecia, Iron deficiency anaemia, Laboratory test abnormal
Clinical narrative: Hair loss - smaller pieces sticking up. Thinner hair - sx started at the end of Dec. 2012.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, Fatigue, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Patient complained of fatigue and stiffness, also reported having a fever. Injection site was red, raised and hot to the touch. Patient advised to take Ibuprofen OTC 2 PO TOD, PRN. As of 9/10/14. No fever still achy and fatigue.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Patient complained of fatigue and stiffness, also reported having a fever. Injection site was red, raised and hot to the touch. Patient advised to take Ibuprofen OTC 2 PO TOD, PRN. As of 9/10/14. No fever still achy and fatigue.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis
Clinical narrative: Patient complained of fatigue and stiffness, also reported having a fever. Injection site was red, raised and hot to the touch. Patient advised to take Ibuprofen OTC 2 PO TOD, PRN. As of 9/10/14. No fever still achy and fatigue.
Age: 0.4
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Local swelling, Rash erythematous
Clinical narrative: Very fussy, inconsolable. Red spots on hands. Swollen arms and legs.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Local swelling, Pyrexia
Clinical narrative: -Day after injection had local swelling and redness which spread to 20cm diameter, and had fever T = 102. -Seen in ER 3 days post vaccination, trusted w/ PO steroids and BENADRYL. -Developed UE mild swelling and (R) facial numbness after steroids.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red right upper arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Patient developed large red welt at injection site, claiming it's not itchy but very hot to the touch. MD recommended treating with ice and BENADRYL.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Periarthritis
Clinical narrative: (L) shoulder pain radiating to (L) elbow. Treatment ongoing with orthopaedics for adhesive capsulitis. Treated with prednisone, steroid injection, physical therapy.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: Extreme swelling entire arm and fever in arm. Treated with ice/TYLENOL.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Pyrexia
Clinical narrative: The night of receiving the vaccine at around 12:30 am, patient started experiencing a fever at approx. 101 degrees F and nausea. Her left arm progressively increased in swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: On 9/9/14 pt received DTaP-IPV immunization. Phone call from parent 9/10/14. Pt seen within the hour with (R) arm swollen 2 times larger than (L) arm, warm to touch, reddish and pt states hurts to move it. No fever. No shortness of breath. Treatment: BENADRYL 25 mg liquid Q 2-3 times a day, Ibuprofen liquid 100 mg Q 6 hours for allergic reaction. Parent informed to contact if not resolving tomorrow.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eyelid ptosis, Irritability, Nuclear magnetic resonance imaging, Pyrexia, Rash
Clinical narrative: Acute onset Rt side ptosis. ? roseola right after vaccine started with fever and fussiness, she had atypical post MMR rash with ptosis fussiness and then had acute onset Rt sided ptosis on 8/26/14 in the evening. She was seen in our office on 8/28/14 and then admitted for rule out ADEM due to ptosis and fussiness - no treatment.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: After receiving vaccine, experienced tingling on both sides of neck, face, lips, eyelids, and cheeks.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Vaccine administered 9/8/14. On 9/13/14 woke at 4 AM with chills. At 8 AM temp of 99.9 and headache. Took 400 mg MOTRIN. At 2 PM began chills. At 4 PM temp of 103.5. No other symptoms. At 10 PM fever subsided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: KINRIX expired 8-29-14 given 9-9-14. No reaction, no treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: KINRIX expired 8-29-14 given 9-9-14. No reaction, no treatment.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: INFANRIX - DTaP expired 9-6-14 and 1 dose given 9-9-14. No reaction - no treatment.
Age: 1.9
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine, INFANRIX expired 9-6-14, given 9-9-14. No treatment, no reaction noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Expired drug administered
Clinical narrative: 0DTAP - IPV expired 08-29-2014 given 9-09-2014.
Age: 47.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rash, redness right arm.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored ROTATEQ (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored RECOMBIVAX HB (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored VAQTA (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a currently 60 year old non-pregnant female patient. On an unknown date in 2014 (also reported as "a couple of weeks ago") the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (dose, route were not reported; lot # J016257, expiry date 20-FEB-2014) for the prevention of shingles. The concomitant medication reported was "generic PLAQUENIL". It was reported that after receiving ZOSTAVAX on an unknown date in 2014 (also reported as "a couple of weeks ago") the patient experienced the arm soreness and the rash. Patient sought a medical attention and she saw a pharmacist. No treatment was given for the event. VZV packed was offered. The outcome of the event (arm soreness and rash) was reported as recovered/resolved on approximately 29-JUL-2014 (also reported as "3 weeks ago"). The relationship between the ZOSTAVAX and the event was not reported. This is one of several reports from the same reporter (reported as "This was the 2nd or 3rd reported by the pharmacist"). Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 12 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (lot # J006850 exp date 31-MAR-2016)(dose and route not specified). IT was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Information has been received from other health professional of unknown age who was enrolled in a study as an elderly subject entitled first ZOSTAVAX trial. Patient's previous medical history and previous drug allergic reactions were not reported. On an unknown date the patient was vaccinated with first dose of ZOSTAVAX (strength, dose and frequency unknown). No concomitant medications were reported. Approximately in 200, at the end of trial patient was informed that he had received ZOSTAVAX. However in the letter patient was informed that second blister dose might be needed. Approximately in 2003, patient discarded the file containing trial contact information. Patient was now contacting as leader of recent journal article addressing shingles. Approximately in 2013 (over the last year), patient developed tingling-itching feeling at bedtime. Patient's family doctor concluded that this problem was not connected with shingles. Patient would like to contact the original principle investigator located agency about this possible side effect and or responsiveness. Action taken with ZOSTAVAX was not applicable. The outcome of tingling-itching feeling at my beltline was unknown. The causality of tingling-itching feeling at beltline to ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-AUG-2014, 2 patients (1409USA007061) were vaccinated with a dose of MMR II (lot number, expiration date, dose and route were not reported) that was improperly stored to 48F for 39 minutes. No concomitant medications were reported. No adverse effect was reported. Follow up information was received from the Registered nurse who stated that she did not had any patient identifiers or dates of vaccine administration. The registered nurse reported the lot numbers and expiration dates: MMR II lot number reported as J010208 expiration date 23-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a license practical nurse concerning a 14 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 injection (dosing regimen and lot # unspecified, expiry: 28-AUG-2014). Concomitant therapy was not reported. The pharmacist reported the patient, who remains Anonymous, received an expired dose of PNEUMOVAX 23 on 10-SEP-2014. The pharmacist reported the vaccine had an expiration date of 28-AUG-2014. No adverse reactions were reported. No PQC (product quality complaint) reported. The outcome of patient received expired dose of PNEUMOVAX 23 on 10-SEP-2014 was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL. No co-suspect and concomitant therapies were reported. The nurse reported that an unknown number of patients received improperly stored GARDASIL, on unknown dates. No adverse symptoms reported. The temperature excursion for GARDASIL, was found to be unsupported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/clinical manager refers to a 11 year old patient. Patient medical history and historical conditions were not reported. On 12-JUL-2013, the patient was vaccinated with GARDASIL (lot # H021608 and expiration date was 13-AUG-2015) first dose, 0.5 ml, once, intramuscular and second dose on 07-JUL-2014 (lot # J012212 and expiration date was 18-FEB-2016) (dose, frequency were not reported). Concomitant therapy was not reported. No PQC was involved. On an unknown date, approximately in 2014 the patient experienced incorrect schedule. No adverse effect was reported. The outcome of incorrect schedule and no adverse effect was unknown. The reporter considered events to be not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Nonspecific reaction
Clinical narrative: This spontaneous report was received from a physician refers to three patients of unknown demographics. On an unknown date all three patients were vaccinated with (Oka/Merck) VARIVAX subcutaneously. On an unknown date all three patients experienced reaction (not specified). The outcome of reaction is unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the third dose of GARDASIL (injection) (dose, route of administration, lot # and expiry date were not reported) 10 weeks after the second dose of GARDASIL instead of waiting the recommended 4 months. No adverse effect was reported. Additional information is not expected because there is no consent to contact the physician.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. No co-suspect and concomitant therapies were reported. The nurse reported that an unknown number of patients received improperly stored PNEUMOVAX 23 on unknown dates. No adverse symptoms reported. The temperature excursion for PNEUMOVAX 23 was found to be a supported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient were vaccinated with VAQTA. No co-suspect and concomitant therapies were reported. The nurse reported that an unknown number of patients received improperly stored VAQTA, on unknown dates. No adverse symptoms reported. The temperature excursion for VAQTA was found to be a unsupported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 15-SEP-2014, the patient inadvertently was vaccinated with ZOSTAVAX, vial, subcutaneous route (dose and lot number not reported) that expired on 14-SEP-2014. Supported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. In September 2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, (dose, route, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 17 year old female patient. On 09-SEP-2014, the patient was vaccinated with the second dose of GARDASIL, injection, 0.5 ml, intramuscularly (lot # and expired date were not reported). Concomitant therapy was not reported. The patient's mother informed an unspecified staff member, that the patient might be pregnant. Patient's last menstrual period had been the last week of July 2013 and home pregnancy tests had been positive. Patient was scheduled to follow-up with a physician on an unspecified date. No adverse effects were reported. There was no treatment was given for adverse event. The outcome of pregnant was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 05-JUN-2014 at 13:43pm (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 deg (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperature were within 2-8 deg (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: 9/4/14 patient returned to pharmacy to report joint pain in left hand (started 9/2/14). Joint pain in right knee (started 9/1/14).
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 0 month old male patient. on 11-JUN-2014 at 03:54 am (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 deg (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 deg (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 16-JUN-2013, the patient was vaccinated with RECOMBIVAX HB (INJ 10 Y) first dose, second dose on 02-SEP-2013 and third dose on 15-OCT-2003 (dose and route was unknown). The reporter stated that the patient received three doses of RECOMBIVAX HB outside of recommended dosing schedule. No adverse event was reported. No product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a 2 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. In August 2014, the patient was vaccinated with the second dose of M-M-R II (dose, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Nurse practitioner reported that a patient was administered the first dose of M-M-R II in January 2014 and the second dose of M-M-R II early in August 2014. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-SEP-2014, the patient was vaccinated with a expired dose of ZOSTAVAX lot # J011211, expiration date 31-JUL-2014. Dose and route was not reported. No symptoms reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Dyspnoea, Erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 32 year old female consumer with allergy to acetaminophen and allergy to ibuprofen referring to herself. None pertinent medical history were reported. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous, for prevention of chickenpox (dose number, dose, anatomical location, lot number and expiration date were not reported). None concomitant therapies were reported. On 27-AUG-2014, the patient experienced dizziness, runny nose, sneezing, itching and swelling at the injection site, redness and shortness of breath, after receiving (Oka/Merck) VARIVAX. No treatment was given for the adverse events. None laboratory diagnostics studies were performed. The patient did not seek medical attention. The outcome of shortness of the events was reported as not recovered. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: This spontaneous report as received from a 32 year old female consumer with allergy to acetaminophen and allergy to ibuprofen referring to herself. None pertinent medical history were reported. On 27-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous, for prevention of chickenpox (dose number, dose, anatomical location, lot number and expiration date were not reported). None concomitant therapies were reported. On 27-AUG-2014, the patient experienced dizziness, runny nose, sneezing, itching and swelling at the injection site, redness and shortness of breath, after receiving (Oka/Merck) VARIVAX. No treatment was given for the adverse events. None laboratory diagnostics studies were performed. The patient did not seek medical attention. The outcome of shortness of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB. No co-suspect and concomitant therapies were reported. The nurse reported that an unknown number of patients received improperly stored RECOMBIVAX HB, on unkonwn dates. No adverse symptoms reported. The temperature excursion for RECOMBIVAX HB, was found to be unsupported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ, oral. No co-suspect and concomitant therapies were reported. The nurse reported that an unkown number of patients received improperly stored ROTATEQ on unknown dates. No adverse symptoms reported. The temperature excursion for ROTATEQ was found to be a supported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.