chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Injection site swelling, Insomnia, Screaming
Clinical narrative: My 2 month old was administered the DTAP-IPV/Hib (Pentacel). She cried as usual and got over it relatively quickly. However, later that night, several hours later, she started screaming uncontrollably as if something was terribly wrong. I had never seen her or any baby scream like this. It was like a different child. No matter what I did, I could not console her. She acted lie she was trying to go to sleep and would drift off, but it didn't last long before she was screaming again.  Her leg was swollen and red as well. After a couple of hours of trying to calm her, I called the pediatrician's office. Over the screaming, I explained what was happening and they told me it was "normal"! I was shocked. I couldn't believe that if this was a typical reaction, why it would be administered. (My 3 year old had received all recommended vaccines and no reactions like this) Something seemed terribly wrong with her. After getting off the phone, I felt no better, but she eventually fell asleep and stopped the screaming. About a week later, she developed thrush and it persisted for about 3 months. We tried all the prescripts for this, but eventually, the only thing that worked was to give her regular probiotics daily. The doctor still insists that she didn't have a reaction and that they almost never have reactions to the vaccines. I have no idea whether there was permanent damage, but I hope and pray not.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports redness around the injection site about 2 inches. Pinkness extending beyond the redness, greater than 2 inches. Warmth and pain at the injection site.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Headache, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Affected arm sore, hard to lift arm, chest pain/SOB for 2 days, finger tips numb, headache and fever.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Affected arm sore, hard to lift arm, chest pain/SOB for 2 days, finger tips numb, headache and fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Rash erythematous, Rash pruritic
Clinical narrative: A red, itchy, sore rash with some bruising developed after zostavax vaccine administration. Size 3x9 cm. Patient started taking Benadryl for the rash and itching.
Age: 71.0
Sex: M
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: Red, itcy rash on stomach, back, chest and arms.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: SEVERE JOINT PAIN IN KNUCKLES, KNEES, ELBOWS, ANKLES, HIPS
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, MEN, TDAP
Symptoms: Blood test, Computerised tomogram, Dizziness, Dyskinesia, Gaze palsy
Clinical narrative: Patient started to arch back, draw uppper extremities up, eyes rolled back in head, then she slumped forward. At this time two staff members assisted her to exam table to lay down. She was responded by nodding head and her eyes were open. BP at this time 80/60 and she reported feeling lightheaded and nauseated. She continue to be very pale and lethargic for approximately 15 minutes. Ambulance was called and transported to hospital for evaluation.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, MEN, TDAP
Symptoms: Lethargy, Nausea, Opisthotonus, Pallor, Urine analysis
Clinical narrative: Patient started to arch back, draw uppper extremities up, eyes rolled back in head, then she slumped forward. At this time two staff members assisted her to exam table to lay down. She was responded by nodding head and her eyes were open. BP at this time 80/60 and she reported feeling lightheaded and nauseated. She continue to be very pale and lethargic for approximately 15 minutes. Ambulance was called and transported to hospital for evaluation.
Age: 1.88
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA
Symptoms: Feeling hot, Oedema peripheral, Pyrexia, Swelling, Tenderness
Clinical narrative: Mild swelling on the evening of vaccine administration. Swelling much more pronounced the next morning and continues to increase. Other symptoms: warmth, tenderness, fever (was 102.6 F on 9/19) Pt. seen 9/20, had swelling of left arm starting below punctum and contimuing below elbow. Covers entire outer aspect of arm. Treatment included Tylenol, ibuprofen, Benadryl, cool compresses. Started Prednisone taper today.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: L upper arm w/ red full mildly indurated 12 x16 cm reaction.
Age: 24.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Chest discomfort, Feeling hot, Headache
Clinical narrative: Pt reports to clinic with a headache, and feeling warm. Pt states that she has a slight tightness in her chest. BP: 126/74, P: 82, OX: 99.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Within one hour R arm became very painful. It radiated up into shoulder and down to wrist. Injection site was painful to touch for 2 full days. On second day, R arm was weak with numbness to wrist.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Pain, red, selling in right shoulder, can not move arm
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Mobility decreased, Oedema peripheral
Clinical narrative: Pain, red, selling in right shoulder, can not move arm
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Severe muscle aches in the arm of the injection that progressed over the day. By the end of the next day, I had horrible joint aches (knees, shoulder, hands, hips, ankles)by evening time I could do nothing but lay with pillows supporting me. Fatigue accompanied the muscle pains.  Lasted 8 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Dyskinesia, Muscle twitching, Posture abnormal, Tic
Clinical narrative: Noticed child suddenly had numerous nervous ticks of the head. Throwing head back over and over, turning head to the side to touch shoulder and raising shoulder slightly while doing this and general jerking and twitching  motions of the head. Later a new one started bringing the chin down to touch chest over and over.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Blepharospasm, Excessive eye blinking, Nervousness
Clinical narrative: NERVOUS EYE TWITCHING AND BLINKING
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, fever (101), achy muscles; lasted for some 3-5 hours overnight. Tylenol, liquids, warm blanket, hot bath.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Culture negative, Henoch-Schonlein purpura, Skin lesion, Varicella virus test negative
Clinical narrative: ~5-7 following the administration of VZV, MMR, and DTaP vaccines he developed a symptoms c/w Henoch Schonlein purpura.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Severe pain, not able to move arm, arm numb
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Skin swelling
Clinical narrative: Onset ~ 20 hours after FluMist; No Sx from immunization until 2 hours prior to presentation in office; erythema and mild swelling of skin surrounding the mouth, but not involving the lips or tongue; Benadryl and cool compress recommended for treatment.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: Patient reported redness and itching of the injection site. Also, noticed hives on lower legs and arms. Prior to injection patient stated being allergic to LATEX. Fluvirin was given as it's approved for patient's with latex allergies.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and light-headedness.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Student sent to Health Office at school; this nurse observed student's left deltoid where he received Meningoccal vaccine; significant redness measured 10cm x 4.5cm in size;  right deltoid where he received the Tdap vaccine; significant redness measured 6.0cm x 5.5 cm in size.  Student reported slight itching in right deltoid, but denied any other symptoms.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Malaise, Pain, Sensation of foreign body
Clinical narrative: Increasing difficulty swallowing - described as a "large peach pit in throat" achy, fatique, malaise.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rubivirus test positive, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Chicken pox illness, rubella virus positive.
Age: 28.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left arm swollen in area where Varicella vaccine was administered. Pt used cool compresses to area.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Immediate post-injection reaction, Influenza like illness, Injection site anaesthesia, Nausea
Clinical narrative: Instantly felt nauseous after administration of Flu Vaccine during Work Flu Clinic. About an hour later felt dizzy and pain. By 11am felt numbness in the left arm where vaccine was administered followed by tingle/pins and needles. From noon into the evening felt as if had "FLU"so went to bed at 8:30pm w/out taking any NSAIds. Woke up fine 09/19 8am.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paraesthesia
Clinical narrative: Instantly felt nauseous after administration of Flu Vaccine during Work Flu Clinic. About an hour later felt dizzy and pain. By 11am felt numbness in the left arm where vaccine was administered followed by tingle/pins and needles. From noon into the evening felt as if had "FLU"so went to bed at 8:30pm w/out taking any NSAIds. Woke up fine 09/19 8am.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: 2 days after flu vaccine was administered, the area around injection site was swollen, red and hot. Also had streaking of red down her arm and around injection site. Saw physician and started on Keflex
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Headache, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Sudden onset severe headache; fever; rash, swelling at injection site; rash of head and neck, shortness of breath, feeling of throat closing.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash, Throat tightness
Clinical narrative: Sudden onset severe headache; fever; rash, swelling at injection site; rash of head and neck, shortness of breath, feeling of throat closing.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site atrophy, Injection site reaction
Clinical narrative: Grandma states 2 days after immunizations, the right upper leg where shot was given the muscle separated from the bone; there was an indentation down the upper thigh. Took to doctor who stated it was OK just to keep eye on it. Took 2 months to heal per Grandma.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Asthenia, Borrelia test negative, Chills, Computerised tomogram head normal
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site rash, Injection site swelling, Leukocytosis, Lumbar puncture normal
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, West Nile virus test negative
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Asthenia, Chills, Computerised tomogram head normal, Full blood count abnormal
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Leukocytosis, Lumbar puncture normal
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia, Nausea, Pyrexia, White blood cell count increased
Clinical narrative: Fever, chills, severe headache, myalgias, arthralgias, malaise, nausea, weakness, injection site swelling and rash, leukocytosis.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea. A second episode occurred at 08:00 PM 9/14/2012.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Dysphonia, Lip swelling, Pruritus, Rash, Urticaria
Clinical narrative: Broke out all over body in hives. From top of head to bottom of feet.  Lips were swollen as well as throat was very hoarse. Itching was unbearable. The intense rash, hives and swelling lasteduntill the 18th of Sept. It is now the 20th of Sept and I still have occurrences of hives in various parts of body.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Blood culture negative, Bradycardia, CSF culture negative, Culture urine negative
Clinical narrative: Developed intractable apnea and bradycardia; poor color and lethargy; patient required intubation for respiratory support; evaluated for sepsis and started on antibiotics; cultures including blood, urine and CSF all negative.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Endotracheal intubation, Lethargy, Sepsis, Skin discolouration
Clinical narrative: Developed intractable apnea and bradycardia; poor color and lethargy; patient required intubation for respiratory support; evaluated for sepsis and started on antibiotics; cultures including blood, urine and CSF all negative.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms (chills, body aches) lowgrade fever without respiratory distress.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, headache, body aches, weakness.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: INJECTION SITE WAS INDURATED (APPROXIMATELY SIZE OF A QUARTER, WITH SURROUNDING REDNESS EXTENDING ONFULL DELTOID REGION AND UNDER ARM, TENDERNESS, BRUISED SENSATION.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Concussion, Disturbance in attention, Dizziness, Fall, Head injury
Clinical narrative: I HAD SORT OF A FAINTING EPISODE. WHEN I WAS ABLE TO RECOVER CONSCIOUSNESS I WAS LAYING FLAT ON THE FLOOR AND HAD URINATED IN MY PANTS. HAD A CONCUSSION AS A RESULT OF FALLING AND HITTING THE BACK OF MY HEAD ON MY TILED BATHROOM FLOOR. I WAS RUSHED INTO THE EMERGENCY ROOM RAN TESTS AND WAS REFERRED TO A NEUROLOGIST. NEUROLOGIST CAME TO A CONCLUSION THAT IT WAS MORE THAT LIKELY A REACTION TO THE VACCINE.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Headache, Irritability, Laceration, Nausea, Strabismus
Clinical narrative: I HAD SORT OF A FAINTING EPISODE. WHEN I WAS ABLE TO RECOVER CONSCIOUSNESS I WAS LAYING FLAT ON THE FLOOR AND HAD URINATED IN MY PANTS. HAD A CONCUSSION AS A RESULT OF FALLING AND HITTING THE BACK OF MY HEAD ON MY TILED BATHROOM FLOOR. I WAS RUSHED INTO THE EMERGENCY ROOM RAN TESTS AND WAS REFERRED TO A NEUROLOGIST. NEUROLOGIST CAME TO A CONCLUSION THAT IT WAS MORE THAT LIKELY A REACTION TO THE VACCINE.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Urinary incontinence, Vaccination complication, Vision blurred
Clinical narrative: I HAD SORT OF A FAINTING EPISODE. WHEN I WAS ABLE TO RECOVER CONSCIOUSNESS I WAS LAYING FLAT ON THE FLOOR AND HAD URINATED IN MY PANTS. HAD A CONCUSSION AS A RESULT OF FALLING AND HITTING THE BACK OF MY HEAD ON MY TILED BATHROOM FLOOR. I WAS RUSHED INTO THE EMERGENCY ROOM RAN TESTS AND WAS REFERRED TO A NEUROLOGIST. NEUROLOGIST CAME TO A CONCLUSION THAT IT WAS MORE THAT LIKELY A REACTION TO THE VACCINE.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Pt did not receive an adverse reaction rather she was given an expired vaccine. Current HPV vaccine expired on 09/15/12 and she received this vaccine on 09/18/12. This was caught by the office manager during a weekly inventory.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Dizziness, Erythema, Headache, Induration
Clinical narrative: Patient states that left arm is red, swollen, and hard as concrete. Patient states she ran a temp of 102.5 during the night. Today patient states she feels like she is wheezing a little, is slightly dizzy, and has a headache. Patient states will see a doctor today.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Wheezing
Clinical narrative: Patient states that left arm is red, swollen, and hard as concrete. Patient states she ran a temp of 102.5 during the night. Today patient states she feels like she is wheezing a little, is slightly dizzy, and has a headache. Patient states will see a doctor today.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness transient, Confusional state, Crying, Fear, Feeling abnormal
Clinical narrative: Saw burst of colors, everything went black, then returned to normal...she became frightened and confused and scared and felt strange, not just of the situation..but of just about everything...it continues....daily now....she cries and cries.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Visual impairment
Clinical narrative: Saw burst of colors, everything went black, then returned to normal...she became frightened and confused and scared and felt strange, not just of the situation..but of just about everything...it continues....daily now....she cries and cries.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed warmth, swelling and pain approximately 10 mm surrounding iz site. Treated with PO Clindamycin for cellulitis.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Tenderness
Clinical narrative: Localized inflamatory erythematous reation. 3cm in diameter and tender to palpation.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Chills, Jaundice
Clinical narrative: Chills, emesis, jaundice
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Chills, emesis, jaundice
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Skin test positive, Vitiligo
Clinical narrative: Vitilgo spots noticeable around eyes starting in May 2007, in between the second and third administration of the Hep B Vaccines.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction (redness, pain, swelling) x 2 wks at injection site followed by 2 wks of redness, swelling, itching upper chest.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Local reaction (redness, pain, swelling) x 2 wks at injection site followed by 2 wks of redness, swelling, itching upper chest.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt's left upper arm is swollen, very sore and warm. Symptoms began shortly after vaccination. Pt went to urgent care 9/20 was given steroid shot and hydrocodone for the pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient reported aches of (hands, legs, head) that started on 9/19/2012 am and were resolved by 9/20/12 afternoon. Patient took acetaminophen for aches.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, CSF protein increased, Diplopia, Fall, Gait disturbance
Clinical narrative: Developed paresthesias in her hands & feet approx 1-2 days after receiving HPV & meningococcal vaccines, she then developed pain in her legs, shoulder & weakness. Weakness & pain progressed & she was unable to walk up stairs & was falling. She also began to experience double vision. She was taken to ER on 9/9/12.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Lumbar puncture abnormal, Musculoskeletal pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Developed paresthesias in her hands & feet approx 1-2 days after receiving HPV & meningococcal vaccines, she then developed pain in her legs, shoulder & weakness. Weakness & pain progressed & she was unable to walk up stairs & was falling. She also began to experience double vision. She was taken to ER on 9/9/12.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Developed paresthesias in her hands & feet approx 1-2 days after receiving HPV & meningococcal vaccines, she then developed pain in her legs, shoulder & weakness. Weakness & pain progressed & she was unable to walk up stairs & was falling. She also began to experience double vision. She was taken to ER on 9/9/12.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient came in had Hep B, PCV 13, PENTACEL and ROTARIX around 3PM parents state no acute illnesses prior to vaccine. Around 9 PMN started having diarrhea and vomiting. Took to Emergency Room and Doctor stated that it was due to vaccine. Unknown if reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain, Swelling
Clinical narrative: On 7/16/12, patient received GARDASIL #1. Patient c/o pain & swelling in pelvis. Patient was on her period for HPV #1 so mom attributed sxs to menses. With GARDASIL #2 on 9/17/12, patient again experienced the same sxs, and she was not having her period. Patient was seen in an urgent care center. She has improved.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Injection about 1:00 pm, next morning woke with HA, fever of 102 and site of injection was swollen, red & itchy. When pt came to pharmacy 3 days after shot the red area was about 6 inches diameter. Pt still had HA. Didn't feel well but was unsure if had a fever still. Slowly, swelling is decreasing.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased
Clinical narrative: Vaccine was put high up on arm & RPH hit bone twice. Patient has difficult time moving arm even after 7 days.
Age: 18.0
Sex: F
Vaccine: HPV4, IPV, TDAP
Symptoms: Asthenia, Crying, Hyperventilation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Tdap was given first to (L) deltoid, followed by polio to left deltoid. HPV adm to (R) deltoid. After HPV, pt became weak, unable to move arm. Pt was responsive, alert & oriented, but hyperventilating. Pt's (R) arm became to shake and the pt became to cry. RN supervisor notified 911 was called and after evaluation, was taken to ER for observation. Pt was nauseated, c/o pain to injection site and unable to move both arms.
Age: 18.0
Sex: F
Vaccine: HPV4, IPV, TDAP
Symptoms: Nausea, Tremor
Clinical narrative: Tdap was given first to (L) deltoid, followed by polio to left deltoid. HPV adm to (R) deltoid. After HPV, pt became weak, unable to move arm. Pt was responsive, alert & oriented, but hyperventilating. Pt's (R) arm became to shake and the pt became to cry. RN supervisor notified 911 was called and after evaluation, was taken to ER for observation. Pt was nauseated, c/o pain to injection site and unable to move both arms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hyperhidrosis, Muscular weakness
Clinical narrative: Pt reported via phone c/o extremely weak on both arms, general fatigue, diaphoresis (duration approximately 40 sec). On 9-15-12 felt better but had another episode as symptoms described above on 9-18-12 again.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling, Rubber sensitivity
Clinical narrative: Patient had swelling, redness, and a knot on the back of left arm where ZOSTAVAX was given. Went to doctor the next day was given antibiotics for cellulitis. Doctor suspected patient may have latex allergy.
Age: 85.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Patient's daughter called. Upset mom's arm is in severe pain still. Also complaints about the injection site (says too high). Wants to take patient into MD.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dizziness, Feeling hot, Headache
Clinical narrative: Flu-like symptoms: 9/18/12 to 9/20/12. Overall body ache head to toe, head felt hot all day, nausea, chills, headache - took Naproxen for headache. Still achy & woozy, no appetite.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nausea, Pain
Clinical narrative: Flu-like symptoms: 9/18/12 to 9/20/12. Overall body ache head to toe, head felt hot all day, nausea, chills, headache - took Naproxen for headache. Still achy & woozy, no appetite.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Erythema, Pain, Pruritus, Rash vesicular
Clinical narrative: Numerous 1-3 mm vesicular erythematous lesions on both hands. Slightly painful. Itchy.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised erythema, Pruritus, Rash
Clinical narrative: Generalized redness, rash and itching.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Injection site nodule, Myalgia, Pain, Pain in extremity
Clinical narrative: Sept. 5, 2012 received FLUZONE vaccine. Sept. 9, 2012 awoke with pain in (L) after, crying in sleep 9/9 - present day arm black and blue down past elbow and up to shoulder, and is "achey" with muscle aches & "knot" where injection was given.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Sept. 5, 2012 received FLUZONE vaccine. Sept. 9, 2012 awoke with pain in (L) after, crying in sleep 9/9 - present day arm black and blue down past elbow and up to shoulder, and is "achey" with muscle aches & "knot" where injection was given.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a male patient of unknown age. The patient had received first dose of VARIVAX (merck) (0.5 ml dose/1 or 2 times, lot # not reported) from another office in 2002. No other co-suspects were reported. No concomitant medications were reported. In 2011 the patient got a bad case of chicken pox. No treatment information was reported. The outcome of chicken pox is unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein, Full blood count, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Initial warmth "redness" pain at injection site, limited range of motion. Redness lasted less than 72 hrs. Pain still present at 72 hr., CBC, ESR, CRP drawn, exam nl except for limited active & passive ROM due to pain.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Red blood cell sedimentation rate
Clinical narrative: Initial warmth "redness" pain at injection site, limited range of motion. Redness lasted less than 72 hrs. Pain still present at 72 hr., CBC, ESR, CRP drawn, exam nl except for limited active & passive ROM due to pain.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, size of small tomato (about 1 inch).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old female patient who on a unspecified date was vaccinated with the first dose of GARDASIL (lot # and dose of administration were not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, at the site of injection, the patient developed site of injection developed redness and site of an area that was rock-hard; this area was six to seven centimeters in diameter. The patient was under the care of the physician. At the time of the report, these adverse events lasted for a week and then resolved (on an unspecified date). Additional information  has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient who on 04-JUN-2009 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided), on 13-APR-2011 was vaccinated with the second dose of GARDASIL (dose, route and lot # not provided) and on 31-AUG-2012, the patient was in the office to receive her third dose of GARDASIL (dose, route and lot # not provided). No adverse symptoms were reported. 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 medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) on 29-JUL-2010. No other co-suspects were reported. No concomitant medications were reported. On 24-JUL-2012 the patient received the second dose of GARDASIL which was late. No symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 11 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot number reported as 0475AE expiration date 14-DEC-2013) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-AUG-2012 the patient experienced headache. She was also experiencing pain, tingling and muscle weakness in the arm that received the GARDASIL. The patient sought medical attention by visiting the pharmacy. No treatment information was reported. The outcome of the headache, pain, tingling, and muscle weakness in the arm was reported as not recovered/not resolved. The causal relationship between the events and GARDASIL was not reported. 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 medical assistant refers to a patient who was vaccinated with the first dose of GARDASIL on an unspecified day in 2008 "about 4 years old", and was to receive the second dose of GARDASIL on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. There was no adverse event reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with an expired dose of RATATEQ (lot # (668359/0982Z), expiration date 06-MAY-2012, reported as 12-MAY-2012, orally, dose not reported) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. 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 Nurse Practitioner refers to a patient of unknown age. The Nurse Practitioner noted that she had a patient in the office and that "it has been over a year since the patient was administered the second dose in the GARDASIL (lot # and dose not reported, intramuscularly) vaccination schedule." The Nurse Practitioner noted that she did not know the date that the first two dose in the GARDASIL vaccination schedule were administered to this patient. At the time of report, there was no known adverse event. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
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 reporter reported that the patient received an expired PNEUMOVAX 23 (lot # 669579/0595AA, expired date 30-AUG-2012) on 10-SEP-2012. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 16 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first and second dose of 0.5 ml GARDASIL (lot # 70049/1261AA, 672232/1495AA) intramuscularly on 14-MAR-2012 and 14-AUG-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The patient became pregnant with an LMP of 24-JUL-2012 and an EDD of 30-APR-2013. Initial exposure to GARDASIL was at 0 weeks. The patient was exposed to GARDASIL during trimester 1. The pregnancy was discovered within in the past week, in approximately August 2012, on an unspecified date. There were no adverse experiences. The patient had not seen a physician at the time of the report. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5 years old patient of unknown gender. The patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 665622/1023Y, exp date: 18-JUL-2012). There was no adverse reaction. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old female patient. The patient was vaccinated with 0.5 ml PNEUMOVAX23 on 14-SEP-2012. Route was unspecified. Lot# was reported as H015581, exp 30-MAR-2012. The reporter stated the patient received PNEUMOVAX23 on 14-SEP-2012 and developed redness, a rash and soreness in her left deltoid where she received the vaccine. Patient also received FLUZONE (manufacturer unknown) on 13-SEP-2012 and developed a similar reaction in her right arm where she received FLUZONE (manufacturer unknown). No treatment was given for the event. No lab diagnostic study was performed. The patient was not recovered. The physician contacted pharmacist to seek medical attention. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health worker refers to a 12 months old male patient. The patient was inadvertently vaccinated with ZOSTAVAX (lot#: 0422AE, expiration date: 27-MAR-2013, 0.65 ml, subcutaneous, left leg) instead of VARIVAX (Merck) today(on 28-AUG-2012). No adverse effects reported at this time. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a doctor pharmacist concerning a 65 years old female patient who was vaccinated once with a 0.5 ml expired dose of PNEUMOVAX23 with lot # (669579/0595AA), IM in deltoid on 09-OCT-2012. The patient had not experienced any adverse effects. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Injection site macule
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old female patient without Pertinent Medical History and Drug Reactions/Allergies. The patient was received her first dose of VARIVAX (Merck) (0.5 mL single dose vaccination, subcutaneous injection, lot # unknown) on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The outcome of single macule at the injection site was reported as not recovered/not resolved. The patient sought medical attention via office visiting. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This spontaneous report was received from a 63 year old nurse regarding herself. The patient's concurrent condition included drug allergy with penicillin. Approximately on an unknown date of September 2009 (reported as 3 years ago), the patient was vaccinated with ZOSTAVAX, 0.65ml subcutaneously. No concomitant medications were reported. On 09-SEP-2012 (reported as 3 days ago), the patient developed nerve pain down her back and arms after receiving ZOSTAVAX. The outcome of the event was reported as not recovered at the time of this report. Additional information is not expected.
Age: 1.55
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site scab, Injection site warmth, Tenderness
Clinical narrative: Information has been received from a nurse concerning an 18 month old female who on an unspecified date was vaccinated with the first dose of VARIVAX (Lot#, dose and route not reported). On an unspecified date the patient experienced injection site reaction. The reaction was red, warm to the touch, injection scabbed and had a lump. The patient was given BACTRIM for the reaction. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the outcome was unknown. Follow-up information has been received from the physician on 28-AUG-2012 via a vaccine adverse experience report concerning the same patient with a weight of 30.4 lbs and a height of 33 inch. The patient had a birth weight of 7 lbs 10 ozs. The patient had none pre-existing allergies, birth defects or medical conditions. It was reported that the patient was vaccinated in left leg with VARIVAX (Merck) (lot # reported as 0047AE, expiration date 20-FEZB-2013) in a private doctor's office/hospital at 10:00 AM on 01-JUN-2012. And injection site became erythematous 11 days post vaccination on 12-JUN-2012. No fever. The patient was slightly tender. Medical/surgical intervention was required. No relevant diagnostic tests and laboratory were reported. The patient had none illness at time of vaccination. There was none adverse event following prior vaccination. The patient was recovered on 30-JUN-2012. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This report was received from Research Group and was assigned manufacturer report number MRK037, concerning a 51 years old female with none relevant medical history. The patient was vaccinated with a dose of ZOSTAVAX (lot# not reported) in April 2012. No other co-suspects were reported. No concomitant medications were included. On the same day of vaccination, the patient experienced arm where she got the shot got a huge red mark on it (3 inches x 3 inch circle) and mark was red, itchy and warm to the touch. The patient did not see her physician regarding the reaction. She did get a prescription for the vaccination. None diagnostic test was carried out to diagnose adverse event. The patient was recovered/resolved from the adverse events after 2 weeks. The reporter considered the adverse events to be related to ZOSTAVAX. This was originally reported by a consumer. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 4 years old patient who on 31-AUG-2012 was vaccinated with an improperly stored dose of M-M-R II (dose, route and lot # not provided). The nurse also indicated that the patient also received another improperly stored vaccine (unspecified name, unspecified manufacturer) during the same appointment. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a 70 years old female consumer reporting on herself with allergy to penicillin, sulfa drugs and steroids and diabetes and a medical history of kidney stones and shingles (in 1989) who in 2007 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot # not provided). In June 2012, the patient developed shingles. She stated she had the rash and blisters. The patient was treated with antivirals (unspecified) and "pain" On an unknown date, electrocardiogram was done, results were not provided. The patient sought unspecified medical attention. At the time of the report, the event outcome was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 0.03
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 days old patient. The reporter noted that the patient was administered a dose of MMR II as well as a dose of VARIVAX (Merck) on the patient's 12th day of life on 23-AUG-2001. Lot # and route was not reported. No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Rash, Skin disorder
Clinical narrative: This spontaneous report as received from a consumer reporting on herself, a 69 years old female patient with no drug reactions or allergies. In July 2008, the patient was vaccinated with ZOSTAVAX (dose and lot # not provided). There was no concomitant medications. The consumer stated that, in July 2008 she received ZOSTAVAX vaccine from her local clinic. In August 2012, the consumer broke out with skin rash that was shingles. She stated that, she had a rash all around her trunk with severe pain. No lab test were performed. The rash has cleared but she still had the nerve pain and the impacted skin felt was very different. She did not go to see her physician and she did not received medication. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age who was vaccinated with PNEUMOVAX23 (dose and lot # not reported) IM on 17-SEP-2010 and on 17-SEP-2012 was vaccinated again after 1-2 years with another dose of PNEUMOVAX23 (dose and lot # not reported). No known adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 63 years old female patient who on 31-AUG-2012, was vaccinated SQ in the left arm with a 0.5 ml dose of VARIVAX (Merck) (lot# 0973AA, exp 17-JUN-2013). It was reported that the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX today "on 31-AUG-2012". No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
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 who was vaccinated with an expired 0.5 ml dose of PNEUMOVAX23 (Lot # 9874603, Exp 30-AUG-2012), IM on 10-SEP-2012. No adverse effects occurred. The patient was in the pharmacy when this happened and was discovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a register nurse refers to a multiple patient of unknown age and gender. On unspecified date, the patients were vaccinated with RECOMBIVAX HB (Dose, route and lot # not reported). The register nurse reported that on unspecified date, unspecific number of patients received RECOMBIVAX HB, in her dialysis unit and did not respond to vaccine. The nurse stated that up to 45% of her dialysis patients did not developed immunity after annual booster dose of RECOMBIVAX HB. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 years old female patient with arthritis, allergic to penicillin and allergic to CIPRO. The patient was vaccinated with one dose of ZOSTAVAX (lot number, dose and injection site were not reported) subcutaneous on 23-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-SEP-2012 the patient experienced pain in her finger joints. There was no treatment given for the adverse event. There was no laboratory diagnostics study performed. The outcome was unknown at the time of report. The patient did not seek medical attention. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) on 27-AUG-2012. Lot number 00768AE was an invalid lot number for ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. Physician reported patient seen in the office with a swollen right arm at the injection site one week after receiving ZOSTAVAX on 04-SEP-2012. Reporter noted there were no other immunizations provided at the time of ZOSTAVAX administration. The outcome of swollen right arm at the injection site was unknown. The patient went to physician's office and sought medical attention. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On an unspecified date the patient might have been vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# unknown) that was exposed to an unsupported temperature excursion (9C for 108 hours total over three separate excursions on unspecified dates). No adverse effect reported. Additional information has been requested.