chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Nuclear magnetic resonance imaging normal, Pericarditis, Rash, Rash erythematous, Thinking abnormal
Clinical narrative: Passed out immediately, but awoke after several seconds. Had cold clammy skin. Blood pressure would not regulate. After half an hour began vomiting. Small red spots began to develop on lower abdomen. Spots developed higher and higher until they reached the midpoint of my neck, and then began to recede. Was rushed to the hospital where it took me roughly 3 hours before my blood pressure reached a level deemed safe to for discharge. Over the next two nights, trying to sleep, I found it difficult to breathe. In the weeks following this event I became forgetful and rather simple minded. It was abnormal for me, because I have a very analytical mind and frequently find myself thinking of all sorts of things. I wish I knew the extend of how that shot affected me.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vomiting
Clinical narrative: Passed out immediately, but awoke after several seconds. Had cold clammy skin. Blood pressure would not regulate. After half an hour began vomiting. Small red spots began to develop on lower abdomen. Spots developed higher and higher until they reached the midpoint of my neck, and then began to recede. Was rushed to the hospital where it took me roughly 3 hours before my blood pressure reached a level deemed safe to for discharge. Over the next two nights, trying to sleep, I found it difficult to breathe. In the weeks following this event I became forgetful and rather simple minded. It was abnormal for me, because I have a very analytical mind and frequently find myself thinking of all sorts of things. I wish I knew the extend of how that shot affected me.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection, Musculoskeletal pain, Pain in extremity, Rash vesicular
Clinical narrative: Pt developed pain in right arm/shoulder on 2/26/12. Within 24 hours developed blister like rash (R) arm c/w shingles area of mid forearm with secondary infection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Severe pain in arm with localized redness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Erythema, Hypotonia, Irritability, Screaming
Clinical narrative: 10 week male 2 days of fussiness above baseline with marked fussiness 3 day post immunization. had 60 second episode of limpness during a screaming episode - red in face/no pallor or cyanosis and was sobbing. No residual sequelae.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Dermatitis atopic, Radioallergosorbent test negative, Rash macular, Rash pruritic, Urticaria
Clinical narrative: Annual FLUMIST on 8/24/2011 with onset of pruritic, red raised patchy macular rash to torso and legs on 8/26/2011 (day 2) that spread to her legs, neck, and face by 8/28/2011 (day 4). She denied any current or prior illness within last 2 weeks or exposure to. She advised prior side effects from 2/5/2007, 10/11/2007, 9/5/2008, 9/11/2009, and 10/26/2010 FLUMIST consisted of body aches and post nasal drip 24 hours later. These symptoms resolved within a day or two; however she denied PND or body aches with 8/24/2011 FLUMIST. She presented to medical on 9/2/2011 for persistence of pruritic macular rash (as above) advising NAFTIN and ketoconazole (prescribed meds for prior skin eczema-contact dermatitis) were effective. She described the difference with this rash vs prior rashes was that this rash was more confluent and hive like in appearance covering more surface area than usual and was to parts of her body not affected by past reactions (face, neck). This macular rash also began to weep on her chest; however she had been scratching this area. There were no papules, pustules or vesicle formations to the affected areas. She denied any headaches, fevers, chest pain, shortness of breath, lymph node swelling, or other systemic symptoms. She denied any new clothing, environmental, food or chemical contacts, soaps, detergents, animal contact, or other known triggers. Providers documented skin with angry appearing red, raised plaques to bilateral cheeks, neck, chest, shoulders, left side torso and right thigh. Suspected diagnosis was atopic dermatitis and was treated with MEDROL dose pack, triamcinolone 0.1% cream, and oral BENADRYL with full resolution of reaction about 5 days later.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Pruritus
Clinical narrative: Mild case of chicken pox when 4yrs old. Small fluid blisters on face & chest & stomach, back & legs. BENADRYL & AVEENO bath for itchiness.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Developed pain (R) shoulder after flu shot - Was seen by PCP & orthopedist for evaluation. Currently getting therapy for shoulder ordered by the orthopedist.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Upper arm where shot given got swollen to almost twice it's size. It got hard, hot & itchy. Symptoms lasted almost 1 week. No treatment. Patient reported 2 months later.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Fatigue, Periorbital oedema
Clinical narrative: Peri-orbital edema, tiredness. Went to ED, administered BENADRYL/steroids. Pt. fully recovered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Soreness, muscle pain at the site/arm of injection.
Age: 14.0
Sex: F
Vaccine: HEPA, IPV, MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 2-21 vaccines administered. 2-22 woke up with plum size area (R) lower arm. 2-23 area smaller than softball size, getting pink instead of red.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 02/22/12: Site of injection hot, red, swollen, hard, and itchy. Symptoms occurring in site. ZOSTAVAX was injected.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Injection site pain, Neuralgic amyotrophy, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Experience pain where shot was administered that in the following weeks travelled down to my arm into my hand. Could lift arm over head. Diagnosed Parsonage Turner Syndrome, brachial neuritis.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Radiculitis brachial
Clinical narrative: Experience pain where shot was administered that in the following weeks travelled down to my arm into my hand. Could lift arm over head. Diagnosed Parsonage Turner Syndrome, brachial neuritis.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Eating disorder, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Extreme weakness - 10 days after shot tingling & numb tongue, mouth - Dec. 7 eating became difficult - numbness in body & hands - Dec. 18-24. Received plasmapheresis & IV/IG in Jan.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nerve conduction studies, Paraesthesia, Plasmapheresis
Clinical narrative: Extreme weakness - 10 days after shot tingling & numb tongue, mouth - Dec. 7 eating became difficult - numbness in body & hands - Dec. 18-24. Received plasmapheresis & IV/IG in Jan.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Electroencephalogram normal, Laboratory test
Clinical narrative: 45 minute seizure activity on 2/25/12 - required ATIVAN and KEPPRA load to stop seizure. Fever and no other symptoms at the time. Hospitalized for spinal tap, labs, observation. Blood cx, CSF cx's were negative. Discharged after 24 hours. MRI/EEG done.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain normal, Pyrexia
Clinical narrative: 45 minute seizure activity on 2/25/12 - required ATIVAN and KEPPRA load to stop seizure. Fever and no other symptoms at the time. Hospitalized for spinal tap, labs, observation. Blood cx, CSF cx's were negative. Discharged after 24 hours. MRI/EEG done.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Heart rate increased, Wheezing
Clinical narrative: Parent (Dad) called the County Health Department to report that at midnight on 02/27/2012 his daughter started to cough, wheeze, and had increased pulse, but no fever was noted.  Parent treated his daughter at home with "steamy shower", OTC Robitussin (which parent reported that he diluted with water).  He further reported that wheezing stopped after the child got out of the shower.  Parent did not take child to ER that evening.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Heart rate increased, Injection site mass, Injection site pain
Clinical narrative: Fever, chills, headache, nausea, and intermittent rapid heartrate that evening.  Also had lump at injection site, with swelling and soreness. Took Motrin/Advil which helped s/s.  Symptoms subsided by early afternoon the next day. Feels fine now (2-29-12).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, nausea, and intermittent rapid heartrate that evening.  Also had lump at injection site, with swelling and soreness. Took Motrin/Advil which helped s/s.  Symptoms subsided by early afternoon the next day. Feels fine now (2-29-12).
Age: 1.69
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash on right cheek and right side of abdomen.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Immobile, Nerve conduction studies, Paraesthesia, Paralysis, Pruritus
Clinical narrative: Severe itching on palms, soles of feet and scalp.  Occurred for several weeks and symptoms escalated over the course of several weeks to tingling, loss of mobility and paralysis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Headache, Lymphadenopathy
Clinical narrative: Fever, redness to arm, HA, nausea increased joint pain, swollen arm, and lymph nodes in neck, chills.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pyrexia
Clinical narrative: Fever, redness to arm, HA, nausea increased joint pain, swollen arm, and lymph nodes in neck, chills.
Age: 20.0
Sex: F
Vaccine: IPV, YF
Symptoms: Injection site erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: On 2/24/12 she reported she had developed itchy hives on arms & hips 2 days after receiving YF VAX & 2" red, sore area at site of YF VAX. Sx's lasted 5 days. No breathing difficulty. Hives were scattered. Took 1/2 BENADRYL during day & full dose at HS x3. No sx's today (2/24/12). Denies had fever.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Autopsy, Death, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Myocarditis, Nausea
Clinical narrative: Patient started feeling flu-like symptoms (nausea, diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later passed away while playing Squash/handball on 10/19/11.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Awoke in AM with pimple like area noted on right rib cage.  Pain started shortly thereafter and a few more bumps appeared.  Seen by MD 2/28/12 diagnosed with shingles.  MD added he did not feel vaccine contributed to outbreak.  Prescribed anti-viral medication, pain med.  Additional area of rash developed on right upper arm early 2/29/12.
Age: 0.37
Sex: F
Vaccine: DTAP, RV5, UNK
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia
Clinical narrative: Baby cried inconsolably for a long period of time (30 min). She also had a fever of 101.  This was not in her nature to cry so much and be so irritable.  She struggled the rest of the night.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Malaise, Night sweats, Pyrexia
Clinical narrative: Generalized joint pain, fever of 100.5 WITH Aleve and Tylenol on board, malaise.  Chills and night sweats into Sunday, 2/26/2012 with resolution of all symptoms except malaise.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Diet refusal, Pyrexia, Urine output decreased
Clinical narrative: Inconsolable crying, refusal to eat, decreased urine output, rectal fever of 100.3
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Diet refusal
Clinical narrative: Crying inconsolably for more than 3 hours. Mother talked to physician on call and gave baby 0.8 ml of concentrated acetaminophen. after 3 hours of crying, gradually stopped crying and fell asleep. He refused feeding at this period.
Age: 1.42
Sex: F
Vaccine: MMR, UNK
Symptoms: Convulsion, Laboratory test
Clinical narrative: She had 2 siezures one at night that lasted about 30 to 45 seconds and a 2nd the next morning that only last a few seconds.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother called us on 2/24/12 to report that patient has emesis x 3 hours -beginning within 1 hour of receiving IPV vaccine. Later in the day he developed low grade fever (100.4); and was 100.8 the following morning. He was completely fine within 24 hours of receiving the vaccine. No diarrhea.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Analgesic drug level, Blood alcohol, Chest X-ray, Drug screen, Electrocardiogram
Clinical narrative: After about 30 minutes baby became unresponsive. Code blue was called. Baby had pulse and was breathing. Her pupils were checked they fell to the side. Baby was taken to ER for further evaluation. Once child was at the ER the baby became alert and started crying.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Metabolic function test, Pupillary light reflex tests abnormal, Unresponsive to stimuli
Clinical narrative: After about 30 minutes baby became unresponsive. Code blue was called. Baby had pulse and was breathing. Her pupils were checked they fell to the side. Baby was taken to ER for further evaluation. Once child was at the ER the baby became alert and started crying.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, tenderness & pain at site. Pt seen at office 2/29/12. Pt prescribed BENADRYL PRN.
Age: 29.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Alopecia
Clinical narrative: This case was downloaded on 16. Sep.2011 from the FDA Vaccine Adverse Reporting System, VAERS ID: 415728. This case concerns a 29-year-old female patient who, 28.Dec.2010, received the first oral dose of VIVOTIF (batch number 3001879). On the same day, she received an intramuscular injection of DTAP (Sanofi Pasteur, batch number C3518AA) in the left arm. The patient had no known allergy and was reported as healthy. She had a recent history of dengue fever, which she developed twice while living in another country for 4 years. The patient was followed-up by some infectious disease unit and was vaccinated in preparation for her return to the other country. The patient had concomitant medications with multi vitamin concentrate, vitamin C, folic acid and unspecified oral contraceptive pill. Approximately one week after vaccination, the patient began to notice substantial hair loss in the shower. As of 28.Jan.2011, the patient had not recovered. At the time of the report, the outcome was not known. The case was considered not serious.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: This case was downloaded on 16.Sep.2011 from the FDA Vaccine Adverse Event Reporting System, VAERS ID: 418239. This case concerns a 22-year-old female patient who, on 14.Feb.2011, received VIVOTIF (batch number 3001880). The patient had no preexisting conditions or concurrent illness. She had concomitant medication with ORTHO CYCLEN, ibuprofen and doxycycline for unknown indications. On 03.Mar.2011 ie 17 days after vaccination, the patient developed erythema multiforme rash started as hives on the feet, then spread to the heels and the elbows, then to the knees. The patient had treatment with topical steroids and OTC antihistamines. The outcome was reported as not recovered. The case was considered non-serious.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Rash, Rash erythematous
Clinical narrative: This case was downloaded on 16.Sep.2011 from the FDA Vaccine Adverse Event Reporting System, VAERS ID: 418301. This case concerns a 27-year-old female patient who, on 03.Feb.2011, received an oral dose of VIVOTIF (batch number 3001880). The patient had a medical history of allergic reaction (stopped breathing) to pertussis vaccine as a baby. She had no concurrent illness and no concomitant medication was reported. On 07.Feb.2011 ie 4 days after vaccination, the patient developed red bumps all over the legs and mild abdominal pain. She was seen by her primary care doctor who gave her treatment with CIPRO and told her to discontinue VIVOTIF - she had taken two out of four doses. She subsequently recovered. The case was considered non-serious.
Age: 51.0
Sex: M
Vaccine: DTAP, HEP, IPV, HEP, IPV, TDAP
Symptoms: Abdominal pain upper, Pancreatitis
Clinical narrative: Information has been received from a nurse concerning a 51 year old male patient with hypertension and no known drug allergies who on 21-FEB-2012 was vaccinated with a dose of RECOMBIVAX HB Thimerosal Free (lot # 671032/1106AA, exp date 05-APR-2012). Concomitant therapy included lisinopril (manufacturer unknown). The nurse called to report that the patient had been admitted to an unidentified hospital with pancreatitis following RECOMBIVAX HB which was administered  on 21-FEB-2012. The patient received Tdap (manufacturer unknown) and "POLIO" on the same day. It was unknown when the patient was admitted to the hospital. The current condition of the patient was unspecified. The physician was requesting a lot check. A lot check has been initiated. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: DTAP, HEP, IPV, HEP, IPV, TDAP
Symptoms: Pancreatitis
Clinical narrative: Information has been received from a nurse concerning a 51 year old male patient with hypertension and no known drug allergies who on 21-FEB-2012 was vaccinated with a dose of RECOMBIVAX HB Thimerosal Free (lot # 671032/1106AA, exp date 05-APR-2012). Concomitant therapy included lisinopril (manufacturer unknown). The nurse called to report that the patient had been admitted to an unidentified hospital with pancreatitis following RECOMBIVAX HB which was administered  on 21-FEB-2012. The patient received Tdap (manufacturer unknown) and "POLIO" on the same day. It was unknown when the patient was admitted to the hospital. The current condition of the patient was unspecified. The physician was requesting a lot check. A lot check has been initiated. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zoster vaccine administered instead of 2nd dose of varicella vaccine. Still watching for potential adverse outcomes.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Hypotonia, Irritability, Somnolence
Clinical narrative: For 3 days after vaccine slept much more than normal and seemed to have less tone when picked up. Once his sleepiness resolved his tone improved but he started to have high pitched crying and inconsolability.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Hypersomnia, Hypotonia, Irritability, Screaming
Clinical narrative: For 3 days after vaccine slept much more than normal and seemed to have less tone when picked up. Once his sleepiness resolved his tone improved but he started to have high pitched crying and inconsolability.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: 2 mo old 1st set of shots. Screaming inconsolably x3 hrs. No local reaction. Was giving TYLENOL q4H.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dysphemia
Clinical narrative: Patient started stuttering two weeks after being vaccinated.
Age: 1.68
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: 7 days post vaccination of Varicella & MMR (separate inj) on the right leg. Child presents with fever, redness & swelling at the inj site, and a rash.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Chills, Headache, Myalgia
Clinical narrative: Headache, abdominal pain, muscle aches, chills. Symptoms started 2 hours after vaccine administration and lasted for 7 hours. No treatment was provided.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Pt reports joint pain in his right shoulder preventing his ability to raise his arm from Tdap vaccine. Pain started a few days after he received the vaccination and continues. Pt has not taken any medication or seen a medical doctor at this time.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh redness and swelling, pain.
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC
Symptoms: Injection site erythema, Pyrexia, Screaming
Clinical narrative: Information has been received from a consumer concerning her male child, who on an unknown date, was vaccinated with a dose of PEDVAXHIB (Lot #, dose and route not reported). Concomitant therapy might have been PENTACEL and PREVNAR. Consumer reported that, on an unknown date, her son was given five live virus vaccines all at one time and developed screaming for three hours, fever and injection site redness. The mother was not sure what products were given since this was some time ago. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 60.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & erythema at injection site (L) arm after flu vaccine.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Joint swelling, Periarthritis
Clinical narrative: Shoulder was swollen and red mark present for 2 days after flu shot. Made an appointment to see orthopedic on 1-23-12. Doc gave me cortisone said I had frozen shoulder.
Age: 35.0
Sex: M
Vaccine: FLUN3
Symptoms: Nerve conduction studies, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Radiculitis brachial
Clinical narrative: Patient has been treated on two separate occasions for Parsonage-Turner Syndrome (brachial plexus neuritis) following influenza administration in 2003 and again in 2007.  He has been treated my neurology Dr. for the condition.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: "Big hard red bump" on right thigh. At time of visit on 1 Mar, pt had 5.25 x 3.5cm area of erythema & induration, no tenderness, with some surrounding erythema.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Per vaccine administrator, pt has an local reaction on lt arm, redness, tenderness, and swelling at site.
Age: 1.59
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Flushing, Rash
Clinical narrative: Generalized flushing of face; mild rash on face.
Age: 31.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Bruising with local erythematous and warmth.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chills, Cough, Diarrhoea, Headache, Malaise
Clinical narrative: Fever to 103.3F, body aches, malaise, nausea, intermittent headaches, chills, mild cough, diarrhea.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever to 103.3F, body aches, malaise, nausea, intermittent headaches, chills, mild cough, diarrhea.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion, Postictal state, Pyrexia
Clinical narrative: Child experienced a fever to 40.3C and developed a febrile seizure.  By the time mom brought to office pt. was post-ictal.  Ibuprofen given in office, pt. fever decreased and able to go home.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: Shoulder very sore and unable to lift arm. No redness or swelling. Did not seek medical treatment until December. X-rays and MRI were normal. Doctor "thinks it is coincidental" with receiving the shot. Received a cortisone shot without improvement and is now doing physical therapy. Able to raise arm up but not to the side.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: This case was forwarded by Crucell. This initial case was received from a health professional and concerns a female patient of unspecified age who, on an unspecified date in Dec.2011, received the first dose of VIVOTIF (batch no: not reported). The patient's medical history and concomitant medications were not reported. At an unspecified time following the first dose of VIVOTIF, the patient developed an apparently non-urticarial rash on her abdomen. It was reported that the patient had decided to take the second of the four doses of VIVOTIF on 20.Dec.2011. At the time of reporting, the outcome was unknown. The event was considered non-serious.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Severe upper arm pain and swelling.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever greater than 102 deg. F, chills, body aches, pinkness at site of injection, swelling of bicep at site of injection.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Infrequent bowel movements, Intestinal obstruction, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: SX: Bowel Obstruction - no bowel movements for one day, projectile vomiting. DX: Intussusception. TX: Air Enema Reduction.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: SX: Bowel Obstruction - no bowel movements for one day, projectile vomiting. DX: Intussusception. TX: Air Enema Reduction.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: ITCHING AND RASH ALL OVER BODY WITH RED UNDERTONES. SOME SHORTNESS OF BREATH. PT STATES, "I TOOK SOME BENADRYL ONCE THE SYMPTOMS STARTED." PT CAME BACK TO THE MEDICAL CENTER ON 2/29/2012 STATED SHE HAD THE ITCHING, RASH ALL OVER BODY AND SHORTNESS OF BREATH THE NIGHT BEFORE. SHE ALSO STATED, "I'M STILL HAVING ITCHING AT THE SITE. THE SITE HAS SOME LOCALIZE SWELLING. PT SAW PHYSICIAN ASSISTANT WHO ORDERED MEDICATION AND CONSULTED TO IMMUNOLOGY.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: ITCHING AND RASH ALL OVER BODY WITH RED UNDERTONES. SOME SHORTNESS OF BREATH. PT STATES, "I TOOK SOME BENADRYL ONCE THE SYMPTOMS STARTED." PT CAME BACK TO THE MEDICAL CENTER ON 2/29/2012 STATED SHE HAD THE ITCHING, RASH ALL OVER BODY AND SHORTNESS OF BREATH THE NIGHT BEFORE. SHE ALSO STATED, "I'M STILL HAVING ITCHING AT THE SITE. THE SITE HAS SOME LOCALIZE SWELLING. PT SAW PHYSICIAN ASSISTANT WHO ORDERED MEDICATION AND CONSULTED TO IMMUNOLOGY.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Pain at the injection site and entire arm became progressively weak where it is difficult to lift a coffee cup and cannot lift arm over his head. Saw his primary physician who advised him to see an Orthopedic MD, but does not have an appointment for 3 weeks. Took Ibuprofen for the pain.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Lip blister
Clinical narrative: Rec'vd Tdap 2/23/12 - 2 days later noticed redness, itching 1 in below injection site - on 2-28-12 noticed more redness et itching. Pain only when scratches, area warm to touch. No fever - had blister lower lip - no other problems.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Tinnitus
Clinical narrative: Patient c/o headache, tinnitus, and "not feeling well" x24 hrs after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 12 hrs after vaccine, pt developed red, warm area on thigh that progressively got bigger. 2 days after came to office with 6x8 inch area of warmth, redness, tenderness with no induration. Put on antibiotics & steroids.
Age: 0.4
Sex: M
Vaccine: HIBV
Symptoms: Haematoma
Clinical narrative: Information has been received from a physician concerning an approximately 22 week old ("between 5 and 6 months") male patient with hemophilia and no drug reactions/allergies who on an unknown date was intramuscularly vaccinated with a dose of PEDVAXHIB (lot # and exp not reported). There was no concomitant medication. The reporter stated that the patient developed hematoma that was "more prominent than usual" but it slowly resolved within days. No lab diagnostics studies were performed. It was unknown if the patient sought medical attention. The physician also reported that the patient received PEDIARIX (lot #, exp unspecified) and PREVNAR (lot #, exp unspecified) via IM injection and developed hematoma. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Rash pruritic
Clinical narrative: A report was received from a nurse on 27.Jun.2011, and concerns a 41-year-old female patient who, on 17.Jun.2011, received the first dose of VIVOTIF (batch number and expiry date unknown). The patient's medical history and concomitant medications were not provided. At unspecified time after VIVOTIF administration, the patient developed a rash on her face. The patient took BENADRYL. On 19.Jun.2011, the patient took the second capsule and, at an unspecified time later, the rash spread from her face to her arms, legs and ears. The rash was itchy but was not raised. The patient discontinued taking the vaccine. At the time of reporting, the patient had not yet recovered. The event was considered non-serious. Follow-up information received from Crucell, on 01.Aug.2011 stated that no further follow-up information had been available.
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Malaise, Pyrexia
Clinical narrative: This spontaneous report from a physician was received on 16. Jun.2011 and concerns a male patient of unspecified age who had received VIVOTIF (batch no: unknown). The patient's medical history was not included and no concomitant medication was indicated. On an unspecified date, after taking the third capsule of VIVOTIF, the patient developed malaise and abdominal distress. After taking the fourth capsule the patient boarded a plane and his symptoms worsened with fever, chills, malaise and intense abdominal pain. He called his physician from where he was and the physician prescribed antibiotics (no details reported). At the time of reporting, the outcome of the event was unknown. This case was considered non-serious. Follow-up was received from Crucell on 01.Aug.2011 in which they reported that a request for follow-up had been returned with no forwarding address.
Age: 11.0
Sex: F
Vaccine: HIBV, HIBV, HPV4, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health worker concerning an 11 year old female who on 18-JAN-2011 was vaccinated with the fifth dose of Hib vaccine (route, dose unspecified) instead of meningitis vaccines (manufacturer unknown). The patient did not seek medical attention. At the time of the report, the outcome was unknown. Follow up information has been received from a licensed practical nurse who reported that an 11 year old female student with bronchitis at time of vaccination and no known drug allergies who on 17-JAN-2011 (previously reported as "18-JAN-2011") at 4:00 pm was vaccinated with the fifth dose of PEDVAXHIB (Lot# 666090/1423Y) in her right deltoid (route, dose unspecified). Concomitant therapy included meningococcal vaccine (unspecified), ACTHIB (Lot# UH224AA) in her left deltoid at 4:00 pm on 17-JAN-2011, GARDASIL (Lot# 666118/1539Y) in her left deltoid at 4:00 pm on 17-JAN-2011, and VARIVAX (Lot# 665086/0998Y), SC, post her left upper arm at 4:00 pm on 17-JAN-2011. The licensed practical nurse reported that this was not actually an adverse event. The patient was inadvertently given extra Hib dose. The nurse followed up with the patient and no untoward side effects. No further information is available.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Joint swelling, Rash generalised
Clinical narrative: A spontaneous report from a physician was received and concerns a female patient of unspecified age who received a dose of oral VIVOTIF (batch number 3001880) on an unspecified date. The patient's medical history and concomitant medications were not provided. On an unspecified date the patient developed swelling of the ankles, abdominal pain and raised dots all over her body. At the time of this report, the outcome was unknown. The events were considered non-serious. Follow-up information received on 07.Apr.2011: 3 unsuccessful attempts were made to obtain information from the reporting physician. The case is now closed.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Joint swelling, Rash generalised
Clinical narrative: A spontaneous report from a physician was received and concerns a 29-year-old female patient who received a dose of oral VIVOTIF (batch number 3001880) on an unspecified date. The patient's medical history and concomitant medications were not provided. On an unspecified date the patient developed swelling of the ankles, abdominal pain and raised dots all over her body. At the time of this report, the outcome was unknown. The events were considered non-serious. Follow-up information received on 07.Apr.2011: 3 unsuccessful attempts were made to obtain further information from the reporting physician. The case is now closed.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Pharyngeal disorder, Rash
Clinical narrative: This spontaneous case was received from a health care professional (log-no.: 10031101) on 03.Oct.2011. It concerns a 63-year-old female patient who had received the first oral dose of VIVOTIF (Lot-no.: 3002084) on 29.Sep.2011. The patient's medical history was not included and no concomitant medication was indicated. On the 30.Sep.2011, one day after vaccination, the patient experienced a rash on her trunk. On 01.Oct.2011 the patient took the second oral dose of VIVOTIF. In the evening of the same day the rash worsened and the patient additionally suffered from throat and breathing difficulties. On an unspecified date the patient went to the emergency room. At the time of the report, the outcome of the event is unknown. The events were considered non-serious.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: This spontaneous report from a nurse was received on 21.Nov.2011 and concerns a 64-year-old female patient, who received VIVOTIF (batch no: 3002119). No concomitant medication was reported. On 16.Nov.2011, the patient received the third dose of oral VIVOTIF. On the 04.Nov.2011 the patient already received unspecified hepatitis a vaccine (manufacturer and batch not reported, tetanus-diphtheria-pertussis vaccine (manufacturer and batch not reported) and polio vaccine (manufacturer and batch not reported). On 17.Nov.2011, the patient began to feel an itchy sensation on her left forearm. This then became red and raised, eventually turned into fluid filled sores. This then occurred on her left help also. A similar reaction was described to previous exposure to poison ivy. The patient hadn't sought medical treatment as of 21.Nov.2011, when the provider, that dispensed VIVOTIF, was contacted. At the time of this report, the patient had not yet recovered. The event was considered non-serious.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Case received from a nurse on 26.Apr.2011 and forwarded by Crucell Vaccines Inc.: A spontaneous report was received and concerns a 34-year-old female patient who received VIVOTIF (batch number unknown). She took the first dose of VIVOTIF on an unspecified Thursday in the evening. On Friday evening, the day after VIVOTIF administration, the patient developed a rash on her legs. The patient called the clinic and was told to discontinue the VIVOTIF. The reporting nurse was to administer the injectable vaccine to the patient. At the time of this report, the outcome was unknown. The event was considered non-serious.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Inj site red, itchy.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Blood pressure decreased, Dizziness, Feeling hot, Hunger, Malaise
Clinical narrative: Case received on 24.Oct.2011 from a pharmacist and forwarded by Crucell. The case was processed together with follow-up information received on 25- and 26.Oct.2011. This case concerns the reporter, a 52-year-old female patient who, on 21.Oct.2011, received the first dose of VIVOTIF (batch number 3002105). The patient had received Japanese encephalitis vaccine on 18.Oct.2011 and had concomitant medication with ARMOUR THYROID. It was also reported that the patient had taken VIVOTIF twice in the past without problems. On 21.Oct.2011 at 7:30, the patient took the first dose of VIVOTIF with an extra glass of water. At 8:00 ie less than one hour after VIVOTIF intake, she took her ARMOUR THYROID medication. At 8:30-9:00, the patient had breakfast with cereals and almond milk. At 11:30, while she was at work, the patient began to feel hot and took off her lab coat. Over the next hour she became very hungry. At 12:30, the patient began to feel ill and needed to sit down; she then became hot and felt like she was going to pass out. The paramedics came, administered unspecified IV treatment and took the patient to an ER, where she was stabilised. She was found with dropped blood pressure and shock. At the time of this report, the outcome was unknown. The case was considered non-serious.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Shock
Clinical narrative: Case received on 24.Oct.2011 from a pharmacist and forwarded by Crucell. The case was processed together with follow-up information received on 25- and 26.Oct.2011. This case concerns the reporter, a 52-year-old female patient who, on 21.Oct.2011, received the first dose of VIVOTIF (batch number 3002105). The patient had received Japanese encephalitis vaccine on 18.Oct.2011 and had concomitant medication with ARMOUR THYROID. It was also reported that the patient had taken VIVOTIF twice in the past without problems. On 21.Oct.2011 at 7:30, the patient took the first dose of VIVOTIF with an extra glass of water. At 8:00 ie less than one hour after VIVOTIF intake, she took her ARMOUR THYROID medication. At 8:30-9:00, the patient had breakfast with cereals and almond milk. At 11:30, while she was at work, the patient began to feel hot and took off her lab coat. Over the next hour she became very hungry. At 12:30, the patient began to feel ill and needed to sit down; she then became hot and felt like she was going to pass out. The paramedics came, administered unspecified IV treatment and took the patient to an ER, where she was stabilised. She was found with dropped blood pressure and shock. At the time of this report, the outcome was unknown. The case was considered non-serious.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Joint swelling, Rash generalised
Clinical narrative: Case forwarded by Crucell Vaccines Inc. on 18.Feb.2011. A spontaneous report from a physician was received and concerns a 27-year-old female patient who received a dose of oral VIVOTIF (batch number 3001879) on an unspecified date. The patient's medical history and concomitant medications were not provided. On an unspecified date the patient developed swelling of the ankles, abdominal pain and raised dots all over her body. At the time of this report, the outcome was unknown. The events were considered non-serious. Follow-up information received on 07.Apr.2011: 3 unsuccessful attempts were made to obtain further information from the reporting physician. The case is now closed.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception, Lethargy, Ultrasound scan abnormal, Vomiting
Clinical narrative: Acute onset vomiting, lethargy, pyloric ultrasound diagnosed intussusception reduced by air/contrast enema. Hospitalized x 2 days.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Client stated that one hour post vaccination whith second Dose of Hep B (Adult dose) she started to have hives on her left arm around the injection site, later the rash went to the other arm, legs and almost all body. Client used OTC hydrocortisone cream and Benadryl; since she still have the hives, client was advice to go to Her private doctor for further treatment.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches and high fever after injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: PATIENT NOTES RED, PRURITIC RASH TO SITE OF YELLOW FEVER VACCINE. DENIES SYSTEMIC REACTION, WHEEZING, SHORTNESS OF BREATH. RASH IS LOCALIZED.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: After the Varivax vaccine was administered in patient's left arm, the site where the Varivax was given became swollen and was more stiff compared to the skin surrounding the injection. No pain was stated from the patient after the vaccine was given. Patient told of symptoms indicating a severe adverse reaction and to seek medical care if they did occur.  Current VIS was given in two languages (3/13/08). Two days later on 3/01/2012 at 2;40 patient came to have her Mantoux skin test read and the PHN assessed the vaccine administration site. The erythema was measured, horizontally the erythema was 70mm and vertically it was 50mm.  Client stated no pain was felt.  Just that it was itchy and swollen.  Client put ice on the area as well as Benedryl cream, which she stated helped to relieve the swelling and itching.  The site where the Varivax was given was warm to the touch. PHN again educated client of severe allergic reaction and what to do if those symptoms were to occur. On 3/01/2012 Dr. was called and the PHN reported the reaction.  The Dr. told the PHN to advise the patient to not get another Varivax vaccine.  Also if the site gets worse to go and see a doctor.  Dr. also advised the patient to take oral Benadryl 25mg three times per day.  Client has no primary physician.  Merck & Co. is the manufacturer of Varivax.  Lot#: 0450AA. Expiration date: 3/28/13. Additional vaccines given on 02/28/2012 were the Tdap vaccine in her Left Deltoid and the MMR vaccine in her Right Arm.
Age: 42.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Skin tightness
Clinical narrative: After the Varivax vaccine was administered in patient's left arm, the site where the Varivax was given became swollen and was more stiff compared to the skin surrounding the injection. No pain was stated from the patient after the vaccine was given. Patient told of symptoms indicating a severe adverse reaction and to seek medical care if they did occur.  Current VIS was given in two languages (3/13/08). Two days later on 3/01/2012 at 2;40 patient came to have her Mantoux skin test read and the PHN assessed the vaccine administration site. The erythema was measured, horizontally the erythema was 70mm and vertically it was 50mm.  Client stated no pain was felt.  Just that it was itchy and swollen.  Client put ice on the area as well as Benedryl cream, which she stated helped to relieve the swelling and itching.  The site where the Varivax was given was warm to the touch. PHN again educated client of severe allergic reaction and what to do if those symptoms were to occur. On 3/01/2012 Dr. was called and the PHN reported the reaction.  The Dr. told the PHN to advise the patient to not get another Varivax vaccine.  Also if the site gets worse to go and see a doctor.  Dr. also advised the patient to take oral Benadryl 25mg three times per day.  Client has no primary physician.  Merck & Co. is the manufacturer of Varivax.  Lot#: 0450AA. Expiration date: 3/28/13. Additional vaccines given on 02/28/2012 were the Tdap vaccine in her Left Deltoid and the MMR vaccine in her Right Arm.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Body temperature increased, Chills
Clinical narrative: Mild, chills and low temp.
Age: 26.0
Sex: M
Vaccine: JEV1, MNQ, RAB, TDAP, TYP, YF
Symptoms: Hypersensitivity, Throat irritation, Urticaria
Clinical narrative: Hives, itchy feeling in throat and eyes mild allergic reaction. 50mg Benadryl give via IM injection to right arm.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: Pt given flu and MCV4 same arm. 6 hrs post vacc. - red, itchy, swollen at injection site right arm. Pt notes fever last night, now with nasal discharge and sore throat. Pt re evalauted 3/1/12 by MD - cold compress applied right arm, administered 400mg ibuprofen, rx given for hydroxyzine and Keflex, DC'd to home, advised to watch for increased signs symptoms of infection/fever.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Rhinorrhoea
Clinical narrative: Pt given flu and MCV4 same arm. 6 hrs post vacc. - red, itchy, swollen at injection site right arm. Pt notes fever last night, now with nasal discharge and sore throat. Pt re evalauted 3/1/12 by MD - cold compress applied right arm, administered 400mg ibuprofen, rx given for hydroxyzine and Keflex, DC'd to home, advised to watch for increased signs symptoms of infection/fever.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Over last 3 to 4 days, feels like certain ways she moves her shoulder hurts. Also notes intense pain and swelling at injection site and myalgias in proximal arm near shoulder; decreased shoulder movement b/c of pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Over last 3 to 4 days, feels like certain ways she moves her shoulder hurts. Also notes intense pain and swelling at injection site and myalgias in proximal arm near shoulder; decreased shoulder movement b/c of pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: After receiving vaccines pt developed local red rash at each injection site. Pt denied itching or burning at site. Pt was treated with BENADRYL 25mg PO and observed for 30 minutes. Rash subsided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Swelling 3-4" diameter on both upper arms.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy, Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Hard lump at insertion site, very warm to touch at site, red, itchy, very sore, unable to move arm without significant pain. Headache for 24 hours.