chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: TTOX
Symptoms: Blood test, Computerised tomogram, Laboratory test, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Tingling and pain in left arm and left leg.  Tingling on left side of face.  Pain in left hand and swelling.
Age: 54.0
Sex: F
Vaccine: TTOX
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and pain in left arm and left leg.  Tingling on left side of face.  Pain in left hand and swelling.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Immediate post-injection reaction, Injection site pain, Lethargy, Mobility decreased
Clinical narrative: Reports pain in L upper arm immediately after vaccination.  Pain increased that evening and during the night.  Seen in ER early AM on 10/13/12, given "a shot for the swelling" and released home.  Pain continued and she was seen by her PCP on 10/15/12.  MRI done and WNL per client.  Given pain medication and antibiotic which she did not continue due to side effects.  Lack of appetite resulting in 8# weight loss.  Also reports lethargy during this time.  Pain did seem to subside temporarily, but client contacted writer on 10/31/12 to report that pain and inability to move arm continues.  Referred to her PCP for continued medical care.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Swelling, Weight decreased
Clinical narrative: Reports pain in L upper arm immediately after vaccination.  Pain increased that evening and during the night.  Seen in ER early AM on 10/13/12, given "a shot for the swelling" and released home.  Pain continued and she was seen by her PCP on 10/15/12.  MRI done and WNL per client.  Given pain medication and antibiotic which she did not continue due to side effects.  Lack of appetite resulting in 8# weight loss.  Also reports lethargy during this time.  Pain did seem to subside temporarily, but client contacted writer on 10/31/12 to report that pain and inability to move arm continues.  Referred to her PCP for continued medical care.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Ecchymosis, Injection site discolouration, Injection site induration, Injection site mass
Clinical narrative: Mom brought her son in for an office visit concerned about lump under the skin of his left upper lateral thigh.  Per office visit notes: "States has immunizations on 11-2-12 since then has had lump on left thigh.  Afebrile, no c/o discomfort, no difficulty moving leg."  "Normal activity, no change in appetite."  "Inspection: Left outer thigh  1 1/2cm x 2cm grayish, nontender, indurated area."  "Dx: ecchymosis, reassurance offered, symptoms treatment measures reviewed."  "Patient to return on a prn basis."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Localized redness in the size of a football, soreness, and pain localized to area of injection, lasted for about 4 to 5 days. Pt was advised to take Benadryl.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Diarrhoea
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Echocardiogram normal, Electroencephalogram normal, Fatigue, Feeling abnormal, Headache
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal, Speech disorder, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound Doppler normal, Visual impairment
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphasia, Cognitive disorder, Computerised tomogram head, Diarrhoea, Fatigue
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Headache, Neck pain, Nuclear magnetic resonance imaging, Visual impairment
Clinical narrative: 11/1/2012, started with severe diarrhea and headache, on 11/2/2012 had Visual problem for approx 5 minutes felt like my eyes were looking in another direction and everything was real far away, on 11/3/2012 had difficulty speaking for approx 45 minutes, went to ER, was worked up for a stroke, DX: TIAs possible MS. To date my brain is foggy, difficulty speaking on occasion getting words out can't remember what to say, headaches and very tired.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia, Pain
Clinical narrative: Pain in left arm when lifting or moving arm.  No swelling or redness at injection site but inner muscle (?) pain. On  3 ibuprofen and ice 3 times a day for two weeks and pain returns if meds wear off. Dr suggesting steroid treatment or orthopedic appointment if this doesn't help, which it is only masking the pain.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Dysgraphia, Dyskinesia, Muscular weakness, Myalgia
Clinical narrative: Felt ferverish (without a fever). Muscle soreness, muscle weakness, lack of fine muscle control (had trouble writing/typing). Symptoms got worse and gradually subsided by 11/06/2012 (1 week).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling cold, Hot flush, Nausea
Clinical narrative: Pt reaction at "4:30 yesterday, I had severe difficulty breathing, I got nauseated to my stomach, I had a hot flash and immediately had a cold flash and then I got dizzy and that only lasted twenty minutes. After that I just had a general shortness of breath feeling and then about 2 hours later I had another episode just like that one. All I've been having since then is a general shortness of breath, a little dizziness and on and off nausea".
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Pain
Clinical narrative: Pt says, when she got the shot, she got "a small piercing pain in the top of my had that lasted a second. Then I developed the aches and the pains. Around 5:00, I got a little nauseated. Around 7:30 I got up off the couch to go to the bathroom and I was dizzy. Then I went to bed and woke at 3 am and I felt like I was leaning sideways. I was very dizzy". Pt says she's been very dizzy until 7:30 this morning and now she's just a little bit dizzy. "It's like a pressure in my head pushing down and then kind of swimming. It's not continual, it just comes and goes. The nausea is gone".
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Migraine
Clinical narrative: Case number PHEH2012US021623 is an initial spontaneous report received from a physician on 26 Oct 2012: This report refers to an adult female patient. She was vaccinated with the first dose of post exposure series of RABAVERT (batch number: unknown) intramuscularly on an unspecified date in Oct 2012. Three days after vaccination, she experienced a migraine-like headache and exhaustion. She received second dose of RABAVERT (batch number: unknown) intramuscularly on 25 Oct 2012 and experienced migraine-like headache, fatigue (see related case: PHEH2012US021823). The final outcome was reported as condition unchanged at the time of reporting. No further information about seriousness and causality was reported.
Age: 80.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Burning sensation, Oedema peripheral, Rash, Rash erythematous
Clinical narrative: Patient stopped by today as a walk in c/o developed rash and swelling over left arm after getting pneumonia shot yesterday. Denies any difficulty breathing or sob. No itchiness over the rash, but feeling burns. O/E: Alert and oriented, not in distress. VS: stable. Lungs: Clear CVS: S1 S2 regular, Abdomen: benign. CNS: no focal deficit: Skin: erythematous rash noted over left arm. A/P: rash left arm, due to reaction to PNEUMOVAX. Will put on MEDROL dose pack and BENADRYL prn. Outpatient Pneumococcal vaccine ordered. Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt. deltoid. Manufacturer: Merck Lot #: 1427Y Exp. date: 7/3/11. Symptoms: Symptoms: 1. Angioedema, 3. Paresthesia. Treatment Drugs Used: 1 - Methylprednisolone Dose: ud Units: Tab Freq: Every day Route: PO.
Age: 80.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Burning sensation, Oedema peripheral, Rash, Rash erythematous, Vaccination complication
Clinical narrative: Patient stopped by today as a walk in c/o developed rash and swelling over left arm after getting pneumonia shot yesterday. Denies any difficulty breathing or sob. No itchiness over the rash, but feeling burns. O/E: Alert and oriented, not in distress. VS: stable. Lungs: Clear CVS: S1 S2 regular, Abdomen: benign. CNS: no focal deficit: Skin: erythematous rash noted over left arm. A/P: rash left arm, due to reaction to PNEUMOVAX. Will put on MEDROL dose pack and BENADRYL prn. Outpatient Pneumococcal vaccine ordered. Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt. deltoid. Manufacturer: Merck Lot #: 1427Y Exp. date: 7/3/11. Symptoms: Symptoms: 1. Angioedema, 3. Paresthesia. Treatment Drugs Used: 1 - Methylprednisolone Dose: ud Units: Tab Freq: Every day Route: PO.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Arm swollen, painful, red, difficulty raising arm up 2 days after vaccine, fevers 2 days later, oral antibiotics x 3 days no better.
Age: 1.04
Sex: F
Vaccine: FLU3, MMRV, PNC, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 12 months old female patient. On 25-OCT-2012, the patient was vaccinated with VARIVAX (Merck) (lot# , dose, frequency and route not provided) and PROQUAD (Merck) (lot#, dose, frequency and route not provided) at the same visit, separate sites. No adverse event reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Epstein-Barr virus test negative, Headache, Musculoskeletal stiffness, Pain in extremity, Rash erythematous
Clinical narrative: Rash and swelling headache and sore arm and stiff neck. Pt given Tylenol and Motrin and given heating pad.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Swelling
Clinical narrative: Rash and swelling headache and sore arm and stiff neck. Pt given Tylenol and Motrin and given heating pad.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Client stated she discovered a reddened area that is warm to the touch and non tender 5-6 inches below the site of her flu vaccination. Client states the reddened area is the size of a deck of playing cards. Client denies any redness, swelling, warmth or tenderness at injection site.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Pain, redness, swelling, throbbing, warmth.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Burning sensation, Chest discomfort, Chills, Cough
Clinical narrative: Yellow discharge secreted through both eyes impairing vision and requiring excessive blinking. Nasal discharge and chest cough. Dizziness, heavy-feeling chest, general malaise. Aches, chills, loss of appetite. Stomach upset and mild diarrhea for over 30 hours. Lungs still burn at onset of exercise.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Excessive eye blinking, Eye discharge
Clinical narrative: Yellow discharge secreted through both eyes impairing vision and requiring excessive blinking. Nasal discharge and chest cough. Dizziness, heavy-feeling chest, general malaise. Aches, chills, loss of appetite. Stomach upset and mild diarrhea for over 30 hours. Lungs still burn at onset of exercise.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Rhinorrhoea, Visual impairment
Clinical narrative: Yellow discharge secreted through both eyes impairing vision and requiring excessive blinking. Nasal discharge and chest cough. Dizziness, heavy-feeling chest, general malaise. Aches, chills, loss of appetite. Stomach upset and mild diarrhea for over 30 hours. Lungs still burn at onset of exercise.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia, Thirst, Tremor
Clinical narrative: 102+ fever, violent shakes, einter body in pain, coughing, intense thirst.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Nausea, Vomiting
Clinical narrative: Pt to lobby with c/o itching, redness, at injection site. Pt c/o N, V, D with s/s starting in the PM hours after vaccine administration on 11/06/2012.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 102 joint pain profound fatigue ongoing joint pain and myalgia.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client received shot in am.  That evening, he reports that he noticed hives on his arm that continued into following day.  Not really itchy, thought it was poison ivy (client is a park ranger). Hives continued on both arms and eventually resolved by 10/30/2012.  He did not seek medical treatment for this.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Patient felt somewhat ill..felt "strange".
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Sore throat followed a few days later by congestion, malaise, low grade fever, runny nose, and a few days later by vomiting. Lasted almost 2 weeks. This was a mandatory vaccine at work, many people had flu symptoms. We were not informed to report any of this to CDC. Everyone just called out sick.  Lot # 123121 from Novartis.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Sore throat followed a few days later by congestion, malaise, low grade fever, runny nose, and a few days later by vomiting. Lasted almost 2 weeks. This was a mandatory vaccine at work, many people had flu symptoms. We were not informed to report any of this to CDC. Everyone just called out sick.  Lot # 123121 from Novartis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness at site that is approx 2 inch long.  No pain.  Some itching.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Contraindication to vaccination
Clinical narrative: It was not documented by parent that child has Reactive Airway Diseaese. Should not have received Flu Mist. MD instructed parent to give him Vitamin C and to go to bed early.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Haematoma
Clinical narrative: Hematoma, diagnosed cellulitis.  Treated with Levaquin for 10 days.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Student visited health services on 11/7 to report that he had a fever for a day or so after the shot.  He did not record a temperature or return to the health services until 11/7.  Reported that he was tired, achey, and had a fever for a day and a half.
Age: 31.0
Sex: M
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Death
Clinical narrative: Pronounced dead at home in bed.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Blister
Clinical narrative: Blister like rash developed on the arm of the injection site.  Spread to neck and abdomen.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, headache, sore throat, persistent cough, difficulty breathing, fatigue, congestion, itching. Treatment: antibiotic, cough meds, analgesic, inhaler.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, headache, sore throat, persistent cough, difficulty breathing, fatigue, congestion, itching. Treatment: antibiotic, cough meds, analgesic, inhaler.
Age: 71.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Cough, Injected limb mobility decreased, Injection site pain, Malaise, Musculoskeletal pain
Clinical narrative: Right deltoid pain and Right shoulder sharp, stabbing pain radiating into upper arm and elbow, limited ROM, pain getting progressively worse with arm abduction and arm rotation movements, alleviated with arm rest. Diagnosed with Rt brachial neuritis treatment neurontin 300 mg every 8 hours, Motrin 800 mg every 6 hours, ice/hot packs, arm resting. Also reported runny/stuffy nose, malaise, dry cough. Diagnosed with URI treatment symptomatic.
Age: 71.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Nasal congestion, Pain, Radiculitis brachial, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Right deltoid pain and Right shoulder sharp, stabbing pain radiating into upper arm and elbow, limited ROM, pain getting progressively worse with arm abduction and arm rotation movements, alleviated with arm rest. Diagnosed with Rt brachial neuritis treatment neurontin 300 mg every 8 hours, Motrin 800 mg every 6 hours, ice/hot packs, arm resting. Also reported runny/stuffy nose, malaise, dry cough. Diagnosed with URI treatment symptomatic.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Low Grade fever. Muscle aches.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: The morning after the injection complained of pain in the right arm extending from shoulder to wrist. Complained of difficulty raising arm due to the pain. Pain slowly subsided over the next several days. No reddness, swelling of fever were reported. As of today 20 days after the flu injection continue to have pain from injection site to top of shoulder. Is taking over the counter anti inflammatory which only give slight relief.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Amnesia, Chills, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: Sore red arm at injection site. 11/02/12 stated having nausea, chills, memory loss, headache and felt miserable.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea
Clinical narrative: Sore red arm at injection site. 11/02/12 stated having nausea, chills, memory loss, headache and felt miserable.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pt stated that at time of administration she "felt medication being injected, felt medicine going in". Pt later stated that she had tenderness and soreness in that muscle group. Has persisted for 2 weeks.
Age: 28.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, TYP
Symptoms: Loss of consciousness
Clinical narrative: Vagal loss of consciousness, patient lost conscious for 10 seconds, was placed in supine position and feet were elevated.  Patient regained consciousness and had no further difficulty.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Intensive care, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history included spinal cord injury. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as H016823, expiry date and route not reported). No concomitant medications were reported. On an unknown date the patient experienced local swelling at the injection site, malaise, fever and was also hospitalized in an intensive care unit (ICU). The name of hospital and dates of hospitalization were unknown. The patient received unspecified treatment in the hospital. The outcome of local swelling at the injection site, malaise and fever was unknown. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: SMALL
Symptoms: Acute myocardial infarction
Clinical narrative: A subject (age and gender not reported) received the following vaccinations: On 06 August 2012 an injection of ACAM2000 (lot number not reported); On 20 July 2012 an injection of ANTHRAX (manufacturer and lot number not reported); On 05 August 2012 an injection of Tdap (manufacturer and lot number not reported). On 19 August 2012, the subject was diagnosed with acute myocardial infarction of inferolateral wall. This study case was received from the investigator on 26 October 2012. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Eye swelling, Malaise, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Initial report was received from a healthcare professional on 29 October 2012. A patient (age, date of birth and gender not reported) had received an injection of FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a reaction involving swelling of the eyes, slight throat swelling along with typical symptoms of slight sore throat and generalized malaise. The reaction was short-lived. The patient received an influenza vaccine last year without reaction. The patient's outcome was recovered. Documents held by sender: None.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 29 October 2012. An 81-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, lot number UH729AB, on 23 October 2012 and the same day experienced erythema, pain, blistering, and warmth at the injection site. The patient was evaluated on 23 October 2012 and 24 October 2012 and prescribed BACTRIM DS and prednisone for possible cellulitis. No culture performed to determine bacterial cause of possible cellulitis. The patient had an allergy to amoxicillin and a history of atrial fibrillation and breast cancer in 1997 with lymph node removal and right side lumpectomy. The patient was no acutely ill at the time of vaccination. The patient's outcome was not reported. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: 3 vaccines given to this patient 11/06/2012 HPV Lot# H010649 MCV4 Lot # U4289AA Flu Lot # UH745AB. 5 minutes after injections were given patient felt lightheaded, fainted and became very pale. Initial BP: 90/50 mmHg. Patient assessed, assisted with head down, legs up and administration of fluids and sugar provided after the patient referred that his last meal was over 7 hours prior. Kept in observation for about 45 minutes and d/c home with BP 110/70 mmHg. Be aware that this was his last HPV dose and he did not have this problem in the past.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye swelling, Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: Red, swollen, watery eyes; scratchy throat, hoarseness. Similar reaction last year, but not as bad (also 20 + yrs ago).
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Pt states feeling itchiness a few hours after receiving flu vaccine and PPD testing. Today she reports welts, hives and itchiness. Denies breathing difficulty. States itchy throat after receiving. Pt. received vaccine 11/6/2012. Was referred to immediate care ctr.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: SOB, chest tightness, hives on body, face, mouth, eyes. Treated at clinic with 50mg BENADRYL IM and 600mg Ibuprofen PO.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Chills, Feeling cold, Flushing, Heart rate increased
Clinical narrative: Vaccine given 10/29/12. Started with redness at site & feeling achy, cold & shaking chills evening of 10/30/12. Flushed face, achy AM of 10/31/12 increased redness to (R) deltoid area 430PM 10/31/12 - seen by provider. Red & indurated area (R) deltoid measures: 11cm x 7.5 cm. Increased BP & pulse noted, no fever. 10/31/12 - Treated with antibiotics, f/u in 2 days. Sooner if increasing problems.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Tremor
Clinical narrative: Vaccine given 10/29/12. Started with redness at site & feeling achy, cold & shaking chills evening of 10/30/12. Flushed face, achy AM of 10/31/12 increased redness to (R) deltoid area 430PM 10/31/12 - seen by provider. Red & indurated area (R) deltoid measures: 11cm x 7.5 cm. Increased BP & pulse noted, no fever. 10/31/12 - Treated with antibiotics, f/u in 2 days. Sooner if increasing problems.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Fatigue, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Cough, sore throat, slight difficulty breathing, bloodshot eyes - 2-6 hrs post vaccination. Tired, sore throat - 6 to 48 hrs post vaccination.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Received vaccine 11.5.12. Noticed itching of upper chest 11.6.12. Noticed red rash that evening. No progression of rash since then redness/swelling/tenderness at injection site.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Pain
Clinical narrative: Muscle weakness/pain. Muscle weakness has been present for 3 weeks & got progressively worse. 1 month post injection pain is resolving slowly, but still having some pain with lifting.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported itching an hour after vaccine administration. When returned home, he noted hives to entire body, they did go away in a few days. Patient did not go to MD. He stated he took BENADRYL to control symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Paraesthesia, Skin warm
Clinical narrative: Raised area Lt arm - swollen, feels warm to touch. Size of swollen is approx 2" long and 1" wide - hard to touch. Lt hand feels slight tingling.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: He received IV SOLUMEDROL followed by short course of prednisone for rash following administration of his influenza vaccine. Patient reports he is feeling well. Rash resolved in 3-4 days. Erythematous rash to the entire extremity.  Methylprednisolone 125 mg once, diphenhydramine 25 mg once.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: I had a flu shot 9/24/12. My arm has been sore since then. It hurts when I use my arm.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt reported pain in upper arm from time of administration that lasted ~20 days. Pt follow up with clinic and reported that MD felt that the injection was delivered too high. No redness or swelling at inj site at any time.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented on 11/1/12 with bilateral upper arm redness and swelling. Referred patient to primary care doctor and he prescribed Methylprednisolone dose pak and Zpak.
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: "I feel itchy" belly, legs. Sm. hive noted on the back of the neck. BENADRYL 12.5mg meltable given.
Age: 83.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Headache, Rhinorrhoea
Clinical narrative: Nose running, headache, tummy upset.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Patient states she had itching all over body after the vaccination. She has never had a reaction before.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Vaccine received ~12:30pm. Onset of rash on hands and arms upon waking up on 10/21. Rash also appeared on legs and in spots on back. Rash is red, raised, itchy bumps. Treating with topical hydrocortisone and oral antihistamines.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus generalised, Swelling face, Urticaria
Clinical narrative: (R) side of face (cheek & lips) started swelling at 1030AM. 120PM c/o itching & welts all over body. Instructed to take BENADRYL q4 hours for the next 24 hours - cool cloths on swelled areas. Hives were gone by next AM - still has some swelling in face.
Age: 24.0
Sex: F
Vaccine: FLUN3
Symptoms: Contraindication to vaccination, Maternal exposure during pregnancy
Clinical narrative: Pregnant pt inappropriately received FLUMIST. She reports that during the next 48 hours she had no headache, fever, swelling or malaise.
Age: 0.41
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient was given influenza vaccine instead of polio.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient complained of itching on arms, legs, back & ears - 10 minutes after receiving a flu shot.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Eyelid oedema, Ocular hyperaemia, Oral discomfort, Throat tightness
Clinical narrative: Burning feeling in mouth that lasted about 2 hrs. Feeling of throat closing about an hour after shot had mild wheezing, eyes got red & puffy & swollen. Took 50mg BENADRYL - sxs lasted about 4 hrs.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Burning feeling in mouth that lasted about 2 hrs. Feeling of throat closing about an hour after shot had mild wheezing, eyes got red & puffy & swollen. Took 50mg BENADRYL - sxs lasted about 4 hrs.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Extremely sore shoulder with limited movement.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Muscle tightness, Palpitations, Tremor
Clinical narrative: Increased "racing" heartbeats,  shaky, tightening in neck/chest, wheezy and coughing repeatedly. She was taken to ED for evaluation. Pt received BENADRYL and epinephrine in ED.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Increased "racing" heartbeats,  shaky, tightening in neck/chest, wheezy and coughing repeatedly. She was taken to ED for evaluation. Pt received BENADRYL and epinephrine in ED.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received flu shot on 10/12/12; she reported to employee health office on 10/15/12 with c/o redness/swelling at site (size of dollar (paper)) and painfulness. PO BENADRYL was given. She stated that it felt better now. Was worse the day before.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, IPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Blood ketone body, Chest pain, Cough, Eye pruritus, Heart rate increased
Clinical narrative: C/o nausea and vomiting, itchy eyes, cough, chest pain, body aches, increased heart rate. Went to MC. States she was given TYLENOL and fluids. Was released with a prescription for loratidine.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: C/o nausea and vomiting, itchy eyes, cough, chest pain, body aches, increased heart rate. Went to MC. States she was given TYLENOL and fluids. Was released with a prescription for loratidine.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Inflammation, Tendonitis
Clinical narrative: Inflammation of left shoulder as result of flu vaccination. Symptoms showed the evening after vaccination. Patient received medical care 10 days after and received NSAID from MD. On and off he is still having symptoms with inflamed tendon.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Myalgia
Clinical narrative: Pt. said had immediate muscle pain once given & though the acute pn. lessened, she still has sharp muscle pain with use. She is currently using CELEBREX 200 BID x2 weeks for the pain.
Age: 51.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Fever & rash.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness
Clinical narrative: C/o lightheadedness, cold & clammy 15 minutes after vaccine administration.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin lesion
Clinical narrative: Rash/lesion on fingers and face, back - above bottom.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain at injection site - right arm deltoid region. Began after injection on 10-23-12 until reported 11-7-12. Referred to primary care physician for treatment.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site pain, Myalgia, Periarthritis
Clinical narrative: I received the high dose flu vaccine by injection in my upper left arm close to my shoulder. I received the pneumonia vaccine by injection in my upper right arm close to my right shoulder. Both injections were administered by a pharmacist. Several hours after the vaccinations, my upper arms started to hurt. The pain became so excruciating that I was unable to undress or dress myself, my shoulders were frozen. The pain persisted for 48 hours. There was no redness but my muscles pained on any movement.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenopia, Dysphonia, Fatigue, Headache, Myalgia
Clinical narrative: Headache/nausea; extreme fatigue; muscle soreness; hoarseness; tired eyes.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Headache/nausea; extreme fatigue; muscle soreness; hoarseness; tired eyes.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Chills, Cough, Lung infection, Pyrexia
Clinical narrative: Fever; Chills; Cough; Lung infection; Weakness.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Pt received flu shot on 11/6/12 called us on 11/7/12 reporting swelling, redness, tenderness in her arm. Advised to take BENADRYL and seek medical attention if things get worse.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: None -> no adverse events/symptoms (patient received ZOSTAVAX on 8/30/11, then again on 11/2/12 by accident).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient states she had pain immediately while receiving the injection in her left deltoid. Denies numbness or tingling. No redness, edema, or bruising at injection site. Patient contacted me 3 weeks after the vaccine, stating her deltoid still hurts.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess drainage, Asthenia, Axillary pain, Bacterial test positive, Burning sensation
Clinical narrative: 48 hrs after Shingles vaccine, developed a rough, red skin rash at vaccine site and a small 1 inch red, rough skin area about 4 inches from injection site near armpit. The armpit site developed swelling and deep redness that spread about 6 inches across whole armpit and became very painful. On 5th day body aches, headache, chills and general weakness developed along with a violent itching and burning in armpit and surrounding areas. Dr. visit resulted in oral antibiotic script-CIPRO. After 4 days of no improvement and a second dr visit, was treated with 10 days IV vancomycin plus 4 wks doxycycline. Attempts at lancing area produced no result but at day 10 abscess opened and began to drain. Area drained for a week and then began to heal up. Am left with scarring and occasional tingling and itching in area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry skin, Erythema, Headache, Neutrophil percentage increased
Clinical narrative: 48 hrs after Shingles vaccine, developed a rough, red skin rash at vaccine site and a small 1 inch red, rough skin area about 4 inches from injection site near armpit. The armpit site developed swelling and deep redness that spread about 6 inches across whole armpit and became very painful. On 5th day body aches, headache, chills and general weakness developed along with a violent itching and burning in armpit and surrounding areas. Dr. visit resulted in oral antibiotic script-CIPRO. After 4 days of no improvement and a second dr visit, was treated with 10 days IV vancomycin plus 4 wks doxycycline. Attempts at lancing area produced no result but at day 10 abscess opened and began to drain. Area drained for a week and then began to heal up. Am left with scarring and occasional tingling and itching in area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus, Scar, Staphylococcus test positive
Clinical narrative: 48 hrs after Shingles vaccine, developed a rough, red skin rash at vaccine site and a small 1 inch red, rough skin area about 4 inches from injection site near armpit. The armpit site developed swelling and deep redness that spread about 6 inches across whole armpit and became very painful. On 5th day body aches, headache, chills and general weakness developed along with a violent itching and burning in armpit and surrounding areas. Dr. visit resulted in oral antibiotic script-CIPRO. After 4 days of no improvement and a second dr visit, was treated with 10 days IV vancomycin plus 4 wks doxycycline. Attempts at lancing area produced no result but at day 10 abscess opened and began to drain. Area drained for a week and then began to heal up. Am left with scarring and occasional tingling and itching in area.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan, Vaccination site erythema, Vaccination site rash, White blood cell count increased
Clinical narrative: 48 hrs after Shingles vaccine, developed a rough, red skin rash at vaccine site and a small 1 inch red, rough skin area about 4 inches from injection site near armpit. The armpit site developed swelling and deep redness that spread about 6 inches across whole armpit and became very painful. On 5th day body aches, headache, chills and general weakness developed along with a violent itching and burning in armpit and surrounding areas. Dr. visit resulted in oral antibiotic script-CIPRO. After 4 days of no improvement and a second dr visit, was treated with 10 days IV vancomycin plus 4 wks doxycycline. Attempts at lancing area produced no result but at day 10 abscess opened and began to drain. Area drained for a week and then began to heal up. Am left with scarring and occasional tingling and itching in area.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Flushing, Headache, Injection site erythema
Clinical narrative: Patient got the ZOSTAVAX on Sunday at the pharmacy. On Tuesday patient felt very fatigue, diminished appetite and has a slight headache. The site itself is tender and red. Patient said she had a flushed face, watery eyes, and tenderness at the site on Monday.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lacrimation increased
Clinical narrative: Patient got the ZOSTAVAX on Sunday at the pharmacy. On Tuesday patient felt very fatigue, diminished appetite and has a slight headache. The site itself is tender and red. Patient said she had a flushed face, watery eyes, and tenderness at the site on Monday.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received shingles vaccine on 11/3/12, then broke out in rash on arms and legs the next day. No other symptoms experienced, patient improving.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, HPV2, MNQ, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10x10cm circular area of significant swelling & warmth around injection site. Also pain around injection site. (Possible cellulitis vs. allergic reaction).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with GARDASIL (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccine doses that were exposed to temperature above 46 F to 45 minutes, with the highest temperature of 78 F for 15 minutes. No adverse effect reported. No treatment information was reported. Information about PNEUMOVAX 23, RECOMBIVAX, PEDVAXHIB and VAQTA that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1211USA001296, 1211USA001297, 1211USA001298 and 1211USA001299. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Oto temp 98.1. Redness warmth swelling 10 cm width x 7 cm length above (L) elbow. No redness discomfort at site of injection (L) deltoid. Area started swelling 1 day after injection.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Varicella like rash on face, neck maculopapular, no vesicles found.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TD, VARCEL
Symptoms: Eye swelling, Food allergy
Clinical narrative: Client received vaccines at approx 9:45 AM. Parents brought client back to clinic at 1:00 PM stating "her eyes are swollen since 45 min after vaccines given". Instr. to take to Emergency Room. Phoned Dad next day - he states "she is fine today" - Dr. said it was from a food allergy".
Age: 0.34
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 4 mo patient given KINRIX.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local title: Physician, Clinic note date of note: FEB 01, 2012 at 10:43 02/01/2012 Addendum Status: Complete. Patient return stating the arm where she had the pneumonia shot this morning is swollen. Patient said the swelling has stopped worsening the last 1-2 hrs. Slightly red and warm. No fever, no shortness of breath or wheezing. No swelling of her lips. PE: Lt deltoid area slightly swollen and warm to touch. No erythema. No limitation of movement. MEDROL dose pack ordered. BENADRL qid prn (patient has at home). Return if symptom worsens, arm turns red, sob, wheezing or swelling starts. Patient acknowledged understanding. Local title: Nursing Primary Care Note Date of Note: FEB 01, 2012 at 08:55 This is the patient's initial visit to establish care and receive medication. The following screening options were offered: *PNEUMOVAX: Patient received 0.5ml of pneumococcal vaccine IM at this encounter. Site: Lt deltoid. Manufacturer: Merck Lot #: 0895AA Exp. date: 11/12/2012
Sex: U
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient received a dose of GARDASIL (lot#, dose frequency and route not provided). The physician reported that he had a patient who on an unknown date had a rash on their arm for 6 months after receiving the vaccine. The outcome of the event was unknown. The relatedness of the event with GARDASIL was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 16 years old female patient with no pertinent medical history or drug reactions/allergies who on 21-JUN-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL intramuscular (lot # 657737/0522U, expiration date on 08-FEB-2010), on 16-AUG-2007 received the second dose of GARDASIL, 0.5 mL intramuscular (lot # 658222/0927U, expiration date on expiration date on 17-MAR-2010) and on 27-DEC-2007, the patient received the third dose of GARDASIL, 0.5 mL intramuscular (lot # 658558/1061U, expiration date on 14-APR-2010). The nurse reported that on 25-SEP-2012, the patient had an abnormal PAP smear that tested positive for GARDASIL strain. The nurse also noted that the patient did not have sexual contact before start of GARDASIL in May 2007. No treatment was given for the event. At the time of the report, the patient had not recovered from the event. The patient did not seek medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. A consumer reported that on an unknown date her daughter was administered a first dose of intramuscular GARDASIL (lot#, dose/frequency not provided) injection and they missed the 2nd administration. There was no adverse reaction. No additional information was reported. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Pt developed soreness at injection site. Next day developed redness and pain/swelling at elbow below injection site. Primary doctor treated pt for possible cellulitis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site swelling, Pain, Pruritus, Rash generalised
Clinical narrative: Upper body rash, burning itch, swollen injection site, aches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX sub-q on left upper arm and developed a large raised, warm, red area of inflammation that was painful to the touch.