chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Approximately, 10-15 minutes after receiving Tdap in Right deltoid, area began feeling very hot, feverish, notified infection control nurse, said just a localized reaction; at approximately 12:30 PM entire right arm, right shoulder, and neck began itching, areas were red and warm, took Claritin 10mg at approximately 2 PM due to itching continued; site of infection was sore; which progressively got worse over the next 24 hrs, warm to touch, red splotches on neck, arm, shoulder. Temp around 99.7,orally, my usual body temp is 97.0-97.5. 9/26/2013- Right arm remained extremely sore, burning sensation similar to sunburn in shoulder and neck, tired, generalized body aches, nasal congestion started. 9/27/2013- arm continues to have burning sensation, noticed bright red area on shoulder; left forearm to elbow rash apparent, as well as lighter rash on Right forearm; throat sore, nasal congestion, left nare had scant blood in mucus. 9/28/2013- not as achy, rash looks better, right arm burning sensation remains as well as bleb and small red area where injection given, throat really sore, hard to swallow, no appetite, feel tired, no fever, left eye has pink eye upon waking with slight crusty drainage, left nare still producing scant bleeding in mucus, feels like ulcer or sore in nare, throat ticklely feeling, mild coughing beginning.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Throat irritation
Clinical narrative: Approximately, 10-15 minutes after receiving Tdap in Right deltoid, area began feeling very hot, feverish, notified infection control nurse, said just a localized reaction; at approximately 12:30 PM entire right arm, right shoulder, and neck began itching, areas were red and warm, took Claritin 10mg at approximately 2 PM due to itching continued; site of infection was sore; which progressively got worse over the next 24 hrs, warm to touch, red splotches on neck, arm, shoulder. Temp around 99.7,orally, my usual body temp is 97.0-97.5. 9/26/2013- Right arm remained extremely sore, burning sensation similar to sunburn in shoulder and neck, tired, generalized body aches, nasal congestion started. 9/27/2013- arm continues to have burning sensation, noticed bright red area on shoulder; left forearm to elbow rash apparent, as well as lighter rash on Right forearm; throat sore, nasal congestion, left nare had scant blood in mucus. 9/28/2013- not as achy, rash looks better, right arm burning sensation remains as well as bleb and small red area where injection given, throat really sore, hard to swallow, no appetite, feel tired, no fever, left eye has pink eye upon waking with slight crusty drainage, left nare still producing scant bleeding in mucus, feels like ulcer or sore in nare, throat ticklely feeling, mild coughing beginning.
Age: 0.65
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Cluster of red rash at injection site on left leg, spread across arms, legs, back, face, belly, chest, hands and feet.  Erythematous maculopapular rash.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Burning sensation, Chills, Feeling cold, Headache
Clinical narrative: Immediate burning and physical pain entire length of arm into hand and fingers (middle, ring, and pinky) as medication traveled down arm. By 9-28 (approx. 2:00 am) could not lift my right arm (injection was in right arm) to shoulder height, fever (100.6), extreme chills, severe back and body aches (similar to flu). Could not get warm. Sweating and nausea. I took acetaminophen (500mg and buffered aspirin (500mg) at 2:00 am and again at 11:00 am. It is now 4:30 PM and I still have body aches, headache, and low grade fever.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Influenza like illness, Injected limb mobility decreased, Nausea
Clinical narrative: Immediate burning and physical pain entire length of arm into hand and fingers (middle, ring, and pinky) as medication traveled down arm. By 9-28 (approx. 2:00 am) could not lift my right arm (injection was in right arm) to shoulder height, fever (100.6), extreme chills, severe back and body aches (similar to flu). Could not get warm. Sweating and nausea. I took acetaminophen (500mg and buffered aspirin (500mg) at 2:00 am and again at 11:00 am. It is now 4:30 PM and I still have body aches, headache, and low grade fever.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Immediate burning and physical pain entire length of arm into hand and fingers (middle, ring, and pinky) as medication traveled down arm. By 9-28 (approx. 2:00 am) could not lift my right arm (injection was in right arm) to shoulder height, fever (100.6), extreme chills, severe back and body aches (similar to flu). Could not get warm. Sweating and nausea. I took acetaminophen (500mg and buffered aspirin (500mg) at 2:00 am and again at 11:00 am. It is now 4:30 PM and I still have body aches, headache, and low grade fever.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Heart rate increased, Nausea
Clinical narrative: Nausea, chills, headache, rapid heartbeat.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Rash erythematous
Clinical narrative: Red rash on stomach. The rash has spread and is now on my stomach, chest, groin, underarms, arms, legs. Have gone to dermatologist many times and he prescribes steroid creams. They don't help.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain in extremity
Clinical narrative: Bilateral lower extremity aches and pain. Rx Motrin 800mg #30 one tid prn pain. Rx Vicodin 5/325 #30 one qid prn pain.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Myalgia, Pain
Clinical narrative: INTENSE ACHES, AND CHILLING, ACHES BEGAN A FEW HRS AFTER INJECTION, CHILLING AND TEMP ELEVATION TO 100.5 OCCURRED AT APPROX 10:00PM, AND LASTED FOR 90 MINUTES. OK NEXT AM EXCEPT 4 ALL OVER MUSCLE ACHES FROM INTENSE CHILLING.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Injection site pain
Clinical narrative: Severe / acute pain in arm where pneumococcal polysaccharide was administered.  Pain was from top of shoulder to elbow.  Could not put any pressure on area due to pain.  On 9/28 acute pain still in back bicep.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Bedridden, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Sweats, chilling, muscle aches, injection site reaction, fatigue. Pt was bedridden for about 14 hours and couldn't fall asleep; had to miss work.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Initial insomnia, Injection site reaction, Myalgia
Clinical narrative: Sweats, chilling, muscle aches, injection site reaction, fatigue. Pt was bedridden for about 14 hours and couldn't fall asleep; had to miss work.
Age: 52.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Skin warm
Clinical narrative: 3" red circle surrounding site 24h after administration. Localized, sore, warm to touch. No other symptoms reported.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient noticed a large, red, itchy rash roughly 4 inches in diameter at the site of injection. Patient applied ice and the rash improved, shrinking in 2 inches in diameter.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Injection site mass
Clinical narrative: After injection a lump presented at site, patient became light headed and sweating profusely.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Palpitations, Pollakiuria, Tremor
Clinical narrative: Pt. experienced tremors, heart racing, increase in urination, weakness and light-headedness. Pt received 1 hot of Epi pen and patient went to E. R. where they received Benadryl and Prednisone 20 mg two daily for 5 days.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Swelling and redness on inside of right arm, beginning about midway down upper inside arm and continuing below the elbow to about halfway down lower arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Eyelids pruritus
Clinical narrative: Swelling and itching around eyes. Patient took Benadryl and is improving.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site pain, Pyrexia
Clinical narrative: Cellulitis with fever and injection site pain. Prescribed Cephalexin 500 mg BID for 5 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 61 year old female patient. No medical history or drug reactions were reported. On 11-SEP-2013, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # J003808, 03-JUL-2014), subcutaneously. Concomitant therapies included FLONASE, vitamin D (unspecified), ZYRTEC and aspirin. On 18-SEP-2013, the patient was diagnosed with shingles. Patient received treatment with ZOVIRAX. Patient sought medical attention: Office visit. Laboratory Diagnostics Studies Performed included culture swabs, pending results. The outcome of shingles was reported as not recovered. VZVIP packet faxed. Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient (her son) of unknown age. On an unknown date the patient was vaccinated with a dose of PEDVAXHIB (lot#, expiration date and route not reported). On an unknown date there was a possibility that her son had been administered sterile diluent instead of PEDVAXHB on an unspecified date. Cannot rule out PEDVAXHIB. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions/allergies. Pharmacist reported that the patient came into the pharmacy today, 25-SEP-2013, and stated after receiving ZOSTAVAX (vial, lot #, dose/frequency were unspecified), on an unspecified date at another unspecified pharmacy, she experienced redness at the injection site that subsided within a few hours. The patient showed the pharmacist where the ZOSTAVAX was administered and the pharmacist believed the ZOSTAVAX was given via the intramuscular route instead of the subcutaneous route. The pharmacist stated this was the first time the unspecified patient was seen at the pharmacy therefore she had minimal information. The outcome was reported as recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLUN3, HEPA, HPVX, VARCEL
Symptoms: Chest X-ray, Chest discomfort, Injection site rash, Laboratory test
Clinical narrative: This spontaneous report ws received from a Licensed Practical Nurse refers to a 17 year old female patient. On an unknown date, the patient was vaccinated with dose 2 of VARIVAX (Merck) and GARDASIL in the same arm and second dose of VAQTA in the other arm. The patient also received intranasal FLUMIST. On an unknown date, 24-48 hours after vaccination the patient complained of chest heaviness. The patient also developed a rash at the injection site of VARIVAX. A chest X-ray and number of unspecified tests were performed (results not provided). Patient sought medical attention: made a phone call to office and visit to emergency room. The outcome of chest heaviness and rash at the injection site was reported as recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Approximately on 28-AUG-2013 (reported as two weeks ago) the patient was vaccinated with a dose of PNEUMOVAX 23, injection in the arm (dose, route, lot number and expiration date not provided). On the same date the patient was vaccinated with ZOSTAVAX and influenza virus vaccine (manufacturer unknown) in the other arm. The patient did have a reaction in the PNEUMOVAX 23 arm. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Approximately on 28-AUG-2013 (reported as two weeks ago) the patient was vaccinated with a dose of PNEUMOVAX 23, injection in the arm (dose, route, lot number and expiration date not provided). On the same date the patient was vaccinated with ZOSTAVAX and influenza virus vaccine (manufacturer unknown) in the other arm. The patient did have a reaction in the PNEUMOVAX 23 arm. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dizziness, Hyperhidrosis, Nausea, Tremor
Clinical narrative: Nausea, upset stomach, vomiting, light headedness, sweat, shaking. Few hours after vaccine administration. Resulted to ER visit and overnight hospitalization.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Nausea, upset stomach, vomiting, light headedness, sweat, shaking. Few hours after vaccine administration. Resulted to ER visit and overnight hospitalization.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Diarrhoea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Cough sore throat vomiting diarrhea high fever up to 105. 3 ER visits one Monday night. On Friday early morning one. Friday late morning  diagnosed on 9/27 second ER visit as pneumonia treatment azythromycin.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, Injection site pain, Needle issue, Pain
Clinical narrative: Pain in shoulder which received the injection (left) when lifting arm out and away from body and when lifting straight. On going issue as of 9/29/2013.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Balance disorder, Musculoskeletal discomfort, Vertigo positional
Clinical narrative: Vertigo lasting 30 seconds. Very positional in nature. Left with anxiety and unbalance afterward. Discomfort in neck and upper back.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pharyngeal oedema, Pruritus
Clinical narrative: Rash, throat swelling, dizzy, itching, pressure in chest, slight difficulty breathing. Took 50 mg. Benadryl (Diphenhydramine HCl).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, throat swelling, dizzy, itching, pressure in chest, slight difficulty breathing. Took 50 mg. Benadryl (Diphenhydramine HCl).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Local swelling
Clinical narrative: Swelling of entire upper arm and into lower arm. Redness that spread to entire arm and continued to spread for 48 hours reaching a 4"x7" red patch and swelling that encompassed entire limb. After 48 hours the redness began to dissipate as did the swelling.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: SORE THROAT, COUGH, FEVER, VOMITING, DIARRHEA.
Age: 1.6
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Ran fever in evening. Called 911 at 10:30 PM he had a seizure was taking by ambulance to hospital and diagnosed with febrile seizure fur to fever of 103.7 at admitting.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pharyngeal oedema
Clinical narrative: Chills, sore throat, cough, throat swelled, aches.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Decreased appetite, Fatigue, Lethargy
Clinical narrative: Body chills & aches, low temperature, tiredness, chest muscles discomfort no appetite first day. Feeling of lethargy for 3 days, 4th day pretty much back to normal. Never had a reaction like this before in all the many years of getting a flu vaccine.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: Body chills & aches, low temperature, tiredness, chest muscles discomfort no appetite first day. Feeling of lethargy for 3 days, 4th day pretty much back to normal. Never had a reaction like this before in all the many years of getting a flu vaccine.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Cough, Dizziness
Clinical narrative: Started with a cough, sore throat, dizzy, all joint hurting, vomiting, cold shivering, all lasting until 2am 9/29/2013.  Headache and weakness on 9/29/2013.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Oropharyngeal pain, Vomiting
Clinical narrative: Started with a cough, sore throat, dizzy, all joint hurting, vomiting, cold shivering, all lasting until 2am 9/29/2013.  Headache and weakness on 9/29/2013.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hives at injection site and all over body on arms and back, and left leg.  Injection was right arm upper muscle.  More hives and extreme itching feeling for one week and continous since.  Pharmacist said to take Benadryl.  Lot number for vaccine is 1307601 per Pharmacist.  RX #0155447-13463. Fluvirin Vial #2013-14 5ML NDC #66521-0116-10.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash papular
Clinical narrative: Awakened scratching my sides and hips.  A red rash and red welts covered my shoulders, my torso, my back and hips. This seemed to localized on my right side, the side I was laying on.  The next day the rash was less prominent, less localized, some generalized itching. Two and a half days after the injection, the rash localized to points where my clothing was tight, groin, waist, and bra strap.  That was 9 PM on 9/22/13 and I took pictures at that time. The following morning the rash and itch were almost gone.  No further problem.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Fatigue, body aches, chills, cough, sore throat, headache.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Fatigue, body aches, chills, cough, sore throat, headache.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Extreme radiating shoulder pain, unable to lift or use the left arm.  Injection was given in the acromion process joint instead of deltoid muscle.  Dr. see on 9/24/13 for arm pain prescribed corticosteroids.  Will be going back due to no improvement in the impingement syndrome.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a Healthcare Worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, expiry not reported). On an unknown date, the patient developed mumps after receiving the MMR II vaccine. The patient sought medical attention. The patient was hospitalized, for an unspecified duration, for the Mumps. The outcome of mumps was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had a FLUZONE HD on 9/11/13. The vaccine was given in the lower third of the left deltoid. On 9/27/13 the patient presented to the pharmacy complaining that his shoulder was still sore. Instructed him to take NSAIDS and follow up in 2 weeks.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient was see in ER on 8/17/13 with complaint of painful rash. Was given Acyclovir, Prednisone Clobetasol and PERCOCET. He is being treated with LYRICA and LIDODERM patches as of 9/29/13 symptoms of painful rash not resolved.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Loss of consciousness
Clinical narrative: Patient passed out around 5:30 pm. Pt also reported headache. Pt went to ER at midnight and stayed for 12 hours.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Urticaria
Clinical narrative: Pt received PNEUMOVAX and FLUVIRIN on 9/23. Arm received PNEUMOVAX in swelled 2x normal and very painful. This has resolved but 4 welts on inside of arm (dime-nickel size) remain and arm painful. Pt has tried hot showers. Will try BENADRYL, cold packs and TYLENOL/ibuprofen.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient received influenza vaccine in left deltoid and PNEUMOVAX in right deltoid on 9/23/13. On 9/25/13, patient noticed quarter-size welts on right arm and shoulder surrounding area of injection. Patient presented to pharmacy and pharmacist on duty suggested BENADRYL and follow-up with physician. Patient took BENADRYL and rash resolved by 9/29/13.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nodule
Clinical narrative: Patient received FLUZONE HD on 9-15-13 at 7:00pm. He waited with me until we left at 7:10. On 9-16-13 he reports he had a small knot behind his ear. He waited until that afternoon to go to walk-in clinic because lymph glad was bigger. They gave him KENALOG injection and BENADRYL and stated it was a reaction to the shot.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Injection site swelling, Pain, Swelling
Clinical narrative: Patient reported swelling, redness (erythremia) of entire injection site Did not reduce with ice treatment. Pain and swelling lead patient to visit his doctor. He was prescribed Cephalexin for it. Suspected local infection. Reaction occurred only with Pneumovax, flu vaccine she        was fine.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back disorder, Dyspnoea
Clinical narrative: Patient is fine after Fluvirin shot. Patient reacts to Pneumovax (2nd shot). Patient complained of SOB 911 was called immediately. Pt also complained of terrible back. Paramedic determined pt's signs and symptoms are not due to an allergic to the vaccines.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Local swelling, Skin warm
Clinical narrative: Round, red, raised area warm to touch (3 to 4 inches). Two rings at site of injection pink/red outer area and closer to the area was a darker pink/red area.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: 9/25/13 pt received AFLURIA at 10:10AM. Pt came back at approx. 7:00PM with raised bumps approx. 8mm in diameter on forearms and 1 one neck. Pt stated itching on head and back as well. Pt went to (on 9/26/13) immediate care, received Rx for prednisone and ZYRTEC (filled on 9/27/13).
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: The day after the vaccine patient reports rash developed on left and right side of waist. He states it is itchy which comes on and off. Patient reported the symptoms to his doctor on 9/26/13 and doctor recommended hydrocortisone cream which patient states helps the itch. Symptoms present now for 2 weeks.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Flu vaccine admin. 9/21/13. On 9/23/13 pt. returned to store to report pain, inflammation and warm at injection site. Pharmacist referred to physician. Pt. dx: cellulitis.  Rx cephalexin 500 mg TID x 10.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Patient received vaccine on 9/25/13 and the next day noticed a large, red, inflamed area on the arm near the injection site that covered a 2x2 area. it was also red and itchy.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site nodule
Clinical narrative: Patient reported knot in her arm where vaccine was administered and that she couldn't raise her arm above her head. Patient stated she needed help the next day getting dressed.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 19 years old male patient. On 23-NOV-2010 the patient was vaccinated with a 0.5 ml dose of VAQTA ("25/0.5 U/ml" as reported) (lot # unspecified) intramuscular (location and indication unspecified). The nurse reported that on 23-JUL-2013 the patient was inadvertently administered a pediatric dose of VAQTA. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Type 1 diabetes mellitus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist heard that on an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route unspecified). On an unknown date the patient might have developed type 1 diabetes after administration of ZOSTAVAX. The event outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. ON 26-SEP-2013 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 with lot # 0225AE and expiration date of 03-JUN-2013 intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Inflammation, Pruritus
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 year old female patient. The patient has no pertinent medical history and no drug reactions/allergies. On 16-SEP-2013 the patient was vaccinated with a full dose of ZOSTAVAX (lot # J003806, Exp date: 03-JUL-2014), subcutaneously. Concomitant therapies included EVISTA. The patient experienced redness, inflammation, burning, itching (pruritus), erythema and "hot" after receiving ZOSTAVAX (in September 2013). Patient called physician's office on 18-SEP-2013 to report reaction and was  instructed to use cold compress to site, BENADRYL and Hydroxyzine. No lab diagnostics studies performed. Patient was seen by physician in office 19-SEP-2013. VZVIP packet faxed. The outcome of the events was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Loss of consciousness
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 15 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On an unknown date in June 2012, the patient was vaccinated with a dose of GARDASIL Vial WET SD 120 Y, lot #, dose, frequency, route unspecified. On 03-SEP-2013 the patient was vaccinated with her 4th dose of GARDASIL Vial WET SD 120 Y, lot#, dose, frequency, route unspecified. Concomitant therapy possibly included an unspecified hepatitis A virus vaccine (manufacturer unknown). On 03-SEP-2013 the patient passed out after receiving the 4th dose of GARDASIL. No treatment was given for the event, and no lab diagnostics studies performed. The outcome of the event was unknown. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a male patient of unknown age. Approximately on 06-SEP-2013 (reported as 10 days ago) the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot #, expiration date unknown), subcutaneously. The client was ordered a prescription for an antiviral but the prescription has not been filled. Pharmacist stated the client usually got an antiviral medication as prophylaxis therapy for cold sores. However pharmacist stated she did not know if the patient had an active ace of cold sores at the time of this report. The outcome of cold sores was unknown. Causality was not reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 65 year old female patient. The patient had drug reactions/allergies to penicillin, cephalosporin, doxycycline (diarrhea reaction), tetracycline, LEVAQUIN (caused sleepiness), FOSAMAX (with unspecified reaction), codeine and NAPROSYN. The pharmacist reported that the patient developed red bumps and swelling at the injection site of a PNEUMOVAX23 (lot# unspecified) (dose, route and location unspecified, could not be ruled out). The patient received the Pneumococcal vaccination at her physician's office (name of physician unspecified) within the last two days approximately 10-SEP-2013. The patient had sought medical attention via contacted the pharmacist. No lab diagnostic study was performed. At the time of report, the outcome of the event was recovering. This is one of several reports received from the same patient. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lymph node pain
Clinical narrative: This spontaneous report was received from a physician refers to a 25 year old female patient with vitamin C allergy (unspecified reaction) and no pertinent medical history. On 03-SEP-2013 the patient was vaccinated with 0.5 milliliters (ml), dose 1 GARDASIL (lot # J005679, expiration date 27-NOV-2015)intramuscularly in the left deltoid. Concomitant therapies included FLEXERIL. On an unknown date in September 2013 she developed a large area of tenderness and swelling at the injection site that was also itchy. The patient also reported having tender axillary and mandibular lymph nodes. The physician called into the physicians office on 06-SEP-2013 to report this event. The patient was seen by the physician on 10-SEP-2013 at which time she declined medication for treatment. The physician stated when he saw the patient, on 10-SEP-2013 she "seemed fine and was recovered". Laboratory diagnostic studies were not performed for this event. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-SEP-2013, patient was in the physician's office and would receive a third dose of GARDASIL (lot#, expiry not reported) today. The nurse reported that the first and second doses of GARDASIL (lot#, expiry not reported) were administered on unspecified dates about 4 years ago approximately in September 2009. No adverse effects reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old not pregnant female patient. Pharmacist reported that patient had titers drawn one month ago in August 2013 on an unspecified date and the patient was negative for hepatitis B immunity. Patient had received all doses in the series of an unspecified hepatitis B vaccine, could not rule out RECOMBIVAX HB (thimerosal status was not provided). Patient initially was administered hepatitis B vaccine series six years ago, in approximately 2007, on an unspecified date, (lot# unspecified) (dose, route and location unspecified). The outcome of event was not provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site swelling, Joint range of motion decreased
Clinical narrative: High injection site. Upper arm soreness and pain. Limited arm motion.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: High injection site. Upper arm soreness and pain. Limited arm motion.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: High injection site. Upper arm soreness and pain. Limited arm motion.
Age: 18.0
Sex: M
Vaccine: FLUN4, HEP, IPV, TYP, VARCEL, YF, FLUN4, HEP, IPV, TYP, VARCEL, YF
Symptoms: Flushing, Swelling face, Urticaria
Clinical narrative: Face flushed, wheals on neck and trunk, denies any difficulty in swallowing or tightness in throat.
Age: 18.0
Sex: M
Vaccine: FLUN4, HEP, IPV, TYP, VARCEL, YF, FLUN4, HEP, IPV, TYP, VARCEL, YF
Symptoms: Dysphagia, Flushing, Throat tightness, Urticaria
Clinical narrative: Face flushed, wheals on neck and trunk, denies any difficulty in swallowing or tightness in throat.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Swelling face
Clinical narrative: Swelling in arm where shot was given 2 days after show was given. Swelling moved to the feet along with hand sized red patches over her body. Steroids shots were given around day 5 - break out started clearing day 7 patches came back worse than before - oral steroids given for 6 days.
Age: 76.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Rash erythematous
Clinical narrative: Swelling in arm where shot was given 2 days after show was given. Swelling moved to the feet along with hand sized red patches over her body. Steroids shots were given around day 5 - break out started clearing day 7 patches came back worse than before - oral steroids given for 6 days.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood creatine phosphokinase normal, Chills, Cyanosis, Injection site discolouration, Injection site erythema
Clinical narrative: Pt states body pain, low grade fevers that started the evening of 9/20/2013. Chills, rash and bad body pains that continued through the next 3 days. Right arm is painful to touch and flex or extend arm. Pt told to take Benadryl as needed. Lab draw for creatinine kinase totals done 09/24/2013.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Pt states body pain, low grade fevers that started the evening of 9/20/2013. Chills, rash and bad body pains that continued through the next 3 days. Right arm is painful to touch and flex or extend arm. Pt told to take Benadryl as needed. Lab draw for creatinine kinase totals done 09/24/2013.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Pt states body pain, low grade fevers that started the evening of 9/20/2013. Chills, rash and bad body pains that continued through the next 3 days. Right arm is painful to touch and flex or extend arm. Pt told to take Benadryl as needed. Lab draw for creatinine kinase totals done 09/24/2013.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood creatine phosphokinase, Chills, Pain, Pyrexia, Rash
Clinical narrative: Pt states body pain, low grade fevers that started the evening of 9/20/2013. Chills, rash and bad body pains that continued through the next 3 days. Right arm is painful to touch and flex or extend arm. Pt told to take Benadryl as needed. Lab draw for creatinine kinase totals done 09/24/2013.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Pt states body pain, low grade fevers that started the evening of 9/20/2013. Chills, rash and bad body pains that continued through the next 3 days. Right arm is painful to touch and flex or extend arm. Pt told to take Benadryl as needed. Lab draw for creatinine kinase totals done 09/24/2013.
Age: 0.39
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: S.U.I.D/S.I.D.S? Death cert. not yet available. For autopsy result, contact medical examiner or child's HCP.
Age: 1.16
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever..going up and down...caused a febrile seizure...emergency room reported no infection.
Age: 4.0
Sex: U
Vaccine: VARCEL, UNK
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient with no drug reactions/allergies. There was no pertinent medical history. On an unknown date in 2007, the patient was vaccinated with either PROQUAD, (lot number, expiry date was unknown) or VARIVAX, (lot number, expiry date was unknown), subcutaneously in the left thigh. No concomitant medications were taken. The physician could not confirm which product was administered. Approximately on an unknown date in 2007, 48 hours after vaccination the patient experienced 20 typical varicella type lesions cascading to the leg and tremendous pain at location of lesions cascading down left leg described as pain associated with shingles. The patient sought medical attention. The patient was hospitalized for an unspecified length of time and was treated with fluids and intravenous pain medications. On an unspecified date, the events were recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, UNK
Symptoms: Herpes zoster, Pain in extremity, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient with no drug reactions/allergies. There was no pertinent medical history. On an unknown date in 2007, the patient was vaccinated with either PROQUAD, (lot number, expiry date was unknown) or VARIVAX, (lot number, expiry date was unknown), subcutaneously in the left thigh. No concomitant medications were taken. The physician could not confirm which product was administered. Approximately on an unknown date in 2007, 48 hours after vaccination the patient experienced 20 typical varicella type lesions cascading to the leg and tremendous pain at location of lesions cascading down left leg described as pain associated with shingles. The patient sought medical attention. The patient was hospitalized for an unspecified length of time and was treated with fluids and intravenous pain medications. On an unspecified date, the events were recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, UNK
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient with no drug reactions/allergies. There was no pertinent medical history. On an unknown date in 2007, the patient was vaccinated with either PROQUAD (merck), (lot number, expiry date was unknown) or VARIVAX, (lot number, expiry date was unknown), subcutaneously in the left thigh. No concomitant medications were taken. The physician could not confirm which product was administered. Approximately on an unknown date in 2007, 48 hours after vaccination the patient experienced 20 typical varicella type lesions cascading to the leg and tremendous pain at location of lesions cascading down left leg described as pain associated with shingles. The patient sought medical attention. The patient was hospitalized for an unspecified length of time and was treated with fluids and intravenous pain medications. On an unspecified date, the events were recovered. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, UNK
Symptoms: Herpes zoster, Pain in extremity, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient with no drug reactions/allergies. There was no pertinent medical history. On an unknown date in 2007, the patient was vaccinated with either PROQUAD (merck), (lot number, expiry date was unknown) or VARIVAX, (lot number, expiry date was unknown), subcutaneously in the left thigh. No concomitant medications were taken. The physician could not confirm which product was administered. Approximately on an unknown date in 2007, 48 hours after vaccination the patient experienced 20 typical varicella type lesions cascading to the leg and tremendous pain at location of lesions cascading down left leg described as pain associated with shingles. The patient sought medical attention. The patient was hospitalized for an unspecified length of time and was treated with fluids and intravenous pain medications. On an unspecified date, the events were recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Blood potassium abnormal, Blood sodium abnormal, Eyelid oedema, Eyelid pain
Clinical narrative: This spontaneous report was received from a 80 year old female patient. Current conditions of the patient included KEFLEX allergy, clindamycin allergy, cefuroxime allergy and cipromycin allergy. The medical history included stent in heart. On 02-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). Concomitant therapies included gabapentin, metoprolol, losartan potassium (reported as Losartan), chlorthalidone, ZETIA, LIPITOR, SYNTHROID, PEPCID, meclizine, RENEW LIFE ULTIMATE FLORA CRITICAL COLON (reported as ultimate flora), ersupoloate and ultra B12. On an unknown date in the third week of June 2013, the patient developed shingles, including blisters above the eye, the hairline and 3-4 inches down her face. She still feels pain and swelling in eyelids. Also, a week after developing shingles (approximately on an unknown date in June 2013), she was hospitalized for potassium and sodium level problems. Length of stay was not specified. The patient sought medical attention (went to eye doctor). Unspecified test was performed and her eyes were dilated. She was treated with eye drops (unspecified) and gabapentin. The patient had not recovered from the events at the time of report. In addition the patient mentioned that she was hospitalized for cold on an unknown date (length of stay was unspecified) at the same facility. Outcome of cold was unknown. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Laboratory test, Mydriasis, Nasopharyngitis, Pupil dilation procedure
Clinical narrative: This spontaneous report was received from a 80 year old female patient. Current conditions of the patient included KEFLEX allergy, clindamycin allergy, cefuroxime allergy and cipromycin allergy. The medical history included stent in heart. On 02-JAN-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). Concomitant therapies included gabapentin, metoprolol, losartan potassium (reported as Losartan), chlorthalidone, ZETIA, LIPITOR, SYNTHROID, PEPCID, meclizine, RENEW LIFE ULTIMATE FLORA CRITICAL COLON (reported as ultimate flora), ersupoloate and ultra B12. On an unknown date in the third week of June 2013, the patient developed shingles, including blisters above the eye, the hairline and 3-4 inches down her face. She still feels pain and swelling in eyelids. Also, a week after developing shingles (approximately on an unknown date in June 2013), she was hospitalized for potassium and sodium level problems. Length of stay was not specified. The patient sought medical attention (went to eye doctor). Unspecified test was performed and her eyes were dilated. She was treated with eye drops (unspecified) and gabapentin. The patient had not recovered from the events at the time of report. In addition the patient mentioned that she was hospitalized for cold on an unknown date (length of stay was unspecified) at the same facility. Outcome of cold was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Case number PHEH2013US020099 is an initial spontaneous report from the consumer received on 23 Sep 2013. The report refers to a 63-year-old male patient. He was vaccinated with FLUVIRIN (batch number: not reported) in the upper arm via intramuscular route, on an unknown date in Oct 2012. Twelve hours after vaccination, he presented with raised red rash all over his body. The outcome of the event reported as recovered on an unknown date in Oct 2012.
Age: 1.02
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Intussusception, Laboratory test
Clinical narrative: Initial report was received 23 September 2013 from a consumer. A 12-month-old male patient received Influenza vaccine (manufacturer unknown) and Varicella vaccine (other manufacturer); lot numbers, routes, sites and dates of administration not reported, and an unspecified amount of time later, the patient developed intussusception leading to hospitalization (dates not reported). The patient was seen by a GI physician and an immunologist. Outcome was not reported. This patient previously experienced "crying for days" after receiving DTAP, RV, HIB and IPOL vaccines at two, four and six months of age (captured in case number 2013-09796). This patient experienced a subsequent event after receiving DTAP vaccine at 2 years of age (captured in case number 2013-09797). Documents held by sender: None.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA014075 and 1309USA014074). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. On 10-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 10-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. The reporter mentioned that the injection site reaction was not local anymore but had encompassed the entire arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA014075 and 1309USA014074). Additional information has been requested.