chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash erythematous, Rash pustular
Clinical narrative: This spontaneous report as received from a patient, as part of a marketing research program, refers to himself or herself. On an unknown date the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (lot #, expiration date, dose, route not reported). The patient felt on 26-OCT-2013 injuring by left shoulder and arm. The patient went to the doctor and at that time did not have a rash on the patient's arm, just pain in the shoulder joint and upper arm area. The patient was given pain medications and told that the patient had pulled muscles. On 31-OCT-2013 ("five days later"), the patient developed a red rash, then fluid filled pus pockets beginning at my shoulder going down to the hand and into fingers. The patient went to doctor on 02-NOV-2013 ("Sunday") and was told that it was contact dermatitis and if it was the shingles it was to late to begin viral medications. The patient was given prednisone shot and pills to take. On 05-NOV-2013 morning ("Tuesday morning") the patient woke up with severe shoulder joint pain, more blisters, and swollen arm, the patient went to the regular doctor was told the patient had full blown shingles and the doctor wanted the patient to stop the prednisone and wrote prescription for a viral medication to begin taking immediately and stronger pain medications. The patient was at home resting and felt terrible. The doctor was hoping that the viral medications will help. The outcome of the event was unknown. Follow up information has been received from the patient, as part of a marketing research program, refers to himself/herself. The patient stated he/she had been suffering from shingles on and off for 39 years. Even after the vaccine he/she was still getting them. At the time of the report, the outcome of the patient was unknown. Additional information has been requested. It has been determined that initial receipt date of MARRS # 1311USA002469 shoulder be 05-NOV-2013, but entered as 06-NOV-2013 by mistake. Therefore, that MARRS # 1311USA002469 is being deleted from our files and the cases consolidated into MARRS # 1312USA000882.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pain, Full blood count normal, Headache, Influenza virus test negative, Laboratory test normal
Clinical narrative: Fever, headache and eye pain and neck pain - 24 hours after vaccine. Went to ER - normal lumbar puncture and CBC and chemistry rapid flu (-) in office.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture normal, Neck pain, Pyrexia
Clinical narrative: Fever, headache and eye pain and neck pain - 24 hours after vaccine. Went to ER - normal lumbar puncture and CBC and chemistry rapid flu (-) in office.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt complaining of extreme pain. Arm has limited mobility. In a lot of pain.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The medical history includes breast cancer. On 25-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot#/batch# were not reported). Concomitant therapies included dexamethasone (manufacturer unknown) which was administered on 01-DEC-2013. The pharmacist reported that the patient has had breast cancer for an unspecified period of time and was diagnosed with breast cancer on an unspecified date before ZOSTAVAX was administered. The reported adverse event was cancer. The patient sought medical attention (went to unspecified physician). It was reported that she will be beginning chemotherapy to treat breast cancer soon. The outcome of breast cancer was unknown. Upon internal review the event breast cancer considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. On an unspecified date "within the last week", in November 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). It was reported that the patient developed swelling at the injection site on an unspecified date in November 2013. The patient was treated with ice on injection site and BENADRYL. At the time of reporting, the patient was not recovered. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a Pharmacy student refers to a female patient of unknown age. On 16-NOV-2013 the patient was vaccinated with an inadvertent low dose of ZOSTAVAX, VIAL, (lot #, expiration date, dose and route unspecified) as a result of needle leakage. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer via her sister-in-law refers to her 12 year old son. On 19-NOV-2013 the patient was vaccinated with his third dose of GARDASIL (lot #, expiration date, dose and route unspecified). In November 2013 the patient experienced redness, swelling, inflammation, and warmth at the injection site after administration. The injection site reaction was treated with ice compresses. The event outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Pyrexia
Clinical narrative: Right arm red and swollen. Patient unable to move arm, fever began on 12/2/13. Was given an injection of Lincomycin and started on clindamycin and patient is to return if not better.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was received either RECOMBIVAX HB (intramuscular, dose detail and lot number unspecified) or PEDIARIX (dose detail and lot number unspecified) on the following dates: 23-JUN-2012, 14-JUL-2012, 06-OCT-2012, 18-NOV-2012, 11-SEP-2013. It was unknown which dates correspond to RECOMBIVAX HB and which dates correspond to PEDIARIX. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diplopia, Eye inflammation, Immune system disorder, Visual acuity reduced
Clinical narrative: This spontaneous report as received from a male, 66 year old consumer with none drug reactions/allergies who was referring to herself. The patient's medical history included vertigo (no dates provided). On 05-NOV-2013 the patient was vaccinated with influenza virus vaccine (manufacturer unknown) injection, one dose (strength not reported) route reported as injection (no further specified). Other suspect therapies included pneumococcal vaccine, polyvalent (manufacturer unknown) administered at the same date on 05-NOV-2013 (dose, strength, route lot number not reported). No concomitant therapies reported. On 09-NOV-2013, the patient experienced inflammation of the eyes, poor vision, double vision and his immune system was "stirred up" (no further specified). The patient was treated with acyclovir, PRED FORTE and cyclopentolate hydrochloride. The patient sought medical attention by doctor visit. None laboratory tests were performed. It was reported that the patient takes multivitamin. The patient was recovering from the events. The reporter did not assess the relationship between the therapy with suspect therapies and the adverse events. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of unknown age. The patient had no medical history. On 25-NOV-2013 the patient was vaccinated with M-M-R II lot number J002934 and expiry date 15-MAR-2013, 0.5 ml, subcutaneous, as required for unspecified enrollment. Other suspect therapies included a single 0.5 mL dose of VARIVAX (merck) (Lot number J006161 and expiration date 20-MAY-2015) on the same day. Both vaccines were administered via the subcutaneous route. Concomitant medications were none. On the day of report, the patient stated that she took an at home pregnancy test a couple of days after her appointment on 25-NOV-2013, and the test came back positive. The patient stated that she had not yet been seen by her unspecified obstetrician and gynecologist (OBGYN). The nurse stated that according to the paperwork the patient filled out during her 25-NOV-2013 office visit, the patient's last menstrual period was on 24-NOV-2013. The estimated date of delivery (EDD) was of 31-AUG-2014. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female with mild anemia and a medical drug history of iron supplement. The patient was vaccinated intramuscularly with lot # (671006/1391AA: exp date 12-APR-2014), 0.5 ml dose of GARDASIL on 19-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was at 25 week and 4 days of gestation. The LMP was of 02-APR-2012 and an EDD of 07-JAn-2013. The patient had an office visit, no treatment was given an no lab diagnostic tests were performed. The outcome of pregnancy was pending. Follow up information received. All telephone attempts to obtain follow up had been unsuccessful. The case was lost to follow up and pregnancy outcome was lost to follow up. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Reaction to food additive
Clinical narrative: Lump underneath injection site, which over a two day period got larger with a red ring around the lump. Pt called back and said she was allergic to MSG.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history was not provided. On 26-NOV-2013 the patient was inadvertently administered a dose of RECOMBIVAX HB (lot # J000722) that had been improperly stored. Dose and route were not reported. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the mother of a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1. It was reported that the patient missed the second dose of GARDASIL. No adverse event symptoms reported. No product quality complaint was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 12-JUL-2012 and 13-NOV-2012 the patient was vaccinated with the first dose and the second dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified) respectively. The patient did not get the third dose yet. No adverse effect reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Pain, Paraesthesia, Photophobia
Clinical narrative: Stinging sensation, needle, burning on right side of head. Cannot see out of right eye when bright of lights shine eye.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown demographics. On 02-MAY-2013, the patient was vaccinated with GARDASIL dose 1. On 29-OCT-2013, the patient was vaccinated with GARDASIL dose 2. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity
Clinical narrative: Slightly swollen, extreme pain, unable to lift arm and unable to pick anything up. Left arm.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Erythema, Pyrexia
Clinical narrative: Began having fever same day of vaccine. Rt leg, 102 axillary. Redness approx quarter-half dollar in size. Pt taken to emergency room then followed up with PCP next day.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red at administration site. Area is feverish and tender.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Large edematous area around site of administration area very sore to the touch and painful. Pt has received flu shot before with no reactions.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site swelling, Visual impairment
Clinical narrative: Five hours after receiving the injection I developed severe cold chills and visual disturbance in right eye lasting one to two minutes. Also had localized swelling and redness at site.
Age: 20.0
Sex: M
Vaccine: MMR, TYP, YF
Symptoms: Swelling face
Clinical narrative: 1500 reports pt for facial swelling 0.3mg epi-pen IV started, 25mg benadryl IV slow push, 8mg dexamethasone, 500mg NS. Swelling resolved.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, VIIth nerve paralysis
Clinical narrative: Woke a.m. 11/8 with (R) facial droop eval in ER - transferred due to very morbid obesity - needed lg CT scanner went in a amb. to R/O stroke. Seen in their ER/sent home with Dx of Bells Palsy.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Rash erythematous, Rash pruritic, Swelling face
Clinical narrative: Pt c/o swollen face and hands  later the same day followed by a red, bumpy, itchy rash on arms, legs, and trunk.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II inadvertently instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain throughout the arm lasted for 3 days. OTC pain med: ALEVE and Naproxen helped.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol, Burning sensation, Glomerular filtration rate, Incorrect storage of drug, Myalgia
Clinical narrative: This spontaneous report as received from a 75 year old male consumer regarding himself. Patient concurrent condition included gastroesophageal reflux disease, herpes and sinusitis. The patient's medical history included thyroid removed. On 18-DEC-2006 the patient was vaccinated with ZOSTAVAX dose 1. Concomitant therapies included ACYCLOVIR, METHOCARBAMOL, DICLOFENAC, GABAPENTIN, CARVEDILOL, ATORVASTATIN, SYNTHROID, PRILOSEC and FLUTICASONE. The patient stated that the vaccine was left out at room temperature before administration. On 25-JAN-2013 the patient experienced sore muscle around his neck which he felt he recovered from one month later (approximately February 2013). On 01-NOV-2013, the patient experienced a sore muscle around his neck pain and burning sensation which he described as a bee sting or bad sunburn. The patient was treated with CAPZASIN HP (unspecified dose and frequency) and the patient reported that CAPZASIN burned his skin. The patient was also used BIOFREEZE as a treatment for the events. On an unknown date the patient also underwent kidney function test, GFR test and VAP test- results not provided. The patient sought medical attention and visited the physician. The outcome of burning sensation which he described as a bee sting or bad sunburn and a sore muscle around his neck again was reported as not recovered/not resolved. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Renal function test
Clinical narrative: This spontaneous report as received from a 75 year old male consumer regarding himself. Patient concurrent condition included gastroesophageal reflux disease, herpes and sinusitis. The patient's medical history included thyroid removed. On 18-DEC-2006 the patient was vaccinated with ZOSTAVAX dose 1. Concomitant therapies included ACYCLOVIR, METHOCARBAMOL, DICLOFENAC, GABAPENTIN, CARVEDILOL, ATORVASTATIN, SYNTHROID, PRILOSEC and FLUTICASONE. The patient stated that the vaccine was left out at room temperature before administration. On 25-JAN-2013 the patient experienced sore muscle around his neck which he felt he recovered from one month later (approximately February 2013). On 01-NOV-2013, the patient experienced a sore muscle around his neck pain and burning sensation which he described as a bee sting or bad sunburn. The patient was treated with CAPZASIN HP (unspecified dose and frequency) and the patient reported that CAPZASIN burned his skin. The patient was also used BIOFREEZE as a treatment for the events. On an unknown date the patient also underwent kidney function test, GFR test and VAP test- results not provided. The patient sought medical attention and visited the physician. The outcome of burning sensation which he described as a bee sting or bad sunburn and a sore muscle around his neck again was reported as not recovered/not resolved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 13 years old female patient with no pertinent medical history. The patient's drug reactions/allergies included CIPRO, ELMIRON and acetaminophen, and LORTAB. The patient's history of previous pregnancies and live births were not known. Thw patient was intramuscularly vaccinated with lot # (666595/0096Z) dose 1, 0.5 ml GARDASIL on 29-JUN-2012. No concomitant medications were reported. A urine pregnancy test at the Health Department on 29-JUN-2012 was negative. The patient contacted the nurse to inform her that, after she consulted with an unspecified OB/GYN practice, she has been determined to be pregnant. No problem reported. The LMP and EDD were not known. No treatment was given for AE. The outcome of vaccine exposure during pregnancy and no adverse event was unknown. Follow up attempt was performed to obtain pregnancy outcome information. There was no response, the case is lot to follow up. All telephone attempts to obtain follow up have been unsuccessful. Pregnancy outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dermatitis, Erythema, Pruritus, Rash
Clinical narrative: Anaphylactic, hives, pruritis, erythema, inflammation of skin, rashes are hot to the touch.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Urticaria
Clinical narrative: Anaphylactic, hives, pruritis, erythema, inflammation of skin, rashes are hot to the touch.
Age: 50.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Axillary pain, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Stiff neck and collar bone, swollen gland and pain in armpit area.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Splotchy rash under the site of injection.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster (Shingles).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING AT SITE REDNESS/TENDERNESS/PAIN.
Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood test, Computerised tomogram, Dehydration, Dizziness, Nasopharyngitis
Clinical narrative: Started as a cold the first day or so. Then started getting slight fever spikes. OTC meds at this point were treating my symptoms. Then on 11/28/2013 I ended up being taken to the ER for intense dizziness, nausea, and vomiting. Was released same day with RX meds to treat symptoms. Less then 24 hrs. later back in ER with even more intense dizziness, vomiting, and dehydration.
Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Started as a cold the first day or so. Then started getting slight fever spikes. OTC meds at this point were treating my symptoms. Then on 11/28/2013 I ended up being taken to the ER for intense dizziness, nausea, and vomiting. Was released same day with RX meds to treat symptoms. Less then 24 hrs. later back in ER with even more intense dizziness, vomiting, and dehydration.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus, Rash
Clinical narrative: Developed itchy, raised rash on face and arms 15 min after being vaccinated no diff swallowing/breathing. Gave BENADRYL 50 mg and CLARITIN 10 mg po.
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Paraesthesia, Pyrexia, Tremor
Clinical narrative: A report was received from a physician concerning a female. Medical history and concomitant medications were not reported. The patient received nasal FLUMIST Quadrivalent (Intranasal). Two weeks later, she started having left facial paresthesias, tremor, fever, and headache. Physician stated he thought some of the paresthesias and tremor were still ongoing. At the time of reporting, the outcomes of fever and headache were unknown. The reporter assessed the left facial paresthesias and tremor to be serious as important medical events and the fever and headache to be non-serious.
Age: 43.0
Sex: F
Vaccine: FLUR3
Symptoms: Anaphylactic reaction
Clinical narrative: Within 5 min of receiving vaccine pt had anaphylactic reaction and was given oral BENADRYL, 2 EPIPENS, went to ER and was given IV BENADRYL and steroids. Flu vaccine given due to hospital employee rules.
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient took VIVOTIF dose #1 on 11/30 and dose #2 on 12/2. Patient woke up Tues 12/3 and noticed a non-raised, non-itchy red/blotchy rash on her abdomen. It has not worsened or spread as of 12/5.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 1.5 x 3 cm area of faint erythema and induration and min tenderness (R) deltoid at site of DTAP injection.
Age: 0.18
Sex: F
Vaccine: DTAP, IPV, RV5
Symptoms: Diarrhoea, Faeces discoloured, Occult blood positive, Vomiting
Clinical narrative: On 12/4/13 child vomited 3x, had lg bout of diarrhea. Followed by 4 more bouts of unusually colored diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Mild redness and warmth in left lateral thigh at site of vaccine (VARIVAX and KINRIX). Redness measures approximately 6 cm around. Some tenderness at visit which was 2 days after administration of vaccine.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Headache, Nausea, Swelling
Clinical narrative: Redness, swelling, HA, nausea, SOB.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Expired drug administered
Clinical narrative: Expired Hep A vaccine given.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Pt received MENVEO vaccine on 12/20/13. Developed rash at injection site on 11/25/2013. Rash also spread albows, nees, abdomen, hands. Itchy at times. No difficulty breathing. Pt referred derm and seen 12/7/13 and told by derm rash due MENVEO vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 52 year old female patient with attention deficit disorder and allergy to BIAXIN, morphine and penicillin. On 20-NOV-2013, the patient was vaccinated with ZOSTAVAX in the right arm, (dose, route and lot number were not reported). Concomitant therapies included acyclovir (the patient might be taking acyclovir periodically), STRATTERA, lorazepam and CELEBREX. Approximately on 20-NOV-2013, after receiving ZOSTAVAX, the patient developed a puff, red area on her right arm at the injection site. Treatment was not given for the adverse events. Lab studies were not performed. The patient visited office to seek medical attention. The outcome of puffy, red area at the injection site was reported as not recovered. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pt called describing tenderness and itching in the arm where she received the vaccine.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: PATIENT RECEIVED A FLU VACCINE ON MONDAY (10/28) AND TOWARD THE END OF THE DAY, AND NEXT DAY, SHE STARTED TO DEVELOP SOME SHORTNESS OF BREATH, COUGH, CHILLS, AND SWEATS. PATIENT WAS GIVEN A SOLU-MEDROL INJECTION, COMBIVENT NEBULIZER, PREDNISONE, AND AZITHROMYCIN. UPON DISCHARGE PATIENT REMAINED ON PREDNISONE X 10 DAYS AND WAS PRESCRIBED ADVAIR.
Age: 31.0
Sex: M
Vaccine: DTAP, FLU3, PPV
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: Fever, 2 weeks of muscle spasm, extreme soreness.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cellulitis, Chest pain, Chills, Dizziness
Clinical narrative: Started to realize that I wasn't feeling well in the middle of the night. Night of 12/03/2013-12/04/2013. Awoke on 12/04/2013 around 6:30am with red swollen area around where the shot was administered in upper left arm. Painful, feeling cold like symptoms, fever and chills. Had to leave school early around 11:00am due to lack of energy and feeling sick. Went to work even though I wasn't tip top. Got home at 10:00pm feeling sick. Had difficulty sleeping due to night sweats. Went to clinic on 12/5/2013 around 9am and was advised to seek further medical attention immediately. Went to facility at 10:00am 12/05/2013. By this time I was experiencing shortness of breath, dizziness/lightheaded, pain shooting from left arm into my shoulder, sharp chest pains, tightness in the throat and pain in my face/temples. Was told that I had an infection, by Doctor, and was told it was probably cellulitis. Was prescribed Cephalexin 500mg  3x a day. Also was told by doctor to rest/take off from work and school from 12/05/2013-12/06/2013 and that I should be able to return to work/school on 12/07/2013.  Also was advised that if symptoms worsen, or my tongue and throat swell further to go to the emergency room.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Facial pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started to realize that I wasn't feeling well in the middle of the night. Night of 12/03/2013-12/04/2013. Awoke on 12/04/2013 around 6:30am with red swollen area around where the shot was administered in upper left arm. Painful, feeling cold like symptoms, fever and chills. Had to leave school early around 11:00am due to lack of energy and feeling sick. Went to work even though I wasn't tip top. Got home at 10:00pm feeling sick. Had difficulty sleeping due to night sweats. Went to clinic on 12/5/2013 around 9am and was advised to seek further medical attention immediately. Went to facility at 10:00am 12/05/2013. By this time I was experiencing shortness of breath, dizziness/lightheaded, pain shooting from left arm into my shoulder, sharp chest pains, tightness in the throat and pain in my face/temples. Was told that I had an infection, by Doctor, and was told it was probably cellulitis. Was prescribed Cephalexin 500mg  3x a day. Also was told by doctor to rest/take off from work and school from 12/05/2013-12/06/2013 and that I should be able to return to work/school on 12/07/2013.  Also was advised that if symptoms worsen, or my tongue and throat swell further to go to the emergency room.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Malaise, Nasopharyngitis, Night sweats, Pyrexia
Clinical narrative: Started to realize that I wasn't feeling well in the middle of the night. Night of 12/03/2013-12/04/2013. Awoke on 12/04/2013 around 6:30am with red swollen area around where the shot was administered in upper left arm. Painful, feeling cold like symptoms, fever and chills. Had to leave school early around 11:00am due to lack of energy and feeling sick. Went to work even though I wasn't tip top. Got home at 10:00pm feeling sick. Had difficulty sleeping due to night sweats. Went to clinic on 12/5/2013 around 9am and was advised to seek further medical attention immediately. Went to facility at 10:00am 12/05/2013. By this time I was experiencing shortness of breath, dizziness/lightheaded, pain shooting from left arm into my shoulder, sharp chest pains, tightness in the throat and pain in my face/temples. Was told that I had an infection, by Doctor, and was told it was probably cellulitis. Was prescribed Cephalexin 500mg  3x a day. Also was told by doctor to rest/take off from work and school from 12/05/2013-12/06/2013 and that I should be able to return to work/school on 12/07/2013.  Also was advised that if symptoms worsen, or my tongue and throat swell further to go to the emergency room.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Started to realize that I wasn't feeling well in the middle of the night. Night of 12/03/2013-12/04/2013. Awoke on 12/04/2013 around 6:30am with red swollen area around where the shot was administered in upper left arm. Painful, feeling cold like symptoms, fever and chills. Had to leave school early around 11:00am due to lack of energy and feeling sick. Went to work even though I wasn't tip top. Got home at 10:00pm feeling sick. Had difficulty sleeping due to night sweats. Went to clinic on 12/5/2013 around 9am and was advised to seek further medical attention immediately. Went to facility at 10:00am 12/05/2013. By this time I was experiencing shortness of breath, dizziness/lightheaded, pain shooting from left arm into my shoulder, sharp chest pains, tightness in the throat and pain in my face/temples. Was told that I had an infection, by Doctor, and was told it was probably cellulitis. Was prescribed Cephalexin 500mg  3x a day. Also was told by doctor to rest/take off from work and school from 12/05/2013-12/06/2013 and that I should be able to return to work/school on 12/07/2013.  Also was advised that if symptoms worsen, or my tongue and throat swell further to go to the emergency room.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Nerve injury, Pain, Pain in extremity
Clinical narrative: Initial soreness of left arm, increased in severity overnight.  Treated with ibuprofen - soreness was more severe than usually experienced with flu shot.  Soreness got better but didn't subside, getting worse over time and now very painful from shoulder to elbow, with painful and/or limited mobility.
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient being seen in clinic by public and immunizations for health card clearance for employment at CDC. Improper screening performed by technician and patient not fully screened for all questions. Patient is 36 weeks pregnant and was administered Flumist. Patient does not currently have an OB in the area due to recently moving to the area. She called OB in old location to speak with them about event.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness the size of a large lemon. Slight soreness.
Age: 82.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: LARGE RED HOT SWELLING 6" BY 6" ON UPPER ARM.  HOT HARD AND ITCHY.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient was given pneumococcal vaccine in right deltoid. Within 5 minutes he developed severe itching and redness at the injection site.  Redness spread to upper arm, neck and face.  Denies SOB/tongue or throat swelling.  Patient was given 50mg oral diphenhydramine and observed in clinic. Symptoms began to resolve in 30 minutes.
Age: 11.0
Sex: F
Vaccine: MEN, TD
Symptoms: Dyskinesia, Heart rate decreased, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Fainting, jerking, loss of consciousness, low blood pressure (73/34), low heart rate (30s). Laid down, ice, rest.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On approximately November 2008 (possibly five years ago) the patient was vaccinated with the first dose of RECOMBIVAX HB (route, lot number and expiration date not reported). There was no concomitant medication reported. It was reported that the patient might receive a second dose on 22-NOV-2013 of RECOMBIVAX HB (route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to an approximately 27 year old female patient with no pertinent medical history, drug reactions or allergies. On 04-NOV-2013, the patient was vaccinated with MMR II for routine vaccination. No concomitant medication reported. On 01-NOV-2013, the patient had a negative "blood pregnancy test". The patient was then seen by the physician, on 04-NOV-2013, at which time she received MMR II. The patient went to an unspecified Urgent Care facility, on 20-NOV-2013, due to the fact that she was experiencing nausea. The patient "took a pregnancy test" while at the Urgent Care facility which tested positive. The patient called the physician, on an unspecified date, to report this information. The physician stated she had not seen the patient since 04-NOV-2013 and stated she did not know the patient's current gestation or if she was still experiencing the nausea; "I guess she could be 3 weeks pregnant but I don't know". The patient became pregnant with last menstrual period (LMP approximately on 31-OCT-2013 and expected delivery date (EDD) approximately on 07-AUG-2014. The pregnancy outcome was pending. At the time of the report, the outcome of pregnancy test was positive was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Red spots and itching at injection site about 1 wk after injection and continuing but better. Using witch hazel for itching.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Diarrhoea, Local swelling, Pain in extremity, Vomiting
Clinical narrative: Child began vomiting at 6 PM. Diarrhea began around 2:30 am, along with vomiting. Child vomited repeatedly and voided bowels at the same time. Took Child to ER around 10:30 am 12/05/2013. Was given anti nausea medication and sent home. 2 hours later Child then began to have severe leg pain and swelling. Returning to the ER at 2:30pm 12/05/2013.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray normal, Chest discomfort
Clinical narrative: Noticed slight tightness in chest. It was worse by next morning and progressed. Visited pharmacy on 10/3 and talked to pharmacy rep., who suggested an expectorant and said it was probably just my body's reaction to vaccine. My inhaler wasn't helping much, if at all. By 10/6, it was so bad I went to ER for treatment. As I have no medical insurance, and am considered low-income, I had to decline the ER doctor's recommendation of hospitalization for an additional day or two.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bursitis, Hypoaesthesia, Muscle injury, Muscular weakness
Clinical narrative: Extreme muscle pain, weakness, numbness and overall weakness and guarding of my right arm from shoulder pad to inner arm fold.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Tendonitis
Clinical narrative: Extreme muscle pain, weakness, numbness and overall weakness and guarding of my right arm from shoulder pad to inner arm fold.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Audiogram, Deafness unilateral, Dizziness, Tinnitus
Clinical narrative: Dizziness onset within 14 hours followed by unilateral tinnitus and hearing loss left ear.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Headache, Hypersensitivity, Lacrimation increased, Oropharyngeal pain
Clinical narrative: Patient called help line and reported that he was having an allergic reaction to the flu vaccination. His symptoms included watery and itchy eyes, sore throat, headache and body aches. He denied a rapid heartbeat, dizziness and shortness of breath. These symptoms occurred about 2 hours after the vaccination.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient called help line and reported that he was having an allergic reaction to the flu vaccination. His symptoms included watery and itchy eyes, sore throat, headache and body aches. He denied a rapid heartbeat, dizziness and shortness of breath. These symptoms occurred about 2 hours after the vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Convulsion, Disorientation, Electrocardiogram, Electroencephalogram abnormal
Clinical narrative: Seizure - collapsed while in the bathroom, roommates described a seizure, hit head in fall, was unconscious for a brief period and then disoriented when she regained consciousness. A second seizure occurred on November 29 also in the morning. This one lasted approximately 4 - 6 minutes. She was disoriented upon regaining consciousness, taken to the hospital where EEG confirmed a seizure and she was diagnosed with epilepsy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Epilepsy, Fall, Head injury, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Seizure - collapsed while in the bathroom, roommates described a seizure, hit head in fall, was unconscious for a brief period and then disoriented when she regained consciousness. A second seizure occurred on November 29 also in the morning. This one lasted approximately 4 - 6 minutes. She was disoriented upon regaining consciousness, taken to the hospital where EEG confirmed a seizure and she was diagnosed with epilepsy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Seizure - collapsed while in the bathroom, roommates described a seizure, hit head in fall, was unconscious for a brief period and then disoriented when she regained consciousness. A second seizure occurred on November 29 also in the morning. This one lasted approximately 4 - 6 minutes. She was disoriented upon regaining consciousness, taken to the hospital where EEG confirmed a seizure and she was diagnosed with epilepsy.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Vaccination site abscess, Vaccination site induration
Clinical narrative: Local abscess formation at site of vaccine, 3x3 cm with induration.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Vaccination site pain
Clinical narrative: Patient report having local pain at vaccination site the day of vaccination. There is limited range of motion at the vaccinated area (arm does not extend above ear level). Shooting pain reported with certain actions involving vaccinated arm. Pain not relieved by analgesics or anti inflammation medication.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mydriasis
Clinical narrative: 09/26/2013-1634-pt sitting on exam table, author providing post inoculation edu. Eyes dilated to 7mm, expression went flat, mute and fell back to supine on table. After 30 sec of silence pt blinks, pupils return to 3mm, patient smiles and states "I'm fine". She laid supine for 15 minutes, sits up. Left ambulatory with mom at side. No s/s of acute distress.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Flushing, Induration, Injection site pain
Clinical narrative: 12/3/13 1530 intradermal vaccine 1700 burning itching begins 2000 viewed arm huge bullseye indurated wheal took 25 mg BENADRYL 600 mg MOTRIN, ice pack went to sleep. 12/4/13 0800 condition worsened red area spread 1430 employee health at hospital. 12/4/13 1430 employer stated severe local reaction, recommended ice, MOTRIN, antihistamines, visit MD if worsens 2000 onset of flushing, chills, temp normal. 12/5/13 0800 deep muscle pain radiating down arm and across chest, flushing, itching, burning, pain at site, induration reduced somewhat. 12/5/13 0830 visited provider given 60 mg prednisone and 5 days at 40 mg a day, advised to continue antihistamines and MOTRIN daily. 12/5/13 1300 visited pharmacy to inform of reaction and file report.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Myalgia, Pruritus, Urticaria
Clinical narrative: 12/3/13 1530 intradermal vaccine 1700 burning itching begins 2000 viewed arm huge bullseye indurated wheal took 25 mg BENADRYL 600 mg MOTRIN, ice pack went to sleep. 12/4/13 0800 condition worsened red area spread 1430 employee health at hospital. 12/4/13 1430 employer stated severe local reaction, recommended ice, MOTRIN, antihistamines, visit MD if worsens 2000 onset of flushing, chills, temp normal. 12/5/13 0800 deep muscle pain radiating down arm and across chest, flushing, itching, burning, pain at site, induration reduced somewhat. 12/5/13 0830 visited provider given 60 mg prednisone and 5 days at 40 mg a day, advised to continue antihistamines and MOTRIN daily. 12/5/13 1300 visited pharmacy to inform of reaction and file report.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Skin warm, Urticaria
Clinical narrative: Patient's left arm had a large whelp (5 inches in diameter) that was circular develop. Area was warm to touch and slightly inflamed/red.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date (reported as in recent past), the past was vaccinated with ZOSTAVAX lot # J006153 expiry date 30-AUG-2014 (dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced arm redness, a "hard spot" and heat at injection site but no itching was reported. The reporter stated that BENADRYL was given at the time of injection as treatment. The symptoms lasted an unspecified "couple of weeks". The outcome of arm redness, a "hard spot" and heat at injection site was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a reporter of unspecified profession refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with M-M-R II. Dose, lot and expiry date were unknown. The patient received the first dose of M-M-R II at kindergarten age (unspecified age). No adverse effect was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Appendicectomy, Exposure during pregnancy, Nausea, Pelvic congestion, Pelvic pain
Clinical narrative: This spontaneous prospective pregnancy report as received from a 2" year old female consumer regarding herself as a patient with pelvic congestion syndrome (PCS). There was no drug reactions or allergies. On 19-OCT-2013, the patient was vaccinated with M-M-R II (lot and dose not reported), dose 1, route reported as injection. Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 13-OCT-2013 and EDD of 20-JUL-2014. The patient believed that she was pregnant as of 19-OCT-2013. Initial exposure to M-M-R II was at 1 week. The pregnancy outcome was pending. In October 2013, the patient experienced cramping in the pelvic area and nausea. In 2013 (exact date unknown) the patient underwent an appendectomy. On 16-NOV-2013 the patient gave herself a home pregnancy test that resulted positive. She gave herself a second one on 18-NOV-2013 and it was positive. The patient has not yet seen a physician. No treatment given for the events. The outcome of cramping in the pelvic area, nausea and appendectomy were unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 2" year old female consumer regarding herself as a patient with pelvic congestion syndrome (PCS). There was no drug reactions or allergies. On 19-OCT-2013, the patient was vaccinated with M-M-R II (lot and dose not reported), dose 1, route reported as injection. Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP of 13-OCT-2013 and EDD of 20-JUL-2014. The patient believed that she was pregnant as of 19-OCT-2013. Initial exposure to M-M-R II was at 1 week. The pregnancy outcome was pending. In October 2013, the patient experienced cramping in the pelvic area and nausea. In 2013 (exact date unknown) the patient underwent an appendectomy. On 16-NOV-2013 the patient gave herself a home pregnancy test that resulted positive. She gave herself a second one on 18-NOV-2013 and it was positive. The patient has not yet seen a physician. No treatment given for the events. The outcome of cramping in the pelvic area, nausea and appendectomy were unknown. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Cytogenetic analysis abnormal, Laboratory test normal
Clinical narrative: This case was received on 25 November 2013 via a third party query tool search on the VAERS database, under reference number 499176. A 23-year-old male patient had received the following vaccinations on 28 February 2003: TdaP intramuscularly, lot # U0816AA, (manufacturer and site not reported), Smallpox vaccine, lot # 4020071 (manufacturer not reported), into the left arm and Hepatitis A, (manufacturer not reported) lot # VHA733B6 intramuscularly into the left arm. On 01 May 2003, the patient experienced severe low back pain, intermittent paralysis and severe joint pain. The patient was diagnosed with ankylosing spondylitis. The patient concomitant medications, medical history and current illness were reported as none. Laboratory data included HLB27 gene testing positive. All other labs that could be run for these issues were negative. Cytogenetic analysis was abnormal. The patient was treated with LORTAB, Meloxicam and muscle relaxers. The patient required an emergency room visit. The patient outcome was not recovered. No further details were available at the time of this report. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was not available for use at the time of the patient's vaccination. Documents held by sender: None.