chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Atrophy, Muscular weakness, Musculoskeletal pain, Nerve compression
Clinical narrative: Extreme left shoulder and arm pain. Shoulder and arm weakness. Xrays and MRI of neck to rule out nerve compression. Referred to Ortho June 24, 2013. Ordered MRI of left shoulder. MRI on June 26, 2013 indicating edema and atrophy of supra scapular and infra scapular muscles resulting in compression of supra scapular nerve. NCS/EMG scheduled for July 8, 2013.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema, Pain in extremity, X-ray
Clinical narrative: Extreme left shoulder and arm pain. Shoulder and arm weakness. Xrays and MRI of neck to rule out nerve compression. Referred to Ortho June 24, 2013. Ordered MRI of left shoulder. MRI on June 26, 2013 indicating edema and atrophy of supra scapular and infra scapular muscles resulting in compression of supra scapular nerve. NCS/EMG scheduled for July 8, 2013.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 657 year old female patient with no drug reaction and no known allergies, and no pertinent medical history, who on 02-JUL-2013, was vaccinated with a dose of ZOSTAVAX 0.65ml, subcutaneously (lot # J001003, exp: 24-APR-2014) for shingles prevention. Concomitantly, the patient was on following therapies: unspecified stomach medication, unspecified blood pressure medication, unspecified anti-depressant and unspecified pain management medication. On 03-JUL-2013, the patient visited the pharmacist stating that she had redness and swelling at injection site. The patient also stated that there was a lump at injection site and the site was hot to touch. No treatment was given for the events. The patient did not visit her primary healthcare provider. The outcome of the events was reported as not recovered. The relatedness of the events to therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 29-AUG-2011 the patient was vaccinated with the first dose of VAQTA 25U injection (Lot # not reported) (0.5 ml, intramuscular route). On 20-JAN-2012 the patient was vaccinated with the second VAQTA 25U injection (Lot # not reported) (0.5 ml, intramuscular route). It was reported that the second dose was administered "too early". No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient. On 26-JUN-2013 the patient was vaccinated with PROQUAD (lot # reported as J001011, expire date 28-JUL-2014), injection that went through a temperature excursion that was not supported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who on 02-JUL-2013, was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # not reported). The pharmacist noted that as she was removing the needle after administering ZOSTAVAX to a patient, a drip of fluid was expelled from the injection site. No adverse effect was reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning 19 year old patient, gender unspecified. In 2008, the patient was vaccinated with the first dose of VAQTA 25/0.5 (route and lot number not reported). On 18-JUN-2013, (also reported as 20-JUN-2013) the patient was vaccinated with the second dose of VAQTA 25/0.5 (route and lot number not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The reporting nurse was informed by unspecified staff member at unspecified, alternate office site, that the patient received a pediatric dose of VAQTA. The nurse reported that a patient had received a pediatric dose of VAQTA that was administered two days ago in error (as the second dose of VAQTA).  Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a mother refers to a male child of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date in 2007, the patient experienced patient diagnosed with autism after receiving M-M-R II. The outcome of was unknown. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: This spontaneous report was received from a other health professional refers to a 6 year old male patient with unspecified preservative allergy, jello allergy and neomycin allergy. The patient's medical history included Kawasaki's disease. Patient was previously vaccinated with M-M-R II on 08-MAR-2006 and developed flushing, sneezing and water eyes(see related case 1307USA002246). Patient was also previously vaccinated with DTaP(manufactured by GlaxoSmithKline) and inactivated IPV (manufactured by PMC per the caller) on 08-MAR-2006. On 20-MAR-2008, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiry not reported). On 20-MAR-2008, the patient developed wheezing and hives. The patient was given a nebulizer treatment and an unspecified steroid medication, then was evaluated in the emergency room at the Hospital and released. No other vaccines were given on 20-MAR-2008. The patient's symptoms resolved that same day on 20-MAR-2008. The outcome of wheezing and hives was reported as recovered. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: 6/28/13 Received TDAP shot next day in LA redness, swelling office visit 7/5/13 developed cellulitis.
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 an unknown date in August 2012, the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot#, expiration date not reported) intramuscularly. On an unknown date in October 2012, the patient was vaccinated with dose 2, 0.5 ml GARDASIL (lot# and expiration date not reported) intramuscularly. On an unknown date in December 2012, the patient was vaccinated with dose 3, GARDASIL (lot# and expiration date not reported) intramuscularly. The nurse noted that the patient was administered GARDASIL in a shorter than acceptable time frame. No adverse effect was reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chromaturia, Faeces discoloured
Clinical narrative: This spontaneous report as received from a 66 year old male patient with high blood pressure, antidepressant, hypothyroidism, diabetes type 2, glaucoma and no known drug reaction/allergies or pertinent medical history. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX as a vaccine. Concomitant therapies included losartan (manufacturer unspecified), levothyroxine sodium, metformin, unspecified eye drops for glaucoma and bupropion hydrochloride. On 19-JUN-2013, the patient experienced very dark stool and reddish urine after having taken ZOSTAVAX. The patient did not seek medical attention. No treatment was given. No lab diagnostic tests were performed. The outcome of the events was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself (weight 200, height 5 feet 7 in). The patient had shingles in the past. One year ago approximately in July 2012, the patient was vaccinated with ZOSTAVAX (lot number, dose, strength, frequency, route and site unspecified). The patient was now presenting shingles (date unspecified). The outcome of shingles was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (lot number, dose and frequency were not reported) orally. On an unknown date the patient experienced abdominal cramps after receiving ROTATEQ. The action was not provided. The outcome of abdominal cramps was reported as recovered/resolved. The patient had sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received form a nurse practitioner  refers  to female patient of unknown age. Five years ago, in approximately July 2008 the patient was vaccinated with the first dose of GARDASIL (lot number, indication and injection site were not reported) (0.5 ml, intramuscular). The patient was in the office on 02-JUL-2013 to receive her second dose of GARDASIL. No adverse effect reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age, unknown gender. On 07-JUN-2013 the patient was vaccinated subcutaneously with 0.5 ml an improperly stored PROQUAD (lot # H020137, expiry date 07-MAY-2014). The PROQUAD (Merck) had had multiple excursions over the past three months reaching the highest temperature of 11F for a total time of 500 hours. The nurse stated that she did not believe that the PROQUAD overall average temperature remained between 58F and 5F. No adverse effect reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Has swelling and redness (R) thigh - MMR-Varicella site. Rx - Prednisone 18mg daily x 5 days. Cephalexin 200mg bid x 10 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Warm to touch, red area about 1-2" diameter.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: Minutes after vaccination symptoms reported were "hot, dizzy, clammy". Denied difficulty breathing, did not lose consciousness. Sitting when symptoms occurred. Reports ate lunch, drank water today. Given juice in office. Left with mother. Denied above symptoms. To seek care for further or similar symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a child patient of unknown age. On 27-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 23 year old patient. On 25-JUN-2013, the patient was vaccinated with an expired dose of 0.5ml GARDASIL. (lot # 666162/0565Z, expiry date 15-SEP-2012, route was intramuscular). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration
Clinical narrative: Developed 5x5 cm induration in left deltoid.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pain, Pruritus
Clinical narrative: Induration post vaccination with ZOSTAVAX increased induration in 24 hrs from 5 x 3.5 cm to 8 x 7 cm. Red, very warm, swollen, painful and itchy.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling
Clinical narrative: Induration post vaccination with ZOSTAVAX increased induration in 24 hrs from 5 x 3.5 cm to 8 x 7 cm. Red, very warm, swollen, painful and itchy.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Dizziness, Feeling hot
Clinical narrative: Minutes after vaccination symptoms reported were "hot, dizzy, clammy". Denied difficulty breathing, did not lose consciousness. Assisted to chair to sit by myself and mother. Did not fall. Reports ate lunch, drank water today. Given juice in office. Left with mother. Denied above symptoms. To seek care if further or similar symptoms.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 73 year old female patient, with no drug reactions/allergies and no pertinent medical history, who in 2012 (on an unspecified date), was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). There was no concomitant medication involved. On 12-JUN-2013, the patient developed shingles on unspecified areas of the body. The patient was given VALTREX and TYLENOL #3. The outcome of shingles on unspecified areas of the body was reported as recovering. The relatedness between shingles on unspecified areas of the body and therapy with ZOSTAVAX was unknown. No laboratory diagnostic studies were performed. The patient sought medical attention - she came to the physician's office. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26 year old female patient. In June 2012 the patient received her first dose of GARDASIL (lot # not reported) (0.5ml dose and intramuscular route). On 28-SEP-2012 the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (0.5ml dose and intramuscular route). Concomitant therapy was not reported. It was reported that at the time of the report the patient had not received the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. On 25-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot number and dose not reported), subcutaneous. The patient experienced leakage of clear fluid, at the injection site, when the patient received ZOSTAVAX on 25-JUN-2013. There were no other adverse events reported. The outcome of leakage of clear fluid, at the injection site was unknown. The causal relationship was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Tuberculin test positive
Clinical narrative: This spontaneous report was received from a physician regarding a 13 year old male patient with no pertinent medical history or drug reactions or allergies. On 28-JUN-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose and route not reported) for immunization. Other suspect therapies included MANTOUX SKIN TEST administered intradermally on 28-JUN-2013. There was no concomitant medications. The physician reported that the mother of the patient believed that the concurrent administration of GARDASIL and MANTOUX SKIN TEST that were both administered during an office visit, may have caused her son to have a positive PPD test on 01-JUL-2013. The physician prescribed the patient Isoniazid and ordered a chest x-ray to be obtained as soon as possible to determine if the PPD result wsa a false positive or not. Outcome for the PPD test positive was unknown at the time of the report. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dyskinesia, Muscle disorder, Myalgia, Urinary incontinence
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route and lot number were not reported), 0.65 ml unspecified site. Concomitant medications were not reported. Pharmacist stated that "a few weeks after that administration of ZOSTAVAX vaccine, patient started having muscle pain, then lost of control of his muscles, and then lost of control of his urine". The outcome of the patient at the moment of the report was not reported. The relationship between ZOSTAVAX and the events was not reported. Patient sought unspecified medical attention. Patient performed a blood test to rule "out other viruses". Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route and lot number were not reported), 0.65 ml unspecified site. Concomitant medications were not reported. Pharmacist stated that "a few weeks after that administration of ZOSTAVAX vaccine, patient started having muscle pain, then lost of control of his muscles, and then lost of control of his urine". The outcome of the patient at the moment of the report was not reported. The relationship between ZOSTAVAX and the events was not reported. Patient sought unspecified medical attention. Patient performed a blood test to rule "out other viruses". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation, Needle issue, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, injection site and indication were not reported) subcutaneously. On 26-JUN-2013 the patient might not have received a full dose of ZOSTAVAX due to vaccine "leaking" from the injection site or the needle hub or syringe. No adverse effect reported. The outcome and ation taken were not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. On 10-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001004 (expiring 24-APR-2014) (dose, route and site not provided). On 11-JUN-2013 the patient experienced injection site reaction in the form of redness, swelling and a significant rash, extending from the top of shoulder, down to the elbow. The reaction occurred within 24 hours of the administration of the vaccine. The patient consulted the pharmacist for medical attention. Topical antibiotic was prescribed as a treatment for the adverse events. The outcome of events was reported as recovered. The causal relationship was not reported. It was noted that this dose was one of the two doses from the same lot and pharmacy for with an AE had been reported. Each dose represented the last remaining doses within that lot. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Cellulitis, severe & crippling pain, swelling, fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient said a lump formed at reaction site.  Site was red and itchy.  On 7/6/13 injection site was just red and swollen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: RED OVAL AROUND INJ SITE (2IN X 3.5IN), RAISED, HARD LUMP UNDER SKIN, VERY HOT TO TOUCH.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Injection site pain, Insomnia, Muscular weakness, Musculoskeletal pain
Clinical narrative: Severe, radiating pain from TDAP injection site, pain down forearm, into shoulder and breast area. Severe muscle weakness and deep pain - could not move arm without excruciating pain after a few hours of getting the TDAP shot. I did not have this reaction when I got the booster shot 5 years ago, so this is different reaction. Could not sleep all night due to severe pain in shoulder, forearm, and intense pain at site of injection.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe, radiating pain from TDAP injection site, pain down forearm, into shoulder and breast area. Severe muscle weakness and deep pain - could not move arm without excruciating pain after a few hours of getting the TDAP shot. I did not have this reaction when I got the booster shot 5 years ago, so this is different reaction. Could not sleep all night due to severe pain in shoulder, forearm, and intense pain at site of injection.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Concussion, Confusional state, Electrocardiogram QT prolonged, Fall, Head injury
Clinical narrative: Syncope and fall. Struck head on fall. Vomiting confusion after fall and transported to ER.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope and fall. Struck head on fall. Vomiting confusion after fall and transported to ER.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Injection site reaction, Nausea, Oedema peripheral
Clinical narrative: Nausea, arm swelling, red rash at injection site, dizziness, chills. Treated with prednisone, Benadryl.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Nausea, arm swelling, red rash at injection site, dizziness, chills. Treated with prednisone, Benadryl.
Age: 1.34
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Somnolence
Clinical narrative: Red spotty rash. Varying size of red dots. Pin size to Pea size. Light and dark red. Mostly on the back and spotty on the rest of the body. Slightly raised and clear separation between each spot. The child is very drowsy. At he time of this report he has no fever. The child is also taking Zyrtec for seasonal allergy relief. Called the Dr. and she instructed to monitor closely and if a fever over 103 degrees occurs get to ER.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Nausea (18 hrs), vomiting (7 hours), diarrhea (24 hours), muscle cramps (24 hrs.), fever (24 hrs). Red, swollen injection site (4 days). Large, painful lump at injection site (5 days and counting...
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Muscle spasms, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea (18 hrs), vomiting (7 hours), diarrhea (24 hours), muscle cramps (24 hrs.), fever (24 hrs). Red, swollen injection site (4 days). Large, painful lump at injection site (5 days and counting...
Age: 54.0
Sex: M
Vaccine: TTOX
Symptoms: Vomiting
Clinical narrative: Donor was vomiting an extreme amount. She then called the paramedics to take her to the hospital.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Aura, Body temperature increased, Chills, Dizziness, Erythema
Clinical narrative: 05/31/2013--started with flu-like symptoms; body aches, chills, temp of 101, arm was very sore, red & swollen. For that whole week, body was weak & achy; and site where shot given was very sore, red, swollen, hard & warm to touch. Exactly 1 week following injection (06/06/13); started with a horrible "migraine." Was vomiting, etc... (never had a headache (or vomited with a headache) like this before. Since that headache, haven't been the same; I have continuous ringing in my ears, I often feel dizzy/lightheaded, my neck feels sore/stiff at times, and my eyesight feels (hard to describe) "heavy" and "slow-motioned" and along with that I have a constant light aura which feels as though it's going to trigger another headache. I've made two separate calls to each my PCP, and also my Ob/Gyn (the location I had the vaccination done) since after I've had this shot.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 05/31/2013--started with flu-like symptoms; body aches, chills, temp of 101, arm was very sore, red & swollen. For that whole week, body was weak & achy; and site where shot given was very sore, red, swollen, hard & warm to touch. Exactly 1 week following injection (06/06/13); started with a horrible "migraine." Was vomiting, etc... (never had a headache (or vomited with a headache) like this before. Since that headache, haven't been the same; I have continuous ringing in my ears, I often feel dizzy/lightheaded, my neck feels sore/stiff at times, and my eyesight feels (hard to describe) "heavy" and "slow-motioned" and along with that I have a constant light aura which feels as though it's going to trigger another headache. I've made two separate calls to each my PCP, and also my Ob/Gyn (the location I had the vaccination done) since after I've had this shot.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Migraine, Musculoskeletal stiffness, Neck pain, Oedema peripheral
Clinical narrative: 05/31/2013--started with flu-like symptoms; body aches, chills, temp of 101, arm was very sore, red & swollen. For that whole week, body was weak & achy; and site where shot given was very sore, red, swollen, hard & warm to touch. Exactly 1 week following injection (06/06/13); started with a horrible "migraine." Was vomiting, etc... (never had a headache (or vomited with a headache) like this before. Since that headache, haven't been the same; I have continuous ringing in my ears, I often feel dizzy/lightheaded, my neck feels sore/stiff at times, and my eyesight feels (hard to describe) "heavy" and "slow-motioned" and along with that I have a constant light aura which feels as though it's going to trigger another headache. I've made two separate calls to each my PCP, and also my Ob/Gyn (the location I had the vaccination done) since after I've had this shot.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Tinnitus, Visual impairment, Vomiting
Clinical narrative: 05/31/2013--started with flu-like symptoms; body aches, chills, temp of 101, arm was very sore, red & swollen. For that whole week, body was weak & achy; and site where shot given was very sore, red, swollen, hard & warm to touch. Exactly 1 week following injection (06/06/13); started with a horrible "migraine." Was vomiting, etc... (never had a headache (or vomited with a headache) like this before. Since that headache, haven't been the same; I have continuous ringing in my ears, I often feel dizzy/lightheaded, my neck feels sore/stiff at times, and my eyesight feels (hard to describe) "heavy" and "slow-motioned" and along with that I have a constant light aura which feels as though it's going to trigger another headache. I've made two separate calls to each my PCP, and also my Ob/Gyn (the location I had the vaccination done) since after I've had this shot.
Age: 0.16
Sex: M
Vaccine: DTAP, RVX
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Faeces discoloured, Headache
Clinical narrative: Diarrhea, fever 102, mucousy stool that is bright green and brown, vomiting, headache, fussiness, painful abdomen, not wanting to nurse. Treatment has been nursing, shower, kept warm and cool as needed.
Age: 0.16
Sex: M
Vaccine: DTAP, RVX
Symptoms: Irritability, Mucous stools, Pyrexia, Vomiting
Clinical narrative: Diarrhea, fever 102, mucousy stool that is bright green and brown, vomiting, headache, fussiness, painful abdomen, not wanting to nurse. Treatment has been nursing, shower, kept warm and cool as needed.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area around shot (about the size of a silver dollar) became red and warm to the touch.  It remained that way for approximately three weeks.  Had never had any kind of reaction to shots before.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administration error, Insomnia, Musculoskeletal pain, Pain, Syringe issue
Clinical narrative: Initial and follow-up information has been received from a physician and certified medical assistant concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of GARDASIL (lot#654540/0800F). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with the safety mechanism and the "physician used the syringe improperly when vaccinating the patient." On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an x-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. Follow-up information from the certified medical assistant reported that the patient was never diagnosed with anything and was not prescribed any treatment. At the time of follow-up, the patient had recovered from the event. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness, X-ray normal
Clinical narrative: Initial and follow-up information has been received from a physician and certified medical assistant concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of GARDASIL (lot#654540/0800F). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with the safety mechanism and the "physician used the syringe improperly when vaccinating the patient." On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an x-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. Follow-up information from the certified medical assistant reported that the patient was never diagnosed with anything and was not prescribed any treatment. At the time of follow-up, the patient had recovered from the event. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arteriogram, Echocardiogram normal, Headache, Neck pain, Red blood cell sedimentation rate normal
Clinical narrative: 48 hours after ZOSTAVAX vaccine received, simultaneous symptoms presented as follows: moderate constant frontal and occipital headache x 24 days; neck pain developed day 14 - bilateral visual midline cloudiness occurs with any eye movement and appear to be permanent; Branch retinal artery occlusion right eye with resultant permanent visual field deficits. Diagnosis: Unknown. Treatment: started Day 18 after vaccination: Rx VALTREX 1 gm TID x 7 days. TORADOL 30 mg IM x 1 dose. Headaches resolved after VALTREX. Rx completed. But bilateral visual midline cloudiness with any eye movement remains.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Retinal artery occlusion, Ultrasound Doppler normal, Vision blurred, Visual field defect, Visual field tests
Clinical narrative: 48 hours after ZOSTAVAX vaccine received, simultaneous symptoms presented as follows: moderate constant frontal and occipital headache x 24 days; neck pain developed day 14 - bilateral visual midline cloudiness occurs with any eye movement and appear to be permanent; Branch retinal artery occlusion right eye with resultant permanent visual field deficits. Diagnosis: Unknown. Treatment: started Day 18 after vaccination: Rx VALTREX 1 gm TID x 7 days. TORADOL 30 mg IM x 1 dose. Headaches resolved after VALTREX. Rx completed. But bilateral visual midline cloudiness with any eye movement remains.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: 48 hours after ZOSTAVAX vaccine received, simultaneous symptoms presented as follows: moderate constant frontal and occipital headache x 24 days; neck pain developed day 14 - bilateral visual midline cloudiness occurs with any eye movement and appear to be permanent; Branch retinal artery occlusion right eye with resultant permanent visual field deficits. Diagnosis: Unknown. Treatment: started Day 18 after vaccination: Rx VALTREX 1 gm TID x 7 days. TORADOL 30 mg IM x 1 dose. Headaches resolved after VALTREX. Rx completed. But bilateral visual midline cloudiness with any eye movement remains.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Irritability, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient. On 10-JUN-2013 the patient was vaccinated subcutaneous in the right arm with a third dose of VARIVAX (Merck) (lot # H018790, exp. date: 15-OCT-2014). On 10-JUN-2013, the patient experienced 6.5x7.5cm area of swelling; red and hot. The patient was fussy. There was no illness at time of vaccination. There were no pre-existing allergies, birth defects and medical conditions. The outcome of the events was unknown. The patient had 3 siblings, one of them was a 13 month old male patient was vaccinated with the first dose of VARIVAX on 01-MAY-2013 and on the same day the patient experienced localized redness, large area of swelling 6 x 8cm, very hard and hot (captured in 1306USA008678). This is one of several reports from same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Feeling hot, Irritability, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old male patient. On 10-JUN-2013 the patient was vaccinated subcutaneous in the right arm with a third dose of VARIVAX (Merck) (lot # H018790, exp. date: 15-OCT-2014). On 10-JUN-2013, the patient experienced 6.5x7.5cm area of swelling; red and hot. The patient was fussy. There was no illness at time of vaccination. There were no pre-existing allergies, birth defects and medical conditions. The outcome of the events was unknown. The patient had 3 siblings, one of them was a 13 month old male patient was vaccinated with the first dose of VARIVAX on 01-MAY-2013 and on the same day the patient experienced localized redness, large area of swelling 6 x 8cm, very hard and hot (captured in 1306USA008678). This is one of several reports from same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Biopsy kidney abnormal, Blood albumin decreased, Dyspnoea, Fluid overload
Clinical narrative: Approximately 3 weeks after flu vaccine I noticed significant and persistent frothy urine (proteinuria). In the span of several weeks of proteinuria, this led to fluid retention and fluid overload, causing shortness of breath and hospitalization. I was diagnosed with nephrotic syndrome and renal biopsy showed minimal change disease. I was started on high dose steroids six months. I relapsed six months after steroid taper and had to be put on high dose steroid therapy again. There are several case reports showing development of minimal change disease after administration of vaccines, including influenza vaccination.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Fluid retention, Glomerulonephritis minimal lesion, Laboratory test normal, Nephrotic syndrome, Protein urine present
Clinical narrative: Approximately 3 weeks after flu vaccine I noticed significant and persistent frothy urine (proteinuria). In the span of several weeks of proteinuria, this led to fluid retention and fluid overload, causing shortness of breath and hospitalization. I was diagnosed with nephrotic syndrome and renal biopsy showed minimal change disease. I was started on high dose steroids six months. I relapsed six months after steroid taper and had to be put on high dose steroid therapy again. There are several case reports showing development of minimal change disease after administration of vaccines, including influenza vaccination.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Proteinuria
Clinical narrative: Approximately 3 weeks after flu vaccine I noticed significant and persistent frothy urine (proteinuria). In the span of several weeks of proteinuria, this led to fluid retention and fluid overload, causing shortness of breath and hospitalization. I was diagnosed with nephrotic syndrome and renal biopsy showed minimal change disease. I was started on high dose steroids six months. I relapsed six months after steroid taper and had to be put on high dose steroid therapy again. There are several case reports showing development of minimal change disease after administration of vaccines, including influenza vaccination.
Sex: M
Vaccine: FLUX
Symptoms: Electrocardiogram abnormal, Tachycardia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-Jun-3013) concerns an elderly male patient. Earlier this year, the patient received influenza (batch and manufacturer unspecified) for vaccination. The patient developed a tachycardia and went to the emergency room following vaccination with flu vaccine. The patient had an abnormal EKG (electrocardiogram) in the emergency room. The patient sought medical attention via emergency room visit. The event outcome was recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful, red, swollen injection site left deltoid.
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Headache, Ocular hyperaemia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number and injection site were not reported) (0.65 ml, subcutaneous) as shingles vaccine by a different unspecified pharmacy. The patient had complained of a headache on 27-JUN-2013 after receiving the ZOSTAVAX and called her unspecified physician. The physician told the patient to give it 24 hours. When the patient woke this morning (on 28-JUN-2013) she noticed that her right eye was red and appeared to have "popped a blood vessel" in the eye. There was no treatment given for adverse event. The outcome was reported as not recovered/not resolved. The action taken was not provided. The patient had called her physician for medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient with no drug reactions or allergies who on 27-JUN-2013, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H011048, Exp. Date: 05-SEP-2013). Concomitant therapies included chlorthalidone, lisinopril (manufacturer unknown), potassium, LIPITOR, COREG and NIASPAN, the patient took antihypertensives and medications for high cholesterol. It was reported that on an unspecified time in June the patient received MEDROL for an unknown reason. The pharmacist reported that the patient developed rash at unspecified time and went to family physician. The physician wrote for patient to receive ZOSTAVAX to help reduce symptoms. On 27-JUN-2013, the patient came to pharmacy with no mention any symptoms and was vaccinated. On 28-JUN-2013, the patient came back to pharmacy and reported that he broke out this morning. The patient developed a rash (rash was all over) and burning, no burst blisters. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for rash all over and burning and ZOSTAVAX was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt had an egg shaped bump at injection site that was red, itchy, and swollen.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Feeling hot, Tremor
Clinical narrative: Vaccinated at 2:34 pm; pt returned at 3:20 pm with cc: hot, light headedness; BP measured at 3:25 pm = 135/90 mmHg; BP at 3:35 pm = 134/92 AOX3; Rph noted hands were shaking; denied airway constriction; no swelling at injection site. Pt requested to 911 ambulance to ER; No tx at ER pt was released by 7:10 pm; 6/27/13 f/u fine.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, X-ray
Clinical narrative: Three spots appeared on shoulder day after injection and patient experienced pain in left shoulder.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cyanosis, Nausea, Pallor
Clinical narrative: Child became nauseated and pale after receiving immunizations. She also displayed bluish coloration around the mouth. After cool compresses and legs were elevated child was WNL status. Mother took child to PCP for evaluation which was WNL.
Age: 22.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Corneal reflex decreased, Headache, Hypoaesthesia, Vision blurred, Vomiting
Clinical narrative: Headache, vomiting day of vaccine. Numbness (started on my left side of face then moved to my right side). Blurred vision, trouble blinking (lagging).
Age: 22.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ageusia, Hypoaesthesia, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: Headache, vomiting day of vaccine. Numbness (started on my left side of face then moved to my right side). Blurred vision, trouble blinking (lagging).
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: After pt returned home, pt felt sharp pain radiating through her right arm (site of administration). In addition pt is experiencing a rash around site of injection that is continuing to spread.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Blister, Rash papular, Scab, Skin lesion
Clinical narrative: Erythematous papular, vesicles and crusted lesions on trunk and spreading to neck and shoulders, bilaterally.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: On 7/3/13 arm red and swollen starting at site and then swelling increased going from armpit down to elbow with increase redness, swelling and pain saw doctor received ROCEPHIN injection and po antibiotics on 7/5/13.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid erythematous, warm, and mildly edematous.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Local rash at the site of injection.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Serum sickness
Clinical narrative: Local rash at the site of injection.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Noticed bruising and petechiae over L upper arm around area of injection upon waking 4 days after vaccination.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt displayed what appeared to be a rash on both arms.  Pt said she already took Benadryl.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: After administering vaccines (Hep. A, Varicella, MCV4, and HPV) the patient became ligtheaded and fainted.  She was change from a sitting to a lying position, her blood pressure was taken (BP=90/57, HR=56).  She was monitored for an additonal 10-15 minutes and left the clinic in stable condition.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Mother reports faint red, flat rash noted on both arms.  No blisters noted.  Used OTC cortisone cream to relieve mild itching, rash continues, but may be fading per mother.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood culture, Chest X-ray, Computerised tomogram head, Convulsion, Full blood count
Clinical narrative: Fever of 102.3, seizure lasting for 15-20 min.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Lumbar puncture, Pyrexia, Urine analysis
Clinical narrative: Fever of 102.3, seizure lasting for 15-20 min.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dysphonia, Fatigue, Malaise
Clinical narrative: GENERAL MALAISE, FATIGUE, RASPY VOICE.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Rash
Clinical narrative: Pneumovax administered on 7/3/13. By 7/4/13 am redness noted around injection site. By 7/5/13 cellulitis appeared around injection site, approx 10 cm x 25 cm. Antibiotic (cephalexin) started on 7/5/13. Cellulitis rash resolving by 7/7/13. vital signs normal.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Blood product transfusion, Burning sensation, Fall, Gait disturbance
Clinical narrative: Swelling & stiffness in arm @ injection site. 01/08/2013 numbness in feet. 01/15/2013 numbness/tingling in feet, hands. 01/21/2013 burning sensation through shoulders, neck pain. 01/24/2013 symptoms continue, losing mobility in hands. 01/26/2013 symptoms continue, barely able to walk. 01/28/2013 Dr appt, muscle relaxers prescribed 01/29/2013 fall, unable to walk. 01/30/2013 Dr appt, carried to car, ER, hospitalization. Diagnosis- GBS Guillain-Barré syndrome. In the days/weeks following hospitalization: spinal tap, paralysis, plasma TPE, tracheotomy, ICU, code blue-resuscitation. 02/26/2013 transferred to another hospital, start of rehabilitation. Several weeks later massive blood clot in left leg. Made choice to leave hospital on 03/30/2013, due to no health insurance and the financial burden this was putting on my family.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Injection site reaction, Injection site swelling, Intensive care
Clinical narrative: Swelling & stiffness in arm @ injection site. 01/08/2013 numbness in feet. 01/15/2013 numbness/tingling in feet, hands. 01/21/2013 burning sensation through shoulders, neck pain. 01/24/2013 symptoms continue, losing mobility in hands. 01/26/2013 symptoms continue, barely able to walk. 01/28/2013 Dr appt, muscle relaxers prescribed 01/29/2013 fall, unable to walk. 01/30/2013 Dr appt, carried to car, ER, hospitalization. Diagnosis- GBS Guillain-Barré syndrome. In the days/weeks following hospitalization: spinal tap, paralysis, plasma TPE, tracheotomy, ICU, code blue-resuscitation. 02/26/2013 transferred to another hospital, start of rehabilitation. Several weeks later massive blood clot in left leg. Made choice to leave hospital on 03/30/2013, due to no health insurance and the financial burden this was putting on my family.