chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: DPP, IPV, MM, SMALL
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Vertigo
Clinical narrative: Severe vertigo.  (see comments above)
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: PATIENT CAME IN ON 12/27/12 REPORTING THAT SHE HAD A FEVER ON 12/24/12 AND CONTINUE TO HAVE A RASH+SWELLING OF THE LEFT ARM NEAR INJECTION SITE.  RASH+SWELLING HAD SUBSIDED BUT STILL VISIBLE.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Eating disorder, Vomiting
Clinical narrative: Vomiting, diarrhea, stopped eating, dehydration.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: Frozen shoulder symptoms in left arm.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Activities of daily living impaired, Amnesia, Bedridden, Blood test
Clinical narrative: I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram, Decreased appetite, Fall, Gait disturbance
Clinical narrative: I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Lumbar puncture, Lung disorder
Clinical narrative: I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination, Nuclear magnetic resonance imaging, Osmotic demyelination syndrome, Pneumonia, Septic shock
Clinical narrative: I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Thrombosis, Vocal cord paralysis, X-ray
Clinical narrative: I received the annual influenza inoculation in early November 2009. It was not the H1N1 vaccine. About two weeks later my feet became numb. I paid it no mind as I thought I had banged them rearranging furniture in my home. Day's later my shins became numb and I began rubbing them as I thought there was a circulation problem. My colleagues at work were keen to notice this and urged me to see my doctor. At that time I did not visit my doctor as I have always been in good health. Days later my thighs became numb and I was having difficulty walking. I made an appointment with my Primary Care physician at the clinic. The doctor wrote two scripts, which I had filled and told me: "Don't be surprised if you lose your ability to walk." I was very taken aback by this comment. A couple of days later my knees felt like they were buckling, I was falling, losing time at work, not eating and eventually became bed ridden. I lost my locomotion. The medication the doctor prescribed for me did nothing to help. I eventually phone Dr., at the clinic and spoke with him directly. During our conversation and with me describing what had and was happening to me he said he wanted to check a couple of things and he would call me back immediately. Approximately 15 minutes later I received a telephone call from a social worker at the clinic. This individual instructed me: "After this call is finished to immediately dial 911 and tell the operator you have been instructed by the clinic to get to the nearest emergency room immediately. Do you understand me?" I said: "Yes." After dialing 911 moments later two police cruiser, a fire engine and EMT ambulance were at my front door. I was carried out in a stretcher and taken to the ER, where I currently resided at that time. I was told, in the ER, that I was being admitted to the hospital immediately as of 28-NOV-2009. I lay in the ICU for one month with initial diagnosis's until I could safely be moved, where I spent the following six months. I was eventually diagnosed with the following: 1. Guillain-Barre. 2. Pneumonia. 3. Hole in my right lung. 4. Septic shock. 5. Paralyzed larynx. 6. Stroke. 7. Blood clots in both lungs and both legs. 8. Central Pontine Mylenoysis. 9. Short and long term memory loss. All of this because of a flu shot that was given to me as a benefit to keep myself healthy, my co-workers and the general public from becoming ill.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Mobility decreased, Neuritis, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient states that starting 12/24/12 he developed severe pain in right arm as day progressed he lost function of right arm/hand. Patient went to ER. Doctor diagnosed him with "neuritis" resulting from flu vaccination. Rx prednisone, ketorolac, PERCOCET.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Patient states that starting 12/24/12 he developed severe pain in right arm as day progressed he lost function of right arm/hand. Patient went to ER. Doctor diagnosed him with "neuritis" resulting from flu vaccination. Rx prednisone, ketorolac, PERCOCET.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, C-reactive protein normal, Metabolic function test, Metabolic function test normal
Clinical narrative: Approx 3 weeks after the vaccine, she developed severe arthralgias and weakness affecting both hips and knees.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Approx 3 weeks after the vaccine, she developed severe arthralgias and weakness affecting both hips and knees.
Age: 0.48
Sex: M
Vaccine: DTAPIPVHIB, FLUX, PNC, RV5
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: Redness, induration at vaccine site on right thigh.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. The patients were vaccinated with a late second dose of GARDASIL (Lot# not reported) on an unspecified date. No symptoms were reported. The physician also reported that there were an unspecified number of patients who have received other unspecified vaccine doses late but he was unable to provide the names of the other vaccines. No symptoms were reported. The physician stated that patients received vaccine doses late usually because they were in school or because they lived far away so it was difficult for them to return for their follow up doses. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a second expired dose of GARDASIL (Lot # 666929/0331Z, expiration date 20-NOV-2012) on 07-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient got inj. 12/17/12. Came back to the pharmacy 12/27/12 with rash all over left side of body. Stated she should contact her MD which she did. Called back later in day. Put on anti-viral med.
Age: 66.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Patient experienced mild redness and muscle ache at injection site. Patient stated symptoms were tolerable. No treatment needed.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills myalgias within 5 hours of receiving vaccine. 2 prior vaccines for HPV no problem.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at site of vaccines. Parents used cold compress and Ibuprofen. Redness and swelling improved over 3 days. Area of redness after resolution reported to be about 2 inches.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist who received the following information from a nurse, refers to a 57 years old female patient with high blood pressure, hypothyroidism, mood disorder, depression and anxiety. The patient had no reported allergies. The patient was vaccinated subcutaneously with PNEUMOVAX 23 on 08-DEC-2012 (dose not reported) (lot # H014282, exp date 09-APR-2014). No other co-suspects were reported. Concomitant medications included LEVOXYL, thiamine, trazodone hydrochloride, EFFEXOR XR, FLUVIRIN, folic acid, LOPRESSOR, multivitamins (unspecified) and PRILOSEC. On 09-DEC-2012 the patient developed swelling, pain and suspected cellulitis in the arm where the injection was received. The patient was given cephalexin (manufacturer unspecified). The patient had not recovered yet. A lot check was requested. The pharmacist also reported that the nurse practitioner told her that 2 additional patients (demographics unspecified) also had swelling, pain and suspected cellulitis after receiving PNEUMOVAX 23 in the past. It was unspecified what lot of PNEUMOVAX 23 this 2 patients received. It was unspecified what date PNEUMOVAX 23 was received in these 2 patients. All other information of this 2 patient was unspecified (case # 1212USA005279). The relationship between swelling, pain and suspected cellulitis in the arm where the injection was received and PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unknown number of patients who have been administered improperly stored VARIVAX over the last 2 years (since approximately December 2010). No other co-suspects were reported. No concomitant medications were reported. It has been determined that the thermometer used to monitor the freezer temperature in the last 2 years may have provided inaccurate temperature readings. The nurse was not able to confirm the exact number or identities of the patients at the time of the report. No adverse effects reported. Patients outcome was uknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The pharmacist reported that the cap on a vial of ZOSTAVAX was flipped in the pharmacy prior to attempting to vaccine te a patient. Because the cap was flipped the pharmacist did not give the patient the dose because he wanted to check first. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 78 years old female patient reporting on himself, with diabetes, cholesterol, hypertension and neuropathy on feet and no drug reactions or allergies, who on approximately on 1996 (on his 62 years old), was vaccinated with dose 1 ZOSTAVAX (lot 3, dose and route not provided). No other co-suspects were reported. Concomitant medications included metformin, NEURONTIN, simvastatin (manufacturer unknown) and lisinopril. At age 62 the patient was in Merck Sharp & Dohme clinical trial for ZOSTAVAX and the patient did state she was given a placebo and after the study was given the real ZOSTAVAX. This year 2012 the patient stated she had an outbreak of shingles and wanted to know if we recommend a booster. The patient sought medical attention and was treated with acyclovir. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unspecified date the patient was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (lot# not reported). In 2012 a few weeks ago the patient who had been vaccinated with ZOSTAVAX had a shingles outbreak on his torso. Unspecified treatment was given for the event. At the time of report, the outcome of event was recovering. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 25 patients of unknown age and sex. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and then, VAQTA (LOT #: 0628AE, exp 26-JAN-2015 and LOT # 0273AE exp 06-DEC-2014) was administered to 25 patients. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Patient's outcome was unknown. This is one report of several reports from the same source. 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 medical assistant refers to a female patient of unknown age who on 25-MAY-2012, was vaccinated with dose 1 GARDASIL injection (dose, route and lot number not provided). It was reported that the patient also received dose of GARDASIL on 02-JUL-2012 and on 15-SEP-2012. No adverse effect reported. No treatment information was reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV4
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a physician refers to a 24 years old male patient with no pertinent medical history and no drug reactions or allergies, who on 12-DEC-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 19-DEC-2012, the patient developed groin swelling after receiving the first dose. No treatment was given for the experience. NO lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the physician. The relatedness for patient developed groin swelling was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 9 patients of unknown age and sex. The registered nurse reported that VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 31 F degrees on 01-OCT-2012 and RECOMBIVAX HB, 5mcg/5ml, (Lot Number: 0384ae, exp: 02-NOV-2014 and Lot Number: 0293ae, exp: 01-SEP-2014) was then, administered to a 9 patients over a period of eight weeks. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Patients outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Rash morbilliform, Rash papular, Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 months old male patient with none medical history and none drug allergies. The patient was subcutaneously vaccinated with 0.5 ml M-M-R II (lot# reported as 0288AE) on 03-DEC-2012. Concomitant medications included: AMOXIL and completed one week ago before vaccination. In December 2012 the patient experienced rash from head to toe. Certain areas of patient's body, both cheeks, back of both arms, upper part of both thighs have welts like rash and rest of the body is covered with generalized papular fine rash. Physician diagnosed rash as "measles type rash". Patient was taken to an immediate care clinic on unspecified date and BENADRYL was given for the adverse event. None lab diagnostics was performed. The outcome of the adverse events was unknown at the time of report. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 69 year old female patient. On an unknown date in september 2012, the patient was vaccinated with (Merck) VARIVAX, (lot number, expiration date and route not reported) instead of ZOSTAVAX, (lot number, expiration date and route not reported) due to human error. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Oral papule, Purulent discharge
Clinical narrative: This spontaneous report as received from a 73 years old female patient regarding herself. The patient's medical history included chicken pox during childhood. Drug reactions or allergies were none. On 08-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). Concomitant medications were none. On 08-DEC-2012, the patient had an adverse reaction with ZOSTAVAX. The patient reported that a cold sore formed on her lip, around the sore there were pus filled papules and the consumer reported that it could be chicken pox. Laboratory diagnostic test were not performed. The patient sought no medical attention and no treatment was provided. All the reported events were not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 17-DEC-2012, the patient was vaccinated with an expired dose of live, oral, ROTATEQ (lot number and expiry date were reported as 670011/1393AA and 03-DEC-2012 respectively, route not reported). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus
Clinical narrative: This spontaneous report as received from a 60-year-old female patient regarding herself who has allergy to sulfa. Pertinent medical history was none. Patient weight was reported as 150 (units unknown). Approximately on an unspecified date in November 2012 (reported as a little over 2 weeks). The patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, dose and route were not reported) in left arm. Concomitant medications included high blood pressure, thyroid and cholesterol medications, niacinamide and cyanocobalamin. On 13-DEC-2012, the patient had blisters on her hands, started with itching and burning on her hands resulting in blisters which stops on the side of her thumbs being a dime size may be little smaller. The patient sought no medical attention and no treatment was provided. The outcome of all the reported events was unknown. Additional information is not expected.
Age: 30.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative concerning an approximately 30 year old (reported as in their 30s) patient. On 14-DEC-2012, the patient was incorrectly vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose, route unspecified). No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of ROTATEQ (Lot# 670011/1393AA, expired date 03-DEC-2012) (dose and route not reported). No adverse effects were reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Infectious mononucleosis
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 4 years old female patient. The patient was vaccinated with, 0.5 milliliters (ml) (Merck) VARIVAX(lot number, expiry date were not reported) intramuscularly. No concomitant medications were reported. On an unknown date, the patient developed mononucleosis after receiving (Merck) VARIVAX. It was unspecified if the patient sought medical attention. Treatment details were unspecified. The outcome of mononucleosis was unknown. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report as received from a 63 year old female consumer reporting on herself with breast cancer who in February 2011 was vaccinated with an unspecified of ZOSTAVAX (dose, route and lot number not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that on 15-DEC-2012 recently she got shingles. Acyclovir was given as a treatment for the events. A blood work done every 6 months (No results provided). The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. The patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Feeling hot, Laboratory test, Pruritus
Clinical narrative: This spontaneous report as received from a 66 years old male patient concerning himself. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route unspecified) on an unknown date. Concomitant medications included prednisone (manufacturer unknown), INDERAL, PERIACTIN, amitriptyline hydrochloride (manufacturer unknown) and pravastatin sodium. Patient stated that he was administered ZOSTAVAX and developed severe hives, welts, red hands, hot spots, tongue swelling and a lot of itching on an unknown date. Lab diagnostics studies of blood work was performed on 10-DEC-2012, 2 weeks ago, with no results provided. The events were not improved and the outcome of all events were reported as not recovered/not resolved. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue, Urticaria
Clinical narrative: This spontaneous report as received from a 66 years old male patient concerning himself. The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, route unspecified) on an unknown date. Concomitant medications included prednisone (manufacturer unknown), INDERAL, PERIACTIN, amitriptyline hydrochloride (manufacturer unknown) and pravastatin sodium. Patient stated that he was administered ZOSTAVAX and developed severe hives, welts, red hands, hot spots, tongue swelling and a lot of itching on an unknown date. Lab diagnostics studies of blood work was performed on 10-DEC-2012, 2 weeks ago, with no results provided. The events were not improved and the outcome of all events were reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. On 20-DEC-2012 the patient was accidentally vaccinated with a dose of ZOSTAVAX (lot number was reported as H016230, expiry date was 30-NOV-2013, route and dose were not reported) which had been stored in the refrigerator at 8 degrees Celsius for a full month, 720 hours. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 0.74
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 8 months old (also reported as 9 month old) patient. On 21-DEC-2012 the patient was vaccinated with a dose of VAQTA (Lot#, dose and route not reported) instead of dose of RECOMBIVAX HB. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to an infant patient of unknown age and sex. On an unknown date the patient was vaccinated orally with the first dose of live, oral, ROTATEQ. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was due to receive Dose 2 of live, oral, ROTATEQ on an unspecified date but "got sick" (unspecified illness) shortly before the appointment so the patient did not receive Dose 2. This occurred sometime in the past (unspecified date) and the patient never returned for Dose 2. The nurse reported that at the present time the patient was older than 32 weeks of age. So far the patient had received only one dose total of live, oral, ROTATEQ and would not be receiving any further doses. Dose 1 of live, oral, ROTATEQ was administered correctly according to the prescribing information. The outcome of "got sick" was unknown. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cognitive disorder, Dyspnoea, Impaired work ability, Pain, Pleural effusion
Clinical narrative: Fever, dyspnea, pneumonia, cognitive changes 2nd to illness & fever, severe respiratory issues. Unable to work. Achy all over. Lungs filled with fluid.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pneumonia, Pyrexia, Respiratory disorder
Clinical narrative: Fever, dyspnea, pneumonia, cognitive changes 2nd to illness & fever, severe respiratory issues. Unable to work. Achy all over. Lungs filled with fluid.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: After getting shingles shot, begin to develop chicken pox. It then became shingles. It started on lower back - left side- and neck - left side-. Since then, I developed shingles on both legs, both wrists, and shoulders. Some places have started to get better; however, new places have broken out in the last few days.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: After getting shingles shot, begin to develop chicken pox. It then became shingles. It started on lower back - left side- and neck - left side-. Since then, I developed shingles on both legs, both wrists, and shoulders. Some places have started to get better; however, new places have broken out in the last few days.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Convulsion, Crying, Incorrect dose administered, Musculoskeletal stiffness
Clinical narrative: Patient's mother described seizure-like behavior including screaming, crying and breath holding.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Breath holding, Crying, Screaming, Seizure like phenomena
Clinical narrative: Patient's mother described seizure-like behavior including screaming, crying and breath holding.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Burning pain sensation through muscles in arm around injection site, followed by constant muscle pain. Feels like sore muscles; unable to move arm with normal motion; moderate pain when touched.
Age: 48.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Axillary pain, Blood test, Computerised tomogram, Fatigue, Groin pain
Clinical narrative: Muscle aches, lymph node swelling all over body, rash all over body, fatigue, pain under arms and in groin area.
Age: 48.0
Sex: F
Vaccine: FLUX, MMR
Symptoms: Lymphadenopathy, Myalgia, Rash generalised
Clinical narrative: Muscle aches, lymph node swelling all over body, rash all over body, fatigue, pain under arms and in groin area.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Bed rest, Computerised tomogram normal, Gait disturbance, Nausea, Vertigo
Clinical narrative: Serious flu shot side effect received FLUVIRIN multidose vial 2012-13 5ML MFG: NOVARTIS -NDC: 665221-0115-10- vaccination ~5PM Dec 14, 2012. Awaked at 5AM Dec 15 by incapacitating vertigo and nausea. No other flu like symptoms i.e. temperature, aches, headaches, etc. Nausea stopped by one dose of Ondansetron. Severity of vertigo has now required full bed rest with eyes closed 24/7 for 7 days. Vertigo has not responded to four different medications prescribed by the Doctor -Meclizine, Lorazepam, TAMIFLU, Methylprednisolone-. Beginning day eight eyes was beginning to focus without objects spinning permitting short periods of reading or TV. Upright walking now possible but requires help and/or use of wall of adjacent objects. I had instructed the pharmacist of A previous case of the flu contracted via a flu shot 15 years previous. She insisted current formulation could neither cause the flow or cause side effects. Because of that assurance and the marketing push from my insurance company I took the flu shot. NEVER AGAIN!
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Computerised tomogram normal
Clinical narrative: Case number PHEH2012US025446 is an initial spontaneous report received from a nurse on 26 Dec 2012: This report refers to an adult female patient. Her medical history included osteopenia, GERD (gastrooesophageal reflux disease), sciatica, back pain hypertension benign, insomnia, restless leg syndrome, skin lesion and hypercholesterolemia. She was not allergic to eggs and she did not have previous reactions. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1205121 and expiry date: Jun 2013) intramuscularly in to the left deltoid at a dose of 0.5 ml on 18 Oct 2012. She tolerated the shot without any immediate reaction. 24 hours after vaccination she experienced loss of taste and smell. She was examined by an ENT specialist and had undergone a CT-Scan (computed tomography) with negative results. The reporter assessed this event as serious due to persistent and significant disabling. The outcome was reported as condition unchanged at the time of reporting. No further information about causality was provided.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea
Clinical narrative: Took flu shot at 11:30 AM Nov. 1, 2012. Taken to Emergency Room at 4:30 p.m. Nov 1, 2012. Could not breath. Chills.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Lip swelling, Oedema mouth, Paraesthesia oral, Swollen tongue
Clinical narrative: Patient developed progressive swelling & tingling of her lips shortly after she received the flu shot. The reaction progressed to swelling of her mouth & tongue she took ATIVAN & a glass of wine, but had progression & presented to the Emergency Room where she was observed to have aggressive angioedema. O2 sat 95%.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Pharyngeal oedema, Uvulitis, Vomiting
Clinical narrative: Patient received FLUZONE HIGH DOSE vaccination in Left deltoid at outpatient pharmacy at ~1500 on 12/17/12. Within 3 hours of the injection, patient reported subsequent uvula/throat swelling and reported to local hospital for treatment. On evaluation in the ER patient had noted uvulitis with no tongue or lip swelling. No injection site reaction, hives or rash noted. Patient had difficulties with throat swelling causing increased phlegm build up from mechanical issues causing at least one episode of vomiting. Patient had no other signs of recent viral infection or other possible causes for this reaction. Treatment: Patient received one dose of Dexamethasone 10mg PO in ER and swelling improved. No further treatment done. Patient discharged to home.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Antineutrophil cytoplasmic antibody increased, Biopsy skin abnormal, Blood test normal, Diarrhoea, Dry skin
Clinical narrative: I received the pneumococcal PPV23 Merck & Co. Lot number 0556AE .5 mL VIS version 10/6/09 at the clinic on 10/16/2012. By that evening I was experiencing redness, soreness around the injection sight, headache, nausea but did not have a fever. By the next day there was a 4 inch circular raised rash at the sight and a very swollen and extremely tender lump 1 1/2 inch around anterior to the injection site. I still had the headache, nausea, and some diarrhea. I went back to the shot clinic and a doctor looked at it quickly but said the shot may have hit a lymph node and not to worry. After about the 3rd day the lump and tenderness as well as the headache had subsided. The rash, however, remained for a few more days. I had noticed some roughness on my upper back but couldn't see much. On October 29 after showering I noticed probably 20 purple oval/irregular spots on each of my lower legs. I am IN REMISSION for Wegener's Granulomatosis -6 months oral CYTOXAN and prednisone ending in Feb 2010- and knew the disease could show up on skin or in my lungs. Oct 30 In went to a local Emergi-Care and the doctor drew some bloodwork/urine sample and looked online and felt the purple spots looked like vasculitis photo and showed to me. She called my immunologist. He wanted the lab results. We were leaving town the next morning for 12 days but my doctor felt I could go. The labs came back negative over the following 12 day the rash spread to my stomach, upper and lower back, thighs and arms, and chest. During that time my immunologist was monitoring my rash via photos I had emailed. He recommended skin biopsies using immunofluorescence staining. I went to a dermatologist for the biopsies. He took three and they all came back Lichenoid Dermatitis. My immunologist felt that this indicated the rash was from a drug interaction or from the vaccine. Since there had been no changes to my medications that left the pneumococcal vaccine as the likely cause. I had bloodwork/urine sample repeated on my return Nov. 13, 2012 and they were ruling out the Wegeners.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Hyperkeratosis, Immunology test, Injection site erythema, Injection site mass
Clinical narrative: I received the pneumococcal PPV23 Merck & Co. Lot number 0556AE .5 mL VIS version 10/6/09 at the clinic on 10/16/2012. By that evening I was experiencing redness, soreness around the injection sight, headache, nausea but did not have a fever. By the next day there was a 4 inch circular raised rash at the sight and a very swollen and extremely tender lump 1 1/2 inch around anterior to the injection site. I still had the headache, nausea, and some diarrhea. I went back to the shot clinic and a doctor looked at it quickly but said the shot may have hit a lymph node and not to worry. After about the 3rd day the lump and tenderness as well as the headache had subsided. The rash, however, remained for a few more days. I had noticed some roughness on my upper back but couldn't see much. On October 29 after showering I noticed probably 20 purple oval/irregular spots on each of my lower legs. I am IN REMISSION for Wegener's Granulomatosis -6 months oral CYTOXAN and prednisone ending in Feb 2010- and knew the disease could show up on skin or in my lungs. Oct 30 In went to a local Emergi-Care and the doctor drew some bloodwork/urine sample and looked online and felt the purple spots looked like vasculitis photo and showed to me. She called my immunologist. He wanted the lab results. We were leaving town the next morning for 12 days but my doctor felt I could go. The labs came back negative over the following 12 day the rash spread to my stomach, upper and lower back, thighs and arms, and chest. During that time my immunologist was monitoring my rash via photos I had emailed. He recommended skin biopsies using immunofluorescence staining. I went to a dermatologist for the biopsies. He took three and they all came back Lichenoid Dermatitis. My immunologist felt that this indicated the rash was from a drug interaction or from the vaccine. Since there had been no changes to my medications that left the pneumococcal vaccine as the likely cause. I had bloodwork/urine sample repeated on my return Nov. 13, 2012 and they were ruling out the Wegeners.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Lichenoid keratosis, Nausea
Clinical narrative: I received the pneumococcal PPV23 Merck & Co. Lot number 0556AE .5 mL VIS version 10/6/09 at the clinic on 10/16/2012. By that evening I was experiencing redness, soreness around the injection sight, headache, nausea but did not have a fever. By the next day there was a 4 inch circular raised rash at the sight and a very swollen and extremely tender lump 1 1/2 inch around anterior to the injection site. I still had the headache, nausea, and some diarrhea. I went back to the shot clinic and a doctor looked at it quickly but said the shot may have hit a lymph node and not to worry. After about the 3rd day the lump and tenderness as well as the headache had subsided. The rash, however, remained for a few more days. I had noticed some roughness on my upper back but couldn't see much. On October 29 after showering I noticed probably 20 purple oval/irregular spots on each of my lower legs. I am IN REMISSION for Wegener's Granulomatosis -6 months oral CYTOXAN and prednisone ending in Feb 2010- and knew the disease could show up on skin or in my lungs. Oct 30 In went to a local Emergi-Care and the doctor drew some bloodwork/urine sample and looked online and felt the purple spots looked like vasculitis photo and showed to me. She called my immunologist. He wanted the lab results. We were leaving town the next morning for 12 days but my doctor felt I could go. The labs came back negative over the following 12 day the rash spread to my stomach, upper and lower back, thighs and arms, and chest. During that time my immunologist was monitoring my rash via photos I had emailed. He recommended skin biopsies using immunofluorescence staining. I went to a dermatologist for the biopsies. He took three and they all came back Lichenoid Dermatitis. My immunologist felt that this indicated the rash was from a drug interaction or from the vaccine. Since there had been no changes to my medications that left the pneumococcal vaccine as the likely cause. I had bloodwork/urine sample repeated on my return Nov. 13, 2012 and they were ruling out the Wegeners.