chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Pt was given PPD and HPV vaccine.  Within 15 minutes, she reported some lh.  Pt was observed and then d/ced.  She was waiting in waiting room and 30 minutes after, she complained for feeling flushed, hot, abdominal pain.  Vitals were obtained.  Pt initially with bp of 115/68, HR 93 prior to procedure.  After, it was 88/62, HR 46.  She then began to complain of throat tightness and tingling. Epinephrine administered, with bp 90/59, HR 63 and pt elected to go to ED via private vehicle.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a pharmacist referring to an unspecified number of patients of unknown age and gender on pediatric dialysis. On an unknown date, in the past, the patients were vaccinated with the complete hepatitis b vaccine (recombinant) (manufacturer unknown) series (dose, route and lot not reported) pediatric doses, but did not respond. These pediatric dialysis patients then received additional doses of pediatric hepatitis b vaccine (recombinant) (manufacturer unknown) and still did not respond. Nurse manager told the pharmacist that these patients received a total of 8 to 10 doses of unspecified pediatric hepatitis B vaccine (with no response). Nurse told the pharmacist that these patients received a total of 8 to 10 doses of pediatric hepatitis b vaccine (recombinant (manufacturer unknown) (with no response). Antibody titers for hepatitis B were negative. At the time of the report, the outcome for the adverse event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: The day following vaccination, the patient developed soreness in arm and tenderness which still persists. She has limited use of her arm due to the pain.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection was given on 1-31-14. It stayed sore, swollen, itchy and red all weekend I couldn't sleep on it due to soreness.
Age: 1.41
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: We were performing influenza desensitization on patient. We had administered 1:100 dilution 0.05ml and 1:10 dilution 0.05ml with no problems. Approx 13 minutes after 3rd dose of full strength 0.05ml IM patient developed hives on chin, chest and 1 large hive on his belly. We administered BENADRYL 12.5mg and monitored pt. No additional problems.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bruxism, Computerised tomogram head normal, Convulsion, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: 3 minute seizure, not fever related, on evening 2-1-14. Associated with stiffening of body, teeth clenching and eyes rolled back.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, C-reactive protein, Full blood count normal, Headache
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Liver function test abnormal, Malaise, Pyrexia, Red blood cell sedimentation rate normal, Serum sickness-like reaction
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urine analysis normal, Vasculitic rash
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein increased, Conjunctival hyperaemia, Conjunctivitis
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Laboratory test, Liver function test abnormal, Pain, Platelet count increased
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Polymerase chain reaction, Pruritus, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Serum sickness, Swelling, Urine analysis, Vasculitic rash
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vasculitis, White blood cell count normal
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Full blood count, Full blood count normal, Headache
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hepatic enzyme increased, Pyrexia, Rash, Red blood cell sedimentation rate, Serum sickness-like reaction
Clinical narrative: Serum sickness-like illness beginning 1/27/14 with vasculitic rash, fever to 103, malaise, headache, abdominal pain, and joint pains (esp. LE's).
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Pt. was given an expired Tdap vaccine, no adverse reactions were noted, new non-expired vaccine was given.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Pt. was given expired Tdap vaccine, no adverse reactions reported, new non-expired vaccine was given.
Sex: F
Vaccine: FLU3, PPV, TDAP, TYP
Symptoms: Chills, Erythema, Eye irritation, Headache, Night sweats
Clinical narrative: 4 hours after receiving vaccines, got chills, HA, burning eyes, body aches, and severe right arm pain, red area on right arm and night sweats.
Sex: F
Vaccine: FLU3, PPV, TDAP, TYP
Symptoms: Pain, Pain in extremity
Clinical narrative: 4 hours after receiving vaccines, got chills, HA, burning eyes, body aches, and severe right arm pain, red area on right arm and night sweats.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, Swelling, Tenderness of upper left arm.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Blepharospasm, Muscle spasms
Clinical narrative: Eye twitching, facial muscle spasm after receiving the Flu vaccine (shot). Occurs throughout the day, multiple times. Same reaction occured last year at age 3 when he received the Flu Mist vaccination.  Reaction lasted a few weeks last year and then stopped suddenly.  Multiple tests were performed last year to rule out other illness.
Age: 1.08
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PNEUMOVAX 23.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hypoaesthesia, Skin discolouration
Clinical narrative: Middle finger of right hand turned white and numb.  I was cold and tried rubbing hands together to get warm.  Finger stayed numb for 20 minutes until I ran under warm water for several minutes.  No further episode until today, 2/3/2014.  At work when getting cold, middle finger of right hand and two middle fingers of left hand turned white and numb.  This had never happened to me prior to receiving the vaccine.  I disregarded it when it happened the first time, although, my first reaction was that it was a reaction from the flu shot.  Now that it's happening again, I am concerned.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: Her arm is red, warm, itchy and hard. It is sore to the touch. It started at injection site and it spread over arm. The MD diagnosed cellulitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: Her arm is red, warm, itchy and hard. It is sore to the touch. It started at injection site and it spread over arm. The MD diagnosed cellulitis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Her arm is red, warm, itchy and hard. It is sore to the touch. It started at injection site and it spread over arm. The MD diagnosed cellulitis.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Started developing rash on 2/1/14. Rash got worse on 2/2/14 so mother brought child to be evaluated - diagnosed with erythema multiforme. Advised to stop use of amoxicillin (which had been prescribed on 1/27/14).  Unsure if rash due to amoxicillin, underlying viral/bacterial infection or due to varicella vaccine that was administered on 1/20/14.
Age: 45.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Axillary pain, Chills, Injection site pain, Tenderness, Tremor
Clinical narrative: Extremely tender injection site, underarm very sore/tender, chills/shakes for receiving Infulenza and Pneumococcal at same time while recovering from bad cold.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, PNC13, RV5
Symptoms: Allergy test positive, Allergy to animal, Anaphylactic shock, Dermatitis contact, Eczema
Clinical narrative: Approximately 4 hours after receiving the 2-month vaccinations for DTaP, Polio, Rotavirus, Pc and HIB, my child developed a high-pitched scream and could not be consoled.  He was in such pain that he could not be touched.  I called Dr. numerous times and was told the high-pitched scream was normal and was "pain from the injection site" and to "give more Tylenol."  He experienced three rounds of high-pitched screaming for 30 minutes each, separated by deep, unwakable sleep for an hour.  At no time was I advised to go to the ER or other hospital for an EEG to monitor encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, PNC13, RV5
Symptoms: Emotional distress, Food allergy, Injection site pain, Pain, Rash
Clinical narrative: Approximately 4 hours after receiving the 2-month vaccinations for DTaP, Polio, Rotavirus, Pc and HIB, my child developed a high-pitched scream and could not be consoled.  He was in such pain that he could not be touched.  I called Dr. numerous times and was told the high-pitched scream was normal and was "pain from the injection site" and to "give more Tylenol."  He experienced three rounds of high-pitched screaming for 30 minutes each, separated by deep, unwakable sleep for an hour.  At no time was I advised to go to the ER or other hospital for an EEG to monitor encephalitis.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, IPV, PNC13, RV5
Symptoms: Rash generalised, Screaming, Seasonal allergy, Skin test positive
Clinical narrative: Approximately 4 hours after receiving the 2-month vaccinations for DTaP, Polio, Rotavirus, Pc and HIB, my child developed a high-pitched scream and could not be consoled.  He was in such pain that he could not be touched.  I called Dr. numerous times and was told the high-pitched scream was normal and was "pain from the injection site" and to "give more Tylenol."  He experienced three rounds of high-pitched screaming for 30 minutes each, separated by deep, unwakable sleep for an hour.  At no time was I advised to go to the ER or other hospital for an EEG to monitor encephalitis.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diet refusal, Local swelling, Skin reaction
Clinical narrative: Inconsolable crying lasting 2 hrs and 50 minutes, she wouldn't even nurse which is really odd for my baby, she stopped right as I started gathering things up to take her to the emergency room. Right leg was red and swollen starting the following morning and remained that way for about 48 hours.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Childhood disintegrative disorder, Diarrhoea, Laboratory test
Clinical narrative: Diarrhea during the night. Complete regression on potty training and occasional diarrhea during the day.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Inconsolable crying for 2 hours and 50 minutes started within 2 hours of receiving vaccinations, right leg became swollen, red and hot to the touch within just a few hours also. I began to notice child waking up gasping for breath within 2 weeks, this led to a sleep study and diagnosis of obstructive sleep apnea at 11 months of age.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Sleep apnoea syndrome, Sleep study abnormal
Clinical narrative: Inconsolable crying for 2 hours and 50 minutes started within 2 hours of receiving vaccinations, right leg became swollen, red and hot to the touch within just a few hours also. I began to notice child waking up gasping for breath within 2 weeks, this led to a sleep study and diagnosis of obstructive sleep apnea at 11 months of age.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Distractibility, Epistaxis, Full blood count normal, Headache, Irritability
Clinical narrative: Irritable, epistaxis x 1, headache, nausea, distractible.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Metabolic function test normal, Nausea
Clinical narrative: Irritable, epistaxis x 1, headache, nausea, distractible.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Pt received the HPV quadrivalent vaccine. Lot#J013777.  Exp date: 11Aug2016. Pt had a vasovagal episode afterwards.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Pt fainted and seized.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photopsia, Syncope
Clinical narrative: Pt fainted and seized.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray
Clinical narrative: I woke up with intense pain in my left upper shoulder in the general vicinity of where I received my shot.  I could not lift my arm.  It hurt to use my arm for driving, typing, for doing anything.  It was a dull, numb pain, and almost felt muscular in nature - or nerve related.  I have tried anti-inflammatories, ice, physical therapy, etc. all to no avail.  It has been 16 months and the pain still persists.  Saw a shoulder specialist and a general doctor.  Neither want to believe it is related to the vaccine.  Nothing else happened to the shoulder except the flu vaccination.  There seem to be a group of people that have similar adverse reactions to the flu shot.  I have had the shot virtually my whole life with no issues.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Asthma, Chest X-ray abnormal, Condition aggravated, Feeling abnormal
Clinical narrative: Asthma symptoms escalated and maintenance medications did not relieve symptoms.  I was unable to rest at night, felt terrible, and became weaker while awaiting next Dr. appointment.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pulmonary function test abnormal, Restlessness
Clinical narrative: Asthma symptoms escalated and maintenance medications did not relieve symptoms.  I was unable to rest at night, felt terrible, and became weaker while awaiting next Dr. appointment.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Asthma, Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Asthma symptoms escalated and maintenance medications did not relieve symptoms.  I was unable to rest at night, felt terrible, and became weaker while awaiting next Dr. appointment.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Insomnia, Pulmonary function test normal, Restlessness
Clinical narrative: Asthma symptoms escalated and maintenance medications did not relieve symptoms.  I was unable to rest at night, felt terrible, and became weaker while awaiting next Dr. appointment.
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Swollen tongue, Throat tightness
Clinical narrative: Allergic - Throat tightening eye swelling tongue swelling.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Inflammation, Pain in extremity, Skin warm
Clinical narrative: Whole upper arm became inflamed - reddened to extreme. Pain and heat and indurated. Lt. arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discharge, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction at injection site, minor swelling, warm to touch, pink in color. Located on left deltoid area. Per patient it doesn't hurt any longer, only discomfort when touching. Pt given ibuprofen.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Local reaction at injection site, minor swelling, warm to touch, pink in color. Located on left deltoid area. Per patient it doesn't hurt any longer, only discomfort when touching. Pt given ibuprofen.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Decreased appetite, Injection site reaction, Rash, Rash follicular
Clinical narrative: At 4 months shots PEDIARIX, PCV13, HIB, rotavirus she developed a follicular rash on both thighs. It lasted a few days. No fevers, acted well. This week at 6 months shots, noted below identical rash both thighs, extending up to belly. No fever, decreased appetite, but exam otherwise well.
Age: 0.09
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Occult blood positive
Clinical narrative: Persistent loose stools - obvious change from pre-vaccine. Eating, acting well otherwise.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia, Pain
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a currently 83 year old female patient. The patient had a medical history of shingles. On approximately January-2012, reported as approximately two years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot and expiration dates were not reported) for shingles prevention. Co-suspect or concomitant therapies were not reported. Since approximately January-2012, the patient had had recurring bouts of shingles on unspecified dates after being vaccinated with ZOSTAVAX. The patient reported that the shingles outbreak after vaccination followed the same dermatome as the shingles outbreak prior to being vaccinated. Also stated to had ongoing pain and neuralgia with the current outbreak of shingles and felt that the symptoms of the shingles virus had not lessened in severity and/or duration after having been vaccinated with ZOSTAVAX. The outcome for shingles was unknown at the time of the report. The patient was treated with Acyclovir and an unspecified topical cream on unspecified dates. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pancreatitis
Clinical narrative: This spontaneous report as received from a physician via company representative, referring to a male of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 0.5 ml (route, lot and expiration date were not reported). Co-suspect or concomitant therapies were not reported. On an unknown date, within one week after vaccination, the patient developed pancreatitis. The patient would not receive further dosing with was vaccinated with GARDASIL. GARDASIL was not reintroduced. At the time of the report was unknown if the patient had recovered from pancreatitis. It was unknown if the patient may had sought medical attention. Upon internal review, pancreatitis was considered as medically significant. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pancreatitis
Clinical narrative: This spontaneous report as received from a physician via company representative, referring to a male of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 0.5 ml (route, lot and expiration date were not reported). Co-suspect or concomitant therapies were not reported. On an unknown date, within one week after vaccination, the patient developed pancreatitis. The patient would not receive further dosing with GARDASIL. GARDASIL was not reintroduced. On an unknown date, the patient was hospitalized for an unknown amount of time. It was unknown what type of medical attention was received for the patient. The patient now recovered from pancreatitis. Upon internal review, pancreatitis was considered as medically significant. This is one of two reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia, Pain
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to currently 69 year old female patient. The patient had a medical history of shingles. On approximately January-2012, reported as approximately two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot and expiration dates were not reported). Co-suspect or concomitant therapies were not reported. Since approximately January-2012, the patient had had recurring bouts of shingles on unspecified dates after being vaccinated with ZOSTAVAX. The patient reported that the shingles outbreak after vaccination followed the same dermatome as the shingles outbreak prior to being vaccinated. Also stated to had ongoing pain and neuralgia with the current outbreak of shingles and felt that the symptoms of the shingles virus had not lessened in severity and/or duration after having been vaccinated with ZOSTAVAX. The outcome for shingles was unknown at the time of the report. The patient was treated with Acyclovir and an unspecified topical cream on unspecified dates. This is one of two reports from the same source. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 month old female patient. Medical history and drug reactions/allergies were not reported. On 14-JAN-2013, the patient was vaccinated with VARIVAX lot # reported as J002319, first dose, (expiry date, dose and route not reported) concomitantly with MMR II (lot, dose and route not reported). On 24-JAN-2013, the patient experienced dime-size red spot that was not raised, at the injection site. The nurse was contacted (sought for medical attention). The outcome of the event was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Local swelling
Clinical narrative: This spontaneous report as received from a now 67 year old female patient refers to herself. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (lot#, expiry date, route, dose and strength not reported). On an unknown date, the patient experienced infection and severe swelling of arm. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. The patient experienced severe skin rash while taking OXYTROL (for women) (OTC product) which was captured in case MARRS#1312USA009541. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTP, MMRV
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old male patient. On 10-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) (route, dose and lot # not reported) and a dose of DTP (manufacturer unknown) route, dose and lot # not reported) at a separate injection site. On 11-JAN-2014, the patient was taken to the Emergency Room where he was treated for a febrile seizure and a temperature which spiked 103.7 degrees F. It was unspecified if the child was admitted to the Hospital, however he was stabilized and discharged. The outcome of febrile seizure was reported as recovered/resolved. Upon internal review febrile seizure was considered to be medically significant. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Gait disturbance, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot# U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there". The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated that he felt like he was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other "unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, using a "cane" to help him walk was considered as disability. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Walking aid user
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot# U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there". The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated that he felt like he was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other "unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, using a "cane" to help him walk was considered as disability. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Infusion, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot# U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there". The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated that he felt like he was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other "unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, using a "cane" to help him walk was considered as disability. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Walking aid user
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot# U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there". The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated that he felt like he was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other "unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, using a "cane" to help him walk was considered as disability. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Skin warm
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot# unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot# U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there". The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated that he felt like he was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other "unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, using a "cane" to help him walk was considered as disability. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 25 year old female patient. The patient had no medical history, no drug reactions or allergies. On 25-NOV-2013 the patient was vaccinated subcutaneously with a single 0.5 ml dose of M-M-R II (lot number J002934 and expiry date 15-MAR-2013) and a single 0.5 ml dose of VARIVAX (Merck) (lot number J006161 and expiration date 20-MAY-2015). There were no concomitant medications. On 02-DEC-2013, the patient stated that she took an at home pregnancy test a couple of days after her appointment on 25-NOV-2013, and the test came back positive. The patient stated she had not yet been seen by her unspecified obstetrician and gynecologist (OBGYN). The nurse stated that according to the paperwork the patient filled out during her 25-NOV-2013 office visit, the patient's last menstrual period was on 24-NOV-2013. The estimated date of delivery (EDD) was of 31-AUG-2014. No treatment was given. The pregnancy outcome was unknown (outcome pending). Follow up information was received from the nurse and the physician concerning a female patient, a student, who on 25-NOV-2013 at 7pm was vaccinated subcutaneously in right arm with the first 0.5 ml dose of M-M-R II (lot number J002934 and expiry date 15-MAR-2013) and in left arm with the first 0.5 ml dose of VARIVAX (Merck) (lot number J006161, also reported as J002934, and expiration date 20-MAY-2015). The patient was not tested for varicella antibodies before vaccination with varicella zoster vaccine (VZV) containing vaccine. On 07-DEC-2013 the patient experienced spontaneous abortion. Laboratory data was unknown. It was reported that M-M-R II and VARIVAX (Merck) were not continued. The outcome of event was unknown. The relatedness between the event and suspect therapies was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Presented ER with arm pain and red macular rash - was treated in ER with 1 gram ROCEPHIN. Treated for cellulitis. Discharge exam on 12/24/13 was normal. She went back to ER and treated for gastroenteritis on 12/26/13. TX with cephalexin. F/U appt. on 12/27 was good.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Gastroenteritis, Pain in extremity, Rash macular
Clinical narrative: Presented ER with arm pain and red macular rash - was treated in ER with 1 gram ROCEPHIN. Treated for cellulitis. Discharge exam on 12/24/13 was normal. She went back to ER and treated for gastroenteritis on 12/26/13. TX with cephalexin. F/U appt. on 12/27 was good.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a female consumer (age not reported) regarding on herself who on an unknown dates received dose 1 and 2 of GARDASIL in "her butt". In January 2014, the patient received dose 3 of GARDASIL in her arm. The patient explained that her vaccines were given in the correct scheduled, however due to the type of administration area where she had her first 2 injections, the office was considering to revaccinate her using the last dose as the first of the series. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information has been received from a female consumer (age not reported) regarding on herself who on an unknown dates received dose 1 and 2 of GARDASIL in "her butt". In January 2014, the patient received dose 3 of GARDASIL in her arm. The patient explained that her vaccines were given in the correct scheduled, however due to the type of administration area where she had her first 2 injections, the office was considering to revaccinate her using the last dose as the first of the series. Additional information has been requested.
Age: 0.49
Sex: M
Vaccine: RVX
Symptoms: Vomiting
Clinical narrative: Vomiting...lasting about one minute.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient arrives to our pharmacy Sunday 02/02/2014 around 9:10AM informing us that she is still experiencing soreness on her upper left arm from a flu shot on 10/30/2013 around 7:30PM, particularly at the injection site. She was administered Fluzone Intradermal (NDC: 49281-0707-55, LOT #: UT4726AA, Exp: 04/23/2014) by RPh. When asked why it took her over 3 months to notify us about this adverse reaction, patient stated she thought it would eventually go away. When asked if she sought out medical attention with her primary physician, patient stated that she hadn't yet but had "set an appointment this Tuesday or Wednesday." When asked, patient denied doing any strenuous activity or heavy lifting between then and present time. Her primary physician was contacted by RPh on 02/03/14 with no response, so a message was left.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Feeling cold, Heart rate increased, Injection site reaction, Paraesthesia
Clinical narrative: Tingling at vaccine injection site (left shoulder), followed by cold feeling. Feelings of cold and tingling spreading out from shoulder to rest of arm, left leg, and back of neck. Elevated heartrate and breathing, as well as mild chest pain; may or may not be from panic attack that happened after initial feelings of cold and tingling spreading along limbs. Doctor prescribed normal dose of OTC aspirin. Tingling returns intermittently, but much less severe and does not spread beyond shoulder of vaccine injection site.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Respiratory rate increased
Clinical narrative: Tingling at vaccine injection site (left shoulder), followed by cold feeling. Feelings of cold and tingling spreading out from shoulder to rest of arm, left leg, and back of neck. Elevated heartrate and breathing, as well as mild chest pain; may or may not be from panic attack that happened after initial feelings of cold and tingling spreading along limbs. Doctor prescribed normal dose of OTC aspirin. Tingling returns intermittently, but much less severe and does not spread beyond shoulder of vaccine injection site.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given KINRIX on 5/3/2013 when he was 7 years old.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a 14 month old (currently 4 years old) male patient. On an unknown date when the patient was 14 months old he was vaccinated with a single dose of both VARIVAX (Merck) (lot#, expiration date, dose, route, indication not reported) and M-M-R II (lot# expiration date, dose, route, indication not reported) on an unspecified date about a month after first dose of VARIVAX (Merck) and M-M-R II were administered on an unspecified date. No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pallor
Clinical narrative: Patient had reaction within 5-7 minutes after HPV vaccine given - and tdap given after hPV. He turned pale - partially following commands immediately was put on flat position, was breating on his own - checked blood pressure was 130/65 - pulse rate in 60's up to 80 in 2 minutes, O2 sats 95/97 % RA and was better in 5-7 minutes and following commands better. Send by EMS to emergency room. Left there in 1/2 hr with any test after observation.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Disorientation, Malaise, Pallor, Respiratory rate increased
Clinical narrative: Patient had reaction within 5-7 minutes after HPV vaccine given - and tdap given after hPV. He turned pale - partially following commands immediately was put on flat position, was breating on his own - checked blood pressure was 130/65 - pulse rate in 60's up to 80 in 2 minutes, O2 sats 95/97 % RA and was better in 5-7 minutes and following commands better. Send by EMS to emergency room. Left there in 1/2 hr with any test after observation.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report as received from a female pharmacist of unknown age refers to herself. The pharmacist reported that she herself was exposed to a spillage of reconstituted ZOSTAVAX (dose unknown) on 30-JAN-2014 when it spilled from the vial onto the skin of her hand. She reported no adverse experiences. This is one of several reports received from the same source. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist reported that on 30-JAN-2014 a patient missed a dose of ZOSTAVAX because of a product quality defect with the ZOSTAVAX vial. The patient was scheduled to receive the ZOSTAVAX vaccine today on 30-JAN-2014, but she hd not yet been able to receive a dose. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with allergy to SULFA and no pertinent medical history. On 28-JAN-2014 the patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # J007301, expire on 20-SEP-2014). Concomitant therapies included ibandronate sodium. On 30-JAN-2014, the patient experienced stiffness in her neck. No treatment was given for the event. No lab diagnostics studies were performed. The outcome of stiffness in her neck was reported as not recovered/not resolved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown gender. On an unknown date, an 8 year old patient was vaccinated with a first dose of GARDASIL injection (strength, route, lot number and expiration date not provided). The patient received the remaining 2 doses of GARDASIL on schedule. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to a female patient of unknown age. In 2008 the patient was vaccinated with the third dose of GARDASIL dose, lot # and route unknown. The representative stated that she did know that the patient received the 1st and 2nd shots of GARDASIL, but specific dates were unknown. On an unknown date after receiving the 3rd shot of the GARDASIL vaccine the patient experienced abdominal pain. The outcome of abdominal pain was unknown. The relatedness between abdominal pain and GARDASIL was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Decreased appetite, Muscle spasms, Nausea
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 14 year old female patient. The patient pertinent medical history included type II diabetic. On 27-JAN-2014, the patient was vaccinated with GARDASIL lot # J010668 (Expiry: 29-APR-2016) dose 3 in the right arm. It was reported that on 23-JUL-2013, the patient was vaccinated with frist dose of GARDASIL. On 25-SEP-2013, the patient was vaccinated with second dose of GARDASIL. On 27-JAN-2014, after receiving the third dose of GARDASIL, the patient experienced stomach che, cramps, decreased appetite and nausea. The patient sought medical attention and had the doctor appointment. It was reported that the patient did not had any treatment for the events. It was also reported that the vaccine GARDASIL was not reintroduced. The outcome of the events stomach ache, cramps, decreased appetite and nausea was unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician via company representative concerning a 20 year old female no pregnant patient who on 20-JAN-2009 was vaccinated with a first 0.5 ml dose of GARDASIL, IM (lot # not provided). On 20-APR-2009 was vaccinated with a second 0.5 ml dose of GARDASIL, IM, (Lot # 661952/1129X, exp date 12-MAR-2011), right arm and on 31-JUL-2009, was vaccinated with 0.5 ml third dose of GARDASIL, IM (lot # 662404/0312Y, exp dose 30-APR-2011), right arm. The physician stated that in January 2014, the patient was diagnosed with HPV after she had a Smear cervix (pap smear test). The representative described that patient informed the physician over the phone "recently" (no dates provided) of the results of her pap smear test from "January 2014". The outcome of HPV positive was reported as not recovered. The representative also reported that the patient informed the physician that she was not sexually active when she received the first and second dose of GARDASIL. Additional information has been requested.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Eyelid oedema, Ocular hyperaemia, Rash erythematous
Clinical narrative: 2/3/14 at 415 PM. Parent notified health dept by phone, describes symptoms - (R) side of daughters face red rash from top of (R) side of head to the (R) side of chin, eye was swollen closed and sclera was red. Parent took her to the ER and Dr did not order any tests, they observed her and sent her home as symptoms subsided. T 99.3.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest pain, Myelitis transverse
Clinical narrative: Severe pain around my chest, loss of strength on both legs, sent to emergency room for treatment.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Intense burning and pain near injection site. Has taken APAP or ASA but as soon as wears off, pain returns. This is day 5.