chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The pharmacist noted the patient first had shingles in December 2011. The patient was subsequently in April 2012 vaccinated with ZOSTAVAX (dose, route and lot not reported). Within the past week or so the patient developed another episode of shingles that was just as bad as her first episode. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with live ZOSTAVAX (lot # not reported). The patient developed shingles within two weeks. It was unspecified whether the patient sought for medical attention. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 month old patient (gender was not reported). It reported that on 18-FEB-2013, the patient was vaccinated with a dose 0.5 ml of GARDASIL (route and lot number not reported). It stated that this was related to a staff error and not product confusions. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unknown number of patients (age and gender unknown). On an unknown date, the patients were vaccinated with PROQUAD (Merck) (lot number H015624, expiration date on 21-FEB-2014; lot number H015629, expiration date on 21-FEB-2012) (dose and route not reported). Other suspect therapies included on 16-DEC-2012, VARIVAX (Merck) (lot number H106600, expiration date on 05-SEP-2014) (dose and route not reported) and on 19-DEC-2012, VARIVAX (Merck) (lot number H17705, expiration date on 25-SEP-2014) (dose and route not reported). It was reported that some doses of improperly stores PROQUAD (Merck) might have been administered to unknown number of patients. The vaccines were exposed to 4 hours at room temperature and 45 hours at refrigerated temperature and were found to be not stable. No adverse effects reported. In a follow-up, was reported that an unknown number of patients may have received VARIVAX (Merck) that was improperly stored. VARIVAX (Merck) were exposed in addition to 4 hours at room temperature and 45 hours at refrigerated temperature also exposed to 5.86F to 15F for 5 minutes and it was doing this 3 times in 1 hour every day since the received dates of the VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site cellulitis, Injection site rash, Swelling
Clinical narrative: (+) Swelling, erythema, rash (L) thigh "overnight" (L) thigh cellulitis (Rx) Childrens BENADRYL > as directed Childrens ADVIL amoxicillin 400/5 1 tsp BID x 10 days.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to a her son of unknown age. The patient was vaccinated with 2 doses of GARDASIL (lot number, route, site not reported) on schedule approximately in 2012. The patient was supposed to receive the last dose in December 2012 and had not received the dose at reporting time due to office scheduling delays. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. 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 pharmacist refers to a patient of unknown age. On 16-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot # 667165/1167Z, expired date 08-DEC-2012). No adverse effect reported. It was unknown if the patient had sought medical attention. The outcome of the patient was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. About two weeks ago (approximately on 29-JAN-2013) the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot # was unknown) and had an "injection site reaction, with body aches and swelling at the injection site that necessitated a trip to the emergency room. Concomitant therapies included MENACTRA, TVAP and another unspecified vaccine (manufacturer unknown). The outcome of event was reported as recovered resolved on an unspecified date. The treatment was given for event by unspecified medication for dehydration. The patient had sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. Two weeks ago, on 27-JAN-2013 the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were not reported) in the upper left arm. On an unknown date in 2013 the patient had pain in her left arm for several days. The outcome of pain in her left arm was reported as recovered on unspecified date. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bladder catheterisation, Blood culture, Full blood count, Irritability, Pyrexia
Clinical narrative: Low grade fever at onset, then 102-103 overnight. Also c/o intermittent fussiness.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis
Clinical narrative: Low grade fever at onset, then 102-103 overnight. Also c/o intermittent fussiness.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Patient states she still has pain in her left arm. States difficulty with activities such as putting on seat belt. She says pain has progressed since the vaccine was administered.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body pain, headache, joint pain, (R) arm pain, fever 100.7.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: A few days after pt received flu vaccine, she complained pain and numbness on her left arm. Rash & numbness never went away ever since.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Red / warm area - upper left arm (back).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: Welts (L) arm intradermal injection. Redness at injection on 4th day & "itching" then hives in groin Sun at emergency room approx 1 pm increase in hives. Rx with BENADRYL. 1 hr later had hives from shoulder to feet. Back at ER - tx steroid shot & oral with BENADRYL 4 x day, ALLEGRA 2 x day, XANAX BID. 20th before feeling better.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dizziness postural, Injection site erythema
Clinical narrative: Next day had dizziness and increased dizziness the following day. Friday had redness at injection site size of dime. Dizziness increased when standing or while turning head when sitting.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Screaming
Clinical narrative: Screaming for over 4 hours despite TYLENOL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash and itching 2 days after vaccination ice.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Dyspnoea, Influenza, Pyrexia
Clinical narrative: Fever, mother reported breathing difficulty at home prior to ER visit, diagnosed with influenza at ER visit.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported). The patient developed shingles within two weeks. It was unspecified whether the patient sought for medical attention. The patient was treated with VALTREX and was still having postherpetic neuralgia. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient (age and gender unknown). On 19-FEB-2013, the patient was vaccinated with ZOSTAVAX (lot # 672478/1603AA; expiration date on 13-JAN-2013) 0.65 ml, subcutaneous route as prophylaxis. No adverse event reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Oropharyngeal pain, Pruritus, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse care professional refers to a 6 year old male patient with no known allergies. On 17-MAY-2007 the patient was vaccinated with his first dose of MMR II lot # reported as subcutaneous in the left arm. The same day the patient also received his first dose of VARIVAX (Merck), lot # reported as 0301U, subcutaneous in the left arm, and also his first dose of HAVRIX (lot number AHAVB130AA) IM in the right thigh. On 13-MAY-2010 the patient was vaccinated with his second dose of MMR II lot # 665098/0855Y, subcutaneous in the left arm. The same day the patient also received his second dose of VARIVAX (Merck), lot # 662575/0045Y, subcutaneous in the right arm. on 11-FEB-2013, at 9:30 am, the patient experienced small, itchy lesions for 2 days with sore throat, afebrile and was diagnosed with varicella (750 positive lesions). The outcome of patient's varicella was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm swollen, red, painful. Warm compresses, antibiotics, CT scan.
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Deafness, Dizziness
Clinical narrative: A report has been received from a health professional concerning a female patient. The patient's medical history and concomitant medication were not provided. The patient had been receiving nasal H1N1 (intranasal). She experienced hearing loss and dizziness. The outcome of the event of hearing loss and dizziness is unknown. Reporter assessed the event of hearing loss to be serious due to important medical event and the event of dizziness to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Expired FLUMIST was given at 400pm. No reaction. Manufacturer was notified as well as staff from Public Health office.
Age: 2.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired FLUMIST was given at 400pm. No reaction. Manufacturer was notified as well as staff from Public Health office.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Burning sensation, Deafness, Gait disturbance, Malaise, Nerve injury
Clinical narrative: A report has been resolved from a Health Professional concerning a 39 year old female patient. No medical history, no other health conditions and no history of vertigo was provided. The patient may have been taking an unspecified medication at the time, but she didn't think she was. In 2009 the patient received nasal H1N1. Within 24 hours of her vaccination she got very sick. Her vertigo started in the middle of the night, and it was very severe so that she could barely walk across the room. She was sick all over (not further specified) and stayed at home for 1.5 days before going to urgent care. The vertigo was not as severe as it was initially, but it had not gone away. Her neurologist and 2 separate ENTs told her that the virus in the vaccine caused nerve damage in her ear. When she was taking the mist the side of her nose hurt and she also had strong burning there. This was the same side where he ear was damaged. She had tinnitus, vertigo, and had lost hearing on that side. The outcome of the event of nerve damage, very sick, side of her nose hurt and burning is unknown. According to the reporter the assessment of the Serious criteria for the event of nerve damage was as follows: important medical event was considered to be non serious.
Age: 39.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rhinalgia, Tinnitus, Vertigo
Clinical narrative: A report has been resolved from a Health Professional concerning a 39 year old female patient. No medical history, no other health conditions and no history of vertigo was provided. The patient may have been taking an unspecified medication at the time, but she didn't think she was. In 2009 the patient received nasal H1N1. Within 24 hours of her vaccination she got very sick. Her vertigo started in the middle of the night, and it was very severe so that she could barely walk across the room. She was sick all over (not further specified) and stayed at home for 1.5 days before going to urgent care. The vertigo was not as severe as it was initially, but it had not gone away. Her neurologist and 2 separate ENTs told her that the virus in the vaccine caused nerve damage in her ear. When she was taking the mist the side of her nose hurt and she also had strong burning there. This was the same side where he ear was damaged. She had tinnitus, vertigo, and had lost hearing on that side. The outcome of the event of nerve damage, very sick, side of her nose hurt and burning is unknown. According to the reporter the assessment of the Serious criteria for the event of nerve damage was as follows: important medical event was considered to be non serious.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Bone pain, Fall, Fatigue, Headache, Influenza like illness
Clinical narrative: A report has been received from a physician concerning her son, who is a 12 year old male patient (height: 161.0 centimeters; weight 54.0 kg). No medical history, concurrent disease or concomitant medication was provided. On 01-Feb-2013, the patient was vaccinated with nasal FLUENZ. On 03-Feb-2013, the boy suffered from flu-like symptoms like rhinitis, bone pain, headache, sore throat, weariness and fever. On an unknown date, the patient recovered from these symptoms but he experienced rotatory vertigo from 04-Feb-2013 onwards. The reporter described it as rotatory vertigo with a tendency to fall and certainly not orthostatic. At the time of the follow-up information, on 07-Feb-2013, the vertigo was still ongoing. The reporting physician assessed the events as certainly related to FLUENZ. The reporter considered rotatory vertigo to be serious with life-threatening criteria of seriousness, and the event of flu-like symptoms to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Oropharyngeal pain, Pyrexia, Rhinitis, Vertigo
Clinical narrative: A report has been received from a physician concerning her son, who is a 12 year old male patient (height: 161.0 centimeters; weight 54.0 kg). No medical history, concurrent disease or concomitant medication was provided. On 01-Feb-2013, the patient was vaccinated with nasal FLUENZ. On 03-Feb-2013, the boy suffered from flu-like symptoms like rhinitis, bone pain, headache, sore throat, weariness and fever. On an unknown date, the patient recovered from these symptoms but he experienced rotatory vertigo from 04-Feb-2013 onwards. The reporter described it as rotatory vertigo with a tendency to fall and certainly not orthostatic. At the time of the follow-up information, on 07-Feb-2013, the vertigo was still ongoing. The reporting physician assessed the events as certainly related to FLUENZ. The reporter considered rotatory vertigo to be serious with life-threatening criteria of seriousness, and the event of flu-like symptoms to be non-serious.
Age: 74.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Gait disturbance, Myalgia
Clinical narrative: Muscle leg pain, bilateral, from hips down. Continuous pain. Difficulty walking and lifting legs. Gait is a shuffle instead of a walk. Sometimes she will go to walk and her leg won't move. The more activity the worse symptoms. At night cannot get comfortable no matter the position.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Injection site pain, Muscular weakness
Clinical narrative: 01-17-2013 pt stated he had chills/fever 101.7, 01/18/13 101 with night sweats x couple of weeks. Pain at inject. site as well. 1/21/13 contacted office - Prednisone prescribed. 1/25/13 knees hot & burning. 1/26 (5th day Prednisone) tapered - down until 2/5. 02/03/2013 pt relates pains returned in shoulder, dull pain, weakness down arm into hand. 02/05/2013 pt reports slight weakness & dull pain in upper (L) arm / shoulder. 02/06/2013 reports weight from 164 down to 152, muscle aches & pains "stiffness" cannot weakness, feel awful. Continues with multiple complaints to this date of 02/21/2013.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Night sweats, Pyrexia, Weight decreased
Clinical narrative: 01-17-2013 pt stated he had chills/fever 101.7, 01/18/13 101 with night sweats x couple of weeks. Pain at inject. site as well. 1/21/13 contacted office - Prednisone prescribed. 1/25/13 knees hot & burning. 1/26 (5th day Prednisone) tapered - down until 2/5. 02/03/2013 pt relates pains returned in shoulder, dull pain, weakness down arm into hand. 02/05/2013 pt reports slight weakness & dull pain in upper (L) arm / shoulder. 02/06/2013 reports weight from 164 down to 152, muscle aches & pains "stiffness" cannot weakness, feel awful. Continues with multiple complaints to this date of 02/21/2013.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Anxiety, Blood creatine phosphokinase, Chills, Depression, Feeling abnormal
Clinical narrative: 01-17-2013 pt stated he had chills/fever 101.7, 01/18/13 101 with night sweats x couple of weeks. Pain at inject. site as well. 1/21/13 contacted office - Prednisone prescribed. 1/25/13 knees hot & burning. 1/26 (5th day Prednisone) tapered - down until 2/5. 02/03/2013 pt relates pains returned in shoulder, dull pain, weakness down arm into hand. 02/05/2013 pt reports slight weakness & dull pain in upper (L) arm / shoulder. 02/06/2013 reports weight from 164 down to 152, muscle aches & pains "stiffness" cannot weakness, feel awful. Continues with multiple complaints to this date of 02/21/2013.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Feeling jittery, Muscle tightness, Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 01-17-2013 pt stated he had chills/fever 101.7, 01/18/13 101 with night sweats x couple of weeks. Pain at inject. site as well. 1/21/13 contacted office - Prednisone prescribed. 1/25/13 knees hot & burning. 1/26 (5th day Prednisone) tapered - down until 2/5. 02/03/2013 pt relates pains returned in shoulder, dull pain, weakness down arm into hand. 02/05/2013 pt reports slight weakness & dull pain in upper (L) arm / shoulder. 02/06/2013 reports weight from 164 down to 152, muscle aches & pains "stiffness" cannot weakness, feel awful. Continues with multiple complaints to this date of 02/21/2013.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Tremor, Weight decreased
Clinical narrative: 01-17-2013 pt stated he had chills/fever 101.7, 01/18/13 101 with night sweats x couple of weeks. Pain at inject. site as well. 1/21/13 contacted office - Prednisone prescribed. 1/25/13 knees hot & burning. 1/26 (5th day Prednisone) tapered - down until 2/5. 02/03/2013 pt relates pains returned in shoulder, dull pain, weakness down arm into hand. 02/05/2013 pt reports slight weakness & dull pain in upper (L) arm / shoulder. 02/06/2013 reports weight from 164 down to 152, muscle aches & pains "stiffness" cannot weakness, feel awful. Continues with multiple complaints to this date of 02/21/2013.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reddened, raised area at site shot was given about the size of a softball.
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a Nurse practitioner, refers to a female patient of unknown age with no pertinent medical history reported and no drugs reactions or allergies reported. By "the end of January 2013" the patient was vaccinated with a single dose of ZOSTAVAX (lot number and expiration date not provided) (0.65ml, subcutaneous, anatomical location not reported0 for immunization to prevent shingles. No other co-suspects or concomitant medications were reported. On 29-JAN-2013 the patient developed a shingles like rash at the injection site, where she was given ZOSTAVAX. The patient sought unspecified medical attention. The patient's primary care physician did a culture of the rash and prescribed an antiviral medication for the patient. At the time of the report the outcome of the shingles like rash at the injection site was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Red, hard lump, swelling below injection site 2 x 2 area.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/rash at injection site.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, IPV
Symptoms: Excessive eye blinking, Fall, Head injury, Hyperhidrosis, Incoherent
Clinical narrative: Approx. 5 min after vaccination, child fell against wall and hit head on floor. Eyes were fluttering, did not respond to conversation or commands, diaphoretic, and became incontinent. Wet towel applied to forehead, legs elevated on chair. Responds to mothers voice after about 5 seconds, able to open eyes and spoke to mother. Administrative clerk called for Emergency Response Team and second nurse called 911 EMS. Vital signs and verbal instructions with appropriate responses obtained, Emergency Response Team on site within 1 minute of incident. 911 arrived at approx 5:12 and transported by ambulance at 520. Informed supervisor and program manager of incident.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, IPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx. 5 min after vaccination, child fell against wall and hit head on floor. Eyes were fluttering, did not respond to conversation or commands, diaphoretic, and became incontinent. Wet towel applied to forehead, legs elevated on chair. Responds to mothers voice after about 5 seconds, able to open eyes and spoke to mother. Administrative clerk called for Emergency Response Team and second nurse called 911 EMS. Vital signs and verbal instructions with appropriate responses obtained, Emergency Response Team on site within 1 minute of incident. 911 arrived at approx 5:12 and transported by ambulance at 520. Informed supervisor and program manager of incident.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Middle insomnia, Pyrexia
Clinical narrative: Child was brought to clinic for high fever upon waking in middle of the night. Temperature was 104 per mother's statement. In clinic at 0255 am temp. 102.7 rectal. Infant was given immunizations late afternoon - approximately 10 hours prior to fevering. Temperature taken prior to administering shots 98.4. Child given TYLENOL 0.8 ml and alternating ibuprofen per MD's orders.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Fatigue, Headache, Injection site swelling, Neck pain
Clinical narrative: Pt received injection 2/12/13 later on in the day developed lg local warm & tender to the touch. Next day c/o itch, rash on legs, butt, arms, ankles & feet swelling at injection site. Spread to the rest of her arm. One week later still has a rash in inner thighs, neck is sore, congested, fatigue, cough, mucous, headache, earaches, sinus pain.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Productive cough, Pruritus, Rash, Respiratory tract congestion
Clinical narrative: Pt received injection 2/12/13 later on in the day developed lg local warm & tender to the touch. Next day c/o itch, rash on legs, butt, arms, ankles & feet swelling at injection site. Spread to the rest of her arm. One week later still has a rash in inner thighs, neck is sore, congested, fatigue, cough, mucous, headache, earaches, sinus pain.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Sinus headache, Skin warm, Tenderness
Clinical narrative: Pt received injection 2/12/13 later on in the day developed lg local warm & tender to the touch. Next day c/o itch, rash on legs, butt, arms, ankles & feet swelling at injection site. Spread to the rest of her arm. One week later still has a rash in inner thighs, neck is sore, congested, fatigue, cough, mucous, headache, earaches, sinus pain.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: C/O nausea, vomiting, vertigo, fatigue, malaise, chills, low grade fever. Has follow up Friday 2/22/13 sees MD at hospital.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Vertigo, Vomiting
Clinical narrative: C/O nausea, vomiting, vertigo, fatigue, malaise, chills, low grade fever. Has follow up Friday 2/22/13 sees MD at hospital.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 70 year old (approximately) female patient, who on 14-DEC-2006, was vaccinated subcutaneously with a dose of ZOSTAVAX 0.65 ml, in the left arm (lot number reported as 1212F). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient had a current outbreak of shingles on her face. Unspecified treatment was reported. The patient sought medical attention, the patient's husband went to the office for a visit on 15-FEB-2013 and let them know of his wife's shingles outbreak. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse events was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PNC, PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician, concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (Lot # and expiration date were not reported). Physician reported that on the same day the patient was also vaccinated with a dose of PREVNAR. There were no adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender, who on 16-FEB-2013, was vaccinated with a dose of GARDASIL (dose and route were not reported) (lot number reported as 1167Z) (expiration date: 08-DEC-2012). No adverse effects reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer concerning her 11 year old daughter who was vaccinated with GARDASIL (dose, route and lot not reported) 6 months ago approximately in August 2012 and the date of the report on 19-FEB-2013 was going to get the second shot on 19-feb-2013. No adverse reactions were reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a physician refers to a female patient (age unknown) with asthma, peanut allergy, broccoli allergy and wheat allergy. On an unknown date, the patient was vaccinated with first dose of GARDASIL (120 microgram) (lot number, dose, frequency and route were not reported). On an unknown date, the patient was vaccinated with second dose of GARDASIL (120 microgram) (lot number, dose, frequency and route were not reported. The vaccination dates were according to the vaccination schedule. Concomitant therapies included FLONASE, ASMANEX TWISTHALER and albuterol. On an unknown date, the patient developed "a sensation of itching and possible swelling in her throat 30 minutes to one hour after receiving her second dose." The patient sought medical attention and was not treated for the events. Laboratories were not performed. On unspecific date, the patient recovered from a sensation of itching and possible swelling in her throat. The outcome of a sensation of itching and possible swelling in her throat was reported as recovered/resolved. The events of a sensation of itching and possible swelling in her throat were unknown related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender unspecified). On 13-FEB-2013 the patient was vaccinated with ZOSTAVAX that might have been improperly stored and in which there was no data to support it. Lot # and administration route were unspecified. The patient was not experiencing any known symptoms. It was unspecified if the patient sought medical significant or not. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: Mild swelling, erythema around eyes, blotchiness on back. BENADRYL given, 12.5 mg, po. "Observed for a few minutes." Some of redness around eyes did resolve.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Depression, Dizziness, Headache, Inflammation
Clinical narrative: 11/7/12 - Vaccine given. 11/19/12 - Pt called stated since injection she had felt dizzy, headaches, vomiting, body aches, possible seizure, depression and anxiety, and nightmares. 12/26/12 Pt seen in ER 3 times. Pain, muscle spasms. Also seen by endo and has inflammation in thyroid and elevated T3 & T4. 2/21/13 - Diagnosed per pt with Lupus and myopathy.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Muscle spasms, Myopathy, Nightmare, Nuclear magnetic resonance imaging
Clinical narrative: 11/7/12 - Vaccine given. 11/19/12 - Pt called stated since injection she had felt dizzy, headaches, vomiting, body aches, possible seizure, depression and anxiety, and nightmares. 12/26/12 Pt seen in ER 3 times. Pain, muscle spasms. Also seen by endo and has inflammation in thyroid and elevated T3 & T4. 2/21/13 - Diagnosed per pt with Lupus and myopathy.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Systemic lupus erythematosus, Thyroxine increased, Tri-iodothyronine increased, Vomiting
Clinical narrative: 11/7/12 - Vaccine given. 11/19/12 - Pt called stated since injection she had felt dizzy, headaches, vomiting, body aches, possible seizure, depression and anxiety, and nightmares. 12/26/12 Pt seen in ER 3 times. Pain, muscle spasms. Also seen by endo and has inflammation in thyroid and elevated T3 & T4. 2/21/13 - Diagnosed per pt with Lupus and myopathy.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Autoimmune disorder, Incomplete course of vaccination, Laboratory test
Clinical narrative: 11/7/12 - Vaccine given. 11/19/12 - Pt called stated since injection she had felt dizzy, headaches, vomiting, body aches, possible seizure, depression and anxiety, and nightmares. 12/26/12 Pt seen in ER 3 times. Pain, muscle spasms. Also seen by endo and has inflammation in thyroid and elevated T3 & T4. 2/21/13 - Diagnosed per pt with Lupus and myopathy.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Skin warm
Clinical narrative: This spontaneous report was received from a 82 year old female patient with no pertinent medical history and no drug allergy. On 09-OCT-2012, the patient was vaccinated with ZOSTAVAX (one injection, lot # H012521) for shingles vaccination. Therapy route was unspecified. Concomitant therapies included loratadine (manufacturer unknown) and SYNTHROID. On 13-OCT-2012, the patient had an outbreak of shingles on her face that she described as red and hot, and felt like her face was being cut by glass. Patient was recovered from the event approximately on 10-NOV-2012, "after 4 weeks". No treatment was given. No lab was done. The patient spoke to pharmacist to seek medical significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a 60 year old female registered nurse with hypertension and hypothyroidism refers to herself. The patient did not have drug reactions/allergies. The patient's medical history included slight low Ig A and Ig G levels. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) 0.65 ml, subcutaneous in the left arm. On 07-FEB-2013 the patient developed a blister on the end of her nose the day after she received ZOSTAVAX. She stated that she also developed a blister on the bridge of her nose and a small red area on her right cheek. She was experiencing warmth and redness on her left arm at the injection site. Acyclovir three times a day-started on 08-FEB-2013, ALLEGRA once a day was given as treatment for adverse event. No lab diagnostic studies were performed. The outcome of adverse event was not recovered. The patient had sought medical attention via office visit. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: This spontaneous report as received from internet referred to a female student (patient) of unknown age. On an unknown date the patient was vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Patient who was taken to hospital, said she thought she might pass out or vomit after she was vaccinated. At the time of reporting the outcome and relationship were unknown. But "authorities believed the reactions were likely to be related to having an injection not the vaccine itself." This is one of several reports that received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to a possible 9 patients of unknown ages. The patients were vaccinated with improperly stored doses of GARDASIL (Lot # not reported) from October 2012 to December 2012. The patients were not experiencing any known symptoms. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. No further information is available.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old male patient who on 22-JAN-2013, was intended to receive PPD skin test, was inadvertently vaccinated with PNEUMOVAX 23 dose 1, subcutaneous. No concomitant medications were reported. The physician stated that on 22-JAN-2013, the patient developed a 5-6 cm area of redness, swelling, induration, and heat at the injection site. The patient was treated with KEFLEX and MEDROL dose pack and has recovered. No further information provided. The relatedness adverse events was unknown for PNEUMOVAX 23. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The reporter stated that on 11-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # 1716AA, 0.65 ml, subcutaneous route) with an expiration date of 02-FEB-2013. No other co-suspects or concomitant medications were reported. Also it was reported, that the patient was not experiencing any known symptoms. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). The nurse reported that on an unknown date, the patient experienced redness and swelling at the injection site. The outcome of redness at the injection site and swelling at the injection site was unknown. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV, HEPA, HPV4, TDAP
Symptoms: Convulsion, Dizziness, Dyskinesia, Loss of consciousness, Urinary incontinence
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 year old female patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). The nurse reported that on an unknown date, the patient experienced redness and swelling at the injection site. The outcome of redness at the injection site and swelling at the injection site was unknown. This is one of two reports concerning the same patient. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a  69 year old female patient who on 14-FEB-2013, was vaccinated with PNEUMOVAX 23 dose 1, intramuscular (lot #: H014561 Exp date: 21-MAR-2014) (dose not provided. No concomitant medications were reported. The physician stated that on 14-FEB-2013, a patient, who was administered PNEUMOVAX 23, developed a 5-6 cm area of pain, swelling, and induration at the injection site. The patient was evaluated at a local emergency room and prescribed Doxycycline, BENADRYL, and topical hydrocortisone cream. The patient recovered in 36 hours. The relatedness adverse events was unknown for PNEUMOVAX 23. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and unspecified gender. The Registered Nurse stated the patient was vaccinated with GARDASIL (lot# and expiration date unspecified) first dose (route and anatomical location unspecified by the reporter) on an unspecified date in December 2012. No other co-suspects were reported. No concomitant medications were reported. Second dose of GARDASIL was administered on an unspecified date in January 2013 and third dose was administered on 12-FEB-2013. GARDASIL was administered outside of the prescribing information. The Registered Nurse stated that there were only 18 weeks between the first and third doses of GARDASIL. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 73 year old male patient, who on 21-DEC-2007, was vaccinated subcutaneously with a dose of ZOSTAVAX 0.65 ml, in the left arm (lot number reported as 1414U). The medical assistant reported that the patient developed a mild case of shingles in 2012. The patient sought medical attention, he went to the office for a visit on 15-FEB-2013. On an unspecified date, the patient recovered from the adverse event. This is one of the two reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old female patient. The patient had not pertinent medical history or drug reactions/allergies. On 18-FEB-2013, the patient was vaccinated with a first dos eof GARDASIL (lot # H017598; expiration date: 02-JUL-2015) (dose, frequency route was not provided0 and fainted in the office. The patient sought medical attention, was treated with orange juice, cool cloth to her head. On the same date, the patient recovered. The relatedness for the adverse event was unknown for therapy with GARDASIL. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information has been received from a physician concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On 06-OCT-2011, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot number were not reported) and on 18-FEB-2013, the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot number were not reported). No co-suspect medications were reported. No concomitant medications were reported. No adverse symptoms reported. No treatment information or laboratory studies were reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Impaired healing, Injection site reaction, Injection site scab, Mass excision
Clinical narrative: Shot area never healed - oozing & scab, oozing again. Told I was reacting to shot. Insisted to see Dermo doc - biopsy was cancer & 5 years later lump removed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant, Wound secretion
Clinical narrative: Shot area never healed - oozing & scab, oozing again. Told I was reacting to shot. Insisted to see Dermo doc - biopsy was cancer & 5 years later lump removed.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Injection site discharge, Squamous cell carcinoma
Clinical narrative: Shot area oozed then scale. Repeat & repeat. Told I had reaction to vaccine! Derma biopsy = squamous cell carcinoma! Removed.
Age: 0.9
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 month and 2 week old patient of unknown gender. On 14-FEB-2013, the patient was vaccinated intramuscularly (IM) with a 0.5 ml one time dose of VAQTA (Lot # not provided). No concomitant medications reported. No adverse effect reported. Patient's outcome was unknown. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Loss of consciousness, Malaise, Unresponsive to stimuli
Clinical narrative: I believe I had a HHE event. I suddenly felt ill, with abdominal cramping and pass out. I was unresponsive for 4-5 minutes. My RN wife tried to wake me up. I regained conscious on my own. I have never had such a reaction ever prior to that day (nor any after). I am glad I was not driving alone or flying alone.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dysphagia, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old male patient without pertinent medical history. The patient had no drug reactions or allergies. On an unknown date the patient was vaccinated with the first dose of VARIVAX (merck) subcutaneously. On 18-FEB-2013 the patient was vaccinated with the second dose of VARIVAX (merck) (lot number was reported as 1908AA, expired date 05-DEC-2013) subcutaneously. There was no concomitant medication. On 18-FEB-2013 the patient developed itchy welts on his bilateral arms below his elbows. There was no treatment given for adverse event and no laboratory diagnostics study performed. Action taken and causality was not provided. The patient outcome was reported as not recovered. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old male patient without pertinent medical history. The patient had no drug reactions or allergies. On an unknown date the patient was vaccinated with the first dose of VARIVAX (merck) subcutaneously. On 18-FEB-2013 the patient was vaccinated with the second dose of VARIVAX (merck) (lot number was reported as 1908AA, expired date 05-DEC-2013) subcutaneously. There was no concomitant medication. On 18-FEB-2013 the patient developed itchy welts on his bilateral arms below his elbows. There was no treatment given for adverse event and no laboratory diagnostics study performed. Action taken and causality was not provided. The patient outcome was reported as not recovered. The patient had sought unspecified medical attention. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Wheezing
Clinical narrative: Initial information has been received from an office manager and a nurse practitioner concerning a 4 year old male patient with asthma, allergic reaction to bee sting. On 18-FEB-2013, the patient was vaccinated with the second dose of M-M-R II(lot H012140 exp date 29-JUN-2014)  (dose, route were not reported). Other suspect vaccination included second dose of (Merck) VARIVAX (lot H016911 exp date 10-SEP-2014) (18-FEB-2013). Concomitant vaccination given the same day included a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified) (18-FEB-2013), tetanus toxoid(diphtheria toxoid(+) pertussis acellular vaccine (unspecified) (+) and IPOL (18-FEB-2013) (dose, route were not reported), all of them on the same date. Concomitant therapies included ibuprofen, budesonide. On 18-FEB-2013, the patient was given ibuprofen and 4 vaccines and within 5 minutes he had an allergic reaction. He began wheezing and was administered oxygen, albuterol and epinephrine. He was transferred and admitted to the hospital. The nurse practitioner stated that the reaction was anaphylactic and life threatening. At the time of report, the patient had not recovered. Anaphylactic reaction was considered to be life threatening, medically significant and disabling by the reporter. Additional information has been requested.