chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Night sweats, Oedema peripheral, Pain in extremity, Pyrexia, Tremor
Clinical narrative: First, pain at injection site. Then, increasing pain radiating throughout entire arm.  Swelling of entire arm and inability to move fingers wrist etc.  Excruciating pain ("worse than childbirth").  Shaky, near blackout several times, nausea, vomiting mucous. Fever.   Night sweats continue (night of May 3). Pain entirely resolved by May 3. No evidence of lasting disability at this time.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: First, pain at injection site. Then, increasing pain radiating throughout entire arm.  Swelling of entire arm and inability to move fingers wrist etc.  Excruciating pain ("worse than childbirth").  Shaky, near blackout several times, nausea, vomiting mucous. Fever.   Night sweats continue (night of May 3). Pain entirely resolved by May 3. No evidence of lasting disability at this time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: Local skin reaction, redness, swelling.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Flatulence
Clinical narrative: Bloating, flatulence, stomach cramping, diarrhea - unresolved.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Do not know if reaction happened sooner because he wore long sleeve shirt that day. Arm swollen from shoulder to elbow with redness. Arm is hard like a rock with a reddish rash. Painful to the touch he says. He complaining about itching and pain mainly. Took him to urgent care at the hospital where he received his four year old boosters, they said it was localized reaction and to give him ibuprofen every 8 hours and to come back in two days for reassessment. He has slept half of the day. I also administered 5ml of Benadryl to him today.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Local reaction, Rash erythematous, Somnolence
Clinical narrative: Do not know if reaction happened sooner because he wore long sleeve shirt that day. Arm swollen from shoulder to elbow with redness. Arm is hard like a rock with a reddish rash. Painful to the touch he says. He complaining about itching and pain mainly. Took him to urgent care at the hospital where he received his four year old boosters, they said it was localized reaction and to give him ibuprofen every 8 hours and to come back in two days for reassessment. He has slept half of the day. I also administered 5ml of Benadryl to him today.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Coma
Clinical narrative: Information has been received via a claims administrator, from a lawyer, concerning a male customer (age not reported) of a pharmacy who allegedly went into a coma a few days after receiving a pneumonia and flu shot. The claims administrator reported the male indicated that the PNEUMOVAX vaccine from MSD was involved in the incident. The "date of loss" was reported as 31AUG2012. At this time if has not been determined which vaccine was responsible for this occurrence. The lot number for PNEUMOVAX is 1947AA, with an expiration date of 20OCT2013. Treatment and outcome of event was not reported. Coma was considered to be a medically significant event. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information has been received from a female consumer reporting on herself for VARIVAX (Merck) a pregnancy registry product who in August 2011, was vaccinated with a dose of VARIVAX (Merck) (lot number, route and dose not reported). Consumer reported that she was administered VARIVAX (Merck) in August 2011 and now she was 14 weeks pregnant. The consumer provided the name of the nurse practitioner, but did not state whether contact could be made with the nurse practitioner regarding the adverse event before consumer disconnected. The consumer did not want to give any additional information for the adverse event. The patient sought medical attention by contacting the nurse practitioner. Follow up information was received from a healthcare worker indicating that the 35 year old female patient on an unknown date was referred to a high risk perinatal center for reason unknown. It was reported that the pregnancy outcome of the patient was a spontaneous abortion. The reporter stated they did not know the exact date of the abortion but estimated it was between the date of her first OB intake on 18-OCT-2011 and a follow up call made by the Center to the patient on 18-NOV-2011 (between gestational weeks 14-18) when spontaneous abortion was reported. The patient's OB intake information stated there was no previous miscarriages. It was reaffirmed the patient's last menstrual period (LMP) was 12-JUL-2011. The dose series of VARIVAX (Merck) and the patient's status was unknown. Upon internal review spontaneous abortion was considered to be medically significant. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral, Rash, Secretion discharge
Clinical narrative: This spontaneous report as received from a licensed practical nurse concerning a 68 year old male patient with no drug reactions or allergies reported. On 21-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose not reported) (Lot number J000444, expiration date 11-APR-2014). The nurse reported that the patient developed a blistering oozing rash and arm swelling after receiving ZOSTAVAX and was hospitalized in an unspecified hospital. The nurse requested a lot check for ZOSTAVAX lot the patient received. The patient sought medical attention. No PQC involved. At the time of report, the patient had not recovered from the events. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Lymphadenopathy, Swelling
Clinical narrative: Redness and swelling started one day after injection. Two days later, swelling of lymph node in right axilla. Advised to use ibuprofen and cold compress.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: About 4:00 pm Patient waves at RN. RN went to patient and she said feeling dizzy, nausea, hot. Ambulance came. Observed. No treatment.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: Pt received vaccine on 4-29-13. Left arm, lower upper aspect, no fever. Elbow to shoulder - red, swollen rash under arm. Pt noticed 5-1-13. Dr rx given for cephalexin 5-2-13.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients medical history, drug reactions or allergies were not provided. On an unknown date, the unspecified number of patients have received a dose of GARDASIL (dose, route and lot number were not provided) off schedule on unspecified dates. No adverse symptoms reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned on this report. Additional information will be provided if available. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old patient of unknown gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX 23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX 23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
Age: 65.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old patient of unknown gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX 23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection reaction, swelling at least 6 inches to include the whole upper arm and redness. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX 23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash generalised, Skin burning sensation
Clinical narrative: My skin boiling and on fire little red bumps all over my face. Goes and comes back at the weird times.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Auricular swelling, Disorientation, Dyspnoea, Erythema, Eye pruritus
Clinical narrative: Reaction 11:20 AM swelling of eyes with itchiness, swelling of lips, nose, ears, developing hives and redness on skin, disorientation, sleepy followed by swelling of tongue, throat difficulty breathing. 11:35 AM Treatment Epinephrine Auvi-Q auto injector.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Reaction 11:20 AM swelling of eyes with itchiness, swelling of lips, nose, ears, developing hives and redness on skin, disorientation, sleepy followed by swelling of tongue, throat difficulty breathing. 11:35 AM Treatment Epinephrine Auvi-Q auto injector.
Age: 5.0
Sex: M
Vaccine: HIBV, PPV
Symptoms: Local reaction
Clinical narrative: LARGE LOCAL REACTION.  LASTED TEN DAYS. TREATED WITH ANALGESICS, TOPICAL ICE, BENADRYL AND TOPICAL OVER THE COUNTER CORTISONE CREAM.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pyrexia
Clinical narrative: LARGE LOCAL REACTION, LOW GRADE FEVER.  TREATED WITH ORAL ANALGESICS, LOCAL ICE AND ORAL ANTIBIOTICS.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Incisional drainage, Injection site pain, Injection site swelling, Laboratory test, Local reaction
Clinical narrative: Started with large local reaction, later developed fever up to 102F.  Initially treated in urgent care with a shot of antibiotic and oral antibiotics.  On 4/15/2013 hospitalized, requiring IV antibiotics. Went home on 4/18/2013. Showed improvement but continued to have swelling and tenderness at the injection site.  Hospitalized on 5/1/2013, needed to have the site of injection lanced to release possible infection.  As of 5/3/2013 was in the hospital.  No further info is available.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Started with large local reaction, later developed fever up to 102F.  Initially treated in urgent care with a shot of antibiotic and oral antibiotics.  On 4/15/2013 hospitalized, requiring IV antibiotics. Went home on 4/18/2013. Showed improvement but continued to have swelling and tenderness at the injection site.  Hospitalized on 5/1/2013, needed to have the site of injection lanced to release possible infection.  As of 5/3/2013 was in the hospital.  No further info is available.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia, Condition aggravated, Fatigue, Headache
Clinical narrative: Began as mild nausea, headache, pain in spine, cramping in abdomen.  Symptoms increased the next day to include rapid heartbeat, feeling of not getting enough oxygen, fever of 102, weakness, exhaustion, previous symptoms also increased.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Heart rate increased, Nausea, Pyrexia, Respiration abnormal, Spinal pain
Clinical narrative: Began as mild nausea, headache, pain in spine, cramping in abdomen.  Symptoms increased the next day to include rapid heartbeat, feeling of not getting enough oxygen, fever of 102, weakness, exhaustion, previous symptoms also increased.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Aphagia, Cheilitis, Feeling abnormal, Pyrexia, Rash erythematous
Clinical narrative: He broke out in a terrible rash all over his entire body.  The rash turned into open sores, especially around his lips and on top of his hands.  They scabbed over.  He had a fever for 3 days and would not eat.  He was miserable.  It took a long time for him to heal.  He STILL has small patches of red bumps 3 months later.
Age: 1.27
Sex: M
Vaccine: MMR
Symptoms: Rash generalised, Scab, Skin ulcer
Clinical narrative: He broke out in a terrible rash all over his entire body.  The rash turned into open sores, especially around his lips and on top of his hands.  They scabbed over.  He had a fever for 3 days and would not eat.  He was miserable.  It took a long time for him to heal.  He STILL has small patches of red bumps 3 months later.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral, Swelling
Clinical narrative: Administered Rt arm sq. Grew from 12:20 -> 12:40 1.5" > 1 inch section "puffy. looks like swelling grew from bumps to (inside) a larger reddish (blister round bumps - clusters. Advised 12:55 -> pt to f/u after phone cl MD appt. No pain No breathing problems.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Eye irritation, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-APR-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # J000493, expired date 14-APR-2013) subcutaneously. It was reported that the patient experienced redness at injection site immediately after vaccination, on approximately 25-APR-2013. On 27-APR-2013, the patient experienced redness and bumpiness without vesicles on the arm of the injection site. The patient stated that the redness was the length of her of upper arm. It was itchy, hot and sore. The patient also stated that her lips started to swell and she had a burning sensation in her eyes. The patient also said that she had joint and muscle pain with a slightly elevated body temperature on 27-APR-2013. The patient did not seek medical attention. She took MOTRIN and BENADRYL. She stated that as of today (on 29-APR-2013) the injection site had no more bumps and the redness was going away. She did however still have stiffness in her elbows, hips and knees. Therapy with ZOSTAVAX was reported as continued. The patient status was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Joint stiffness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-APR-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # J000493, expired date 14-APR-2013) subcutaneously. It was reported that the patient experienced redness at injection site immediately after vaccination, on approximately 25-APR-2013. On 27-APR-2013, the patient experienced redness and bumpiness without vesicles on the arm of the injection site. The patient stated that the redness was the length of her of upper arm. It was itchy, hot and sore. The patient also stated that her lips started to swell and she had a burning sensation in her eyes. The patient also said that she had joint and muscle pain with a slightly elevated body temperature on 27-APR-2013. The patient did not seek medical attention. She took MOTRIN and BENADRYL. She stated that as of today (on 29-APR-2013) the injection site had no more bumps and the redness was going away. She did however still have stiffness in her elbows, hips and knees. Therapy with ZOSTAVAX was reported as continued. The patient status was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-APR-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # J000493, expired date 14-APR-2013) subcutaneously. It was reported that the patient experienced redness at injection site immediately after vaccination, on approximately 25-APR-2013. On 27-APR-2013, the patient experienced redness and bumpiness without vesicles on the arm of the injection site. The patient stated that the redness was the length of her of upper arm. It was itchy, hot and sore. The patient also stated that her lips started to swell and she had a burning sensation in her eyes. The patient also said that she had joint and muscle pain with a slightly elevated body temperature on 27-APR-2013. The patient did not seek medical attention. She took MOTRIN and BENADRYL. She stated that as of today (on 29-APR-2013) the injection site had no more bumps and the redness was going away. She did however still have stiffness in her elbows, hips and knees. Therapy with ZOSTAVAX was reported as continued. The patient status was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 61 year old patient. On 30-APR-2013, the patient was mistakenly vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not reported) instead of ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative concerning a 35 year old patient of unknown gender. On an unknown date, a 35 year old patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that there had been an unspecified number of patients either late for their second or third dose of GARDASIL (lot # unspecified). The nurse could not provide any patient specific details at the time of the call. No adverse event reported. The therapy start dates were not reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Incorrect storage of drug, Injection site erythema, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 5-year-old male patient with no pertinent medical history and drug reactions/allergies. On 15-APR-2013 the patient was wrongly vaccinated with PROQUAD (Merck) (lot # H020137, expiration date 07-MAY-2014) instead of his second dose of MMR II, intramuscularly in the right arm. The vaccine PROQUAD was improperly stored and was exposed to the refrigerator temperatures not greater than 46 Fahrenheit (F) for 30 days (720 hours). Other suspect therapies included MMR II, KINRIX, KINRIX and VARIVAX (Merck). On 19-FEB-2009, patient was vaccinated with dose 1 MMR II (lot #, expiration date and route not reported). On 15-APR-2013, patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date not reported) intramuscularly in the right arm and a dose of KINRIX in the left arm. On 16-APR-2013 patient developed a "red, raised and hot area" around the injection sites on both the arms. Ice was given as a treatment for the event. No laboratory diagnostic studies were performed. Patient sought medical attention for the event by office visit. Approximately on an unknown date in April 2013, the patient recovered from the events. Causality was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 81 year old female patient with diabetic, hyperthyroidism and sulfur allergy. On 16-APR-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot# J000436, expired date 10-APR-2014) subcutaneously. No concomitant medications. The next day, on 17-APR-2013 the patient experienced "weak and tired", and the patient also stated the injection site area was "slightly pink". On 30-APR-2013 the patient sought medical attention, at an unspecified primary healthcare provider. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient had not recovered. The pharmacist did not assess drug relationship. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Visiting Nurse (L.V.N.) refers to a 50 year old female patient with allergies of skin rash/hives to SIMCOR, hypercholesterolemia and being a smoker. On 22-APR-2013 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX lot # J000427 (Exp: 10-APR-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included LEXAPRO, NASONEX and VYTORIN. On 23-APR-2013, the nurse reported that the patient developed redness, swelling, warmth and pain of her left arm, at the injection site, after receiving ZOSTAVAX. The affected area of her left arm had increased in the past two days, and on 25-APR-2013 the area affected was from her shoulder down to her elbow. The patient sought medical attention by calling to physician's office. Treatment of BENADRYL and ADVIL or ALEVE was given. None lab diagnostics studies were performed. At the reporting time, the patient was not recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Visiting Nurse (L.V.N.) refers to a 50 year old female patient with allergies of skin rash/hives to SIMCOR, hypercholesterolemia and being a smoker. On 22-APR-2013 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX lot # J000427 (Exp: 10-APR-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included LEXAPRO, NASONEX and VYTORIN. On 23-APR-2013, the nurse reported that the patient developed redness, swelling, warmth and pain of her left arm, at the injection site, after receiving ZOSTAVAX. The affected area of her left arm had increased in the past two days, and on 25-APR-2013 the area affected was from her shoulder down to her elbow. The patient sought medical attention by calling to physician's office. Treatment of BENADRYL and ADVIL or ALEVE was given. None lab diagnostics studies were performed. At the reporting time, the patient was not recovered. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from an approximately 86 year old female patient with no pertinent medical history and no drug reactions or allergies regarding herself to report how she was feeling. On 25-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included vitamins (unspecified) and calcium (unspecified). Approximately on 01-JUN-2012 (reported as a week after vaccination), the patient started to feel numbness that went down to legs and feet. The patient sought an unspecified medical attention. She was told to take B12. On an unknown date, nerve test on legs and magnetic resonance imaging (MRI) were performed. The outcome of the event was reported as not resolved as this feeling had not gone away since the vaccination. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report was received from an approximately 86 year old female patient with no pertinent medical history and no drug reactions or allergies regarding herself to report how she was feeling. On 25-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included vitamins (unspecified) and calcium (unspecified). Approximately on 01-JUN-2012 (reported as a week after vaccination), the patient started to feel numbness that went down to legs and feet. The patient sought an unspecified medical attention. She was told to take B12. On an unknown date, nerve test on legs and magnetic resonance imaging (MRI) were performed. The outcome of the event was reported as not resolved as this feeling had not gone away since the vaccination. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a young child patient of unknown age. On 29-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot number, dose, route and injection site were not reported) instead of PCV (manufacturer unknown). No side effects were reported. No demographics were provided for the patient involved. The action taken, outcome and causality were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary function test
Clinical narrative: Difficulty breathing, short of breath. Hospitalized until November 22, 2013 with long term ongoing care continuing.
Age: 1.3
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: 04/28/2013 Moderate other Client had a fever of 101 F degrees on 4/19/13 (doctor prescribed amoxicillin), 102 on 4/26 and 103 on 4/27. Parent noticed numerous small, flat, non-sleeping, non-itchy red dots on the client's back, chest, and belly on 4/28. This rash became blotchy-looking on 4/29. Client was symptom free on 5/1/13.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox diagnosed by ER community hospital on 5/3/13.
Age: 1.01
Sex: M
Vaccine: HEPA, HPV4, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Administration of GARDASIL to 12 month old instead of ordered Varicella. No known adverse event.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pruritus, Skin warm
Clinical narrative: Redness measuring 5 cm x 2 cm left arm warmth, itching at site.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Extreme dizziness and nausea started 5/1/13 nauseousness 5/2/13 vomited 5/3/13.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old female patient. On 30-APR-2013, the patient was administered expired oral ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral for prophylaxis. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician refers to a 17 week old male patient. On 01-MAR-2013 the patient was vaccinated with dose 1, oral, ROTATEQ (lot #, expiration date and route not reported) at 17 weeks of age from a different unspecified physician. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 34 year old female with no drug allergy and no medical history who on 06-SEP-2011 was vaccinated with a first dose of VARIVAX (Merck). No concomitant medication. The patient emailed the patient's primary care physician on 19-SEP-2011, and the patient informed the paitent's primary care physician that the patient was pregnant. Urine pregnancy test was performed (no details reported). The patient's LMP was unknown. Patient received no treatment. Follow-up received. A call was placed to the first physician's office and was told that there was no physician by that name who worked there or any record of the patient. A call was placed to the second physician's office. The office staff told that there was no record of the patient in their files and thus had no outcomes to report. Case was lost to follow-up. Additional information is not expected.
Age: 1.49
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Rt leg upper thigh 1.5/1.5 lesion on scar tissue.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: Developed skin rash and blisteres on scalp.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Acne, Burning sensation, Erythema, Headache, Pain
Clinical narrative: Developed skin rash and blisteres on scalp.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Developed skin rash and blisteres on scalp.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Headache, Herpes zoster, Pain
Clinical narrative: Developed skin rash and blisteres on scalp.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Tenderness
Clinical narrative: Localized swelling and tenderness, denies any other side effects.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Cyanosis, Cyanosis central, Livedo reticularis, Pyrexia, Rash
Clinical narrative: Acrocyanosis, central cyanosis, mottling, fever to 105.0, papular rash on face, spreading down to the rest of body by morning, lasting 48 hrs.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Acrocyanosis, central cyanosis, mottling, fever to 105.0, papular rash on face, spreading down to the rest of body by morning, lasting 48 hrs.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Felt bad, headache, body aches, fever that started 5/3/2013, general flu like symptoms. Went to a golf tournament in the cold/rain on Thursday (5/2) and Friday (5/3). Felt worse Friday and over the weekend. Still not feeling well today (5/6).
Age: 0.81
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Severe fever above 103F lasting > 4 days; Remedial treatment for fever using acetaminophen and ibuprofen.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Blood test normal, Dizziness, Dyskinesia, Muscle twitching, Thirst
Clinical narrative: Pt reported feeling dizzy, thirsty. Arms began "twitching" which progressed to all extremities, body begain to "jolt." Patient's parents took him to ER where they drew blood for testing, which came back negative. He received Ativan and was discharged at 3:30 AM.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Urine analysis
Clinical narrative: Pt reported feeling dizzy, thirsty. Arms began "twitching" which progressed to all extremities, body begain to "jolt." Patient's parents took him to ER where they drew blood for testing, which came back negative. He received Ativan and was discharged at 3:30 AM.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Blood test normal, Dizziness, Muscle twitching, Neurological examination normal, Seizure like phenomena
Clinical narrative: Pt reported feeling dizzy, thirsty. Arms began "twitching" which progressed to all extremities, body begain to "jolt." Patient's parents took him to ER where they drew blood for testing, which came back negative. He received Ativan and was discharged at 3:30 AM.
Age: 19.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Thirst, Urine analysis normal
Clinical narrative: Pt reported feeling dizzy, thirsty. Arms began "twitching" which progressed to all extremities, body begain to "jolt." Patient's parents took him to ER where they drew blood for testing, which came back negative. He received Ativan and was discharged at 3:30 AM.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Pain, Pruritus, Rash
Clinical narrative: Pt developed soreness/pain on the morning of 05/03/2013.  That night he developed a rash accompanied by itching and burning. Pt followed up with the facility on 05/04/2013 and was seen by M.D. and was instructed to take Benadryl to alleviate symptoms.  Pt. was instructed to follow up the next day if symptons persisted.  Pt is going to be seen at Urgent Care today 05/06/2013.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: ITCHING STARTING UNDER ARMS AND MOVED OUT TO THE REST OF BODY.  HAS GRADUALLY INCREASED IN SEVERITY TO WHERE PATIENT NOW ITCHES PROFUSLY FROM HEAD TO TOE.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Body temperature increased, Headache, Nausea, Pain
Clinical narrative: Received 3rd RABAVERT am of 4-24-13 and client report felt fine until 8 pm had slight nausea then developed body aches and headache and temp of 102.5 around 4 am on 4/25/13 that broke by 7 am and then had a headache that lasted until around noon on 4/25/13.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Local reaction, Swelling
Clinical narrative: Localized reaction red and swollen size of 50 cent piece. Used cold pack to site and resolved.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Disorientation, Lethargy
Clinical narrative: This spontaneous report was received from a father refers to his 16 year old son (who is the patient). The patient had no pertinent medical history, drug reactions or allergies. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, within a couple of days after the vaccination the patient started feeling extremely disoriented and lethargic to the point he had missed a week of school. There was no laboratory test performed. The patient was prescribed a Z-PAK as a treatment at the doctors office. The outcome of the event was reported as not recovered. The patient sought medical attention (doctor visit). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: CSF culture, CSF white blood cell count negative, Computerised tomogram normal, Confusional state, Headache
Clinical narrative: This spontaneous report was received from a father refers to his 16 year old son (who is the patient). The patient had no pertinent medical history, drug reactions or allergies. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, within a couple of days after the vaccination the patient started feeling extremely disoriented and lethargic to the point he had missed a week of school. There was no laboratory test performed. The patient was prescribed a Z-PAK as a treatment at the doctors office. The outcome of the event was reported as not recovered. The patient sought medical attention (doctor visit). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Lethargy, Pain, Rhinitis, Sinusitis, Somnolence
Clinical narrative: This spontaneous report was received from a father refers to his 16 year old son (who is the patient). The patient had no pertinent medical history, drug reactions or allergies. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, within a couple of days after the vaccination the patient started feeling extremely disoriented and lethargic to the point he had missed a week of school. There was no laboratory test performed. The patient was prescribed a Z-PAK as a treatment at the doctors office. The outcome of the event was reported as not recovered. The patient sought medical attention (doctor visit). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Viral infection, Vomiting
Clinical narrative: This spontaneous report was received from a father refers to his 16 year old son (who is the patient). The patient had no pertinent medical history, drug reactions or allergies. Approximately on an unknown date in April 2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, within a couple of days after the vaccination the patient started feeling extremely disoriented and lethargic to the point he had missed a week of school. There was no laboratory test performed. The patient was prescribed a Z-PAK as a treatment at the doctors office. The outcome of the event was reported as not recovered. The patient sought medical attention (doctor visit). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: May 2nd had local reaction at site of Tdap warm and red about the size of palm of hand and swollen. Started May 1st. No fever or c/o pain or other symptoms. Resolved with ice pack to site when checked on 5/3/13.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction to Tdap shot swollen, red and warm. Used cold pack and resolved over the next week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 02-MAY-2013 the patient was vaccinated with expired ZOSTAVAX lot # 0467AE, subcutaneous, dosing information was not provided, expiry date 04-apr-2013. No adverse effect was reported. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pruritus, Vomiting, Wheezing
Clinical narrative: Within 2 minutes of receiving hepatitis A and varicella immunizations patient began to complain of severe pruritus. She also had multiple episodes of emesis and very mild wheezing. She was given a dose of epinephrine and transported via ambulance to closest ED.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (Lot number, expiry date, dose and route were not specified) in the unspecified arm. On an unknown date, the patient experienced a paresthesia reaction such as pins and needles in arm and fingers after receiving the first dose of GARDASIL. The outcome of paresthesia reaction such as pins and needles in arm and fingers was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On unspecified dates in April 2013, "the last 2 to 3 weeks", unspecified number of patients was vaccinated with VAQTA, 0.5 ml, intramuscular. Lot# was unspecified. Physician called to report that his nurse was stating that the plunger rod was falling out of an unspecified number of VAQTA pediatric prefilled syringes as they pull back on the plunger to aspirate during administration of product to an unspecified number of unspecified patients the last 2 to 3 weeks, PQC filed. Physician noted that the nurses had had to use unspecified syringes (manufacturer unknown) to administer VAQTA, pediatric doses from these prefilled syringes because of the issues with the plunger rods. No adverse effect reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site warmth
Clinical narrative: (R) deltoid red patch 10 x 6.5 cm irregular border, indurated, warm to touch one day after the vaccine was administered. Near vaccine site was a patch of red papules grouped together where MMRV was administered. (R) upper arm posterior where MMRV.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Sm red lump at injection site is resolving.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a consumer referring to herself, a 75 year old female patient with high blood pressure but running very normal. On 08-JUN-2012 the patient was vaccinated with ZOSTAVAX single dose (lot number, expiration date, therapy route and anatomical location unknown) (prevent shingles). Concomitant therapies included losartan potassium (manufacturer unknown), gabapentin (manufacturer unknown), aspirin 81 mg (manufacturer unknown), pravastatin sodium (manufacturer unknown) and metoprolol (manufacturer unknown). In September 2012 the reporter stated that she developed a rash 3 months later but no in area where injection was given, rash was on stomach, back, arms and upper legs, the patient sought unspecified medical attention and a dermatologist prescribed a compound for rash. It was reported that the adverse event improve but rash reappear on back little bumps. The outcome of generalized rash was reported as recovering. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Pt received Tdap due to laceration on LE from rusty metal. After 20 mins, began to feel itchy extremities, face, then torso. Very minimal fine rash. Denies any respiratory sx. No tingling of tongue or throat. Eval by provider, rash diminished, sx decreased. Pt left after 60 mins. BENADRYL 25 mg q 6 hours prn. 5/6/13 Pt states rash resolved arm pain decreased.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No medical history was reported. On an unknown date 2 years ago approximately in May 2011, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiry not reported). His job in law enforcement is requiring him to take another unspecified Hepatitis B vaccine today 02-MAY-2013. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 9 month old patient (gender unknown). No medical history was reported. On 03-AUG-2012, the patient was vaccinated with a dose of VAQTA (lot # H010145, expiry not reported) intramuscularly when the patient was nine months old. No concomitant medications were reported. No adverse effect reported. The nurse inquired on lot # H010145 as to whether it is a Hepatitis A or Hepatitis B vaccine. Nurse also inquired if the vaccine VAQTA can be counted as it was given to the patient early. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Convulsion
Clinical narrative: 15 yr. old male with 2 of seizures, 3 days after patient was given HPV vaccine 4/29/13.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Community Nurse Practitioner refers to a patient of unknown age. On 26-APR-2013 the patient was vaccinated with a dose of GARDASIL (lot# not reported), intramuscularly. The nurse practitioner noted that the patient was administered a dose of CERVARIX on 26-OCT-2012 and another dose of CERVARIX on 26-NOV-2012. The patient was administered a dose of GARDASIL today (26-APR-2013). No adverse effect was reported. Additional information has been requested.
Age: 39.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 39 year old patient, gender unspecified. Approximately on an unknown date in April 2008 (reported as four years ago) the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and route not reported) to prevent herpes simplex. No adverse effect reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 month old female patient. On 29-APR-2013, the patient was administered expired ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Gave DTaP, MMR, Polio, and Varicella immunizations around 1330 on 4-19-13. Patient had febrile seizure at 0400 4-20-13 and was taken to ER by grandma.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction
Clinical narrative: Patient had mild headache and localized site reaction the night of injection, 4/2/13. Gotten worse into second day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Swelling upper posterior arm soft tissue subq hard area 3-4 cm erythema 8 x 4 cm. Pt given cool soaks BENADRYL crm for pruritus. AUGMENTIN for 10 days.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old female patient. On 30-APR-2013, the patient was administered expired oral ROTATEQ (lot # 0923AA; expiry date: 25-APR-2013) 2ml oral. No adverse effects were reported. The outcome of the event was unknown. This is one of three reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: SMALL, YF
Symptoms: Activities of daily living impaired, Lymphadenopathy
Clinical narrative: Patient states strong lympn node reaction w/ swelling. Patient went to ER on 23 Feb and treated with antibiotic & Benadryl. Followed up in clinic on 25 Feb 13.  Returned to duty with temporary flying restrictions.