chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.57
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 months old patient. The patient was vaccinated with the first and only dose of live, oral, ROTATEQ (lot number not provided) oral on 28-SEP-2012 when the patient was "one year and six months old". No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Flushing
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old female patient with no drug reaction or allergies. The patient was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y, expired date 18-SEP-2011) on 03-SEP-2009. No other co-suspects were reported. No concomitant medications were reported. On 03-SEP-2009 the patient became very faint and flushed. The patient was in the office at that time, and she had to lie down for a while. The patient was recovered on an unspecified date. Nurse stated the patient did not want to continue with additional doses to complete the series. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a company representative regarding her 15 year old son who was a patient. The patient was vaccinated with GARDASIL, (lot number was not reported) intramuscularly. There was no concomitant medication. The reporter stated that she could not remember when her son who was patient received his 1st or 2nd dose. She reported that the patient was late receiving the 3rd dose. She does not remember the date when his 3rd dose should have been administered. No treatment information was reported. There was no lab diagnostics studies. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Erythema, Syncope
Clinical narrative: This spontaneous report as received from a physician referred to a female patient in her early 20's years with none drug reactions/allergies. The patient's current condition included attention deficit disorder (ADD). The patient was vaccinated IM with the first dose of 0.5 GARDASIL (lot # (0420AE, Exp Date: 01-DEC-2014) at an unspecified facility prior to September 2009. On 19-SEP-2012 the GARDASIL. Concomitant therapy included unspecified medication for ADD. On 19-SEP-2012 the patient developed syncope, while she was still in the physician's office, after receiving the second dose of GARDASIL. A red, blistered area was also noted on her right, lower leg after receiving GARDASIL. Oral fluids and cool compresses applied to the patient in the office. It was unknown if the red, blistered area on the leg was present before receiving GARDASIL. The syncope had resolved prior to the patient leaving the physician's office, but the status of the patient's right, lower leg was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported, formulation also reported as "inhaler"). No other co-suspects were reported. No concomitant medications were reported. It was reported that about a month ago (in approximately September of 2012), while on PNEUMOVAX 23 the patient's arm became very swollen. No treatment information was reported. It was reported that the patient sought unspecified medical attention. At the time of report, the outcome of the patient's event was unknown. The relatedness for the patient's event was not reported for PNEUMOVAX 23. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report was received from a register nurse concerning a 60 year old female patient with high cholesterol, amoxicillin allergy and sulfa allergy. The patient's medical history included shingles in February 2012. On an unknown day, in September 2012 (one week ago) the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Concomitant medications included: ESTRACE. On 27-SEP-2012, the patient developed an outbreak of shingles on her arm at the ZOSTAVAX injection site. The patient received VALTREX as treatment for the event. At the time of the report, the patient had not recovered from the event. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with first dose of PNEUMOVAX23 in October 2003 and second dose (intramuscular, 0.5ml, Lot# reported as H010515, Exp date 13-Feb-2014) on 29-SEP-2012. Concomitant medications included lisinopril, simvastatin, an antihistamine and aspirin. On 29-SEP-2012 the patient began to experience some discomfort in the injection arm. On 01-OCT-2012, the patient presented to the pharmacist with her injection arm red, warm and an area approximately 4 inches by 6 inches swollen. The area of swelling extended distally to the patient's elbow. The patient had sought medical attention via consulting pharmacist and no treatment was given for the adverse events. At the time of reporting the outcome was unknown.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult female patient. The patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot number not reported) on 17-JAN-2012 and would "now" like to received her second dose "today", on 02-OCT-2012. No adverse symptoms reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via field representative refers to 4 patients of unknown demographics. On an unknown date the patients were vaccinated with unspecified doses of VARIVAX (Merck) (lot # not reported) vial, dosage and not reported. No concomitant medications were reported. Field representative left message on the afterhours PIR line. The field representative was told by the physician that since he had been in practice (amount of time unspecified), he has had 4 patients who developed shingles within 18 months of receiving VARIVAX (Merck). There were not serious complications associated with these patients. No further details were noted on the afterhours. The outcome of the event shingles was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to some patients felt "uncomfortable" with injection of ZOSTAVAX (route, dose and lot # were not reported) with 25 gauge with 5/8 length needle and she called to inquire if any higher gauge needle or shorter needle can be used to minimize pain. Specific number of patients unknown. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patients sought medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from registered nurse regarding a 21 year old female patient. The patient's medical history included dermatitis, hydrocodone allergy. The concurrent condition included allergic rhinitis and asthma. The patient was vaccinated with MMR II. Concomitant medications included drospirenone, YAZ, albuterol and CLODERM. The patient had previously received 2 doses of MMR II each on separate unspecified dates in the past. On 17-AUG-2012, the patient titre levels was performed and the patient was found to have low titre levels for measles, mumps and rubella,. No treatment information was reported. The outcome of the event was reported as not recovered (reported as "not changed"). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician refers to a 65 years old female patient, who on unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # and dose not reported). On an unknown date, following the vaccination, the patient experienced arm swelling "from the deltoid down to the elbow like a long string of red reaction". The patient sought medical attention, she went to urgent care. No treatment was reported. The outcome of arm swelling "from the deltoid down to the elbow like a long string of red reaction" was reported as recovering/resolving. The relatedness for arm swelling "from the deltoid down to the elbow like a long string of red reaction" was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Injection site rash, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 60 years old female patient with Meniere's disease and allergy to TOPROL and diltiazem. The patient was vaccinated subcutaneously in the left arm with 0.65 ml ZOSTAVAX (lot # reported as H011333; expiration date 08-SEP-2013) on 25-SEP-2012. No other co-suspects were reported. There were no concomitant medications. The nurse reported that last night, on 26-SEP-2012, the patient developed cellulitis of her left deltoid. She also had nausea and a slight fever. The injection site area had small bumps and nurse said that "it almost looked like she was developing shingles". The patient visited the office and was given FAMVIR and unspecified antibiotic as a treatment. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to currently 61 years old female patient with no pertinent medical history. On unknown date (reported as "more than 10 years ago"), the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that the patient's recent (date unspecified) hepatitis b titer came back negative. No treatment information was reported. It was reported that the patient saw physician. At the time of the report, the patient's outcome was unknown. The relatedness for the patient's event was unknown for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant regarding two patients who were vaccinated with a dose of PNEUMOVAX 23. It was reported that two patients developed cellulitis after receiving a dose of PNEUMOVAV 23. One patient received PNEUMOVAX 23 on 03-AUG-2012 and the other patient received PNEUMOVAX 23 on 06-AUG-2012 (MARRS# 1210USA003251). It was reported both patients were vaccinated with a dose PNEUMOVAX 23 (Lot number 672041/1477AA; expiration date 14-MAY-2013) 5 ml. Conflicting information, expiration date 14-MAY-2012 also reported. No further information was provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 69 years old female patient. The patient was vaccinated SC. into back of right arm with a dose of 0.65 ml ZOSTAVAX (lot number reported as "H011431", expired date 12-SEP-2012) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that patient had rash on her unspecified arm and unspecified leg now. The patient had contacted pharmacy for medical attention. A the time of the report, the patient was not recovered. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a nurse who reported that some patients were administered improperly stored RECOMBIVAX HB 2.5 ug/0.5 mL (lot# reported as 0391AE, expiration date unspecified) and pneumococcal 14v polysaccharide vaccine (MARRS # 1210USA002676). RECOMBIVAX 23 was exposed to two temperature excursions, exposed to 10 degrees celsius for 72 hours and a day later, exposed to 12 degrees celsius for 48 hours. No adverse effects were reported. Specific number of patients was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that some patients were administered improperly stored PNEUMOVAX 23 (lot number 1947AA; expiration date unspecified) and RECOMBIVAX HB (MARRS # 1209USA010375). PNEUMOVAX 23 was exposed to two temperature excursions: exposed to 10 degrees celsius for 72 hours and a day later, exposed to 12 degrees celsius for 48 hours. No adverse effects were reported. The specific number of patients was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 75 years old female patient without drug reaction/allergies and unspecified pertinent medical history. On 26-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unspecified date of September 2012, the patient experienced warmth, swelling and a lump around injection site after receiving ZOSTAVAX. There was not treatment given for the event. The patient talked with the pharmacist for medical attention. The patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning her father (patient) of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX) (lot number, dose unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient experienced injection site redness and swelling about an inch in diameter. The patient did not seek medical attention. The events injection site redness and swelling were resolved in about a week (date unspecified). The relatedness for injection site redness and swelling was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age and medical history. The patient was vaccinated with ZOSTAVAX on 27-SEP-2012. Dose and route were not reported. No other co-suspects were reported. No concomitant medications were reported. In approximately September 2012, the patient experienced local injection site reactions including pain, swelling, redness and warmth around the injection site after receiving ZOSTAVAX. Treatment information was not reported. The patient's outcome was not reported. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 68 years old female patient with unknown medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 24-SEP-2012. Lot number H011331 (in validation), expiration date 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. After vaccination, at the site of injection and around it (about a couple of inches) the patient had redness, not raised and itching that went down the arm a little bit (2-3 inches down from the injection site). No treatment was given. No laboratory test was performed. At the time of reporting, the patient had not recovered from the events. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant regarding a patient who on 06-AUG-2012 was vaccinated with a dose of PNEUMOVAX 23. (Lot number 672041/1477AA; expiration date 14-MAY-2013, also reported as 14-MAY-2012). It was reported that the patient developed cellulitis after receiving a dose of PNEUMOVAX 23. No further information was provided. No further information is expected.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Cough, Salivary hypersecretion
Clinical narrative: Information has been received from a physician concerning a 2 months old female patient with gastrooesophageal reflux disease and no drug reactions/allergies, who on 30-AUG-2012 was vaccinated with a dose of ROTATEQ orally (dose not reported) (Lot # 0209AE, Exp: 28-SEP-2013 - in validation process). No other co-suspects were reported. No concomitant medications were given. The physician reported that on 30-AUG-2012 the patient developed immediate coughing and salivating after administration of 1-2 drops of ROTATEQ. The coughing persisted for 10 minutes and the increased salivation required suctioning in the office. The infant then nursed for a few minutes and fell asleep. The patient was monitored in the office and was released to home fully recovered on the same day. No laboratory diagnostic studies were performed. The relatedness for immediate coughing and increased salivation was unknown for ROTATEQ. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Cough, Immediate post-injection reaction, Salivary hypersecretion
Clinical narrative: Information has been received from a physician concerning a 2 months old female patient with gastrooesophageal reflux disease and no drug reactions/allergies, who on 30-AUG-2012 was vaccinated with a dose of ROTATEQ orally (dose not reported) (Lot # 0209AE, Exp: 28-SEP-2013 - in validation process). No other co-suspects were reported. No concomitant medications were given. The physician reported that on 30-AUG-2012 the patient developed immediate coughing and salivating after administration of 1-2 drops of ROTATEQ. The coughing persisted for 10 minutes and the increased salivation required suctioning in the office. The infant then nursed for a few minutes and fell asleep. The patient was monitored in the office and was released to home fully recovered on the same day. No laboratory diagnostic studies were performed. The relatedness for immediate coughing and increased salivation was unknown for ROTATEQ. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with penicillin allergy, sulfa allergy and naproxen allergy. The pharmacist reported that two patients experienced injection site reactions after receiving ZOSTAVAX. This is first of two patients. The patient was vaccinated with ZOSTAVAX (lot number reported as 0365AE, expiry date reported as 23-MAR-2013) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-SEP-2012 the patient experienced patient developed a painful, red hard, raised, hot to touch area on her arm at injection site. No treatment information was reported. Medical attention was sought for the event. The patient came back into pharmacy and she her physician. The outcome of the event was reported as not recovered/not resolved. The pharmacist was requesting a lot check for ZOSTAVAX for the above mentioned lot number at the time of report. This case is linked to the case 1209USA005103 (Same Reporter Link). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with penicillin allergy, sulfa allergy and naproxen allergy. The pharmacist reported that two patients experienced injection site reactions after receiving ZOSTAVAX. This is first of two patients. The patient was vaccinated with ZOSTAVAX (lot number reported as 0365AE, expiry date reported as 23-MAR-2013) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-SEP-2012 the patient experienced patient developed a painful, red hard, raised, hot to touch area on her arm at injection site. No treatment information was reported. Medical attention was sought for the event. The patient came back into pharmacy and she her physician. The outcome of the event was reported as not recovered/not resolved. The pharmacist was requesting a lot check for ZOSTAVAX for the above mentioned lot number at the time of report. This case is linked to the case 1209USA005103 (Same Reporter Link). Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 61 years old female patient with penicillin allergy. The patient was vaccinated with the first dose of PNEUMOVAX 23 lot # (669579/0595AA; exp. date 30-AUG-2012) (dose not reported) on 04-OCT-2011. Second dose of PNEUMOVAX 23 lot # (672074/1502AA; exp. Date 19-MAY-2013) (dose not reported) on 24-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist noted that subsequent to the second administration of PNEUMOVAX 23 on 25-SEP-2012, the patient experienced high fever and was very tired. No treatment information was reported. The patient was not recovered from the events at the time of the report. The relatedness for the patient experienced high fever and the patient was very tired is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Fatigue, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 61 years old female patient with penicillin allergy. The patient was vaccinated with the first dose of PNEUMOVAX 23 lot # (669579/0595AA; exp. date 30-AUG-2012) (dose not reported) on 04-OCT-2011. Second dose of PNEUMOVAX 23 lot # (672074/1502AA; exp. Date 19-MAY-2013) (dose not reported) on 24-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist noted that subsequent to the second administration of PNEUMOVAX 23 on 25-SEP-2012, the patient experienced high fever and was very tired. No treatment information was reported. The patient was not recovered from the events at the time of the report. The relatedness for the patient experienced high fever and the patient was very tired is unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # 0171AE, exp date 02-MAR-2012) subcutaneously in the left arm on 26-SEP-2012. The pharmacist reported that a patient developed swelling at the injection site during vaccination with ZOSTAVAX and stated that she did not feel well. The pharmacist had only delivered a small amount of the ZOSTAVAX (about 0.1 ml) when the patients arm started to swell and the patient stated that she did not feel well. The pharmacist did not complete the ZOSTAVAX vaccination (stopped after only 0.1 ml of the ZOSTAVAX was administered). The patient rested for about 15 minutes (in the pharmacy) and said that she felt better and left the store. The pharmacist stated that the present status of the patient was unspecified since she had not been able to contact the patient since the patient was vaccinated with ZOSTAVAX on 26-SEP-2012. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling, Malaise, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 years old female patient. The patient was vaccinated with ZOSTAVAX (lot # 0171AE, exp date 02-MAR-2012) subcutaneously in the left arm on 26-SEP-2012. The pharmacist reported that a patient developed swelling at the injection site during vaccination with ZOSTAVAX and stated that she did not feel well. The pharmacist had only delivered a small amount of the ZOSTAVAX (about 0.1 ml) when the patients arm started to swell and the patient stated that she did not feel well. The pharmacist did not complete the ZOSTAVAX vaccination (stopped after only 0.1 ml of the ZOSTAVAX was administered). The patient rested for about 15 minutes (in the pharmacy) and said that she felt better and left the store. The pharmacist stated that the present status of the patient was unspecified since she had not been able to contact the patient since the patient was vaccinated with ZOSTAVAX on 26-SEP-2012. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia oral, Musculoskeletal stiffness
Clinical narrative: Felt dizzy, light headed whn walking, tingling in jaw line and mubness in tongue, felt faint.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Felt dizzy, light headed whn walking, tingling in jaw line and mubness in tongue, felt faint.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Headache, Nausea
Clinical narrative: Severe headache for three consecutive days, accompanied by nausea.  Presented to emergency deparment on 10/6 as symptoms were worsening and became unbearable.
Age: 41.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Rash
Clinical narrative: Rash on face, chest, arms and back.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soreness, dull ache in arm of vaccination, eventual decreasing lack of motion. Symptoms have lasted 1 year.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner via a field representative refers to a 24 years old female patient who on 29-MAR-2012 was vaccinated with a first dose of GARDASIL (lot #, route and dose not reported). On 21-MAY-2012 she was vaccinated with a second dose of GARDASIL (lot #, route and dose not reported). The patient had come to get her third dose of vaccine on 27-SEP-2012 but the nurse was hesitant to give her the third dose of vaccine due to what happened to the patient after the second dose of 1 GARDASIL on 21-MAY-2012 after which the patient who was sitting down fainted and also hit her head on the garbage can. The patient told the nurse practitioner that she also convulsed (medically significant), upon getting the second dose. The patient sought medical attention since she saw the doctor on call. The outcome of the events was unknown. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dialysis, Fatigue, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Began having fatigue in legs on Nov. 18, 2011. On Nov. 19 could only walk from bed to bathroom and other short distances before having to sit. On Nov. 20 could stand but not walk and weakness in hands. Admitted to hospital. Diagnosed 11/21 GBS - treated with IVIG. After 3 3/4 doses of IVIG went into kidney failure. Had to have 2 kidney dialysis treatments. Was released to rehabilitation hospital on Dec. 2, 2011. Received inpatient physical therapy until Dec 7, 2011. Was released on Dec 7, 2011. Continued outpatient physical therapy 2 days a week for 6 weeks.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Muscular weakness, Nerve conduction studies, Renal failure
Clinical narrative: Began having fatigue in legs on Nov. 18, 2011. On Nov. 19 could only walk from bed to bathroom and other short distances before having to sit. On Nov. 20 could stand but not walk and weakness in hands. Admitted to hospital. Diagnosed 11/21 GBS - treated with IVIG. After 3 3/4 doses of IVIG went into kidney failure. Had to have 2 kidney dialysis treatments. Was released to rehabilitation hospital on Dec. 2, 2011. Received inpatient physical therapy until Dec 7, 2011. Was released on Dec 7, 2011. Continued outpatient physical therapy 2 days a week for 6 weeks.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood lactic acid increased, Chills, Injection site pain, Laboratory test normal, Muscle spasms
Clinical narrative: Sore arm at site of injection, fever 104 degrees F, cold shaking chills, nausea, vomiting, muscle cramps, tingling and paresthesia in bilateral heels and fingers.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Sore arm at site of injection, fever 104 degrees F, cold shaking chills, nausea, vomiting, muscle cramps, tingling and paresthesia in bilateral heels and fingers.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever and pain to arm where shot administered and sore throat.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Confusional state, Electrocardiogram, Eye disorder, Head injury, Syncope
Clinical narrative: Mom reports he did fine the rest of the day after vaccine, no fever or syncope. He got up the next day, ate breakfast and went outdoors to ride his bike. He rode his bike around the neighborhood for awhile and then "felt like my eyes needed to close" and the next thing he knew a neighbor was shaking him awake. He had apparently fainted, unable to describe much of a prodrome. Unknown how long he was "out" but likely seconds to a minute. Hit his head (not wearing a helmet)and scraped up his left side. Some residual confusion after (rang doorbell at his own home) but was fine in the days after. Mom did not report event to our office until several weeks later.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, erythematous rash and slight swelling from inj site extending down to elbow. pt reported that it was getting progressively worse from Sun to Mon. Pt advised by RPh on duty to seek medical intervention if needed but he was not too concerned at the time. Follow up call to pt by RPh on 10/9 revealed that rash and redness appeared slightly better.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, Nausea, body ache, fever to 103F, chills.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, body aches, low grade fever, cills, nausea.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Low grade fever, body aches, chills, nausea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: 14th day post immunizations developed red raised rash over entire body except palsm/soles. No vesivles/pustules present. Fever of 103 F. Approximately 100 spots/mother. Took child to EMR, physician attributed rash/fever to immu perscribed steroid cream and NASAIDS's. Day 3-4 resolved all symptoms.
Age: 0.44
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Rash macular, Urticaria
Clinical narrative: 11:55 AM - PEDIARIX, Hib and PREVNAR vaccines given. Almost immediate localized red reaction around every injection site. Hives noted above diaper line on lower back, red blotchy area noted (R) lower leg. No treatment given resolved on its own. Evaluated by MD (L) thigh erythematous areas. 1 inj. site about 6cm 1 inj site about 4cm (R) thigh injection site abt 4cm.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Ear discomfort, Feeling abnormal, Oropharyngeal pain
Clinical narrative: Woke up at 2am with sore throat and difficulty breathing. Took TYLENOL on Sunday and gargled with salt water and took lozenges. Monday felt horrible. Ears are plugged, felt chills. Body aches/soreness.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Woke up at 2am with sore throat and difficulty breathing. Took TYLENOL on Sunday and gargled with salt water and took lozenges. Monday felt horrible. Ears are plugged, felt chills. Body aches/soreness.
Age: 15.0
Sex: M
Vaccine: HEP, HPV4, IPV, MNQ, TDAP, VARCEL
Symptoms: Depressed level of consciousness, Hypoaesthesia, Posture abnormal
Clinical narrative: Client began to lean forward in the chair after receiving the HPV Vaccine. He had previously had 5 other injection and a TB test. Serial vitals taken, Oxygen applied per mask, ammonia per nares when no immediate response to O2. Given crackers & water. Had not eaten any breakfast. After return to conscious state assisted to lie down & rest in exam room. Nurse & family remained at his side. He reported he was feeling better. Some numbness in fingers remained. Assisted to a chair as he progressively aroused. MMR Vaccine held. Info sent to school nurse to expalin why it was not given as requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Viral test
Clinical narrative: Pt developed shingles in Dermatone where vaccine administered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling jittery, Pruritus, Rash macular
Clinical narrative: Red blotches on arms,back, chest, feeling itchy. Administered 0.5mg epinephrine subcutaniously at 11:09 AM. Pt began to feel jittery after Epi. Itchiness subsided. participant called PCP. PCP advised as long as participant was feeling ok to schedule an appointment at a later date. At 13:40hrs puls 84 and resp regular participant went back to work.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site red, warm to the touch, slight pain.
Age: 5.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, X-ray limb normal
Clinical narrative: Left thigh redness, swelling and pain increasing over 2 days, fever, treated with antibiotics for possible cellulitis.
Age: 1.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, warm bumpy rash on her thigh.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: No symptoms, signs or treatment provided.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 01-Oct-2012) concerns a 23-year-old female patient, who had a pertinent medical history of Behcet's Syndrome and asthma. She was allergic to DAPSONE. Concomitant medications included prednisolone, cyclosporine, paracetamol/codeine combination, procaterol hydrochloride, celecoxib, tramadol, beclomethasone diproprionate and omeprazole. On 26-Sep-2012 the patient received AFLURIA (batch number: P58507) in the left arm. On the same date the patient also received PNEUMOVAX 23 (batch number: 0709AE) injection in right deltoid intramuscularly for vaccination. She received AFLURIA in the opposite arm from PNEUMOVAX 23 vaccination. She also had a previous vaccination with PNEUMOVAX 23 (date unspecified). On 27-Sep-2012 the patient had onset of high fever, pain in the joints and vomiting. On 28-Sep-2012 she went to the Emergency Room and was hospitalised on the same day for treatment. The event outcome was not recovered. On 01-Oct-2012 the nurse considered event as serious (due to hospitalisation).
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 years old female patient with Behcet's syndrome, asthma and allergy to dapsone. On an unspecified date the patient had the first dose of PNEUMOVAX23. On 26-SEP-2012 the patient was vaccinated IM in the right deltoid with the second dose of PNEUMOVAX23 (lot# reported as 0709AE, exp. date: 04-JAN-2014). Other suspect therapies included AFLURIA (lot # P58507, exp. date: 30-JUN-2013) on 26-SEP-2012 in the opposite arm at the same visit, separate site as the PNEUMOVAX23 vaccination. Concomitant medications included prednisone, cyclosporine, PROAIR, TYLENOL WITH CODEINE, CELEBREX, tramadol hydrochloride, QVAR and PRILOSEC. On 27-SEP-2012 the patient experienced high fever, pain in the joints and vomiting. The patient had called the physician's office on 28-SEP-2012 and reported that she was going to the emergency room for treatment of high fever, pain in her joints and vomiting. The nurse reported that the patient went to the emergency room on 28-SEP-2012 and was hospitalized on 28-SEP-2012, for treatment of high fever, pain in the joints and vomiting. The patient at the time of the report (01-OCT-2012) was hospitalized where she was admitted on 28-SEP-2012. The nurse requested a lot check for the PNEUMOVAX 23. The outcome of the adverse event was reported as not recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Diarrhoea, Dyspnoea
Clinical narrative: Difficulty breathing. Coughing. Diarrhea. Symptoms started about 2-3 hrs after injections lasting next 24 hr. No treatment.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Diarrhoea, Dyspnoea
Clinical narrative: (1) Difficulty breathing. (2) Coughing. (3) Diarrhea. Symptoms started 2-3 hrs after injection lasting next 24 hrs - no treatment.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Eye pain, Eye pruritus, Eye swelling
Clinical narrative: Itchy, swelling throat started first accompanied by coughing and clearing of throat with lots of phlegm. This lasted until close to 9:00pm.  Next symptom began around 8:30 with itchy, painful swollen eyes. They were red and sore and eye drops did not help at all. This symptom began to ease around 9:15 and then I got very very cold and my teeth began to chatter violently. I got in bed with all my clothes on and tried to warm up. I also began getting very achy. I went to sleep and throughout the night my fever broke and my body aches abated.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Increased upper airway secretion, Ocular hyperaemia, Pain, Pharyngeal oedema
Clinical narrative: Itchy, swelling throat started first accompanied by coughing and clearing of throat with lots of phlegm. This lasted until close to 9:00pm.  Next symptom began around 8:30 with itchy, painful swollen eyes. They were red and sore and eye drops did not help at all. This symptom began to ease around 9:15 and then I got very very cold and my teeth began to chatter violently. I got in bed with all my clothes on and tried to warm up. I also began getting very achy. I went to sleep and throughout the night my fever broke and my body aches abated.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Itchy, swelling throat started first accompanied by coughing and clearing of throat with lots of phlegm. This lasted until close to 9:00pm.  Next symptom began around 8:30 with itchy, painful swollen eyes. They were red and sore and eye drops did not help at all. This symptom began to ease around 9:15 and then I got very very cold and my teeth began to chatter violently. I got in bed with all my clothes on and tried to warm up. I also began getting very achy. I went to sleep and throughout the night my fever broke and my body aches abated.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, pain in entire arm where shot was administered, and swelling and hardening of injection location. Antibiotic and warm compresses was given.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Received flu shot Friday mid-afternoon. By late Friday afternoon had strong headache and took 2 Tylenol, then another 2 Tylenol before bed. Sat/sun took 2 Aleve which only took the edge off.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chills, Injection site erythema, Pain, Pyrexia
Clinical narrative: Chills, fever, severe body aches, 3mm erythema at injection site (left deltoid).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Hepatitis, Hepatitis viral test negative
Clinical narrative: This spontaneous report was received from a physician concerning a 12 months old male baby with CHARGE syndrome who on 26-JAN-2012 was vaccinated with a dose of MMR II (dose and route not provided) (lot # 662352/1249X, expiration date on 05-SEP-2010) and a dose of VARIVAX (Merck) (dose and route not provided) (lot # 0509X, expiration date in March 2010). Concomitant therapy included erythromycin. On 31-JAN-2009, the patient developed vomiting following administration of MMR II and VARIVAX (Merck). On an unknown date, the patient was hospitalized for dehydration related to vomiting and was diagnosed with "significant" hepatitis. On 04-FEB-2009, the patient's aspartate aminotransferase (AST) was 629 and alanine aminotransferase (ALT) 1078, that normalized over next two or three weeks. On an unknown date, the patient's liver function tests and hepatitis viral panel were normal. The physician reported that the patient was "ultimately" fine. The relatedness for significant hepatitis was unknown for MMR II and VARIVAX (Merck). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Liver function test normal, Vomiting
Clinical narrative: This spontaneous report was received from a physician concerning a 12 months old male baby with CHARGE syndrome who on 26-JAN-2012 was vaccinated with a dose of MMR II (dose and route not provided) (lot # 662352/1249X, expiration date on 05-SEP-2010) and a dose of VARIVAX (Merck) (dose and route not provided) (lot # 0509X, expiration date in March 2010). Concomitant therapy included erythromycin. On 31-JAN-2009, the patient developed vomiting following administration of MMR II and VARIVAX (Merck). On an unknown date, the patient was hospitalized for dehydration related to vomiting and was diagnosed with "significant" hepatitis. On 04-FEB-2009, the patient's aspartate aminotransferase (AST) was 629 and alanine aminotransferase (ALT) 1078, that normalized over next two or three weeks. On an unknown date, the patient's liver function tests and hepatitis viral panel were normal. The physician reported that the patient was "ultimately" fine. The relatedness for significant hepatitis was unknown for MMR II and VARIVAX (Merck). Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Erythema, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: 28 y/o M presents to VHC (walk-in) at 10 AM on 28JUN12. States he went to Clinic and they told him to come to VHC for eval of primary SPV site LUE. Patient receive primary SPV on 18JUN12, in addition to AVA#1 and Typhoid Vi. He also received Hep A #2 or # 3- documentation in record not clear on 23APR12. Denies viral or GI illness in weeks prior to receipt of above vaccines. Today is day # 10 s/p primary SPV, so he is typically in window for maximum cytokine activity of SPV (live virus). He reports that last evening he began to feel "flu-like" symptoms and took some Equate generic Flu Relief medication and an ALEVE this morning. He denies any CP, deep pressure in center of chest, but does endorse slight SOB (non-positional) last night. Actually felt better when he was in supine position. He endorses redness, warmth and a red streak going from deltoid toward left axilla (lymphangitis). He has also felt some tenderness in his left axilla. "Robust take" day #10 s/p SPV normal variant.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Lymphangitis, Skin warm, Tenderness
Clinical narrative: 28 y/o M presents to VHC (walk-in) at 10 AM on 28JUN12. States he went to Clinic and they told him to come to VHC for eval of primary SPV site LUE. Patient receive primary SPV on 18JUN12, in addition to AVA#1 and Typhoid Vi. He also received Hep A #2 or # 3- documentation in record not clear on 23APR12. Denies viral or GI illness in weeks prior to receipt of above vaccines. Today is day # 10 s/p primary SPV, so he is typically in window for maximum cytokine activity of SPV (live virus). He reports that last evening he began to feel "flu-like" symptoms and took some Equate generic Flu Relief medication and an ALEVE this morning. He denies any CP, deep pressure in center of chest, but does endorse slight SOB (non-positional) last night. Actually felt better when he was in supine position. He endorses redness, warmth and a red streak going from deltoid toward left axilla (lymphangitis). He has also felt some tenderness in his left axilla. "Robust take" day #10 s/p SPV normal variant.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Fall, Gaze palsy, Head injury, Seizure like phenomena
Clinical narrative: Approx 1 min after vaccination, pt standing, fell to ground and hit head on floor. Pt began seizure like activity including convulsing and eyes rolling back. Ammonia inhalant administered with no response. Episode lasted approx 30-45 seconds. Pt vitals were stable following event and pt was alert and oriented. EMS arrived and pt was transported to local hospital for evaluation.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Approx 1 min after vaccination, pt standing, fell to ground and hit head on floor. Pt began seizure like activity including convulsing and eyes rolling back. Ammonia inhalant administered with no response. Episode lasted approx 30-45 seconds. Pt vitals were stable following event and pt was alert and oriented. EMS arrived and pt was transported to local hospital for evaluation.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Electroencephalogram, Fall, Laboratory test, Loss of consciousness
Clinical narrative: Pt received ADACEL on 9/12/12. On 9/22/12 pt had seizure - where he fell to floor & had diffuse body shaking/twitching. Pt "out" x 4 minutes. Transported to ER, labs & EEG done. Pt given IV fluids, placed on Abx & antiseizure med.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching, Tremor
Clinical narrative: Pt received ADACEL on 9/12/12. On 9/22/12 pt had seizure - where he fell to floor & had diffuse body shaking/twitching. Pt "out" x 4 minutes. Transported to ER, labs & EEG done. Pt given IV fluids, placed on Abx & antiseizure med.
Age: 1.88
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash, Thrombocytopenia
Clinical narrative: Fever following vaccines - post 11 days and rash post 5 days vaccine. Dx Mth thrombocytopenia.